SURGICAL DRAPE

K140195 · Griffith-Lucas, LLC · KKX · Sep 10, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140195
• Device Name: SURGICAL DRAPE
• Applicant: Griffith-Lucas, LLC
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Sep 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Surgical Drape is intended for external use only and is used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using ethylene oxide.

Device Story

Surgical drapes are single-use, disposable, nonwoven fabric sheets; three-layer composite design with absorbent top layer and protective film backing to prevent fluid strike-through. Used in surgical environments to cover patients and isolate incision sites from contamination. Operated by nursing teams during surgical procedures. Provides a sterile barrier; classified as AAMI PB 70 Level 4. Benefits include reduction of microbial contamination risk during surgery.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (cytotoxicity, irritation, sensitization, pyrogenicity) and performance testing (AAMI PB 70 liquid barrier, flammability per 16 CFR 1610, synthetic blood penetration per ASTM F1670-08, and seal/package integrity per ASTM F1929 and ASTM F1140).

Technological Characteristics

Three-layer nonwoven composite (tissue/poly/tissue); heat-welded lamination. Barrier performance: AAMI PB 70 Level 4. Sterilization: Ethylene Oxide. Dimensions: various. Standards: ASTM F1670-08, ASTM F1929, ASTM F1140, 16 CFR 1610.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination during surgical procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• DRAPE SURGICAL UTILITY DRAPE STERILE (K843496)
• Busse Surgical Drape I (K082297)
• Dukal 20-001, 20-002 (K083320)

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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Griffith-Lucas LLC C/O Mr. Mike Gu Regulatory Affairs Manager 7th Floor, Jingui Business Building No.982 Congyun Road, Baiyun District Guangzhou, Guangdong, 510420 CHINA

Re: K140195

Trade/Device Name: Surgical Drape, Model 42526 and 42527 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: August 13, 2014 Received: August 18, 2014

Dear Mr. Gu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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Digitally signed by Richard C. Chapman -S Date: 2014.09.10 16:53:37 -04'00'

for

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

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## Indications for Use

510(k) Number (if known) K140195

Device Name

Surgical Drape, models 42526 and 42527

#### Indications for Use (Describe)

The Surgical Drape is intended for external use only and is used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using ethylene oxide.

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

- Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

| | In accordance with 21 CFR 807.92 the following summary of information is provided: |
|---------------------------|------------------------------------------------------------------------------------|
| Date: | January 06 2014 |
| Submitter: | Manufacturer: GRIFFITH-LUCAS LLC. |
| | Address: 6027 STITT ST.MONROE NC, 28110 USA |
| Primary Contact Person: | Mike Gu |
| | Regulatory Affairs Manager |
| | OSMUNDA Medical Device Consulting Co., Ltd |
| | Tel: [phone] |
| | Fax: [phone] |
| Secondary Contact Person: | Bill Marks |
| | President |
| | GRIFFITH-LUCAS LLC. |
| | Ph:[phone] |
| | Fax:[phone] |
| Device:<br>Trade Name: | Surgical Drapes |
| Common/Usual Name: | Surgical Drapes |
| Regulation description : | Surgical drape and drape accessories |
| Review panel: | General & Plastic Surgery |
| Device class: | 2 |
| Classification Names: | 878.4370 |
| Product Code: | KKX |
| Predicate Device(s): | DRAPE SURGICAL UTILITY DRAPE STERILE K843496 |
| | Busse Surgical Drape I K082297 |
| | Dukal 20-001, 20-002 K 083320 |
| Device Description: | Surgical drapes are intended to provide protection from microbial and |
| | other contamination. The Lucas surgical drapes described in this |
| | submission are one-piece, single use disposable sheets designed to |
| | provide an absorbent sterile barrier during surgical procedures. The |
| | drapes cover the patient and are made of an absorbent nonwoven |
| | fabric backed with a protective film that stops fluid strike-through. |
| | There are various sizes to meet the surgeon's needs. In general, the |
| | surgeon delineates with proposed field of surgery and charges the |
| | nursing team with the responsibility of draping the patient suing |
| | different types of drapes, with & without fenestration. |
| Intended Use: | The Surgical Drape is intended for external use only and is used as |
| | covering a protective patient such as to isolate a site of surgical |
| | incisions from microbial and other contamination. They are provided |

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### sterile using ethylene oxide.

### Lucas surgical drapes are made of nonwoven fabric composes of a three-layer Technology: composite comprised of a top layer, middle layer and bottom layer, they passed the industry standard tests that measure fluid and synthetic blood penetration, they are classified as a level 4 device under the AAMI PB 70 for barrier performance.

