(189 days)
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.
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 document describes the non-clinical performance testing and acceptance criteria for the 3M™ Steri-Drape™ Fabric Surgical Drapes to establish substantial equivalence to a predicate device (3M™ Steri-Drape™ Fabric Surgical, K031287).
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Non-Clinical Performance Test | Acceptance Criteria (Predicate Performance) | Reported Device Performance (3M™ Steri-Drape™ Fabric Surgical Drape) | Substantial Equivalence Comparison |
|---|---|---|---|
| Tensile Strength (MD) | 108 N | 106 N | Substantially Equivalent |
| Tensile Strength (CD) | 70.7 N | 58 N | Substantially Equivalent |
| Burst Strength (Dry) | 225 kPa | 231 kPa | Substantially Equivalent |
| Burst Strength (Wet) | 199 kPa | 193 kPa | Substantially Equivalent |
| Resistance to Liquid Penetration | AAMI Level 4 - 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 |
| Linting | Pass with a Log10 (lint count) of $\le$ 4.0 | Pass with a Log10 (lint count) of $\le$ 4.0 | Substantially Equivalent |
| Particulate | 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 | Class I Normal | Class I Normal | Substantially Equivalent |
| Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic | Substantially Equivalent |
| Irritation | Non-Irritating | Non-Irritating | Substantially Equivalent |
| Sensitization | Non-Sensitizing | Non-Sensitizing | Substantially Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test set. It mentions tests were conducted on the "sterilized, final finished device." The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document details non-clinical performance testing of surgical drapes, which typically relies on laboratory measurements and standardized test methods rather than expert interpretation of data like in medical imaging. Therefore, the concept of "experts establishing ground truth" in the manner of medical professionals is not applicable here. The "ground truth" is defined by the technical specifications and performance characteristics outlined in the relevant ANSI/AAMI, ASTM, ISO, and CFR standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is non-clinical laboratory testing, there is no human adjudication process involved as would be for diagnostic 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
Not applicable. This document pertains to the performance and equivalence of surgical drapes, not a diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" used for these tests is based on established industry standards and regulatory requirements for surgical drapes, such as:
- ANSI/AAMI PB70: 2012 (Liquid barrier performance)
- ASTM F1670-08 (Resistance to synthetic blood penetration)
- ISO 9073-3:1989 (Tensile strength and elongation)
- ISO 13938-1:1999 (Bursting strength)
- ISO 9073-10:2003 (Lint and particle generation)
- 16 CFR Part 1610 (Flammability)
- ISO 10993-5:2009 (Cytotoxicity)
- ISO 10993-10:2010 (Irritation and skin sensitization)
The performance of the device is assessed against the numerical and qualitative criteria specified in these standards, with the predicate device's performance serving as the benchmark for "substantially equivalent" claims.
8. The sample size for the training set
Not applicable. This document describes the testing of a medical device (surgical drapes), not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
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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)
{3}------------------------------------------------
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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 ofPanel)241cm · 95in (Length) | Laparoscopic Drape/LithotomyPosition |
