(143 days)
Models: U403-91, U410-91 Unimed Reusable Finger Clip SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg. These devices are for prescription use only.
The subject devices, Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series), are fully compatible reusable sensors for use with Philips Itellivue MP30. These sensors are supplied non-sterile. The subject sensors (Models: U403-91 and U410-91) consist of a plug/connector (Philips D8 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Patient-contacting materials of the subject sensors include ABS, silicone, and TPU, all of which have been qualified against biocompatibility requirements in ISO 10993-5, ISO 10993-10, and ISO 10993-23.
The Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) are subject to the following acceptance criteria and the performance study described was conducted to prove the device meets these criteria. It's important to note that the provided document is a 510(k) summary, which is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily a full clinical trial report for novel device approval.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature / Acceptance Criteria | Subject Device (Model: U410-91, U403-91) Reported Performance | Predicate Device (K062605) Performance |
|---|---|---|
| Performance (Arms) | ||
| Saturation Accuracy (SpO2), No Motion (70-100%) | ±3% (70-100%) | ±3% (70-100%) |
| Pulse Rate Accuracy (PR), No Motion (30-250 bpm) | ±3 bpm (30-250 bpm) | ±2% or 1 bpm, whichever is greater (30 to 300 bpm) |
| Low Perfusion Accuracy (SpO2, 70-100%) | SpO2 ±3% (70-100%) | SpO2 ±3% (70-100%) |
| Low Perfusion Accuracy (Pulse, 30-250 bpm) | Pulse ±3 bpm (30-250 bpm) | Pulse ±2% or 1 bpm, whichever is greater (30 to 300 bpm) |
Note¹: The document states that according to ISO 80601-2-61:2017, both Subject Device and Predicate Device have validated accuracy over the claimed pulse range and are therefore considered substantially equivalent, despite the difference in stated accuracy metrics for pulse rate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Clinical Study Test Set: 12 human adult volunteers.
- Data Points: The clinical study contains "more than the minimum 200 data points."
- Data Provenance:
- The document implies the clinical study was conducted by or on behalf of Unimed Medical Supplies Inc., which is based in China. The data provenance regarding the country of origin of the study conduct is therefore likely China or an authorized testing facility.
- The study involved clinical hypoxia tests, which are prospective in nature, as they involve actively inducing hypoxia in volunteers to collect data on sensor performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth. However, for pulse oximetry accuracy studies involving induced hypoxia, the ground truth (arterial oxygen saturation, SaO2) is typically established by co-oximetry readings from arterial blood samples, which are analyzed by laboratory equipment. This process relies on the accuracy of the co-oximeter and the proper drawing and handling of blood samples by trained medical personnel. It doesn't involve subjective expert consensus in the same way an imaging study would.
4. Adjudication Method for the Test Set
Not applicable. For pulse oximetry accuracy studies using induced hypoxia and co-oximetry, the ground truth is an objective physiological measurement from a laboratory instrument (co-oximeter) from arterial blood samples. There is no human adjudication process involved in establishing this ground truth, unlike with subjective visual assessments in imaging.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The provided document details a clinical study to validate the device's standalone accuracy against established physiological measurements (co-oximetry) in human volunteers. It is not an MRMC study comparing human reader performance with and without AI assistance, as the device is a sensor for measuring physiological parameters, not an AI-powered diagnostic imaging tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes. The clinical hypoxia test described is a standalone performance test for the Unimed Reusable Finger Clip SpO2 Sensors. The study directly assesses the device's ability to accurately measure SpO2 against the ground truth (SaO2 from co-oximetry) without human interpretation or intervention in the measurement process itself.
7. The Type of Ground Truth Used
The ground truth used was outcomes data / physiological measurement, specifically:
- Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is considered the gold standard for measuring oxygen saturation in blood for pulse oximeter accuracy studies.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For medical device premarket notifications like this, the focus is on a verification/validation study (the "clinical study" mentioned here) rather than an AI/machine learning model where distinct training and test sets are common. The device is a sensor, not a machine learning algorithm that undergoes a training phase.
9. How the Ground Truth for the Training Set was Established
As this is a sensor device and not an AI/ML model, there isn't a "training set" in the typical sense for which ground truth would be established for model training. The "ground truth" (SaO2 via co-oximetry) was established for the 12-subject clinical validation study as described above.
