The Fingertip Pulse Oximeter are intended for measuring function of atterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches to 0.9 inches) and for patients during no-motion condition. The device is prescription only.

Device Description

The subject device AVITA Pulse Oximeter with Bluetooth is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for lifesustaining, not for implant and does not contain drug or biological products. The device is for prescription use. The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.

AI/ML Overview

The provided text is a 510(k) Summary for the AViTA Pulse Oximeter (SP62B). It addresses medical device regulation, but it does not describe acceptance criteria and a study that proves the device meets specific acceptance criteria in the manner requested (e.g., in the context of an AI/ML algorithm's performance).

Instead, the document details the equivalence of the new device to a predicate device based on various non-clinical performance and safety tests, and a clinical validation of SpO2 performance.

Therefore, I cannot fully answer your request based on the provided text because the information specifically about "acceptance criteria and a study that proves the device meets the acceptance criteria" for an AI/ML device's performance, including details like sample size for test sets, data provenance, expert ground truth establishment, adjudication, MRMC studies, or standalone algorithm performance, is not present.

The document mentions "acceptance criteria" generally for biocompatibility tests, electrical safety, and EMC testing, but not for an AI/ML performance study as implied by your detailed questions.

Here's what can be extracted and inferred from the text regarding the device's overall performance validation, with limitations noted:

1. A table of acceptance criteria and the reported device performance:

The document states performance specifications rather than explicit acceptance criteria in a table format for each test, but the overall statement is that the device "met the acceptance criteria" for various tests. For SpO2 accuracy, the performance is explicitly stated.

Test/Parameter	Acceptance Criteria (Implied/General)	Reported Device Performance
SpO2 Accuracy (70-100% range)	Within acceptable limits per ISO 80601-2-61 (likely ±2% or similar based on predicate)	ARMS (Accuracy Root Mean Square) = 1.89%
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ISO 80601-2-61	Complied with all listed standards
Biocompatibility	Compliance with ISO 10993-1, -5, -10, -23 and FDA Biocompatibility guidance	All tested standards met the acceptance criteria
Software V&V	Compliance with FDA Guidance for "Moderate" level of concern software	Demonstrates functional performance and compliance
Cleaning Validation	Device performance not affected after multiple cleaning procedures	Performance not affected as illustrated in user manual

2. Sample size used for the test set and the data provenance:

Test set sample size: For the clinical performance testing, it mentions "healthy, adult volunteers." The exact number (sample size) is not specified in the provided text.
Data provenance: "healthy, adult volunteers." The country of origin is not specified. The study was prospective as it involved clinical validation testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable in the context of a pulse oximeter's SpO2 accuracy against a reference measurement. Pulse oximeters are typically validated against arterial blood gas (ABG) measurements (co-oximetry) in a controlled desaturation study, where the ABG is the direct, objective ground truth. Expert readers are not usually involved in establishing ground truth for SpO2 values.
The document implies the adherence to ISO 80601-2-61 for clinical performance, which outlines the methodology for such studies.

4. Adjudication method for the test set:

Not applicable/Not specified. For SpO2 accuracy, the "ground truth" is typically the co-oximeter measurement from arterial blood, not a subjective interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI/ML device for diagnostic image interpretation. It is a pulse oximeter measuring physiological parameters.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the AI/ML sense. The device itself is "standalone" in that it directly measures SpO2 and PR; it's not an AI algorithm assisting a human interpreter.

7. The type of ground truth used:

For SpO2 accuracy, the ground truth is implied to be co-oximetry measurement from arterial blood gas (ABG), as is standard for pulse oximeter validation according to ISO 80601-2-61. The document states "Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%."

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.

9. How the ground truth for the training set was established:

Not applicable. (See point 8)

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.

February 19, 2025

AVITA Corporation Maggie Chao Adm. Manager 9F, No.78, Sec.1, Kwang Fu Road, Sanchong Dist., New Taipei City, 24158 Taiwan

Re: K242455

Trade/Device Name: AViTA Pulse Oximeter (SP62B) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: January 22, 2025 Received: January 22, 2025

Dear Maggie Chao:

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 (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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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) K242455

Device Name AVITA Pulse Oximeter (SP62B)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for AViTA. The logo features the word "AViTA" in blue, with a stylized heart shape surrounding it. The top of the heart is yellow, the bottom is red, and the right side is green. There is a registered trademark symbol to the bottom right of the heart.

