(226 days)
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.
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.
The document describes the acceptance criteria and the study conducted for the Surgical Drape, models 42526 and 42527, manufactured by GRIFFITH-LUCAS LLC.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Measure) | Reported Device Performance (Lucas Surgical Drape) |
|---|---|
| Barrier Properties | AAMI PB70 Barrier Level 4 |
| Liquid Barrier Performance | AAMI PB70 Barrier Level 4 |
| Flammability | Meets CFR Part 1610 Standard |
| Resistance to Penetration by Synthetic Blood | Meets ASTM F 1670-08 Standard |
| Seal Leaks in Porous Medical Packaging | Meets ASTM F1929 Standard |
| Internal Pressurization Failure Resistance | Meets ASTM F1140 Standard |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, no pyrogen |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "bench tests to demonstrate that the proposed device performs within its specifications" and provides a list of standards met for various tests. However, it does not explicitly state the specific sample sizes used for each of these bench tests.
The data provenance is from non-clinical (bench) testing performed by GRIFFITH-LUCAS LLC. There is no information regarding the country of origin of the data beyond the manufacturer being in China, but the tests performed are based on international standards (AAMI, CFR, ASTM). The studies are prospective in the sense that they were conducted specifically for the purpose of demonstrating the device's performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the ground truth for this device's performance is established through adherence to standardized non-clinical test methods and specified acceptance criteria (e.g., AAMI PB70 Barrier Level 4, ASTM standards) rather than expert consensus on a test set of data.
4. Adjudication Method for the Test Set:
This information is not applicable. The performance is evaluated against defined physical and chemical standards, not through expert adjudication of subjective assessments. The tests have pass/fail criteria based on objective measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The subject of this premarket submission, SURGICAL DRAPE, did not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical surgical drape, not an AI algorithm or software. The "standalone performance" refers to the device's functional characteristics (e.g., barrier properties, biocompatibility) when tested independently according to established standards.
7. The Type of Ground Truth Used:
The ground truth used for performance validation is based on established industry standards and regulatory criteria. These include:
- AAMI PB70 (liquid barrier performance and classification)
- CFR Part 1610 (flammability)
- ASTM F 1670-08 (resistance to penetration by synthetic blood)
- ASTM F1929 (seal leaks in porous medical packaging)
- ASTM F1140 (internal pressurization failure resistance)
- Biocompatibility standards (cytotoxicity, irritation, sensitization, pyrogenicity)
8. The Sample Size for the Training Set:
This information is not applicable. This submission is for a physical medical device (surgical drape), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as point 8.
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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 (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.
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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: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Bill Marks |
| President | |
| GRIFFITH-LUCAS LLC. | |
| Ph:(704)283-4667 | |
| Fax:(704) 291-7442 | |
| 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 SURGICALUTILITYDRAPESTERILE | Busse SurgicalDrape I | Dukal 20-001, 20-002 | SURGICAL DRAPE |
| K number | K843496 | K082297 | K 083320 | |
| Manufacturer | BUSSE HOSPITALDISPOSABLES, INC | BUSSE HOSPITALDISPOSABLES, INC | Dukal Corporation | GRIFFITH-LUCASLLC |
| Intended Use | TheBusseHospitalDisposables isintended forexternal use onlyand is used as aprotective patientcovering, such asto isolate a site ofsurgical incisionsfrom microbialand othercontamination.They are providedsterile usingethylene oxide. | The Busse SurgicalDrape is intendedfor external useonly and is usedas a protectivepatient covering,such as to isolatea site of surgicalincisions frommicrobial andothercontamination.They are providedsterile usingethylene oxide. | The Dukal 20-001-Fenestrated DukalSurgical Drape,Blue, 18" x 26",with 3"Fenestration, and20-002 - DukalSurgicalDrape, Blue, 18" x26" is a devicemade of naturalor syntheticmaterialsintended to beused as aprotective patientcovering, such asto isolate a site ofsurgical incisionfrom microbialand othercontamination. | TheSurgicalDrape is intendedfor external useonly and is usedas a protectivepatient covering,such as to isolatea site of surgicalincisions frommicrobial andothercontamination.They are providedsterile usingethylene oxide. |
| Materials | Tissue/Poly/TissueDrape | Tissue/Poly/TissueDrape | Tissue/Poly/TissueDrape | Tissue/Poly/TissueDrape |
| Sterile | EO | EO | EO | EO |
| Lamination | Heat welded | Heat welded | Heatwelded(threelayers) | Heatwelded(threelayers) |
| Dimension | Various size | Various size | L*W: 18"*26";Fenestration: Φ3" | Various size |
| Barrierproperties | AAMI PB70Barrier Level 4 | AAMI PB70Barrier Level 4 | AAMI PB70Barrier Level 4 | AAMI PB70Barrier Level 4 |
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| Environment ofUse | During surgeries | During surgeries | During surgeries | During surgeries |
|---|---|---|---|---|
| Performance | AAMI PB70Barrier Level 4 | AAMI PB70Barrier Level 4 | AAMI PB70Barrier Level 4 | AAMI PB70Barrier 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: DeviceSpecificGuidanceRequirementsfor Comparison | Guidance onPremarketNotification510(k)Submissions forSurgical Gownsand SurgicalDrapes | Guidance onPremarketNotification510(k)Submissions forSurgical Gownsand SurgicalDrapes | Guidance onPremarketNotification510(k)Submissions forSurgical Gownsand SurgicalDrapes | Guidance onPremarketNotification510(k)Submissions forSurgical Gownsand SurgicalDrapes |
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.
-
- 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
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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.
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).
§ 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.