← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K963965 # CTS MIDCAB STITCHER (K963965) _Cardiothoracic Systems, Inc. · GEI · Mar 17, 1998 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K963965 ## Device Facts - **Applicant:** Cardiothoracic Systems, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Mar 17, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures. ## Device Story Vascular Stitcher is a stainless steel surgical instrument designed for needle holding and suturing. Operates in semi-automatic or manual modes. Used in general surgery and endoscopic procedures, with or without trocar sleeves. Compatible with CTS-specific needles and sutures. Facilitates vascular tissue approximation. Operated by surgeons in clinical or OR settings to improve suturing efficiency and access in minimally invasive environments. ## Clinical Evidence No clinical data provided. Substantial equivalence established through descriptive comparison of design, materials, and intended use. ## Technological Characteristics Stainless steel construction. Manual or semi-automatic mechanical operation. Designed for use with compatible needles and sutures. Form factor optimized for endoscopic and general surgical access. ## Regulatory 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. ## Predicate Devices - Young Boomerang Needle Holder - Harris Boomerang Needle Holder - Millin Boomerang Needle Holder - U.S. Surgical EndoStitch Suturing Instrument - U.S. Surgical Endoscopic Needle Driver ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 501(k) Premarket Notification Vascular Stitcher MAR 17 1998 K963965 # 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. 25 ID {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 Stitcher 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. {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 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 Re: K963965 Trade Name: Vascular Stitcher Regulatory Class: II Product Code: GEI Dated: December 22, 1997 Received: December 24, 1997 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 (QS) 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. MAR 17 1998 {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, ![img-0.jpeg](img-0.jpeg) 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 ☑ (Per 21 CFR 801.109) ![img-1.jpeg](img-1.jpeg) 6 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K963965](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K963965) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com