NTID is a handheld vital signs monitor that continuously monitors end tidal carbon dioxide (EtCO2), respiratory rate (RR), oxygen saturation (SpO2), and pulse rate. The unit is intended for monitoring only . The unit transfers history data to PC through a USB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.

Device Description

NTID Vital Signs Monitor provides:

SpO2 monitoring
Pulse rate (PR) monitoring
End tidal carbon dioxide (EtCO2) monitoring
Respiration rate (RR) monitoring
CO2 and SpO2 waveform display
Audible and visual physiological and technical alarms
Trend graph and trend table review
Alarm event records review
History data storage
Rechargeable batteries
External power supply and charger
The monitor is intended for monitoring adult and pediatric patients in clinical environments where healthcare is provided by healthcare professionals.
The product is composed of monitor, SpO2 sensor, Mainstream/Sidestream CO2 sensor, charging base, USB Adapter and PC software.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the NT1D Vital Signs Monitor, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides specific accuracy criteria for SpO2, Pulse Rate, and EtCO2.

Parameter	Acceptance Criteria (NT1D Vital Signs Monitor)	Reported Device Performance (NT1D Vital Signs Monitor)
SpO2 Accuracy	+/- 2% (for 70-100% SpO2) (1SD)	+/- 2% (for 70-100% SpO2)
Pulse Rate	+/- 1 bpm or +/- 2% (take the larger one)	+/- 1 bpm or +/- 2% (take the larger one)
EtCO2 Accuracy	+/- 2 mmHg (0-40mmHg)	+/- 2 mmHg (0-40mmHg)
	+/- 5% of reading (41-70mmHg)	+/- 5% of reading (41-70mmHg)
	+/- 8% of reading (71-100mmHg)	+/- 8% of reading (71-100mmHg)
	+/- 10% (101-150mmHg)	+/- 10% (101-150mmHg)
Respiration Rate	+/- 1bpm	+/- 1bpm

Note: For SpO2 accuracy per decade (70-80%, 80-90%, 90-100%), the NT1D also reports +/- 2%, aligning with its overall 70-100% accuracy claim. The predicate devices did not specify accuracy in these discrete ranges.

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

SpO2 Module (Clinical Trial for T400A sensor):
- Sample Size: Ten healthy volunteers.
- Data Provenance: Prospective, from the Hypoxia Research Laboratory, University of California, San Francisco, USA.
CO2 Module: The document states that the CO2 module has already obtained 510(k) numbers (K042601 for Capnostat 5 CO2 Sensor and K053174 for LoFlo C5 CO2 Sensor). This implies that the performance of the CO2 module within the NT1D is based on the previously established performance and clearance of these predicate CO2 sensors. Therefore, a new specific clinical test set for the CO2 module with the NT1D is not detailed, as its equivalence is established through the cleared components.

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

The document describes an invasive laboratory test for SpO2 accuracy. For such tests, the "ground truth" for oxygen saturation is typically established using a co-oximeter on arterial blood samples, which is considered the gold standard.

The study was conducted in a "Hypoxia Research Laboratory."
While the document doesn't explicitly state the number or qualifications of clinicians involved in sample collection or co-oximeter operation, such laboratory tests are generally performed by trained medical and/or laboratory professionals with expertise in invasive blood gas analysis and co-oximetry, ensuring the accurate establishment of the ground truth. The mention of "co-oximeter sample value" confirms this method.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense for these types of clinical performance tests.

For the SpO2 accuracy study, the performance is assessed by comparing the device readings against the co-oximeter reference values obtained from arterial blood samples. There isn't a subjective interpretation by multiple experts that would require an adjudication method like 2+1 or 3+1. The process is a direct comparison of quantitative measurements.

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 MRMC study was done. This device is a vital signs monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data alongside an AI. The evaluation focuses on the device's accuracy in measuring physiological parameters (SpO2, PR, EtCO2, RR).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The clinical trial for the SpO2 module (with the T400A sensor) and the reliance on previously cleared CO2 modules represent standalone performance evaluations. The device's measurement outputs are directly compared to a reference standard (co-oximeter for SpO2, and the previously established accuracy of the predicate CO2 sensors). Human interaction is for device operation and data collection, not for interpretation that influences the device's core measurement output.

