(195 days)
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No
The provided text describes standard pulse oximeters and does not mention any AI or ML capabilities, image processing, or details about training/test sets which are common indicators of AI/ML in medical devices.
No
The device is a pulse oximeter intended for "spot checking of functional arterial oxygen saturation (SpO2) and pulse rate," which are diagnostic or monitoring functions, not therapeutic ones.
Yes
Explanation: The device is a pulse oximeter, which measures functional arterial oxygen saturation (SpO2) and pulse rate. These measurements provide information about the patient's physiological state, which can be used to identify or monitor medical conditions, making it a diagnostic device.
No
The device description is not found, but the intended use describes "Finger Type Pulse Oximeter" and "Handheld Pulse Oximeter," which are hardware devices. There is no mention of software as the primary component.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use of these pulse oximeters is to measure functional arterial oxygen saturation (SpO2) and pulse rate directly from the patient's finger or body. This is a non-invasive measurement of physiological parameters, not an analysis of a biological sample.
- The description focuses on measuring physiological signals. The devices are described as pulse oximeters, which work by shining light through tissue and measuring the absorption to determine oxygen saturation. This is a physical measurement, not a chemical or biological analysis of a sample.
Therefore, these devices fall under the category of medical devices that measure physiological parameters, but they are not IVDs.
N/A
Intended Use / Indications for Use
Finger Type Pulse Oximeter, AB-F1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult patients use.
Handheld Pulse Oximeter, AH-S1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.
Handheld Pulse Oximeter, AH-M1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.
Product codes
DQA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult patients (for AB-F1)
Adult, pediatric and neonatal patients (for AH-S1 and AH-M1)
Intended User / Care Setting
hospital type facilities as well as in the home care environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Acare Technology Company, Limited C/O Ms. Diana Hong General Manager MID-Link Consulting Company, Limited P.O. Box 237-023 Shanghai China 200237
DEC 2 2 2011
Re: K111617
Trade/Device Name: Finger Type Pulse Oximeter, AB-F1, Handheld Pulse Oximeter, AH-S1 and Handheld Pulse Oximeter, AH-M1 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 30, 2011 Received: December 12, 2011
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 approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirements for annual regionatemisbranding 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 (1 vir 1) with of ound 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.
1
Page 2 - Ms. Hong
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be act rood a determination that your device complies with other requirements mean that I Dr mas made statutes and regulations administered by other Federal agencies. Of the For of 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 (reporting of increated as set forth in the quality systems (QS) regulation (21 CFR Part 820); procetee requirements 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Exhibit#2 Indications for Use Statement
510(k) Number: K111617 Device Name: Finger Type Pulse Oximeter, AB-F 1
Indications for Use:
Finger Type Pulse Oximeter, AB-F1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult patients use.
XPRESCRIPTION USE (Part 21 CFR 801 Subpart D) JOVER-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)
Page 1 of 3
L. Schulthe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
WILL be 510(k) Number:
3
Indications for Use Statement
510(k) Number: K111617 Device Name: Handheld Pulse Oximeter, AH-S1
Indications for Use:
Handheld Pulse Oximeter, AH-S1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.
XPRESCRIPTION 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 ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 3
L Schulte
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
4 111 617 510(k) Number:
4
Indications for Use Statement
510(k) Number: K111617 Device Name: Handheld Pulse Oximeter, AH-M1
Indications for Use:
Handheld Pulse Oximeter, AH-M1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.
ZPRESCRIPTION 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 ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 3 of 3
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: ull 617