The COOK- Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers. The COOK-Swartz Doppler Flow Probe is supplied sterile and intended for one time use

Device Description

The Modified COOK-Swartz Doppler Flow Probe is intended for monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures. The COOK-Swartz Doppler Flow Probe is supplied sterile, and nonpyroqenic and is intended for one-time use. Reasonable assurance of biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing.

AI/ML Overview

The provided document is a 510(k) summary for a Special 510(k) Device Modification for the COOK-Swartz Doppler Flow Probe. This type of submission is for modifications to a legally marketed device and primarily focuses on demonstrating substantial equivalence to the predicate device, rather than providing extensive de novo clinical study data to demonstrate novel performance against acceptance criteria.

Therefore, the document does not contain the detailed information typically found in a clinical study report that establishes acceptance criteria and then proves the device meets those criteria.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (COOK-Swartz Doppler Flow Probe D.C. #K964001) based on intended use, material composition, and method of operation. It does not provide specific performance metrics or acceptance criteria for the modified device.

2. Sample Size Used for the Test Set and Data Provenance

This information is not present in the document. Since it's a 510(k) for a device modification showing substantial equivalence, a formal "test set" with a specified sample size for performance evaluation in the way a de novo clinical study would isn't typically included in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not present. The document doesn't describe a study involving expert panels for ground truth establishment.

4. Adjudication Method

This information is not present. No adjudication method is mentioned as there is no description of a study involving multiple readers or complex diagnostic interpretations requiring consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not present. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device in question is a Doppler flow probe, which is a diagnostic tool, not an AI-assisted diagnostic software.

6. Standalone (Algorithm Only) Performance Study

This information is not present. The device is hardware (a probe), not a standalone algorithm. Therefore, "algorithm-only" performance is not applicable.

7. Type of Ground Truth Used

This information is not present. Given that the submission is for a device modification demonstrating substantial equivalence to a predicate, a new "ground truth" establishment for performance validation is not usually required or detailed in this type of submission summary.

8. Sample Size for the Training Set

This information is not present. The document does not describe the development of an algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not present, as no training set or ground truth for an algorithm is mentioned.

Summary of the Document's Approach:

The provided document (K022649) is a Special 510(k) Device Modification for the COOK-Swartz Doppler Flow Probe. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (COOK-Swartz Doppler Flow Probe D.C. #K964001).

The argument for equivalence is based on:

Intended Use: "monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures." (The modified device also adds "and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers" which is also aligned with the predicate's expanded indications as K964001's indications include "monitor blood flow intraoperatively, during intraoperative neuro-vascular procedures, and following reconstructive micro-vascular procedures, re-implantation and free flap transfer.")
Material Composition: "biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing."
Method of Operation: Implied to be similar as it's a modification to an existing device.
Manufacturing: "manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to the currently marketed and distributed COOK-Swartz Doppler Flow Probe D.C. #K964001."

No new clinical data, performance criteria, or "proof of meeting acceptance criteria" in the sense of a novel functional claim are presented in this summary. The FDA's letter explicitly states: "We have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This confirms that the modification was deemed equivalent without requiring new, extensive performance studies detailed in this summary.

Summary

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KOZ

6 2002

SEP

Special 510 (k) Device Modification COOK-Swartz Doppler Flow Probe and Monitor System

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K. 510 (K) SUMMARY

Submitted By:

Thomas J. Kardos Vice President, Requlatory Affairs Cook Vascular Incorporated P.O. Box 529 Leechburg, PA 15656 (724) 845-8621 August 6, 2002

Device:

Trade Name:

COOK-Swartz Doppler Flow Probe

Common/Usual Name:

Blood Flow Sensor or Probe, Doppler Catheter

Proposed Classification Name:

Diagnostic Ultrasonic Transducer probe, 21 CFR Part 892.1580 (90-ITX)

Predicate Devices:

The Modified COOK-Swartz Doppler Flow Probe is substantially equivalent to the currently marketed COOK-Swartz Doppler Flow Probe D.C. #K964001, 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 the currently marketed and distributed COOK-Swartz Doppler Flow Probe D.C. #K964001 by Cook Vascular Incorporated. 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2002 SEP

Mr. Thomas J. Kardos Vice President. Regulatory Affaris Cook Vascular Incorporated P.O. Box 529, Route 66 River Road LEECHBURG PA 15656-0529

Re: K022649

Trade Name: Cook-Swartz Doppler Flow Probe Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: August 6, 2002 Received: August 9, 2002

Dear Mr. Kardos:

We have reviewed your Section 510(k) premarket 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 legally marketed predicate 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling. and prohibitions against misbranding and adulteration.

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

Transducer Model Number

COOK-Swartz Doppler Flow Probe

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean

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that FQA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your 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, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free 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 regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours.

David A. Seipmann

/rr

Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Cook-Swartz Doppler Flow Probe Device Name:

. _

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)				P
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)				P

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David Chi Atayman

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) A
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022649

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Device Name: Cook Vascular Blood Flow Monitor (D.C.#K964001)

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diag̀nostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)				P
Intraoperative Neurological				P
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)				P

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: The Cook Vascular Blood Flow Monitor is used with the

Cook-Swartz Doppler Flow Probe (D.C. #K964001) and the Cook Vascular

Shapeable Doppler Flow Probe (D.C. #K002958) to monitor blood flow intra-

operatively, during intraoperative neuro-vascular procedures, and following

reconstructive micro-vascular procedures, re-implantation and free flap transfer.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Arvid A. Slayton

and R. 510(k) Nur

Prescription Use (Per 21 CFR 801.109)

、

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Special 510 (k) Device Modification COOK-Swartz Doppler Flow Probe and Monitor System

Page 1 of 1

510(k) Number (if known): K022649

Device Name: COOK- Swartz Doppler Flow Probe

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram

Perscription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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.