(175 days)
Not Found
No
The description details a standard pulse oximetry principle based on Lambert Beer Law and photoelectric technology, processed by electronic circuits and a microprocessor. There is no mention of AI or ML.
No.
The device is described as a non-invasive tool for "spot-checking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate," which are diagnostic measurements, not treatments.
Yes
The device is described as "non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate." Spot-checking of physiological parameters for "oxygen saturation of arterial hemoglobin (Spo2) and pulse rate" are measurements that assist in diagnosis, therefore qualifying it as a diagnostic device.
No
The device description explicitly details hardware components like a clamping finger-type sensor, light sources (660nm and 905nm), electronic circuits, and a microprocessor, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The JPD-500A Fingertip Pulse Oximeter is a non-invasive device that measures oxygen saturation and pulse rate directly from the fingertip. It does not analyze samples taken from the body.
Therefore, based on the provided information and the definition of an IVD, the JPD-500A Fingertip Pulse Oximeter is not an In Vitro Diagnostic device. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The JPD-500A fingertip pulse oximeter is intended for 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, very easy to use it.
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 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 / human nail tip
Indicated Patient Age Range
adult and pediatric patients
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 10 healthy, nonsmoking, light-to-dlark-skinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the proposed device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter. The accuracy of the device is in comparison with the CO-oximeter samples measured over the SpO2 range of 70-100%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical hypoxia accuracy testing (controlled desaturation study) was conducted during induced hypoxia studies on 10 healthy, nonsmoking, light-to-dlark-skinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the proposed device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter. The accuracy of the device is in comparison with the CO-oximeter samples measured over the SpO2 range of 70-100%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the STANDARD; and the Agreement between Methods of Measurement with Multiple Observations per each subject was 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. By analyzing, these few outliers are occasional, which does not raise safety and performance concerns regarding the accuracy of the device.
15 subjects were enrolled for the clinical study, who are healthy, non-smoking, competent adults, between twenty-seven and forty-four (27-44) years of age, they were provided EC (Ethics Committee)-approved informed consent as documented on an informed consent form. 5 patients were excluded during test based on the exclusion criteria and the criteria for determining stability of the SaO2 at the pulse oximeter probe site.
In addition, there were no reported adverse effects during these investigations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: 70%-100%: ± 2%, 0%-69%: no definition
Pulse rate accuracy: ± 2bpm
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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with the head tilted upwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
Shenzen Jumper Medical Equipment Co., Ltd. C/O Field Fu, Consultant Shenzen Joyantech Consulting Co., Ltd 4th Floor, Jinhui Building Nanhai Blvd. Nanshan District, Shenzen Guangdong, China 518000
Re: K140582
Trade/Device Name: JPD-500A Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 21, 2014 Received: July 31, 2014
Dear Mr. Fu:
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours.
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Chapter 04 Indications for Use
510(k) Number (if known): K140582
Device Name: Fingertip Pulse Oximeter Model: JPD-500A
Indications for Use:
The JPD-500A Fingertip Pulse Oximeter is non-invasive device intended for spotchecking 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).
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Shenzhen Jumper Medical Equipment Co., Ltd. Sponsor: Fingertip Pulse Oximeter, model: JPD-500A Subject Device:
Chapter 05 510(k) Summary
510(K) Summary as required by 21 CFR 807.92(c).
1.0 Information of Submitter and Correspondent
Submitter's information:
Shenzhen Jumper Medical Equipment Co., Ltd.
Address: 5th Floor, Building No.34, Baoyuan Industrial Zone, Xixiang Street, Baoan District, Shenzhen 518102, P.R. China.
Phone: +86-755-2669 2192
Fax: +86-755-2685 2025
Contact Person: Yi Hui
E-mail: info@jumper-medical.com
Submission correspondent's information:
Shenzhen Joyantech Consulting Co., Ltd. Address: 4th Floor, Jinhui Building, Nanhai BLVD, Nanshan District, Shenzhen, Guangdong, China. Contact person: Mr. Field.Fu E-mail: cefda13485@163.com
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Fingertip Pulse Oximeter |
| Model: | JPD-500A |
| Classification name: | Oximeter |
| Review Panel: | Anesthesiology |
| Product Code: | DQA |
| Device 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
Shenzhen Jumper Medical Equipment Co.. Ltd. Sponsor: Subject Device: Fingertip Pulse Oximeter, model: JPD-500A
4.0 Device Description
The JPD-500A fingertip pulse oximeter is intended for 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, very easy to use it.
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 data is shown on the Oximeter's display through electronic circuits and a microprocessor.
5.0 Intended Use
The JPD-500A Fingertip Pulse Oximeter 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.
6.0 Indications for Use
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).
7.0 Summary comparing technological characteristics with predicate device
5
| 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 |
Shenzhen Jumper Medical Equipment Co., Ltd. Sponsor: Subject Device: Fingertip Pulse Oximeter, model: JPD-500A
8.0 Performance Summary
JPD-500A Fingertip Pulse Oximeter conforms to the following standards:
- IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance, 2005, CORR.1:2006 + CORR.2: 2007;
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests;
- IEC 60601-1-11:2010 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment;
- ISO 80601-2-61:2011 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter;
- . IEC 62304:2006 Medical device software – Software life cycle processes;
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process;
- 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.
