K Number
K994087
Device Name
SUPERSTITCH
Manufacturer
Date Cleared
2000-03-01

(89 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
Device Description
The SuperStitch® device is 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. SuperStitch® applies one nonabsorbable sterile surgical suture. The knot pusher is comprised of two components: a snare to capture one strand of the The safet positive is veniprises or used to advance the tied knot to the surface of the tissue.
More Information

No
The summary describes a mechanical surgical device for vascular stitching and knot pushing. There is no mention of AI, ML, image processing, or data-driven performance metrics.

No
The device is described as a surgical tool used for performing vascular stitching, applying sutures, and tying knots, which are all actions performed during treatment but are not therapeutic actions in themselves.

No
Explanation: The device description states its use is for "performing vascular stitching in general surgery," which is a therapeutic or surgical function, not a diagnostic one.

No

The device description clearly describes a physical surgical device used for vascular stitching, including components like a knot pusher and snare, indicating it is a hardware device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
  • SuperStitch® Function: The SuperStitch® device is a surgical tool used directly on the body during surgical procedures to apply sutures to blood vessels. It is an in vivo device, not an in vitro device.

The provided information clearly describes a surgical instrument used for stitching blood vessels during surgery, which falls under the category of surgical devices, not in vitro diagnostics.

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 (comma separated list FDA assigned to the subject device)

GCJ, OCW, GAW

Device Description

The SuperStitch® device is 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. SuperStitch® applies one nonabsorbable sterile surgical suture. The knot pusher is comprised of two components: a snare to capture one strand of the The safet positive is veniprises or used to advance the tied knot to the surface of the tissue.

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

Not Found

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Vascular Stitcher (K963965)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

AutoSuture™ Endoscopic Suturing Device (K934738), AutoSuture Endoscopic Knot Pusher™ (K925149)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the serpent and staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Sutura™, Inc. Mr. Dave Barry Vice President, Regulatory Affairs and Quality Assurance 17080 Newhope Street Fountain Valle,y CA 92708

JUL 2 7 2015

K994087 Re:

Trade/Device Name: SuperStitch® Vascular Suturing Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, OCW, GAW Dated (Date on orig SE ltr): December 1, 1999 Received (Date on orig SE ltr): December 3, 1999

Dear Mr. Barry,

This letter corrects our substantially equivalent letter of March 1, 2000.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

K994087

INDICATIONS FOR USE STATEMENT

Sutura™, Inc.

SuperStitch®

510(k) Number: K994087

SuperStitch® vascular suturing device Device Name:

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 Drug Evaluation (ODE)

Nko for Izo

(Division Sign-Off) Division of General Restorative Devices 1994087 510(k) Number ..

Yes

Prescription Use (Per 21 CFR 801.109)

3

SUMMARY OF SAFETY AND EFFECTIVENESS

Sutura™, Inc.

SuperStitch®

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

| Company: | Sutura™, Inc.
17080 Newhope Street
Fountain Valley, CA 92708
Phone: (714) 437-9801
Fax: (714) 437-9806 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------|
| Company Representative: | David B. Barry
Vice President, RA/QA |
| Date 510(k) Prepared: | December 1, 1999 |
| Device Name: | SuperStitch® vascular suturing device |
| Classification Name: | Needle, Suturing, Disposable (21 CFR §878.4800) |
| Product Code: | GCJ |
| Classification: | Class II |

Devices to which Equivalence is Claimed

Automatic suturing devices are made by various manufacturers. The technological characteristics of the SuperStitch® and accessory Knot Pusher are substantially equivalent to the following devices:

Vascular Stitcher (K963965), CardioThoracic Systems, Inc. AutoSuture™ Endoscopic Suturing Device (K934738), U.S. Surgical Corporation AutoSuture Endoscopic Knot Pusher™ (K925149), U.S. Surgical Corporation

Indication 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.

Device Description:

The SuperStitch® device is designed for use with or without an access device (e.g., trocar, sheath, or cannula) depending on the endoscopic technique, for use during

4

1

minimally invasive surgical procedures, or for application directly to a vessel or wound site in an open setting. SuperStitch® applies one nonabsorbable sterile surgical suture.

The knot pusher is comprised of two components: a snare to capture one strand of the The safet positive is veniprises or used to advance the tied knot to the surface of the tissue.