(531 days)
Not Found
Not Found
No
The summary describes a mechanical surgical instrument for suturing and makes no mention of AI or ML capabilities.
No
The device is described as a surgical product used for vascular suturing, which is a procedural tool rather than a device designed to directly treat, mitigate, or prevent a disease or condition.
No
The device is described as a surgical product used for suturing, not for diagnosing conditions or diseases. Its function is to perform a surgical procedure rather than to identify or assess medical conditions.
No
The device description explicitly states it is a "stainless steel surgical product" and is designed for use with "CTS compatible needle and suture," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "performing vascular suturing in general surgery, including endoscopic procedures." This describes a surgical tool used on the patient's body during a procedure.
- Device Description: The description details a "stainless steel surgical product designed for use with CTS compatible needle and suture." This further reinforces its role as 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 about a patient's health. The provided information does not mention any interaction with patient specimens or diagnostic testing.
Therefore, the Vascular Stitcher is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Vascular Stitcher is a stainless steel surgical product designed for use with CTS compatible needle and suture in a semi-automatic or manually operated mode. The Vascular Stitcher is designed for use with or without trocar sleeves depending on the endoscopic technique or whether during minimally invasive surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general surgery, endoscopic procedures
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
501(k) Premarket Notification Vascular Stitcher
MAR 17 1998 长963965
CardioThoracic Systems, Inc. 510(k) Summary Vascular Stitcher 510(k) Notification K963965
GENERAL INFORMATION
| Manufacturer: | CardioThoracic Systems, Inc. |
|---|---|
| 10600 North Tantau Avenue | |
| Cupertino, California | |
| (408) 342-1700 | |
| (408) 342-1717 FAX | |
| Est. Reg. No. (awaiting issuance) | |
| Contact Person: | Michael J. Billig |
| Vice President, Regulatory, Quality, and Clinical Research | |
| Date Prepared: | September 28, 1996 |
DEVICE DESCRIPTION
Classification: Class I
Trade Name: Vascular Stitcher
Generic/Common Name: Needle Holder/Needle Driver
PREDICATE DEVICES
- (1) Young Boomerang Needle Holder
- (2) Harris Boomerang Needle Holder
- (3) Millin Boomerang Needle Holder
- (4) U.S. Surgical EndoStitch Suturing Instrument
- (5) U.S. Surgical Endoscopic Needle Driver
INTENDED USE
The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures.
1
501(k) Premarket Notification Vascular Stitcher
PRODUCT DESCRIPTION
The Vascular Stitcher is a stainless steel surgical product designed for use with CTS compatible needle and suture in a semi-automatic or manually operated mode. The Vascular Stitcher is designed for use with or without trocar sleeves depending on the endoscopic technique or whether during minimally invasive surgical procedures.
SUBSTANTIAL EQUIVALENCE
The Vascular Stitcher is substantially equivalent to other predicate devices currently being marketed. The marketed predicate devices are identified above. The Vascular Sticher is substantially equivalent to the predicate devices with regard to intended use, function, physical characteristics, and materials.
SUMMARY
As contained in this 510(k) summary, the Vascular Stitcher is substantially equivalent to the predicate devices identified, in that, the stitcher has similar functions and is composed of similar materials as the predicate devices.
11
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes extending upwards and to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael J. Billig Vice President, Regulatory, Quality, and Clinical Research 10600 N. Tantau Avenue Cupertino, California 95014-0739
K963965 Re: Trade Name: Vascular Stitcher Regulatory Class: II Product Code: GEI Dated: December 22, 1997 Received: December 24, 1997
MAR 1 7 1998
Dear Mr. Billig:
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 current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21-CFR Part-820) and that, .. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.
3
Page 2 - Mr. Billig
This letter will allow you to begin marketing your device as described 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) 594-4595. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
501(k) Premarket Notification Vascular Stitcher
Vascular Stitcher 510(k) Premarket Notification
STATEMENT OF INDICATIONS OF USE
The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures.
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | C463965 |
| 510(k) Number |