(322 days)
Not Found
No
The description details a standard pulse oximetry principle based on light absorption and a microprocessor, with no mention of AI or ML algorithms for data processing or interpretation.
No.
A therapeutic device is used to treat or prevent a medical condition. This device is a diagnostic tool that measures oxygen saturation and pulse rate, providing information about a patient's physiological state without directly treating them.
No.
The device is intended for non-invasive spot-check or continuous monitoring of physiological parameters (oxygen saturation and pulse rate), not for diagnosing a disease or condition. While the information it provides can be used by a healthcare professional to inform a diagnosis, the device itself does not perform the diagnostic function.
No
The device description explicitly details hardware components like light sources (660nm and 905nm), a sensor, electronic circuits, a microprocessor, and a display, indicating it is a physical device, not software-only.
Based on the provided information, the OX201 Pulse Oximeter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- OX201 Function: The OX201 Pulse Oximeter is a non-invasive device that measures oxygen saturation and pulse rate by placing a sensor on the fingertip. It does not analyze any specimens taken from the body.
Therefore, the OX201 Pulse Oximeter falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
adult and pediatric patients (weight ≥ 40kg)
Intended User / Care Setting
Home, hospital and clinic environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of SpO2: 70%-100%, ±2%; Less than 70% no definition
Accuracy of pulse rate: ±2bpm or ±2% (whichever is greater)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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.
1
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
2
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)
| 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 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.
5
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
6
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
Comparison | Subject Device | Predicate Device
(K082641) | Judgment |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Company | Dongguan Lingxin
Technologies Co., LTD | Contec Medical Systems
Co., Ltd. | -- |
| Device Name | Pulse Oximeter | Fingertip Pulse Oximeter | Same |
| Model | OX201 | CMS-50D | -- |
| 510(k) Number | Pending | K082641 | -- |
| Intended patient
population | Adult and Children | Adult and Children | Same |
| Intended
application site | Fingertip | Fingertip | Same |
| 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 | The Fingertip Pulse
Oximeter is a non-invasive
device intended for spot-
check of oxygen saturation
of arterial hemoglobin
(SpO2) and pulse rate of
adult and pediatric patients
in home and hospital
environments (including
clinical use in internist/
surgery, anesthesia,
intensive care, etc). The
device is not intended for
continuous monitoring. | Same |
| Prescription or
OTC | Prescription | Prescription | Same |
| Contact material | Silica rubber | Silica rubber | Same |
| Display type | Color OLED display, 4
display directions | Color OLED display, 4
display directions | Same |
| Measurement
range of SpO2 | 70-100% | 0-100% | Similar |
| Accuracy of SpO2 | 70%-100%, ±2%;
Less than 70% no
definition | 70%-100%, ±2%;
Less than 70% no
definition | Same |
| Elements of
Comparison | Subject Device | Predicate Device
(K082641) | Judgment |
| Resolution of
SPO2 | 1% | 1% | Same |
| Transducer of
SPO2 | Dual-wavelength LED
sensor | Dual-wavelength LED
sensor | Same |
| Measurement
wavelength of
SPO2 | Red light:660nm, Infrared
light: 905nm | Red light: 660nm, Infrared
light: 880nm | Similar
Note 1 |
| Measurement
range of pulse rate | 25-250bpm | 20-250bpm | Similar
Note 2 |
| Accuracy of pulse
rate | ±2bpm or ±2% (whichever
is greater) | ±2bpm or ±2% (whichever
is greater) | Same |
| Resolution of
pulse rate | 1 bpm | 1 bpm | Same |
| Pulse intensity of
pulse rate | Bar graph indicator | Bar graph indicator | Same |
| Design principle | 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 light scan be focused onto a human nail
tip through a clamping finger-type sensor. A measured
signal obtained by a photosensitive element, will be
shown on the Oximeter's display through process in
electronic circuits and microprocessor shown on the
Oximeter's display through electronic circuits and a
microprocessor. | Same | |
| Power source | DC3V, 2 × AAA batteries | DC3V, 2 × AAA batteries | Same |
| Other function | Low battery voltage indicate;
Automatically power off;
General setup and sounds
setup and Bluetooth | Low battery voltage indicate;
Automatically power off;
General setup and sounds
setup | Similar
Note 3 |
| Elements of
Comparison | Subject Device | Predicate Device
(K082641) | Judgment |
| Dimensions | 62 $\times$ 34 $\times$ 34mm
(L $\times$ W $\times$ H) | 57 $\times$ 31 $\times$ 32mm
(L $\times$ W $\times$ H) | Similar |
| Weight | 50g (including two AAA
batteries ) | 50g (including batteries) | Same |
| Operation
condition | 10-40°C, 15-95%RH,
70kPa-106kPa | 5-40°C, ≤90%RH, 70kPa-
106kPa | Similar |
| Storage condition | -20-60°C, 15-95%RH,
70kPa-106kPa | -40-60°C, ≤95%RH,
50kPa-106kPa | Similar |
| Classification | Internally powered
equipment, type BF
applied part | Internally powered
equipment, type BF
applied part | Same |
| Grade of
waterproof | IPX2 | IPX1 | Similar |
| Material of applied
part | Silicon rubber | Silicon rubber | Same |
| Material of
housing | ABS | ABS | Same |
| Performance | Compliance with ISO
80601-2-61 | Compliance with ISO 9919 | Similar
Note 4 |
| Biocompatibility | All the patient contacting
materials are compliance
with ISO 10993-1/-5/-10 | All the patient contacting
materials are compliance
with ISO 10993-1/-5/-10 | Same |
| Electrical Safety | Compliance with IEC
60601-1 | Compliance with IEC
60601-1 | Same |
| Safety of home
healthcare
environment | Compliance with IEC
60601-1-11 | -- | Similar |
| EMC | Compliance with IEC
60601-1-2 | Compliance with IEC
60601-1-2 | Same |
8
9
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
10
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.