Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical surgical drape and the summary describes its material properties and performance characteristics, with no mention of AI or ML.

Therapeutic

No
The device is a surgical drape used to create a sterile field during surgery, not to treat a disease or condition.

Diagnostic

No

Explanation: The device is a surgical drape used to create a sterile field during surgical procedures, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical surgical drape made of fabric and film, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "create a sterile field for surgical procedures" and provide a barrier during surgery. This is a physical barrier function, not a diagnostic function.
Device Description: The description focuses on the physical properties of the drape (material, layers, barrier level) and its role in preventing fluid strike-through and microbial penetration during surgery. It does not mention any interaction with biological samples for diagnostic purposes.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
Performance Studies: The performance studies focus on physical properties and biocompatibility, not diagnostic accuracy or performance metrics relevant to IVDs (like sensitivity, specificity, etc., in a diagnostic context).

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical drape does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

3M Steri-Drape Fabric Surgical Drapes are used to create a sterile field for surgical procedures. They are provided sterile and intended for external use only.

3M Steri-Drape non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide (EtO) processing.

Non-sterile surgical drapes are sold to repackager or relabeler establishments for EtO sterilization according to ISO 11135-1:2007. Sterile surgical drapes are sold directly to end users after EtO sterilization validation to ISO 11135-1:2007.

Product codes (comma separated list FDA assigned to the subject device)

KKX

Device Description

The 3M Steri-Drape Fabric Surgical Drapes are one-piece, dual layer, single use disposable drapes with an AAMI Level 4 Liquid Barrier. The drapes are made of a blue absorbent nonwoven fabric thermally bonded to a blue protective barrier film. The drapes are intended to be placed over the patient prior to surgery and are designed to provide an absorbent sterile barrier during surgical procedures and stop fluid strike-through to protect the surgical site and patient from microbial penetration.

Steri-Drape Fabric Surgical Drapes are either provided sterile to end-users or non-sterile to kit manufacturers for further processing including EtO sterilization according to ISO 11135-1:2007

The drapes are provided in multiple sizes and shapes to meet the requirements of various clinical procedures. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes. All models utilize the same material technology.

The following tables list the catalog numbers of the drapes that are included within the scope of this submission. The drapes are separated into categories based on similarity of the design and features. The categories are as follows:

Category 1 - These drapes are comprised entirely of a non-woven/film construction and may or may not feature an aperture. The entire non-woven/film portion of the drape is considered an AAMI Level 4 Barrier, with the barrier continuing to the edge of the aperture. Any component material attached to or configured within the aperture is identical to that used in the corresponding, currently marketed, predicate drapes.

Category 2 –These drapes are comprised of a non-woven / film construction and also contain either a film area with aperture or incise area. The AAMI Level 4 Barrier non-woven/film portion of the drape continues to the edge of the film or incise area. The component materials of the film area with aperture or incise area are identical to those used in the corresponding, currently marketed, predicate drapes.

Category 3 - These drapes are comprised entirely of a non-woven/film construction and feature an aperture. Additionally, these drapes include an extra absorbent layer on top of the drape and side film segments. The entire non-woven woven portion of the drape is considered an AAMI Level 4 Barrier with the barrier continuing to the edge of the aperture. The extra absorbent layer on top of the drape are illustrated with a crosshatch. and side film segments are identical to those used in the corresponding, currently marketed, predicate drapes and do not impact barrier performance of the non-woven/film portion.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance testing was conducted using the sterilized, final finished device and consisted of the following tests in order to demonstrate substantial equivalence:

Tensile strength
Burst strength
Resistance to liquid penetration
Linting and particulate
Flammability
Biocompatibility (cytotoxicity, irritation and sensitization)

Key Results:

Tensile Strength: Test Article: Machine Direction (MD) = 106 N, Cross Direction (CD) = 58 N. Predicate: Machine Direction (MD) = 108 N, Cross Direction (CD) = 70.7 N. Substantially Equivalent.
Burst Strength: Test Article: Dry = 231 kPa, Wet = 193 kPa. Predicate: Dry = 225 kPa, Wet = 199 kPa. Substantially Equivalent.
Resistance to Liquid Penetration: Test Article: AAMI Level 4 - Pass with an AQL of 4% and RQL of 20%. Predicate: AAMI Level 4 - Pass with an AQL of 4% and RQL of 20%. Substantially Equivalent.
Linting: Test Article: Pass with a Log10 (lint count) of

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a cascading manner. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

August 18, 2014

3M Health Care Mr. Mark Burville Regulatory Affairs Manager 3M Center, 2510 Conway Ave., Building 275-5W-06 St Paul, MN 55144

Re: K140330 Trade/Device Name: 3 M Steri-Drape Fabric Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: July 14, 2014 Received: July 16, 2014

Dear Mr. Burville,

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. Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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

1

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 (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 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,

Mary S. Runner -S

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

2

Indications for Use

510(k) Number (if known) K140330

Device Name 3M Steri-Drape Fabric Surgical Drapes

Indications for Use (Describe)

3M Steri-Drape Fabric Surgical Drapes are used to create a sterile field for surgical procedures. They are provided sterile and intended for external use only.

