The SuperStitch 5F, 12F & EL sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SuperStitch 5F, 12F & EL are not intended for blind vascular closure.

Device Description

The SuperStitch 5F, 12F & EL versions are hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, a pre-loaded guidewire, a KnotPusher accessory for advancing the knot to the wound site, and a KwiKnot accessory.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (SuperStitch® 5F, 12F & EL Vascular Suture Delivery Device). This document is a regulatory submission to the FDA for market clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results or acceptance criteria in the manner typically seen for novel AI/software as a medical device (SaMD) products.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not present in this type of document because the device relies on existing technology and a predicate device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/present in this document. The 510(k) focuses on demonstrating substantial equivalence, not meeting specific performance metrics from a detailed clinical study with pre-defined acceptance criteria. The claim is that the device has "the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the currently marketed SuperStitch," with only minor modifications in diameter or length. This implies the performance is expected to be equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This device is a manual surgical suturing device, not an AI/software device that would typically have a "test set" in the context of AI performance evaluation. The submission relies on the established safety and effectiveness of its predicate device, the original SuperStitch Vascular Suturing Device, without presenting a specific clinical "test set" for the new iterations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth establishment, in the context of expert consensus, is typically for evaluating diagnostic or prognostic algorithms. This device is a surgical instrument.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. MRMC studies are typically for evaluating the impact of AI on diagnostic performance of human readers. This device is a surgical tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/algorithm-only device.

7. The Type of Ground Truth Used

Not applicable. For this type of device, safety and effectiveness would be demonstrated through bench testing, biocompatibility, sterilization validation, and potentially animal or limited human use data, all aimed at showing that the device performs its intended function safely and effectively, similar to its predicate. The concept of "ground truth" as used in AI evaluation does not directly apply here.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of what is available in the document regarding how the device meets acceptance criteria (through the lens of substantial equivalence):

The device (SuperStitch 5F, 12F & EL) gained market clearance based on its substantial equivalence to a previously cleared predicate device, Sutura's SuperStitch Vascular Suturing Device.

Acceptance Criteria (Implied by Substantial Equivalence): The device is considered to meet acceptance criteria if it:
- Has the same intended use.
- Has the same indications for use.
- Has the same principles of operation.
- Has fundamental technological characteristics that are equivalent.
- Any differences do not raise new questions of safety or effectiveness.
Study Proving Acceptance Criteria (Demonstration of Substantial Equivalence):
- The "study" here is the 510(k) submission itself, which argues for substantial equivalence.
- The document explicitly states: "The SuperStitch 5F, 12F & EL has the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the currently marketed SuperStitch, except that the SuperStitch 5F, 12F & EL provide the option of diameter or lengths for use by the physician. This minor modification to the SuperStitch does not raise any new questions of safety or effectiveness. Thus, the SuperStitch 5F, 12F & EL are substantially equivalent."

In essence, for this specific K062125 submission, the "acceptance criteria" were met by demonstrating that the new devices are essentially minor variations of an already cleared and accepted device, and therefore share its established safety and effectiveness profile. No new clinical trials or performance studies specific to these minor modifications were required or presented in this summary document.

Summary

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OCT 1 9 2006

K062125

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510(k) SUMMARY

Sutura, Inc.'s SuperStitch® 5F, 12F & EL

OCT 1 9 2006

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708

Phone: (714) 437-9801 Facsimile: (714) 437-9806

Contact Person: Anthony Nobles Date Prepared: July 19, 2006

Alternate Contact:

Gerard J. Prud'homme Hogan & Hartson L.L.P. 555 Thirteenth St., NW Washington D.C., 20004 Phone: (202) 637-5600

Name of Device and Name/Address of Sponsor

SuperStitch 5F, 12F & EL

Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708

Common or Usual Name

SuperStitch Guidewire Vascular Suture Delivery Device

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Classification Name

Suture, Nonabsorbable, Synthetic, Polypropolene

Predicate Devices

Sutura's SuperStitchVascular Suturing Device

Intended Use/Indications for Use

Technological Characteristics

Substantial Equivalence

The SuperStitch 5F, 12F & EL has the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the currently marketed SuperStitch, except that the SuperStitch 5F, 12F & EL provide the option of diameter or lengths for use by the physician. This minor modification to the SuperStitch does not raise any new questions of safety or effectiveness. Thus, the SuperStitch 5F, 12F & EL are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2006

Sutura, Inc. % Hogan & Hartson, L.L.P. Mr. Gerard J. Prud'homme 555 Thirteenth Street. NW Washington, District of Columbia 20004

Re: K062125

Trade/Device Name: SuperStitch® 5F Vascular Suture Delivery Device SuperStitch® 12F Vascular Suture Deliver Device SuperStitch® Extended Length Vascular Suture Deliver Device Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: September 21, 2006 Received: September 21, 2006

Dear Mr. Prud'homme:

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

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Page 2 - Mr. Gerard J. Prud'homme

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.

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Feli Pedr

Mark N. Melkerson 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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SuperStitch® 5F Vascular Suture Delivery Device SuperStitch® 12F Vascular Suture Delivery Device SuperStitch® Extended Length Vascular Suture Delivery Device

Indications for Use:

The SuperStitch 5F, 12F & EL is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SuperStitch 5F, 12F & EL is not intended for blind vascular closure.

Prescription Use X (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pohm

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number

\\DC - 80169/0002 - 2336580 v1

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.