AVITA CORPORATION

510(K) Submission for AViTA Pulse Oximeter

510(K) Summary

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Image /page/5/Picture/0 description: The image shows the logo for AViTA. The logo features the word "AViTA" in blue, with a stylized heart shape behind it. The heart is composed of three colored segments: yellow at the top, red at the bottom, and green on the right side. A registered trademark symbol is present near the bottom right of the heart.

APPLICANT INFORMATION 1

Applicant:	AVITA Corporation
Address:	9F, No.78, Sec.1, Kwang-Fu Rd., San-Chung District, New Taipei
	City 24158, Taiwan
Applicant Establishment Number:	9617543
Applicant Contact:	Maggie Chao
Email:	Maggie_chao@avita.com.tw
Phone Number:	+886-2-8512-1568
Fax Number:	+886-2-8512-1347
Date of Submission:	August 19, 2024

SUBJECT DEVICE 2

Trade/Proprietary Name:	AViTA Pulse Oximeter
Common Name:	Pulse Oximeter
Review Panel:	Anesthesiology
Classification Product Code:	DQA
Regulation Number:	870.2700
Device Class:	II

3 PREDICATE DEVICE

510(k) Number:	K223399
Manufacturer:	AViTA Corporation

DEVICE DESCRIPTION 4

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Image /page/6/Picture/0 description: The image shows the AViTA logo, which is a stylized heart shape with the letters "AViTA" to the left of the heart. The heart is made up of three different colors: yellow at the top, red on the left side, and green on the right side. Below the logo, the text "include alarms." is written in a simple, sans-serif font.

5 INDICATIONS FOR USE

The Fingertip Pulse Oximeter are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches) and for patients during no-motion condition. The device is prescription only.

TECHNOLOGICAL CHARACTERISTICS 6

AViTA pulse oximeters work by the principles of spectrophotometry, emitting two different wavelengths of light, typically red and infrared, through a pulsating capillary bed, such as a fingertip. The sensor on the other side of the tissue detects the light that emerges from the tissues. The intensity of red and infrared light that is transmitted through the capillary bed.

Based on the differences in absorption between oxygenated and deoxygenated blood at specific wavelengths, the device can calculate the ratio of oxygenated hemoglobin (HbO) to total hemoglobin in the blood, which is known as oxygen saturation (SpO2).

It's important to keep the finger or the measurement site stationary during the reading to avoid introducing motion artifacts that could affect the accuracy of the measurement. Additionally, it is recommended to use the pulse oximeter before or after engaging in sports activities rather than during physical exercise. Do not use for continuous monitoring.

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Image /page/7/Picture/0 description: The image shows the logo for AViTA. The logo features the word "AViTA" in blue, with a stylized heart shape surrounding it. The heart is composed of three colored sections: a yellow arc at the top, a green curve forming the right side, and a red curve at the bottom left. A registered trademark symbol is visible near the bottom right of the heart.

