Pulse Oximeter
Device Facts
| Record ID | K210305 |
|---|---|
| Device Name | Pulse Oximeter |
| Applicant | Dongguan Lingxin Technologies Co., Ltd. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Dec 22, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The OX201 Pulse Oximeter is a non-invasive device intended for prescription use spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients (weight ≥ 40kg) in home, hospital and clinic environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
Device Story
Fingertip pulse oximeter; uses photoelectric oxyhemoglobin inspection technology; inputs light at 660nm (red) and 905nm (near-infrared) through finger; sensor detects light absorption; microprocessor calculates SpO2 and pulse rate using Lambert-Beer Law; displays results on color OLED; used by clinicians or patients for spot-checks; provides non-invasive physiological data to assist in health assessment.
Clinical Evidence
Clinical testing conducted per Annex EE of ISO 80601-2-61:2011 to evaluate SpO2 accuracy in human subjects. Non-clinical data includes biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and bench testing (ISO 80601-2-61).
Technological Characteristics
Materials: ABS housing, silicon rubber applied part. Sensing: Dual-wavelength LED (660nm/905nm). Power: 2x AAA batteries (DC3V). Connectivity: Bluetooth. Form factor: Fingertip clip. Software: Moderate level of concern. Standards: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11.
Indications for Use
Indicated for spot-check of SpO2 and pulse rate in adult and pediatric patients (weight ≥ 40kg) in home, hospital, and clinic settings. Contraindicated for continuous monitoring, use during motion, or use with low perfusion.
Regulatory Classification
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.
Predicate Devices
- CMS-50D Finger Pulse Oximeter (K082641)
Submission Summary (Full Text)
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December 22, 2021
Dongguan Lingxin Technologies Co., LTD % Reanny Wang Manager Shenzhen Reanny Medical Devices Mangement Consulting., Ltd Room 1813 of Gebu Commercial Building, Hongxing, Songgang Street, Baoan District Shenzhen, Guangdong 518000 China
Re: K210305
Trade/Device Name: Pulse Oximeter, Model: OX201 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 22, 2021 Received: November 22, 2021
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 (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 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) 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 (OS) 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-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/cdrl-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 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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## Indications for Use
510(k) Number (if known) K210305
Device Name Pulse Oximeter, Model: OX201
#### Indications for Use (Describe)
The OX201 Pulse Oximeter is a non-invasive device intended for prescription use spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients (weight ≥ 40kg) in home, hospital and clinic environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
Type of Use (Select one or both, as applicable)
| <span style="font-family: Arial;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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# 510(k) Summary
This 510(K) summary is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.
The assigned 510(k) number is: K210305
## 1.0 Information of Submitter and Correspondent
### Submitter's information:
| Company Name: | Dongguan Lingxin Technologies Co., LTD |
|------------------|-----------------------------------------------------------|
| Street Address: | Room 301, No.3 Liantang Road, Aoshitang, Dongcheng Street |
| City: | Dongguan |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | +86(769)-89605029 |
| Fax: | +86(769)-89605029 |
| Contact Person: | Wayne |
| Contact Title: | General Manager |
| Contact Email: | Wayne@ijoyen.com |
Summary prepared: D December 22, 2021
### Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 1407#, Jingting Building, Dongzhou Community, Guangming Street,
Guangmeing District, Shenzhen 518000, China
Contact Person: Reanny Wang; E-mail: reanny@reanny.com
## 2.0 Device Information
| Type of 510(k) submission: | Traditional |
|----------------------------|----------------|
| Trade Name: | Pulse Oximeter |
| Model: | OX201 |
| Classification name: | Oximeter |
| Review Panel: | Anesthesiology |
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| Product Code: | DQA |
|--------------------|----------|
| Device Class: | Class II |
| Regulation Number: | 870.2700 |
## 3.0 Predicate Device Information
| Sponsor: | Contec Medical Systems Co., Ltd. |
|----------------|----------------------------------|
| Device: | CMS-50D Finger Pulse Oximeter |
| 510(K) Number: | K082641 |
## 4.0 Device Description
The OX201 pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rage (PR) of single adult and pediatric patient in home and hospital.
The fingertip pulse oximeter features small size, low power consumption, convenient operation and portability. Power consumption of the product is low and two AAA batteries can be operated continuously for 24 hours. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement, use it very easy.
Principle of the fingertip pulse oximeter as follows:
A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones.
Operation principle of the instrument:
Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 905nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant dada is shown on the Oximeter's display through electronic circuits and a microprocessor.
## 5.0 Intended Use
The OX201 Pulse Oximeter is a non-invasive device intended for prescription use spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients (weight ≥ 40kg) in home, hospital and clinic environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
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# 6.0 Summary comparing technological characteristics with predicate device
| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Same |
| Appearance | Similar |
| Patients contact materials | Same |
| Performance | Similar |
| Biocompatibility | Same |
| Mechanical safety | Same |
| Energy source | Same |
| Electrical safety | Same |
| Standards met | Same |
| EMC | Same |
| Function | Similar |
## 7.0 Performance Summary
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
### Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
### Biocompatibility testing
The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests, results of which demonstrate the biocompatibility of the subject device:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
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### Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2007 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
### Bench Testing
Bench testing was conducted, and the results show that the subject device complies with the ISO 80601-2-61: 2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61. Clause 201.12.1.104.
### Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
### Cleaning Validation
Cleaning and disinfection validation testing was conducted in accordance with FDA quidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Moreover, the performance of the subject device shows no degradation after repeated cleaning and disinfection as suggested in the manual.
### Clinical data:
Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO 2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
## 8.0 Comparison to predicate device
The subject device OX201 Pulse Oximeter is substantially equivalent to CMS-50D Fingertip Pulse Oximeter whose 510(k) number is K082641.
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| Elements of<br>Comparison | Subject Device | Predicate Device<br>(K082641) | Judgment |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Company | Dongguan Lingxin<br>Technologies Co., LTD | Contec Medical Systems<br>Co., Ltd. | -- |
| Device Name | Pulse Oximeter | Fingertip Pulse Oximeter | Same |
| Model | OX201 | CMS-50D | -- |
| 510(k) Number | Pending | K082641 | -- |
| Intended patient<br>population | Adult and Children | Adult and Children | Same |
| Intended<br>application site | Fingertip | Fingertip | Same |
| Intended use | The OX201 Pulse Oximeter<br>is a non-invasive device<br>intended for prescription use<br>spot-check<br>of oxygen saturation of<br>arterial hemoglobin (SpO2)<br>and pulse rate of adult and<br>pediatric<br>patients (weight ≥ 40kg) in<br>home, hospital and clinic<br>environments. The device<br>is not intended for<br>continuous monitoring, use<br>during motion or use with<br>low perfusion | The Fingertip Pulse<br>Oximeter is a non-invasive<br>device intended for spot-<br>check of oxygen saturation<br>of arterial hemoglobin<br>(SpO2) and pulse rate of<br>adult and pediatric patients<br>in home and hospital<br>environments (including<br>clinical use in internist/<br>surgery, anesthesia,<br>intensive care, etc). The<br>device is not intended for<br>continuous monitoring. | Same |
| Prescription or<br>OTC | Prescription | Prescription | Same |
| Contact material | Silica rubber | Silica rubber | Same |
| Display type | Color OLED display, 4<br>display directions | Color OLED display, 4<br>display directions | Same |
| Measurement<br>range of SpO2 | 70-100% | 0-100% | Similar |
| Accuracy of SpO2 | 70%-100%, ±2%;<br>Less than 70% no<br>definition | 70%-100%, ±2%;<br>Less than 70% no<br>definition | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device<br>(K082641) | Judgment |
| Resolution of<br>SPO2 | 1% | 1% | Same |
| Transducer of<br>SPO2 | Dual-wavelength LED<br>sensor | Dual-wavelength LED<br>sensor | Same |
| Measurement<br>wavelength of<br>SPO2 | Red light:660nm, Infrared<br>light: 905nm | Red light: 660nm, Infrared<br>light: 880nm | Similar<br>Note 1 |
| Measurement<br>range of pulse rate | 25-250bpm | 20-250bpm | Similar<br>Note 2 |
| Accuracy of pulse<br>rate | ±2bpm or ±2% (whichever<br>is greater) | ±2bpm or ±2% (whichever<br>is greater) | Same |
| Resolution of<br>pulse rate | 1 bpm | 1 bpm | Same |
| Pulse intensity of<br>pulse rate | Bar graph indicator | Bar graph indicator | Same |
| Design principle | A mathematical formula is established making use of<br>Lambert Beer Law according to Spectrum Absorption<br>Characteristics of Reductive hemoglobin (RHb) and<br>Oxyhemoglobin (HbO2) in glow and near-infrared zones.<br>Operation principle of the instrument: Photoelectric<br>Oxyhemoglobin Inspection Technology is adopted in<br>accordance with Capacity Pulse Scanning and<br>Recording Technology, so that two beams of different<br>wavelength of light scan be focused onto a human nail<br>tip through a clamping finger-type sensor. A measured<br>signal obtained by a photosensitive element, will be<br>shown on the Oximeter's display through process in<br>electronic circuits and microprocessor shown on the<br>Oximeter's display through electronic circuits and a<br>microprocessor. | Same | |
| Power source | DC3V, 2 × AAA batteries | DC3V, 2 × AAA batteries | Same |
| Other function | Low battery voltage indicate;<br>Automatically power off;<br>General setup and sounds<br>setup and Bluetooth | Low battery voltage indicate;<br>Automatically power off;<br>General setup and sounds<br>setup | Similar<br>Note 3 |
| Elements of<br>Comparison | Subject Device | Predicate Device<br>(K082641) | Judgment |
| Dimensions | 62 $\times$ 34 $\times$ 34mm<br>(L $\times$ W $\times$ H) | 57 $\times$ 31 $\times$ 32mm<br>(L $\times$ W $\times$ H) | Similar |
| Weight | 50g (including two AAA<br>batteries ) | 50g (including batteries) | Same |
| Operation<br>condition | 10-40°C, 15-95%RH,<br>70kPa-106kPa | 5-40°C, ≤90%RH, 70kPa-<br>106kPa | Similar |
| Storage condition | -20-60°C, 15-95%RH,<br>70kPa-106kPa | -40-60°C, ≤95%RH,<br>50kPa-106kPa | Similar |
| Classification | Internally powered<br>equipment, type BF<br>applied part | Internally powered<br>equipment, type BF<br>applied part | Same |
| Grade of<br>waterproof | IPX2 | IPX1 | Similar |
| Material of applied<br>part | Silicon rubber | Silicon rubber | Same |
| Material of<br>housing | ABS | ABS | Same |
| Performance | Compliance with ISO<br>80601-2-61 | Compliance with ISO 9919 | Similar<br>Note 4 |
| Biocompatibility | All the patient contacting<br>materials are compliance<br>with ISO 10993-1/-5/-10 | All the patient contacting<br>materials are compliance<br>with ISO 10993-1/-5/-10 | Same |
| Electrical Safety | Compliance with IEC<br>60601-1 | Compliance with IEC<br>60601-1 | Same |
| Safety of home<br>healthcare<br>environment | Compliance with IEC<br>60601-1-11 | -- | Similar |
| EMC | Compliance with IEC<br>60601-1-2 | Compliance with IEC<br>60601-1-2 | Same |
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As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The different technological characteristics between the subject and predicate devices will not raise different questions of safety or effectiveness
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# 9. Conclusion
Verification and validation testing was conducted on the subject device Pulse Oximeter and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the subject device is substantially equivalent to the predicate device. The subject device and the predicate device has the same intended use, and technological differences does not raise different questions of safety and effectiveness.
