(315 days)
Not Found
No
The device description relies on established principles of spectrophotometry and signal processing using a microprocessor, with no mention of AI/ML techniques for data analysis or interpretation.
No.
The device is intended for "spot-checking" of oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
The device is intended for "spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)," which are measurements used by healthcare professionals to monitor and assess a patient's physiological status, contributing to diagnosis.
No
The device description explicitly details hardware components like a clamping finger-type sensor, light sources (660nm red and 905nm infrared light), electronic circuits, and a microprocessor, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that this device is a "non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)." It works by placing a finger into the device and using light absorption characteristics. It does not involve the collection or analysis of any bodily fluids or tissues.
- The principle of operation is based on light absorption through the skin and tissue. The description explains the use of Lambert Beer Law and Photoelectric Oxyhemoglobin Inspection Technology, which are applied to light passing through the fingertip. This is a physical measurement, not a chemical or biological analysis of a specimen.
Therefore, while this is a medical device, it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
Product codes (comma separated list FDA assigned to the subject device)
DOA
Device Description
The Fingertip Pulse Oximeteris intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in the home and hospital.
The fingertip pulse oximeter features a small size, low power consumption, a convenient operation, and portability.It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement.
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 red and 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 red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data 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 & Pediatric
Intended User / Care Setting
home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
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 hypoxia accuracy testing (controlled desaturation study) was conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the subject device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device). The accuracy of the subject device is in comparison with the control device over the SpO2 range of 70~100%. Data was calculated and analyzed using the mean bias (B), root-mean-square (Ams), PRECISION (standard deviation of the residuals (Sres) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the ISO 80601-2-61;
Besides, the Agreement between methods of measurement with multiple observations for both all subjects pooled and individual test subjects were analyzed with the Bland and Altman statistics, the analysis demonstrated that the vast majority of data is within ±95% limit of agreement, the data points beyond or below this scope were regarded as outliers. The outliers only occurred occasionally and after being analyzed, it was determined that the outliers do not raise performance concerns regarding the accuracy and precision of the device.
During the clinical study, 12 subjects were enrolled, who are healthy, nonsmoking, competent adults, between twenty-one and thirty-two (21-32) years of age, and they were provided EC (Ethics Committee)-approved informed consent as documented on an informed consent form. No case was lost in this trial. The trial completed 12 cases, on which 294 data sets were collected, of which 288 were valid. 6 data sets which less than 70% were excluded.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing according to ISO 14155:2011 and ISO 80601-2-61: 2011 has also been performed on the device.
Clinical hypoxia accuracy testing (controlled desaturation study) was conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the subject device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device). The accuracy of the subject device is in comparison with the control device over the SpO2 range of 70~100%. Data was calculated and analyzed using the mean bias (B), root-mean-square (Ams), PRECISION (standard deviation of the residuals (Sres) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the ISO 80601-2-61;
Besides, the Agreement between methods of measurement with multiple observations for both all subjects pooled and individual test subjects were analyzed with the Bland and Altman statistics, the analysis demonstrated that the vast majority of data is within ±95% limit of agreement, the data points beyond or below this scope were regarded as outliers. The outliers only occurred occasionally and after being analyzed, it was determined that the outliers do not raise performance concerns regarding the accuracy and precision of the device.
