(164 days)
Med-link Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.
Med-Link Pulse Oximeter is to spot-check oxygen saturation in blood (SpO2) and pulse oximeter is used on adults and pediatrics at hospital, clinics, and/or home. The device mainly consists of power supply module, detector and emitter LED, signal collection and processor module, user interface and button control. There is no visual or audio alarm. The device is reusable and non-sterile. The device has AM801. The device contains a dual light source (Red LED and Infrared red LED) and a photo detector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed in an oxygen saturation measurement (SpO2). Because a measurement of SpO2 is dependent on light from the device, excessive ambient light can interfere with this measurement. The wavelength of red LED is 660mm and infrated LED is 905nm with maximum optical output power of 15mW.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Std. ISO 80601-2-61) | Reported Device Performance (Med-link Pulse Oximeter) | Pass/Fail |
|---|---|---|---|
| SpO2 Accuracy | ARMS value ≤ 3% within the range of 70-100% SaO2 (per ISO 80601-2-61) | Overall ARMS value ≤ 3% within the range of 70-100% SaO2 | Pass |
| SpO2 Range | (Implied by accuracy testing range) 70-100% | 70% to 100% | Pass |
| SpO2 Resolution | Not explicitly stated as acceptance criteria, but common for pulse oximeters is 1% | 1% | Pass |
| SpO2 Accuracy (good perfusion) | 90% to 100% range: ±2%; 70% to 89% range: ±3%; <70%: unspecified. | 90% to 100% range: ±2%; 70% to 89% range: ±3%; <70%: unspecified. | Pass |
| SpO2 Accuracy (low perfusion) | 90% to 100% range: ±2%; 70% to 89% range: ±3%; <70%: unspecified. | 90% to 100% range: ±2%; 70% to 89% range: ±3%; <70%: unspecified. | Pass |
| Pulse Rate Accuracy | (Implied by general performance standards) | ±3 bpm (good perfusion), ±3 bpm (low perfusion) | Pass |
| Operating Principle | Meets the requirements of ISO 80601-2-61 | Uses dual light sources (Red LED 660nm, Infrared LED 905nm) and photodetector. | Pass |
| Biocompatibility | Meets ISO 10993-5 and ISO 10993-10 | No cytotoxicity, significant irritation, or evidence of sensitization. | Pass |
| Electrical Safety | Compliance with IEC 60601-1 | Complies with IEC 60601-1 | Pass |
| EMC | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Pass |
| Performance | Compliance with ISO 80601-2-61 | Complies with ISO 80601-2-61 | Pass |
| Software V&V | Complies with FDA Guidance, "moderate" level of concern | Successfully passed Function Module Test, Main Performance Test, System Integrated Test. | Pass |
Note: The specific acceptance criteria for SpO2 and Pulse Rate accuracy are directly stated in the comparison table within the 510(k) summary as the device's specifications, and the clinical study confirms the SpO2 accuracy "pass[es] a SpO2 accuracy specification of 3%".
Study Details:
2. Sample size used for the test set and the data provenance:
- Sample Size: 12 healthy adult volunteer subjects.
- Data Provenance: Prospective clinical study conducted in China (Yue Bei People's Hospital).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts.
- The ground truth was established by Reference CO-Oximetry, a standard laboratory method for measuring functional SaO2 from arterial blood samples. The expertise required would be in performing and interpreting these laboratory tests, but specific qualifications are not mentioned.
4. Adjudication method for the test set:
- Adjudication method is not applicable in this context as the ground truth was derived from objective laboratory measurements (CO-Oximetry) rather than expert review of images or clinical assessments requiring adjudication. The comparison was directly between the device's reading and the CO-Oximetry result.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This study focuses on the accuracy of the device against a gold standard (CO-Oximetry) rather than comparing human reader performance with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical study evaluated the "Shenzhen Med-link Pulse oximeter" directly, measuring its SpO2 accuracy performance compared to arterial blood CO-Oximetry. This represents the standalone performance of the device's measurement algorithm.
7. The type of ground truth used:
- Outcomes Data / Laboratory Gold Standard: The ground truth for SpO2 accuracy was established using arterial blood CO-Oximetry, which is considered the gold standard for directly measuring arterial oxygen saturation (SaO2).
8. The sample size for the training set:
- The document does not mention a separate training set or its sample size. Pulse oximeters typically rely on physical principles and calibration, not machine learning models that require a distinct training set in the same manner as AI algorithms for image classification, for example. The clinical study described is for validation.
