(217 days)
The Fingertip Pulse Oximeter JPD-500F is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
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This FDA 510(k) clearance letter for the Fingertip Pulse Oximeter (Model JPD-500F) does not contain detailed information about the acceptance criteria or the specific study details for proving the device meets those criteria.
FDA 510(k) clearance letters primarily state that the device is "substantially equivalent" to a legally marketed predicate device. They typically do not include the raw data, study designs, or detailed performance metrics that would be found in a full submission. The letter confirms the device type, its classification, and intended use.
Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, one would need to access the full 510(k) submission document or a summary thereof, which often includes details of the performance testing and acceptance criteria.
However, I can infer some general information about what would typically be required for a pulse oximeter's acceptance criteria and how a study would prove it, even if the specifics are not in this document:
Inferred Information (Based on typical regulatory requirements for pulse oximeters, not directly from this document):
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Table of Acceptance Criteria and Reported Device Performance: This would typically involve accuracy and precision metrics for SpO2 and pulse rate.
- Acceptance Criteria (Example):
- SpO2 Accuracy: Aroot mean square (ARMS) difference between the device reading and reference measurement ≤ 3.0% saturation for SpO2 values between 70% and 100%. Clinical bias (mean difference) might also be specified.
- Pulse Rate Accuracy: Mean absolute difference (MAD) or ARMS difference between device reading and reference measurement ≤ 5 bpm for pulse rates between X and Y bpm.
- Reported Device Performance: This would be the actual ARMS, bias, or MAD values achieved in the clinical study.
- Acceptance Criteria (Example):
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Sample Size used for the test set and the data provenance:
- Sample Size: For SpO2 accuracy, typically involves at least 10-15 healthy adult volunteers for induced hypoxia studies (SpO2 levels typically varied down to ~70%). The number of measurements taken for each subject at various saturation levels would be substantial. Pediatric studies would involve a separate cohort.
- Data Provenance: Prospective, controlled clinical study; likely performed in a clinical setting (e.g., hospital, specialized lab) where reference SpO2 can be accurately measured (e.g., using arterial blood gas analysis with a co-oximeter). Country of origin is often the manufacturing country or a location with appropriate facilities for such studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for SpO2 and Pulse Rate accuracy. The "ground truth" for pulse oximetry is typically established through direct physiological measurements, not expert consensus.
- For SpO2, the gold standard (ground truth) is typically arterial blood gas analysis using a co-oximeter. This is a direct laboratory measurement, not an expert visual assessment.
- For Pulse Rate, the ground truth can be simultaneously recorded ECG or a direct arterial line measurement.
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Adjudication method for the test set:
- Not applicable for SpO2 and Pulse Rate accuracy. Adjudication is used when human interpretation is part of the ground truth establishment (e.g., reading medical images). Here, direct instrumental measurements provide the ground truth.
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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 standalone measurement device, not an AI-assisted diagnostic tool that interprets complex data for human readers. Therefore, an MRMC study is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone performance study. Pulse oximeters are designed to provide direct measurements, so their performance is inherently evaluated in a standalone manner. The device outputs SpO2 and pulse rate, and these outputs are compared against a reference standard.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For SpO2: Co-oximetry of arterial blood samples.
- For Pulse Rate: Electrocardiogram (ECG) or arterial line measurement.
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The sample size for the training set:
- This information would not be relevant for a traditional pulse oximeter like this (JPD-500F). Pulse oximeters rely on optical principles and signal processing algorithms that are typically developed based on physiological models and empirical calibration, not machine learning algorithms that require large "training sets" in the sense understood in AI/ML contexts. The "calibration" would be performed during device design and manufacturing using established standards.
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How the ground truth for the training set was established:
- As above, not applicable in the AI/ML sense. Calibration procedures involve ensuring the device's optical sensors and algorithms accurately convert light absorption measurements into SpO2 and pulse rate, typically checked against known physical standards and reference instruments during development and manufacturing.
To summarize, while the provided document confirms the FDA clearance for the device, it lacks the detailed performance study information. The questions regarding expert consensus, adjudication, MRMC studies, and AI-like "training sets" are generally not applicable to the analytical performance evaluation of a pulse oximeter, which relies on comparing device output against direct physiological reference measurements.
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November 3. 2017
Shenzhen Jumper Medical Equipment Co., Ltd. % Migo Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1122#, International Mayor Communication Center Baishizhong Road 55# Nanshan District, Shenzhen, 518000 CHINA
Re: K170965
Trade/Device Name: Fingertip Pulse Oximeter (Model JPD-500F) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: September 15, 2017 Received: October 5, 2017
Dear Migo Yang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Fingertip Pulse Oximeter (Model: JPD-500F)
Indications for Use (Describe)
The Fingertip Pulse Oximeter JPD-500F is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 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).