7. The Type of Ground Truth Used

For SpO2: Invasive laboratory testing (in vivo) using co-oximetry on arterial blood samples, which is considered the gold standard for SpO2 measurement.
For CO2: Ground truth for the CO2 sensors (Capnostat 5 and LoFlo C5) would have been established during their initial 510(k) clearances, likely through comparison to reference gas analyzers or other established methods for CO2 measurement in controlled environments.

8. The Sample Size for the Training Set

The document does not specify a training set size because this device is a vital signs monitor based on established spectrophotometry (SpO2) and infrared absorption (CO2) principles, not a machine learning or AI-driven algorithm that typically requires a large training dataset. The "training" for such devices is inherent in their physics-based design and calibration.

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

As mentioned above, there is no explicit "training set" in the context of machine learning. The device's design and calibration are based on fundamental scientific principles and established measurement techniques.
- For SpO2, the underlying principles of differential light absorption by oxyhemoglobin and deoxyhemoglobin are well-understood and form the basis of the device's algorithms. Calibration would involve using known oxygen concentrations.
- For CO2, the principle of infrared absorption by CO2 molecules is used. Calibration would involve using gas mixtures with known CO2 concentrations.

Summary

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Exhibit#3 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92

1.0 Submitter's Information

Establishment Registration Name:

NEWTECH, INC

6th Industrial Road, NO. 1 Chuangye Dasha, Building C Nanshan District, Shenzhen Guangdong, 518067, P.R.CHINA

Contact Person of applicant

Ms. Zhou yanping & Mr. Chen Siping

Certification Dept. Manager

Tel: +86-755-26525910 Fax: +86-755-2652912 Email: chensp@sznewtech.com

Contact Person of the Submission:

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd .O. Box 237-023 Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

Device Information 2.0

Type of 510(k) submission:	Traditional
Device Common Name:	Pulse Oximeter and carbon dioxide detector
Trade Name:	NT1D Vital Signs Monitor
Model:	NT1D
Classification name:	Oximeter

AUG 27 2013

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Product Code:	DQA
Secondary Product Code	CCK
Classification:	Class II
Regulation Number	21 C.F.R. 870.2700

3.0 Predicate Device Information

1. TidalWave SP pulse oximeter / carbon dioxide monitor Models 710/715 (510(k)
  No. K032971), dated 8/26,2004 .
1. SOLARIS NT1 and NT1A Handheld Pulse Oximeter with sensor accessories (510(k) No. K073249), dated 7/25,2008
1. Capnostat 5 CO2 Sensor (510(k) No. K042601), dated 11/19,2004, LoFlo C5 CO2 Sensor, (510(k) No. K053174),dated 1/12,2006

Device description 4.0

NTID Vital Signs Monitor provides:

- SpO2 monitoring
- Pulse rate (PR) monitoring
- End tidal carbon dioxide (EtCO2) monitoring
- Respiration rate (RR) monitoring
- CO2 and SpO2 waveform display
••• Audible and visual physiological and technical alarms
- Trend graph and trend table review
- Alarm event records review
- History data storage
- Rechargeable batteries
- External power supply and charger

The monitor is intended for monitoring adult and pediatric patients in clinical environments where healthcare is provided by healthcare professionals.

The product is composed of monitor, SpO2 sensor, Mainstream/Sidestream CO2 sensor, charging base, USB Adapter and PC software.

产 SpO2 theory of operation

Pulse oximetry is based on two principles: (1).The oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (i.e. Spectrophotometry), and (2). The volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (i.e. plethysmography). A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption

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during the pulsatile cycle. Red and infrared low-voltage light-emitting diodes (LEDs) in the oximetry probe serve as light sources; a photodiode serves as the photo detector.

Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation .To identify the oxygen saturation of arterial bemoglobin, the monitor uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood volume and light absorption increase.

During diastole, blood volume and light absorption reach their lowest point . The monitor bases its SpO2 measurements on the difference between maximum and minimum absorption (i.e., Measurements at systole and diastole). By doing so, it focuses on light absorption by pulsatile arterial blood, eliminating the effects of nonpulsatile absorbers such as tissue, bone, and venous blood.