3M Steri-Drape non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.

Non-sterile surgical drapes are sold to repackager or relabeler establishments for EtO sterilization according to ISO 11135-1:2007. Sterile surgical drapes are sold directly to end users after EtO sterilization validation to ISO 11135-1:2007.

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)

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Catalog Number(s)	Dimensions	Name/Descriptor
1031	228cm · 90in (Width Top)
182cm · 72in (Width Bottom)
285cm · 112in (Length)	Laparoscopic Drape/Supine Position
1032	228cm · 90in (Width Top)
117cm · 46in (Length of
Panel)
241cm · 95in (Length)	Laparoscopic Drape/Lithotomy
Position
1034	152cm x 200cm
60in x 78in	Central Venous Catheter Drape
1078	196cm x 200cm
No inches stated	Perineal Drape with Pouch
1079	195cm · 77in (Width Top)
117cm · 46in (Length of
Panel)
179cm · 70in (Length)	Gynecologic Drape
1080	195cm · 77in (Width Top)
117cm · 46in (Length of
Panel)
179cm · 70in (Length)	Gynecologic Drape
1081	152cm x164cm Upper
60in x 64in
117cm / 46in Lower	TUR/Urological Drape
1082	235cm · 92in
300cm · 118 in	Abdominal Vaginal Drape
1084	86cm x108cm
34in x 42in	Under Buttocks Drape with Pouch
1089	57cm x 66cm
22in x 26in	Utility Sheet (2)
1090	182cm x 228cm
72in x 90in	Femoral Angiography Drape
1092	57cm x 66cm
22in x 25in	Small Drape with Adhesive Aperture
1094	226cm x 320cm
90in x 126in	Arthroscopy Sheet with Pouch
1135	279cm x 183cm
110in x 72in
15cm x 13cm
5.9in x 5 in	Peripherally Inserted Central Catheter
Drape
*1190NS	228cm x 330cm
89in x 130in	Femoral Angiography Drape
1191	229cm x 330cm
90in x 130in	Femoral Angiography Drape
Catalog Number(s)	Dimensions	Name/Descriptor
1192	152cm x 170cm
60in x 67in	Venous/Arterial Access Drape
1193	290cm x 345cm
114in x 136in	Angiography Drape
1194	292cm · 115in (Width Top)
228cm · 89in (Width Bottom)
304cm · 120in (Length)	Arthroscopy Sheet with Pouch
2065	195cm · 77in (Width Top)
271cm · 106in (Total Length)	Abdominoperineal Incise Drape
7964	254cm x 279cm
100in x 110in	Abdominoperineal Incise Drape-
Lithotomy Position
7965	254cm · 100in (Width Top)
195cm · 76in (Width Bottom)
308cm · 121in (Length)	Cesarean Section Incise Sheet with
Pouch
7966	254cm · 100in (Width Top)
195cm · 76in (Width Bottom)
310cm · 122in (Length)	Cesarean Section Sheet with Aperture
Pouch
9023	76cm x 170cm
29in x 67in	Perineal Aperture Drape
9026	6cm x 8cm (Aperture)
2.3in x 3.1in
55cm x 55cm
21in x 21in	Aperture Drape
9027	Part 1 50cm x 75cm
19in x 19in
Part 2 50cm x 75cm
19in x 19in	Adjustable Aperture Drape
9027L	Part 1 75cm x 100cm
29in x 39in
Part 2 75cm x 100cm
29in x 39in	Adjustable Adhesive Aperture Drape
9028	6cm x 8cm (Aperture)
2.3 in x 3.1 in
75cm x 75cm
29in x 29in	Adhesive Aperture Drape
9029	15 cm x 6 cm (Aperture)
6 in x 2 in
75cm x 75cm
29in x 29in	Adhesive Aperture Drape
9030	6cm x 8cm (Aperture)
2 in x 3in
152cm x 120cm
60in x 47in	Adhesive Aperture Drape
Catalog Number(s)	Dimensions	Name/Descriptor
9031	8cm x 6cm (Aperture)	Adhesive Aperture Drape
	3 in x 2 in
	150cm x 183cm
	59in x 72in
*9033NS	150cm x 183cm	Triangular Aperture Drape
	59in x 72in
9040	75cm x 114cm	Leggings (2)
	29in x 44in
9040L (pair)	85cm x 130cm	Legging Long
	33in x 51in
9041	35cm x 60cm	Extremity Cover (S)
	13.5in x 23.5in
9042	35cm x 100cm	Extremity Cover (L)
	13.5in x 39in
9043	7 cm x 70 cm (split)	Adhesive Split Sheet
	2.5in x 25 in
	152cm x 183cm
	60in x 72in
9044	7cm x 70cm (split)	Adhesive Split Sheet
	2.5in x 25 in
	152cm x 250cm
	60in x 98in
9045	20cm x 100cm (split)	Adhesive Split Sheet
	7in x 39 in
	228cm x 260cm
	89.5in x 102in
9045R	20cm x 100cm (split)	Reinforced Adhesive Split Sheet
	7in x 39 in
	228cm x 260cm
	89.5in x 102in
9046	183cm x 200cm	Bilateral Adhesive Split Sheet
	72in x 78in
