(15 days)
No
The device description and performance summary focus on mechanical components and their function in facilitating a surgical procedure. There is no mention of AI, ML, image processing, or data-driven decision-making.
No.
The device maintains hemostasis and facilitates surgical procedures rather than treating a specific disease or condition.
No
The device is designed to maintain hemostasis and facilitate the completion of a proximal anastomosis during CABG procedures, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components: Proximal Seal, Delivery Device, Loader, and Aortic Cutter. It is a system of physical devices used in a surgical procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cardiac surgeons during CABG procedures to maintain hemostasis and facilitate a proximal anastomosis. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components (Proximal Seal, Delivery Device, Loader, Aortic Cutter) are all designed for direct surgical intervention and manipulation of the aorta.
- Anatomical Site: The device is used on the aorta, which is an internal organ within the patient's body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for 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.
Product codes
DXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiac surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. No new safety or effectiveness issues were raised during the testing program.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HEARTSRING II, HEARTSTRING (K022880)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(K) SUMMARY 11.0
ー
| Submitter | Guidant Corporation, Cardiac Surgery | FEB - 8 - 2008 |
|---|---|---|
| Submitter's | ||
| Address | 170 Baytech Drive | |
| San Jose, CA 95134 | ||
| Telephone | (408) 635-6835 | |
| Fax | (408) 635-3907 | |
| Contact Person | Elizabeth Trujillo | |
| Date Prepared | December 10, 2007 | |
| Device Trade | ||
| Name | HEARTSTRING® III Proximal Seal System | |
| Device Common | ||
| Name | Proximal Seal System | |
| Device | ||
| Classification | ||
| Name | Vascular Clamp | |
| Device | ||
| Classification | Class II | |
| Summary of | ||
| substantial | ||
| equivalence | The design, materials, method of delivery, and intended use features of the | |
| HEARTSTRING® III Proximal Seal System are substantially equivalent with | ||
| regard to those features in the predicate devices: the HEARTSRING II and the | ||
| HEARTSTRING (K022880, September 13, 2002). | ||
| Device | ||
| description | 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. | ||
| Indications for | ||
| 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. | ||
| Technological | ||
| characteristics | The Guidant HEARTSTRING® III Proximal Seal System incorporates the same | |
| fundamental scientific technology as the predicate devices. | ||
| Performance | ||
| data | 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. No new | ||
| safety or effectiveness issues were raised during the testing program. |
1
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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.
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 for
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. |
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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