The Pulse oximeter determines SpO2 and pulse rate by passing two wavelengths of light, one red and one infrared, through body tissue to a photodetector. During measurement, the signal strength resulting from each light source depends on the color and thickness of the body tissue, the probe placement, the intensity of the light sources, and the absorption of the arterial and venous blood (including the time varying effects of the pulse) in the body tissue. (Refer To Figure E3-1)

Image /page/2/Figure/5 description: This image shows a diagram of an Oxi-Pulse device. The diagram shows an LED and infrared LED light source, a detector, and a pulse bar graph. The Oxi-Pulse device measures 96% Sp02 and 72 pulse.

Figure E3-1: SpO2 Theory of Operation

The Pulse Oximeter processes these signals, separating the time invariant parameters (tissue thickness, skin color, light intensity, and venous blood) from the time variant parameters (arterial volume and SpO2) to identify the pulse rate and calculate oxygen saturation. Oxygen saturation calculations can be performed because oxygen saturated blood predictably absorbs less red light than oxygen depleted blood.

A CO2 theory of overation

CO2 monitoring is to monitor the respiration of a patient by detecting the concentration of CO2 generated during respiration. The maximum concentration of CO2 at the end of exhalation is called End-Tide CO2 (EtCO2). The minimum concentration of CO2 at the end of inspiration is called Inspiration CO2 (FiCO2). CO2 is generated by cells in the body during metabolizing, and is breathed out via breathing system. The concentration of CO2 breathed out from the lung reflects directly the situation of metabolizing and breathing system. If the concentration of CO2 is high, it means that

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metabolism is over active, such as blood poisoning or acute fever. If the concentration of CO2 is low, it is commonly due to a weak output ability of the heart, or the heartbeat stopped, or insufficient blood flow with less oxygen. Monitoring CO2 is used to warn the doctor of the abnormal breathing and metabolizing during anaesthesia.

The measurement value of CO2 is represented by a pressure level, with the unit: "mmHg" or "%". Generally, the maximum acceptable value is 38mmHg (5%) when air pressure is 760mmHg. The concentration of CO2 varies rapidly from 0% to 5%. To detect the concentration of CO2 accurately, the monitor needs to be very sensitive.

The monitor is used to measure EtCO2 and respiration rate of adult and pediatric patients.

5.0 Intended Use

NTID is a handheld vital signs monitor that continuously monitors end tidal carbon dioxide (EtCO>), respiratory rate (RR), oxvgen saturation (SpO2), and pulse rate. The unit is intended for monitoring only. The unit transfers history data to PC through a USB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.

6.0 Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent(SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards.

No	Description
1	IEC60601-1:1988+A1:1991+A2:1995Medical electrical equipment-Part1: General requirements for basic safetyand essential performance
2	IEC 60601-1-2: 2007Medical equipment-Part1-2: General requirements for safety-Collateralstandard: Electromagnetic compatibility-Requirements and tests
3	ISO 9919:2005Medical electrical equipment - Particular requirements for the basic safetyand essential performance of pulse oximeter equipment for medical use
4	ISO 21647:2004Medical electrical equipment - Particular requirements for the basic safetyand essential performance of respiratory gas monitors. (Anesthesia)
5	FCC CFR 47 Part 15 Part CRadio frequency devices

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Comparison to predicate device and conclusion 7.0

The proposed device NT1D vital signs monitor is substantially equivalent to systems marketed predicate devices. The intended use of NTID vital signs monitor is same to TidalWave SP pulse oximeter. The design, the technological characteristics and the energy source are similar to TidalWave SP pulse oximeter. The comparison of technological characteristics between the proposed device and the predicate device in following table. Then NTID has two parts, one is SpO2 part, the other is CO2 part. The SpO2 part pulse oxygen sensor has three types, that is S400A .S400P and T400A. S400A and S400P are the finger sensors of the predicate device NT1/NT1A which numbered K073249. The SpO2 accuracy of NTID is same as NT1&NTIA.The CO2 part is provided by Respironics Novametrix , which has gotten 510(k) No. The mainstream CO2 sensor is Capnostat 5 CO2 Sensor, which 510(k) No. is K042601. The sidestream CO2 sensor is LOFlo C5 CO2 Sensor, which 510(k) No. is K053174. The notable difference between the NTID and the predicate device is wireless transmission fuction. About this function, NT1D does the FCC test, and the test result is pass, which confirmed that it will no effect on performance.