DEVICE COMPARISON TABLE 7

Item	Proposed Device	Predicate Device	Predicate Device
ProductName	AViTA Pulse Oximeter	AViTA Pulse Oximeter	Beijing Choice PulseOximeter
Model No.	SP62B	SP61	MD300C228
510(k) Information
RegulationNumber	870.2700	870.2700	870.2700
Classification	Class II	Class II	Class II
Product Code	DQA	DQA	DQA
K. No.	-	K223399	K232975
Indication for Use
Statement	The Fingertip Pulse Oximeterare intended for measuringfunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate for adults as non-invasive spot checking inprofessional caring environment.It is designed for fingersbetween 0.8cm and 2.3cm (0.3inches to 0.9 inches) and forpatients during no-motioncondition.	The Fingertip Pulse Oximeterare intended for measuringfunctional oxygen saturationof arterial hemoglobin (SpO2)and pulse rate for adults asnon-invasive spot checking inprofessional caringenvironment. It is designed forfingers between 0.8cm and2.3cm (0.3 inches to 0.9inches) and for patients duringno-motion condition.	The Pulse Oximeter is ahandheld non-invasive deviceintended forspot-checking of oxygensaturation of arterialhemoglobin (SpO2) andPulse Rate of adult,adolescent child and infantpatients in hospitals,hospital-type facilities andhomecare. The device can beused by the people whosefinger thickness is between8mm and 22mm (0.3 inchesto 0.9 inches).
Population	adults	adults	adult, adolescent, childand infant patients
Application site	finger	finger	finger
Performance	normal condition	normal condition	normal condition
Stand-alone ormodule	stand-alone	stand-alone	stand-alone
Single use ornot	multiple use	multiple use	multiple use
Useenvironment	professionalcaring environment	professionalcaring environment	hospitals, hospital-typefacilities and homecare
Comparison	The proposed device and the predicated device have the same intended use and classification. Allchanges in indications for use would not affect the safety andeffectiveness. The AViTA Pulse Oximeter SP62B is substantially equivalent to the predicatedevice (K223399) concerning the same intended use.
	Test Principle		Traditional 510(k)
	AViTA pulse oximeters	AViTA pulse oximeters	The pulse oximeter works by
	work by the principles of	work by the principles of	applying a sensor
	spectrophotometry, emitting	spectrophotometry, emitting	to a pulsating arteriolar
	two different wavelengths of	two different wavelengths	vascular bed. The sensor
	light, typically red and	of light, typically red and	contains a dual light
	infrared, through a pulsating	infrared, through a pulsating	source and photo detector.
	capillary bed, such as a	capillary bed, such as a	The one
	fingertip. The sensor on the	fingertip. The sensor on the	wavelength of light source is
	other side of the tissue	other side of the tissue	660nm, which is red light;
	detects the light that	detects the light that	the other is 905nm, which is
	emerges from the tissues.	emerges from the tissues.	infrared-red light.
	The device then measures	The device then measures	Skin, bone, tissue and
	the intensity of red and	the intensity of red and	venous vessels
	infrared light that is	infrared light that is	normally absorb a
	transmitted through the	transmitted through the	constant
	capillary bed.	capillary bed.	amount of light over time.
			The photo detector
	Based on the differences in	Based on the differences in	in finger sensor collects
	absorption between	absorption between	and converts the light into
Principle	oxygenated and	oxygenated and	electronic signal which is
	deoxygenated blood at	deoxygenated blood at	proportional to the light
	specific wavelengths, the	specific wavelengths, the	intensity. The arteriolar
	device can calculate the ratio	device can calculate the	bed normally pulsates and
	of oxygenated hemoglobin	ratio of oxygenated	absorbs variable amounts
	(HbO) to total hemoglobin in	hemoglobin (HbO) to total	of light during systole and
	the blood, which is known as	hemoglobin in the blood,	diastole, as blood volume
	oxygen saturation (SpO2).	which is known as oxygen	increases and decreases.
		saturation (SpO2).	The ratio of light absorbed
	It's important to keep the		at systole and diastole is
	finger or the measurement	It's important to keep the	translated
	site stationary during the	finger or the measurement	into an oxygen saturation
	reading to avoid introducing	site stationary during the	measurement. This
	motion artifacts that could	reading to avoid introducing	measurement is referred to
	affect the accuracy of the	motion artifacts that could	as SpO2.
	measurement.	affect the accuracy of the
	Additionally, it is	measurement.Page 6 of 11Additionally, it is

Image: AVITA logo	recommended to use thepulse oximeter before orafter engaging in sportsactivities rather than duringphysical exercise. Do notuse for continuousmonitoring.The proposed devices of thissubmission do not differfrom the predicate device.	recommended to use thepulse oximeter before orafter engaging in sportsactivities rather than duringphysical exercise. Do notuse for continuousmonitoring.The proposed devices of thissubmission do not differfrom the predicate device.	Traditional 510(k)
MeasurementMethod	Wavelength	Wavelength	Wavelength
Comparison	The proposed device and the predicated device have the same principle. There is noadditional question of safety and effectiveness as compared to the predicate device.AVITA Pulse Oximeter SP62B is substantially equivalent to the predicateddevice K223399) concerning the test principle.
	Energy
Type	Battery	Battery	Battery
Battery	AAA Alkaline battery x 1	AAA Alkaline battery x 1	AAA Alkaline battery x 2
Comparison	There is no additional question of safety and effectiveness as compared to the predicatedevice raised by the battery. The AVITA Pulse Oximeter SP62B is substantiallyequivalent to the predicate device (K223399) concerning the energysource.
	Operation Features
On/Off	Automatic turn on and off	Automatic turn on and off	Automatic turn on and off
Display	Two color OLED	Two color OLED	LCD
Input Key	A 4-directional key	A 4-directional key	A 2-directional key
Warning/Indicator	Visual indicator	Visual indicator	Visual indicator
Warning /IndicatorFunction	Reading starts to flash whendetects user SpO2 and Pulserate.Display shows "Finger Out"when nomeasurement detects.	Reading starts to flash whendetects user SpO2 and Pulserate.Display shows “FingerOut” when nomeasurement detects.	the device will power offautomatically in 8 secondswhen "Finger out" isdisplayed
DisplayRotation	Yes	Yes	Yes
Bluetooth	BLE 4.2	N/A	BLE 5.0
Comparison	The proposed device is configured the Bluetooth 4.2 module which predicate

