The ENclose™ 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 anastomoses in ascending aortas free of atheromatous disease.

Device Description

The modified ENclose™ Anastomosis Assist Device is a intraoperative device used to assist in the creation of one or more proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ENclose™ Anastomosis Assist Device, seeking to expand its indications for use from single-vessel to one-to-three proximal anastomoses during coronary artery bypass grafting (CABG) procedures. The submission claims substantial equivalence to its previously cleared version (InCluder™ Vascular Clamp - K010694).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating "functional equivalence" and "substantial equivalence" to the predicate device for the expanded use. The performance is reported in a summary statement rather than specific quantitative metrics.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device for single anastomosis	"The new anastomosis device is identical to the previous device. Equivalency can be seen with respect to place of manufacture, physical appearance, functional testing, material certification, surgical technique and indications for use." (Initial claim for the single anastomosis device in comparison to K010694)
Functional equivalence for 1-3 proximal anastomoses	"Clinical testing conducted in Canada and Europe demonstrate the functional equivalence of the added ENclose™ Anastomosis Assist Device."
Safety for 1-3 proximal anastomoses	"The collected clinical data demonstrate that one to three proximal anastomoses are no more difficult and are just as safe as the existing single anastomosis procedure performed using the previously cleared ENCLOSE™ Anastomosis Assist Device."
No increase in difficulty for 1-3 proximal anastomoses	"The collected clinical data demonstrate that one to three proximal anastomoses are no more difficult..."

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

Sample Size: The text does not provide a specific sample size for the clinical testing. It only states "Clinical testing conducted in Canada and Europe."
Data Provenance: The data was collected from "Canada and Europe." It explicitly states "Clinical testing," implying prospective collection, though the precise study design (e.g., randomized controlled trial, observational) is not detailed.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth within the clinical testing. It refers to "cardiac surgeons" as the intended users, but doesn't detail their role in defining study outcomes or ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a surgical clamp, not an imaging interpretation device where MRMC studies are typically performed. The comparison is between the new device's performance for 1-3 anastomoses and the predicate device's performance for single anastomosis, based on overall reported safety and difficulty.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The ENclose™ Anastomosis Assist Device is a surgical instrument, not an algorithm or AI system. Its performance is directly tied to its use by a human surgeon.

7. The Type of Ground Truth Used

The "ground truth" for the clinical testing appears to be based on observed clinical outcomes (safety, difficulty) during coronary artery bypass grafting procedures performed using the device for 1-3 anastomoses, compared to the previously established performance of the predicate device for single anastomosis. There is no mention of "expert consensus," "pathology," or other specific types of ground truth often seen in diagnostic device studies.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical surgical instrument, not a machine learning model that requires a training set. The development of the device would involve engineering and material testing, not data training.

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

This question is not applicable as there is no training set for a device of this nature.

Summary

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JAN 1 6 2003

Summary of Safety Information	NOVARE SURGICAL SYSTEMS, INC.	K023682JANUARY 15, 2003
Premarket Notification, Section 510(k)
Regulatory Authority:	Safe Medical Devices Act of 1990, 21 CFR 807.92
Device Name:	ENclose™ Anastomosis Assist Device
Common Name(s):	Vascular Clamp
Classification Name(s):	Vascular Clamp
Manufacturer:
Name:	Novare Surgical Systems, Inc.
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 vessel temporarily. (b) Classification. Class II (performance standards).

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

Equivalent Predicate Device:

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

1. InCluder™ Vascular Clamp - Novare Surgical Systems, Inc., K010694

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 identical to the previous device. Equivalency can be seen with respect to place of manufacture, physical appearance, functional testing, material certification, surgical technique and indications for use. A feature comparison chart follows this section.

FEATURE	ENclose™ Anastomosis Assist Device	Includer™ Vascular Clamp -K010694	SE?
Indications for Use:	The ENclose™ 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, except single anastomosis	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:	K023682	K010694	YES

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Device Description:

The change is limited to a request for multiple use. The modified ENclose™ Anastomosis Assist Device is a intraoperative device used to assist in the creation of one or more proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG).

Clinical Testing Summary. Clinical testing conducted in Canada and Europe demonstrate the functional equivalence of the added ENclose™ Anastomosis Assist Device. The one to three vessel use ENCLOSE™ Anastomosis Assist Devices' level of performance is substantially equivalent to the existing legally marketed ENCLOSE™ Anastomosis Assist Device (InCluder™, K010694) cleared for single vessel use. The collected clinical data demonstrate that one to three proximal anastomoses are no more difficult and are just as safe as the existing single anastomosis procedure performed using the previously cleared ENCLOSE™ Anastomosis Assist Device.

Please refer to the product instructions for use for a more complete listing of indications, warnings, cautions and precautions.

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

Snecial Controls:

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

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

Novare Surgical Systems, Inc. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

Sterility Processing:

The ENclose™ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2003

Novare Surgical Systems, Inc. c/o Mr. David Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389

Re: K023682

Enclose™ Anastomosis Assist Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: October 31, 2002 Received: November 1, 2002

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, listing 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) 594-4646. 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 Part 807.97) you may obtain. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nalgtleh
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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K023682 510(k) Number:

ENclose™ Anastomosis Assist Device Device Name(s):

Indication(s) for Use:

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

Nolen Tull

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K023682

Prescription Use
(Per 21 CFR 801.109)

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

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).