(211 days)
Not Found
No
The summary describes a mechanical vascular clamp and does not mention any AI or ML components or functionalities.
Yes
The device is described as an "Occluding Clamp" intended to "temporarily occlude a coronary artery to optimize the exposure during the anastomosis" during coronary artery bypass surgery, which is a medical procedure aimed at treating a health condition.
No
The device is described as an "Occluding Clamp" used to temporarily occlude a coronary artery during surgery, which is a therapeutic or interventional function, not a diagnostic one. Its purpose is to optimize exposure for anastomosis, not to diagnose a condition.
No
The device description explicitly states it is a "vascular clamp applier," which is a physical medical device used in surgery, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporarily occlude a coronary artery to optimize the exposure during the anastomosis" in patients undergoing coronary artery bypass surgery. This is a surgical tool used directly on the patient's body during a procedure.
- Device Description: It is described as a "vascular clamp applier," which is consistent with a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
Therefore, the AUTO SUTURE* Occluding Clamp** is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AUTO SUTURE* Occluding Clamp** device is intended for use in those patients undergoing coronary artery bypass surgery when the surgeon determines that it is desirable to temporarily occlude a coronary artery to optimize the exposure during the anastomosis.
Product codes
DXC
Device Description
The AUTO SUTURE* Occluding Clamp** device is a vascular clamp applier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 AUTO SUTURE* Occluding Clamp** device was tested both in-vitro and in-vivo to evaluate its performance. The results of the testing demonstrate the subject device to be safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
UNITED STATES SURGICAL CORPORATION 510(k) Premarket Notification AUTO SUTURE* Occluding Clamp** Device
MAY 23 1997
SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:
| SUBMITTER: | United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856
(203) 845-1000 |
| ------------ | ------------------------------------------------------------------------------------------------ |
|---|
Victor Clavelli CONTACT PERSON: (203) 845-4543
October 16, 1996 DATE PREPARED:
Vascular Clamp CLASSIFICATION NAME:
AUTO SUTURE* Occluding Clamp** device COMMON NAME:
PROPRIETARY NAME: Trademark name not yet determined
PREDICATE DEVICE: RMITM YACOUBIANTM Clamp, K920936
The AUTO SUTURE* Occluding Clamp** device is a DEVICE DESCRIPTION: vascular clamp applier.
- INTENDED USE: The device is intended for use in those patients undergoing coronary artery bypass surgery when the surgeon determines that it is desirable to temporarily occlude a coronary artery to optimize the exposure during the anastomosis.
The AUTO SUTURE* Occluding Clamp** device is MATERIALS: comprised of materials which are in accordance with ISO Standard # 10993-1.
THE AUTO SUTURE* Occluding Clamp** device was PERFORMANCE: tested both in-vitro and in-vivo to evaluate its performance. The results of the testing demonstrate the subject device to be safe and effective.
- Trademark of United States Surgical Corporation ** Trademark name not yet determined
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of an eagle or bird-like figure with three curved lines representing its wings or body. The text "SERVICES - USA" is arranged in an arc above the bird figure, and the text "DEPARTMENT OF HEALTH & HUM" is arranged in an arc below the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 1997
Mr. Victor Clavelli Sr. Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Re: K964251 AUTO SUTURE* Occluding Clamp** Device Regulatory Class: II (two) Product Code: DXC Dated: February 21, 1997 February 24, 1997 Received:
Dear Mr. Clavelli:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in
2
requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described to a m in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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UNITED STATES SURGICAL CORPORATION 510(k) Premarket Notification AUTO SUTURE* Occluding Clamp** Device
INDICATIONS FOR USE: ll.
510(k) Number (if known):
AUTO SUTURE* Occluding Clamp** device Device Name:
Indications for use:
The AUTO SUTURE* Occluding Clamp** device is intended for use in those patients undergoing coronary artery bypass surgery when the surgeon determines that it is desirable to temporarily occlude a coronary artery to optimize the exposure during the anastomosis.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K964251 |
| Prescription Use: | ✓ | OR | Over-The-Counter Use: |
|---|---|---|---|
| ------------------- | ------------------------------------------------------------------- | ---- | ----------------------- |
- Trademark of United States Surgical Corporation ** Trademark name not yet determined
,