| 1034 | 152cm x 200cm60in x 78in | Central Venous Catheter Drape |
| 1078 | 196cm x 200cmNo inches stated | Perineal Drape with Pouch |
| 1079 | 195cm · 77in (Width Top)117cm · 46in (Length ofPanel)179cm · 70in (Length) | Gynecologic Drape |
| 1080 | 195cm · 77in (Width Top)117cm · 46in (Length ofPanel)179cm · 70in (Length) | Gynecologic Drape |
| 1081 | 152cm x164cm Upper60in x 64in117cm / 46in Lower | TUR/Urological Drape |
| 1082 | 235cm · 92in300cm · 118 in | Abdominal Vaginal Drape |
| 1084 | 86cm x108cm34in x 42in | Under Buttocks Drape with Pouch |
| 1089 | 57cm x 66cm22in x 26in | Utility Sheet (2) |
| 1090 | 182cm x 228cm72in x 90in | Femoral Angiography Drape |
| 1092 | 57cm x 66cm22in x 25in | Small Drape with Adhesive Aperture |
| 1094 | 226cm x 320cm90in x 126in | Arthroscopy Sheet with Pouch |
| 1135 | 279cm x 183cm110in x 72in15cm x 13cm5.9in x 5 in | Peripherally Inserted Central CatheterDrape |
| *1190NS | 228cm x 330cm89in x 130in | Femoral Angiography Drape |
| 1191 | 229cm x 330cm90in x 130in | Femoral Angiography Drape |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 1192 | 152cm x 170cm60in x 67in | Venous/Arterial Access Drape |
| 1193 | 290cm x 345cm114in 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 279cm100in x 110in | Abdominoperineal Incise Drape-Lithotomy Position |
| 7965 | 254cm · 100in (Width Top)195cm · 76in (Width Bottom)308cm · 121in (Length) | Cesarean Section Incise Sheet withPouch |
| 7966 | 254cm · 100in (Width Top)195cm · 76in (Width Bottom)310cm · 122in (Length) | Cesarean Section Sheet with AperturePouch |
| 9023 | 76cm x 170cm29in x 67in | Perineal Aperture Drape |
| 9026 | 6cm x 8cm (Aperture)2.3in x 3.1in55cm x 55cm21in x 21in | Aperture Drape |
| 9027 | Part 1 50cm x 75cm19in x 19inPart 2 50cm x 75cm19in x 19in | Adjustable Aperture Drape |
| 9027L | Part 1 75cm x 100cm29in x 39inPart 2 75cm x 100cm29in x 39in | Adjustable Adhesive Aperture Drape |
| 9028 | 6cm x 8cm (Aperture)2.3 in x 3.1 in75cm x 75cm29in x 29in | Adhesive Aperture Drape |
| 9029 | 15 cm x 6 cm (Aperture)6 in x 2 in75cm x 75cm29in x 29in | Adhesive Aperture Drape |
| 9030 | 6cm x 8cm (Aperture)2 in x 3in152cm x 120cm60in 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 315cm72in x 124in | Thyroid Drape |
| 9052 | 355cm x 293cm140in x 115in | Hand Drape |
| 9053 | 228cm x 300cm89in x 118in | Extremity Drape |
| 9054 | 195cm x 300cm77in 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 300cm77in x 118in | Bilateral Foot Drape |
| 9057 | 292cm · 115in (Width Top)228cm · 89in (Width Bottom)305cm · 120in (Length) | Extremity Drape with AnesthesiaScreen |
| 9058 | 228cm x 300cm90in 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 85cm33in x 33in | Under Buttock Drape with Cuff |
| 9067 | 45cm x 37cm17.75in x 14.5in | Drape Sheet |
| 9069 | 90cm x 75cm36in x 30in | Drape Sheet |
| 9070 | 114cm x 87cm45in x 34in | Turban Drape Sheet |
| 9071 | 97cm x 97cm38 in x 38in | Drape Sheet |
| 9072 | 114cm x 150cm44in x 59in | Drape Sheet |
| 9074 | 150cm x 150cm60in x 60in | Instrument Table Cover/Drape Sheet |
| 9077 | 200cm x 250cm78in x 59in | Drape Sheet |
| 9077R | 150cm x 200cmNo inches stated | Instrument Table Cover Reinforced |
| 9079 | 200cm x 228cm78in x 90in | Drape Sheet |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9083 | 55cm x 55cm19.75in x 19.75in | Adhesive Towel Drape |
| 9084 | 75cm x 75cm29in x 29in | Adhesive Towel Drape |
| 9085 | 100cm x 85cm39in x 33in | Adhesive Towel Drape |
| 9085W | 97cm x 115cm38in x 45in | Adhesive Towel Drape |
| 9086 | 100cm x75cm39in x 29in | Adhesive Towel Drape |
| 9087 | 183cm x 183cm72in x 72in | Adhesive Drape Sheet |