9046L	228cm x 260cm	Bilateral Adhesive Split Sheet
	89in x 102in
9047	183cm x 152cm	Neuro Split Sheet with Pouch
	72in x 60in
9048	20cm x 40cm (split)	Adhesive Split Sheet
	7in x 15 in
	228cm x 260cm
	90in x 102in
9050	12cm x 18cm (aperture)	Adhesive Aperture Drape
	4.5in x 8in
	228cm x 300cm
	90in x 138in
Catalog Number(s)	Dimensions	Name/Descriptor
9051	183cm x 315cm
72in x 124in	Thyroid Drape
9052	355cm x 293cm
140in x 115in	Hand Drape
9053	228cm x 300cm
89in x 118in	Extremity Drape
9054	195cm x 300cm
77in x 118in	Hand and Foot Drape
9055	300cm · 118in (Width Top)
228cm · 90in (Width Bottom)
353cm · 139in (Length)	Hip Drape with Pouches
9056	195cm x 300cm
77in x 118in	Bilateral Foot Drape
9057	292cm · 115in (Width Top)
228cm · 89in (Width Bottom)
305cm · 120in (Length)	Extremity Drape with Anesthesia
Screen
9058	228cm x 300cm
90in x 118in	Bilateral Knee Drape
9062	254cm · 100in (Width Top)
183cm · 72in (Width Bottom)
285cm · 112in (Length)	Laparotomy Drape-Transverse
9063	254cm · 100in (Width Top)
183cm · 72in (Width Bottom)
285cm · 112in (Length)	Laparotomy Drape
9066	85cm x 85cm
33in x 33in	Under Buttock Drape with Cuff
9067	45cm x 37cm
17.75in x 14.5in	Drape Sheet
9069	90cm x 75cm
36in x 30in	Drape Sheet
9070	114cm x 87cm
45in x 34in	Turban Drape Sheet
9071	97cm x 97cm
38 in x 38in	Drape Sheet
9072	114cm x 150cm
44in x 59in	Drape Sheet
9074	150cm x 150cm
60in x 60in	Instrument Table Cover/Drape Sheet
9077	200cm x 250cm
78in x 59in	Drape Sheet
9077R	150cm x 200cm
No inches stated	Instrument Table Cover Reinforced
9079	200cm x 228cm
78in x 90in	Drape Sheet
Catalog Number(s)	Dimensions	Name/Descriptor
9083	55cm x 55cm
19.75in x 19.75in	Adhesive Towel Drape
9084	75cm x 75cm
29in x 29in	Adhesive Towel Drape
9085	100cm x 85cm
39in x 33in	Adhesive Towel Drape
9085W	97cm x 115cm
38in x 45in	Adhesive Towel Drape
9086	100cm x75cm
39in x 29in	Adhesive Towel Drape
9087	183cm x 183cm
72in x 72in	Adhesive Drape Sheet
9088	200cm x 250cm
78in x 59in	Adhesive Drape Sheet
9089	170cm x 170cm
67in x 67in	Adhesive Drape Sheet
9090	300cm x 228cm
118in x 90in	Adhesive Drape Sheet
9196	16cm x 95cm (Split)
6in x 37in
228cm x 260cm
90in x 102in	Shoulder Split Sheet with Pouch
Catalog Number(s)	Dimensions	Name/Descriptor
1031	27cm x 30cm
10.5in x 11.5in (Aperture)
228cm · 90in (Width Top)
182cm · 72in (Width Bottom)
285cm · 112in (Length)	Laparoscopic Drape/Supine Position
1032	27cm x 30cm
10.5in x 11.5in (Aperture 1)
12cm x 15.5cm
4.5in x 6cm (Aperture 2)
228cm · 90in (Width Top)
117cm · 46in (Length of Panel)
241cm · 95in (Length)	Laparoscopic Drape/Lithotomy
Position
1034	34.5cm x 34.5cm (13.5in x 13.5in)
Film with 10cm (4 in) Circle Aperture
152cm x 200cm
60in x 78in	Central Venous Catheter Drape
1078	9cm x 12cm
3.3in x 4.5in (Aperture)
196cm x 200cm
77in x 78in	Perineal Drape with Pouch
1079	9cm x 12cm
3.3in x 4.5in (Aperture)
195cm · 77in (Width Top)
117cm · 46in (Length of Panel)
179cm · 70in (Length)	Gynecologic Drape
1080	9cm x 12cm
3.3in x 4.5in (Aperture)
195cm · 77in (Width Top)
117cm · 46in (Length of Panel)
179cm · 70in (Length)	Gynecologic Drape
1081	20cm x 10cm (7.8in x 3.9in)
Film with 6cm
(2 in) Circle Aperture
152cm x164cm (60in x 64in)
117cm · 46in (Length of Panel)	TUR/Urological Drape
Catalog Number(s)	Dimensions	Name/Descriptor
1082	23cm x 28cm	Abdominal Vaginal Drape
	9in x 11in (Aperture)
	235cm · 92 in (Width)
	300cm · 118 in (Length)
1084	86cm x 63cm	Under Buttocks Drape with Pouch
	34in x 24.5in (Pouch)
	86cm x45cm
	34in x 17.5in
1089	57cm x 66cm	Utility Sheet (2)
	22in x 26in
1090	6.4cm x 8.9cm	Femoral Angiography Drape
	2.5in x 3.5in (Aperture)
	182cm x 228cm
	72in x 90in
1092	6cm · 2.25in (Circle	Small Drape with Adhesive Aperture
	Aperture)
	57cm x 66cm
	22in x 25in
1094	23cm x 28cm (9in x 11in) Film	Arthroscopy Sheet with Pouch
	with 6cm (2.25in) Circle
