(140 days)
K#050056, K#051352
K#050056,K#051352
No
The description details standard pulse oximetry technology based on light absorption and pulse detection, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is described as a pulse oximeter for monitoring oxygen saturation and pulse rate, which are diagnostic/monitoring functions, not therapeutic. It does not provide any treatment or therapy.
Yes
Explanation: The device is intended for "non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate," which are diagnostic measurements used by healthcare professionals to assess a patient's condition.
No
The device description explicitly details hardware components such as a handheld unit, LCM monitor, LED, speaker, and reliance on alkaline batteries, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This device measures physiological parameters (oxygen saturation and pulse rate) directly from the patient's finger using light absorption. It does not involve the analysis of blood, urine, tissue, or any other sample removed from the body.
- The intended use describes direct patient monitoring. The device is used for "non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of patients on fingers". This is a direct physiological measurement, not an in vitro test.
Therefore, the Quanta Pulse Oximeter, Model no. Pulse Link 1000 (or QH100), is a medical device but not an IVD.
N/A
Intended Use / 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.
Product codes
DQA
Device Description
The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) is a digital handheld 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingers (forefinger or middle finger)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Trained healthcare professionals in hospital, hospital type facilities, as well as in the home care environment.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#050056, K#051352
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K08 3079
5 2009 MAR
Section 4【B】 510(k) Summary
1
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 Department |
| 2F, 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 Oximeter |
| 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 |
| 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 |
| (K#050056) marketed by NONIN MEDICAL, INC.. | |
| • OXIMAX Pulse Oximeter, Model #NPB-40 | |
| (K#051352)marketed by NELLCOR PURITAN | |
| BENNETT, INC. | |
| 5. 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. | |
| Product: Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) | |
| Page 1 of 3 | |
| Section 4 - 510(k) Summary | |
| REV. (B |
Section 4 - 510(k) Summary
2
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
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)
3
-
- 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.
4
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.
5
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
6
Indications for Use
510(k) Number (if known):_|