The Proximal Seal System is intended for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.

Device Description

The Proximal Seal System is designed to create a hemostatic environment at the site of a proximal anastomosis during coronary artery bypass graft surgery, eliminating the need for a side-biter or cross clamp of the aorta and minimizing aortic manipulation. When used in conjunction with off-pump cardiac surgery the Proximal Seal System alleviates the need for any form of clamping. Additionally, the Proximal Seal System eliminates the need for clamping with the side-biter clamp during on-pump cardiac surgery.

AI/ML Overview

This device, the Guidant Proximal Seal System, is a Class II medical device intended for use in Coronary Artery Bypass Graft (CABG) procedures. It is a vascular clamp designed to maintain hemostasis and facilitate proximal anastomosis without the need for an aortic clamp.

The provided information does not contain acceptance criteria in a quantitative or formal sense, typical of studies for AI/software devices. This is a traditional medical device (hardware) submission from 2002.

Instead, the submission states that the device was evaluated through bench testing and animal testing to demonstrate performance and substantial equivalence to predicate devices.

Here's an analysis of the provided text, outlining the available information and highlighting what is not applicable or not provided for this type of device submission based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Not explicitly stated in the provided text in a quantitative manner (e.g., specific thresholds for success, pressure limits, or a specific range of values).	"All bench testing results met specified requirements." (without detailing what those requirements were).
	Functionality confirmed.
	Biocompatibility confirmed.
	Sterilization confirmed.
	Packaging confirmed.

Note: For a traditional hardware medical device like this in 2002, "acceptance criteria" were often implicit in design specifications and testing protocols (e.g., "device must not leak under X pressure," "material must be biocompatible per ISO XYZ"). The summary provided does not break down these specific pass/fail metrics.

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

Sample Size for Test Set: Not specified in the provided summary. The summary mentions "bench testing" and "animal testing," but no specific number of units tested or animals used is given.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given it's animal testing, it would be prospective within a controlled laboratory environment.

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

Not Applicable / Not Provided: This device submission does not involve human expert interpretation for "ground truth" in the way an AI/software device submission would. The performance was likely assessed by engineers, lab technicians, and possibly veterinary professionals during animal studies.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided: Adjudication methods (like 2+1, 3+1) are typically used when subjective human interpretation is involved in establishing ground truth for performance evaluation (e.g., in diagnostic imaging studies). This traditional device's performance relies on objective measurements and observations in bench and animal testing.

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

No: An MRMC comparative effectiveness study is not mentioned and would not be applicable for this type of hardware device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, especially in medical imaging.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No: This is a hardware medical device, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.

7. The Type of Ground Truth Used

Not Directly Applicable in the AI Sense: For this hardware device, "ground truth" would be established through:
- Objective Measurements: Bench testing would have involved quantifiable metrics like burst pressure, flow rates, material strength, leakage rates, etc., compared against predefined specifications.
- Biological Observation: Animal testing would have involved surgical observation of successful hemostasis, patency, tissue response, and lack of adverse events.
- Biocompatibility Testing: Compliance with established biocompatibility standards.

8. The Sample Size for the Training Set

Not Applicable: This is not an AI/machine learning device; therefore, there is no "training set."

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

Not Applicable: As there is no training set, this question is not relevant.

Summary of Device Features and Evaluation:

Intended Use: To create a hemostatic environment at the site of a proximal anastomosis during CABG, eliminating the need for an aortic clamp.
Predicate Devices: Baladi Inverter (K980128) and Novare Enclose anastomotic assist devices.
Evaluation Approach: Bench testing (functionality, biocompatibility, sterilization, packaging) and animal testing.
Conclusion: "All bench testing results met specified requirements." and the device was found to be "substantially equivalent to the predicate devices with regard to intended use, indications, device characteristics, method of use, labeling, and safety features."

Summary

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K022880

APPENDIX A. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Name, Address, Phone and Fax number of the Applicant A.
Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054

Telephone: (408) 845-1910 Fax: (408) 845-1855

B. Contact Person Debbie Cogan Regulatory Affairs Associate
C. Date Prepared August 13, 2002

D. Device Name

Trade Name: Guidant Proximal Seal System Classification Name: Vascular Clamp Product Classification Code: DXC Device Classification: Class II Establishment Registration #: 2953359

E. Device Description

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F. Intended Use

Substantial Equivalence G.

Guidant proposes that the Proximal Seal is similar to and substantially equivalent to the Baladi Inverter (K980128) and the Novare Enclose anastomotic assist devices. The subject device is substantially equivalent to the predicate devices with regard to intended use, indications, device characteristics, method of use, labeling, materials, and safety features.

H. Device Testing Results and Conclusion

Guidant Cardiac Surgery performed bench testing and animal testing which included biocompatibility, sterilization, packaging, and functionality to confirm that the proximal Seal device is equivalent to the predicate devices. All bench testing results met specified requirements.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2002

Guidant Corporation C/O Mr. P.N. Ruys KEMA Medical N.V. Kema Utrechtseweg 310 NL-6812 AR Amhem, The Netherlands

Re: K022880

Trade Name: Proximal Seal System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (two) Product Code: DXC Dated: August 13, 2002 Received: August 30, 2002

Dear Mr. Ruys:

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.

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

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Page 2 - Mr. P.N. Ruys

forth in the quality systems (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.

R. Tucker, M.P.

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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APPENDIX E: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_O2280

Device Name:

Proximal Seal System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022880

Labels	Values
Prescription Use	☑
OR
(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).