	Aperture
	226cm x 320cm
	90in x 126in
1135	28cm x 26cm (11in x 10in)	Peripherally Inserted Central Catheter
	Film with 15cm x 13cm (5.9in	Drape
	x 5in) Aperture
	183cm x 279cm
	72in x 110in
*1190NS	10cm x 7.5cm	Femoral Angiography Drape
	4in x 3in (Aperture)
	91cm x 330cm
	35in x 130in
	228cm x 330cm
	89in x 130in
1191	11cm x 14cm	Femoral Angiography Drape
	4in x 5.5in (Aperture)
	91cm x 228cm
	35in x 89in
	229cm x 330cm
	90in x 130in
1192	8cm x 20cm	Venous/Arterial Access Drape
	3in x 7.5in (Aperture)
	152cm x 170cm
	60in x 67in
Catalog Number(s)	Dimensions	Name/Descriptor
1193	7.5cm x 10cm
3in x 4in (Aperture)
154cm x 154cm
60in x 60in
290cm x 345cm
114in x 136in	Angiography Drape
1194	23cm x 28cm (9in x 11in) Film
with 6cm (2.25in) Circle
Aperture
292cm · 115in (Width Top)
228cm · 89in (Width Bottom)
304cm · 120in (Length)	Arthroscopy Sheet with Pouch
2065	41cm x 45cm
(16in x 17in) Incise
12cm x 15.5cm
(4.75in x 6in) Aperture
195cm · 77in
271cm · 106in
117cm · 46in (Length of Panel)	Abdominoperineal Incise Drape
7964	30cm x 30cm
12in x 12in (Incise)
254cm x 279cm
100in x 110in	Abdominoperineal Incise Drape-
Lithotomy Position
7965	30cm x 30cm
12in x 12in (Incise)
254cm · 100in (Width Top)
195cm · 76in (Width Bottom)
308cm · 121in (Length)	Cesarean Section Incise Sheet with
Pouch
7966	30cm x 30cm
12in x 12in (Incise) with 20cm
x 24 cm (8in x 9.5in) Aperture
254cm · 100in (Width Top)
195cm · 76in (Width Bottom)
310cm · 122in (Length)	Cesarean Section Sheet with Aperture
Pouch
9023	6cm x 8cm
2.3in x 3.1in (Aperture)
76cm x 170cm
29in x 67in	Perineal Aperture Drape
9026	6cm x 8cm
2.3in x 3.1in (Aperture)
55cm x 55cm
21in x 21in	Aperture Drape
Catalog Number(s)	Dimensions	Name/Descriptor
9027	11cm x 12.5cm
4in x 5in (Aperture)
Part 1 50cm x 75cm 19in x 29in
Part 2 50cm x 75cm 19in x 29in	Adjustable Aperture Drape
9027L	11cm x 12.5cm
4in x 5in (Aperture)
Part 1 75cm x 100cm
29in x 39in
Part 2 75cm x 100cm
29in x 39in	Adjustable Adhesive Aperture Drape
9028	6cm x 8cm
2.3in x 3.1in (Aperture)
75cm x 75cm
29in x 29in	Adhesive Aperture Drape
9029	15 cm x 6 cm
6in x 2in (Aperture)
75cm x 75cm
29in x 29in	Adhesive Aperture Drape
9030	6cm x 8cm
2in x 3in (Aperture)
152cm x 120cm
60in x 47in	Adhesive Aperture Drape
9031	8cm x 6cm
3in x 2in (Aperture)
150cm x 183cm
59in x 72in	Adhesive Aperture Drape
*9033NS	12cm x 11cm
4.5in x 4in (Aperture)
150cm x 183cm
59in x 72in	Triangular Aperture Drape
9040	75cm x 114cm (includes foldover)
29in x 44in	Leggings (2)
9040L (pair)	85cm x 130cm (includes foldover)
33in x 51in	Legging Long
9041	35cm x 60cm (includes foldover)
13.5in x 23.5in	Extremity Cover (S)
9042	35cm x 100cm (includes foldover)
13.5in x 39in	Extremity Cover (L)
Catalog Number(s)	Dimensions	Name/Descriptor
9043	7cm x 70cm
2.5in x 25in (Split)
152cm x 183cm
60in x 72in	Adhesive Split Sheet
9044	7cm x 70cm
2.5in x 25in (Split)
152cm x 250cm
60in x 98in	Adhesive Split Sheet
9045	20cm x 100cm
7in x 39 in (Split)
228cm x 260cm
89.5in x 102in	Adhesive Split Sheet
9045R	20cm x 100cm
7in x 39 in (Split)
228cm x 260cm
89.5in x 102in	Reinforced Adhesive Split Sheet
9046	15cm x 50 cm
6in x 19in (Split)
183cm x 200cm
72in x 78in	Bilateral Adhesive Split Sheet
9046L	44cm x 100cm
17in x 39in (Split)
228cm x 260cm
90in x 102in	Bilateral Adhesive Split Sheet
9047	16cm x 40cm
6in x 15in (Split)
183cm x 152cm
72in x 60in	Neuro Split Sheet with Pouch
9048	20cm x 40cm
7in x 15in (Split)
228cm x 260cm
90in x 102in	Adhesive Split Sheet
9050	12cm x 16 cm
4.5in x 6in (Aperture)
228cm x 300cm
90in x 118in	Adhesive Aperture Drape
9051	12cm x 12cm
4.5in x 4.5in (Aperture)
183cm x 315cm
72in x 124in	Thyroid Drape
Catalog Number(s)	Dimensions	Name/Descriptor
9052	15cm x 25cm (5.9in x 9.8in)	Hand Drape
	Film with 3cm
	(1 in) Circle Aperture
	355cm x 293cm
	140in x 115in