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February 20, 2025
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Unimed Medical Supplies, Inc. Huanyu Zeng Regulatory Affairs Specialist Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan District Shenzhen, 518108 China
Re: K243086
Trade/Device Name: Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91); Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: January 20, 2025 Received: January 21, 2025
Dear Huanyu Zeng:
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/cdrb/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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/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 Anesthesia, Respiratory, and Sleep 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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
Indications for Use (Describe)
Models: U403-91, U410-91 Unimed Reusable Finger Clip SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg. These devices are for prescription use only.
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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Image /page/4/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" above the word "UNIMED" in a bold, sans-serif font. Below the word "UNIMED" is the text "medical supplies" in a smaller font. To the right of the text is a red oval containing a white stylized "UM".
510(K) Summary
1. Submitter
| Date Prepared: | Jan. 20, 2025 |
|---|---|
| Submitter/Manufacturer: | Unimed Medical Supplies Inc.Bld#8, Nangang 3rd Industrial Park, Tangtou,Shiyan, Baoan District, Shenzhen, China 518108FDA Establishment Number: 3007307487 |
| Contact: | Zeng HuanyuRA SpecialistTel: +86-755 26695165E-mail: zenghy@unimed.cn |
| 510(k) Submission Type | This is a traditional 510(k). |
| 2. Proposed Device | |
| Trade Name: | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) |
| Common Name: | Oximeter Sensor |
| Model Numbers | U403-91, U410-91 |
| Classification: | Medical Specialty: CardiovascularRegulation: 21 CFR 870.2700 – OximeterProduct Code: DQAClass: II |
3. Predicate Device
| 510(K) No. | Trade Name |
|---|---|
| K062605 | Philips Reusable SpO2 Sensor, Models M1196A andM1196T |
4. Device description
The subject devices, Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series), are fully compatible reusable sensors for use with Philips Itellivue MP30. These sensors are supplied non-sterile.
The subject sensors (Models: U403-91 and U410-91) consist of a plug/connector (Philips D8 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting
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Image /page/5/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" above the word "Unimed" in large, bold letters. Below "Unimed" are the words "medical supplies" in a smaller font. To the right of the text is a red circle containing a stylized white design.
diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements.
Patient-contacting materials of the subject sensors include ABS, silicone, and TPU, all of which have been qualified against biocompatibility requirements in ISO 10993-5, ISO 10993-10, and ISO 10993-23.
5. Intended use/Indications for use
Models: U403-91, U410-91
Unimed Reusable Finger Clip SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg. These devices are for prescription use only.
| Feature | Subject Device(Model: U410-91,U403-91) | Predicate Device(K062605) | Comparison toPredicate Device |
|---|---|---|---|
| General Information | |||
| Device name | Unimed ReusableFinger Clip SpO2Sensors (UXXX-91Series) | Philips Reusable SpO2Sensor, ModelsM1196A and M1196T | / |
| ClassificationRegulation/ ProductCode | 21 CFR 870.2700,Class II/DQA | 21 CFR 870.2700,Class II/DQA | Identical |
| Intendeduse/Indications for use | Models:U403-91,U410-91UnimedReusableFingerClipSpO2Sensorsare indicatedforcontinuousnon-invasivemonitoringoffunctionaloxygensaturationofarterialhemoglobin (SpO2) and | TheM1196AandM1196T reusable Clipsensorsprovidecontinuous,non-invasivemeasurement of arterialoxygensaturation(pulse rate signal andplethysmograph wave)to any SpO2 device thathas passed validation | Substantiallyequivalent |
| Feature | Subject Device(Model: U410-91,U403-91) | Predicate Device(K062605) | Comparison toPredicate Device |
| pulse rate (PR) foradult patients weighinggreater than 30 kg.These devices are forprescription use only. | testing. Either sensorcan be comfortablyclipped onto the fingerof patients weighing >40 kg (typically adultpatients). | ||
| Principle of operation | Two-wavelengthrelative opticalabsorption | Two-wavelengthrelative opticalabsorption | Identical |
| Intended patientpopulation | Adults | Patients weighing > 40kg (typically adultpatients) | Substantiallyequivalent |
