(195 days)
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.
Not Found
The provided document is limited to the FDA 510(k) clearance letter and Indications for Use statements for three pulse oximeters (AB-F1, AH-S1, and AH-M1). It confirms that the devices are substantially equivalent to previously marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria or the specifics of a study proving device performance against those criteria. This type of detailed study information (performance data, sample sizes, ground truth establishment, expert qualifications, etc.) is typically found in the 510(k) submission's safety and effectiveness section, which is not part of this publicly available clearance letter.
Therefore, I cannot extract the requested information from the provided text. I can only confirm that:
- Device Names: Finger Type Pulse Oximeter, AB-F1; Handheld Pulse Oximeter, AH-S1; Handheld Pulse Oximeter, AH-M1
- Intended Use: Spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities and home care environment.
- Patient Population: AB-F1 for adult patients. AH-S1 and AH-M1 for adult, pediatric, and neonatal patients.
- Regulatory Status: Substantially equivalent (510(k) K111617) to a predicate device.
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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.
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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
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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:
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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:
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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
§ 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).