9053	11cm x 26cm (4.3in x 10in)	Extremity Drape
	Film with 6cm x 8cm (2in x
	3in) Aperture
	228cm x 300cm
	89in x 118in
9054	15cm x 25 cm (5.9in x 9.8in)	Hand and Foot Drape
	Film with 3cm
	(1 in) Circle Aperture
	195cm x 300cm
	77in x 118in
9055	34cm x 39cm (13in x 15in)	Hip Drape with Pouches
	Film with 20cm x 17.5cm (8in
	x 7in) Aperture
	300cm · 118in (Width Top)
	57cm · 22in
	(Width Bottom) 353cm · 139in
	(Length)
	246cm 96in (Length of
	Pouches)
	228cm · 90in (Total Overall
	Width Bottom)

9056	25cm x 50cm (9.8in x 19.6 in)	Bilateral Foot Drape
	Film with 4cm (1.5in) Circle
	Aperture
	195cm x 300cm
	77in x 118in
9057	11cm x 26 cm (4.3in x 10in)	Extremity Drape with Anesthesia
	Film with 6cm x 8cm (2in x	Screen
	3in) Aperture
	292cm · 115in (Width Top)
	228cm · 89in (Width Bottom)
	305cm · 120in (Length)
9058	11cm x 26 cm (4.3in x 10in)	Bilateral Knee Drape
	Film with 6cm x 8cm (2in x
	3in) Aperture
	228cm x 300cm
	90in x 118in
Catalog Number(s)	Dimensions	Name/Descriptor
9062	30cm x 10cm
12in x 4in (Aperture)
254cm · 100in (Width Top)
183cm · 72in (Width Bottom)
285cm · 112in (Length)	Laparotomy Drape-Transverse
9063	10cm x 30cm
4in x 12in (Aperture)
254cm · 100in (Width Top)
183cm · 72in (Width Bottom)
285cm · 112in (Length)	Laparotomy Drape
9066	85cm x 85cm
33in x 33in
Cuff is 25 cm of the 85 cm.	Under Buttock Drape with Cuff
9067	45cm x 37cm
17.75in x 14.5in	Drape Sheet
9069	90cm x 75cm
36in x 30in	Drape Sheet
9070	114cm x 87cm
45in x 34in	Turban Drape Sheet
9071	97cm x 97cm
38 in x 38in	Drape Sheet
9072	114cm x 150cm
44in x 59in	Drape Sheet
9074	150cm x 150cm
59in x 59in	Instrument Table Cover/Drape Sheet
9077	200cm x 150cm
78in x 59in	Drape Sheet
9079	200cm x 228cm
78in x 90in	Drape Sheet
9083	55cm x 55cm
19.75in x 19.75in	Adhesive Towel Drape
9084	75cm x 75cm
29in x 29in	Adhesive Towel Drape
9085	100cm x 85cm
39in x 33in	Adhesive Towel Drape
9085W	115cm x 97cm
45in x 38in	Adhesive Towel Drape
9086	100cm x75cm
39in x 29in	Adhesive Towel Drape
9087	183cm x 183cm
72in x 72in	Adhesive Drape Sheet
9088	250 cm x 150 cm
98in x 59in	Adhesive Drape Sheet
9089	170cm x 170cm
67in x 67in	Adhesive Drape Sheet
Catalog Number(s)	Dimensions	Name/Descriptor
9090	300cm x 228cm
118in x 90in	Adhesive Drape Sheet
9196	16cm x 95cm
6in x 37in (Split)
228cm x 260cm
90in x 102in	Shoulder Split Sheet with Pouch

