(15 days)
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.
The HEARTSTRING® III Proximal Seal System delivers a hemostatic seal device designed to enable the proximal anastomosis of an aortic graft without the need for an aortic clamp during coronary artery bypass graft (CABG) surgery. The Proximal Seal System is comprised of the Proximal Seal, Delivery Device, Loader and the Aortic Cutter. The proximal Seal is a semi-spherical shaped device that is delivered into the aorta via the punch hole site and provides a sealed region to facilitate the proximal anastomosis. The Loader is a mechanism that rolls the Proximal Seal and loads the Seal into the Delivery Device. The Delivery Device is a plastic injected molded device that is used to deploy the Seal inside of the aorta. The HEARTSTRING® Aortic Cutter creates the aortotomy and hole opening in the aorta for the anastomosis.
This 510(k) summary for the HEARTSTRING® III Proximal Seal System does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a definitive study proving the device meets those criteria. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description and intended use.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The results of the verification testing demonstrate that the Guidant HEARTSTRING® III Proximal Seal System meet the established acceptance criteria and performs in a manner equivalent to the predicate devices."
However, the actual specific acceptance criteria (e.g., maximum allowable blood leakage, deployment success rate, seal integrity under specific pressures, etc.) and the quantifiable reported device performance against those criteria are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The summary mentions "verification testing" but does not detail the sample size (number of tests, number of devices/simulations, patients, etc.) or the provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available in the provided text. The nature of this device (a surgical tool for hemostasis) suggests that "ground truth" would likely be established through physical performance testing rather than expert review of data like images.
4. Adjudication Method for the Test Set
This information is not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study is typically performed for devices that involve human interpretation of medical images or data where the AI assists in that interpretation. The HEARTSTRING® III Proximal Seal System is a physical surgical device. Therefore, a MRMC study is not applicable and was not performed.
6. Standalone (Algorithm Only) Performance Study
The HEARTSTRING® III Proximal Seal System is a physical medical device, not an algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The performance data mentioned refers to the physical device's performance through "verification testing."
7. Type of Ground Truth Used
Based on the nature of the device (a surgical tool for hemostasis), the ground truth for performance testing would likely be based on objective physical measurements and observations during simulations, bench testing, and potentially animal or cadaveric studies. For example, ground truth could involve:
- Absence of bleeding/hemostasis.
- Integrity of the seal under specified pressure.
- Successful deployment.
- Ease of use or deployment time.
- Mechanical strength and durability.
However, the specific methods for establishing ground truth are not detailed in this summary.
8. Sample Size for the Training Set
This information is not applicable as the HEARTSTRING® III Proximal Seal System is a physical device and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
{0}------------------------------------------------
510(K) SUMMARY 11.0
ー
| Submitter | Guidant Corporation, Cardiac Surgery | FEB - 8 - 2008 |
|---|---|---|
| Submitter'sAddress | 170 Baytech DriveSan Jose, CA 95134 | |
| Telephone | (408) 635-6835 | |
| Fax | (408) 635-3907 | |
| Contact Person | Elizabeth Trujillo | |
| Date Prepared | December 10, 2007 | |
| Device TradeName | HEARTSTRING® III Proximal Seal System | |
| Device CommonName | Proximal Seal System | |
| DeviceClassificationName | Vascular Clamp | |
| DeviceClassification | Class II | |
| Summary ofsubstantialequivalence | The design, materials, method of delivery, and intended use features of theHEARTSTRING® III Proximal Seal System are substantially equivalent withregard to those features in the predicate devices: the HEARTSRING II and theHEARTSTRING (K022880, September 13, 2002). | |
| Devicedescription | The HEARTSTRING® III Proximal Seal System delivers a hemostatic seal devicedesigned to enable the proximal anastomosis of an aortic graft without the need foran aortic clamp during coronary artery bypass graft (CABG) surgery. | |
| The Proximal Seal System is comprised of the Proximal Seal, Delivery Device,Loader and the Aortic Cutter. The proximal Seal is a semi-spherical shapeddevice that is delivered into the aorta via the punch hole site and provides a sealedregion to facilitate the proximal anastomosis. The Loader is a mechanism thatrolls the Proximal Seal and loads the Seal into the Delivery Device. The DeliveryDevice is a plastic injected molded device that is used to deploy the Seal inside ofthe aorta. The HEARTSTRING® Aortic Cutter creates the aortotomy and holeopening in the aorta for the anastomosis. | ||
| Indications forUse | The Proximal Seal System is intended for use by cardiac surgeons during CABGprocedures to maintain hemostasis and to facilitate the completion of a proximalanastomosis without application of an aortic clamp. | |
| Technologicalcharacteristics | The Guidant HEARTSTRING® III Proximal Seal System incorporates the samefundamental scientific technology as the predicate devices. | |
| Performancedata | The results of the verification testing demonstrate that the GuidantHEARTSTRING® III Proximal Seal System meet the established acceptancecriteria and performs in a manner equivalent to the predicate devices. No newsafety or effectiveness issues were raised during the testing program. |
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around the perimeter. At the center of the seal is a stylized emblem, consisting of a symbol that resembles an abstract caduceus or a staff with intertwined snakes, representing health and medicine.
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.
{2}------------------------------------------------
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
{3}------------------------------------------------
12.0 INDICATIONS FOR USE STATEMENT
| 510(k)number(if known) | The 510(k) number has not been issued yet.K080169 |
|---|---|
| Device name | HEARTSTRING® III Proximal Seal System |
| Indications forUse | The Proximal Seal System is intended for use by cardiac surgeons duringCABG procedures to maintain hemostasis and to facilitate the completion of aproximal anastomosis without application of an aortic clamp. |
のお気になる。
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K680169
§ 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).