HONGYU DISPOSABLE SURGICAL DRAPES

K141324 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · KKX · Apr 14, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K141324
• Device Name: HONGYU DISPOSABLE SURGICAL DRAPES
• Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Apr 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

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.

Device Story

Synthetic surgical drapes; provide sterile barrier to isolate incision sites from microbial/fluid contamination. Used in clinical/surgical settings; operated by healthcare staff. Features include reinforcements, fenestrations, medical tape, PE film, and tube holders. Sterilized via ethylene oxide; single-use. Protects patient by maintaining sterile field during invasive procedures.

Clinical Evidence

Bench testing only. Compliance verified against AAMI PB70-2012 (liquid barrier), ASTM F1670-08 (synthetic blood penetration), 16 CFR 1610:2008 (flammability), ASTM D5034-09/D5587-08 (strength), ISO 9073-10:2003 (linting), ASTM F1868-12 (thermal resistance), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation/sensitization), and package integrity standards (ASTM F88-05, F1140-00, F1929-98).

Technological Characteristics

Synthetic nonwoven fabric; Level 4 AAMI PB70 liquid barrier performance. Includes reinforcements, fenestrations, medical tape, PE film, and Velcro-style holders. Sterilized via ethylene oxide (ISO 11135-1). Biocompatible per ISO 10993-5 and 10993-10.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination in healthcare facilities. Applicable to various surgical procedures including C-section, arthroscopy, bladder, split (U), arm/wrist, abdominal, shoulder, lithotomy, neck, fenestrated, simple, extremity, universal, head, craniotomy, buttock, dental, ENT, pediatric laparotomy, ophthalmic, angiography, and articulation surgeries.

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

• Cardinal Health Tiburon® surgical drape (K130404)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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## 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: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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- 4. 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:

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, 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

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

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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.

#### 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

- 8. 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 are<br>devices made of synthetic material intended to<br>be used as a protective patient covering to<br>isolate a site of surgical incision from<br>microbial and other contamination. The drape<br>is sterilized using ethylene oxide and is<br>intended for single external use only.<br><br>This drape is classified as Level 4 per AAMI<br>Standard PB70 liquid barrier performance and<br>classification of protective apparel and drapes<br>intended for use in health-care facilities. | Cardinal Health Tiburon® surgical drapes are<br>devices made of nature or synthetic material<br>intended to be used as a protective patient<br>covering to isolate a site of surgical incision<br>from microbial and other contamination. The<br>drape is sterilized using ethylene oxide and is<br>intended for single external use only.<br><br>This drape is classified as Level 4 per AAMI<br>Standard PB70 liquid barrier performance and<br>classification of protective apparel and drapes<br>intended for use in health-care facilities. | |
| Components | Basic drape, Reinforcement, PE pouch, Incise<br>film, Elastomeric film | SAME | |
| Sterile | EO sterilization | EO sterilization | |
| Single Use | Yes | Yes | |
| Resistance to Blood and<br>Liquid Penetration | Level 4 per AAMI PB 70 | Level 4 per AAMI PB 70 | |
| Fire Protection | Class I | Class I | |
| Biocompatibility | Cytotoxicity<br>Conform to the requirement of ISO 10993-5<br>No Cytotoxic Potential under the conditions of<br>study | Conform to the requirement of ISO 10993-5<br>No Cytotoxic Potential under the conditions of<br>study | |
| | Irritation<br>Conform to the requirement of ISO 10993-10<br>No Primary Skin Irritation under the<br>conditions of the study | Conform to the requirement of ISO 10993-10<br>No Primary Skin Irritation under the<br>conditions of the study | |
| | Sensitization<br>Conform to the requirement of ISO 10993-10 | Conform to the requirement of ISO 10993-10 | |
| | | Not a Dermal Sensitizer under the<br>conditions of the study | Not a Dermal Sensitizer under the<br>conditions 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.