(26 days)
Not Found
No
The description focuses on a mechanical suture delivery device and its physical characteristics, with no mention of AI or ML capabilities.
Yes
The device is a therapeutic device because it performs vascular stitching in general surgery, which is a treatment or intervention.
No
The device description clearly states its purpose is for performing vascular stitching and applying sutures for closure, not for diagnosing conditions.
No
The device description clearly describes a hand-held, physical device used for delivering sutures, including mentions of materials, sterilization, and accessories like a KnotPusher. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "performing vascular stitching in general surgery, including endoscopic procedures." This describes a surgical tool used on the patient's body to perform a physical action (stitching).
- Device Description: The description details a "hand-held and operated device" that "applies one nonabsorbable monofilament suture." This is a mechanical device for surgical manipulation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The SuperStitch does not interact with specimens in this way.
The SuperStitch is a surgical device used directly on the patient during a procedure, not an in vitro diagnostic device used to analyze samples.
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 difference between the modified SuperStitch and the cleared SuperStitch is a change in one of the shaft materials.
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
vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / general surgery, endoscopic procedures, minimally invasive surgical procedures, open setting
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
Results of scientific testing have ensured that the materials are biocompatible and physical properties are appropriate for the intended use.
Key Metrics
Not Found
Predicate Device(s)
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
K020940 (P.1 of 2)
K Sutura, Inc. SuperStitch® Vascular Suture Delivery Device
APR 1 7 2002
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: | March 22, 2002 |
| 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®, K012865 |
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™
Page 16
1
K020940(1d0f2)
for advancing the knot to the wound site and the Kwiknot™ knot tying device
The principal difference between the modified SuperStitch and the cleared SuperStitch is a change in one of the shaft materials.
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
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three faces in profile, overlapping each other and facing to the right. The faces are abstract and appear to be formed by a single continuous line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2002
Mr. James Bonds Vice President, Quality Assurance and Regulatory Affairs Sutura, Inc. 17080 Newhope Street Fountain Valley, California 92708
Re: K020940
Trade/Device Name: Superstitch® vascular suturing device Regulation Number: 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: March 21, 2002 Received: March 22, 2002
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 yours,
Muriam C. Provost
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:
020940
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)
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K620940
Prescription Use 1 (Per 21 CFR 801.109)
OR
Over-the-Counter Use