SuperStitch is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the SuperStitch® Vascular Suture Delivery Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria, and thus the provided text does not contain the detailed information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, etc.).

Here's a breakdown of what can be extracted or inferred from the provided information, and what cannot:

1. A table of acceptance criteria and the reported device performance:

Cannot be extracted. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not typically include a table of pre-defined acceptance criteria (e.g., specific performance metrics like accuracy, sensitivity, specificity) for device performance or reported device performance against such criteria. The "study" mentioned is a comparison to a predicate, not a performance study against specific acceptance metrics for a "new" device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be extracted. Since there isn't a "test set" in the sense of a clinical or image-based study to evaluate performance metrics, this information is not present. The "testing" referred to is around design control and material properties, not a clinical performance validation against specific disease states or measurements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Cannot be extracted. No ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Cannot be extracted. No adjudication method is mentioned as there's no test set requiring ground truth establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Cannot be extracted. This device is a surgical suture delivery device and not an AI/imaging device. Therefore, MRMC and human reader improvement with AI assistance are not relevant and are not discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Cannot be extracted. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Cannot be extracted. No ground truth is established for device performance in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for this submission would be the performance and safety characteristics of the predicate device.

8. The sample size for the training set:

Cannot be extracted. This is not an AI/machine learning device. No training set is used.

9. How the ground truth for the training set was established:

Cannot be extracted. No training set or associated ground truth establishment is mentioned.

Summary based on the provided text:

The provided document, K020940, describes a 510(k) premarket notification for the Sutura SuperStitch® Vascular Suture Delivery Device. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (Sutura SuperStitch®, K012865), rather than to establish specific performance criteria through a standalone clinical study.

Acceptance Criteria and Device Performance:

The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating that the modified SuperStitch device performs as safely and effectively as the predicate device.
The "reported device performance" is essentially that the device maintains the same intended use, functionality, and reliability as the predicate device, following a material change in one of the shaft components.
The document states: "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."
No specific quantitative performance metrics (e.g., success rates, complication rates, specific mechanical test results with associated acceptance thresholds) are provided in this summary document. This level of detail would typically be in the full submission, not the public summary.

Study Type and Details:

The "study" conducted for this 510(k) was a comparison to a predicate device to demonstrate substantial equivalence. It was not a comparative effectiveness study involving human readers or a standalone performance study with defined clinical endpoints.
The evaluation focused on material changes, biocompatibility, and physical properties under simulated and actual conditions of use.
Sample Size, Ground Truth, and Adjudication: These concepts (test set, training set, ground truth established by experts, adjudication methods, MRMC studies) are not applicable to this type of device and 510(k) submission. The assessment was primarily engineering and material-based, ensuring the modified device's characteristics were equivalent to the cleared predicate.

In conclusion, the requested detailed information (acceptance criteria, specific study parameters, sample sizes, ground truth, MRMC, etc.) is not present in this 510(k) summary because it primarily addresses substantial equivalence for a non-AI surgical device with a material modification, rather than a clinical performance study with predefined metrics for a "new" device concept.

Summary

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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 StreetFountain Valley, CA 92708Tel: 714.437.9801Fax: 714.437.9806
B. Contact Person:	James BondsVice 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:

Page 16

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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.

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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.

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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

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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)

Over-the-Counter Use

Regulation Number and Section

§ 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.