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.

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.

AI/ML Overview

This submission is a 510(k) premarket notification for a Class II medical device, "The Finger Guard®," an accessory to a reusable oximeter finger sensor/probe. The device is a tubular clear sheath/sleeve designed to be placed on a digit, with the pulse oximeter sensor/probe placed over the sleeve, to provide a minimum physical barrier and help prevent gross contamination of the sensor/probe.

Based on the provided information, the submission does not include a study with acceptance criteria and reported device performance in the typical sense of a clinical or performance study for diagnostic accuracy or efficacy. Instead, the entirety of the submission focuses on demonstrating substantial equivalence to an existing predicate device, the Coverox Sheath (K964821).

The assessment for substantial equivalence is based on a comparison of intended use, materials of construction, technical characteristics, and product labeling between The Finger Guard® and the predicate device. The core argument for equivalence hinges on the idea that despite a slight technical difference in placement (on the finger versus on the probe), both devices achieve the same function of acting as a physical barrier for gross contamination without impeding the pulse oximeter's reading.

Therefore, many of the specific questions regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not applicable in this context. The "acceptance criteria" here are essentially whether the new device can be shown to be as safe and effective as the predicate device by meeting the FDA's criteria for substantial equivalence.

Here's an attempt to answer the questions based on the available information, noting when information is absent due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission focusing on a physical barrier accessory, traditional performance metrics like sensitivity, specificity, accuracy, or clinical outcomes are not presented. The "acceptance criteria" are implied by the comparison to the predicate device, specifically:

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Intended Use: Similar to predicate.	Both devices are accessories to reusable pulse oximeter finger sensor/probes, providing a barrier against contamination.
Material: Biocompatible and transparent.	New device uses clear low-density polyethylene copolymer film. Predicate uses "clear plastic." Both are transparent. The new device's material is considered safe for skin contact.
Technical Characteristics: Allows oximeter reading; provides physical barrier.	The Finger Guard® is a clear plastic sleeve placed directly on the finger, transparent and thin enough to allow oximeter readings. It provides a physical barrier. The predicate also does this, though placed on the sensor/probe.
Safety: Does not introduce new safety concerns.	The difference in placement (on finger vs. on probe) does not raise new safety issues, as the same type of material contacts the skin.
Effectiveness: Similar effectiveness as a barrier.	Both provide a gross contamination barrier and allow for pulsation readings.
Labeling: Appropriate for single use, non-sterile, disposable.	Consistent with predicate (single use, non-sterile, disposable). New device specifies latex-free, powder-free.

2. Sample size used for the test set and the data provenance

Not applicable. There was no formal "test set" in the sense of a data set used for performance evaluation of an algorithm or diagnostic device. The evaluation was a comparison of device characteristics to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth was established by experts for a test set. The substantial equivalence argument relies on the inherent characteristics of the device and comparison to an already cleared device.

4. Adjudication method for the test set

Not applicable. No adjudication method for a test set was mentioned, as there was no test set or clinical study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical accessory, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical accessory, not an algorithm.

7. The type of ground truth used

Not applicable. The "ground truth," in an indirect sense, would be the established safety and effectiveness of the existing predicate device, the Coverox Sheath, which the FDA had already cleared. The substantial equivalence relies on demonstrating that The Finger Guard® is sufficiently similar to this cleared device.

8. The sample size for the training set

Not applicable. There was no training set, as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established

Not applicable. There was no training set or associated ground truth.

Summary

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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

: 上一

Product Code: DQA

Applicant: T F & G Products 6956 Oro Bangor Hwy. Oroville, CA 9566-8249 Telephone: 530-679-0443

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 areusable pulse oximeterfinger tip sensor/probe to.It may provide a minimumbarrier protection from thedigit on which the devicewill be used. It may helpprevent transfer ofcontamination to the probe.	For use in conjunction witha reusable pulse oximeterfinger tip sensor/probe ofthe clothes pin style. Itprovides a grosscontamination barrierbetween the finger and theprobe. It prevents transferof contamination to theprobe.
Materials of construction	Clear low densitypolyethylene copolymerfilm.	Clear plastic; type or gradeunknown.
Technical Characteristics	The Finger Guard® is aclear plastic sleeve placeddirectly on the finger. It istransparent and of suchthickness as to allow thereading of the pulsation ofthe blood in the finger.After use the sleeve isremoved and discarded.	The Coverox is a clearplastic sheath placeddirectly on the sensor/probe.It is transparent and of sucha thickness as to allow thereading of the pulsation ofthe blood in the finger.After use the sheath isremoved and discarded.
Product Labeling	Single use, non-sterile, latexfree, powder free,disposable	Single use, non-sterile,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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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.

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 (240) 276-0120. 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/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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( CONFIDENTIAL

1.2 A

Statement of Indications for Use

510(k) Number: Not Known

Device Name: The Finger Guard®

Indications For Use:

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)

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

DRH, Office of Device Evaluation (ODE) Concurrence of

Sylter 4. Dicken C und

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MK, 12/15

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).