HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only.

This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Models C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Simple Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, ENT Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.

Device Description

This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

HONGYU Disposable Surgery Drapes offer a variety of surgery drapes (23 types), including C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Fenestrated Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, Dental Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.

The HONGYU Disposable Surgery Drapes have a basic drape. Additionally, each of the drapes has different drape components according to the intended clinical surgery sites, such as the reinforcement, fenestration, single-coating/ double-coating medical tape. PE film and Velcro-style line holders/ tube holders.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (HONGYU Disposable Surgical Drapes) and includes a summary of non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it does not contain information about a clinical study involving human subjects or AI performance. Therefore, I cannot fully answer all aspects of your request, particularly those pertaining to AI assistance, human reader performance, training set, or ground truth derived from pathology/outcomes data.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-AI, non-diagnostic product, and its performance is evaluated against material properties and sterile barrier standards. The acceptance criteria are typically the standards themselves, and the reported performance is conformity to these standards.

Acceptance Criteria (Standard)	Reported Device Performance
Barrier Performance:
AAMI PB70-2012 (Level 4 liquid barrier performance)	Conforms to Level 4
ASTM F1670-08 (Resistance to penetration by synthetic blood)	Conforms (implied by Level 4 and non-clinical test conclusion)
Flammability:
16 CFR Part 1610:2008 (Flammability of Clothing Textiles)	Class I
Mechanical Strength:
ASTM D5034-09 (Breaking Strength and Elongation of Textile Fabrics)	Conforms (implied by non-clinical test conclusion)
ASTM D5587-08 (Tearing Strength of Fabrics)	Conforms (implied by non-clinical test conclusion)
Particle Generation:
ISO 9073-10:2003 (Lint and Other Particles Generation in the Dry State)	Conforms (implied by non-clinical test conclusion)
Thermal/Evaporative Resistance:
ASTM F1868-12 (Thermal and Evaporative Resistance of Clothing Materials)	Conforms (implied by non-clinical test conclusion)
Biocompatibility:
ISO 10993-5:2009 (Cytotoxicity)	No Cytotoxic Potential
ISO 10993-10:2010 (Irritation)	No Primary Skin Irritation
ISO 10993-10:2010 (Sensitization)	Not a Dermal Sensitizer
Sterilization:
ISO 11135-1:2007 (Ethylene oxide sterilization process)	Conforms (implied by non-clinical test conclusion and EO sterilization)
ISO 10993-7:2008 (Ethylene oxide sterilization residuals)	Conforms (implied by non-clinical test conclusion)
Packaging Integrity:
ASTM F88-05 (Seal Strength of Flexible Barrier Materials)	Conforms (implied by non-clinical test conclusion)
ASTM F1140-00 (2005) (Internal Pressurization Failure Resistance of Unrestrained Package)	Conforms (implied by non-clinical test conclusion)
ASTM F1929-98 (2004) (Detecting Seal Leaks in Porous Medical Package by Dye Penetration)	Conforms (implied by non-clinical test conclusion)

2. Sample size used for the test set and the data provenance

The document describes non-clinical tests on the device materials and packaging, not human studies. Therefore, there isn't a "test set" in the context of patient data. The samples would be batches of the surgical drape and its component materials. The document does not specify the number of samples tested for each non-clinical test. The provenance of the data is from Weihai Hongyu Nonwoven Fabric Products Co., Ltd in China, performing tests to demonstrate conformity to international and US standards. These tests are inherently retrospective in the sense that they are performed on manufactured products.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical device that relies on standardized material testing. "Ground truth" in this context refers to the defined parameters of the standards themselves (e.g., a material either passes a certain barrier test or it doesn't). No human experts are involved in establishing "ground truth" for each individual test sample; rather, the tests are performed by technicians/engineers following established protocols.

4. Adjudication method for the test set

Not applicable. As described above, there is no need for adjudication as these are objective material property tests against defined standards.

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 device is a surgical drape, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used

The "ground truth" for the performance of this device is established by international and national consensus standards for material properties, barrier performance, biocompatibility, and sterilization. For example, the "ground truth" for liquid barrier performance is a specified level (like Level 4) defined within the AAMI PB70 standard. "Pathology" or "outcomes data" are not relevant for the substantial equivalence demonstration of this type of device.

8. The sample size for the training set

Not applicable. This is a non-AI product, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set.