During the clinical study, 12 subjects were enrolled, who are healthy, nonsmoking, competent adults, between twenty-one and thirty-two (21-32) years of age, and they were provided EC (Ethics Committee)-approved informed consent as documented on an informed consent form. No case was lost in this trial. The trial completed 12 cases, on which 294 data sets were collected, of which 288 were valid. 6 data sets which less than 70% were excluded. The result met the criteria specified in the ISO 80601-2-61; In addition, there were no reported adverse effects during these investigations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: ±2%: (70%~100%), Unspecified : (0%~69%)
Pulse rate accuracy: ±2 bpm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2017
Shenzhen Fitfaith Technology Co.,ltd % Migo. Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1122#, Internation Mayor Communication Center, Baishizhong Rd 55#, Nanshan District, Shenzhen, 518000 CN
Re: K163135
Trade/Device Name: Fingertip Pulse Oximeter (Model: A300, A310, M110, M120, M130, M150, M160, M170, M230) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: July 15, 2017 Received: August 7, 2017
Dear Migo. Yang:
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. 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Tara A. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163135
Device Name
Fingertip Pulse Oximeter (Model: A300, A310, M100, M110,M120,M130,M150,M170,M230)
Indications for Use (Describe)
The Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
| 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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3
510(k) Summary
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1 Administrative Information
| Submission Date | Aug 18,2016 |
|---|---|
| Manufacturer | |
| information | Submitter's Name: Shenzhen Fitfaith Technology Co.,Ltd. |
| Address: Area B, Floor 9, Building D1, Tangwei Industrial Park | |
| Donglong Road, Guangming New District, ShenZhen, | |
| Guangdong, China. | |
| Contact person: Yuan.Junfeng | |
| TEL: +86-0755-29544253-803 | |
| FAX: +86-0755-29544253-801 | |
| E-Mail: 160666@qq.com | |
| Submission | |
| Correspondent | Contact person: Miss Migo. Yang |
| E-Mail: migo@cefda.com | |
| Shenzhen Joyantech Consulting Co., Ltd. | |
| 1122#, International Mayor Communication Center, | |
| Baishizhong Road 55#, Nanshan District, Shenzhen, | |
| Guangdong, China. | |
| Image: Logo | Contact person: Mr. Field.Fu |
| E-Mail: cefda13485@163.com | |
| Shenzhen Joyantech Consulting Co., Ltd. | |
| 1122#, International Mayor Communication Center, | |
| Baishizhong Road 55#, Nanshan District, Shenzhen, | |
| Guangdong, China | |
| Establishment | |
| registration number | NA |
2 Device Information
| Type of 510(k)
| submission: | Traditional |
|---|---|
| Trade Name: | Fingertip Pulse Oximeter (Model: A300, A310, M100, |
| M110,M120,M130,M150,M160,M170,M230) | |
| Classification | |
| name: | Oximeter |
| Review Panel: | Anesthesiology |
| Product Code: | DQA |
| Device Class: | II |
| Regulation | 870.2700 |
| Number: | K163135 |
4
3 Predicate Device Information
Shenzhen Jumper Medical Equipment Co., Ltd. Sponsor: JPD-500A Fingertip Pulse Oximeter Device: K140582 510(K) Number:
4 Device Description
The Fingertip Pulse Oximeteris intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in the home and hospital.
The fingertip pulse oximeter features a small size, low power consumption, a convenient operation, and portability.It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement.
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 red and 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 red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor.
5 Intended Use
The subject device is intended for measuring the functional oxygen saturation and pulse rate (PR) through a patient's finger. It is applicable for spot-checking SpO2 and pulse rate (PR) of adult and pediatric patients in homes and clinics.
6 Indications for Use
The Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery. anesthesia, intensive care, etc).
5
7 Contraindications
- High-frequency electrosurgical
- Placement of a sensor on an extremity with a blood pressure cuff arterial catheter, or intravascular line
- The patient has hypotension severe vasoconstriction severe anemia or hypothermia.
- The patient is in cardiac arrest or is in shock.
- Fingernail polish or false fingernails may cause inaccurate SpO2 readings.
6
8 SE Comparison
| Characteristics | Subject device | Predicate device
(K140582) | Remark | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------|
| Device name | Fingertip Pulse Oximeter
A300,A310,M100,M110,M
120,M130,M150,M160,M1
70,M230 | Fingertip Pulse Oximeter | / | |
| Model | Note:
A300 and M110 are totally
identical model except for
model name based on
customer's requirement;
A310 and M100 are totally
identical model except for
model name based on
customer's requirement; | JPD-500A | / | |
| Manufacturer | Shenzhen Fitfaith
Technology Co.,Ltd. | Shenzhen Jumper
Medical Equipment
Co.,Ltd | / | |
| Intended patient
population | Adult & Pediatric | Adult & Pediatric | same | |
| Intended application
site | Fingertip | | same | |
| Intended
Environments | home & hospital | | same | |
| Prescription & OTC | Prescription | | same | |
| Intended use | The subject device is intended for measuring the
functional oxygen saturation and pulse rate through
patient's finger. It is applicable for spot-checking SpO2
and pulse rate of adult and pediatric patients in homes
and clinics. | | same | |
| Indications for Use | The Fingertip Pulse
Oximeter is non-invasive
device intended for spot-
checking of functional
oxygen saturation of
arterial hemoglobin
(SpO2) and pulse rate
(PR). The portable
