ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM by ETHICON ENDO-SURGERY, INC.

The Ethicon Endo Surgery® Endoscopic Suturing System (ESS) is a sterile, single-use, disposable suturing system for use in gastrointestinal procedures. It consists of the following components:

Endoscopic suturing device (ESD)
ESD mounting tool
Four (4) needle/ suture packs each in a needle-loading tool
Endoscopic knotting element device (KED)
Four (4) knotting element implants
KED handle stop
KED threading tool
The endoscopic suturing device (ESD) is the suturing component of the system. The ESD is mounted on commercially available flexible gastrointestinal endoscopes with 9.9-10.5 mm outer diameter and minimum 2.8 mm working channel such as the Olympus GIF-100 or GIF-140. Under endoscopic visualization, the ESD enables the physician to create continuous or interrupted suture lines in soft tissue. The ESD consists of a suturing assembly activated through a flexible control shaft terminating in an ergonomic handle. The suture assembly consists of a tissue recess and needle/suture assembly. The needle/suture assembly is loaded in the ESD prior to use with the supplied needle-loading tool. The suturing assembly of the ESD contains a tissue recess, which allows access to an amount of tissue necessary to achieve tissue bites. After tissue is located in the recess of the suturing assembly, the handle is squeezed. The handle is connected to a control cable, which actuates the needle/suture assembly, causing a circular needle, with suture attached, to be partially rotated within the suturing assembly. Following a full revolution (approximately 4 strokes), the needle returns to a stored position within the suturing assembly. The device is repositioned to perform another tissue bite or stitch. Following completion of the last stitch, the endoscope and ESD are removed. By spacing the stitches appropriately and then tightening the suture line, tissue approximation will be achieved.
The knotting element device (KED) is the suture terminating and cutting component of the system. The KED is used for the endoscopic termination of two ends of suture. The KED consists of an end-effector (a suture cutter and a two-piece knotting element implant) activated through a flexible control shaft terminating in an ergonomic handle. The knotting element implant consists of a mating polymer inner lock and outer washer sleeve, which is threaded with suture and crimped together through the actuation of the device. The two ends of the suture are threaded through the knotting element with the assistance of the KED threading tool and, while external tension is held on the ends of the suture lines, the device is passed through the working channel, over the suture to the termination location inside the body. The suture line is tightened, and the handle is activated to release the knotting element implant and to cut the suture line leaving approximately 1 cm of suture material and the knotting element implant. The mating parts of the knotting element implant secure the two ends of the suture. This fixation replaces the knot component of suture. The device and scope are then free of the suture line and can be removed.
The device is available with a variety of suture materials. The materials are described in the following table.
Trade Name: Pronova®, Material Type: Poly (hexafluoropropylene-VDF), Brief Description: Nonabsorbable, monofilament
Trade Name: Prolene®, Material Type: Polypropylene, Brief Description: Nonabsorbable, monofilament
Trade Name: Coated Vicryl®, Coated Vicryl® Plus Antibacterial, Material Type: Polyglactin 910, Brief Description: Absorbable, braided with and without antibacterial coating
Trade Name: PDS® II, Material Type: Polydioxanone, Brief Description: Absorbable, monofilament
Trade Name: Monocryl®, Monocryl® Plus Antibacterial, Material Type: Poliglecaprone 25, Brief Description: Absorbable, monofilament with and without antibacterial coating
The Ethicon Endo Surgery® Endoscopic Suturing System (ESS) is packaged sterile for single patient use. This system is commonly referred to by the product code EES01. Ethicon Endo Surgery also intends to market the ESD and KED separately. These product codes are yet to be determined.

AI/ML Overview

The provided text (K061770) describes the Ethicon Endo Surgery Endoscopic Suturing System (ESS) and its 510(k) summary for FDA clearance. However, it does not contain details about specific acceptance criteria, device performance metrics, or the study design that would include information on sample size, data provenance, expert qualifications, or adjudication methods.