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Image /page/8/Picture/0 description: The image shows the logo for AViTA. The logo has the word "AViTA" in blue font. To the right of the word is a heart shape, with the top of the heart in green, the top left in yellow, and the bottom left in red.

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Image /page/9/Picture/0 description: The image shows the logo for AVITA. The word "AVITA" is in blue, and there is a heart-shaped design to the right of the word. The heart is colored in yellow, red, and green.

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	device is configured the Bluetooth 5.0 module. The Bluetooth is the independent functionmodule, it would not affect other function module of the device. In additional 510(k)embedded software could meet the requirements of Submissions for Software Containedin Medical Devices, the related document of software could refer to Software Documentsection of this submission. Therefore, this difference does not affect substantiallyequivalence between proposed device and predicatedevice on safety and effectiveness.
General Specification
OperatingTemp	5 °C to 40 °C ( 41 °F to104 °F)	5 °C to 40 °C ( 41 °F to104 °F)	0 °C to 40 °C ( 32 °F to104 °F)
StorageTemp.	-30°C to 70 °C (-22 °F to158 °F)	-30°C to 70 °C (-22 °F to158 °F)	-25~~70°C (-13~~158 °F )
Humidity	10% - 90%(non-condensing)	10% - 90%(non-condensing)	15% to 93%, non-condensing for bothoperating and storage
AtmosphericPressure	700 hPa - 1060 hPa for bothoperating andstorage	700 hPa - 1060 hPa for bothoperating andstorage	70kPa~106kpa for bothoperating and storage
WaterResistance	IP22	IP22	IEC 60601-1-11
Comparison	There's no difference in usage life and atmospheric pressure. The AVITA Pulse OximeterSP62B is substantially equivalent to the predicate device (K223399)concerning the technological characteristics.
		Classification
Applied Part	Type BF	Type BF	Type BF
Safety	IEC 60601-1	IEC 60601-1	IEC 60601-1
EMC	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2
HarmonizedStandard	ISO 80601-2-61	ISO 80601-2-61	ISO 80601-2-61
Mode ofOperation	Spot checking	Spot checking	Spot checking
		Appearance
Weight	weight without battery:26.5g	weight without battery:25g	weight without battery:50g
Size	L68 mm x W37.8 mmxH28.5 mm	L68 mm x W37.8 mmxH27.7 mm	L58 mm x W32mm x H34mm
Comparison	The differences of general specification and appearance will not be considered as a NSEbetween the proposed device and the predicate device. The AVITA Pulse OximeterSP62B is substantially equivalent to the predicate device (K223399)concerning the general specification and appearance.Pulse Oximetry Specification

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Image /page/12/Picture/0 description: The image shows a logo for AViTA. The logo features the word "AViTA" in blue, sans-serif font. Above the "A" is a curved yellow shape, and below the "A" is a curved red shape. To the right of the word is a green heart shape, with the "R" symbol inside a circle in the bottom right corner of the heart.

