Pulse Oximeter

K203854 · Shenzhen Hexin Zondan Medical Equipment Co., Ltd. · DQA · Apr 23, 2021 · Cardiovascular

Device Facts

• Record ID: K203854
• Device Name: Pulse Oximeter
• Applicant: Shenzhen Hexin Zondan Medical Equipment Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Pulse Oximeter 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.

Device Story

Portable fingertip pulse oximeter; uses photoelectric oxyhemoglobin inspection technology; emits red and near-infrared light through a clamping finger-type sensor; measures light absorption based on Lambert-Beer Law; calculates SpO2 and pulse rate; powered by internal AAA batteries; used by clinicians or patients in homes and hospitals for spot-checking; provides real-time SpO2 and PR values on a display; assists healthcare providers in assessing patient oxygenation status; benefits patients through non-invasive, rapid monitoring.

Clinical Evidence

Clinical validation performed per ISO 80601-2-61 on 12 healthy adult volunteers (5 male, 7 female) with varying skin pigmentations. 278 data points collected across 70%-100% SpO2 range. Subject device compared against laboratory CO-Oximeter. Results: Arms < ±2% SpO2; Bland-Altman analysis confirmed agreement within 95% limits.

Technological Characteristics

Materials: ABS enclosure, silicone clip. Sensing: Photoelectric plethysmography (Red 660nm, IR 905nm). Power: 2x AAA 1.5V alkaline batteries. Connectivity: Standalone. Safety: Type BF applied part. Standards: ISO 10993-1, ISO 80601-2-61, IEC 60601-1, IEC 60601-1-11.

Indications for Use

Indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc.) for non-invasive spot-checking of functional oxygen saturation (SpO2) and pulse rate (PR).

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

• Fingertip Pulse Oximeter (K163135)

Submission Summary (Full Text)

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April 23, 2021

Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. John Liu RA Manager Floor 14, Block D, Dianlian Technology Building, the Crossing between South Circle Road and South Fuli Road, Shenzhen, Guangdong 518106 China

Re: K203854

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 23, 2021 Received: March 23, 2021

Dear John 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K203854

Device Name Pulse Oximeter

Indications for Use (Describe)

The 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)

| <span style="font-size:10pt">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:10pt">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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Image /page/3/Picture/2 description: The image contains a logo for ZONDAN. The logo features a green graphic of two overlapping cards with a white heart and heartbeat symbol on them. To the right of the graphic is the company name "ZONDAN" in bold, black letters, and below that is the tagline "Core Technology Care for Life" in a smaller, gray font.

# 510(k) Summary

This summary of 510(k) information is submitted as required by requirements of 21 CFR 807.92.

### 1. Submitter's Identification

| Applicant: | Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Floor 14, Block D, Dianlian Technology Building, the<br>Crossing between South Circle Road and South Fuli Road,<br>Guangming District, 518106 Shenzhen, Guangdong, China |
| Contact person: | Li Feng<br>General Manager<br>Tel: [phone]<br>E-mail: [e-mail] |
| Prepared by: | Mr. John Liu<br>Regulatory Manager<br>E-mail: [e-mail] |
| Date prepared: | Dec. 21, 2020 |

## 2. Subject device information

Device Common Name: Oximeter Device Trade Name: Pulse Oximeter Model: A2, A3, A4, A5 Regulation Number: 21 CFR 870.2700 Regulation Name: Oxiemter Regulatory Class: II Product Code: DQA

## 3. Predicate device information

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Image /page/4/Picture/2 description: The image shows the logo for Zondan. The logo consists of a green square with a white heart and an EKG line inside of it. To the right of the square is the word "ZONDAN" in large, bold, black letters. Below the word "ZONDAN" is the phrase "Core Technology Care for Life" in smaller, gray letters.

510(k) Number: K163135 Trade/ Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Manufacturer: Shenzhen Fitfaith Technology Co., Ltd.

#### 4. Device description

The Pulse Oximeter 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.

The Pulse Oximeter is as a stand-alone device, which is powered by an internal battery. The device is for multi-use. The device is not for life supporting or life sustaining, not for implant. The device is not sterile, the device is not a reprocessed single-use device, and the device does not contain drug or biological products.

