(105 days)
K 964821
K 964821
No
The device description and intended use clearly describe a physical barrier accessory for a pulse oximeter, with no mention of any software, algorithms, or data processing that would involve AI or ML.
No.
The device acts as a barrier or accessory for a pulse oximeter sensor, not to directly treat or diagnose a medical condition. Its purpose is to provide minimum barrier protection, not therapeutic benefit.
No
The device is described as a "tubular clear sheath/sleeve" intended to provide "minimum barrier protection" between a digit and a pulse oximeter probe. It functions as an accessory to the pulse oximeter, not as a device that itself diagnoses any condition. Its purpose is protective and hygienic rather than diagnostic.
No
The device is described as a physical sheath/sleeve, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Finger Guard Function: The Finger Guard's intended use is to provide a barrier between a digit and a pulse oximeter sensor. It does not perform any tests on bodily samples. It is an accessory to a diagnostic device (the pulse oximeter), but it is not a diagnostic device itself.
- Lack of Diagnostic Information: The description does not mention any analysis of biological samples or the generation of diagnostic information.
Therefore, based on the provided information, the Finger Guard is not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digit
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 964821
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
CONFIDENTIAL
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 a | |
| reusable pulse oximeter | ||
| finger tip sensor/probe to. | ||
| It may provide a minimum | ||
| barrier protection from the | ||
| digit on which the device | ||
| will be used. It may help | ||
| prevent transfer of | ||
| contamination to the probe. | For use in conjunction with | |
| a reusable pulse oximeter | ||
| finger tip sensor/probe of | ||
| the clothes pin style. It | ||
| provides a gross | ||
| contamination barrier | ||
| between the finger and the | ||
| probe. It prevents transfer | ||
| of contamination to the | ||
| probe. | ||
| Materials of construction | Clear low density | |
| polyethylene copolymer | ||
| film. | Clear plastic; type or grade | |
| unknown. | ||
| Technical Characteristics | The Finger Guard® is a | |
| clear plastic sleeve placed | ||
| directly on the finger. It is | ||
| transparent and of such | ||
| thickness as to allow the | ||
| reading of the pulsation of | ||
| the blood in the finger. | ||
| After use the sleeve is | ||
| removed and discarded. | The Coverox is a clear | |
| plastic sheath placed | ||
| directly on the sensor/probe. | ||
| It is transparent and of such | ||
| a thickness as to allow the | ||
| reading of the pulsation of | ||
| the blood in the finger. | ||
| After use the sheath is | ||
| removed and discarded. | ||
| Product Labeling | Single use, non-sterile, latex | |
| free, 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.
2
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.
3
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:
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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