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).

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.

AI/ML Overview

The provided text describes the 510(k) submission for a Pulse Oximeter, asserting its substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided information:

Key Takeaway: This submission focuses on demonstrating substantial equivalence of a new Pulse Oximeter to an existing one, primarily through non-clinical testing and a clinical study to validate SpO2 accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely defined by regulatory standards (ISO 80601-2-61 for SpO2 accuracy) and comparison to a predicate device. The performance is reported in relation to these standards and the predicate.

Acceptance Criteria / Performance Metric	Specific Criterion / Reported Performance
Functional Oxygen Saturation (SpO2) Accuracy (Primary Clinical Metric)	Criterion: Root-mean-square (Arms) value of the Pulse Oximeter is less than ±2% SpO2 over the declared range of 70% to 100% (per ISO 80601-2-61).Reported Performance: The root-mean-square (Arms) value of the Pulse Oximeter is less than ±2% SpO2 over the declared range of 70% to 100%. Agreement between Methods of Measurement with Multiple Observations per each subject was analyzed with the Bland and Altman statistics, demonstrating the vast majority of data is within ±95% limit of agreement.
Pulse Rate (PR) Display Range	Criterion (Predicate): 25bpm~~250bpmReported Performance (Subject Device): 30bpm~~240bpm (Different from predicate, but complies with claimed display range according to bench test report).
Pulse Rate (PR) Measurement Accuracy	Criterion (Predicate): ±2bpmReported Performance (Subject Device): ±1bpm (Different from predicate, but complies with claimed measurement accuracy according to bench test report). This indicates improved accuracy compared to the predicate, which is a positive difference.
Operating Environment	Criterion (Predicate): Temperature: 5°C ~ 40°C, Humidity: 15% ~ 85%Reported Performance (Subject Device): Temperature: 5°C ~ 40°C, Humidity: 30% ~ 80% (non-condensing), Atmospheric pressure: 70kPa ~ 106kPa (Differences verified conforming to IEC 60601-1, IEC 60601-1-11, ISO 80601-2-61).
Storage & Transport Environment	Criterion (Predicate): Temperature: -20°C ~ +55°C, Humidity: 10% ~ 95%Reported Performance (Subject Device): Temperature: -20°C ~ +55°C, Humidity: 10% ~ 93% (non-condensing), Atmospheric pressure: 70kPa ~ 106kPa (Differences verified conforming to IEC 60601-1, IEC 60601-1-11, ISO 80601-2-61).
Electrical Safety	Criterion: Compliance with ANSI AAMI ES60601-1:2005/(R)2012Reported Performance: Pass
Electromagnetic Compatibility (EMC)	Criterion: Compliance with IEC 60601-1-2 Edition 4.0 2014-02Reported Performance: Pass
Home Healthcare Environment Requirements	Criterion: Compliance with IEC 60601-1-11 Edition 2.0 2015-01Reported Performance: Pass
Biocompatibility	Criterion: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10Reported Performance: Pass for all (ISO 10993-1, ISO 10993-5: Tests for in vitro cytotoxicity, ISO 10993-10: Tests for irritation and skin sensitization).
Risk Management	Criterion: Compliance with ISO 14971 Second edition 2007-03-01Reported Performance: Pass
Software Level of Concern	Criterion: FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff"Reported Performance: MODERATE level of concern; software validation documentation summarizes required information.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Testing for SpO2 Accuracy): 12 healthy adult volunteers (5 men and 7 women).
Data Points: 278 data points were sampled for analysis.
Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. in China, so it is likely from China.
- Retrospective or Prospective: The description "The clinical testing was completed..." suggests a prospective study, as it was conducted specifically to validate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable in the context of this Pulse Oximeter clinical study. The ground truth (SaO2 values) was established by a laboratory CO-oximeter measurement of arterial blood samples.
Qualifications of Experts: Not applicable, as expert consensus was not the method for ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was established by direct measurement using a CO-oximeter, not by expert review requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. This device is a Pulse Oximeter, which provides objective measurements (SpO2, PR). Its performance is evaluated against reference methods (CO-oximeter reading of blood samples) and relevant standards, not by comparing human reader performance with and without AI assistance. Therefore, an MRMC study is not relevant for this type of device.
Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Yes. The clinical study for SpO2 accuracy (comparing the device's SpO2 readings to CO-oximeter SaO2 readings) is an example of standalone performance testing. The device operates independently to provide these measurements.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for SpO2 accuracy was established by outcomes data, specifically:
- Measurement of arterial hemoglobin oxygen (SaO2) values from blood samples using a CO-oximeter. This is considered the gold standard for measuring blood oxygen saturation.

8. The Sample Size for the Training Set

Sample Size: Not applicable. Pulse Oximeters generally rely on optical principles and algorithms based on physiological models (Lambert-Beer Law) rather than machine learning models requiring extensive training data. The "algorithm" here refers to the embedded logic for calculation of SpO2 and PR, derived from established principles, not a typical AI/ML training process.

