The 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.

Device Description

Wound retraction device providing access and protection from wound contamination. The Wound Protector Cylindrical Film is designed to retract an incision and provide protection from wound contamination. The Interior and Exterior rings are flexible to aid insertion, film retraction, and removal.

AI/ML Overview

The provided text describes a 510(k) summary for the Covidien Wound Protector, a sterile surgical drape. This document focuses on the device's technical characteristics and performance data related to its physical properties and usability, rather than clinical performance against specific metrics like accuracy or diagnostic efficacy that would require a study with human subjects, ground truth, and statistical analysis.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and the information provided. The "performance data" section in the document refers to a series of in-vitro and in-vivo tests designed to confirm the device's mechanical integrity and functionality, not a clinical study to prove efficacy or diagnostic capability.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test/Characteristic)	Reported Device Performance (Implied "Meets" for 510k Clearance)
Film Penetration (Tear) Resistance (ASTM D3787)	Passed (Implied by 510k clearance)
Strength of Attachment between Film and Exterior Ring (Tensile/Elongation)	Passed (Implied by 510k clearance)
Strength of Attachment between Film and Interior Ring (Tensile/Elongation)	Passed (Implied by 510k clearance)
Film Weld Seam Strength (ASTM D412)	Passed (Implied by 510k clearance)
Ease of Digital Insertion	Passed (Implied by 510k clearance)
Incision Retraction / Rolling	Passed (Implied by 510k clearance)
Ease of Use	Passed (Implied by 510k clearance)
Instrument Access / Specimen Removal	Passed (Implied by 510k clearance)
Specimen Manipulation	Passed (Implied by 510k clearance)
Ease of Removal	Passed (Implied by 510k clearance)
Film Tear Resistance In-Vivo	Passed (Implied by 510k clearance)
Tissue Trauma	Passed (Implied by 510k clearance)
Biocompatibility (ISO 10993-1: 2009)	Passed (Evaluated as per standard)

Note: The document lists the tests performed, and the 510(k) clearance implies that the device met the acceptance criteria for all these tests. Specific numerical values for the performance are not provided in this summary.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for each test. The performance data refers to in-vitro and in-vivo testing. For in-vivo tests, the sample size would typically refer to the number of animals or human subjects, but this is not provided. For in-vitro tests, the sample size would be the number of units tested.
Data Provenance: The document does not specify the country of origin of the data. It mentions both in-vitro (laboratory) and in-vivo testing, but does not indicate if it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, these tests are typically prospective tests conducted specifically for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device is a physical surgical drape, not an AI or diagnostic device that relies on interpretation of data to establish ground truth with experts. The "tests" are about physical properties and usability, not diagnostic accuracy.

4. Adjudication method for the test set

Not Applicable. As there's no diagnostic component requiring expert judgment or consensus, no adjudication method like 2+1 or 3+1 is relevant.

5. 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 is not an AI-assisted diagnostic or imaging device. Therefore, an MRMC comparative effectiveness study is not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used

For physical/mechanical tests (in-vitro): Ground truth is established by objective measurements against industry standards (e.g., ASTM D3787, ASTM D412) or established engineering specifications for strength, tear resistance, etc.
For usability/in-vivo tests: Ground truth for "Ease of Use," "Incision Retraction," "Tissue Trauma," etc., would be established through observation, subjective assessment by trained personnel (possibly surgeons or medical professionals simulating use), and potentially histological examination for tissue trauma. However, the specific methodology for establishing this "ground truth" (or assessment criteria) is not detailed.
For biocompatibility: Ground truth is established by adherence to the ISO 10993-1:2009 standard, which involves specific biological evaluation tests to ensure the materials are safe for patient contact.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

Summary

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Covidien (formerly registered as Tyco Healthcare, LP)

Page 1 of (2)

510(k) Summary of Safety and Effectiveness

SUBMITTER:

Covidien (formerly registered as Tyco Healthcare, LP) 60 Middletown Avenue North Haven, CT 06473 Tel. No .: (203) 492-5000

CONTACT PERSON:

Joseph Canavan Senior Design Quality Engineer Covidien Phone: (203) 492-8032 Fax: (203) 492-5029

DATE PREPARED: January 6, 2012

TRADE/PROPRIETARY NAME: Wound Protector

COMMON/USUAL NAME: Sterile Surgical Drape

CLASSIFICATION NAME: Surgical Drape and Drape Accessories per 21 CFR 878.4370

PREDICATE DEVICE: Applied Medical, Alexis ™ Wound Retractors (K041711) .

DEVICE DESCRIPTION:

Wound retraction device providing access and protection from wound contamination.

INTENDED USE: The 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.

TECHNOLOGICAL CHARACTERISTCS:

MATERIALS:

PERFORMANCE DATA:

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

The Wound Protector Cylindrical Film is designed to retract an

incision and provide protection from wound contamination. The Interior and Exterior rings are flexible to aid insertion, film

All patient-contacting components of the Wound Protector are

accordance with ISO 10993-1: 2009, Biological Evaluation of

comprised of materials that have been evaluated in

medical devices -- Part 1: Evaluation and Testing.

Film Penetration (Tear) Resistance (ASTM D3787) O
Strength of Attachment between Film and Exterior Ring O (Tensile/Elongation)
Strength of Attachment between Film and Interior Ring O (Tensile/Elongation)
Film Weld Seam Strength (ASTM D412) 0
Ease of Digital Insertion 0

retraction, and removal.

Traditional 510(k), Wound Protector

Page 22 of 66

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KI20061

Covidien (formerly registered as Tyco Healthcare, LP)

Page 29(2)

Incision Retraction / Rolling O
Ease of Use 0
Instrument Access / Specimen Removal 0

Specimen Manipulation 0
Ease of Removal o
Film Tear Resistance In-Vivo O
Tissue Trauma O .

Traditional 510(k), Wound Protector

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

Covidien LLC % Mr. Joseph Canavan Senior Design Quality Engineer 60 Middleton Avenue North Haven, Connecticut 06472

Re: K120061

Trade/Device Name: Wound Protector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCI, KKX Dated: January 6, 2012 Received: January 9, 2012

MAR 2 7 2012

Dear Mr. Canavan:

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

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Page 2 - Mr. Joseph Canavan

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 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 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Malle

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

Enclosure

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Covidien (formerly registered as Tyco Healthcare, LP)

KI 20061 Indications for Use

510(k) Number (if known):

Device Name: Wound Protector

Indications for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Niel RP Sedano for mxn

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

510(k) Number K12006

Traditional 510(k), Wound Protector

Page 20 of 66

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.