### 5. Intended Use

The Pulse Oximeter 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. Indication for Use

The 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).

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Image /page/5/Picture/2 description: The image shows the logo for ZONDAN. The logo consists of a green graphic on the left, which includes a white heart with an EKG line inside of it. To the right of the graphic is the company name, "ZONDAN" in bold, black letters. Below the company name is the tagline "Core Technology Care for Life" in a smaller, gray font.

# 7. Substantial Equivalence Comparison

| Characteristics | Subject device | Predicate device<br>(K163135) | Remark |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Device name | Pulse Oximeter | Fingertip Pulse<br>Oximeter | NA |
| Model | A2, A3, A4, A5 | A300 | NA |
| Manufacturer | Shenzhen Hexin<br>ZONDAN Medical<br>Equipment Co.,Ltd. | Shenzhen Fitfaith<br>Technology Co., Ltd. | NA |
| Classification | Class II | Class II | Substantially<br>Equivalent. |
| Product code | DQA | DQA | Substantially<br>Equivalent. |
| Prescription or<br>OTC | Prescription | Prescription | Substantially<br>Equivalent. |
| Intended use | The Pulse Oximeter is<br>intended for measuring<br>the functional oxygen<br>saturation and pulse<br>rate (PR) through a<br>patient's finger. It is<br>applicable for<br>spot-checking SpO2<br>and pulse rate (PR) of<br>adult and pediatric<br>patients in homes and<br>clinics. | The Fingertip Pulse<br>Oximeter is intended<br>for measuring the<br>functional oxygen<br>saturation and pulse<br>rate (PR) through a<br>patient's finger. It is<br>applicable for<br>spot-checking SpO2<br>and pulse rate (PR) of<br>adult and pediatric<br>patients in homes and<br>clinics. | Substantially<br>Equivalent. |
| Indications for | The Pulse Oximeter is | The Fingertip Pulse | Substantially |
| use | non-invasive device<br>intended for<br>spot-checking of<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate (PR). The<br>portable fingertip<br>device is indicated for<br>adult and pediatric<br>patients in home and<br>hospital environments<br>(including clinical use<br>in internist/ surgery,<br>anesthesia, intensive<br>care, etc). | Oximeter is<br>non-invasive device<br>intended for<br>spot-checking of<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2)<br>and pulse rate (PR).<br>The portable fingertip<br>device is indicated for<br>adult and pediatric<br>patients in home and<br>hospital environments<br>(including clinical use<br>in internist/ surgery,<br>anesthesia, intensive<br>care, etc). | Equivalent. |
| Design principle | A mathematical formula is established making<br>use of Lambert Beer Law according to Spectrum<br>Absorption Characteristics of Reductive<br>hemoglobin (RHb) and Oxyhemoglobin (HbO2)<br>in red and near-infrared zones. Operation<br>principle of the instrument: Photoelectric<br>Oxyhemoglobin Inspection Technology is<br>adopted in accordance with Capacity Pulse<br>Scanning and Recording Technology, so that two<br>beams of different wavelength of lights can be<br>focused onto a human nail tip through a<br>clamping finger-type sensor A measured signal | | Substantially<br>Equivalent. |
| Environment of<br>use | Home and Hospital | Home and Hospital | Substantially<br>Equivalent. |
| Patient type | Adult and Pediatric | Adult and Pediatric | Substantially<br>Equivalent. |
| Intended<br>application site | Fingertip | Fingertip | Substantially<br>Equivalent. |
| Type, Degree of<br>protection<br>against electric<br>shock | Internally powered<br>equipment;<br>Type BF applied part. | Internally powered<br>equipment;<br>Type BF applied part. | Substantially<br>Equivalent. |
| Power supply | 2*AAA 1.5V alkaline<br>battery | 2*AAA 1.5V alkaline<br>battery | Substantially<br>Equivalent. |
| Work current | <40mA | <40mA | Substantially<br>Equivalent. |
| Light<br>specification | Wavelength:<br>RED: 660nm±5nm,<br>IR: 905nm±5nm | Wavelength:<br>RED: 660nm±3nm,<br>IR: 905nm±5nm | Substantially<br>Equivalent. |
| | Maximum optical<br>power:<br>RED: 1.5mW,<br>IR: 1.2mW | Maximum optical<br>power:<br>RED: 1.5mW,<br>IR: 1.2mW | Substantially<br>Equivalent. |
| SpO2 display<br>range | 0%~100% | 0%~100% | Substantially<br>Equivalent. |
| SpO2<br>measurement | 70%-100%, accuracy:<br>±2%;<br><70%, no definition. | 70%-100%, accuracy:<br>±2%;<br><70%, no definition. | Substantially<br>Equivalent. |
| accuracy | | | |
| SpO2 resolution | 1% | 1% | Substantially Equivalent. |
| Pulse rate display range | 30bpm~240bpm | 25bpm~250bpm | Different Note 01 |
| Pulse rate measurement accuracy | $\pm$ 1bpm | $\pm$ 2bpm | Different Note 02 |
| Pulse rate resolution | 1bpm | 1bpm | Substantially Equivalent. |
| Operation environment | Temperature:<br>5°C ~ 40°C<br>Humidity:<br>30% ~ 80%<br>(non-condensing)<br>Atmospheric pressure:<br>70kPa ~ 106kPa | Temperature:<br>5°C ~ 40°C<br>Humidity:<br>15% ~ 85%<br>(non-condensing) | Different Note 03 |
| Storage & Transport environment | Temperature:<br>-20°C ~ +55°C<br>Humidity:<br>10% ~ 93%<br>(non-condensing)<br>Atmospheric pressure:<br>70kPa ~ 106kPa | Temperature:<br>-20°C ~ +55°C<br>Humidity:<br>10% ~ 95%<br>(non-condensing) | |
| Contacting material | ABS (Acrylonitrile butadiene styrene copolymers) for enclosure, silicone for clip | ABS (Acrylonitrile butadiene styrene copolymers) for enclosure, silicone for clip | Substantially Equivalent. |
| Contact<br>duration | <24h | <24h | Substantially<br>Equivalent. |
| Contact type | Skin surface-contacting | Skin<br>surface-contacting | Substantially<br>Equivalent. |
| Biocompatibility of patient<br>contact parts | Comply with ISO<br>10993-1 | Comply with ISO<br>10993-1 | Substantially<br>Equivalent. |