| Intended applicationsite | Finger | Finger | Identical |
| Prescription or OTC | Rx Only | Rx Only | Identical |
| Use type | Reusable | Reusable | Identical |
| Sensor StructureComposition | Sensor connector,cable, LED&PD, fingerclip | Sensor connector,cable, LED&PD, fingerclip | Identical |
| Raw material | Sensor connector:Philips D Connect 8pin connector.Cable: Copperconductor in TPUjacket.LED wavelength: 663nm/890 nmPatient-contactingmaterial:ISO10993-compliant | Sensor connector:Philips D Connect 8pin connector.Cable: Copperconductor in TPUjacket.LED wavelength: ~660nm/~890 nmPatient-contactingmaterial:ISO10993-compliant | Substantiallyequivalent |
| Performance (Arms) | |||
| Saturation Accuracy,No Motion | $\pm$ 3% (70-100%) | $\pm$ 3% (70-100%) | Identical |
| Pulse Rate Accuracy,No Motion | $\pm$ 3 bpm (30-250 bpm) | $\pm$ 2% or 1 bpm,whichever is greater | Substantiallyequivalent¹ |
| Feature | Subject Device(Model: U410-91,U403-91) | Predicate Device(K062605) | Comparison toPredicate Device |
| (30 to 300 bpm) | |||
| Low PerfusionAccuracy | SpO2 ±3% (70-100%) | SpO2 ±3% (70-100%) | Identical |
| Pulse ±3 bpm (30-250bpm) | Pulse ±2% or 1 bpm,whichever is greater(30 to 300 bpm) | Substantiallyequivalent¹ | |
| Environmental | |||
| Operating Temperature | 5 to +40 °C | 0 to 40 °C (32 to 104°F) | Substantiallyequivalent |
| Operational/StorageHumidity | 10-85% | 15 to 90% | Substantiallyequivalent |
| Biocompatibility | Pass ISO 10993cytotoxicity, skinirritation and skinsensitivity tests | Pass ISO 10993cytotoxicity, skinirritation and skinsensitivity tests | Identical |
| Energy source | Monitor power supply | Monitor power supply | Identical |
Comparison to predicate devices 6.
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Image /page/6/Picture/0 description: The image shows the logo for Unimed medical supplies, a brand of Xinwell. The word "Unimed" is written in a bold, sans-serif font, with the words "medical supplies" written in a smaller font below. To the right of the word "Unimed" is a red circle with the letters "UM" written in white. The word "Xinwell" is written in blue.
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Image /page/7/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" at the top, followed by the word "Unimed" in a large, bold font. Below the word "Unimed" is the text "medical supplies" in a smaller font. To the right of the text is a red oval with a white design inside.
Note:
- According to the requirements of "201.12.1.104 Pulse rate ACCURACY" of ISO 80601-2-61:2017, both Subject Device and Predicate Device have validated accuracy over the claimed pulse range and are therefore considered substantially equivalent.
7. Non-clinical test data
Non-clinical tests were conducted to verify that the proposed devices met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The conducted non-clinical tests conformed to the following the recognized standards:
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin
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Image /page/8/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in blue, followed by the word "UNIMED" in gray, and the words "medical supplies" in a smaller gray font. To the right of the text is a red oval containing a white design.
sensitization
- ISO 10993-23 Biological evaluation of medical devices Part 23: Tests for irritation ●
Clinical test data 8.
Clinical studies were conducted under an approved protocol with subject informed consent to determine the accuracy of proposed device. The clinical studies were conducted per following standards:
- ISO 80601-2-61 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff
Clinical hypoxia test results were obtained in human adult volunteers (the study population includes sufficient darkly pigmented subjects) to validate the accuracy of the subject devices versus arterial oxygen saturation (SaO2) as determined by co-oximetry.
Twelve subjects were enrolled for the clinical study. The Fitzpatrick Scale was used to determine their skin pigmentation scores. Three dark subjects (Fitzpatrick Type 5-6) in this study allow a proper evaluation of the sensor accuracy in dark population. The study contains more than the minimum 200 data points, and the clinical study results support device accuracy claims for the specified saturation range.
9. Substantial Equivalence Statement
Based on the comparison, analysis, and the submitted non-clinical data, Unimed believes that the Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) are as safe and effective and are substantially equivalent to the predicate devices.
§ 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).