DOPPLER MONITOR by COOK VASCULAR, INC.

The Cook Vascular Blood Flow Monitor - Model DP-M350 is intended for monitoring blood flow in vessels intraoperatively, and following micro-vascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for one-time use.

Device Description

The proposed device is monitor unit that generates a (20 MHz) signal and conducts it to an attached probe that contains a piezo-electric crystal which transmits and then receives Doppler frequency sound waves. The returning signal is amplified and projected via the proposed monitoring unit as an audible output. The monitor unit has two input channels and also provides an adjunct visible (LED) indicator that is used as a complimentary information source to the primary audible indicator. The predicate device was submitted as a system, the proposed device is only the monitoring unit.

AI/ML Overview

The Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350 is a monitoring unit that generates a 20 MHz signal and transmits and receives Doppler frequency sound waves via an attached probe. The returning signal is amplified and projected as an audible output. The monitor unit also features two input channels and a visible LED indicator as a complementary information source.

Here's an analysis of the provided information regarding the device's acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device's acceptance criteria are demonstrated through a series of engineering and performance tests, rather than a clinical performance study with statistical metrics like sensitivity or specificity. The "acceptance criteria" are implied by the successful completion of these tests.

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Electrical Safety	Electrical Safety Testing	Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor.
Power/Battery	Battery Testing	Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor.
Electromagnetic Compatibility	EMC Testing	Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor.
Software Functionality	Software Validation	Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor.
Durability/Reliability	Shock/Vibration Testing	Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor.
Mechanical Integrity	Mechanical Validation	Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor.
Packaging Integrity	Packaging Testing	Provides reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor.

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

The provided text does not specify sample sizes for any of the tests conducted. The studies appear to be engineering and performance verification tests of the device itself, rather than studies involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective nature for a clinical test set is not applicable here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The tests described are engineering validations, not studies requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the tests described (engineering and performance validation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study described focuses on the technical performance and safety of the device itself, not on its impact on human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a blood flow monitor that provides an audible and visual output to a human user; it is not an algorithm that operates standalone without human involvement in the diagnostic or monitoring process. Therefore, the concept of a "standalone" algorithm performance study as typically understood in AI/imaging is not applicable to this device. The tests performed are for the device's technical functionality, which is its standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed would be the engineering specifications, regulatory standards (e.g., electrical safety standards, EMC standards), and design requirements for each test category. For instance, for "Electrical Safety Testing," the ground truth is compliance with relevant electrical safety standards. For "Software Validation," the ground truth is that the software performs according to its design specifications. There is no mention of expert consensus, pathology, or outcomes data as ground truth.

8. The Sample Size for the Training Set

This information is not applicable. The Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350 is a hardware device with associated software, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable as there is no training set for an AI/machine learning algorithm. The "ground truth" for the device's development would be its design specifications and validated engineering principles.

Summary

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K110347 Page 1/2

MAR 1 6 2011

510(k) Summary

Submitted by:

Jim Ferguson Quality Systems Manager Cook Vascular, Incorporated 1186 Montgomery Lane Vandergrift, Pa 15690 724-845-8621, XT 2227 April 10, 2006

Device:

Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350 Trade name: Cardiovascular Blood Flow Meter, 870.2100 Proposed Classification:

Predicate Devices:

The Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350 is the same in terms of intended use, materials of construction and technology characteristics to the predicate devices that have been found substantially equivalent.

Device Description:

Substantial Equivalence:

This device will be manufactured to specified process controls and a Quality Assurance program. This device will undergo validated packaging operations indicative of devices currently manufactured by Cook Vascular. Being the same as the predicate devices in respect to indication for use and no changes in the fundamental scientific technology, this device meets the requirements for section 510(k) substantial equivalence. It is to be noted that this change is the roquitements or evil be used with the currently marketed Cook- Swartz Doppler Flow Probes.

The only changes to the device are an added visual display, software controls for visual indicator, on/off switch, channel selector and volume. Additionally a chargeable battery system has been added.

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K 110347 Page 2/2

Test Data:

The Cook Vascular, Inc. Blood Flow Monitor – Model DP-M350 was subjected to the flowing tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Electrical Safety Testing 1.
1. Battery Testing
EMC Testing ന്
Software Validation 4.
1. Shock/Vibration Testing
1. Mechanical Validation
1. Packaging Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Monitor.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Cook Vascular, Inc. % Mr. Jim Ferguson, Jr. Quality Systems Manager 1187 Montgomery Lane Vandergrift, Pennsylvania 15690

MAR 1 6 20:1

Re: K110347

Trade/Device Name: Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350 Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: II Product Code: DPW, ITX, JOP Dated: February 3, 2011 Received: February 16, 2011

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 that FDA 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

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Page 2 - Mr. Jim Ferguson, Jr.

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html far the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regultive (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Aty B. Rh
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K110347

510(k) Number:

Device Name:

Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

· I

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Knape for WKM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110347

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Regulation Number and Section

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).