(183 days)
The Finger Clip Pulse Oximeter is a handheld non-invasive and multi-use device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate in hospital-type facilities, and homecare.
This device is not recommended for use during exercise or low perfusion scenarios.
This device is not intended for use on infants and newborns. (Recommended for people over 3 years and the thickness of finger greater than or equal to 7mm).
Not Found
The provided text is an FDA 510(k) clearance letter for a Finger Clip Pulse Oximeter. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the detailed information required to answer your specific questions about acceptance criteria and the comprehensive study that proves the device meets those criteria.
The information you're asking for (acceptance criteria table, study sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in the summary of safety and effectiveness (SSE) or clinical study reports that are part of the original 510(k) submission. These documents are generally not made public in their entirety by the FDA in the clearance letter itself.
The clearance letter only states the following relevant points:
- Device Name: Finger Clip Pulse Oximeter
- Regulation Number: 21 CFR 870.2700 (Oximeter)
- Regulatory Class: Class II
- Product Code: DQA
- Indications for Use: Handheld non-invasive and multi-use device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate in hospital-type facilities, and homecare. Not recommended for use during exercise or low perfusion scenarios. Not intended for use on infants and newborns (recommended for people over 3 years and finger thickness >= 7mm).
To answer your request, I would need access to the actual 510(k) submission's technical documentation, specifically the performance testing and clinical data sections, which are not included in the provided text.
Therefore, I cannot populate the table or provide details on the study as requested, as the necessary information is not present in the given document.
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October 31, 2023
Guangdong Genial Technology Co., Ltd. % Reanny Wang General Manager Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community Guangming Street, Guangming District Shenzhen, Guangdong 518000 China
Re: K231243
Trade/Device Name: Finger Clip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: April 30, 2023 Received: May 1, 2023
Dear Reanny Wang:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
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See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality 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) K231243
Device Name Finger Clip Pulse Oximeter
The Finger Clip Pulse Oximeter is a handheld non-invasive and multi-use device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate in hospital-type facilities, and homecare.
This device is not recommended for use during exercise or low perfusion scenarios.
This device is not intended for use on infants and newborns. (Recommended for people over 3 years and the thickness of finger greater than or equal to 7mm).
Type of Use (Select one or both, as applicable)
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).