FLEXIBLE VASCULAR CLAMP, VERSION 2 by ALLEGIANCE HEALTHCARE CORP.

Used to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.

Device Description

The Allegiance Flexible Vascular Clamp, Version 2 is a reusable device which features a stainless steel handle, flexible shaft and jaws. This clamp is designed to be used with a variety of inserts which gently surround blood vessels and offer differing degrees of atraumatic occlusion. Following the clamping of the blood vessel, the shaft of the device can be bent out of the way to enhance visualization of and access to the operative field.

AI/ML Overview

The provided text describes a medical device, the "Allegiance Flexible Vascular Clamp, Version 2", and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically associated with AI/algorithm performance.

The document is a 510(k) submission, focused on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission generally relies on comparing the new device's design, materials, and intended use to an existing device, rather than conducting new clinical trials or performance studies against defined acceptance metrics for AI.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies. These elements are not present in the provided text.

Based on the information provided, here's what can be extracted, though it doesn't align with the AI/algorithm-focused questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria are that the new device (Flexible Vascular Clamp, Version 2) is substantially equivalent to the predicate device (Cosgrove™ Clamp) in terms of:
- Intended use
- Performance attributes
- Atraumatic Jaw design characteristic
- Materials
Reported Device Performance: The document states that "All materials used in the composition of the Flexible Vascular Clamp, Version 2 were subjected to performance and physical tests to evaluate the safety, effectiveness". However, no specific performance metrics or results from these tests are reported in the provided text. The document instead emphasizes equivalence to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. The document describes a comparison to a predicate device, not a performance study with a test set composed of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Ground truth establishment for a test set is not relevant to this type of regulatory submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is not an AI device, and no MRMC study is mentioned.

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

Not applicable/Not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not provided. The ground truth concept, as it applies to AI/algorithm validation, is not present here. The basis for approval is "substantial equivalence" to a predicate device, which itself has an established regulatory history.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI device that uses a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided.

Summary

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MAY 1 8 1999

Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a plus sign made up of small circles. The word is in black and the background is white.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085

847.473.1500 FAX: 847.785.2461

SUMMARY OF SAFETY AND EFFECTIVENESS Attachment E

Manufacturer:

Allegiance Healthcare Corporation V. Mueller Business Unit 1430 Waukegan Road McGaw Park, IL 60085

Patricia Sharpe-Gregg Regulatory Affairs Contact 1500 Waukegan Road McGaw Park, Illinois 60085

Telephone:

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification:

Predicate Device: (K974769)

Description:

(847) 578-3636

April 9, 1999

Flexible Vascular Clamp, Version 2

Vascular Clamp

Cosgrove™ Clamp

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Intended Use:	The Allegiance Flexible Vascular Clamp,Version 2 is intended to be used for thetemporary occlusion of blood vessels andother delicate vessels during surgery. Surgicalapplications include pulmonary andgastrointestinal procedures, peripheralclamping, minimally invasive and standardopen cardiovascular and cardio-thoracicprocedures such as occlusion of the aorta andvena cava, cross-clamping of the aorta, etc.
Substantial Equivalence:	The Allegiance Flexible Vascular Clamp,Version 2 is substantially equivalent to theAllegiance Cosgrove™ Clamp in that:
	Intended use is the same Performance attributes are the same Atraumatic Jaw design characteristic is the same Materials are the same
Summary of Testing:	All materials used in the composition of theFlexible Vascular Clamp, Version 2 weresubjected to performance and physical tests toevaluate the safety, effectiveness and
Common Name:	Vascular Clamp
Classification:	Vascular Clamp
Predicate Device:(K974769)	Cosgrove™ Clamp
Description:	The Allegiance Flexible Vascular Clamp,Version 2 is a reusable device which featuresa stainless steel handle, flexible shaft andjaws. This clamp is designed to be used with avariety of inserts which gently surround bloodvessels and offer differing degrees ofatraumatic occlusion. Following the clampingof the blood vessel, the shaft of the device canbe bent out of the way to enhance visualizationof and access to the operative field.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 18 1999

Ms. Patricia Sharpe-Gregg Manager, Requlatory Affairs Allegiance Healthcare Corporation V. Mueller Business Unit 1430 Waukegan Road McGaw Park, IL ୧୦୦୫ ମ

K991589 Re: Flexible Vascular Clamp, Version 2 Trade Name: Requlatory Class: II Product Code: DXC May 6, 1999 Dated: Received: May 7, 1999

Dear Ms. Sharpe-Greqq:

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 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 reqistration, listinq of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Reqister. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices

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Paqe 2 - Ms. Patricia Sharpe-Gregg

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) 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 the 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) 594-4586. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. The word is black and slightly slanted to the right. To the left of the word is a symbol that looks like a plus sign made up of small dots. The dots are arranged in a grid-like pattern, with the center dot being the largest and the surrounding dots decreasing in size as they move away from the center.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA FAX: 847-785-2461 78-3636

Special 510(k) Device Modification: Flexible Vascular Clamp, Version 2 V. Mueller Business Unit Page 1 of 1

510(k) Number (if known):

Unknown

Device Name:

Flexible Vascular Clamp, Version 2

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

tolem. Re-for TJC

vision Sign=Off) Division of Cardiovascular, Respiratory, and Neurological Dev

510(k) Number

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).