		Traditional 510(k
Range	0% to 100%	0% to 100%	0% to 100%
Resolution unit	1%	1%	1%
Accuracy	70% to 100% range ± 2%,less than 70% areunspecified	70% to 100% range ± 2%,less than70% are unspecified	70% to 100% range ± 2%,less than0~69% no definition
Comparison	The AVITA Pulse OximeterSP62B is substantially equivalent to the predicatedevice (K223399) concerning the general specification and appearance.
Biocompatibility Testing
cytotoxicity	In accordance with ISO10993-1	In accordance with ISO10993-1	In accordance with ISO10993-1
skinsensitization,	In accordance with ISO10993-1	In accordance with ISO10993-1	In accordance with ISO10993-1
skin irritation	In accordance with ISO10993-1	In accordance with ISO10993-1	In accordance with ISO10993-1
Material used	Enclosure material: ABSLens: PMMAMylar: PET	Enclosure material: ABSLens: PMMAMylar: PET	Battery Cover: ABSEnclosure: ABSScreen protect Film:PMMAPower Button: ABS
Comparison	The AVITA Pulse Oximeter SP62B is substantially equivalent to the predicatedevice (K223399) concerning the general specification and appearance.
Pulse Rate Specification
Range	30 to 250 bpm	30 to 250 bpm	30 to 250 bpm
Resolution unit	1 bpm (no decimal)	1 bpm (no decimal)	1 bpm (no decimal)
Accuracy	±2 bpm or ±2%,whichever is greater	±2 bpm or ±2%,whichever is greater	30 bpm~~99 bpm, ± 2 bpm;100 bpm~~250 bpm, ± 2%
Comparison	The AVITA Pulse Oximeter SP62B is substantially equivalent to the predicatedevice (K223399) concerning the performance specification

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Image /page/13/Picture/1 description: The image shows the logo for AViTA. The logo features the text "AViTA" in a bold, sans-serif font, with the "A" and "V" in blue and the "iTA" in black. Above the text is a stylized heart shape, with the top portion in yellow, the bottom left portion in red, and the right side in green. A registered trademark symbol is located to the bottom right of the heart.

8 PERFORMANCE TESTING

The following tests were conducted to evaluate the safety and effectiveness of the subject device, and the test results indicated that the subject device is safe and effective.

8.1 Performance Data

All necessary performance testing was conducted oxygenated hemoglobin characterization testing on the subject device to support a determination of substantial equivalence to the predicate device in accordance with ISO 80601-2-61.

8.2 Electrical Safety and EMC Testing

The laboratory tests of electroal safety, electromagnetic compatibility, testing were conducted and showed that the subject device complied with IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests, IEC 60601-1-11 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical systems used in home healthcare environment, and ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

Biocompatibility testing 8.3

The biocompatibility evaluation for the subject device with surface contact and prolonged duration was in accordance with the FDA Biocompatibility guidance (Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"). The standards below are tested and met the acceptance criteria.

Biological evaluation (ISO10993-1)
Cytotoxicity (ISO10993-5)
Sensitization (ISO10993-10)
Irritation (ISO10993-23)

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Image /page/14/Picture/1 description: The image shows the logo for AViTA. The logo consists of the word "AViTA" in blue, with a stylized heart shape surrounding it. The top of the heart is yellow, the left side is red, and the right side is green. There is a registered trademark symbol in the bottom right corner of the heart.

8.4 Software Verification and Validation

Software verification and validation were provided in compliance with FDA Guidance "The Content of the Premarket Submission for Software Contained in Medical Devices". The verifications and validations demonstrate that the subject device work functionally. The software for the subject device is a "moderate" level of concern, which is identical to the predicate device. A failure or latent flaw in the software could not directly cause serious injury or death to the patient or operator, but a non-serious injury could occur. According to FDA Guidance document, the software validation documentation summarized the required for a Moderate level of concern device.

Cleaning Validation 8.5

Cleaning validation was executed in accordance with FDA Guidance "Reprocessing Medical Device in Health Care Setting: Validation Methods and Labeling" The performance of the subject device will not be affected after multiple cleaning procedures as illustrated in user manual.

Clinical Performance 8.6

Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%. The ARMS for SpO2 under no motion was found to be 1.89%. No adverse effects and complications happened during the clinical study.

9 SUBSTANTIAL EQUIVALENCE

Based upon equivalences in: intended use, patient population, conditions of use, operating principles, and the non-clinical performance data, the subject device have been shown to be safe and effective and to perform equivalently as compared to the legally marketed predicate device. Therefore, the subject devices are substantially equivalent to the legally marketed predicate device.

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).