The Quanta Pulse Oximeter , Model no. Pulse Link 1000 (or QH100) is a handheld pulse oximeter with alarm. It is intended to be used by trained healthcare professionals in hospital, hospital type facilities, as well as in the home care environment .

The Pulse Link 1000 Pulse Oximeter is indicated for non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of patients on fingers (forefinger or middle finger).

The Pulse Link 1000 Pulse Oximeter is re-useable. It is indicated for adult patients under no-motion conditions.

Device Description

The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) is a digital handheid pulse oximeter that displays numerical values for blood oxygen saturation (%SpO2) and pulse rate. It provide audible and visual alarms for both medium and high priority conditions.

The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) will typically operate for 24 hours continuously between alkaline battery replacements. The QH100 Oximeter requires no routine calibration or maintenance other than replacement of alkaline batteries and basic cleaning.

The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) 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. Oxygen saturation and pulse rate values are displayed by LCM monitor. On each detected pulse, the LED indicates the health condition of the patient. If the health condition of the patient is bad ( under some specific criteria), the LED will blink red and beeps alarm from the speaker. A sensor disconnect is also indicated by the LED blinking yellow and beeps alarm from the speaker. The remaining energy of the battery is indicated by the marked scale of the battery indicator on the LCM monitor.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. The submission is a 510(k) summary for a pulse oximeter, and it focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred regarding performance and compliance:

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

The document does not provide a table of acceptance criteria with specific numerical values for accuracy or other performance metrics. Instead, it states that the device conforms to applicable standards. The "performance" section mentions:

Acceptance Criteria (Inferred from Standards)	Reported Device Performance
Operating specifications	Conforms to ISO 9919
Safety requirements	Conforms to IEC 60601-1
EMC requirements	Conforms to IEC 60601-1-2

It is inferred that the acceptance criteria are the requirements outlined in these standards. The device's reported performance is simply that it "conforms" to these standards, implying it meets their respective requirements. Specific accuracy ranges for SpO2 or pulse rate are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given 510(k) summary. The document states "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness," indicating that some testing was done, but details regarding sample size, data provenance, or study design (retrospective/prospective) are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Given that this is a pulse oximeter and the claim is conformance to standards, the "ground truth" would typically come from reference instrumentation in a controlled environment, not expert human assessment in the way it might for imaging diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are not typically relevant for performance testing of a pulse oximeter where objective measurements against a reference are paramount.

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

An MRMC study is not applicable and was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that relies on human readers interpreting results.

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

Yes, a standalone performance assessment was done, as detailed in the "bench testing" mentioned in the conclusions. The device's performance is determined by its ability to accurately measure SpO2 and pulse rate independently. The summary states: "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This implies the device was tested to perform its intended function on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The direct ground truth used is not explicitly stated, but for a pulse oximeter conforming to ISO 9919, the ground truth for SpO2 accuracy would typically be established using invasive arterial blood gas analysis (CO-Oximetry) as a reference method in controlled desaturation studies on healthy volunteers. The ground truth for pulse rate would be a highly accurate heart rate monitor.

8. The sample size for the training set

This information is not provided. Pulse oximeters generally do not use "training sets" in the same way machine learning algorithms do. Their operation is based on established physical principles of light absorption by oxygenated and deoxygenated hemoglobin. If any calibration or algorithm tuning occurred, the data used for that is not disclosed here.

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

This information is not provided and is likely not relevant in the context of a traditional pulse oximeter device design.

Summary

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K08 3079

5 2009 MAR

Section 4【B】 510(k) Summary

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ﻨﺘ

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. Submitter's Name:	Quanta Computer Inc.
Address:	BG1 Medical Devices Department2F, No. 188, Wen Hwa 2nd Rd.,Kuei Shan Hsiang, Tao Yuan Shien 33377, TAIWAN
Phone:	+886-3-327-2345 #18029
Fax:	+886-3-327-2345
Contact:	Jason Hung / Title: Specialist 1
2. Device Name :
Trade Name:	Quanta Pulse OximeterModel no.: Pulse Link 1000 (or QH100)
Common Name:	Pulse Oximeter
Classification name	Oximeter
3. DEVICE CLASS	The Quanta Pulse Oximeter , Model no.: Pulse Link1000 (or QH100) has been classified as
	Regulatory Class: II
	Panel: Anesthesiology
	Product Code: DQA
	Regulation Number: 21CFR 870.2700
4. Predicate Device:	• Palmsat Pulse Oximeter, Model #2500A(K#050056) marketed by NONIN MEDICAL, INC..
	• OXIMAX Pulse Oximeter, Model #NPB-40(K#051352)marketed by NELLCOR PURITANBENNETT, INC.
5. Intended Use:	The Quanta Pulse Oximeter , Model no. Pulse Link 1000 (orQH100) is a handheld pulse oximeter with alarm. It isintended to be used by trained healthcare professionals inhospital, hospital type facilities, as well as in the home careenvironment.
Product: Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100)Page 1 of 3Section 4 - 510(k) SummaryREV. (B

Section 4 - 510(k) Summary

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The Pulse Link 1000 Pulse Oximeter is indicated for non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of patients on fingers (forefinger or middle finger).

The Pulse Link 1000 Pulse Oximeter is re-useable. It is indicated for adult patients under no-motion conditions.

The Quanta Pulse Oximeter , Model no.: Pulse Link Description: 1000 (or QH100) is a digital handheid pulse oximeter that displays numerical values for blood oxygen saturation (%SpO2) and pulse rate. It provide audible and visual alarms for both medium and high priority conditions.

Device

Product: Quanta Pulse Oximeter , Model no .: Pulse Link 1000 (or QH100) Page 2 of 3 Section 4 - 510(k) Summary REV. (B)

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1. Performance In terms of operating specification, Safety & EMC Summary: requirements, the device conforms to applicable standards included ISO 9919, IEC 60601-1 and IEC 60601-1-2 requirements.

8. Conclusions:

The Quanta Pulse Oximeter , Model no .: Pulse Link 1000 (or QH100) has the same intended use and similar technological characteristics as the Palmsat Pulse Oximeter, Model #2500A (K#050056) marketed by NONIN MEDICAL, INC. and OXIMAX Pulse Oximeter , Model #NPB-40 (K#051352)marketed by NELLCOR PURITAN BENNETT, INC ... Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The Quanta Pulse Oximeter , Model no .: Pulse Link 1000 (or QH100) is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Public Health Service

5 2009 MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Quanta Computer Incorporated C/o Ms. Jennifer Reich Harvest Consulting Corporation 2904 North Boldt Drive Flagstaff, Arizona 86001

K083079 Re:

Trade/Device Name: Quanta Pulse Oximeter Regulation Number: 21 CFR 880.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 25, 2009 Received: February 26, 2009

Dear Ms. Reich:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Reich

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D, Watson for
Ginette Y. Michaud, M.D.

Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_|<083079

Device Name: Quanta Pulse Oximeter , Model no. : Pulse Link 1000 (or QH100) Quanta Computer Inc. BG1 Medical Devices Department

Indications For Use:

The Pulse Link 1000 Pulse Oximeter is re-useable. It is indicated for adult patients under no-motion conditions.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use 21 CFR 807 Subpart C)

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

Concurrence of CDR/F, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K08309

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).