| 9088 | 200cm x 250cm78in x 59in | Adhesive Drape Sheet |
| 9089 | 170cm x 170cm67in x 67in | Adhesive Drape Sheet |
| 9090 | 300cm x 228cm118in x 90in | Adhesive Drape Sheet |
| 9196 | 16cm x 95cm (Split)6in x 37in228cm x 260cm90in x 102in | Shoulder Split Sheet with Pouch |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 1031 | 27cm x 30cm10.5in x 11.5in (Aperture)228cm · 90in (Width Top)182cm · 72in (Width Bottom)285cm · 112in (Length) | Laparoscopic Drape/Supine Position |
| 1032 | 27cm x 30cm10.5in x 11.5in (Aperture 1)12cm x 15.5cm4.5in x 6cm (Aperture 2)228cm · 90in (Width Top)117cm · 46in (Length of Panel)241cm · 95in (Length) | Laparoscopic Drape/LithotomyPosition |
| 1034 | 34.5cm x 34.5cm (13.5in x 13.5in)Film with 10cm (4 in) Circle Aperture152cm x 200cm60in x 78in | Central Venous Catheter Drape |
| 1078 | 9cm x 12cm3.3in x 4.5in (Aperture)196cm x 200cm77in x 78in | Perineal Drape with Pouch |
| 1079 | 9cm x 12cm3.3in x 4.5in (Aperture)195cm · 77in (Width Top)117cm · 46in (Length of Panel)179cm · 70in (Length) | Gynecologic Drape |
| 1080 | 9cm x 12cm3.3in 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 Aperture152cm 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 10cm3in x 4in (Aperture)154cm x 154cm60in x 60in290cm x 345cm114in x 136in | Angiography Drape |
| 1194 | 23cm x 28cm (9in x 11in) Filmwith 6cm (2.25in) CircleAperture292cm · 115in (Width Top)228cm · 89in (Width Bottom)304cm · 120in (Length) | Arthroscopy Sheet with Pouch |
| 2065 | 41cm x 45cm(16in x 17in) Incise12cm x 15.5cm(4.75in x 6in) Aperture195cm · 77in271cm · 106in117cm · 46in (Length of Panel) | Abdominoperineal Incise Drape |
| 7964 | 30cm x 30cm12in x 12in (Incise)254cm x 279cm100in x 110in | Abdominoperineal Incise Drape-Lithotomy Position |
| 7965 | 30cm x 30cm12in x 12in (Incise)254cm · 100in (Width Top)195cm · 76in (Width Bottom)308cm · 121in (Length) | Cesarean Section Incise Sheet withPouch |
| 7966 | 30cm x 30cm12in x 12in (Incise) with 20cmx 24 cm (8in x 9.5in) Aperture254cm · 100in (Width Top)195cm · 76in (Width Bottom)310cm · 122in (Length) | Cesarean Section Sheet with AperturePouch |
| 9023 | 6cm x 8cm2.3in x 3.1in (Aperture)76cm x 170cm29in x 67in | Perineal Aperture Drape |
| 9026 | 6cm x 8cm2.3in x 3.1in (Aperture)55cm x 55cm21in x 21in | Aperture Drape |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9027 | 11cm x 12.5cm4in x 5in (Aperture)Part 1 50cm x 75cm 19in x 29inPart 2 50cm x 75cm 19in x 29in | Adjustable Aperture Drape |
| 9027L | 11cm x 12.5cm4in x 5in (Aperture)Part 1 75cm x 100cm29in x 39inPart 2 75cm x 100cm29in x 39in | Adjustable Adhesive Aperture Drape |
| 9028 | 6cm x 8cm2.3in x 3.1in (Aperture)75cm x 75cm29in x 29in | Adhesive Aperture Drape |
| 9029 | 15 cm x 6 cm6in x 2in (Aperture)75cm x 75cm29in x 29in | Adhesive Aperture Drape |
| 9030 | 6cm x 8cm2in x 3in (Aperture)152cm x 120cm60in x 47in | Adhesive Aperture Drape |
| 9031 | 8cm x 6cm3in x 2in (Aperture)150cm x 183cm59in x 72in | Adhesive Aperture Drape |
| *9033NS | 12cm x 11cm4.5in x 4in (Aperture)150cm x 183cm59in 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 70cm2.5in x 25in (Split)152cm x 183cm60in x 72in | Adhesive Split Sheet |
| 9044 | 7cm x 70cm2.5in x 25in (Split)152cm x 250cm60in x 98in | Adhesive Split Sheet |
| 9045 | 20cm x 100cm7in x 39 in (Split)228cm x 260cm89.5in x 102in | Adhesive Split Sheet |
| 9045R | 20cm x 100cm7in x 39 in (Split)228cm x 260cm89.5in x 102in | Reinforced Adhesive Split Sheet |
| 9046 | 15cm x 50 cm6in x 19in (Split)183cm x 200cm72in x 78in | Bilateral Adhesive Split Sheet |
| 9046L | 44cm x 100cm17in x 39in (Split)228cm x 260cm90in x 102in | Bilateral Adhesive Split Sheet |
| 9047 | 16cm x 40cm6in x 15in (Split)183cm x 152cm72in x 60in | Neuro Split Sheet with Pouch |
