3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.

Device Description

The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is a sterile adhesive film that is applied pre-operatively to skin. The film adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The CHG contained in the adhesive provides antimicrobial activity to reduce the risk of microbial contamination in the surgical wound.

The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape consists of a transparent, conformable, breathable fluid barrier film laminated to a lightly-tinted, acrylic pressure-sensitive adhesive that contains 2% w/w Chlorhexidine Gluconate (CHG). The adhesive drape is delivered on a silicone-coated release liner that is discarded after application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies conducted to prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Predicate Device K801550)	Reported Device Performance (3M™ Steri-Drape™ CHG)	Comparison
Intended Use	Antimicrobial incise drape with continuous antimicrobial activity for external use only.	Antimicrobial incise drape with continuous antimicrobial activity for external use only.	Same
Design/Materials	Antimicrobial impregnated adhesive coated on breathable film with silicone-coated release liner.	Antimicrobial impregnated adhesive coated on breathable film with silicone-coated release liner.	Same
Antimicrobial Agent	Iodine	Chlorhexidine Gluconate (CHG)	Both are well-characterized, broad-spectrum antimicrobials. Safety and efficacy testing demonstrates substantial equivalence.
Sold Sterile	Yes	Yes	Same
Sterilization Method	Gamma Sterilized, 10⁻⁶ SAL per ISO 11137	Ethylene Oxide sterilized, 10⁻⁶ SAL per ISO 11135	Different sterilization method, but same sterility assurance level (SAL). Iodine not compatible with EO, CHG not compatible with gamma. Both sterilized to 10⁻⁶ SAL.
Packaging	Foil Pouch	Film/Tyvek Pouch	Foil laminate for Ioban (protects from EO if in kit). Film/Tyvek for CHG (enables EO sterilization).
Sterility Assurance Level	SAL 10⁻⁶	SAL 10⁻⁶	Same
Principles of Operation	Sterile adhesive film applied pre-operatively, incised through by surgeon, provides sterile barrier, antimicrobial agent reduces microbial contamination.	Sterile adhesive film applied pre-operatively, incised through by surgeon, provides sterile barrier, antimicrobial agent reduces microbial contamination.	Same
Biocompatibility	Not cytotoxic, slight irritant, not a potential skin sensitizer	Not cytotoxic, slight irritant, not a potential skin sensitizer	Same
Tensile and Elongation	Tensile > 1365 g/25mm and Elongation > 500%	Tensile > 1365 g/25mm and Elongation > 500%	Same
Moisture Vapor Transmission Rate (MVTR)	> 400 g/m²/24 hrs	> 400 g/m²/24 hrs	Same
Flammability	Class I (Normal)	Class I (Normal)	Same
Barrier Performance	Level 4 (according to AAMI PB70:2012)	Level 4 (according to AAMI PB70:2012)	Same
In vitro Antimicrobial Performance	Broad Spectrum, > 4 log reduction at 90 min	Broad Spectrum, > 4 log reduction at 90 min	Same
In vivo Porcine Model (Wound Contamination)	Significant reduction in microbial contamination compared to placebo drape	T0: CHG drape lower than placebo (0.35 log₁₀ difference, P=0.026) T4: CHG drape lower than placebo (0.68 log₁₀ difference, P=0.001) Log₁₀ CFU/cm² under drape lower than placebo (0.70 log₁₀ difference, Exact P-value not provided in text, but indicated as highly significant and lower than 0.0001 based on table format and values)	Test article reduces microbial contamination of surgical wound compared to the placebo
Adhesion to Skin (Wet Challenge)	No statistical difference in skin adhesion when compared to predicate over specific prep solutions.	No statistical difference in skin adhesion over either DuraPrep Solution or PVP-I prep solutions.	Same performance as predicate
Adhesion to Skin (Dry Challenge)	Similar removal force and skin reactions when compared to predicate.	Removal force of test article is higher than predicate, no difference in skin reactions.	Similar performance to predicate
Adhesion to Skin (Fragile Skin)	No adverse events and acceptable removal force.	No adverse events associated with test article post-wear; removal force slightly higher for test article.	Similar performance to predicate

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

Bench Testing (In vitro): The exact sample sizes for each specific bench test (Tensile, MVTR, Flammability, Barrier, Antimicrobial Activity) are not explicitly stated. The document mentions "sample cut to size" for the device components tested. The data provenance is internal, as "Bench testing was performed to demonstrate substantial equivalence for this submission."
In vivo Animal Efficacy Data: The sample size for the porcine model is not explicitly stated. The study involved a comparison of "test versus placebo drape." The data provenance is internal, as "In vivo animal testing was performed to demonstrate antimicrobial efficacy compared with a placebo incise drape."
Clinical Performance Data (Adhesion to Skin):
- In-house clinical panels (wet and dry challenge): The exact number of subjects or samples is not specified, only "Finished Drape Samples, cut to size." Data provenance is internal.
- External clinical study: The exact number of subjects is not specified, but it involved "subjects with very dry and potentially fragile skin types." Data provenance is external ("Outside clinical adhesion studies were conducted").