9. How the Ground Truth for the Training Set Was Established

How Established: Not applicable, as there isn't a "training set" in the sense of an AI/ML model needing to learn from labeled data. The device's underlying principles are based on known physics and physiology, and its accuracy is validated against a gold standard in clinical testing.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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, theCrossing between South Circle Road and South Fuli Road,Guangming District, 518106 Shenzhen, Guangdong, China
Contact person:	Li FengGeneral ManagerTel: +86-755-26865970E-mail: 13602607257@163.com
Prepared by:	Mr. John LiuRegulatory ManagerE-mail: liuming@zondan.com
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 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

6. Indication for Use

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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(K163135)	Remark
Device name	Pulse Oximeter	Fingertip PulseOximeter	NA
Model	A2, A3, A4, A5	A300	NA
Manufacturer	Shenzhen HexinZONDAN MedicalEquipment Co.,Ltd.	Shenzhen FitfaithTechnology Co., Ltd.	NA
Classification	Class II	Class II	SubstantiallyEquivalent.
Product code	DQA	DQA	SubstantiallyEquivalent.
Prescription orOTC	Prescription	Prescription	SubstantiallyEquivalent.
Intended use	The Pulse Oximeter isintended for measuringthe functional oxygensaturation and pulserate (PR) through apatient's finger. It isapplicable forspot-checking SpO2and pulse rate (PR) ofadult and pediatricpatients in homes andclinics.	The Fingertip PulseOximeter is intendedfor measuring thefunctional oxygensaturation and pulserate (PR) through apatient's finger. It isapplicable forspot-checking SpO2and pulse rate (PR) ofadult and pediatricpatients in homes andclinics.	SubstantiallyEquivalent.
Indications for	The Pulse Oximeter is	The Fingertip Pulse	Substantially
use	non-invasive deviceintended forspot-checking offunctional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate (PR). Theportable fingertipdevice is indicated foradult and pediatricpatients in home andhospital environments(including clinical usein internist/ surgery,anesthesia, intensivecare, etc).	Oximeter isnon-invasive deviceintended forspot-checking offunctional oxygensaturation of arterialhemoglobin (SpO2)and pulse rate (PR).The portable fingertipdevice is indicated foradult and pediatricpatients in home andhospital environments(including clinical usein internist/ surgery,anesthesia, intensivecare, etc).	Equivalent.
Design principle	A mathematical formula is established makinguse of Lambert Beer Law according to SpectrumAbsorption Characteristics of Reductivehemoglobin (RHb) and Oxyhemoglobin (HbO2)in red and near-infrared zones. Operationprinciple of the instrument: PhotoelectricOxyhemoglobin Inspection Technology isadopted in accordance with Capacity PulseScanning and Recording Technology, so that twobeams of different wavelength of lights can befocused onto a human nail tip through aclamping finger-type sensor A measured signal		SubstantiallyEquivalent.
Environment ofuse	Home and Hospital	Home and Hospital	SubstantiallyEquivalent.
Patient type	Adult and Pediatric	Adult and Pediatric	SubstantiallyEquivalent.
Intendedapplication site	Fingertip	Fingertip	SubstantiallyEquivalent.
Type, Degree ofprotectionagainst electricshock	Internally poweredequipment;Type BF applied part.	Internally poweredequipment;Type BF applied part.	SubstantiallyEquivalent.
Power supply	2*AAA 1.5V alkalinebattery	2*AAA 1.5V alkalinebattery	SubstantiallyEquivalent.
Work current	<40mA	<40mA	SubstantiallyEquivalent.
Lightspecification	Wavelength:RED: 660nm±5nm,IR: 905nm±5nm	Wavelength:RED: 660nm±3nm,IR: 905nm±5nm	SubstantiallyEquivalent.
	Maximum opticalpower:RED: 1.5mW,IR: 1.2mW	Maximum opticalpower:RED: 1.5mW,IR: 1.2mW	SubstantiallyEquivalent.
SpO2 displayrange	0%~100%	0%~100%	SubstantiallyEquivalent.
SpO2measurement	70%-100%, accuracy:±2%;<70%, no definition.	70%-100%, accuracy:±2%;<70%, no definition.	SubstantiallyEquivalent.
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:5°C ~ 40°CHumidity:30% ~ 80%(non-condensing)Atmospheric pressure:70kPa ~ 106kPa	Temperature:5°C ~ 40°CHumidity:15% ~ 85%(non-condensing)	Different Note 03
Storage & Transport environment	Temperature:-20°C ~ +55°CHumidity:10% ~ 93%(non-condensing)Atmospheric pressure:70kPa ~ 106kPa	Temperature:-20°C ~ +55°CHumidity:10% ~ 95%(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.
Contactduration	<24h	<24h	SubstantiallyEquivalent.
Contact type	Skin surface-contacting	Skinsurface-contacting	SubstantiallyEquivalent.
Biocompatibility of patientcontact parts	Comply with ISO10993-1	Comply with ISO10993-1	SubstantiallyEquivalent.

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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 AAMIES60601-1:2005/(R)2012and A1:2012	Medical electrical equipment - Part 1:General requirements for basic safety andessential performance (IEC 60601-1:2005,MOD)	Pass
IEC 60601-1-2 Edition4.0 2014-02	Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral Standard:Electromagnetic disturbances -Requirements and tests	Pass
IEC 60601-1-11 Edition2.0 2015-01	Medical electrical equipment - Part 1-11:General requirements for basic safety andessential performance - Collateral Standard:Requirements for medical electricalequipment and medical electrical systemsused in the home healthcare environment	Pass
ISO 80601-2-61 Secondedition 2017-12(Corrected version2018-02)	Medical electrical equipment - Part 2-61:Particular requirements for basic safety andessential performance of pulse oximeterequipment	Pass
ISO 10993-1 Fourthedition 2009-10-15	Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process [Including: TechnicalCorrigendum 1 (2010)]	Pass
Pulse Oximeter_Traditional 510k Submission
ISO 10993-5 Thirdedition 2009-06-01	Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity	Pass
ISO 10993-10 ThirdEdition 2010-08-01	Biological evaluation of medical devices -Part 10: Tests for irritation and skinsensitization	Pass
ISO 14971 Secondedition 2007-03-01	Medical devices - Application of riskmanagement 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..

Regulation Number and Section

§ 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).