Table E3-1 Comparison of the technological characteristics between the proposed device and the predicate device.

ComparisonSection	NT1D Vital Signs Monitor	TidalWave SPpulse oximeter / carbon dioxidemonitor (Models 710/715)
Manufacturer	NEWTECH, INC	Respironics Novametrix, Inc
510(k) Number	Pending	K032971
Intended Use	The Newtech NTID is a handheldvital signs monitor thatcontinuously monitors end tidalcarbon dioxide (EtCO2),respiratory rate (RR), oxygensaturation (SpO2), and pulse rate.The unit is intended formonitoring only. The unit	The intended use of the Tidal Wave SP(Models 710/715) is to provide shortterm monitoring of carbon dioxide andoxygen saturation during anesthesia /recovery, in the intensive care unit(ICU), and in Emergency Medicine/Transport or Respiratory care.Separate airway adapters are provided
transfers history data to PC for		pediatric/adult and
through a USB adapter. It is for		neonatal/pediatric use. The TidalWave
use in any environment where		SP (Models 710/715) and its airway
continuous, noninvasive		adapters and sensors are intended to
monitoring of these parameters is		be used by trained operators when
desired, including hospital and		capnographic and/or pulse oximetry
hospital-type facilities. The		monitoring is required in the
monitor is intended for use on		judgement of a physician.
adult and pediatric patients.
Range	0 ~ 100%	0 ~ 100%
Accuracy	±2% SpO2 (for 70 ~ 100%Spo2)(1SD)Unspecified for 0~69% SpO2	±2% SpO2 (for 70 ~ 100%Spo2)(1SD)Unspecified for 0~69% SpO2
Resolution	1%	1%
Audio	Pitch of pulse tone varies withSpo2 value	Pitch of pulse tone varies with Spo2value
Principle	Using the time betweensuccessive pulses	Using the time between successivepulses
Range	30~250bpm	30~250 bpm
Accuracy	±1bpm or ±2% (take the largerone)	±1% of full scale
Resolution	1bpm	1bpm
Principle	On-airway using an infraredabsorption (IR) technique	On-airway using an infraredabsorption (IR) technique
Range	0~150 mmHg	0 ~ 150 mmHg
Accuracy	±2 mmHg (0~~40mmHg)±5% of reading (41~~70mmHg)±8% of reading (71~~100mmHg)±10% (101~~150mmHg)	±2 mmHg (0~~40mmHg)±5% of reading (41~~70mmHg)±8% of reading (71~100mmHg)
Resolution	1 mmHg	1 mmHg
Range	2~150bpm	0~150bpm
Accuracy	±1bpm	±1bpm

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Newtech, Inc.
	K123797Additional Information - Exhibit#3 510(K) SUMMARY

External PowerSupply Input	100~240 VAC,50/60Hz	100~250 VAC,50/60Hz
Battery	4 AA alkaline batteries or Ni-mh batteries	Nickel-metal-hydride or Standard AA lithium