fingertip device is
indicated for adult and
pediatric patients in home
and hospital environments
(including clinical use in
internist/ surgery,
anesthesia, intensive
care, etc). | The JPD-500A Fingertip
Pulse Oximeter is non-
invasive device intended
for spot-checking of
functional oxygen
saturation of arterial
hemoglobin (Spo2) and
pulse rate. The portable
fingertip device is
indicated for adult and
pediatric patients in home
and hospital
environments (including
clinical use in internist/
surgery, anesthesia,
intensive care, etc). | Similar(Note01) | |
| Characteristics | | Subject device | Predicate device
(K140582) | Remark |
| Working 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 red 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 can 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. | | same |
| Light
Specification
on | wavelength | 660nm±3nm for red light,
905nm±5nm for infrared light (IR) | | same |
| | maximum
optical
power | 1.5 mW for red light (660nm)
1.2 mW for IR (905nm) | | same |
| Contact Material | | ABS for enclosure, silica gel for clip | | same |
| Internal Power supply | | 2*AAA 1.5v alkaline battery | | same |
| Working Current | | Less than 40mA(Normal) | 35mA | Similar(Note02) |
| Resolution | SpO2 | 1% | | same |
| | Pulse
rate | 1 bpm | | same |
| Measurement
Range | SpO2 | 0%100% | | same |250 bpm | | same |
| | Pulse
rate | 25
| Measurement
Accuracy | SpO2 | ±2%: (70%~100%)
Unspecified : (0%~69%) | ±2%: (70%~100%)
no definition(0%69%) | same |40°C | | Similar (Note03) |
| | Pulse
rate | ±2 bpm | ±2 bpm | same |
| | | | | |
| Operating
Environment | Temperature | 5°C
| | Humidity | 15%85% non-+50°C | Similar(Note04) |
condensing | 15%80% non-+55°C | -10°C
condensing | |
| Storage &
Transport
Environment | Temperature | -20°C
| | Humidity | 10%~95% | 10%~93% | |
Table 1. Substantial Equivalence Comparison
7
Note01:
The trade name is different, but SE determination does not depend on trade name.
Note02:
The working currents of subject device and predicate device are similar. The subject device met the requirements of IEC 60601-1.
8
Note03:
The humidity under operating environment of subject device and predicate device are similar. The subject device met the requirements of ISO 80601-2-61. Note04:
The Storage & Transport environment of subject device and predicate device are similar. The subject device met the requirements of ISO 80601-2-61.
The subject device is the same as the predicate device in intended use, intended patient population, intended application site, working principle, contact material, internal power supply, display range, resolution. Only their appearance, indication for use (Note01), working current (Note02), operation environment (Note03), storage transport environment (Note04), are a little bit different. However, the minor differences do not raise different questions of safety and effectiveness.
9 Brief discussions of tests
9.1 Brief discussions of the nonclinical tests
The subject device conforms to the following standards:
- ゃ IEC 60601-1:2005+A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ゃ Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests;
- や IEC 60601-1-11: Requirements for Medical Electrical (ME) Equipment and ME Systems used in the Home Healthcare Environment;
- ゃ ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for In Vitro cytotoxicity;
- � ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;
- ゃ ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment;
- ゃ Cleaning and low level disinfection validation.
9.2 Brief discussions of clinical tests
Clinical testing according to ISO 14155:2011 and ISO 80601-2-61: 2011 has also been performed on the device.
Clinical hypoxia accuracy testing (controlled desaturation study) was conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects in an independent research laboratory. The measured arterial
9
hemoglobin saturation value (SpO2) of the subject device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device). The accuracy of the subject device is in comparison with the control device over the SpO2 range of 70~100%. Data was calculated and analyzed using the mean bias (B), root-mean-square (Ams), PRECISION (standard deviation of the residuals (Sres) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the ISO 80601-2-61;
Besides, the Agreement between methods of measurement with multiple observations for both all subjects pooled and individual test subjects were analyzed with the Bland and Altman statistics, the analysis demonstrated that the vast majority of data is within ±95% limit of agreement, the data points beyond or below this scope were regarded as outliers. The outliers only occurred occasionally and after being analyzed, it was determined that the outliers do not raise performance concerns regarding the accuracy and precision of the device.
During the clinical study, 12 subjects were enrolled, who are healthy, nonsmoking, competent adults, between twenty-one and thirty-two (21-32) years of age, and they were provided EC (Ethics Committee)-approved informed consent as documented on an informed consent form. No case was lost in this trial. The trial completed 12 cases, on which 294 data sets were collected, of which 288 were valid. 6 data sets which less than 70% were excluded. The result met the criteria specified in the ISO 80601-2-61; In addition, there were no reported adverse effects during these investigations.
10 Other information (such as required by FDA guidance)
No other information.
11 Conclusions
Based on the clinical and non-clinical testing performed, the results demonstrate that the subject device fingertip pulse oximeter is substantially equivalent to the predicate device JPD-500A Fingertip Pulse Oximeter manufactured by Shenzhen Jumper Medical Equipment Co., Ltd.