K Number
K992612
Device Name
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232
Date Cleared
1999-10-14

(71 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches
Device Description
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is a single patient use reloadable instrument that is intended for the use in minimally invasive surgical applications where soft tissue is being approximate with interrupted stitches. It is designed for use with a 5 mm trocar. The instrument is design for eight-knot deployments.
More Information

Not Found

No
The summary describes a mechanical surgical instrument for tissue fastening and does not mention any computational or data-driven features indicative of AI/ML.

No.
The device is described as a surgical instrument for tissue approximation, not for treating or rehabilitating a condition.

No

The device is described as a "reloadable instrument that is intended for the use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches." Its function is to facilitate suturing and knot deployment, which are therapeutic actions, not diagnostic.

No

The device description clearly states it is a "single patient use reloadable instrument" designed for use with a "5 mm trocar" and for "eight-knot deployments," indicating it is a physical 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
  • Device Description and Intended Use: The description clearly states that the ENDOPATH® Endoscopic Tissue Fastening System is a surgical instrument used during minimally invasive surgical procedures to approximate soft tissue with stitches. This is an in vivo (within the body) application.
  • Lack of Diagnostic Function: The device's purpose is to physically fasten tissue, not to analyze samples or provide diagnostic information.

Therefore, based on the provided information, the ENDOPATH® Endoscopic Tissue Fastening System is a surgical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches.

Product codes (comma separated list FDA assigned to the subject device)

GCJ

Device Description

The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is a single patient use reloadable instrument that is intended for the use in minimally invasive surgical applications where soft tissue is being approximate with interrupted stitches. It is designed for use with a 5 mm trocar. The instrument is design for eight-knot deployments.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

minimally invasive surgical applications

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)

Pre-clinical laboratory evaluations were performed to ensure that the device performs as intended. The bench data and the animal studies demonstrated that the ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® facilitated laparoscopic suturing, allowed one-handed knot deployment, and provided a secured knot in soft tissue with interrupted stitches.

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.

K980022, K972679

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.

Not Found

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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14:57

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992612

510(k) Summary of Safety and Effectiveness

| Submitter | Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Edwin O. Billips |
| Date | August 2, 1999 |
| Device Name | The Classification Name of this device is Manual Surgical Instrument; the
Common Name is Knot Tying Instrument; and the Trade/Proprietary Name
is ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated
VICRYL®. |
| Predicate Device | Ethicon Endo-Surgery's ENDOPATH® Endoscopic Tissue Fastening System
(ETFS)-K980022; Ethicon Endo-Surgery's ENDOPATH® Endoscopic Tissue
Fastening System (ETFS)-K972679. |
| Device
Description | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated
VICRYL® is a single patient use reloadable instrument that is intended for the
use in minimally invasive surgical applications where soft tissue is being
approximate with interrupted stitches. It is designed for use with a 5 mm
trocar. The instrument is design for eight-knot deployments. |
| Intended use | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated
VICRYL® is intended for use in minimally invasive surgical applications
where soft tissue is being approximate with interrupted stitches. |
| | Continued on next page |

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:

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14:57

·

.

510(k) Summary of Safety and Effectiveness,

| Technological
characteristics | The technological characteristics of the New Device are the same as those of
the Predicate Devices. The ENDOPATH® Endoscopic Tissue Fastening
System (ETFS) with Coated VICRYL® utilizes an absorbable suture to
approximate soft tissue with interrupted stitches. | | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Performance
data | Pre-clinical laboratory evaluations were performed to ensure that the device
performs as intended. The bench data and the animal studies demonstrated
that the ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with
Coated VICRYL® facilitated laparoscopic suturing, allowed one-handed knot
deployment, and provided a secured knot in soft tissue with interrupted
stitches. | | | | |
| Conclusion | Based on (21 CFR §807) and the information provided herein, we conclude
that the New Device is as safe, as effective, and performs as well as the
legally marketed device. | | | | |

Ethicon Endo-Surgery, Inc. ENDOPATH®ETFS with Coated VICRYL®

.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes. The bird faces left, and the overall design is simple and monochromatic.

.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Mr. Edwin O. Billips, RAC Senior Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839

Re: K992612

Trade Name: Endopath Endoscopic Tissue Fastening System with coated VICRYL® Regulatory Class: II Product Code: GCJ

Dated: August 2, 1999 Received: August 4, 1999

Dear Mr. Billips:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosures) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent dctcrmination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

3

Page 2 - Mr. Edwin O. Billips RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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510(k) Number (if known):_K992612

ENDOPATH Endoscopic Tissue Fastening System (ETFS) with Coa Device Name: VICRYL ・. ···

Indications For Use:

.

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The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative DevicesK992612
510(k) Number

Prescription Use X

(Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1