Table E3-2 Comparison of the SpO2 Accuracy per Decade

Item		NT1D vitalsigns monitorwith sensorS400A	Tidal Wave SPpulse oximeter / carbondioxide monitor(Models 710/715)	NT1/NT1A PulseOximeter withsensor S400A(cleared K073249)
SpO2Accuracy	70%-80%	$\pm$ 2%	Unspecified	Unspecified
	80%-90%	$\pm$ 2%	Unspecified	Unspecified
	90%-100%	$\pm$ 2%	Unspecified	Unspecified
	70%-100%	$\pm$ 2%	$\pm$ 2%	$\pm$ 2%
Item		NT1D vitalsigns monitorwith sensorS400P	TidalWave SPpulse oximeter / carbondioxide monitor(Models 710/715)	NT1/NT1A PulseOximeter withsensor S400P(cleared K073249)
SpO2,Accuracy	70%-80%	$\pm$ 2%	Unspecified	Unspecified
	80%-90%	$\pm$ 2%	Unspecified	Unspecified
	90%-100%	$\pm$ 2%	Unspecified	Unspecified
	70%-100%	$\pm$ 2%	$\pm$ 2%	$\pm$ 2%
Item		NT1D vitalsigns monitorwith sensorT400A	Tidal Wave SPpulse oximeter / carbondioxide monitor(Models 710/715)	NT1/NT1A PulseOximeter withsensor S400A(cleared K073249)
SpO2Accuracy	70%-80%	$\pm$ 2%	Unspecified	Unspecified
	80%-90%	$\pm$ 2%	Unspecified	Unspecified
	90%-100%	$\pm$ 2%	Unspecified	Unspecified
	70%-100%	$\pm$ 2%	$\pm$ 2%	$\pm$ 2%

Predicate devices TidalWave SP pulse oximeter / carbon dioxide monitor, and NTI/NT1A have no SpO2 Accuracy description in the discrete range of 70%-80%, 80%-90% and 90%-100%. But all the NTID SpO2 Accuracy per decade is ±2%, same as SpO2 Accuracy of 70%-100% of predicate devices. And NTID and NT1/NT1A Pulse Oximeter share two same sensors S400P and S400A. Therefore, NT1D and predicate devices are substantially equivalent.

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Clinical trial conclusion 8.0

NTID vital signs monitor has two measurement modules, which are CO2 module and SpO2 module. The CO2 module has gotten 510(k) number. Capnostat 5 CO2 Sensor numbered K042601 and LoFlo C5 CO2 Sensor numbered K053174. SpO2 model includes three types of sensors, which are S400A, S400P, T400A. S400A and S400P are the finger sensors of the predicate device NT1/NT1A which numbered K073249. And clinical trial was conducted on NTID with T400A sensor. The clinical trial was performed according to Annex EE.2 Procedure for invasive laboratory testing of ISO9919:2005 Medical electrical equipment- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for the medical use on ten healthy volunteers, in Hypoxia Research Laboratory, University of California, San Francisco.

It is notable that for the T400A-160108 sensor, over half (60%) of the individual subjects, the sensors performed with ARMS <2.0%. The sponsor notes that their sensor validation studies were intellectually honest ones that pooled the data and did not seek a rationale to exclude outlier data except where specifically warranted (such as co-oximeter sample value outside the test range). Thus the pooled results for each sensor type, which includes some excellent performance {ARMS<2.0} and some subjects with less accurate performance (ARMS>3.0%, discussed in detail as requested) nevertheless meets the stated accuracy claims.

9.0 -Conclusion:

The conclusions drawn from nonclinical test and clinical tests of the NTID Vital Signs Monitor demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the TidalWave SP pulse oximeter / carbon dioxide monitor numbered K032971, NT1/NT1A Handheld Pulse Oximeter numbered K073249, Capnostat 5 CO2 Sensor numbered K042601 and LoFlo C5 CO2 numbered K053174.

10.0 Prepared Date: August 10, 2013

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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration

Silver Spring, MD 20993-0002

10903 New Hampshire Avenue Document Control Center - WO66-G609

August 27, 2013

New Tech, Incorporated C/O Ms. Diana Hong General Manager MID-Link Consulting Company, Limited P.O. Box 237-023 Shanghai China 200237

Re: K123797

Trade/Device Name: Vital Signs Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 24, 2013 Received: July 29, 2013

Dear Ms. Hong:

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.

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Page 2 - Ms. Hong

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mary-S.Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Newtech, Inc.

Section ] 《Indications for use statement》

Indications for use statement

510(k) Number (if known): 123797

Device Name: Vital Signs Monitor Model: NTID

Indications For Use:

Prescription Use X_ (Part 21 CFR 801 Subpart D)

. ... . . . . .

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Lester W. Schultheis Jr 2013.08.27 09:26:23 -04'00'

(Division Sign-Off) (Division Sign-On)
Division of Anasthesiology, General Hospital Division Control, Dental Devices

| -1 510(k) Number_123797

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).