The SILS™ Clincher* single use articulating clincher has application in a variety . of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures.

The SILS™ Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

The SILS™ Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection.

The SILS™ L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery.

The SILS™ Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

Device Description

Each single use SILSTM Hand Instrument contains a pistol grip, a rigid shaft with an articulating and rotating end effector, and opposing jaws or an electrocautery hook at the distal end.

The clincher, dissector, grasper, and shears contain opposing jaws to manipulate tissue, and the dissector, L-hook, and shears administer electrocautery. The end effector of each instrument articulates when the handle is deflected relative to the shaft and rotates when a rotation wheel is turned.

AI/ML Overview

The provided text describes a 510(k) summary for several endoscopic hand instruments (SILS™ Clincher, Dissector, Grasper, L-Hook, and Shears). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies proving specific performance criteria in a clinical setting. Therefore, many of the requested details, particularly those related to AI algorithm performance studies, will not be present in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy thresholds). The acceptance criteria for a 510(k) submission like this revolve around demonstrating substantial equivalence to legally marketed predicate devices in terms of indications for use, technological characteristics, and safety and effectiveness.

The "performance data" mentioned refers to in-vitro and in-vivo testing to support the intended use and biological evaluation in accordance with ISO 10993-1:2003 for patient contact materials. However, specific quantitative results or how these results meet pre-defined acceptance criteria are not detailed in this summary.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) context):

Acceptance Criteria Category	Specific Criteria (Inferred from 510(k))	Reported Device Performance (as stated in document)
Intended Use	Device performs functions described in Indications for Use (clamping, grasping, dissecting, cutting, cautery in endoscopic procedures).	Stated application in a variety of endoscopic, gynecological, and general laparoscopic procedures for tasks like clamping, grasping, dissecting, cutting, and cautery.
Technological Equivalence	Similar design principles (pistol grip, rigid shaft, articulating/rotating end effector, opposing jaws/electrocautery hook) to predicates.	The clincher, dissector, grasper, and shears contain opposing jaws. Dissector, L-hook, and shears administer electrocautery. End effector articulates and rotates.
Biocompatibility	All patient contact materials comply with ISO 10993-1:2003.	"All patient contact materials in the SILSTM Hand Instruments have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices -- Part 1: Evaluation and Testing."
Safety & Effectiveness	Evidence of safe and effective operation for intended use (e.g., mechanical integrity, electrical safety for cautery).	"In-vitro and in-vivo testing has been performed in support of the intended use of these devices." (No specific results provided in this summary).

Study Details (Based on available information in the document)

Since this is a 510(k) summary for conventional surgical instruments, there is no mention of an AI-powered device or associated studies. Therefore, many of the questions related to AI performance, ground truth, and expert evaluation are not applicable.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable / Not provided. The document refers to "in-vitro and in-vivo testing" but does not specify sample sizes, provenance, or whether the data was retrospective or prospective. This kind of detail is typically found in the full test reports, not a 510(k) summary.
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):
- Not Applicable. As this is not an AI device, there's no concept of establishing "ground truth" by experts in this context for diagnostic performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This is relevant for diagnostic studies with human readers or AI.
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:
- No. This document does not mention an MRMC study or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For mechanical surgical instruments, "ground truth" would relate to successful mechanical operation, tissue manipulation, and safety, assessed through engineering tests, pre-clinical models (in-vitro/in-vivo), and potentially clinical observations, not derived from expert consensus on images or pathology.
The sample size for the training set:
- Not Applicable. There is no AI model mentioned, thus no training set.
How the ground truth for the training set was established:
- Not Applicable. There is no AI model mentioned, thus no training set ground truth.

Summary

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Surgical Devices, a global business unit of Tyco Healthcare Group

5. 510(K) SUMMARY:

510(k) Summary of Safety and Effectiveness:

SEP = 1 2009

SUBMITTER: Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473

CONTACT PERSON:

Robert Zott Program Director, Regulatory Affairs Phone: (203) 492-6013 Fax: (203) 492-5029

DATE PREPARED:

Revised August 13, 2009

TRADE/PROPRIETARY NAME:

SILSTM Clincher* / SILSTM Dissector* SILSTM Grasper* / SILSTM L-Hook* SILS™ Shears*

COMMON/USUAL NAME:

Endoscopic Hand Instruments

CLASSIFICATION NAME:

PREDICATE DEVICE(S):

K951589: Auto Suture™ Modified Endoscopic Hand Instruments K914753: Auto Suture™ Articulating Endoscopic Clamp K914752: Auto Suture™ Articulating Endoscopic Scissors K905426: Auto Suture™ Modified Endo Stream Suction/Irrigation Device K904578: Auto Suture™ Modified Endoscopic Clamp

PRIOR RELATED SUBMISSION(S):

For Single Incision Procedures:

K090419: SILSTM Stitch Endoscopic Suturing Device

K082619: SILS™ Port Multiple Instrument Access Port

K072814: Convenience Kit for "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures."

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All predicate devices including those cleared in the prior related submissions are manufactured by Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien)

· DEVICE DESCRIPTION:

INDICATIONS:

Each single use SILSTM Hand Instrument contains a pistol grip, a rigid shaft with an articulating and rotating end effector, and opposing jaws or an electrocautery hook at the distal end.

The SILS™ Clincher* single use articulating clincher has application in a variety of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures.

The SILSTM Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

The SILSTM Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological. and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection.

The SILSTM Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

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TECHNOLOGICAL CHARACTERISTICS:

.
.
.
.

MATERIALS:

PERFORMANCE DATA:

All patient contact materials in the SILSTM Hand Instruments have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices -- Part 1: Evaluation and Testing.

In-vitro and in-vivo testing has been performed in support of the intended use of these devices.

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Image /page/3/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with healthcare.

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

Covidien LP % Mr. Robert Zott Program Director, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06511

Re: K091869

Trade/Device Name: SILS™ Clincher*, SILS™ Dissector*, SILS™ Grasper*, SILS™ L-Hook*, SILS™ Shears*

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 13, 2009 Received: August 14, 2009

Dear Mr. Zott:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Robert Zott

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/indr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Michal N. Meller

Mark N. Melkerso. Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K091869

Indications for Use

510(k) Number (if known): K091869

Device Name:

Indications For Use:

SILS™ Clincher*, SILS™ Dissector*, SILS™ Grasper*, SILS™ L-Hook*, SILS™ Shears*

Specific trade names to be determined.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number. 2091865

Page 1 of __

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.