THE FINGER GUARD

K052619 · T F & G Products · DQA · Jan 6, 2006 · Cardiovascular

Device Facts

• Record ID: K052619
• Device Name: THE FINGER GUARD
• Applicant: T F & G Products
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Single use, disposable digit cover for use as an accessory to a reusable pulse oximeter finger sensor/probe. The device may provide a minimum physical barrier protection from the digit on which the device will be used. To help prevent gross contamination of the pulse oximeter sensor/probe.

Device Story

The Finger Guard is a tubular, clear, low-density polyethylene copolymer sleeve; designed for single-use, disposable, non-sterile, latex-free, and powder-free application. The device is placed directly on a patient's digit before the reusable pulse oximeter sensor/probe is applied over it. The sleeve is transparent and of sufficient thickness to allow the oximeter to detect blood pulsation through the finger. After use, the sleeve is removed and discarded. The device serves as a physical barrier to prevent gross contamination of the pulse oximeter probe from the patient's digit. It is used in any clinical setting where pulse oximetry is required.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Clear low-density polyethylene copolymer film sleeve. Tubular form factor. Single-use, non-sterile, disposable. Passive physical barrier. No energy source or software.

Indications for Use

Indicated for use as an accessory to a reusable pulse oximeter finger sensor/probe to provide a minimum barrier between the digit and the probe to prevent gross contamination. Intended for use anywhere a pulse oximeter is needed.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Coverox Sheath (K964821)

Submission Summary (Full Text)

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#### CONFIDENTIAL

K052619

#### JAN 6 2006

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

Trade Name: The Finger Guard®

Common Name: Protective digit cover for use with oximeter sensor/probe

Classification Name: Accessory to reusable oximeter finger sensor/ probes

Regulation Number and Class: 870.2700; Class II

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Product Code: DQA

Applicant: T F & G Products 6956 Oro Bangor Hwy. Oroville, CA 9566-8249 Telephone: [phone]

Contact Person: Mariruth Gurley

Intended Use: Single use, disposable digit cover for use as an accessory to a reusable pulse oximeter finger sensor/probe. The device may provide a minimum physical barrier protection from the digit on which the device will be used. To help prevent gross contamination of the pulse oximeter sensor/probe.

Device Description: The device is a tubular clear sheath/sleeve. It has an opening for insertion of a digit. The sleeve is placed on the digit, and the pulse oximeter sensor/probe is placed over the sleeve/sheath.

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## CONFIDENTIAL & PROPRIETARY

Substantial Equivalence: The Finger Guard® is substantially equivalent to the predicate device Coverox Sheath, cleared under K 964821. The following provides a comparison of the new device to the predicate device.

| Device | New Device | Predicate Device |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Finger Guard® | Coverox Sheath Models Number PS65, PS 67 and EPS |
| Class | II | II |
| Intended Use | For use as an accessory to a<br>reusable pulse oximeter<br>finger tip sensor/probe to.<br>It may provide a minimum<br>barrier protection from the<br>digit on which the device<br>will be used. It may help<br>prevent transfer of<br>contamination to the probe. | For use in conjunction with<br>a reusable pulse oximeter<br>finger tip sensor/probe of<br>the clothes pin style. It<br>provides a gross<br>contamination barrier<br>between the finger and the<br>probe. It prevents transfer<br>of contamination to the<br>probe. |
| Materials of construction | Clear low density<br>polyethylene copolymer<br>film. | Clear plastic; type or grade<br>unknown. |
| Technical Characteristics | The Finger Guard® is a<br>clear plastic sleeve placed<br>directly on the finger. It is<br>transparent and of such<br>thickness as to allow the<br>reading of the pulsation of<br>the blood in the finger.<br>After use the sleeve is<br>removed and discarded. | The Coverox is a clear<br>plastic sheath placed<br>directly on the sensor/probe.<br>It is transparent and of such<br>a thickness as to allow the<br>reading of the pulsation of<br>the blood in the finger.<br>After use the sheath is<br>removed and discarded. |
| Product Labeling | Single use, non-sterile, latex<br>free, powder free,<br>disposable | Single use, non-sterile,<br>disposable. |

## Discussion of similarities and differences

The new device and the predicate device are for the same intended use. They are both made of clear plastic. The duration of use of both devices is 15-20 seconds are over time that a pulse oximeter reading is taken. Both devices are single use, non-sterile, and disposable.

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### CONFIDENTIAL

The technical difference between the devices is the placement of the protective sleeve/sheath. The new device is a plastic sleeve placed directly on the finger before the oximeter sensor/probe is placed on the finger. The predicate device is a plastic sheath placed on the oximeter finger sensor/probe itself before the probe is placed on the finger. This technological difference does not raise new issues of safety or effectiveness. The same type of material, i.e. plastic, comes into contact with the skin. Both protective covers allow the oximeter reading to be taken, while providing a physical barrier to gross contamination from the digit to the pulse oximeter probe/sensor. However, THE FINGER GUARD may provide a minimum barrier protection from the digit on which the device will be used. Based on this assessment, the new device is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 6 2006

Ms. Mariruth Gurley President T F & G Products 6956 Oro Bangor Highway Oroville, California 95966-8249

Re: K052619

Trade/Device Name: The Finger Guard® Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 16, 2005 Received: December 19, 2005

Dear Ms. Gurley:

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. Gurley

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/industry/support/index.html.

Sincercly yours,

Sutte y. Michael Toms

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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# Statement of Indications for Use

510(k) Number: Not Known

Device Name: The Finger Guard®

Indications For Use:

The Finger Guard® is intended for use as an accessory to a pulse oximeter reusable finger sensor / probe. When the clear Guard is placed on a digit and the sensor / probe placed over the Guard, it may provide a minimum barrier protection between the digit upon which it is placed and the probe. It can be used anywhere a pulse oximeter is needed.

There is no other use for The Finger Guard®. If The Finger Guard® is used for any other purpose than stated above, it is used in that capacity without The Finger Guard® permission.

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

Over-The -Counter Use _ (21 CFR 8-11 Subpart C)

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DRH, Office of Device Evaluation (ODE) Concurrence of

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