(157 days)
The Finger Pulse Oximeter is a small portable battery powered device that measures %SpO2, pulse rate, and pulse strength on the finger. It may be used as a spot check device in the home, hospital, or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The pulse oximeter will provide reliable measurements on patients ranging from pediatric to adults. This device is not intended for continous patient monitoring. There are no audible or visible patient alarms.
Fox Oximeter is a portable, lightweight, and battery-operated device that measures %SpO2 pulse rate, and pulse strength on the finger of a patient.
The provided submission, K051736 for the Fox Oximeter, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and stating that clinical testing was "Not Applicable."
Here's an analysis based on the provided text, highlighting the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
Not available in the provided text. The document refers to compliance with various electrical and electromagnetic compatibility standards (EN 60601-1-2, EN 55011, 47CFR Part 15 Subpart B, EN 61000-4-2, EN 61000-4-3, EN 61000-4-8), but it does not specify performance acceptance criteria for SpO2, pulse rate, or pulse strength measurements, nor does it report the device's performance against such criteria.
2. Sample Size Used for the Test Set and Data Provenance:
Not available in the provided text. The submission states "Discussion on Clinical Tests Performed: Not Applicable," indicating no clinical test set was used for evaluating the device's performance in terms of SpO2, pulse rate, or pulse strength. The non-clinical tests mentioned are related to safety and electromagnetic compatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as no clinical test set was used to establish performance.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The submission does not mention any clinical study, let alone one involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The submission does not discuss any algorithm-only performance study for the oximeter's core measurement functions. The evaluation focuses on substantial equivalence and compliance with non-clinical standards.
7. Type of Ground Truth Used:
Not applicable in the context of clinical performance evaluation. For the non-clinical tests, the "ground truth" would be the specifications and requirements of the standards themselves (e.g., passing electromagnetic interference tests).
8. Sample Size for the Training Set:
Not applicable. This device is a hardware medical device (oximeter), and there is no mention of a machine learning algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning algorithm.
Summary from the provided document:
The K051736 submission for the Fox Oximeter relies on the claim of substantial equivalence to the predicate device (3420 Digit™ Pulse Oximeter, K013171). The manufacturer performed non-clinical tests to ensure compliance with electrical and electromagnetic compatibility standards. No clinical performance testing against specific acceptance criteria for SpO2, pulse rate, or pulse strength was deemed necessary or performed, as indicated by "Discussion on Clinical Tests Performed: Not Applicable." Therefore, the document does not contain the detailed information requested regarding clinical acceptance criteria, study design, sample sizes, or expert involvement for performance evaluation.
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DEC 2 2005
510(k) Summary
1 Submitter's Identification:
Lee & Xiao 2600 Mission Street, Suite 100 San Marino, CA 91108 Tel: (626)799-0998 Fax: (626)799-1588
Contact Person: Yingchao Xiao, Esq.
Date: June 8, 2005
2. Device Name:
Trade Name: Fox Oximeter Common Name: Oximeter Classification Name: Oximeter
3. Predicate Device Information
The legally marketed device to which the submitter claims equivalence
3420 Digit™ Pulse Oximeter (K013171)
4 Device Description
Fox Oximeter is a portable, lightweight, and battery-operated device that measures %SpO2 pulse rate, and pulse strength on the finger of a patient.
5. Intended Use:
The Finger Pulse Oximeter is a small portable battery powered device that measures %SpO2, pulse rate, and pulse strength on the finger. It may be used as a spot check device in the home, hospital, or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The pulse oximeter will provide reliable measurements on patients ranging from pediatric to adults.
This device is not intended for continous patient monitoring. There are no audible or visible patient alarıns.
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6. Comparison with Predicate Device:
Both Fox Oximeter and 3420 Digit™ Pulse Oximeter are designed to monitor %SpO2, pulse rate, and pulse strength of a patient. The subject device differs from the /05p02, pulse fate, and psential areas: 1) finger holding mechanism; 2) testing subject ucvies in three essential areas off mode. Testing was done to ensure that Fox Oximeter would perform safely and effectively within the environment(s) for which it is to be marketed.
