The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.

Device Description

Wound retraction device providing abdominal access and Protection from wound contamination

AI/ML Overview

Here's an analysis of the provided information regarding the Surgisleeve™ Wound Protector XS, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (Assessment Method)
Film Penetration Resistance	In-vitro testing
Strength of Attachment Between Film and Proximal Ring	In-vitro testing
Strength of Attachment Between Film and Distal Ring	In-vitro testing
Film Weld Seam Strength	In-vitro testing
In-Vivo Use: Ring Insertion and Rolling	In-vivo testing
In-Vivo Use: Instrument Insertion and Removal	In-vivo testing
In-Vivo Use: Specimen removal	In-vivo testing
In-Vivo Use: Thoracic use	In-vivo testing
In-Vivo Use: Thoracic use specimen removal	In-vivo testing
In-Vivo Use: Digital ring removal	In-vivo testing
Biocompatibility (Materials)	Evaluated in accordance with ISO 10993-1:2009

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

The provided 510(k) summary does not specify the sample sizes used for the in-vitro or in-vivo testing. The data provenance (e.g., country of origin, retrospective/prospective) is also not explicitly stated. However, given the context of a 510(k) submission, the testing would typically be conducted by or for the manufacturer (Covidien) and would be considered prospective for the purpose of demonstrating device performance for regulatory submission.

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

This information is not provided in the given document. For a medical device like a wound protector, "ground truth" often relates to objective physical properties and functional performance rather than expert interpretation of images or clinical data. The "in-vivo use" testing would likely involve animal models or human cadavers/simulators, and the assessment would be based on direct observation of the device's function, potentially by engineers, surgeons, or trained personnel.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For the mechanical and functional tests described, it's unlikely that an adjudication process similar to clinical image interpretation (e.g., 2+1, 3+1) would be used. Performance would be assessed against predefined criteria and specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted. The device is a physical wound protector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Surgisleeve™ Wound Protector is a physical medical device, not an algorithm. Its performance is inherent in its design and materials, and it functions independent of any algorithm.

7. Type of Ground Truth Used

The ground truth used for this device would be primarily objective physical measurements and functional performance observations during in-vitro and in-vivo testing. For example:

Film Penetration Resistance: Measured force required to penetrate the film.
Strength of Attachment: Measured force required to detach components.
Weld Seam Strength: Measured strength of the welded seams.
In-Vivo Use: Direct observation and assessment of the device's ability to be inserted, retracted, allow instrument passage, and facilitate specimen removal without failure or adverse events in a simulated or actual surgical environment.
Biocompatibility: Established by adherence to ISO 10993-1:2009, which involves various biological and chemical tests.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The design and manufacturing processes are informed by engineering principles and material science.

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

Not applicable. As the device is not an AI algorithm, there is no training set or associated ground truth establishment process in this context. The "ground truth" for the device's design and manufacturing is derived from established engineering standards, material specifications, and pre-clinical testing protocols.

Summary

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Surgisleeve™ Wound Protector XS

K140064
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510(k) Summary

SUBMITTER:	Covidien60 Middletown AvenueNorth Haven, CT 06473 USATel. No.: (203) 492-5000
CONTACT PERSON:	Michael KoczocikProduct Specialist, Regulatory AffairsPhone: (203) 492-6312Fax: (203) 492-5029
DATE PREPARED:	January 2014
TRADE/PROPRIETARY NAME:	Surgisleeve™ Wound Protector
Product Code(s)	GCJKKX
COMMON/USUAL NAME:	Wound Protector
CLASSIFICATION NAME:	Endoscope and accessories per 21 CFR 876.1500Surgical Drape and Drape Accessories per 21 CFR 878.4370
PREDICATE DEVICE(S):	Applied Medical, Alexis™ Wound Retractors (K041711),Covidien Surgisleeve™ Wound Protector (K120061)
DEVICE DESCRIPTION:	Wound retraction device providing abdominal access andProtection from wound contamination
INTENDED USE:	The Surgisleeve™ Wound Protector is indicated for use to access theabdominal cavity during surgery through an atraumatically retractedincision, deliver maximum exposure of the abdominal cavity withminimum incision size, and protect against wound contaminationduring laparoscopic and open surgery. Additionally, the small sizeWound Protector is indicated for use to access the thoracic cavityduring cardiac and general surgical procedures through anatraumatically retracted incision. The extra-small Wound Protector isalso indicated for use to access the thoracic cavity and other softtissue retraction during cardiac and general surgical proceduresthrough an atraumatically retracted incision.
TECHNOLOGICALCHARACTERISTICS	The Surgisleeve™ Wound Protector Cylindrical Film is designed toretract an incision and provide protection from wound contamination.The interior and exterior rings are flexible to aid insertion, filmretraction, and removal.
MATERIALS:	The Surgisleeve™ Wound Protector is comprised of materials thathave been evaluated in accordance with ISO 10993-1:2009, BiologicalEvaluation of medical devices - Part 1: Evaluation and Testing.

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Surgisleeve™ Wound Protector XS

PERFORMANCE DATA:

In-vitro and in-vivo testing to support the intended use of this device includes:

Film Penetration Resistance .
Strength of Attachment Between Film and Proximal Ring, Distal . Ring
Film Weld Seam Strength .
. In-Vivo Use:
- . Ring Insertion and Rolling,
- Instrument Insertion and Removal, .
- . Specimen removal,
- . Thoracic use,
- . Thoracic use specimen removal,
- . Digital ring removal

CONCLUSION:

The results of the performance evaluation demonstrate that the Surgisleeve™ Wound Protector (subject device) performed substantially equivalent to the predicate devices, the Alexis™ wound retractor (K041711) and the Covidien Surgisleeve™ wound protector (K120061).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 12, 2014

Covidien Mr. Michael Koczocik Product Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K140064

Trade/Device Name: Surgisleeve" Wound Protector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, KKX Dated: January 10, 2014 Received: January 10, 2014

Dear Mr. Koczocik:

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 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

Image /page/2/Picture/11 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 a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

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Page 2 - Mr. Michael Koczocik

forth in the quality systems (OS) 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 tollfree 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/ReportalProblem/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,

Felipe Aquel

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Surgisleeve™ Wound Protector XS

Indications for Use

510(k) Number (if known): K140064

Device Name: Surgisleeve™ Wound Protector

Indications for Use:

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical devices 510(k) Number: K140064

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.