Summary

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

April 14, 2015

Weihai Hongyu Nonwoven Fabric Products Co., Ltd. C/O Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. Post Office Box 120-119 Shanghai. 200120 CHINA

Re: K141324

Trade/Device Name: Hongyu Disposable Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape Regulatory Class: II Product Code: KKX Dated: March 18, 2015 Received: March 19, 2015

Dear Ms. Hong:

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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Page 2 - Ms. Hong

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 (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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division 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) KJ41324

Device Name HONGYU Disposable Surgical Drapes

Indications for Use (Describe)

This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

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

ا 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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Section 3 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number:__K141324

1. Date of Submission: April 9, 2015
Sponsor Identification 2.

Weihai Hongyu Nonwoven Fabric Products Co., Ltd 9-1 Pudong Rd, Economy and technique area, Weihai, Shandong, 264200, China

Establishment Registration Number: 3008489813

Contact Person: Yanfei Liu Position: Registration Manager Tel: +86-631-3636943 Fax: +86-631-3636910 Email: liuyanfei340@163.com

1. Submission Correspondent
  Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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1. Proposed Device Identification
  Proposed Device Trade Name: HONGYU Disposable Surgical Drapes Proposed Device Common Name: Surgical Drape

Regulatory Information: Classification Name: Drape, Surgical Classification: II; Product Code: KKX Regulation Number: 21 CFR 878.4370 Review Panel: General & Plastic Surgery

Intended Use Statement:

This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Models: C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Fenestrated Drape, Simple Drape, Extremity Drape, Universal Drape, Craniotomy Drape, Buttock Drape, Dental Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.

ડ. Predicate Device Identification
510(k) Number: K130404 Product Name: Cardinal Health Tiburon® surgical drape Manufacturer: Cardinal Health 200, LLC

6. Device Description

This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and

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classification of protective apparel and drapes intended for use in health-care facilities.

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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 material used in protective clothing to penetration by synthetic blood.

16 CFR Part 1610:2008 Standard for the Flammability of Clothing Textiles

ASTM D5034- 09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)

ASTM D 5587- 08 Standard Test Method for Tearing Strength of Fabrics by the Trapezoid Procedure

ISO 9073-10:2003 Textiles Test Methods for Nonwovens- Part 10: Lint and Other Particles Generation in the Dry State

ASTM F 1868- 12 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate - Part B- Isothermal Evaporative Resistance

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

ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices

ISO 10993-7: 2008: Biological evaluation of medical device-Part 7: Ethylene oxide sterilization residuals ASTM F88-05 Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM F 1140-00 (2005) Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Package for Medical Applications

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ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration

1. Substantially Equivalent (SE) Conclusion
  The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device(s)	Predicate Device
Product Code	KXX	KXX
Regulation Number	21 CFR 878.4370	21 CFR 878.4370
Intended Use	HONGYU Disposable Surgical Drapes aredevices made of synthetic material intended tobe used as a protective patient covering toisolate a site of surgical incision frommicrobial and other contamination. The drapeis sterilized using ethylene oxide and isintended for single external use only.This drape is classified as Level 4 per AAMIStandard PB70 liquid barrier performance andclassification of protective apparel and drapesintended for use in health-care facilities.	Cardinal Health Tiburon® surgical drapes aredevices made of nature or synthetic materialintended to be used as a protective patientcovering to isolate a site of surgical incisionfrom microbial and other contamination. Thedrape is sterilized using ethylene oxide and isintended for single external use only.This drape is classified as Level 4 per AAMIStandard PB70 liquid barrier performance andclassification of protective apparel and drapesintended for use in health-care facilities.
Components	Basic drape, Reinforcement, PE pouch, Incisefilm, Elastomeric film	SAME
Sterile	EO sterilization	EO sterilization
Single Use	Yes	Yes
Resistance to Blood andLiquid Penetration	Level 4 per AAMI PB 70	Level 4 per AAMI PB 70
Fire Protection	Class I	Class I
Biocompatibility	CytotoxicityConform to the requirement of ISO 10993-5No Cytotoxic Potential under the conditions ofstudy	Conform to the requirement of ISO 10993-5No Cytotoxic Potential under the conditions ofstudy
	IrritationConform to the requirement of ISO 10993-10No Primary Skin Irritation under theconditions of the study	Conform to the requirement of ISO 10993-10No Primary Skin Irritation under theconditions of the study
	SensitizationConform to the requirement of ISO 10993-10	Conform to the requirement of ISO 10993-10
		Not a Dermal Sensitizer under theconditions of the study	Not a Dermal Sensitizer under theconditions of the study

Table 3-1 Comparison of Technology Characteristics

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The HONGYU Disposable Surgical Drapes are determined to be Substantially Equivalent (SE) to the predicate device, Cardinal Health Tiburon® surgical drape.

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.