7. Discussion on Non-Clinical Tests Performed
Fox Oximeter complies with the following standards/regulations:
- 트 EN 60601-1-2: 2002
- EN 55011:1998 + A1:1999 + A2:2002 I
- 47CFR Part 15 Subpart B: 07/2004 1
- EN 61000-4-2: 1995 + A1:1998 + A2:2001 (IEC 1000-4-2) ■
- EN 61000-4-3 : 2002 (IEC 1000-4-3) I
- EN 61000-4-8: 1993 + A1:2001 (IEC 1000-4-8) l
8. Discussion on Clinical Tests Performed
Not Applicable.
9. Conclusion
Fox Oximeter has the same intended use and similar technological characteristics as 3420 Digit™ Pulse Oximeter. Moreover, the comparisons between the subject device and the predicate device demonstrate that any of the differences in their technological characteristics do not raise any questions in terms of the subject device's safety and effectiveness. Therefore, the Fox Oximeter is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2005
Mr. Yingchao Xiao, Esq. Shunsuke Nakanishi Lee & Xiao Attorneys 2600 Mission Street, Suite 100 San Marino, California 91108
Re: K051736
Trade/Device.Name: Fox Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 22, 2005 Received: November 25, 2005
Dear Mr. Xiao:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalent of the device is substantially equivalent (for the devices may referenced above and have decemined the do received predicate devices marketed in
indications for use stated in the enclosure) to legally Medical Davice indications for use stated in the enactment date of the Medical Device interstate commerce prior to May 20, 1770, the chassified in accordance with the provisions of Amendments, of to uevices that nave obcit results as the specific approval of a premarket to the sepperal the Federal Food, Drug, and Cosment Free (110) - market the device, subject to the general approval application (11MT). FOu may) :... I ou news of the Act include controls provisions of the rec. "The gentiral of devices, good manufacturing practice, requirements for animals against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classince (see above) into exontrols. Existing major regulations affecting (PMA), II may be subject to such additions, Title 21, Parts 800 to 898. In the Coderal your device can oc found in the Obac on receive announcements concerning your device in the Federal Register.
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Page 2 - Mr. Xiao
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issuance of a satsonalism with other requirements
mean that FDA has made a determination that your devices Federal agencies mean that FDA has made a decemmance Journinistered by other Federal agencies.
of the Act or any Federal statutes and regulations administrations and of the Act of any rederal statutes and registereds, including, but not limited to: registration
You must comply with all the Act's requirements, including and memorice You must comply with an the Act 3 requirements; massaling on the manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), laociling (21 CFR Part 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirements as set form in the quality Systems (Sections 531-542 of the Act);
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)
the success of the cases of the same of the spinsteans of your device to a This letter will allow you to begil matically your attial equivalence of your device to a
premarket notification. The FDA finding of substantial equivalence and thus, per premarket notification. The FDA midme of sabstanial vegan on the rour 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), If you desire specific advice for your device at (240) 276-0120. Also, please note the regulation please contact the Office of Comphance at (210) 270 first Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21CFR Part 800 entitled, "Misoranding by reference to premail.org/w/inters were the Act from the may obtain other general information on Joan Lapp Consumer Assistance at its toll-free DIVIsion of Binan Manakar (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sumite Y. Michau Omid.
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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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Fox Pulse Oximeter
Indications for Use:
The Finger Pulse Oximeter is a small portable battery powered device that measures %SpO2, The Finger Pulse Oxinceci is a small portable as a spot check device in the home, the Mome, pulse rate, and purse strengh on the mights patient ground transport in clinical and EMS hospital, of cillical environments, medding paneter will provide reliable measurements on patients ranging from pediatric to adults.
This device is not intended for continous patient monitoring. There are no audible or visible patient alarms
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X_____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cum Shom
von Sign-Off)
sion of Anesthesiology, General Hospital,
neceon Control. Dental Devices
(k) Number. K051736
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).