FINGERTIP PULSE OXIMETER

K140582 · Shenzhen Jumper Medical Equipment Co., Ltd. · DQA · Aug 28, 2014 · Cardiovascular

Device Facts

• Record ID: K140582
• Device Name: FINGERTIP PULSE OXIMETER
• Applicant: Shenzhen Jumper Medical Equipment Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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).

Device Story

Portable fingertip pulse oximeter; uses photoelectric oxyhemoglobin inspection technology; emits two light wavelengths (660nm red, 905nm infrared) through finger nail tip; photosensitive element detects transmitted light; microprocessor calculates SpO2 and pulse rate based on Lambert-Beer Law and capacity pulse scanning; output displayed on device screen; used by clinicians or patients for spot-checking; aids in assessing patient oxygenation status; battery-powered.

Clinical Evidence

Controlled desaturation study conducted on 10 healthy, non-smoking, light-to-dark-skinned subjects. SpO2 accuracy compared against CO-oximeter blood samples over 70-100% range. Accuracy calculated using root-mean-squared (Arms) per ISO 80601-2-61; results showed error within specified limits. Bland-Altman analysis confirmed agreement within 95% limits. No adverse effects reported.

Technological Characteristics

Materials: Silica gel (patient contact). Sensing: Photoelectric (660nm/905nm). Power: 2x AAA batteries. Form factor: Portable fingertip clip. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993-1/5/10. Software: IEC 62304 compliant.

Indications for Use

Indicated for adult and pediatric patients requiring spot-check monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in home and hospital settings.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• CMS-50D Finger Pulse Oximeter (K082641)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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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: [phone]

Fax: [phone]

Contact Person: Yi Hui

E-mail: [e-mail]

#### 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: [e-mail]

#### 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 |

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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

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| 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.

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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<br>JPD-500A | Predicate device<br>(K082641) | Judgment |
|-------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------|
| Device name | Fingertip Pulse Oximeter | Fingertip Pulse<br>Oximeter | Same |
| Model | JPD-500A | CMS-50D | -- |
| K Number | Pending | K082641 | -- |
| Characteristics | Subject device<br>JPD-500A | Predicate device<br>(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<br>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<br>JPD-500A | Predicate device<br>(K082641) | Judgment |
| SpO2 measuring<br>range | 0-100% | 35%-99% | Similar |
| SpO2 accuracy | 70%-100%: $\pm$ 2%<br>0%-69%: no definition | 70%-100%: $\pm$ 2%<br>35%-69%: no definition | Similar |
| Pulse rate<br>measuring range | 25-250bpm | 30-240bpm | Similar |
| Pulse rate accuracy | $\pm$ 2bpm | $\pm$ 2bpm or $\pm$ 2% (whichever<br>is greater) | Similar |
| Operation<br>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;<br>Automatically power off;<br>Alarm limits setting function | | Same |

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#### Shenzhen Jumper Medical Equipment Co., Ltd. Sponsor: Subject Device: Fingertip Pulse Oximeter, model: JPD-500A

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| 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