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Image /page/6/Picture/2 description: The image shows the logo for ZONDAN. The logo consists of a green icon with a white heart and an EKG line inside, followed by the word "ZONDAN" in large, bold, black letters. Below the word "ZONDAN" is the tagline "Core Technology Care for Life" in a smaller, gray font.

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Image /page/7/Picture/2 description: The image shows the logo for ZONDAN. The logo features a green graphic on the left, which includes a heart with an EKG line inside of it. To the right of the graphic is the company name, "ZONDAN" in large, bold, black letters. Below the company name is the tagline "Core Technology Care for Life" in a smaller, gray font.

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Image /page/8/Picture/2 description: The image shows the logo for ZONDAN. The logo consists of a green graphic with a white heart and heartbeat line inside of it, and the text "ZONDAN" in bold black letters. Below the company name is the text "Core Technology Care for Life" in a smaller, lighter font.

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Image /page/9/Picture/2 description: The image shows the logo for Zondan. The logo features a green icon with a white heart and a heartbeat line inside. Next to the icon is the word "ZONDAN" in bold, black letters. Below the word is the tagline "Core Technology Care for Life" in a smaller, gray font.

#### Note 01:

The pulse rate display range of the subject device is different from the predicate device. But the subject device complies with the claimed display range according to bench test report.

#### Note 02:

The pulse rate measurement accuracy of the subject device is different from the predicate device. But the subject device complies with the claimed measurement accuracy according to bench test report.

#### Note 03:

The operation and storage & transport environment of subject device are different from predicate device. But the subject device has been verified all the full claimed range according to the IEC 60601-1, IEC 60601-1-11 and ISO 80601-2-61 standards.