The document only states:

"Performance Data. Bench testing was performed to demonstrate that the new device performs as intended. A clinical literature search was also conducted and the literature supports the intended use of the new device."

This is a very high-level statement and lacks the specificity required to answer most of your detailed questions.

Therefore, I cannot populate the table or provide the requested information from the given text. The text does not elaborate on:

Acceptance Criteria and Reported Device Performance: No specific metrics (e.g., success rate, tissue approximation strength, time to suture) or criteria are mentioned, nor are specific performance results reported from the bench testing.
Sample Size and Data Provenance: No numbers for samples (test or training set), nor information on whether the data was from a specific country or if it was retrospective/prospective.
Number of Experts and Qualifications: No mention of experts for ground truth establishment.
Adjudication Method: Not applicable as no expert review process is described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No mention of such a study, or human reader improvement with/without AI. This device is a surgical tool, not an AI diagnostic system.
Standalone Performance Study: The document refers only to "bench testing" and "clinical literature search," not a standalone algorithm performance study. As it's a physical device, the concept of "standalone algorithm performance" (without human-in-the-loop) isn't directly applicable in the same way as an AI diagnostic device.
Type of Ground Truth: Not applicable, as no ground truth for a diagnostic task is mentioned.
Training Set Sample Size: No training set mentioned.
Ground Truth for Training Set: Not applicable.

In summary, the provided 510(k) summary focuses on device description, indications for use, technological characteristics compared to predicate devices, and a general statement about performance data, but it does not provide the detailed study design and results typically found for AI/imaging device clearances related to performance metrics and clinical studies.

Summary

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K061770 Page 1/3

510(k) Summary

SEP 2 5 2006

Company Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242

Contact Tom Bosticco Project Manager, Quality Systems & Regulatory Affairs Telephone: (513) 337-8935 Fax: (513) 337-2935 Email: tbosticc@eesus.jnj.com

Date Prepared June 22, 2006

Device Name Trade Name: Ethicon Endo Surgery Endoscopic Suturing System Common or Usual Name: Endoscopic Suturing System Classification Name: Endoscopes and accessories [21 CFR 876.1500 (KOG)]

Predicate Devices Bard® EndoCinch™ Suturing System (K003956) ENDOPATH® Endoscopic Tissue Fastening System (K972679) LSI Solutions Flexible Suture Placement Device and Acc. (K011016)

Device Description The Ethicon Endo Surgery® Endoscopic Suturing System (ESS) is a sterile, single-use, disposable suturing system for use in gastrointestinal procedures. It consists of the following components:

Endoscopic suturing device (ESD) 1
2 ESD mounting tool
3 Four (4) needle/ suture packs each in a needle-loading tool
4 Endoscopic knotting element device (KED)
5 Four (4) knotting element implants
6 KED handle stop
7 KED threading tool

The endoscopic suturing device (ESD) is the suturing component of the system. The ESD is mounted on commercially available flexible gastrointestinal endoscopes with 9.9-10.5 mm outer diameter and minimum 2.8 mm working channel such as the Olympus GIF-100 or GIF-140. Under endoscopic visualization, the ESD enables the physician to create continuous or interrupted suture lines in soft tissue. The ESD consists of a suturing assembly activated through a flexible control shaft terminating in an ergonomic handle. The suture assembly consists of a tissue recess and needle/suture assembly. The needle/suture assembly is loaded in the ESD prior to use with the supplied needle-loading tool. The suturing assembly of the ESD contains a tissue recess, which allows access to an amount of tissue necessary to achieve tissue bites. After tissue is located in the recess of the suturing assembly, the handle is squeezed. The handle is connected to a control cable, which actuates the needle/suture assembly, causing a circular needle, with suture attached, to be partially rotated within the suturing assembly. Following a full revolution (approximately 4 strokes), the needle returns to a stored position within the suturing assembly. The device is repositioned to perform

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K061770 page 2/3

another tissue bite or stitch. Following completion of the last stitch, the endoscope and ESD are removed. By spacing the stitches appropriately and then tightening the suture line, tissue approximation will be achieved.

