QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100

K083079 · Quanta Computer, Inc. · DQA · Mar 5, 2009 · Cardiovascular

Device Facts

• Record ID: K083079
• Device Name: QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100
• Applicant: Quanta Computer, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

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 Story

Handheld digital pulse oximeter; measures SpO2 and pulse rate via red and infrared light absorption in perfused tissue; detects pulsatile blood flow in vascular bed. Device displays numerical values on LCM monitor; provides audible/visual alarms for medium/high priority conditions and sensor disconnects. Used in hospitals, hospital-type facilities, and home care environments by trained healthcare professionals. Operates on alkaline batteries; requires no routine calibration. LED indicators signal patient health status and battery level. Benefits include continuous, non-invasive monitoring of oxygenation status to support clinical decision-making.

Clinical Evidence

Bench testing only. Device conforms to ISO 9919, IEC 60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Handheld digital pulse oximeter; red/infrared light absorption sensing principle; LCM display; battery-powered (alkaline); reusable sensor; no routine calibration required. Conforms to ISO 9919, IEC 60601-1, and IEC 60601-1-2.

Indications for Use

Indicated for non-invasive continuous monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult patients. Use restricted to no-motion conditions on fingers (forefinger or middle finger).

Regulatory Classification

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.

Predicate Devices

• Palmsat Pulse Oximeter, Model #2500A (K050056)
• OXIMAX Pulse Oximeter, Model #NPB-40 (K051352)

Submission Summary (Full Text)

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K08 3079

5 2009 MAR

# Section 4【B】 510(k) Summary

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# 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 Department<br>2F, No. 188, Wen Hwa 2nd Rd.,<br>Kuei Shan Hsiang, Tao Yuan Shien 33377, TAIWAN |
| Phone: | [phone] #18029 |
| Fax: | [phone] |
| Contact: | Jason Hung / Title: Specialist 1 |
| 2. Device Name : | |
| Trade Name: | Quanta Pulse Oximeter<br>Model no.: Pulse Link 1000 (or QH100) |
| Common Name: | Pulse Oximeter |
| Classification name | Oximeter |
| 3. DEVICE CLASS | The Quanta Pulse Oximeter , Model no.: Pulse Link<br>1000 (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<br>(K#050056) marketed by NONIN MEDICAL, INC.. |
| | • OXIMAX Pulse Oximeter, Model #NPB-40<br>(K#051352)marketed by NELLCOR PURITAN<br>BENNETT, INC. |
| 5. Intended Use: | The Quanta Pulse Oximeter , Model no. Pulse Link 1000 (or<br>QH100) is a handheld pulse oximeter with alarm. It is<br>intended to be used by trained healthcare professionals in<br>hospital, hospital type facilities, as well as in the home care<br>environment. |
| Product: Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100)<br>Page 1 of 3<br>Section 4 - 510(k) Summary<br>REV. (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.

6. Device

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.

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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- 7. 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 [phone]. 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 [phone] or [phone] 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 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.

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

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510(k) Number: K08309