Based on the aforementioned substantial equivalence comparison table, the subject device is as same as predicate device. Only Pulse rate display range (refer to Note 01), Pulse rate measurement accuracy (refer to Note 02), Operation and Storage & Transport environment (refer to Note 03) are different which had been validated. However, the differences would not raise any safety and effectiveness issue based on tests in this submission.

Thus, the subject device is substantially equivalent to the predicate device which is

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Image /page/10/Picture/2 description: The image shows the logo for Zondan. The logo features a green square with a white heart and heartbeat line inside. To the right of the square is the word "ZONDAN" in large, bold, black letters. Below the word "ZONDAN" is the phrase "Core Technology Care for Life" in a smaller, gray font.

legally marketed in US.

## 8. Brief discussions of the non-clinical tests

The following tests were conducted to demonstrate substantial equivalence to the predicate device:

| Test Standard | Description | Result |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ANSI AAMI<br>ES60601-1:2005/(R)2012<br>and A1:2012 | Medical electrical equipment - Part 1:<br>General requirements for basic safety and<br>essential performance (IEC 60601-1:2005,<br>MOD) | Pass |
| IEC 60601-1-2 Edition<br>4.0 2014-02 | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance - Collateral Standard:<br>Electromagnetic disturbances -<br>Requirements and tests | Pass |
| IEC 60601-1-11 Edition<br>2.0 2015-01 | Medical electrical equipment - Part 1-11:<br>General requirements for basic safety and<br>essential performance - Collateral Standard:<br>Requirements for medical electrical<br>equipment and medical electrical systems<br>used in the home healthcare environment | Pass |
| ISO 80601-2-61 Second<br>edition 2017-12<br>(Corrected version<br>2018-02) | Medical electrical equipment - Part 2-61:<br>Particular requirements for basic safety and<br>essential performance of pulse oximeter<br>equipment | Pass |
| ISO 10993-1 Fourth<br>edition 2009-10-15 | Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk<br>management process [Including: Technical<br>Corrigendum 1 (2010)] | Pass |
| Pulse Oximeter_Traditional 510k Submission | | |
| ISO 10993-5 Third<br>edition 2009-06-01 | Biological evaluation of medical devices -<br>Part 5: Tests for in vitro cytotoxicity | Pass |
| ISO 10993-10 Third<br>Edition 2010-08-01 | Biological evaluation of medical devices -<br>Part 10: Tests for irritation and skin<br>sensitization | Pass |
| ISO 14971 Second<br>edition 2007-03-01 | Medical devices - Application of risk<br>management to medical devices | Pass |

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It is concluded that the subject device is in compliance with the requirements of the aforementioned tests.

#### 9. Brief discussions of the clinical tests

The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61. The clinical testing was completed on healthy, non-smoking, a total of 12 healthy adult volunteers (5 men and 7 women) with light to dark skin pigmentations in the range of 70% to 100% against a laboratory CO-Oximeter. The subjects include 10 with light skin, and 2 with dark skin pigmentation. Total 278 data points were sampled for analysis. 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 70%-100%.

Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, the SpO2 accuracy result showed that the root-mean-square (Arms) value of the Pulse Oximeter is less than ±2% SpO2 over the declared range of 70% to 100%; 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.

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Image /page/12/Picture/2 description: The image contains a logo for ZONDAN, a company that appears to be in the healthcare industry. The logo features a green icon resembling a medical chart with a heart and heartbeat symbol inside. Next to the icon is the company name, "ZONDAN," in bold, black letters, followed by the tagline "Core Technology Care for Life" in a smaller, lighter font.

### 10.Software information

The software level of concern for the subject device is MODERATE. According to FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff", the software validation documentation summarizes the required information for a MODERATE Level of Concern device.

### 11. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in in this premarket notification, Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. concludes that the subject device is as safe and as effective, and thus substantially equivalent, to the predicate device, A300 Fingertip Pulse Oximeter manufactured by Shenzhen Fitfaith Technology Co., Ltd..