6
Shenzhen Jumper Medical Equipment Co., Ltd. Sponsor: Fingertip Pulse Oximeter, model: JPD-500A Subject Device:
9.0 Clinical testing
Clinical hypoxia accuracy testing (controlled desaturation study) was conducted during induced hypoxia studies on 10 healthy, nonsmoking, light-to-dlark-skinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the proposed device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter. The accuracy of the device is in comparison with the CO-oximeter samples measured over the SpO2 range of 70-100%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, the result showed that the error is far less than the scope specified in the STANDARD ; and the Agreement between Methods of Measurement with Multiple Observations per each subject was 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. By analyzing, these few outliers are occasional, which does not raise safety and performance concerns regarding the accuracy of the device.
15 subjects were enrolled for the clinical study, who are healthy, non-smoking, competent adults, between twenty-seven and forty-four (27-44) years of age, they were provided EC (Ethics Committee)-approved informed consent as documented on an informed consent form. 5 patients were excluded during test based on the exclusion criteria and the criteria for determining stability of the SaO2 at the pulse oximeter probe site.
In addition, there were no reported adverse effects during these investigations.
10.0 Comparison to predicate device and conclusion
The subject device JPD-500A Fingertip Pulse Oximeter is substantially equivalent to CMS-50D Fingertip Pulse Oximeter whose 510(k) number is K082641.
| Characteristics | Subject device
JPD-500A | Predicate device
(K082641) | Judgment |
|-------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------|
| Device name | Fingertip Pulse Oximeter | Fingertip Pulse
Oximeter | Same |
| Model | JPD-500A | CMS-50D | -- |
| K Number | Pending | K082641 | -- |
| Characteristics | Subject device
JPD-500A | Predicate device
(K082641) | Judgment |
| Manufacturer | Shenzhen Jumper Medical | Contec Medical | |
| | Equipment Co., Ltd. | Systems Co., Ltd. | -- |
| Intended patient | Adult | | Same |
| population | | | |
| Intended | Fingertip | | Same |
| application site | | | |
| | The JPD-500A Fingertip | This Fingertip | |
| | Pulse Oximeter is intended | Oximeter is intended | |
| | for measuring the functional | for measuring the pulse | |
| | oxygen saturation and pulse | rate and functional | |
| | rate through patient's finger. | oxygen saturation | |
| | It is applicable for spot- | (SpO2) through | |
| Intended use | checking SPO2 and pulse | patient's finger. It is | Same |
| | rate of audit and pediatric | applicable for spot- | |
| | patients in homes and | checking SpO2 and | |
| | clinics. | pulse rate of adult and | |
| | | pediatric patients in | |
| | | | |
| | A mathematical formula is established making use of | homes and clinics. | |
| | | | |
| | Lambert Beer Law according to Spectrum Absorption
Characteristics of Reductive hemoglobin(RHb) and | | Same |
| | Oxyhemoglobin (HbO2) in glow and near-infrared | | |
| | zones. Operation principle of the instrument: | | |
| | Photoelectric Oxyhemoglobin Inspection Technology | | |
| | is adopted in accordance with Capacity Pulse | | |
| Design principle | Scanning and Recording Technology, so that two | | |
| | beams of different wavelength of lightscan 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. | | |
| Prescription or OTC | Prescription | | Same |
| Contact material | Silica gel | | Same |
| Characteristics | Subject device
JPD-500A | Predicate device
(K082641) | Judgment |
| SpO2 measuring
range | 0-100% | 35%-99% | Similar |
| SpO2 accuracy | 70%-100%: $\pm$ 2%
0%-69%: no definition | 70%-100%: $\pm$ 2%
35%-69%: no definition | Similar |
| Pulse rate
measuring range | 25-250bpm | 30-240bpm | Similar |
| Pulse rate accuracy | $\pm$ 2bpm | $\pm$ 2bpm or $\pm$ 2% (whichever
is greater) | Similar |
| Operation
temperature | 5°C-40°C | 5°C-40°C | Same |
| Operation humidity | 15%-80% | 30-80%RH | Similar |
| Power source | 2 × AAA batteries | Same | Same |
| Other function | Low battery voltage alarm;
Automatically power off;
Alarm limits setting function | | Same |
7
Shenzhen Jumper Medical Equipment Co., Ltd. Sponsor: Subject Device: Fingertip Pulse Oximeter, model: JPD-500A
8
| Sponsor: Shenzhen Jumper Medical Equipment Co., Ltd. |
|---|
| Subject Device: Fingertip Pulse Oximeter, model: JPD-500A |
11.0 Conclusions
As a comparison result for Clause 7.0, JPD-500A is same as its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the SpO2 measuring range and pulse rate range are a little bit different.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new device. The proposed device is Substantially Equivalent (SE) to the predicate device which is legally marketed in US. Therefore, the subject device is determined as safe and effective as predicate device.
12.0 Summary prepared date
August 28, 2014