| 9048 | 20cm x 40cm7in x 15in (Split)228cm x 260cm90in x 102in | Adhesive Split Sheet |
| 9050 | 12cm x 16 cm4.5in x 6in (Aperture)228cm x 300cm90in x 118in | Adhesive Aperture Drape |
| 9051 | 12cm x 12cm4.5in x 4.5in (Aperture)183cm x 315cm72in 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 10cm12in x 4in (Aperture)254cm · 100in (Width Top)183cm · 72in (Width Bottom)285cm · 112in (Length) | Laparotomy Drape-Transverse |
| 9063 | 10cm x 30cm4in x 12in (Aperture)254cm · 100in (Width Top)183cm · 72in (Width Bottom)285cm · 112in (Length) | Laparotomy Drape |
| 9066 | 85cm x 85cm33in x 33inCuff is 25 cm of the 85 cm. | Under Buttock Drape with Cuff |
| 9067 | 45cm x 37cm17.75in x 14.5in | Drape Sheet |
| 9069 | 90cm x 75cm36in x 30in | Drape Sheet |
| 9070 | 114cm x 87cm45in x 34in | Turban Drape Sheet |
| 9071 | 97cm x 97cm38 in x 38in | Drape Sheet |
| 9072 | 114cm x 150cm44in x 59in | Drape Sheet |
| 9074 | 150cm x 150cm59in x 59in | Instrument Table Cover/Drape Sheet |
| 9077 | 200cm x 150cm78in x 59in | Drape Sheet |
| 9079 | 200cm x 228cm78in x 90in | Drape Sheet |
| 9083 | 55cm x 55cm19.75in x 19.75in | Adhesive Towel Drape |
| 9084 | 75cm x 75cm29in x 29in | Adhesive Towel Drape |
| 9085 | 100cm x 85cm39in x 33in | Adhesive Towel Drape |
| 9085W | 115cm x 97cm45in x 38in | Adhesive Towel Drape |
| 9086 | 100cm x75cm39in x 29in | Adhesive Towel Drape |
| 9087 | 183cm x 183cm72in x 72in | Adhesive Drape Sheet |
| 9088 | 250 cm x 150 cm98in x 59in | Adhesive Drape Sheet |
| 9089 | 170cm x 170cm67in x 67in | Adhesive Drape Sheet |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9090 | 300cm x 228cm118in x 90in | Adhesive Drape Sheet |
| 9196 | 16cm x 95cm6in x 37in (Split)228cm x 260cm90in x 102in | Shoulder Split Sheet with Pouch |
Table 1 – Product Catalog Numbers, Dimensions and Name/Descriptor
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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.
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Table 1 – Product Catalog Numbers, Dimensions and Name/Descriptor
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{13}------------------------------------------------
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{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.
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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.
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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.
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Category 1
| CatalogNumber(s) | Approximate Dimensions | Name/Descriptor | AAMI Level 4Barrier |
|---|---|---|---|
| 1031 | 27cm x 30cm10.5in x 11.5in (Aperture) | LaparoscopicDrape/Supine Position | Entire drape exceptaperture |
| 1031NS | 228cm · 90in (Width Top)182cm · 72in (Width Bottom)285cm · 112in (Length) | ||
| 1032 | 27cm x 30cm10.5in x 11.5in (Aperture 1) | LaparoscopicDrape/LithotomyPosition | Entire drape exceptaperture |
| 1032NS | 12cm x 15.5cm4.5in x 6cm (Aperture 2)228cm · 90in (Width Top)117cm · 46in (Length of Panel)241cm · 95in (Length) | ||
| 1078 | 9cm x 12cm3.3in x 4.5in (Aperture) | Perineal Drape withPouch | Entire drape exceptaperture |
| 1078NS | 196cm x 200cm77in x 78in | ||
| 1079 | 9cm x 12cm3.3in x 4.5in (Aperture) | Gynecologic Drape | Entire drape exceptaperture |
| 1079NS | 195cm · 77in (Width Top)117cm · 46in (Length of Panel)179cm · 70in (Length) | ||
| 1080 | 9cm x 12cm3.3in x 4.5in (Aperture) | Gynecologic Drapewith Pouch | Entire drape exceptaperture |
| 1080NS | 195cm · 77in (Width Top)117cm · 46in (Length of Panel)179cm · 70in (Length) | ||
| 1082 | 23cm x 28cm9in x 11in (Aperture) | Abdominal VaginalDrape | Entire drape exceptaperture |
