SURGICAL DRAPE

• K Number: K140195
• Device Name: SURGICAL DRAPE
• Manufacturer: GRIFFITH-LUCAS LLC
• Date Cleared: 2014-09-10 ( 226 days)
• Product Code: KKX
• Regulation Number: 878.4370

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 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. Lucas surgical drapes are made of nonwoven fabric composes of a three-layer 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.

Predicate Devices

K843496, K082297, K 083320

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical surgical drape and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No
The device is intended to protect the patient from infection during surgery by creating a barrier, not to treat a disease or condition.

Diagnostic

No
The device is a surgical drape intended to provide a protective barrier during surgical procedures to prevent contamination. It does not perform any diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical, disposable sheet made of nonwoven fabric and protective film, intended for physical barrier protection during surgery. It is a hardware device.

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 clearly stated as "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." This describes a physical barrier used during surgery.
• Device Description: The description focuses on the physical properties of the drape (absorbent nonwoven fabric, protective film, barrier performance) and its function in covering the patient.
• Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
• No Mention of Biological Samples: The description does not involve the collection, analysis, or processing of any biological samples.
• Focus on Physical Barrier: The primary function described is creating a sterile physical barrier.

IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This surgical drape does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

KKX

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.
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

site of surgical incisions

Indicated Patient Age Range

Not Found

Intended User / Care Setting

During surgeries

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

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.
Tests performed:

• AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities;
• CFR Part 1610 Standard for the Flammability of Clothing Textiles;
• ASTM F 1670-08: Standard test method for resistance of materials used in protective clothing to penetration by synthetic blood;
• ASTM F1929: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
• 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.
  The subject of this premarket submission, SURGICAL DRAPE, did not require clinical studies to support substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K843496, K082297, K 083320

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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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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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FOR FDA USE ONLY

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:
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
UTILITY
DRAPE
STERILE	Busse Surgical
Drape I	Dukal 20-001, 20-
002	SURGICAL DRAPE
K number	K843496	K082297	K 083320
Manufacturer	BUSSE HOSPITAL
DISPOSABLES, INC	BUSSE HOSPITAL
DISPOSABLES, INC	Dukal Corporation	GRIFFITH-LUCAS
LLC
Intended Use	The
Busse
Hospital
Disposables 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.	The Busse 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.	The Dukal 20-001-
Fenestrated Dukal
Surgical Drape,
Blue, 18" x 26",
with 3"
Fenestration, and
20-002 - Dukal
Surgical
Drape, Blue, 18" x
26" 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
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.
Materials	Tissue/Poly/Tissue
Drape	Tissue/Poly/Tissue
Drape	Tissue/Poly/Tissue
Drape	Tissue/Poly/Tissue
Drape
Sterile	EO	EO	EO	EO
Lamination	Heat welded	Heat welded	Heat
welded(three
layers)	Heat
welded(three
layers)
Dimension	Various size	Various size	L*W: 18"*26";
Fenestration: Φ3"	Various size
Barrier
properties	AAMI PB70
Barrier Level 4	AAMI PB70
Barrier Level 4	AAMI PB70
Barrier Level 4	AAMI PB70
Barrier Level 4

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| Environment of

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