The ENclose™ II Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three proximal anastomoses in ascending aortas free of atheromatous disease.

Device Description

The modified ENclose™ II Anastomosis Assist Device is an intraoperative device used to assist in the creation of one to three proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG) procedures. Materials for the new device are identical to the previous device with the exception of the colorant. The proposed changes are limited to manufacturing/processing changes, a change in the colorant used in the existing plastic of the device, a change in the shape of the expandable region of the lower jaw and the addition of a fiber reinforced polymer hex driver to assist with deployment of the device if desired.

AI/ML Overview

This document is a 510(k) Premarket Notification for the ENclose™ II Anastomosis Assist Device, seeking clearance based on substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The document describes a medical device (a vascular clamp) and its physical characteristics, intended use, and comparison to predicate devices, but it does not detail any performance studies in the way one would for an AI/ML device. This submission focuses on demonstrating substantial equivalence to existing devices through feature comparison and material certification, not through clinical performance metrics against specific acceptance criteria.

Specifically, the document does not provide:

A table of acceptance criteria and the reported device performance for an AI/ML model.
Sample size used for the test set or data provenance for an AI/ML model.
Number of experts and their qualifications for establishing ground truth for an AI/ML test set.
Adjudication method for an AI/ML test set.
Multi-reader multi-case (MRMC) comparative effectiveness study information (human readers improving with AI vs. without AI).
Standalone (algorithm-only) performance data for an AI/ML model.
Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
Sample size for the training set for an AI/ML model.
How ground truth for the training set was established for an AI/ML model.

Because the ENclose™ II Anastomosis Assist Device is a physical surgical instrument and not an AI/ML diagnostic or therapeutic device, the information requested is not applicable to this submission. The "substantially equivalent" claims are based on physical design, materials, manufacturing, intended use, and functional testing, not data-driven performance metrics typical for AI/ML products.

Summary

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Summary of Safety InformationPremarket Notification, Section 510(k)		NOVARE SURGICAL SYSTEMS, INC.AUGUST 16, 2003
Regulatory Authority:	Safe Medical Devices Act of 1990, 21 CFR 807.92
Device Name:	ENclose™ II Anastomosis Assist Device
Common Name(s):	Vascular Clamp
Classification Name(s):	Vascular Clamp
Manufacturer:
Name:	Novare Surgical Systems, Inc.
Reg. Number:	2954739
Address:	10231 Bubb RoadCupertino, CA 95014
Classification(s):
		Sec. 870.4450 Vascular clamp. (a) Identification. A vascular clamp is a surgical instrument used to occlude a blood

Class II for the requested indications Device Class: Cardiovascular Devices Panel Classification Panel: Product Code(s): DXC

vessel temporarily. (b) Classification. Class II (performance standards).

Equivalent Predicate Device:

The ENclose™ Anastomosis Assist Device is substantially equivalent to the following legally marketed vascular clamp(s):

Includer™ Vascular Clamp - Novare Surgical Systems, Inc., K010694 Includer™ (ENclose™) Vascular Clamp - Novare Surgical Systems, Inc., K023682

Sec. 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).

Device Class: Class II Product Code(s): DXC

The new anastomosis device is essentially identical to the previous device. Equivalency can be seen with respect to place of manufacture, physical appearance, functional testification, surgical technique and indications for use. A feature comparison chart follows this section.

FEATURE	ENclose™ II Anastomosis Assist Device	Includer™ / ENclose™	SE?
Indications forUse:	The ENclose™ II Anastomosis Assist Device is intendedfor use by cardiac surgeons in place of partial occludingclamps during coronary artery bypass grafting (CABG)procedures requiring one to three proximal anastomosesin ascending aortas free of atheromatous disease.	Identical	YES
Materials:	Medical grade plastic, stainless steel and silicone	Identical	YES
Design:	Clamp	Identical	YES
Sterilization:	Radiation (e-beam)	Identical	YES
Manufacturer:	Novare Surgical Systems, Inc.	Identical	YES
Product Code:	DXC	Identical	YES
K - Number:	Pending	K010694, K023682	YES

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The proposed changes do not represent a significant or deleterious change to the device. Substantial equivalence is based on all physical and clinical attributes of the device being indistinguishable from the cleared device, including, place of manufacture, physical appearance, though slightly different in color and size, has not affected the performance requirements, functional elements, material certification, surgical technique nor indications for use.

Device Description:

General description of the change(s). The proposed changes are limited to manufacturing/processing changes, a change in the colorant used in the existing plastic of the device, a change in the shape of the expandable region of the lower jaw and the addition of a fiber reinforced polymer hex driver to assist with deployment of the device if desired. The current FDA cleared indications granted for single and up to three anastomosis procedures remains unchanged.

Company Contact:

Mr. Kerry Pope Novare Surgical Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 408.873.3161

Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

Special Controls:

FDA published special controls. The following special controls are believed to apply to the marketing of class II devices:

Compliance with material standards, (i)
Compliance with biocompatability standard, and (ii)
(iii) Compliance with specified labeling requirements.

Novare Surgical Systems, Inc. also meets appropriate general controls authorized under Sections 501, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

Sterility Processing:

The ENclose™ II Anastomosis Assist Device is provided sterile and is designed strictly for single patient use. The device may not be cleaned, reprocessed or reused under any circumstances. The product must be handled, stored and placed into use in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following accepted surgical sterile technique.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2003

Novare Surgical Systems, Inc. c/o David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Suite C-100 Pleasant Hill, CA 94523

Re: K032589

Enclose II Anastomosis Assist Device Regulation Number: 21 CFR 870.4450 Regulation Name: Regulatory Class: Class II Product Code: DXC Dated: August 16, 2003 Received: August 22, 2003

Dear Mr. Schlerf:

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. Iisting 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 (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.

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Page 2 - Mr. David Schlerf

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 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 Section 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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address

http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Odel Tule

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K032589

ENclose™ II Anastomosis Assist Device Device Name(s):

Indications for Use Statement(s):

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

V. Deaton

sion of Cardiovascular Devices

510(k) Number K032589

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional format 1-2-96)

ENCLOSESPECIAL2.DOC

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).