| 1082NS | 235cm · 92 in (Width)300cm · 118 in (Length) | ||
| CatalogNumber(s) | Approximate Dimensions | Name/Descriptor | AAMI Level 4Barrier |
| 1084 | 86cm x 63cm34in x 24.5in (Pouch) | Under Buttocks Drapewith Pouch | Entire drape |
| 1084NS | 86cm x 45cm34in x 17.5in | ||
| 1089 | 57cm x 66cm22in x 26in | Utility Sheet | Entire drape |
| 1089NS | |||
| 1090 | 6.4cm x 8.9cm2.5in x 3.5in (Aperture) | Femoral AngiographyDrape | Entire drape exceptaperture |
| 1090NS | 182cm x 228cm72in x 90in | ||
| 1092 | 6cm · 2.25in (CircleAperture) | Small Drape withAdhesive Aperture | Entire drape exceptaperture |
| 1092NS | 57cm x 66cm22in x 25in | ||
| 1192 | 8cm x 20cm3in x 7.5in (Aperture) | Venous/ArterialAccess Drape | Entire drape exceptaperture |
| 1192NS | 152cm x 170cm60in x 67in | ||
| 9023 | 6cm x 8cm2.3in x 3.1in (Aperture) | Perineal ApertureDrape | Entire drape exceptaperture |
| 9023NS | 76cm x 170cm29in x 67in | ||
| 9026 | 6cm x 8cm2.3in x 3.1in (Aperture) | Aperture Drape | Entire drape exceptaperture |
| 9026NS | 55cm x 55cm21in x 21in | aperture | |
| 9027 | 11cm x 12.5cm4in x 5in (Aperture) | Adjustable ApertureDrape | Entire drape exceptaperture |
| 9027NS | Part 1 50cm x 75cm19in x 29inPart 2 50cm x 75cm19in x 29in | aperture | |
| 9027L | 11cm x 12.5cm4in x 5in (Aperture) | Adjustable AdhesiveAperture Drape | Entire drape exceptaperture |
| 9027LNS | Part 1 75cm x 100cm29in x 39inPart 2 75cm x 100cm29in x 39in | ||
| CatalogNumber(s) | Approximate Dimensions | Name/Descriptor | AAMI Level 4Barrier |
| 9028 | 6cm x 8cm2.3in x 3.1in (Aperture)75cm x 75cm29in x 29in | Adhesive ApertureDrape | Entire drape exceptaperture |
| 9028NS | |||
| 9029 | 15 cm x 6 cm6in x 2in (Aperture)75cm x 75cm29in x 29in | Adhesive ApertureDrape | Entire drape exceptaperture |
| 9029NS | |||
| 9030 | 6cm x 8cm2in x 3in (Aperture)152cm x 120cm60in x 47in | Adhesive ApertureDrape | Entire drape exceptaperture |
| 9030NS | |||
| 9031 | 8cm x 6cm3in x 2in (Aperture)150cm x 183cm59in x 72in | Adhesive ApertureDrape | Entire drape exceptaperture |
| 9031NS | |||
| *9033NS | 12cm x 11cm4.5in x 4in (Aperture)150cm x 183cm59in x 72in | Triangular ApertureDrape | Entire drape exceptaperture |
| 9040 | 75cm x 114cm29in x 44in | Extremity Drape(Leggings) | Entire drape |
| 9040NS | |||
| 9040L | 85cm x 130cm33in x 51in | Extremity Drape(Leggings Long) | Entire drape |
| 9040LNS | |||
| 9041 | 35cm x 60cm13.5in x 23.5in | Extremity Cover (S) | Entire drape |
| 9041NS | |||
| 9042 | 35cm x 100cm13.5in x 39in | Extremity Cover (L) | Entire drape |
| 9042NS | |||
| 9043 | 7cm x 70cm2.5in x 25in (Split)152cm x 183cm60in x 72in | Adhesive Split Sheet | Entire drape exceptaperture |
| 9043NS | |||
| 9044 | 7cm x 70cm2.5in x 25in (Split)152cm x 250cm60in x 98in | Adhesive Split Sheet | Entire drape exceptaperture |
| 9044NS | |||
| CatalogNumber(s) | Approximate Dimensions | Name/Descriptor | AAMI Level 4Barrier |
| 90459045NS | 20cm x 100cm7in x 39 in (Split)228cm x 260cm89.5in x 102in | Adhesive Split Sheet | Entire drape exceptaperture |
| 90469046NS | 15cm x 50cm6in x 19in (Split)183cm x 200cm72in x 78in | Bilateral AdhesiveSplit Sheet | Entire drape exceptaperture |
| 9046L9046LNS | 44cm x 100cm17in x 39in (Split)228cm x 260cm90in x 102in | Bilateral AdhesiveSplit Sheet | Entire drape exceptaperture |
| 90479047NS | 16cm x 40cm6in x 15in (Split)183cm x 152cm72in x 60in | Neuro Split Sheet withPouch | Entire drape exceptaperture |
| 90489048NS | 20cm x 40cm7in x 15in (Split)228cm x 260cm90in x 102in | Adhesive Split Sheet | Entire drape exceptaperture |
| 90509050NS | 12cm x 16 cm4.5in x 6in (Aperture)228cm x 300cm90in x 118in | Adhesive ApertureDrape | Entire drape exceptaperture |
