(160 days)
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 and pediatric patients weighing 10-50 kg. These devices are for prescription use only.
The subject devices, Unimed Reusable Finger Clip SpO2 Sensors, are fully compatible reusable sensors for use with monitors that incorporate Masimo technology. These sensors are supplied non-sterile. The subject sensors consist of a plug/connector (U403-125 and U103-125 with M8 sensor connector, and U403-254 and U103-254 with M10 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. Also, the subject sensors have identical material composition and performance characteristics to the predicate device.
Here's a breakdown of the acceptance criteria and study information for the Unimed Reusable Finger Clip SpO2 Sensors, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Comparison |
|---|---|---|---|
| Saturation Accuracy, No Motion (70-100%) | ± 3% | ± 3% | Identical |
| Pulse Rate Accuracy, No Motion (30-250 bpm) | ± 3 bpm (30-250 bpm) | ± 3 bpm (30-250 bpm) | Identical |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that the clinical study was conducted with "human adult volunteers," including "sufficient darkly pigmented subjects." However, the exact number of subjects (the sample size) is not specified.
- Data Provenance: The data is prospective as it was collected in a "clinical study... under an approved protocol with subject informed consent." The country of origin is not explicitly stated, but the submission is from "Unimed Medical Supplies Inc." located in "Shenzhen, China." It's reasonable to infer the study was conducted there or arranged by their organization.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document mentions that "arterial oxygen saturation (SaO2) as determined by co-oximetry" was used to establish the ground truth. This is a direct physiological measurement and does not involve human expert interpretation for ground truth establishment. Therefore, information about the number or qualifications of experts for ground truth is not applicable in this context.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth was established by co-oximetry, which is an objective measurement, not a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an oximeter sensor, which directly measures physiological parameters (SpO2 and pulse rate). Its performance is evaluated against a gold standard method (co-oximetry), not by comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the clinical study performed appears to be a standalone (algorithm only) performance evaluation. The device, an SpO2 sensor, directly provides measurements. The study evaluated the accuracy of these measurements against a reference method (co-oximetry) without integrating a human in the loop for interpreting the device's output.
7. Type of Ground Truth Used
The ground truth used was outcomes data (physiological measurements), specifically "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is considered a clinical gold standard for measuring blood oxygen levels.
8. Sample Size for the Training Set
Not applicable. The document describes a medical device (SpO2 sensor), not an AI/machine learning algorithm that requires a training set. The device operates based on physical principles (two-wavelength relative optical absorption) and is validated through clinical performance against a reference standard.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI/machine learning algorithm, there is no training set and therefore no ground truth established for a training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo features the FDA acronym in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," also in blue. To the left of the text is a symbol that appears to be part of the official FDA seal.
February 6, 2025
Unimed Medical Supplies, Inc. Huanvu Zeng Regulatory Affairs Specialist Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan Baoan District Shenzhen, 518108 China
Re: K242580
Trade/Device Name: Unimed Reusable Finger Clip SpO2 Sensors (U103-125): Unimed Reusable Finger Clip SpO2 Sensors (U403-254): Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 31, 2024 Received: December 31, 2024
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 (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
{1}------------------------------------------------
2
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 OS 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-devices/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 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
{2}------------------------------------------------
(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-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 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
{3}------------------------------------------------
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 (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)
Indications for Use (Describe)
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 and pediatric patients weighing 10-50 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in a smaller font size above the word "Unimed" in a larger, gray font. To the right of the word "Unimed" is a red oval shape with a white design inside.
510(K) Summary
1. Submitter
| Date Prepared: | Dec. 27, 2024 |
|---|---|
| Submitter/Manufacturer: | Unimed Medical Supplies Inc.Bld#8, Nangang 3rd Industrial Park, TangtouShiyan, 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 |
| Common Name: | Oximeter Sensor |
| Classification: | Medical Specialty: CardiovascularRegulation: 21 CFR 870.2700 – OximeterProduct Code: DQAClass: II |
3. Predicate Device
| 510(K) No. | Trade Name |
|---|---|
| K142832 | Unimed Disposable And Reusable Spo2 Sensors |
4. Device description
The subject devices, Unimed Reusable Finger Clip SpO2 Sensors, are fully compatible reusable sensors for use with monitors that incorporate Masimo technology. These sensors are supplied non-sterile.
The subject sensors consist of a plug/connector (U403-125 and U103-125 with M8 sensor connector, and U403-254 and U103-254 with M10 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. Also, the subject sensors have identical material composition and
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image contains the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in blue, followed by the word "Unimed" in gray. To the right of the text is a red oval shape with a white design inside.
performance characteristics to the predicate device.
The compatibility of the sensors is validated with specific monitor, as shown below:
| Subject device | Compatible monitor |
|---|---|
| U403-254 | |
| U103-254 | Masimo Radical-7 |
| U403-125 | |
| U403-125 |
Compared with the predicate device (U403-125) in K142832, the subject devices have the following changes:
- Change in photodetector (light receiving part of the sensor) with the same spectral wavelength and shorter response time;
- Change in size or interface connector. Specifically, U103-125 is designed in smaller . finger clip size for pediatric use, and U403-254 and U103-254 (smaller finger clip size as U103-125) are designed with a change in the interface connector for expanded compatible options with the same monitor.
Also, the labeling has been revised to increase clarity and accommodate our product launch strategy without affecting safety and effectiveness of the product. Refer to the Summary of Labeling Change for details.
The purpose of the submission is to receive clearance to market U103-125, U403-254, and U103-254 under their own 510k and approval for changes to the cleared device U403-125.
