(461 days)
Not Found
No
The description details standard pulse oximetry technology using light absorption and a microprocessor for calculation, with no mention of AI or ML algorithms.
No.
The device is strictly for spot-checking oxygen saturation and pulse rate and explicitly states it is "not intended to be used under motion or low perfusion scenarios," indicating it is for monitoring and not for treatment or therapy.
Yes
A diagnostic device is one that helps identify or assess a medical condition. This pulse oximeter measures oxygen saturation and pulse rate, which are physiological parameters used in the assessment and monitoring of a patient's health status, fitting the description of a diagnostic function.
No
The device description explicitly states it consists of hardware components including a probe, electronic circuits, display, plastic enclosures, light emitting diodes, a light detector, and a microprocessor. It also mentions being powered by batteries.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. IVDs typically involve testing substances like blood, urine, tissue, or other bodily fluids outside of the body to diagnose or monitor conditions.
- This device measures physiological parameters on the body. The pulse oximeter works by shining light through the finger and detecting the light transmitted. It measures oxygen saturation and pulse rate directly from the patient's body without requiring a sample to be taken and analyzed externally.
The description clearly states the device is used for "spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients." This is a non-invasive measurement performed directly on the patient, which is characteristic of a medical device but not an IVD.
N/A
Intended Use / Indications for Use
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environment. And it is not intended to be used under motion or low perfusion scenarios.
Product codes
DOA
Device Description
The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2), The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. Bluetooth function is available for Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30B, Alpine30BA, Alpine30BH, Alpine20LB, Alpine20LB, Alpine20LBH, Alpine30LB and Alpine30LBH only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
Adult
Intended User / Care Setting
healthcare environment
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
Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment and the FDA Guidance Document for Pulse Oximeters. The subject device of this study was to evaluate the Sp02 accuracy performance of the subject device during stationary (non motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry. There were 12 adult healthy volunteers to validated the SpO2 accuracy of the pulse oximeter, aged 22-37 years old, with skin tones varying from Fitzpatrick I-VI,including five females and seven males. The measure results showed that the subject device perform as claimed during the measurement range of 70-100% with 2% accuracy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Biocompatibility testing: Conducted in accordance with ISO 10993-1, covering Cytotoxicity, Skin Sensitization, and Skin Irritation. Results demonstrate biocompatibility.
Electrical safety and electromagnetic compatibility (EMC): Testing conformed to IEC 60601-1: 2005+A1: 2020 and IEC 60601-1-2: 2015+A1:2020.
Bench Testing: Complies with ISO 80601-2-61: 2017. Pulse Rate Accuracy meets ISO 80601-2-61, Clause 201.12.1.104 requirements.
Software Verification and Validation: Documentation provided per FDA Guidance for software with a moderate level of concern.
Clinical Data:
Study Type: SpO2 accuracy evaluation.
Sample Size: 12 adult healthy volunteers.
Data Source: In-human testing compared to arterial blood CO-Oximetry.
Key Results: The device performed as claimed within the measurement range of 70-100% with 2% accuracy during stationary conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 70-100% with ±2% accuracy.
Pulse Rate Accuracy: ±2 bpm.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 21, 2024
Shenzhen Smallsignal Technology Co., Ltd. Qingliang Liu General Manager Room 901-7,Building 1, No.9, Jinxiu Middle Road, Laokeng Community, Longtian Street, Pingshan Shenzhen, Guangdong 518122 China
Re: K232520
Trade/Device Name: Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: March 2, 2024 Received: October 22, 2024
Dear Qingliang Liu:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/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
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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
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,
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
Submission Number (if known)
Device Name
Fingertip Pulse Oximeter (Models Alpine20, Alpine20H, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine30, Alpine30, Alpine30H, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine20L, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH)
Indications for Use (Describe)
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environment. And it is not intended to be used under motion or low perfusion scenarios.
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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4
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
-
- Submitter: Shenzhen Smallsignal Technology Co., Ltd. Address: Room 40205, Building 1, Huahan Science and Technology Industrial Park, No. 19, Qiyun West Road, Heping Community, Pingshan Street, Pingshan District, Shenzhen, Guangdong Province, China, 518083 TEL: 86 755 23010489
- Contact Person: Qingliang Liu
- Prepare date: October 22, 2024
- Device name Device Name: Fingertip Pulse Oximeter
and classification Models: Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20BA, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH Classification Name: 21 CFR 870.2700 Oximeter
Product code: DQA
Regulatory Class: Class II
- New submission. No prior submission associated with the current submission. 3. Reason for
Submission
Shenzhen AOJ Medical Technology Co.,Ltd., AOJ-70A, AOJ-70B, AOJ-70C, AOJ-70D and 4. Predicate Device(s) AOJ-70E Pulse Oximeter / K202173
-
- Device The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one Description side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpQ2), The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. Bluetooth function is available for Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30B, Alpine30BA, Alpine30BH, Alpine20LB, Alpine20LB, Alpine20LBH, Alpine30LB and Alpine30LBH only.
6. Indications for The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is Use not intended to be used under motion or low perfusion scenarios.
