(29 days)
Not Found
No
The device description focuses on mechanical and material changes, and there is no mention of AI or ML in the text, including the sections specifically checked for these terms.
No
The device is used for performing vascular stitching and is an instrument for surgical procedures, not a device that directly treats a medical condition in a therapeutic manner.
No
The device description clearly states its purpose is for "performing vascular stitching" and "applies one nonabsorbable monofilament suture." This indicates an interventional/surgical function, not a diagnostic one.
No
The device description clearly describes a hand-held, physical device with an operating mechanism, materials, and accessories, indicating it is a hardware medical device.
Based on the provided information, the SuperStitch® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- SuperStitch® Function: The SuperStitch® is a surgical device used during a surgical procedure to physically stitch blood vessels. It directly interacts with the patient's anatomy and is not used to analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "performing vascular stitching in general surgery, including endoscopic procedures." This is a surgical intervention, not a diagnostic test.
- Device Description: The description details a hand-held surgical tool for applying sutures, not a device for analyzing biological samples.
Therefore, the SuperStitch® falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.
Product codes
GAW, GAB
Device Description
The SuperStitch® Vascular Suture Delivery Device is a hand-held and operated device designed for use with or without an access device (e.g. trocar, sheath, or cannula), depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. The SuperStitch® applies one nonabsorbable monofilament suture. After deployment of the device, the physician completes the closure by tying the appropriate surgical knots, Optional accessories for use with the SuperStitch® include the KnotPusher™ for advancing the knot to the wound site and the Kwiknot™ knot tying device The principal differences between the modified SuperStitch® and the cleared SuperStitch® are: (1) changes made within the operating mechanism to improve manufacturability; (2) the addition of longer lengths to accommodate longer (i.e., 25cm) sheaths; (3) change in package to a single sterile barrier; (4) the inclusion of a modified KnotPusher™ accessory that is packaged with the SuperStitch® (5) a change in one of the cannula materials; and (6) the addition of a smaller (6 French) size for compatibility with 6 French procedural sheaths. The Sutura SuperStitch® is a prescription device, restricted to use by or on the order of physicians. The Sutura SuperStitch® is sterilized by ethylene oxide and is non-pyrogenic in an unopened undamaged package, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / general surgery, including 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)
Sutura, Inc. has submitted information on the design, indications, materials, and principle of operation to establish that the modified SuperStitch® Vascular Suture Delivery Device is substantially equivalent to the predicate unmodified SuperStitch® Vascular Suturing Device. The differences in the technological characteristics and size of the modified SuperStitch® have been evaluated through appropriate design control procedures. These methods assessed the new characteristics with regard to functionality and reliability under simulated and actual conditions of use. Results of scientific testing have ensured that the materials are biocompatible and physical properties are appropriate for the intended use. In conclusion, the Sutura SuperStitch® Vascular Suture Delivery Device has been shown to be substantially equivalent to the Class II predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sutura SuperStitch ®, K994087
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
K012865 62 of
SEP 2 5 2001
XI. 510(k) Summary
| A. Sponsor/Submitter: | Sutura, Inc.
17080 Newhope Street
Fountain Valley, CA 92708
Tel: 714.437.9801
Fax: 714.437.9806 |
|-------------------------|-------------------------------------------------------------------------------------------------------------|
| B. Contact Person: | James Bonds
Vice President, QA/RA |
| C. Date of Submission: | August 24, 2001 |
| D. Trade Name: | SuperStitch ® Vascular Suture Delivery Device |
| E. Common Name: | Suture Delivery Device |
| F. Classification: | Class II |
| G. Classification Name: | Suture, Nonabsorbable, Synthetic, Polypropylene |
| H. Product Code: | GAW, GAB |
| I. Predicate Device: | Sutura SuperStitch ® , K994087 |
- J. Intended Use:
SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.
K. Device Description:
The SuperStitch® Vascular Suture Delivery Device is a hand-held and operated device designed for use with or without an access device (e.g. trocar, sheath, or cannula), depending on the endoscopic technique, for use during minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. The SuperStitch® applies one nonabsorbable monofilament suture. After deployment of the device, the physician completes the closure by tying the appropriate surgical knots, Optional accessories for use with the SuperStitch® include the KnotPusher™
000019 Page
1
012865 (Rata)
Sutura, Inc.
SuperStitch® Vascular Suture Delivery Device
for advancing the knot to the wound site and the Kwiknot™ knot tying device
The principal differences between the modified SuperStitch® and the cleared SuperStitch® are: (1) changes made within the operating mechanism to improve manufacturability; (2) the addition of longer lengths to accommodate longer (i.e., 25cm) sheaths; (3) change in package to a single sterile barrier; (4) the inclusion of a modified KnotPusher™ accessory that is packaged with the SuperStitch® (5) a change in one of the cannula materials; and (6) the addition of a smaller (6 French) size for compatibility with 6 French procedural sheaths.
The Sutura SuperStitch® is a prescription device, restricted to use by or on the order of physicians.
The Sutura SuperStitch® is sterilized by ethylene oxide and is non-pyrogenic in an unopened undamaged package, for single use only.
L. Summary of Substantial Equivalence:
Sutura, Inc. has submitted information on the design, indications, materials, and principle of operation to establish that the modified SuperStitch® Vascular Suture Delivery Device is substantially equivalent to the predicate unmodified SuperStitch® Vascular Suturing Device.
The Sutura SuperStitch® has the same intended use as the predicate device. The differences in the technological characteristics and size of the modified SuperStitch® have been evaluated through appropriate design control procedures. These methods assessed the new characteristics with regard to functionality and reliability under simulated and actual conditions of use. Results of scientific testing have ensured that the materials are biocompatible and physical properties are appropriate for the intended use.
In conclusion, the Sutura SuperStitch® Vascular Suture Delivery Device has been shown to be substantially equivalent to the Class II predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2001
Mr. James Bonds Vice President, Quality Assurance and Regulatory Affairs Sutura, Incorporated 17080 Newhope Street Fountain Valley, California 92708
Re: K012865
Trade/Device Name: SuperStitch® Vascular Suturing Device Regulation Number: 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: August 24, 2001 Received: August 27, 2001
Dear Mr. Bonds:
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.
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.
3
Page 2 - Mr. James Bonds
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
L. Mark N. Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number: KOL1365
Device Name: SuperStitch® vascular suturing device
Indications for Use:
SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N Millenson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number | K012865 |
---|---|
--------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
---|---|---|
------------------------------------------ | ---- | ---------------------- |
A- 000001