5. Intended use/Indications for use
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 and pediatric patients weighing 10-50 kg. These devices are for prescription use only.
6. Comparison to predicate device
The subject devices, U403-125, U103-125, U403-254, U103-254, and the predicate device, Unimed Disposable and Reusable SpO2 Sensors (K142832) are compared in the following substantial equivalence table.
{6}------------------------------------------------
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 gray, with the words "medical supplies" written in a smaller font below it. To the right of the word "Unimed" is a red circle with the letters "UM" written in white.
| Feature | Subject Device(Model: U403-254,U103-254,U103-125,U403-125) | Predicate Device(K142832) | Comparison toPredicate Device |
|---|---|---|---|
| General Information | |||
| Device name | Unimed ReusableFinger Clip SpO2Sensors | Unimed Disposable andReusable SPO2 Sensors | / |
| ClassificationRegulation/ ProductCode | 21 CFR 870.2700,Class II/DQA | 21 CFR 870.2700,Class II/DQA | Identical |
| Intendeduse/Indications foruse | Unimed ReusableFinger Clip SpO2Sensors are indicatedfor continuousnon-invasivemonitoring offunctional oxygensaturation of arterialhemoglobin (SpO2)and pulse rate (PR)for adult patientsweighing greaterthan 30 kg andpediatric patientsweighing 10-50 kg.These devices are forprescription useonly. | Unimed Disposable andReusable SPO2 Sensors areindicated for continuousnon-invasive monitoring offunctional oxygen saturationof arterial hemoglobin (SpO2)and pulse rate(PR) for adult40 kg, pediatric patientsweighing 10 -50 kg, andneonatal patients weighing noless than 3 Kg. | Equivalent. Theintended populationis reduced based onthe models in thesubmission, and thestatement of "forprescription useonly" is added in theindications for use tobetter preventnegligence. |
| Principle ofoperation | Two-wavelengthrelative opticalabsorption | Two-wavelength relativeoptical absorption | Same |
| Key performance specifications/ characteristics | |||
| Intended patientpopulation | Adult/Pediatric | Adult/Pediatric/Infant/Neonate | Equivalent. Onlyadult and pediatricsensors are involvedin this submission |
| Feature | Subject Device(Model: U403-254,U103-254,U103-125,U403-125) | Predicate Device(K142832) | Comparison toPredicate Device |
| Intended applicationsite | Finger | Finger or toe | Equivalent. Onlyfinger clip sensorsare involved in thissubmission |
| Prescription or OTC | Rx Only | Rx Only | Identical |
| Use type | Reusable | Disposable/Reusable | Equivalent. Onlyreusable sensors areinvolved in thissubmission |
| Sensor StructureComposition | Sensor connector,cable, LED&PD,finger clip | Sensor connector, cable,LED&PD, adhesivetape/finger clip/soft tip | Equivalent. Onlyfinger clip sensorsare involved in thissubmission |
| Raw material | Cable: Copperconductor in PVCjacketLED wavelength:660nm/905nmPatient-contactingmaterial:ABS/Silicone | Cable: Copper conductor inPVC jacketLED wavelength:660nm/905nmPatient-contacting material:ABS/Silicone | Identical |
| Performance (Arms) | |||
| Saturation Accuracy,No Motion(70-100%) | $\pm$ 3% | $\pm$ 3% | Identical |
| Pulse Rate Accuracy,No Motion | $\pm$ 3 bpm (30-250bpm) | $\pm$ 3 bpm (30-250 bpm) | Identical |
| Environmental | |||
| OperatingTemperature | 5 to 40 °C | 5 to 40 °C | Identical |
| Operational/StorageHumidity | 10 to 85% | 10 to 85% | Identical |
| Biocompatibility | Pass ISO 10993cytotoxicity, skin | Pass ISO 10993 cytotoxicity,skin irritation and skin | Identical |
| Feature | Subject Device(Model: U403-254,U103-254,U103-125,U403-125) | Predicate Device(K142832) | Comparison toPredicate Device |
| irritation and skinsensitivity tests | irritation and skinsensitivity tests | sensitivity tests | |
| Energy source | Monitor powersupply | Monitor power supply | Identical |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in a smaller font above the word "Unimed" in a larger, bold font. To the right of the text is a red oval containing a white stylized "UM".
Add: Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, 518108 Shenzhen, People's Republic of China
http: //www.unimed.cn
{8}------------------------------------------------
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 smaller font above the word "UNIMED" in a larger, bold font. Below "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".
7. Verification and validation testing
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 IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020)
- 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 (IEC 60601-1-2:2014+AMD1:2020)
- ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, COR1: 2018)
- 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 sensitization
- ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
The subject sensors include finger clip housing and silicone pad as patient-contacting components. The type of contact is contact with intact skin and the contact duration is defined as prolonged exposure per ISO 10993-1:2018 (medical devices whose cumulative sum of single, multiple or repeated contact time is likely to exceed 24 h but not exceed 30 d). Therefore, our biocompatibility testing has been specifically designed to meet the corresponding endpoint assessment requirements, including the following tests:
{9}------------------------------------------------
Image /page/9/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 larger, gray font. Below "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".
- Cytotoxicity -
- -Skin sensitization
- -Skin irritation
The results of these tests demonstrate the biocompatibility of the subject devices.
Clinical test data
A clinical study was 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 U403-125 versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical study results support device accuracy claims for the specified saturation range.
Substantial Equivalence Statement 8.
Based on the comparison, analysis, and the submitted verification and validation data, Unimed believes that the Unimed Reusable Finger Clip SpO2 Sensors 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).