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

Device Description

The HEARTSTRING III Proximal Seal System is a device designed to enable the creation of a proximal anastomosis of a vessel graft to the aorta without the need for an aortic clamp during coronary artery bypass graft (CABG) surgery. The HEARTSTRING III Proximal Seal System is comprised of the Proximal Seal, Delivery Device, Loading device and Aortic Cutter. The HEARTSTRING III Seal is a device that is delivered into the aorta via an aortotomy created by the Aortic Cutter and provides a sealed region to facilitate the proximal anastomosis. The Delivery Device is a syringe-like tube with plunger that is used to deploy the HEARTSTRING III Seal inside of the aorta. The Loading Device is a mechanism that rolls the HEARTSTRING III Seal and loads the HEARTSTRING III Seal into the Delivery Device. The Aortic Cutter is a single use (one aortotomy) device that consists of a Grip, a Cutter, Aortic Stop, a Cap, a Needle, a Safety Lock and an Actuation Button. It is used to create the aortotomy for the anastomosis.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study to prove its performance in the format requested. This document is a 510(k) summary for the HEARTSTRING III Proximal Seal System, which focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not specify quantitative acceptance criteria. Instead, it states:

Acceptance Criteria (Implied): Functionality and performance characteristics of the proposed device are comparable to the currently marketed HEARTSTRING III Proximal Seal System (predicate device).
Reported Device Performance: "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed HEARTSTRING III Proximal Seal System."

Acceptance Criteria (Implied)	Reported Device Performance
Functionality comparable to predicate device	Functionality demonstrated to be comparable to predicate device
Performance characteristics comparable to predicate device	Performance characteristics demonstrated to be comparable to predicate device

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

Sample Size for Test Set: Not specified. The document mentions "in-vitro tests" but provides no details on the number of samples or tests conducted.
Data Provenance: Not specified. The tests were "in-vitro," meaning conducted in a lab environment, but the location or whether the data was retrospective/prospective is not mentioned.

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)

This information is not applicable to the type of testing described (in-vitro performance tests for a medical device). "Ground truth" in this context would typically refer to objective measurements of the device's physical and functional properties, not expert consensus on diagnostic images.

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

Not applicable. This concept is usually relevant for human-read evaluations or clinical trials, not for in-vitro performance testing of a device's mechanical or functional properties.

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

No such study was mentioned. The device described is a surgical tool, not an AI-assisted diagnostic or interpretive system.

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

Not applicable. This device is a physical surgical instrument and does not involve an algorithm or AI. The performance discussed is the device's own functionality.

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

For the "in-vitro tests," the "ground truth" would be the objective measurements of the device's physical and functional properties, as compared to established specifications for the predicate device. Details of these specific measurements are not provided in this summary.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable for the same reason as point 8.

Summary

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HEARTSTRING III Proximal Seal System 510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

. -

510(k) Number:	K130382
Date Prepared:	6 March 2013
Device Owner:	MAQUET Cardiovascular LLC45 Barbour Pond DriveWayne, New Jersey 07470
Contact Personnel:	Mark Dinger
Title:	Regulatory Affairs Specialist II
Email:	mark.dinger@maquet.com
Phone:	973-709-7691 Fax: 973-807-1658
Trade Name:	HEARTSTRING III Proximal Seal System:
Device Generic Name:	Vascular Clamp
Classification:	According to 21 CFR 870.4450 of the Federal Food, Drugand Cosmetic Act, the device classification is Class II,Product code DXC.
Predicate Device:	K080169 HEARTSTRING III Proximal Seal System(SE: 8 Feb 2008)
Device Description:	The HEARTSTRING III Proximal Seal System is a devicedesigned to enable the creation of a proximal anastomosisof a vessel graft to the aorta without the need for an aorticclamp during coronary artery bypass graft (CABG)surgery.The HEARTSTRING III Proximal Seal System iscomprised of the Proximal Seal, Delivery Device, Loadingdevice and Aortic Cutter. The HEARTSTRING III Seal isa device that is delivered into the aorta via an aortotomycreated by the Aortic Cutter and provides a sealed region tofacilitate the proximal anastomosis. The Delivery Device isa syringe-like tube with plunger that is used to deploy theHEARTSTRING III Seal inside of the aorta. The Loading

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Device is a mechanism that rolls the HEARTSTRING III Seal and loads the HEARTSTRING III Seal into the Delivery Device. The Aortic Cutter is a single use (one aortotomy) device that consists of a Grip, a Cutter, Aortic Stop, a Cap, a Needle, a Safety Lock and an Actuation Button. It is used to create the aortotomy for the anastomosis.

Indications for Use:

Technological Characteristics

The Proposed HEARTSTRING III Proximal Seal System and the predicate devices have the following similarities:

the same but clarified intended use, ಂ
the same operating principles, o
ం incorporates the same seal device.
sterilized using the same materials and processes. 0
has same packaging. O

The Proposed HEARTSTRING III Proximal Seal System and the predicate devices have the following differences:

Addition of a bridge on the loading device. o
Addition of visual cues on the loading and delivery 0 device.
Change branding colors on loading and delivery o device.

This difference is not considered a technological difference and is substantially equivalent to the predicate devices.

MAQUET Cardiovascular's development process required that the following activities be completed during the development of the Proposed HEARTSTRING III Proximal Seal System:

. Performance testing
. Biocompatibility Testing

The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed HEARTSTRING III Proximal Seal System.

Safety and Performance:

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Conclusion:

Based upon the information submitted in this Traditional 510(k) premarket notification, MAQUET's HEARTSTRING III Proximal Seal System is substantially equivalent to the currently marketed HEARTSTRING III Proximal Seal System. The HEARTSTRING III Proximal Seal System is similar to the predicate devices in the intended use and the fundamental scientific technology of the device. The performance testing established that the proposed HEARTSTRING III Proximal Seal System is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 5, 2013

Maquet Cardiovascular LLC c/o Mr. Mark Dinger Regulatory Affairs Specialist. II 45 Barbour Pond Drive Wayne, NJ 07470

Re: K130382

Trade/Device Name: Heartstring III Proximal Seal System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (two) Product Code: DXC Dated: March 6, 2013 Received: March 7, 2013

Dear Mr. Dinger:

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. 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.

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Page 2 - Mr. Mark Dinger

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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/ucm11.5809.htm for 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 regulation (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

	Matthew-G.-Hillebrenner
for	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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Indications for Use

510(k) Number (if known): K130382

Device Name: HEARTSTRING III Proximal Seal System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR:

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Matthew G. Hillebrenner

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).