The knotting element device (KED) is the suture terminating and cutting component of the system. The KED is used for the endoscopic termination of two ends of suture. The KED consists of an end-effector (a suture cutter and a two-piece knotting element implant) activated through a flexible control shaft terminating in an ergonomic handle. The knotting element implant consists of a mating polymer inner lock and outer washer sleeve, which is threaded with suture and crimped together through the actuation of the device. The two ends of the suture are threaded through the knotting element with the assistance of the KED threading tool and, while external tension is held on the ends of the suture lines, the device is passed through the working channel, over the suture to the termination location inside the body. The suture line is tightened, and the handle is activated to release the knotting element implant and to cut the suture line leaving approximately 1 cm of suture material and the knotting element implant. The mating parts of the knotting element implant secure the two ends of the suture. This fixation replaces the knot component of suture. The device and scope are then free of the suture line and can be removed.

Trade Name	Material Type	Brief Description
Pronova®	Poly (hexafluoropropylene-VDF)	Nonabsorbable, monofilament
Prolene®	Polypropylene	Nonabsorbable, monofilament
Coated Vicryl®Coated Vicryl® PlusAntibacterial	Polyglactin 910	Absorbable, braided with andwithout antibacterial coating
PDS® II	Polydioxanone	Absorbable, monofilament
Monocryl®Monocryl® PlusAntibacterial	Poliglecaprone 25	Absorbable, monofilament withand without antibacterial coating

The device is available with a variety of suture materials. The materials are described in the following table.

The Ethicon Endo Surgery® Endoscopic Suturing System (ESS) is packaged sterile for single patient use. This system is commonly referred to by the product code EES01. Ethicon Endo Surgery also intends to market the ESD and KED separately. These product codes are yet to be determined.

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K061770 Page 3/3

Indications for Use The Ethicon Endo Surgery® Endoscopic Suturing System (ESS) is indicated for endoscopic placement of suture(s) and approximation of soft tissue.

Technological Characteristics The Ethicon Endo Surgery® Endoscopic Suturing System (ESS) is similar to the design of the predicate device, the Bard® EndoCinch™ Suturing System. Both devices mount to a commercially available endoscope and use needle and suture to endoscopically approximate soft tissue. Both devices include an endoscopic means of suture termination. The new device is different from the predicate device in that it uses a curved instead of a straight needle. In addition, the new device utilizes a tissue recess instead of a vacuum chamber in order to access soft tissue for suturing and approximation. A second predicate, LSI Solutions Flexible Suture Placement Device, utilizes a tissue recess similar to the new device. In addition, the LSI device contains an optional vacuum function.

Performance Data. Bench testing was performed to demonstrate that the new device performs as intended. A clinical literature search was also conducted and the literature supports the intended use of the new device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, line-art style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2006

Ethicon Endo-Surgery Inc. % Mr. Tom Bosticco Project Manage, Quality Systems & Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242-2839

Re: K061770

Trade/Device Name: Ethicon Endo Surgery® Endoscopic Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: August 29, 2006 Received: August 30, 2006

Dear Mr. Bosticco:

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 oractice, 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 controis. 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 Fart 820); and if applicable, the electronic product radiation control provisions (Sections 331-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Tom Bosticco

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,

Melkerson

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

510(k) Number (if known): KOLL 770

Device Name: Ethicon Endo Surgery® Endoscopic Suturing System.

Indications for Use:

The Ethicon Endo Surgery Endoscopic Suturing System is indicated for endoscopic placement of suture(s) and approximation of soft tissue.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Division of General, Restorative, age 1 of 1 and Neurological Devices

510(k) Number

(Posted November 13, 2003)

Regulation Number and Section

§ 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.