9. How the ground truth for the training set was established:
- As no separate training set is mentioned in the context of machine learning, this question is not applicable based on the provided information. The device's underlying principles are based on established spectroscopy and signal processing for pulse oximetry.
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Shenzhen Med-link Electronics Tech Co., Ltd Jialing Zhang Regulatory Affairs Specialist 4th and 5th Floor, Building Two, Hualian Industrial Zone Xinshi Community, Dalang Street Shenzhen, Guangdong 518109 China
Re: K202743
Trade/Device Name: Med-Link Temp-pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: January 22, 2021 Received: January 25, 2021
Dear Jialing Zhang:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/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 (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-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,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202743
Device Name Med-link Pulse Oximeter
Indications for Use (Describe)
Med-link Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.
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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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Type of submission:Traditional
The assigned 510(k) number is: K202743
1. Submitter information
Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street, Longhua District, 518109 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: 0086-755-61568825 Fax: 0086-755-6112005 5 Establishment Registration Number: 3006636961
2. Corres pondent
Jialing Zhang (Regulatory Affairs Specialist, Primary Contact) E-mail: user60@med-linket.com
Yi Liu E-mail: user22@med-linket.com
3. Data of Preparation
22nd, Jan. 2021
4. Identification of the Device
Trade Name: Med-link Pulse Oximeter Common Name: pulse oximeter Classification Regulation: 21 CFR 870.2700 Product Code: DQA Class: II Review Panel: Anesthesiology
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Shenzhen Med-link Electronics Tech Co., Ltd.
5. Identification of the Predicate Device
Table 1 Predicate Device Information
| No. | Device Name | CommonName | Manufacturer | Classificationand Code | Classificationregulation | 510(k)number |
|---|---|---|---|---|---|---|
| 1 | Nonin Onyx 3, Model9591 | Finger PulseOximeter | NoninMedical, Inc. | Class II,DQA | 21 CFR870.2700 | K191403 |
Intended Use and Indications for Use of the Subject Device 6.
Med-link Pulse Oximeter is intended for spot checking in measuring functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.
7. Device Description
Med-Link Pulse Oximeter is to spot-check oxygen saturation in blood (SpO2) and pulse oximeter is used on adults and pediatrics at hospital, clinics, and/or home. The device mainly consists of power supply module, detector and emitter LED, signal collection and processor module, user interface and button control. There is no visual or audio alarm. The device is reusable and non-sterile. The device has AM801. The device contains a dual light source (Red LED and Infrared red LED) and a photo detector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed in an oxygen saturation measurement (SpO2). Because a measurement of SpO2 is dependent on light from the device, excessive ambient light can interfere with this measurement. The wavelength of red LED is 660mm and infrated LED is 905nm with maximum optical output power of 15mW.
8. Comparison to the Predicate Device
| Item | Proposed Device | Predicate Device | Verdict |
|---|---|---|---|
| Trade name | Med-link Pulse Oximeter | Nonin Onyx 3, Model9591 FingerPulse Oximeter | / |
| 510(K) Submitter | Shenzhen Med-link Electronics | Nonin Medical, Inc. | / |
| Item | Proposed Device | Predicate Device | Verdict |
| Tech Co., Ltd. | |||
| 510(K) Number | K202743 | K191403 | / |
| ClassificationRegulation | 21 CFR 870.2700 | 21 CFR 870.2700 | Same |
| Classification andCode | Class II,DQA | Class II,DQA | Same |
| Common name | Pulse Oximeter | Finger Pulse Oximeter | Same |
| Type of Use | Prescription | Prescription | Same |
| Intended use | Med-link Pulse Oximeter is intendedfor spot checking in measuring anddisplaying functional arterial oxygensaturation (SpO2) and pulse rate ofpatients in hospitals, physician'soffice, clinical settings and homecare environment. It's a reusabledevice intended for adults andpediatrics who are well or poorlyperfused. | The Nonin® Model 9591 Onyx® 3Finger Pulse Oximeter is a small,lightweight, portable and reusablespot-check device indicated for usein measuring and displayingfunctional oxygen saturation ofaterial hemoglobin(%SpO2) andpulse rate of patients who are wellor poorly perfused. The RespirationRate parameter provides anon-invasive measurement ofrespiration rate, in breaths perminute.For %SpO2, and pulse rate, the 9591is intended for use in hospitals,clinics, long-term care facilities,skilled nursing facilities, and homehealthcare services. It is intended foradult and pediatric patients who arewell or poorly perfused, with digitsthat are between 0.3 | Different note1 |
| Item | Proposed Device | Predicate Device | Verdict |
| long-term care facilities, skillednursing facilities, and homehealthcare services. It it intended foradult who are well perfused, withdigits that are between 0.3 | |||
| OperatingPrinciple | The measurement of PULSEOXIMETER uses a multi-functionaloxyhemoglobinometer to transmitsome narrow spectrum light bandsthrough blood samples, and tomeasure attenuation of spectrumwith different wavelengthsaccording to the characteristic thatRHb, O2Hb, Met Hb and COHbabsorb the light of differentwavelength, thereby determiningO2Hb saturation of differentfractions. O2Hb saturation is called"fractional" O2Hb saturation.Present SpO2 oximeter transmitslight of two wavelengths only, redlight and infrared, to differentiateHbO2 from HbR. One side of thesensor contains two LEDs, and theother side contains a photoelectricdetector. SpO2 oximeter measuresHbO2 saturation in the blood by thelight plethysmograph when the pulse | Pulse oximetry is a non-invasivemethod that passes red and infraredlight through perfused tissue anddetects the fluctuating signalscaused by arterial pulses.Well-oxygenated blood is bright red,while poorlyoxygenated blood is dark red. Thepulse oximeter determinesfunctional oxygen saturation ofarterial hemoglobin (SpO2) fromthis color difference by measuringthe ratio of absorbed red andinfrared light as volume fluctuateswith each pulse. Additionally, thepulse oximeter uses variations in thepulse volume fluctuation'samplitude, baseline shift, and timingto determine the respiratory rate. | Different note1 |
| Item | Proposed Device | Predicate Device | Verdict |
| beats. The result is quite precisewhen HbO2 saturation is between70% to 100%. | |||
| Application site | Finger | Finger | Same |
| Usage | Reusable | Reusable | Same |
| SpO2 range | 70% to 100% | 0% to 100% SpO2 | Different note2 |
| SpO2 resolution | 1% | Not provided | Different note2 |
| SpO2 accuracy undergood perfusion | 90% to 100% range: ±2%;70% to 89% range: ±3%;<70%: unspecified. | ±2 digits | Different note2 |
| SpO2 accuracy underlow perfusion | 90% to 100% range: ±2%;70% to 89% range: ±3%;<70%: unspecified. | ±2 digits | Different note2 |
| Pulse rate range | 30 to 245 bpm | 18~321 BPM | Different note2 |
| Pulse rate resolution | 1 bpm | Not provided | Different note2 |
| Pulse rate accuracyunder good perfusion | ±3 bpm | 20 to 250 BPM±3 digits | Different note2 |
| Pulse rate accuracyunderlow perfusion | ±3 bpm | 40 to 240 BPM±3 digits | Different note2 |
| Applicable population | Adult and pediatric | Adult and pediatric | Same |
| Measurementwavelength | Red: approximately 660nm;Infrared: approximately 905nm | 660 and 910 nanometers | Different note3 |
| OperationEnvironment | Temperature:41°F | Temperature: -5°C | Different note4 |
| Storage Environment | Temperature14°F | Temperature: -40°C | Different note4 |
| Item | Proposed Device | Predicate Device | Verdict |
| Power requirements | 1.5V (AAA)alkaline batteryX2(IEC TypeLR03) | 3V DC | Same |
| Battery life(operating) | 2400 spot checks20 hours continuous | 2000 spot checks25 hours continuous | Different note5 |
| Battery life(storage) | 6 months, with batteries installed | 1 month, with batteries installed | Different note5 |
| User interface | 8 directions for display | Not provided | Different note5 |
| Display parameter | SpO2, Pulse Rate, Pulse WaveformDisplay, Bar Graph(PulseAmplitude Indicator) and BatteryIndicator | SpO2, Pulse Rate and RespirationRate | Different note5 |
| Electrical-type anddegree of protection | Type BF internally powered | Type BF internally powered | Same |
| Enclosure-degreeofingressprotectionagainst liquids | IPX2 | IP32 | Same |
| Measuring Mode | Spot-check | Spot-check | Same |
| Material | Enclosure: ABS;Lens: PC;Silica gel finger pad: Silica gel;Lower middle frame: ABS. | Enclosure: PC;Finger pads:TPE;Battery door: PC. | Differentnote 6 |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Performance | ISO 80601-2-61 | ISO 80601-2-61 | Same |
| Biocompatibility | All the patient-contacting materialsare evaluated by thebiocompatibility standardISO10993-5, ISO 10993-10. | ISO 10993-1 | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
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Image /page/5/Picture/2 description: The image shows the logo for MedLinket. The logo is in blue, except for the "M" which is in orange. The text is simple and modern.
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Image /page/6/Picture/1 description: The image shows the logo for MedLinket. The logo is composed of the letter 'M' in orange and the rest of the word 'MedLinket' in blue. The font is sans-serif and the logo is simple and modern.
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Note 1
The predicate device is a device with an additional function of measuring respiration rate, which the proposed device is not seeking claims for. Thus the difference of intended use and operating principle between the proposed device and the predicate device does not raise new questions of safety and effectiveness, nor would it affect the substantial equivalence between the two devices .
Note 2
Although the measurement ranges and accuracy of SpO2 and pulse rate are different between the proposed device and the predicate device, both devices meet the requirements of ISO 80601-2-61. Such a difference does not raise new questions of safety and effectiveness.
Note 3
Although the measurement wavelengths of the proposed device are different from those of the predicate device, our Pulse oximeter has been compared with the predicate device in intended use, operating principle, safety and performance standard, etc., such a difference doesn't affect the substantial equivalence among other items, nor does it raise new questions of safety and effectiveness.
Note 4
Although some specifications of operating & storage conditions are different for the proposed device and the predicate device, they are all complied with IEC 60601-1 and ISO 80601-2-61. The differences do not raise new questions of safety and effectiveness.
Note 5
Although the battery life for operation and storage, user interface and display parameters are different between the proposed device and the predicate device, these differences don't affect the essential performance and safety of both devices. The two devices have been compared in intended use, operating principle, safety and performance specifications.etc., which indicates the two devices are substantially equivalent.
Note 6
Although patient-contacting materials are different for the proposed device and the predicate device, both of them are complied with ISO 10993-5 and ISO 10993-10. The difference does not affect the safety and effectiveness.
9. Non-clinical Test
A series of safety and essential performance tests were performed to assess the safety and effectiveness of Med-link Pulse Oximeter. The tests listed above were conducted in accordance with
IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.
ISO 80601-2-61 Medical electrical equipment-Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential
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performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests
IEC 60601-1-11 Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
The patient-contacting components and materials are listed together with the corresponding test items in the following table. The contact duration is limited to be within 24 hours, and the type of contact belongs to surface medical device-intact skin. Based on use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process", the device requires the following biocompatibility tests: ISO 10993-5:2009 Biological valuation of medical devices-Part 5: Test for In Vitro Cytotoxicity and ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests forimitation and skin sensitization.
| Patient-contacting Components | Contact Materials | Test items |
|---|---|---|
| Enclosure | ABS | Cytotoxicity |
| Silica gel finger pad | Silica gel | Skin Sensitization Test |
| Lower middle frame | ABS | Skin Irritation Test |
| Lens | PC |
The biocompatibility test results demonstrated that there's no cytotoxic of significant irritation nor evidence of sensitization. The device meets the requirement of Biocompatibility.
Software verification and validation testing were conducted and documentation was provided by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction of, or a latent design flaw in, the software device would lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury. The software was tested according to three steps including Function Module Test (Unit Level), Main Performance Test (Integration Level), and System Integrated Test (System Level). In all test processes, the following main functions are mainly verified: power on/off, low power prompt, measurement and result display, measurement range and accuracy, and display mode switch. All the tests were passed.
We have also conducted other performance tests including SpO2 and PR Accuracy Test, Weak Perfusion Test, Performance Test after Disinfection, Shelf-life Test Per Industry and FDA Staff: Pulse Oximeters-Premarket Notification submission [510(k)s].
10. Clinical performance data
The clinical study was conducted in the Yue Bei People's Hospital in accordance to ISO 14155-2, BS EN ISO 80601-2-61, and the FDA Guidance Document for Pulse Oximeters.
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Objective: The purpose of this study was to evaluate the SpO2 accuracy performance of Shenzhen Med-link Pulse oximeter, during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.
Subjects: After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 19-34yr, 45-102kg, 160-192cm, with light to dark pigmentation) were included in the study to evaluate the SpO2 accuracy performance of the Shenzhen Med-link Pulse oximeter.
Methods: Each system was evaluated during steady state / non-motions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy companson. Accuracy data was calculated using the root-mean-squared (ARMS value) for all subjects.
Adverse events and complications: There were no adverse events during the study.
Conclusion: The results show the Shenzhen Med-link Pulse oximeter to pass a SpO2 accuracy specification of 3 during steady state conditions over the range of 70-100%.
11. Conclusion
Based on the comparison and analysis in this submission, it can be concluded that: Med-link Pulse Oximeter is substantially equivalent to the predicate device.
§ 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).