Table 1 – Product Catalog Numbers, Dimensions and Name/Descriptor

5

6

7

8

The above catalog numbers are also available in non-sterile versions and are designated by NS following the catalog number.

*Note: 1190NS and 9033NS are only available in a non-sterile version.

9

Table 1 – Product Catalog Numbers, Dimensions and Name/Descriptor

10

11

12

13

14

15

16

The above catalog numbers are also available in non-sterile versions and are designated by NS following the catalog number.

*Note: 1190NS and 9033NS are only available in a non-sterile version.

17

510(k) Summary K140330

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Owner's Name

3M Health Care 3M Center, Building 275-5W-06 St. Paul, MN 55144

Contact Person

Mark Burville Regulatory Affairs Manager Telephone: 1-651-737-2027 Fax: 1-651-732-8822 E-Mail: mcburville@mmm.com

Date Summary Prepared

July 14, 2014

Trade/Proprietary Name

3M™ Steri-Drape™ Fabric Surgical Drapes

Common/Usual Name

Drapes, Surgical

Classification Name

Surgical drape and drape accessories

Product Code: KKX per 21CFR 878.4370

Benito Perez

Predicate Devices 3M Steri-Drape Surgical Fabric Drapes K031287

Intended Use

3M Steri-Drape Fabric Surgical Drapes are used to create a sterile field for surgical procedures. They are provided sterile and intended for external use only.

3M Steri-Drape non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide (EtO) processing.

18

Non-sterile surgical drapes are sold to repackager or relabeler establishments for EtO sterilization according to ISO 11135-1:2007. Sterile surgical drapes are sold directly to end users after EtO sterilization validation to ISO 11135-1:2007.

Description of Device

The 3M Steri-Drape Fabric Surgical Drapes are one-piece, dual layer, single use disposable drapes with an AAMI Level 4 Liquid Barrier. The drapes are made of a blue absorbent nonwoven fabric thermally bonded to a blue protective barrier film. The drapes are intended to be placed over the patient prior to surgery and are designed to provide an absorbent sterile barrier during surgical procedures and stop fluid strike-through to protect the surgical site and patient from microbial penetration.

Steri-Drape Fabric Surgical Drapes are either provided sterile to end-users or non-sterile to kit manufacturers for further processing including EtO sterilization according to ISO 11135-1:2007

The drapes are provided in multiple sizes and shapes to meet the requirements of various clinical procedures. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes. All models utilize the same material technology.

The following tables list the catalog numbers of the drapes that are included within the scope of this submission. The drapes are separated into categories based on similarity of the design and features. The categories are as follows:

Category 1 - These drapes are comprised entirely of a non-woven/film construction and may or may not feature an aperture. The entire non-woven/film portion of the drape is considered an AAMI Level 4 Barrier, with the barrier continuing to the edge of the aperture. Any component material attached to or configured within the aperture is identical to that used in the corresponding, currently marketed, predicate drapes.

Category 2 –These drapes are comprised of a non-woven / film construction and also contain either a film area with aperture or incise area. The AAMI Level 4 Barrier non-woven/film portion of the drape continues to the edge of the film or incise area. The component materials of the film area with aperture or incise area are identical to those used in the corresponding, currently marketed, predicate drapes.

Category 3 - These drapes are comprised entirely of a non-woven/film construction and feature an aperture. Additionally, these drapes include an extra absorbent layer on top of the drape and side film segments. The entire non-woven woven portion of the drape is considered an AAMI Level 4 Barrier with the barrier continuing to the edge of the aperture. The extra absorbent layer on top of the drape are illustrated with a crosshatch. and side film segments are identical to those used in the corresponding, currently marketed, predicate drapes and do not impact barrier performance of the non-woven/film portion.

