HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER

K122000 · Changzhou Holymed Products Co., Ltd. · KKX · Dec 12, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122000
• Device Name: HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
• Applicant: Changzhou Holymed Products Co., Ltd.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Dec 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. HM Surgical Equipment Covers are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

Device Story

HM Surgical Drapes and Equipment Covers function as physical barriers to prevent microbial and fluid contamination during surgical procedures. Drapes isolate incision sites; equipment covers protect surgical instruments/equipment. Devices are disposable, single-use, and manufactured from materials including SMS (spunbond-meltblown-spunbond) fabric, SM (spunbond-meltblown) fabric, and polyethylene film. Used in clinical surgical environments; operated by surgical staff. Drapes/covers are applied manually to patients or equipment prior to or during surgery. Benefit: reduction of cross-contamination risk and maintenance of sterile fields.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: SMS, SM, and polyethylene film. Design: Various configurations (fenestrated, split, pouch-integrated, etc.) for specific surgical procedures. Sterilization: Ethylene Oxide (EtO) per ISO 11135-1. Connectivity: None. Energy source: None.

Indications for Use

Indicated for use as protective patient coverings to isolate surgical incision sites from contamination and as protective barriers for surgical equipment. Intended for use in surgical settings; disposable, single-use; available sterile or non-sterile.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### December 12, 2012

Mr. Alan Yu Manager, Quality Assurance/Regulatory Affairs Changzhou HolyMED Products Company, Limited 528 Changwu South Road Wujin District Changzhou, China 213167

Re: K122000

Trade/Device Name: HM Surgical Drapes, HM Surgical Equipment Covers Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX · Dated: November 27, 2012 Received: November 29, 2012

Dear Mr. Yu:

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony De min

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

### 510(k) Number (if known): KI22000 .

Device Name: HM Surgical Drapes

#### Indications for Use:

HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

HM surgical drapes are disposable, single use, sterile or nonsterile.

Non-sterile HM surgical drapes are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

#### Drapes are provided as below

| Drape Model Family | Drape Name | Model Code (Sterile/Nonsterile) | Color | Drape Materials |
|---------------------------|------------------------------------|---------------------------------|-------|---------------------------------------------------|
| Angiography Drapes | Angiography Surgical Drape | 935101/835101 | Blue | SMS base panel with SM pad and polyethylene sides |
| Fenestrated Drape | Clear Legging Surgical Drape | 935201/835201 | Clear | Polyethylene Film |
| Extremity Drapes | Universal Extremity Surgical Drape | 935301/835301 | Blue | SMS base panel with SM pad |
| | Legging Surgical Drape | 935302/835302 | Blue | SMS panel |
| | Head Surgical Drape | 935303/835303 | Blue | SMS panel |
| | Side Surgical Drape | 935304/835304 | Blue | SMS base panel with SM pad |
| | Top Surgical Drape | 935305/835305 | Blue | SMS base panel with SM pad |
| | Bottom Surgical Drape | 935306/835306 | Blue | SMS base panel with SM pad |
| | Bar Surgical Drape | 935307/835307 | Blue | SMS base panel with SM pad |
| Laparotomy Drapes | Laparotomy Surgical Drape | 935401/835401 | Blue | SMS base panel with SM pad |
| Arthroscopy Drapes | Arthroscopy Surgical Drape | 935501/835501 | Blue | SMS base panel with SM Pad and polyethylene pouch |
| Under buttocks Drapes | Under buttocks Surgical Drape | 935601/835601 | Blue | SMS base panel with SM Pad and polyethylene pouch |
| Split Drapes | Split Surgical Drape | 935701/835701 | Blue | SMS base panel with SM pad |
| Lithotomy Drapes | Lithotomy Surgical Drape | 935801/835801 | Blue | SMS base panel with SM pad |
| Laparoscopic Drapes | Laparoscopic Surgical Drape | 935901/835901 | Blue | SMS base panel with SM pad |
| Thyrold Drapes | Thyroid Surgical Drape | 936001/83001 | Blue | SMS base panel with SM pad |
| Abdominal Drapes | Abdominal Surgical Drape | 936101/836101 | Blue | SMS panel |
| C-section Drapes | C-section Surgical Drape | 936201/836201 | Blue | SMS base panel with polyethylene pouch |
| Minor Procedure Drapes | Minor Procedure Surgical Drape | 936301/836301 | Blue | SMS base panel with SM pad |
| Lap Chole Drape | Lap Chole Surgical Drape | 936401/836401 | Blue | SMS base panel with SM pad |
| Universal Spine Drapes | Universal Spine Surgical Drape | 936501/836501 | Blue | SMS base panel with SM pad |
| Cystoscopy Surgical Drape | Cystoscopy T Surgical Drape | 936601/836601 | Blue | SMS base panel with SM pad |
| Chest Surgical Drape | Chest Surgical Drape | 936701/836701 | Blue | SMS base panel with SM pad |
| Utility Surgical Drape | Utility Surgical Drape | 936801/836801 | Blue | SM absorbent panel |
| | Ophthalmic Surgical Drape | 936901/836901 | Blue | SMS base panel with |

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| Cardiovascular Drape | Surgical Drape | 8372-03778 | | polyethylene pouch |
|-------------------------|-------------------------|------------|------|---------------------------------------------------|
| Drape | | 83710-781 | | SM absorbent panel with a<br>polyethylene backing |
| Aperture Surgical Drape | Aperture Surgical Drape | | Blue | SM absorbent panel with a<br>polyethylene backing |

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

Elizabeth F. Claverie 2012.12.11 18:26:29 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:_

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#### INDICATIONS FOR USE

# 510(k) Number (if known): K | 22 000

Device Name: HM Surgical Equipment Covers

#### Indications for Use:

HM Surgical Equipment Covers are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

HM surgical equipment covers are disposable, single use, sterile or nonsterile.

Non-sterile HM surgical equipment covers are to be sold to repackager/relabeler establishments for E!O sterflization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

#### Drapes are provided as below

| Drape Model Family | Equipment Cover Name | Model Code (Sterile/Nonsterile) | Cover | Drape Materials |
|--------------------|----------------------|---------------------------------|-------|----------------------------------------------|
| Equipment Cover | Band Bag | 938101/838101 | Clear | Polyethylene bag |
| Equipment Cover | Mayo Stand Cover | 938102/838102 | Blue | Blue polyethylene tube with SM reinforcement |
| Equipment Cover | Table Cover | 938103/838103 | Blue | Blue polyethylene film with SM reinforcement |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

## Elizabeth F. Claverie 2012.12.11 18:25:53 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: