K Number

Device Name

Finger Type Pulse Oximeter

Manufacturer

TAIDOC TECHNOLOGY CORPORATION

Date Cleared

2016-03-02

(321 days)

Product Code

DQA

Regulation Number

870.2700

Intended Use

The Finger Type Pulse Oximeter is indicated for use in measuring oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for patients during no-motion. The patients are limited to adults with weight above 40 kg. This device is indicated for non-invasive spot checking.

Device Description

The main function of Finger Type Pulse Oximeter is same as the predicate's to monitor the oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Except for the general feature, Finger Type Pulse Oximeter also has the wireless data transmission function which transmits the readings of SpO2 and pulse rate from the Finger Type Pulse Oximeter to the personnel device via Bluetooth pairing. The personnel device may include the smart phone, tablet PC and so on.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K110893

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard pulse oximeter with Bluetooth connectivity and does not mention any AI/ML components or capabilities.

Therapeutic

No
This device is for monitoring oxygen saturation and pulse rate (diagnostic), not for treating a condition.

Diagnostic

Yes

Explanation: The device is described as measuring "oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." These measurements provide information about a patient's physiological state, which can be used by a healthcare professional to identify or monitor a medical condition, thus qualifying it as a diagnostic device. The "Intended Use" explicitly states it's for "spot checking," which implies assessment.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "Finger Type Pulse Oximeter" and describes its function as monitoring SpO2 and pulse rate, implying a physical sensor component that attaches to the finger. The performance studies also include laboratory testing for electrical safety, electromagnetic compatibility, and shock and vibration, which are relevant to hardware components, and biocompatibility testing on the skin contacting material (silicone). While it has wireless data transmission to a personnel device, the core measurement function is performed by a physical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Finger Type Pulse Oximeter measures oxygen saturation and pulse rate non-invasively by placing the device on the finger. It does not analyze samples taken from the body.
Intended Use: The intended use describes measuring physiological parameters directly from the patient, not analyzing biological samples.

Therefore, this device falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device is indicated for non-invasive spot checking.

Product codes (comma separated list FDA assigned to the subject device)

DQA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

The clinical evaluation was conducted and the result of Finger Type Pulse Oximeter is in compliance with the criteria of ISO 9919 standard and FDA guidance - "Pulse Oximeter Premarket Notification Submissions". The functional oxygen saturation (SpO2) measurement has been validated on a total of 14 healthy adult male and female volunteers with 7 dark, 6 intermediate, and 1 light skin pigmentations in the range of 70% to 100%.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The accuracy study was performed to demonstrate the Finger Type Pulse Oximeter meet the criteria of ISO 80601-2-61:2011. The evaluation study is compliance with the standard.
The laboratory testing of electrical safety, electromagnetic compatibility, and shock and vibration meet the relevant requirements of the applicable recognized standard: IEC/EN 60601-1, IEC/EN 60601-1-2 and ISO 80601-2-61.
The software validation was performed to verify and validate the proposed device works functionally and is in compliance with FDA Guidance for the Content of the Premarket Submissions for Software Contained in Medical Devices.
The skin contacting material (silicone) included in the SpO2 probe meets the requirement of the biocompatibility standard, ISO 10993-5:2009 and ISO 10993-10:2010. The tests were performed by MedGaea Life Sciences Institute compiling with U.S. FDA (21 CFR Part 58) on principles of Good Laboratory Practice for Nonclinical Laboratory Studies. The cytotoxicity test is performed to investigate that the skin contacting material is considered non-cvtotoxicity and met the requirements of ISO 10993-5:2009. The skin contacting material revealed no evidence of causing cytotoxicity and did not induce the morphologic changes of cells.
The irritation and skin sensitization tests are executed to evaluate the possibility of local inflammation after a single topical application and the possible response of skin sensitization of skin contacting material. Both studies met the requirements of ISO 10993-10:2010 and the results indicated that the skin contacting material did not cause skin irritation and sensitization.
The clinical evaluation was conducted and the result of Finger Type Pulse Oximeter is in compliance with the criteria of ISO 9919 standard and FDA guidance - "Pulse Oximeter Premarket Notification Submissions". The functional oxygen saturation (SpO2) measurement has been validated on a total of 14 healthy adult male and female volunteers with 7 dark, 6 intermediate, and 1 light skin pigmentations in the range of 70% to 100%.
The SpO2 accuracy result include that the SpO2 value range from 70% to 79% is within 3% and the SpO2 range from 80% to 100% is within 2%. The accuracy of SpO2 to be ±3 dig % was verified over the range of 70% to 100%. The heart rate is within the acceptance criteria of ±1 dig bpm difference. And the root-mean-square (Arms) value is 2.0 with the saturations form 70% to 100%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

The SpO2 accuracy result include that the SpO2 value range from 70% to 79% is within 3% and the SpO2 range from 80% to 100% is within 2%. The accuracy of SpO2 to be ±3 dig % was verified over the range of 70% to 100%. The heart rate is within the acceptance criteria of ±1 dig bpm difference. And the root-mean-square (Arms) value is 2.0 with the saturations form 70% to 100%.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110893

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 2, 2016

TaiDoc Technology Corporation Sharon Peng Regulatory Affairs Specialist 6F, No. 127, Wugong 2nd Rd. Wugu District New Taipei City, Taiwan 24888

Re: K151024

Trade/Device Name: Finger Type Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 7, 2015 Received: February 29, 2016

Dear Sharon Peng:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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

Indications for Use

510(k) Number (if known) K151024

Device Name Finger Type Pulse Oximeter

Indications for Use (Describe)

This device is indicated for non-invasive spot checking.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

This is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is:__k151024

1. Submitter Information

Company Name:	TaiDoc Technology Corporation
Contact Person:	Sharon Peng
Title:	Regulatory Affairs Specialist
Address:	6F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City,
24888, Taiwan
Phone:	+886-2-6625-8188 # 1176
Fax:	+886-2-6625-0288
E-mail:	sharon_peng@taidoc.com.tw
Prepared Date:	March 2, 2016

2. Device name:

Proprietary Name:	Finger Type Pulse Oximeter
Common Name:	Pulse Oximeter
Product Code:	DQA
Classification Panel:	Anesthesiology
Classification:	Class II
Regulation Citation:	21 CFR §870.2700, Oximeter

3. Primary Predicate Device

Proprietary Name:	VTRUST Finger Type Pulse Oximeter
510(k) Number:	K110893

4. Intended Use

The Finger Type Pulse Oximeter is indicated for use in measuring oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for patients during no-motion condition. The patients are limited to adults with weight above 40 kg.

TaiDoc Tech. Corp.	CONFIDENTIAL	C1 - 1 of 6
--------------------	--------------	-------------

This device is indicated for non-invasive spot checking.

5. Device Description:

6. Test Principle:

The Finger Type Pulse Oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate.

7. Substantial Equivalence Information:

Predicate device name:	VTRUST Finger Type Pulse Oximeter
Predicate K number:	K110893

The modified Finger Type Pulse Oximeter have the following Comparison with similarities to the predicate device: predicated device:

same operating principle .
same fundamental scientific technology .
. same intended use

The modified Finger Type Pulse Oximeter encompass the following modification to the predicate device:

. accuracy
operating and storage specification .
. physical appearance
. data transmission function
software .
water resistance level .

Item	Predicate device	Proposed device
Product Name	VTRUST Finger Type Pulse	Finger Type Pulse Oximeter
	Oximeter (K110893)
	Similarity
Detection method	Spectrophotometry	Spectrophotometry
Power source	Two AAA alkaline batteries	Two AAA alkaline batteries
Detection mode	Spot checking	Spot checking
Range of oximetry	0% to 100%	0% to 100%
Resolution of	1%	1%
oximetry
Method	Dual wavelength LED	Dual wavelength LED
Measurement	30 to 250 beats per minutes (bpm)	30 to 250 beats per minutes (bpm)
Range of pulse rate
Resolution of pulse	1 bpm	1 bpm
rate
Accuracy of pulse	±1bpm or ±1%, whichever is greater	±1 bpm or ±1% whichever is greater
rate
Type	LCD Display with white backlight	LCD Display with white backlight
Parameters	SpO2; pulse rate; pulse bar	SpO2; pulse rate; pulse bar
Status	Indicate a stable reading is taken;	Indicate a stable reading is taken;
	Battery status indication	Battery status indication
Memory	None	None
Power button	Yes	Yes
SpO2 % display	Yes	Yes
Pulse amplitude	Yes	Yes
indicator
Pulse rate display	Yes	Yes
Low battery	Yes	Yes
indicator
Sensor error	Yes	Yes
indicator
Display	LCD	LCD

A comparison table that described similarities and modifications is briefly provided below:

CONFIDENTIAL

Modification
Accuracy of
oximetry	70% to 100%: ± 2%