Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and physical performance, with no mention of AI or ML.

Therapeutic

No
The device, Arrow Surgical Drapes, is intended to be a protective patient covering to isolate a surgical incision site from contamination. It does not provide any therapy or treatment for a disease or condition.

Diagnostic

No

Explanation: The device is a surgical drape intended for protection and isolation during surgical procedures, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is composed of physical materials (Barrier, Absorbent, Repellant) and undergoes physical performance testing (Resistance to Liquid Penetration, Tear Resistance, etc.), indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to be a "protective patient covering" to "isolate a site of surgical incision from microbial and other contamination." This is a physical barrier function performed on the patient during a surgical procedure.
Device Description: The description details the physical composition and features of a surgical drape, such as materials, fenestrations, and adhesive.
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis of biological samples.
Performance Studies: The performance studies listed are bench tests evaluating physical properties like resistance to penetration, tear resistance, and flammability. These are relevant to the function of a surgical drape as a physical barrier, not to diagnostic performance.

Therefore, the Arrow Surgical Drapes are classified as a surgical device used in vivo (on the patient's body) during a procedure, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes

KKX

Device Description

Arrow Surgical Drapes are sterile, disposable patient coverings for use in surgical procedures. They are composed of one or more of the following materials: Barrier, Absorbent, and Repellant materials. They may incorporate one or more fenestration openings for surgical site access and can also include medical grade patient fixation adhesive.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following tests were performed to demonstrate substantial equivalence:

Resistance to Liquid Penetration (Synthetic Blood): [AAMI PB70:2003 (ASTM F 1670)]
Resistance to Liquid Penetration (Hydrostatic Pressure): [AAMI PB70:2003 (AATCC 127)]
Spray Impact: [AAMI PB70:2003 (AATCC 42)]
Linting - Gelbo Flex Test: [ISO 9073-10:2004]
Tear Resistance: [ASTM F 5733]
Puncture Penetration: [ASTM F 1342]
Tensile Grab: [ASTM D 5034]
Flammability: [16 CFR Part 1610]

The results of the bench tests demonstrate that Arrow's Surgical Drapes are safe, effective and perform favorably when compared to the predicate drapes.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K032666, K850960

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

K07/491

007 10 2007

:

510 (k) Summary

| Submitter: | ARROW International, Inc.
2400 Bernville Road
Reading, PA 19605-9607 USA |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Karl Nittinger
Regulatory Affairs Specialist
Phone: 610-378-0131, ext. 3405
Fax: 610-478-3128
Email: karl.nittinger@arrowintl.com |
| Date summary prepared: | May 14, 2007 |
| Device trade name: | Surgical Drape
(21 CFR 878.4370, Product Code KKX) |
| Device common name: | Drape |
| Device classification name: | Surgical drape and drape accessories. |
| Legally marketed devices to
which the device is
substantially equivalent: | Medline Industries, Inc. Surgical Drape (K032666) and
Pacon Manufacturing Corp. Surgical Drape (K850960) |
| Description of the device: | Arrow Surgical Drapes are sterile, disposable patient
coverings for use in surgical procedures. They are
composed of one or more of the following materials:
Barrier, Absorbent, and Repellant materials. They may
incorporate one or more fenestration openings for surgical
site access and can also include medical grade patient
fixation adhesive. |
| Indications for 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. |
| Technological
characteristics: | The proposed surgical drapes have the same
technological design characteristics as the predicate
devices. |

:

1

Performance tests:	The following tests were performed to demonstrate substantial equivalence:
	Resistance to Liquid Penetration (Synthetic Blood): [AAMI PB70:2003 (ASTM F 1670)]Resistance to Liquid Penetration (Hydrostatic Pressure): [AAMI PB70:2003 (AATCC 127)]Spray Impact: [AAMI PB70:2003 (AATCC 42)]Linting - Gelbo Flex Test: [ISO 9073-10:2004]Tear Resistance: [ASTM F 5733]Puncture Penetration: [ASTM F 1342]Tensile Grab: [ASTM D 5034]Flammability: [16 CFR Part 1610]
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

2

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.

3

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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

4

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

5

K071491

.

:

Attachment 1: Drape Device Names subject to this submission

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

.