## Determination of Substantial Equivalence:

| Specification | Predicate Device | Predicate Device | Predicate Device | Proposed Device |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | DRAPE SURGICAL<br>UTILITY<br>DRAPE<br>STERILE | Busse Surgical<br>Drape I | Dukal 20-001, 20-<br>002 | SURGICAL DRAPE |
| K number | K843496 | K082297 | K 083320 | |
| Manufacturer | BUSSE HOSPITAL<br>DISPOSABLES, INC | BUSSE HOSPITAL<br>DISPOSABLES, INC | Dukal Corporation | GRIFFITH-LUCAS<br>LLC |
| Intended Use | The<br>Busse<br>Hospital<br>Disposables is<br>intended for<br>external use only<br>and is used as a<br>protective patient<br>covering, such as<br>to isolate a site of<br>surgical incisions<br>from microbial<br>and other<br>contamination.<br>They are provided<br>sterile using<br>ethylene oxide. | The Busse Surgical<br>Drape is intended<br>for external use<br>only and is used<br>as a protective<br>patient covering,<br>such as to isolate<br>a site of surgical<br>incisions from<br>microbial and<br>other<br>contamination.<br>They are provided<br>sterile using<br>ethylene oxide. | The Dukal 20-001-<br>Fenestrated Dukal<br>Surgical Drape,<br>Blue, 18" x 26",<br>with 3"<br>Fenestration, and<br>20-002 - Dukal<br>Surgical<br>Drape, Blue, 18" x<br>26" is a device<br>made of natural<br>or synthetic<br>materials<br>intended to be<br>used as a<br>protective patient<br>covering, such as<br>to isolate a site of<br>surgical incision<br>from microbial<br>and other<br>contamination. | The<br>Surgical<br>Drape is intended<br>for external use<br>only and is used<br>as a protective<br>patient covering,<br>such as to isolate<br>a site of surgical<br>incisions from<br>microbial and<br>other<br>contamination.<br>They are provided<br>sterile using<br>ethylene oxide. |
| Materials | Tissue/Poly/Tissue<br>Drape | Tissue/Poly/Tissue<br>Drape | Tissue/Poly/Tissue<br>Drape | Tissue/Poly/Tissue<br>Drape |
| Sterile | EO | EO | EO | EO |
| Lamination | Heat welded | Heat welded | Heat<br>welded(three<br>layers) | Heat<br>welded(three<br>layers) |
| Dimension | Various size | Various size | L*W: 18"*26";<br>Fenestration: Φ3" | Various size |
| Barrier<br>properties | AAMI PB70<br>Barrier Level 4 | AAMI PB70<br>Barrier Level 4 | AAMI PB70<br>Barrier Level 4 | AAMI PB70<br>Barrier Level 4 |

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| Environment of<br>Use | During surgeries | During surgeries | During surgeries | During surgeries |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Performance | AAMI PB70<br>Barrier Level 4 | AAMI PB70<br>Barrier Level 4 | AAMI PB70<br>Barrier Level 4 | AAMI PB70<br>Barrier Level 4 |
| Biocompatibility | Non-cytotoxic;<br>Non-sensitizing;<br>Non-irritating;<br>No pyrogen | Non-cytotoxic;<br>Non-sensitizing;<br>Non-irritating;<br>No pyrogen | Non-cytotoxic;<br>Non-sensitizing;<br>Non-irritating;<br>No pyrogen | Non-cytotoxic;<br>Non-sensitizing;<br>Non-irritating;<br>No pyrogen |
| Other: Device<br>Specific<br>Guidance<br>Requirements<br>for Comparison | Guidance on<br>Premarket<br>Notification<br>510(k)<br>Submissions for<br>Surgical Gowns<br>and Surgical<br>Drapes | Guidance on<br>Premarket<br>Notification<br>510(k)<br>Submissions for<br>Surgical Gowns<br>and Surgical<br>Drapes | Guidance on<br>Premarket<br>Notification<br>510(k)<br>Submissions for<br>Surgical Gowns<br>and Surgical<br>Drapes | Guidance on<br>Premarket<br>Notification<br>510(k)<br>Submissions for<br>Surgical Gowns<br>and Surgical<br>Drapes |

This comparison of the specifications demonstrates the functional equivalence of the products. The differences discussed in this section do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences.

GRIFFITH-LUCAS LLC believes that the SURGICAL DRAPE is as safe and effective, and performs in a substantially equivalent manner to the predicate devices K843496 and K082297.

## Summary of Non-Clinical Tests:

The SURGICAL DRAPE had met acceptance criteria for performance testing including biocompatibility (in vitro cytotoxicity, irritation testing, skin sensitization testing and pyrogenicity testing), also the sponsor had performed bench tests to demonstrate that the proposed device performs within its specifications.

- 1. AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities;
- 2. CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- 3. ASTM F 1670-08: Standard test method for resistance of materials used in

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protective clothing to penetration by synthetic blood;

- 4. ASTM F1929: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- 5. ASTM F1140: Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.

All tests results met acceptance criteria and were substantially equivalent to the predicate devices.

## Summary of Clinical Tests:

The subject of this premarket submission, SURGICAL DRAPE, did not require clinical studies to support substantial equivalence.

- GRIFFITH-LUCAS LLC considers the Surgical Drape to be as safe, as effective, and Conclusion: performance is substantially equivalent to the predicate device(s).