ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX

K052387 · Arthrex, Inc. · LZB · Nov 29, 2005 · General Hospital

Device Facts

• Record ID: K052387
• Device Name: ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
• Applicant: Arthrex, Inc.
• Product Code: LZB · General Hospital
• Decision Date: Nov 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The Arthrex Fingershield finger guards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.

Device Story

Arthrex Fingershield is a protective finger guard worn over surgical gloves during surgical procedures. Device consists of a woven polyester cylinder containing a radio-opaque Micropake® marker thread. Used by surgeons or surgical staff in clinical/OR settings to prevent glove damage or finger injury while tensioning sutures or tying knots. Device provides a physical barrier; no electronic or algorithmic components. Sterile, single-use, one-size-fits-all design.

Clinical Evidence

Bench testing only.

Technological Characteristics

Woven polyester material; radio-opaque Micropake® marker thread; cylinder form factor; one-size-fits-all; sterile.

Indications for Use

Indicated for use by surgical personnel wearing surgical gloves to provide protection during suture tensioning and knot tying procedures.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Percuguard by Digit-Pro (K992539)
• Latex Finger Cot by Tucker & Associates (K980827)

Submission Summary (Full Text)

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K052387

#### NOV 2 9 2005

## 510(k) Summary

| 510(k) Number: | |
|-----------------|---------------------------------------------|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | Ann Waterhouse |
| Device Name: | Arthrex Fingershield |
| Classification: | Finger Cot |
| Product Code: | LZB |
| Regulation #: | 21 CFR 880.6250 |

#### Description:

The Arthrex Fingershield Finger Guards are woven polyester with a marker thread of radio opaque Micropake®. These are offered in a one size fits all cylinder shape. They are offered sterile.

#### Indications for Use:

The Arthrex Fingershield finger quards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.

#### Substantially Equivalent Product:

Percuguard by Digit-Pro, K992539 Latex Finger Cot by Tucker & Associates, K980827

#### Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device for the previously cleared indications. The materials used in construction of these devices are well characterized in regards to strength and biocompatibility. The Arthrex Fingershield finger guards do not raise any questions regarding safety and effectiveness.

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NOV 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager Arthrex, Incorporated 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K052387

Trade/Device Name: Arthrex Fingershield Finger Guard Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZB Dated: November 10, 2005 Received: November 14, 2005

Dear Ms. Waterhouse:

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 - Ms. Waterhouse

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), n Jose 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/industry/support/index.html.

Sincerely yours.

Syndie Y. Michael Omd

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

# Device Name: Arthrex Fingershield Finger Guard

### Indications for Use:

The Arthrex Fingershield finger guards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.

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

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Shule H. Murphy, hQ 4/24/05

Ansion of Anesthes ... ory. General Hospital. infaction Control. Declai

2(k) Number: K 052387