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

This information is not provided in the document. The studies are primarily focused on physical and microbiological performance, and clinical adhesion, rather than interpretation of diagnostic images or outcomes that would typically require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the studies described do not involve human interpretation or subjective assessments that would require an adjudication method. The studies are quantitative measurements of device performance.

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

An MRMC comparative effectiveness study was not done. This type of study is typically relevant for AI-powered diagnostic devices, which is not the case for this antimicrobial incise drape.

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

This is not applicable as the device is a physical medical device (incise drape), not an algorithm or AI system.

7. The Type of Ground Truth Used

Bench Testing: The ground truth for bench tests is based on objective, quantifiable physical and microbiological properties and established standards (e.g., AAMI PB70:2012, ASTM F1670, 16 CFR 1610, ASTM E2315).
In vivo Animal Efficacy: The ground truth for antimicrobial efficacy in the porcine model was established by measuring microbial contamination (CFU/sample, CFU/cm²) under the test drape versus a placebo drape. This is essentially direct measurement of biological outcome.
Clinical Performance (Adhesion): The ground truth for adhesion studies was based on objective measurements of adhesion properties and visual assessment of skin reactions by unspecified clinical personnel.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI/machine learning model that requires a training set.

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

This is not applicable.

Summary

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3M Infection Prevention

3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul. MN 55144 651 733 1110

K140250

JUL 2 5 2014

510(k) SUMMARY Sponsor Information:

Applicant Name 3M Company 3M Health Care Infection Prevention Division 3M Center 2510 Conway Ave., Bldg 275-5W-06 St. Paul, MN 55144

Contact Person:

Phone Number: Fax Number: e-mail:

651-736-6117 651-737-5320 ktotushek@mmm.com

Kristin Totushek Regulatory Affairs

Date Prepared:

July 23, 2014

Device Name and Classification:

Trade Name:	3M™ Steri-Drape™ CHGAntimicrobial Incise Drape
Common or Usual Name:	Antimicrobial Incise Drape
Classification Name:	Surgical Drape and Drape Accessories
Product Code:	KKX per 21CFR 878.4370
Predicate Device:	3M™ loban™ 2 Antimicrobial Incise Drape(K801550)

Description of Device:

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3M Infection Prevention

3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110

The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape consists of a transparent, conformable, breathable fluid barrier film laminated to a lightly-tinted, acrylic pressuresensitive adhesive that contains 2% w/w Chlorhexidine Gluconate (CHG). The adhesive drape is delivered on a silicone-coated release liner that is discarded after application.

In vitro testing demonstrates that 3MTM Steri-Drape™ CHG Antimicrobial Incise Drape has broad spectrum antimicrobial activity.

Indications for Use:

Catalog #	Color	Size
8840EZ	Light pink	13 in x 13 in	34 cm x 35 cm
8848EZ	Light pink	22 in x 23 in	56 cm x 60 cm
8850EZ	Light pink	22 in x 17 in	56 cm x 45 cm
8851EZ	Light pink	22 in x 33 in	56 cm x 85 cm

Substantial Equivalence:

3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is substantially equivalent to the predicate device, 3M™ Ioban™ 2 Antimicrobial Incise Drape cleared under K801550.

3MTM Steri-Drape™ CHG Antimicrobial Incise Drape is composed of the same or similar components and has the same or similar performance, intended use and indications for use as the predicate device.

Based on the similarities to the predicate device, the minor differences do not present any new safety or effectiveness issues and the device is substantially equivalent to the predicate.

Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:

Characteristic	3M™ Steri-Drape™CHG AntimicrobialIncise Drape	3M™ Ioban™ 2Antimicrobial InciseDrape	Comparison
Intended Use	3M™ Steri-Drape™CHG Antimicrobial	3M™ Ioban™ 2Antimicrobial Incise	Same
Characteristic	3MTM Steri-DrapeTMCHG AntimicrobialIncise Drape	3MTM IobanTM 2Antimicrobial InciseDrape	Comparison
	Incise Drape isindicated for use asan incise drape withcontinuousantimicrobial activity.It is intended forexternal use only.	Drape is indicated foruse as an incise drapewith continuousantimicrobial activity.It is intended forexternal use only.
Design/Materials	Antimicrobialimpregnated adhesivecoated on breathablefilm with silicone-coated release liner.	Antimicrobialimpregnated adhesivecoated on breathablefilm with silicone-coated release liner.	Same
Antimicrobial	ChlorhexidineGluconate (CHG)	Iodine	Both are wellcharacterized, broadspectrum,antimicrobials. Safetyand efficacy testingdemonstratessubstantialequivalence.
Sold Sterile	Yes	Yes	Same
Sterilization Method	Ethylene Oxidesterilized, 106 SALper ISO 11135	Gamma Sterilized,106 SAL per ISO11137	Different sterilizationmethod but samesterility assurancelevel (SAL). Iodineis not compatiblewith Ethylene Oxide.CHG is notcompatible withgamma irradiation.Both devices aresterilized to 106 SALper respective ISOstandards.
Packaging	Film/Tyvek Pouch	Foil Pouch	Foil laminate is usedto protect Ioban fromEO exposure ifsterilized in a kit.Film/Tyvek is used toenable sterilization ofCHG drape with EO.
Sterility AssuranceLevel	SAL 10-6	SAL 10-6	Same
Characteristic	3M™ Steri-Drape™CHG AntimicrobialIncise Drape	3M™ Ioban™ 2Antimicrobial InciseDrape	Comparison
Principals ofOperation	The 3M™ Steri-Drape™ CHGAntimicrobial InciseDrape is a sterileadhesive film that isapplied pre-operatively to skin.The film adheres andconforms to bodycontours, providing asterile surface on topof the skin prior tosurgery. Thesurgeon incisesthrough the adhesivefilm and skin,ensuring a sterile filmbarrier all the way tothe edge of theincision. The CHGcontained in theadhesive providesadditionalantimicrobial activityto reduce the risk ofmicrobialcontamination of thesurgical wound.	The 3M™ Ioban™ 2Antimicrobial InciseDrape is a sterileadhesive film that isapplied pre-operatively to skin.The film adheres andconforms to bodycontours, providing asterile surface on topof the skin prior tosurgery. Thesurgeon incisesthrough the adhesivefilm and skin,ensuring a sterile filmbarrier all the way tothe edge of theincision. The iodinecontained in theadhesive providesadditionalantimicrobial activityto reduce the risk ofmicrobialcontamination of thesurgical wound.	Same
Biocompatibility	Not cytotoxic, slightirritant, not apotential skinsensitizer	Not cytotoxic, slightirritant, not apotential skinsensitizer	Same

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3M Infection Prevention

3M Center
2510 Conway, Bldg 275-05-W-06
St. Paul. MN 55144
651 733 1110

{3}------------------------------------------------

3M Infection Prevention

3M Center 2510 Convay, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110

Bench Testing Performance Data:

Bench testing was performed to demonstrate substantial equivalence for this submission, as recommended by the FDA Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes and the additional recommendations from FDA Draft Guidance on Premarket Notification [510(k)]

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3M Infection Prevention

3 M Center 2510 Conway. Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110

Submissions for Medical Devices that Include Antimicrobial Agents. Data submitted includes:

Barrier performance per AAMI PB70:2012 using ASTM F1670 "Resistance to • Synthetic Blood Penetration"
. Tensile and Elongation
. Flammability testing was performed per 16 CFR 1610
. Moisture Vapor Transmission Rate (MVTR)
in vitro Antimicrobial Activity Spectrum and Minimum Effective Concentration . (MEC) per ASTM E2315
. CHG Release Kinetics

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3M Infection Prevention

3M Center
2510 Conway, Bldg 275-05-W-06
St. Paul, MN 55144 651 733 1110

Characteristic	TestMethodDescription	DeviceComponentTested	Data Summary		Comparison
			Test Article:3MTM Steri-Drape™ CHGAnti-microbialIncise Drape	Predicate:3MTMIoban™ 2Anti-microbialIncise Drape
Tensile andElongation	Based onPSTC-131,ASTMD882,ASTMD3759	FinishedDrape InciseArea,sample cutto size	Tensile > 1365g/25mm andElongation>500%	Tensile >1365g/25mm andElongation>500%	Same
MVTR	Based onASTM E96and PayneCup Method	FinishedDrapesample, cutto size	> 400 g/m²/24hrs	> 400g/m²/24 hrs	Same
Flammability	16 CFR1610	FinishedDrapeSample	Class I(Normal)	Class I(Normal)	Same
BarrierPerformance	AAMIPB70:2012	FinishedDrapeSample, cutto size	Level 4	Level 4	Same
Antimicrobialperformance	ASTME2315	FinishedDrapeSample, cutto size	BroadSpectrum, > 4log reduction at90 min	BroadSpectrum, >.4 logreduction at90 min	Same
Characteristic	Descriptionof TestMethod	Device ComponentTested		DataSummary	Conclusion
		TestArticle	Placebo
Antimicrobialefficacy study-in vivo porcinemodel	Woundcontaminationrates of testversusplacebo drapein an in vivoporcinesurgicalmodel	FinishedDrapesample,cut to size.	Placebodrapesample, cutto size.	T0 $Log_{10}$CFU/sampleCHG drapelower thanplacebo(observeddifference 0.35$log_{10}$ , P=0.026)T4 $Log_{10}$CFU/sampleCHG drapelower thanplacebo(observeddifference 0.68$log_{10}$ ,P=0.001)Difference inchange in $log_{10}$counts/sampleT0 to T4,observeddifference 0.34$log_{10}$ , P=0.14$Log_{10}$CFU/cm²under drapelower thanplacebo(observeddifference 0.70$log_{10}$ , P=	Test articlereducesmicrobialcontaminationof surgicalwoundcompared tothe placebo

{6}------------------------------------------------

3M Infection Prevention

3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110

In vivo Animal Efficacy Data

In vivo animal testing was performed to demonstrate antimicrobial efficacy compared with a placebo incise drape.

{7}------------------------------------------------

3M 1nfection Prevention

3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110

Clinical Performance Data:

In house clinical panels were performed to demonstrate good adhesion to skin. Outside clinical adhesion studies were conducted to demonstrate safety and adhesion to various skin types.

Safety data were collected in these studies to demonstrate substantial equivalence for this submission to the predicate, 3M™ loban™ 2 Antimicrobial Incise Drape.

Test	DeviceComponentTested	Testing Summary	Summary	Comparison
Adhesion toSkin - in houseclinical panels	Finished DrapeSamples, cut tosize	Adhesioncomparison of 3M™Steri-Drape™ CHGAntimicrobial InciseDrape and 3M™loban™ 2Antimicrobial InciseDrape on skinprepped withDuraPrep Solution ora leading PVP-I prepsolution during a wetchallenge wear study	No statisticaldifference inskinadhesionover eitherDuraPrepSolution orPVP-I prepsolutions	Sameperformance aspredicate
Adhesion toskin - in houseclinical panels	Finished DrapeSamples, cut tosize	Adhesioncomparison of 3M™Steri-Drape™ CHGAntimicrobial InciseDrape and 3M loban2 AntimicrobialIncise Drape on skinduring a drychallenge wear study	Removalforce of testarticle ishigher thanpredicate, nodifference inskinreactions	Similarperformance topredicate
Adhesion toskin - externalclinical study	Finished DrapeSamples, cut tosize	Evaluation of skincondition and removalforce post- wear onsubjects with very dryand potentially fragileskin types	No adverseeventsassociatedwith testarticle post-wear;removalforce slightlyhigher fortest article	Similarperformance topredicate

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3M Infection Prevention

3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110

Performance, Safety and Efficacy Conclusion:

Based on bench, animal and clinical studies, 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is as safe, as effective and is demonstrated to be substantially equivalent to the predicate device, 3M™ lobanTM 2 Antinicrobial Incise Drape.

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Image /page/9/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" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures.

Public Health Service

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

July 25, 2014

3M Health Care Infection Prevention Division Ms. Kristin Totushek Regulatory Affairs Specialist 3M Center, 2510 Conway Ave. Bldg 275-5W-06 St. Paul, MN 55144

Re: K 140250

Trade/Device Name: 3MTM Steri-Drape ™ CHG Antimicrobial Incise Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: June 23, 2014 Received: June 24, 2014

Dear Ms. Totushek,

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.

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Page 2 - Ms. Totushek

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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 and Part 809), please contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri Purohit-Sheth, M.D. Clinical Deputy Director

Tejashri Purohit-Sheth, M.D. DAGRID/QDE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140250

Device Name

3MTM Steri-Drape™ CHG Antimicrobial Incise Drape

Indications for Use (Describe)

Catalog # Color	Size
8840EZ		Light pink 13 in x 13 in 34 cm x 35 cm
8848EZ -----------------------------------------------------------------------------------------------------------------------------------------------------------------------		Light pink 22 in x 23 in 56 cm x 60 cm
8850EZ -----------------------------------------------------------------------------------------------------------------------------------------------------------------------		Light pink 22 in x 17 in 56 cm x 45 cm
		8851EZ Light pink 22 in x 33 in 56 cm x 85 cm

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Sreekanth Gutala -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, Sreekanth Guta ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S Date: 2014.07.24 11:04:33 -04'00' PSC Publuhing Services (301) 44)-6740 Es FORM FDA 3881 (1/14) Page 1 of 2

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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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.