| 90519051NS | 12cm x 12cm4.5in x 4.5in (Aperture)183cm x 315cm72in x 124in | Thyroid Drape | Entire drape exceptaperture |
| 90629062NS | 30cm x 10cm12in x 4in (Aperture)254cm · 100in (Width Top)183cm · 72in (WidthBottom)285cm · 112in (Length) | Laparotomy Drape-Transverse | Entire drape exceptaperture |
| 90639063NS | 10cm x 30cm4in x 12in (Aperture)254cm · 100in (Width Top)183cm · 72in (WidthBottom)285cm · 112in (Length) | Laparotomy Drape | Entire drape exceptaperture |
| CatalogNumber(s) | Approximate Dimensions | Name/Descriptor | AAMI Level 4Barrier |
| 90669066NS | 85cm x 85cm33in x 33in | Under Buttock Drapewith Cuff | Entire drape |
| 90679067NS | 45cm x 37cm17.75in x 14.5in | Drape Sheet | Entire drape |
| 90699069NS | 90cm x 75cm36in x 30in | Drape Sheet | Entire drape |
| 90709070NS | 114cm x 87cm45in x 34in | Turban Drape Sheet | Entire drape |
| 90719071NS | 97cm x 97cm38 in x 38in | Drape Sheet | Entire drape |
| 90729072NS | 114cm x 150cm44in x 59in | Drape Sheet | Entire drape |
| 90749074NS | 150cm x 150cm59in x 59in | Drape Sheet | Entire drape |
| 90779077NS | 200cm x 150cm78in x 59in | Drape Sheet | Entire drape |
| 90799079NS | 200cm x 228cm78in x 90in | Drape Sheet | Entire drape |
| 90839083NS | 55cm x 55cm19.75in x 19.75in | Adhesive TowelDrape | Entire drape |
| 90849084NS | 75cm x 75cm29in x 29in | Adhesive TowelDrape | Entire drape |
| 90859085NS9085W | 100cm x 85cm39in x 33in | Adhesive TowelDrape | Entire drape |
| 9085WNS | 115cm x 97cm45in x 38in | Adhesive TowelDrape | Entire drape |
| CatalogNumber(s) | Approximate Dimensions | Name/Descriptor | AAMI Level 4Barrier |
| 9086 | 100cm x75cm39in x 29in | Adhesive TowelDrape | Entire drape |
| 9086NS | |||
| 9087 | 183cm x 183cm72in x 72in | Adhesive Drape Sheet | Entire drape |
| 9087NS | |||
| 9088 | 250cm x 150cm98in x 59in | Adhesive Drape Sheet | Entire drape |
| 9088NS | |||
| 9089 | 170cm x 170cm67in x 67in | Adhesive Drape Sheet | Entire drape |
| 9089NS | |||
| 9090 | 300cm x 228cm118in x 90in | Adhesive Drape Sheet | Entire drape |
| 9090NS | |||
| 9196 | 16cm x 95cm6in x 37in (Split) | Shoulder Split Sheetwith Pouch | Entire drape exceptaperture |
| 9196NS | 228cm x 260cm90in x 102in |
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Category 2
| 1034 | 34.5cm x 34.5cm(13.5in x 13.5in) Filmwith 10cm (4 in) CircleAperture152cm x 200cm60in x 78in | Central Venous CatheterDrape | Entire drape exceptfilm aperture |
|---|---|---|---|
| 1034NS | |||
| 1081 | 20cm x 10cm (7.8in x3.9in) Film with 6cm(2 in) Circle Aperture152cm x164cm60in x 64in Upper117cm (46in) Lower | TUR/Urological Drape | Entire drape exceptfilm aperture |
| 1081NS | |||
| 1094 | 23cm x 28cm (9in x11in) Film with 6cm(2.25in) Circle Aperture226cm x 320cm90in x 126in | Arthroscopy Sheet withPouch | Entire drape exceptfilm aperture |
| 1094NS | |||
| 11351135NS | 28cm x 26cm (11in x 10in) Film with 15cm x 13cm (5.9in x 5in) Aperture183cm x 279cm72in x 110in | Peripherally Inserted Central Catheter Drape | Entire drape except film aperture |
| 11941194NS | 23cm x 28cm (9in x 11in) Film with 6cm (2.25in) Circle Aperture292cm · 115in (Width Top)228cm · 89in (Width Bottom)304cm · 120in (Length) | Arthroscopy Sheet with Pouch | Entire drape except film aperture |
| 20652065NS | 41cm x 45cm (16in x 17in) Incise12cm x 15.5cm (4.75in x 6in) Aperture195cm · 77in271cm · 106in | Abdominoperineal Incise Drape | Entire drape except incise and aperture |
| 79647964NS | 30cm x 30cm12in x 12in (Incise)254cm x 279cm100in x 110in | Abdominoperineal Incise Drape-Lithotomy Position | Entire drape except incise |
| 79657965NS | 30cm x 30cm12in x 12in (Incise)254cm · 100in (Width Top)195cm · 76in (Width Bottom)308cm · 121in (Length) | Cesarean Section Incise Sheet with Pouch | Entire drape except incise |
| 79667966NS | 30cm x 30cm12in x 12in (Incise)with 20cm x 24 cm (8in x 9.5in) Aperture254cm · 100in (Width Top)195cm · 76in (Width Bottom)310cm · 122in (Length) | Cesarean Section Sheet with Aperture Pouch | Entire drape except incise with aperture |
| 9052 | 15cm x 25cm (5.9in x9.8in) Film with 3cm | Hand Drape | Entire drape exceptfilm aperture |
| 9052NS | (1 in) Circle Aperture355cm x 293cm140in x 115in | ||
| 9053 | 11cm x 26cm (4.3in x10in) Film with 6cm x | Extremity Drape | Entire drape exceptfilm aperture |
| 9053NS | 8cm (2in x 3in)Aperture228cm x 300cm89in x 118in | ||
| 9054 | 15cm x 25 cm (5.9in x9.8in) Film with 3cm | Hand and Foot Drape | Entire drape exceptfilm aperture |
| 9054NS | (1 in) Circle Aperture195cm x 300cm77in x 118in | ||
| 9055 | 34cm x 39cm (13in x15in) Film with 20cm x | Hip Drape with Pouches | Entire drape exceptfilm aperture |
| 9055NS | 17.5cm (8in x 7in)Aperture300cm · 118in (WidthTop)228cm · 90in (WidthBottom)353cm · 139in (Length)246cm · 96in (Length ofPouches)228cm · 90in (TotalOverall Width Bottom) | ||
| 9056 | 25cm x 50cm (9.8in x19.6 in) Film with 4cm | Bilateral Foot Drape | Entire drape exceptfilm aperture |
| 9056NS | (1.5in) Circle Aperture195cm x 300cm77in x 118in | ||
| 9057 | 11cm x 26 cm (4.3in x10in) Film with 6cm x | Extremity Drape withAnesthesia Screen | Entire drape exceptfilm aperture |
| 9057NS | 8cm (2in x 3in)Aperture292cm ・ 115in (WidthTop)228cm · 89in (WidthBottom)305cm · 120in (Length) | ||
| 9058 | 11cm x 26 cm (4.3in x10in) Film with 6cm x8cm (2in x 3in)Aperture228cm x 300cm90in x 118in | Bilateral Knee Drape | Entire drape exceptfilm aperture |
| 9058NS |
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Category 3
| *1190NS | 10cm x 7.5cm4in x 3in (Aperture)91cm x 330cm35in c 130in228cm x 330cm89in x 130in (Film) | Femoral Angiography Drape | Fabric drape exceptaperture |
|---|---|---|---|
| 1191 | 11cm x 14cm4in x 5.5in (Aperture)91cm x 228cm35in x 89in229 x 330cm90in x 130in (Film) | Femoral Angiography Drape | Fabric drape exceptaperture |
| 1193 | 7.5cm x 10cm3in x 4in (Aperture)154cm x 154cm60in x 60in290cm x 345cm114 x 136in (Film) | Angiography Drape | Fabric drape exceptaperture |
| 9045R | 20cm x 100cm7in x 39 in (Split)228cm x 260cm89.5in x 102in | Reinforced Adhesive SplitSheet | Fabric drape exceptaperture |
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.
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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.
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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-ClinicalPerformanceTest | TestObjective | TestMethod | Data Summary | SubstantialEquivalenceComparison | |
|---|---|---|---|---|---|
| Test Article:3M™ Steri-Drape™FabricSurgicalDrape | Predicate:3M™ Steri-Drape™FabricSurgicalK031287 | ||||
| TensileStrength | Drape musthaveadequatestrength forsurgicalprocedures. | Test per ISO9073-3 | MachineDirection (MD)= 106 NCross Direction(CD) = 58 | MachineDirection (MD)= 108 NCross Direction(CD) = 70.7 N | SubstantiallyEquivalent |
| Burst Strength | Drape musthaveadequatestrength forsurgicalprocedures. | Test per ISO13938-1 | Dry = 231 kPaWet = 193 kPa | Dry = 225 kPaWet = 199 kPa | SubstantiallyEquivalent |
| Resistance toLiquidPenetration | Drape mustbe resistanttostrikethroughfromblood andbodily fluidsandpotentialinfectiousagents. | AMMI PB70 tested toASTMF1670 | AAMI Level 4- Pass with anAQL of 4%and RQL of20% | AAMI Level 4- Pass with anAQL of 4%and RQL of20% | SubstantiallyEquivalent |
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| 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.
