The Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels following reconstructive microvascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for onetime use.

Device Description

The Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for one-time use. The device is supplied sterile and is intended for one-Reasonable assurance of biocompatibility of time use. the materials comprising the Swartz Doppler Flow Probe is provided by their established history of use in medical product manufacturing.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for the Swartz Doppler Flow Probe and Monitor System (K964001).

The 510(k) summary outlines the device description, its intended use, and claims substantial equivalence to predicate devices based on indications for use, materials, and physical construction. The FDA letter confirms the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.

However, neither document includes the specific details requested in your prompt regarding:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
Method for establishing ground truth for the training set.

The FDA clearance for this device, which was approved in 1998, relies on substantial equivalence to predicate devices rather than requiring extensive clinical performance studies as might be seen for novel or high-risk devices today. The closest information related to performance assessment is the requirement for a "postclearance special report" with "acoustic output measurements based on production line devices," but this is an engineering requirement, not a clinical performance study against acceptance criteria.

Summary

{0}------------------------------------------------

K964001

Swartz Doppler Flow Probe and Monitor System (D.C. # K964001/S002) Response to Questions

APR 17 1998

510 (k) Premarket Notification Swartz Doppler Flow Probe and Monitor System

510 (K) SUMMARY I.

Submitted By:

Neal E. Fearnot President MED Institute, Incorporated P.O. Box 2402 West Lafayette, IN 47906 (317) 463-7537 October 3, 1996

Device: I

Trade Name:	Swartz Doppler FlowProbe and Monitor System
Common/Usual Name:	Blood Flow Sensor, FlowProbe, Flow Monitor
Proposed Classification Name:	Extravascular blood flow3probe, 21 CFR Part870.2120 (74DPT)

Predicate Devices:

The Swartz Doppler Flow Probe is similar to predicate extravascular blood flow probes with respect to intended use, material composition, and method of operation.

Device Description:

Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Pacemaker Corporation. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510 k) substantial equivalency.

। ਰੇ

IV.3

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & H. AN SERVICES. USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right.

APR 17 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neal E. Fearnot, Ph.D., E.E. President Med Institute, Inc. P.O. Box 2402 47906 West Layfayette, IN Re: K964001 Swartz Doppler Flow Probe and Monitor System

Dated: February 18, 1998 Received: February 19, 1998 Requlatory class: II 21 CFR 892.1570/Procode: 90 ITX 21 CFR 870.2120/Procode: 74 JOP

Dear Dr. Fearnot:

We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act. You may, therefore, market the device, subject to the general controls The general controls provisions of the Act include provisions Act (Act). requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions aqainst misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Swartz Doppler Flow Probe and Monitor System, as described in your premarket notification:

Transducer Model Number

20.0 MHz Swartz Doppler Flow Probe

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such Existing major regulations affecting your device can be additional controls. found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may : publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any

obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G,
(enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g.,

{2}------------------------------------------------

Page 2 - Neal E. Fearnot, Ph.D., E.E.

acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your The FDA finding of substantial equivalence of your premarket notification. device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions reqarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Thomas J. Colloton

Lillian Yiry, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

510(k) Number (if known): _ K964001

Device Name:_ Swartz Doppler Flow Probe and Monitor System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.