PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS

K080629 · Promedical Products Co., Ltd. · KKX · Oct 20, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080629
• Device Name: PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
• Applicant: Promedical Products Co., Ltd.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Oct 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

Device Story

Sterile surgical drapes and equipment covers; used as protective barriers to isolate surgical sites from contamination or to cover equipment. Drapes constructed from SMS (spunbond-meltblown-spunbond), spunlace, polyethylene, and air-laid absorbent materials. Equipment covers utilize polyethylene bags, tubes, or films with air-laid reinforcement. Used in clinical/surgical settings to maintain sterile fields. Protects patients and equipment from microbial transfer and fluids during procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: SMS (spunbond-meltblown-spunbond), spunlace, polyethylene, and air-laid absorbent materials. Form factor: Various drapes (fenestrated, split, pouch-integrated) and equipment covers (bags, tubes, table covers). Sterile. No electronic or software components.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial/other contamination, and as protective barrier covers for surgical equipment.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 2008

Mr. Leo Wei Director, Quality Assurance/Regulatory Affairs ProMEDICAL Product Company, Limited 206 Haung He Road West, New North District Changzhou, Jiangsu CHINA 213022

Re: K080629

Trade/Device Name: proMedical Surgical Drape proMedical Surgical Equipment Cover Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX, MMP Dated: September 24, 2008 Received: October 1, 2008

Dear Mr. Wei:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Wei

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Cure

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): K080629

Devise name: proMedical Surgical Drape

Indications for use:

proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

| Drape Model<br>Family | Drape Name | Model<br>Code | Drape Materials |
|----------------------------|---------------------------------------|---------------|----------------------------------------------------------------|
| Angiography<br>Drape | Angiography<br>Surgical Drape | 19-001 | SMS base panel with air-<br>laid pad and<br>polyethylene sides |
| Fenestrated<br>Drape | Clear Legging<br>Surgical Drape | 19-020 | Polyethylene panel |
| Extremity<br>Drape | Universal Extremity<br>Surgical Drape | 19-051 | SMS base panel with air-<br>laid pad |
| | Legging Surgical<br>Drape | 19-052 | SMS panel |
| | Head Surgical Drape | 19-053 | SMS panel |
| | Side Surgical Drape | 19-054 | SMS base panel with air-<br>laid pad |
| | Top Surgical Drape | 19-055 | SMS base panel with air-<br>laid pad |
| | Bottom Surgical<br>Drape | 19-056 | SMS base panel with air-<br>laid pad |
| | Bar Surgical Drape | 19-057 | SMS base panel with air-<br>laid pad |
| Laparotomy<br>Drape | Laparotomy Surgical<br>Drape | 19-100 | Spunlace base panel with<br>air-laid pad |
| Arthroscopy<br>Drape | Arthroscopy<br>Surgical Drape | 19-151 | SMS base panel with<br>polyethylene pouch |
| Under<br>buttocks<br>Drape | Under buttocks<br>Surgical Drape | 19-201 | SMS base panel with air-<br>laid Pad and<br>polyethylene pouch |
| Split Drapes | Split Surgical<br>Drape | 19-251 | SMS base panel with air-<br>laid pad |
| Lithotomy<br>Drape | Lithotomy Surgical<br>Drape | 19-301 | SMS base panel with air-<br>laid pad |
| Laparoscopic<br>Drape | Laparoscopic<br>Surgical Drape | 19-351 | SMS base panel with air-<br>laid pad |
| Thyroid<br>Drape | Thyroid Surgical<br>Drape | 19-401 | SMS base panel with air-<br>laid pad |
| Abdominal<br>Drape | Abdominal Surgical<br>Drape | 19-451 | SMS panel |

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| Drape Model<br>Family | Drape Name | Model<br>Code | Drape Materials |
|-----------------------------------|-----------------------------------|---------------|------------------------------------------------------------|
| C-section<br>Drape | C-section Surgical<br>Drape | 19-501 | SMS base panel with<br>polyethylene pouch |
| Minor<br>Procedure<br>Drape | Minor Procedure<br>Surgical Drape | 19-551 | SMS base panel with air-<br>laid pad |
| Lap Chole<br>Drape | Lap Chole Surgical<br>Drape | 19-601 | SMS base panel with air-<br>laid pad |
| Universal<br>Spine Drape | Universal Spine<br>Surgical Drape | 19-651 | SMS base panel with air-<br>laid pad |
| Cystoscopy T<br>Surgical<br>Drape | Cystoscopy T<br>Surgical Drape | 19-701 | SMS base panel with air-<br>laid pad |
| Chest<br>urgical<br>Drape | Chest Surgical<br>Drape | 19-751 | SMS base panel with air-<br>laid pad |
| Utility<br>Surgical<br>Drape | Utility Surgical<br>Drape | 19-801 | Air-laid absorbent panel |
| Ophthalmic<br>Drape | Ophthalmic Surgical<br>Drape | 19-851 | SMS base panel with<br>polyethylene pouch |
| Cardiovascul<br>ar Drape | Cardiovascular<br>Surgical Drape | 19-901 | Air-laid absorbent panel<br>with a polyethylene<br>backing |
| Aperture<br>Drape | Aperture Surgical<br>Drape | 19-951 | Air-laid absorbent panel<br>with a polyethylene<br>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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

..............................................................................................................................................................................

510(k) Number: K080629

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## Indications for Use

510(k) Number (if known): _K080629

Devise name: proMedical Surgical Equipment Cover

Indications for use:

proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

| Cover Name | Model<br>Code | Cover Materials |
|---------------------|---------------|-------------------------------------------------------|
| Band Bag | 14-001 | Polyethylene bag |
| Mayo Stand<br>Cover | 15-001 | Blue polyethylene tube with Air-laid<br>reinforcement |
| Table Cover | 16-001 | Blue polyethylene film with Air-laid<br>reinforcement |

Shuly A. Mayles, MD

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

510(k) Number:

510(k) Number: K080629

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

. . . .