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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 SurgicalDrapes | 3M Steri-Drape Surgical FabricDrapes K031287 (Predicate) | |
|---|---|---|
| Indications forUse | 3M Steri-Drape Fabric SurgicalDrapes are used to create a sterilefield for surgical procedures. Theyare provided sterile and intendedfor external use only.3M Steri-Drape non-sterile fabricdrapes are provided to othermanufacturers for furtherprocessing using ethylene oxide.3M provides information oncompatibility with ethylene oxideprocessing.Non-sterile surgical drapes are soldto repackager or relabelerestablishments for EtO sterilizationaccording to ISO 11135-1:2007.Sterile surgical drapes are solddirectly to end users after EtOsterilization validation to ISO11135-1:2007. | 3M Steri-Drape Surgical FabricDrapes are used to create a sterilefield for surgical procedures. Theyare provided sterile using ethyleneoxide or gamma radiation andintended for external use only.3M Steri-Drape non-sterile fabricdrapes are provided to othermanufacturers for further processingusing ethylene oxide. 3M providesinformation on compatibility withethylene oxide processing. |
| Principles ofOperation | The drapes cover the patient andare made of an absorbentnonwoven fabric backed with aprotective barrier film that stopsfluid strike-through and aredesigned to protect the surgical siteand patient from microbialpenetration | The drapes cover the patient andare made of an absorbentnonwoven fabric backed with aprotective barrier film that stops fluidstrike-through and are designed toprotect the surgical site and patientfrom microbial penetration |
| ProductFeatures | Low linting, strong, conformableand easy to handle | Low linting, strong, conformable andeasy to handle |
Substantial Equivalence Comparison
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| Nonwoven Layer | Polylactide resin (PLA)Polypropylene resin (PP)Blue pigment blend in polymermatrixProprietary surfactant blend | Polypropylene resin (PP)Titanium DioxideBlue pigment blend in polymermatrixProprietary surfactant |
|---|---|---|
| Barrier FilmLayer | Ethylene-Methyl Acrylate (EMA)copolymersHydrocarbon ResinLow Density Polyethylene resin (LDPE)Linear Low DensityPolyethylene resin (LLDPE)Blue pigment blend in polymermatrix | Metallocene Ethylene OcteneCopolymerAntiblock in polymer matrixLow Density Polyethlene resin (LDPE)Linear Low Density Polyethyleneresin (LLDPE)Blue pigment blend in polymermatrix |
| 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 toaccommodate clinician needs | Various sizes and shapes toaccommodate clinician needs |
| Method ofSterilization | Ethylene Oxide or Non-Sterile | Ethylene Oxide, Gamma Irradiationor Non-Sterile |
| SterilityAssurance Level | $10^{-6}$ | $10^{-6}$ |
| Shelf Life | 3 Years | 3 Years |
| Biocompatibility | Non-CytotoxicNon-SensitizingNon-Irritating | Non-CytotoxicNon-SensitizingNon-Irritating |
| AMMI StandardPB70 BarrierLevel | Level 4 | Level 4 |
| Tensile Strength | MD = 106 NCD = 58.5 N | MD = 108 NCD = 70.7 N |
| Burst Strength | Dry = 231 kPaWet = 193 kPa | Dry = 225 kPaWet = 199 kPa |
| FlammabilityRating | 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 |
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| Particulate | Pass with an Index ParticulateMatter (IPM) of $\leq$ 3, 5 | Pass with an Index ParticulateMatter (IPM) of $\leq$ 3, 5 |
|---|---|---|
| Labeling | Brand name or common namelistedCatalog number listedDrape dimensions and illustrationon labelAMMI Barrier Level ListedSingle use statementLot number listedExpiration date listedNot made with natural rubber latexstatement | Brand name or common namelistedCatalog number listedDrape dimensions and illustration onlabelNo AMMI Barrier Level ListedDo not reuse statementLot number listedExpiration date listedLatex free statement |
| Labeled as Ethylene Oxide or NotSterileSterile unless package is damagedor open statementClass I Normal flammabilitystatement | Labeled as Ethylene Oxide, GammaSterile or Not SterileSterile unless package is damagedor open statementNo 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.
§ 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.