19

20

21

22

23

24

25

26

27

The catalog numbers contained in the Category 1, 2 and 3 tables are also available in non-sterile versions and are designated by NS following the catalog number.

*The 1190NS and 9033NS are only available in a non-sterile version.

28

Technological Characteristics

The scientific characteristics, how the device functions, and the barrier properties of the device described in this submission compared to the predicate have not fundamentally changed. The device is designed to act as a protective barrier to stop fluid strike-through to inhibit the transfer of blood, body fluids and other potentially infectious materials. The primary change is to the non-woven material, which as testing has demonstrated, is substantially equivalent in performance to the predicate.

Summary of Non-Clinical Performance Testing

3M Steri-Drape Fabric Surgical Drapes have been evaluated and tested in accordance with the applicable requirements recommended in the FDA' Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, Infection Control Devices Branch Division of General and Restorative Devices, August 1993 as well as FDA recognized consensus standards, including non-clinical performance testing to the following standards:

. ANSI/AAMI PB70: 2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
. ASTM F1670-08 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
. ISO 9073-3:1989 – Textiles – Test methods for nonwovens – Part 3: Determination of tensile strength and elongation
ISO 13938-1:1999 - Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distention
ISO 9073-10:2003 Textiles Test methods for nonwovens Part 10: Lint and other ● particles generation in the dry state
16 CFR Part 1610:Standard for the Flammability of Clothing Textiles
. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization.

29

In accordance with the above applicable standards and test methods, non-clinical performance testing was conducted using the sterilized, final finished device and consisted of the following tests in order to demonstrate substantial equivalence:

. Tensile strength
. Burst strength
Resistance to liquid penetration ●
Linting and particulate ●
Flammability ●
Biocompatibility (cytotoxicity, irritation and sensitization) .

The non-clinical performance testing summary is as follows:

| Non-Clinical
Performance
Test | Test
Objective | Test
Method | Data Summary | | Substantial
Equivalence
Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------|
| | | | Test Article:
3M™ Steri-
Drape™
Fabric
Surgical
Drape | Predicate:
3M™ Steri-
Drape™
Fabric
Surgical
K031287 | |
| Tensile
Strength | Drape must
have
adequate
strength for
surgical
procedures. | Test per ISO
9073-3 | Machine
Direction (MD)
= 106 N

Cross Direction
(CD) = 58 | Machine
Direction (MD)
= 108 N

Wet = 193 kPa | Dry = 225 kPa

Pass with an
AQL of 4%
and RQL of
20% | AAMI Level 4
Pass with an
AQL of 4%
and RQL of
20% | Substantially
Equivalent |

30

Linting	Drape must have low levels of foreign matter.	Tested to ISO 9073-10	Pass with a Log10 (lint count) of $\le$ 4,0	Pass with a Log10 (lint count) of $\le$ 4,0	Substantially Equivalent
Particulate	Drape must have low levels of foreign matter.	Tested to ISO 9073-10	Pass with an Index Particulate Matter (IPM) of $\le$ 3, 5	Pass with an Index Particulate Matter (IPM) of $\le$ 3, 5	Substantially Equivalent
Flammability	Drape must have low potential for flammability and flame spread.	Tested to 16 CFR Part 1610	Class I Normal	Class I Normal	Substantially Equivalent
Cytotoxicity	Drape must have low potential for cytotoxic reaction.	Tested to ISO 10993-5	Non-Cytotoxic	Non-Cytotoxic	Substantially Equivalent
Irritation	Drape must have low potential as an irritant.	Tested to ISO 10993-10	Non-Irritating	Non-Irritating	Substantially Equivalent
Sensitization	Drape must have low potential as a sensitizer.	Tested to ISO 10993-10	Non-Sensitizing	Non-Sensitizing	Substantially Equivalent

All of the non-clinical performance testing results met the stated acceptance criteria. The test results support the determination of substantial equivalence to the predicate device under K031287 and have met or exceeded the predicate device's performance and establish that the changes do not impact safety or effectiveness or raise new questions about safety and effectiveness.

31

Substantial Equivalence

The 3M Steri-Drape Fabric Surgical Drapes have substantially equivalent product and performance characteristics and intended use as the 3M devices currently on the market under K031287. Further, data shows a substantial equivalence in the performance of these devices and the fundamental scientific technology has not been altered. Therefore, because of 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.

| | 3M Steri-Drape Fabric Surgical
Drapes | 3M Steri-Drape Surgical Fabric
Drapes K031287 (Predicate) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | 3M Steri-Drape Fabric Surgical
Drapes are used to create a sterile
field for surgical procedures. They
are provided sterile and intended
for external use only.

3M Steri-Drape non-sterile fabric
drapes are provided to other
manufacturers for further
processing using ethylene oxide.
3M provides information on
compatibility with ethylene oxide
processing.

Non-sterile surgical drapes are sold
to repackager or relabeler
establishments for EtO sterilization
according to ISO 11135-1:2007.
Sterile surgical drapes are sold
directly to end users after EtO
sterilization validation to ISO
11135-1:2007. | 3M Steri-Drape Surgical Fabric
Drapes are used to create a sterile
field for surgical procedures. They
are provided sterile using ethylene
oxide or gamma radiation and
intended for external use only.

3M Steri-Drape non-sterile fabric
drapes are provided to other
manufacturers for further processing
using ethylene oxide. 3M provides
information on compatibility with
ethylene oxide processing. |
| Principles of
Operation | The drapes cover the patient and
are made of an absorbent
nonwoven fabric backed with a
protective barrier film that stops
fluid strike-through and are
designed to protect the surgical site
and patient from microbial
penetration | The drapes cover the patient and
are made of an absorbent
nonwoven fabric backed with a
protective barrier film that stops fluid
strike-through and are designed to
protect the surgical site and patient
from microbial penetration |
| Product
Features | Low linting, strong, conformable
and easy to handle | Low linting, strong, conformable and
easy to handle |

Substantial Equivalence Comparison

32

| Nonwoven Layer | Polylactide resin (PLA)
Polypropylene resin (PP)
Blue pigment blend in polymer
matrix
Proprietary surfactant blend | Polypropylene resin (PP)
Titanium Dioxide
Blue pigment blend in polymer
matrix
Proprietary surfactant |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Barrier Film
Layer | Ethylene-Methyl Acrylate (EMA)
copolymers
Hydrocarbon Resin
Low Density Polyethylene resin (LDPE)
Linear Low Density
Polyethylene resin (LLDPE)
Blue pigment blend in polymer
matrix | Metallocene Ethylene Octene
Copolymer
Antiblock in polymer matrix
Low Density Polyethlene resin (LDPE)
Linear Low Density Polyethylene
resin (LLDPE)
Blue pigment blend in polymer
matrix |
| Grams/M² | 66 gsm | 62 gsm |
| Packaging | Tyvek/Film | Tyvek/Film |
| Usage | Single Use | Single Use |
| Components | One-piece | One-piece |
| Configurations/
Dimensions | Varies sizes and shapes to
accommodate clinician needs | Various sizes and shapes to
accommodate clinician needs |
| Method of
Sterilization | Ethylene Oxide or Non-Sterile | Ethylene Oxide, Gamma Irradiation
or Non-Sterile |
| Sterility
Assurance Level | $10^{-6}$ | $10^{-6}$ |
| Shelf Life | 3 Years | 3 Years |
| Biocompatibility | Non-Cytotoxic
Non-Sensitizing
Non-Irritating | Non-Cytotoxic
Non-Sensitizing
Non-Irritating |
| AMMI Standard
PB70 Barrier
Level | Level 4 | Level 4 |
| Tensile Strength | MD = 106 N
CD = 58.5 N | MD = 108 N
CD = 70.7 N |
| Burst Strength | Dry = 231 kPa
Wet = 193 kPa | Dry = 225 kPa
Wet = 199 kPa |
| Flammability
Rating | Class I Normal | Class I Normal |
| Linting | Pass with a Log10 (lint count) of ≤
4,0 | Pass with a Log10 (lint count) of ≤
4.0 |

33

| Particulate | Pass with an Index Particulate
Matter (IPM) of $\leq$ 3, 5 | Pass with an Index Particulate
Matter (IPM) of $\leq$ 3, 5 |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling | Brand name or common name
listed
Catalog number listed
Drape dimensions and illustration
on label
AMMI Barrier Level Listed
Single use statement
Lot number listed
Expiration date listed
Not made with natural rubber latex
statement | Brand name or common name
listed
Catalog number listed
Drape dimensions and illustration on
label
No AMMI Barrier Level Listed
Do not reuse statement
Lot number listed
Expiration date listed
Latex free statement |
| | Labeled as Ethylene Oxide or Not
Sterile
Sterile unless package is damaged
or open statement
Class I Normal flammability
statement | Labeled as Ethylene Oxide, Gamma
Sterile or Not Sterile
Sterile unless package is damaged
or open statement
No flammability statement |

Conclusion

Based on the results of the non-clinical performance and biocompatibility testing, the 3M Steri-Drape Fabric Surgical Drapes are as safe, as effective and are demonstrated to be substantially equivalent to the predicate device. The 3M Steri-Drape Fabric Surgical Drape is substantially equivalent to the predicate 3M Steri-Drape Surgical Fabric Drape K031287 in terms of intended use, physical performance testing, material composition, biocompatibility, labeling and safety and effectiveness.