Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

Status: Supersedes “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” (September 1997)

Date: September 2008

Target Audience:

Manufacturers of diagnostic ultrasound devices, non-OEM replacement transducers, reprocessors of single-use transducers, and personnel designing cleaning and disinfecting protocols for transducers

Laws and Regulations 

  1. 21 U.S.C 21 360 Registration of Producers of Drugs and Devices
  2. 21 CFR 807.87 Section 402(j)(5)(B) of the Public Health Service Act
  3. 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System
  4. 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System
  5. 21 CFR 892.1570 Diagnostic Ultrasound Transducer
  6. 21 CFR 876.1500 Endoscope and Accessories
  7. 21 CFR 870.1200 Diagnostic Intravascular Catheter
  8. 21 CFR884.2660 Fetal Doppler Ultrasound
  9. 21 CFR 884.2660 Echocardiograph
  10. 21 CFR870.2330 Cardiovascular Blood Flowmeter
  11. 21 CFR870.2100 Intravascular Ultrasound Catheter
  12. 21 CFR 1020.10 Performance Standard for Ionizing Radiation Emitting Products
  13. 21 CFR 1002.20 Reporting of Accidental Radiation Occurrences
  14. 21 CFR Part 1003 Notification of Defects or Failure to Comply
  15. 21 CFR Part 1004 Repurchase, Repairs, or Replacement of Electronic Products

Summary
In September 2008, the FDA updated guidelines for applying for marketing clearance for diagnostic devices using ultrasonic waves. These devices include imaging systems for visualizing fetuses, tissues, nerves, anatomic structures, and bloodflow below the skin surface. Ultrasonic diagnostic devices are commonly used in obstetrics, cardiac care, regional anesthesia, orthopedic surgery, and general surgery.

This guidance is aimed at manufacturers who plan to apply for marketing approval for diagnostic ultrasound devices. When applying for marketing clearance, manufacturers must submit a 510(K) application, as for all medical devices. However, several technical issues apply specifically to ultrasonic diagnostic devices. The updated guidance addresses these issues as they relate to 501(K) submissions.

The most substantial changes in this guidance are included in 3 appendices. First, the manufacturer no longer needs to submit a 510(K) Special Report related to acoustic output measurements and labeling records if this information is included in the Design History File of the 510(K) application.

Secondly, ultrasonic transducers made by companies that are not original equipment manufacturers (OEMs) that are designed to replace those provided with new equipment should be considered new medical devices, and therefore are required to have 510(K) pre-market approval. The 510(K) application should include comparison between the replacement transducer and the non-OEM transducer using the OEM generator. The application should also include acoustic output comparisons of the OEM and replacement transducers in the various modes, including the Doppler setting, which defines the flow direction of fluids. If the outputs between the 2 products do not agree, then the non-OEM transducers should be referred to as “similar to” and not “replacement” transducers.

Finally, transducers that are sold originally as “single-use” devices but have been reprocessed by the OEM, a third party, or a hospital are also considered “new devices” by the FDA. Therefore, the reprocessor must submit a 510(K). The application should include data that shows that the reprocessed device has the same characteristics and output quality as the new devices. The test methodology for gathering this data must be well described. Each reprocessed transducer should be tested at the end of the reprocessing cycle.

Rationale
The rationale behind this stems from 2 developments. First, ultrasound diagnostic devices are becoming smaller, more portable, and have better imaging capabilities. As a result, clinicians are developing more uses for these devices. In return, more products are in development for these new applications. Also, many of these devices have disposable transducers and other parts that can be expensive. As a result, an “aftermarket” of less expensive non-OEM products and reprocessed used products has evolved. The guidance clarifies how manufacturers of new OEM, non-OEM, and reprocessed devices must apply for marketing clearance.

Recommendations

  1. Manufacturers of all new ultrasonic diagnostic devices must submit a 501(K) application.
  2. Non-OEM transducers require the same 501(K) application and must be tested to assure that they are interchangeable with the OEM products.
  3. All reprocessed single-use transducers require the same 501(K) application as new products and must be tested after each reprocessing to assure that they are the same quality as new products.

Impact
As ultrasound diagnostic devices become more common, a market for non-OEM and reprocessed transducers has grown. These guidelines clarify that non-OEM replacement transducers and reprocessed transducers are subject to the same marketing approval standards as new OEM products.

For more information on this issue, contact the Kulkarni Law Firm.