ARROW INTERNATIONAL, INC., SURGICAL DRAPES

K071491 · Arrow Intl., Inc. · KKX · Oct 10, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071491
• Device Name: ARROW INTERNATIONAL, INC., SURGICAL DRAPES
• Applicant: Arrow Intl., Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Oct 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Arrow 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.

Device Story

Arrow Surgical Drapes are sterile, disposable patient coverings used in surgical settings to isolate incision sites from microbial contamination. Drapes consist of barrier, absorbent, and repellant materials; may incorporate fenestrations for site access and medical-grade patient fixation adhesive. Used by surgical staff to maintain sterile fields. Benefits include reduced risk of surgical site contamination. No electronic or software components.

Clinical Evidence

Bench testing only. Testing included resistance to liquid penetration (AAMI PB70:2003/ASTM F 1670, AATCC 127), spray impact (AATCC 42), linting (ISO 9073-10:2004), tear resistance (ASTM F 5733), puncture penetration (ASTM F 1342), tensile grab (ASTM D 5034), and flammability (16 CFR Part 1610).

Technological Characteristics

Sterile, disposable patient coverings composed of barrier, absorbent, and repellant materials. May include fenestrations and fixation adhesive. Tested per AAMI PB70:2003, ASTM F 1670, AATCC 127, AATCC 42, ISO 9073-10:2004, ASTM F 5733, ASTM F 1342, ASTM D 5034, and 16 CFR Part 1610.

Indications for Use

Indicated for use as a protective patient covering to isolate a surgical incision site from microbial and other contamination during surgical procedures.

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

• Medline Industries, Inc. Surgical Drape (K032666)
• Pacon Manufacturing Corp. Surgical Drape (K850960)

Submission Summary (Full Text)

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K07/491

007 10 2007

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## 510 (k) Summary

| Submitter: | ARROW International, Inc.<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Karl Nittinger<br>Regulatory Affairs Specialist<br>Phone: [phone], ext. 3405<br>Fax: [phone]<br>Email: [e-mail] |
| Date summary prepared: | May 14, 2007 |
| Device trade name: | Surgical Drape<br>(21 CFR 878.4370, Product Code KKX) |
| Device common name: | Drape |
| Device classification name: | Surgical drape and drape accessories. |
| Legally marketed devices to<br>which the device is<br>substantially equivalent: | Medline Industries, Inc. Surgical Drape (K032666) and<br>Pacon Manufacturing Corp. Surgical Drape (K850960) |
| Description of the device: | Arrow Surgical Drapes are sterile, disposable patient<br>coverings for use in surgical procedures. They are<br>composed of one or more of the following materials:<br>Barrier, Absorbent, and Repellant materials. They may<br>incorporate one or more fenestration openings for surgical<br>site access and can also include medical grade patient<br>fixation adhesive. |
| Indications for use: | Arrow Surgical Drapes are intended to be used as a<br>protective patient covering, such as to isolate a site of<br>surgical incision from microbial and other contamination. |
| Technological<br>characteristics: | The proposed surgical drapes have the same<br>technological design characteristics as the predicate<br>devices. |

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| Performance tests: | The following tests were performed to demonstrate substantial equivalence: |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <ul><li>Resistance to Liquid Penetration (Synthetic Blood): [AAMI PB70:2003 (ASTM F 1670)]</li><li>Resistance to Liquid Penetration (Hydrostatic Pressure): [AAMI PB70:2003 (AATCC 127)]</li><li>Spray Impact: [AAMI PB70:2003 (AATCC 42)]</li><li>Linting - Gelbo Flex Test: [ISO 9073-10:2004]</li><li>Tear Resistance: [ASTM F 5733]</li><li>Puncture Penetration: [ASTM F 1342]</li><li>Tensile Grab: [ASTM D 5034]</li><li>Flammability: [16 CFR Part 1610]</li></ul> |
| Assessment of non-clinical performance data: | The results of the bench tests demonstrate that Arrow's Surgical Drapes are safe, effective and perform favorably when compared to the predicate drapes. |
| Summary | Arrow International's Surgical Drapes have the same intended use as the predicate device. Based on the assessment of non-clinical performance data and the technological characteristic comparison, Arrow's Surgical Drapes are substantially equivalent to the legally marketed predicate devices. |

K071491and the comments of the comments of the comments of the comments of

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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted as a triple-stranded design, resembling a bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

OCT 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey D. Ravel Senior Regulatory Affairs Manager ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607

Re: K071491

Trade/Device Name: Arrow Surgical Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 27, 2007 Received: September 28, 2007

Dear Mr.Ravel:

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. Ravel

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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 Statement

510(k) Number: K071491

Device Name: See attached list of product names

Indication For Use: Arrow Surgical Drapes are intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination

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

Over-The-Counter Use ____________ (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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K071491

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K071491

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## Attachment 1: Drape Device Names subject to this submission

| Drape Name | Drape Product<br>Number | Size |
|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------|
| Arrow Surgical Drape<br>Clear Non-absorbable drape with<br>Fenestration | D-60004-001 | 24 in x 30 in |
| Arrow Surgical Drape<br>Non-absorbable drape | K-05600-035 | 12 in x 24 in |
| Arrow Surgical Drape<br>Non-absorbable drape with<br>Fenestration | D-05000-001 | 18 in x 26 in |
| Arrow Surgical Drape<br>Absorbable drape with<br>Fenestration | K-05501-003 | 24 in x 30 in |
| Arrow Surgical Drape<br>Absorbable drape with<br>Fenestration | D-05600-003 | 24 in x 36 in |
| Arrow Surgical Drape<br>Absorbable drape with Multiple<br>Fenestrations | D-45703-008 | 78 in x 99 in |
| Arrow Surgical Drape<br>Absorbable drape with Clear Non-<br>Absorbable Fenestrated Window | D-45703-009 | 68 in x 110 in |
| Arrow Surgical Drape<br>Absorbable drape with Clear Non-<br>Absorbable Fenestrated Window<br>and Tear Line. Breathable in non-<br>critical areas. | D-45703-013 | 54 in x 96 in |
| Arrow Surgical Drape<br>Clear Non-absorbent Drape with<br>Absorbent Edging, Fenestration<br>and Tear Line | K-12703-001 | 21 in x 36 in |

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