5
7. Predicate Device Comparison
Please refer to following table to find differences between the subject device and predicate device.
| ITEM | Proposed Device
Alpine20 series Pulse
Oximeter | Predicate Device
AOJ-70A, AOJ-70B, AOJ-70C,
AOJ-70D and AOJ-70E | Comparison
Result |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Smallsignal
Technology Co., Ltd. | Shenzhen AOJ Medical
Technology Co., Ltd. | --- |
| Indications for
Use | The pulse oximeter is a
reusable device and intended
for spot-checking of oxygen
saturation and pulse rate for
use with the finger of adult
patients in healthcare
environments. And it is not
intended to be used under
motion or low perfusion
scenarios. | The pulse oximeter is a reusable
device and intended for
spot-checking of oxygen
saturation and pulse rate for use
with the finger of adult patients
in healthcare environments. And
it is not intended to be used
under motion or low perfusion
scenarios. | Same |
| Operational Specifications | | | |
| Intended patient
population | Adult | Adult | Same |
| Intended
application site | Finger | Finger | Same |
| use under
motion and low
perfusion
conditions | No | No | Same |
| Measurement
Principles | 2-wavelength Relative
Optical Absorption | 2-wavelength Relative
Optical Absorption | Same |
| Signal Detection
Method | Photodetector | Photodetector | Same |
| SpO2 Range | 35100% | 0100% | Different¹ |
| SpO₂ Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 70100%: ±2%100%: ±2%
0% to 69%: unspecified | 70
0% to 69%: unspecified | Same |
| Pulse Rate Range | 25 bpm ~ 250 bpm | 25 bpm ~ 250 bpm | Same |
| Pulse Rate
Accuracy | ±2 bpm | ±2 bpm | Same |
| Pulse
Rate Resolution | 1 bpm | 1 bpm | Same |
| Shipped Sterile | No | No | Same |
| Storage and
Transport
Environment | Temperature: -10 °C - 40 °C
Humidity: 15%-93%
Atmospheric pressure:
50 kPa-106 kPa | Temperature: -20 °C - 50 °C
Humidity (non-condensing):
10%-95%
Atmospheric pressure: 70
kPa-106 kPa | Different 2 |
| Operating
Environment | Temperature: 5 °C - 40 °C
Humidity: 15%-80%
Atmospheric pressure: 86
kPa-106 kPa | Temperature: 10 °C - 40 °C
Humidity (non-condensing):
15%-95%
Atmospheric pressure: 70
kPa-106 kPa | |
| Compliance Standards | | | |
| Bio-compatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | Different 3 |
| Electrical Safety | IEC 60601-1
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-11 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | |
| Performance | ISO 80601-2-61 | ISO 80601-2-61 | |
| Physical Specifications | | | |
| Dimension
(WidthHeight
Depth) | Alpine20/ 20L series:
61mm×37mm×33mm
Alpine30/ 30L series:
61mm×34mm×32mm | 57mm×30mm×30 mm | Different 4 |
| Data Transmission | | | |
| Data
transmission | Bluetooth is available for
Alpine20B, Alpine20BA,
Alpine20BH, Alpine20BHA,
Alpine30B, Alpine30BA,
Alpine30BH, Alpine30BHA,
Alpine20LB, Alpine20LBH,
Alpine30LB and Alpine30LBH | No available | Different 5 |
Table 1 Comparison between the predicate and the subject device
6
Justification for the differences:
-
- Different SpO2 Range
The measuring range of the predicate is 0100% , while that of the subject is 35100%, and such specification is verified per the international standard ISO 80601-2-61, same as the standard complied with of the predicate, so the different range will be acceptable for the subject device.
- Different SpO2 Range
-
- Different operating, storage and transport environment
Minor difference to operation, storage/transport environment for the subject device, but the system has been proved to be safe and effective since the safety testing was conducted under the suggested environment; Moreover, environment testing data shows the device can work as declared under the suggested conditions. So those changes will not cause any safety and effectiveness problem.
- Different operating, storage and transport environment
-
- Different Biocompatibility test standard
7
The endpoints for the biocompatibility are the same, which include cytoxicity, skin irritation and sensitization, the difference happened due to the irritation was taken from ISO 10993-10 to ISO 10993-23 without no change for the parts applied in the subject device, both of which are used for evaluation for test of irritation. This difference will not raise any safety and effectiveness questions.
-
- Different Physical Specifications
The subject and the predicate are of different size but proximity. Moreover, such engineering design has been verified during the international standards, so such minor different will not raise any safety and effectiveness questions.
- Different Physical Specifications
-
- Different data transmission function
Some models of the subject devices have Bluetooth data transmission function, and the wireless function has been verified to assure its data transmission and cybersecurity. No new safety and effectiveness questions raised.
- Different data transmission function
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 as demonstrated in the non-clinical and clinical evidence.
8. Performance Testing
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
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+A1: 2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2015+A1:2020 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
8
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.
Clinical data
Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2ACCURACY in human subjects of ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment and the FDA Guidance Document for Pulse Oximeters. The subject device of this study was to evaluate the Sp02 accuracy performance of the subject device during stationary (non motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry. There were 12 adult healthy volunteers to validated the SpO2 accuracy of the pulse oximeter, aged 22-37 years old, with skin tones varying from Fitzpatrick I-VI,including five females and seven males. The measure results showed that the subject device perform as claimed during the measurement range of 70-100% with 2% accuracy.
9. Conclusion
Verification and validation testing was conducted on the subject device Fingertip Pulse Oximeter and all testing passed pre-specified criteria. The subject device and the predicate device have the same intended use and the differences in technological features do not raise different questions of safety and effectiveness. This premarket notification submission demonstrates that the subject device is substantially equivalent to the predicate device.