HEARTSTRING III PROXIMAL SEAL SYSTEM

K080169 · Guidant Corporation, Cardiac Surgery · DXC · Feb 8, 2008 · Cardiovascular

Device Facts

• Record ID: K080169
• Device Name: HEARTSTRING III PROXIMAL SEAL SYSTEM
• Applicant: Guidant Corporation, Cardiac Surgery
• Product Code: DXC · Cardiovascular
• Decision Date: Feb 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

HEARTSTRING III Proximal Seal System enables proximal anastomosis of aortic grafts during CABG surgery without aortic clamping. System components: semi-spherical Proximal Seal, Delivery Device, Loader, and Aortic Cutter. Loader rolls and loads seal into Delivery Device; Delivery Device deploys seal into aorta via punch hole site; Aortic Cutter creates aortotomy. Used by cardiac surgeons in OR. Provides sealed region for anastomosis, maintaining hemostasis. Benefits patient by eliminating need for aortic clamp, potentially reducing trauma to aorta.

Clinical Evidence

Bench testing only. Verification testing demonstrated device meets established acceptance criteria and performs equivalently to predicate devices.

Technological Characteristics

System includes plastic injection-molded delivery device, loader, and aortic cutter. Semi-spherical seal. Mechanical deployment mechanism. No electronic components or software.

Indications for Use

Indicated for use by cardiac surgeons during coronary artery bypass graft (CABG) procedures to maintain hemostasis and facilitate proximal anastomosis without aortic clamping.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• HEARTSTRING II (K022880)
• HEARTSTRING (K022880)

Submission Summary (Full Text)

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## 510(K) SUMMARY 11.0

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| Submitter | Guidant Corporation, Cardiac Surgery | FEB - 8 - 2008 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Submitter's<br>Address | 170 Baytech Drive<br>San Jose, CA 95134 | |
| Telephone | [phone] | |
| Fax | [phone] | |
| Contact Person | Elizabeth Trujillo | |
| Date Prepared | December 10, 2007 | |
| Device Trade<br>Name | HEARTSTRING® III Proximal Seal System | |
| Device Common<br>Name | Proximal Seal System | |
| Device<br>Classification<br>Name | Vascular Clamp | |
| Device<br>Classification | Class II | |
| Summary of<br>substantial<br>equivalence | The design, materials, method of delivery, and intended use features of the<br>HEARTSTRING® III Proximal Seal System are substantially equivalent with<br>regard to those features in the predicate devices: the HEARTSRING II and the<br>HEARTSTRING (K022880, September 13, 2002). | |
| Device<br>description | The HEARTSTRING® III Proximal Seal System delivers a hemostatic seal device<br>designed to enable the proximal anastomosis of an aortic graft without the need for<br>an aortic clamp during coronary artery bypass graft (CABG) surgery. | |
| | The Proximal Seal System is comprised of the Proximal Seal, Delivery Device,<br>Loader and the Aortic Cutter. The proximal Seal is a semi-spherical shaped<br>device that is delivered into the aorta via the punch hole site and provides a sealed<br>region to facilitate the proximal anastomosis. The Loader is a mechanism that<br>rolls the Proximal Seal and loads the Seal into the Delivery Device. The Delivery<br>Device is a plastic injected molded device that is used to deploy the Seal inside of<br>the aorta. The HEARTSTRING® Aortic Cutter creates the aortotomy and hole<br>opening in the aorta for the anastomosis. | |
| Indications for<br>Use | The Proximal Seal System is intended for use by cardiac surgeons during CABG<br>procedures to maintain hemostasis and to facilitate the completion of a proximal<br>anastomosis without application of an aortic clamp. | |
| Technological<br>characteristics | The Guidant HEARTSTRING® III Proximal Seal System incorporates the same<br>fundamental scientific technology as the predicate devices. | |
| Performance<br>data | The results of the verification testing demonstrate that the Guidant<br>HEARTSTRING® III Proximal Seal System meet the established acceptance<br>criteria and performs in a manner equivalent to the predicate devices. No new<br>safety or effectiveness issues were raised during the testing program. | |

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FEB - 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Guidant Corporation c/o Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062-2096

Re: K080169

HEARTSTRING® III Proximal Seal System Regulation Number: 21 CFR §870.4450 Regulation Name: Vascular clamp Regulatory Class: II Product Code: DXC Dated: January 15, 2008 Received: January 24, 2008

Dear Mr. Devine:

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. Ned Devine

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Oma R. bohner

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

Enclosure

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## 12.0 INDICATIONS FOR USE STATEMENT

| 510(k)<br>number<br>(if known) | The 510(k) number has not been issued yet.<br>K080169 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | HEARTSTRING® III Proximal Seal System |
| Indications for<br>Use | The Proximal Seal System is intended for use by cardiac surgeons during<br>CABG procedures to maintain hemostasis and to facilitate the completion of a<br>proximal anastomosis without application of an aortic clamp. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | |
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OR

| Over-The-Counter Use | |
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K680169
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