(100 days)
Not Found
Not Found
No
The summary describes a standard blood pressure cuff and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is a blood pressure cuff, which is used for diagnostic purposes (to determine blood parameters) rather than for treating or curing a disease or condition.
Yes
The device is used "to determine blood parameters," which is a diagnostic function.
No
The device description explicitly states it is a "Disposable blood Pressure Cuff," which is a physical hardware component. The performance studies also mention testing per ISO 10993 and AAMI SP10, which are standards for physical medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters. This describes a device that interacts with the body externally to measure a physiological parameter (blood pressure), not a device that analyzes samples taken from the body (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description focuses on the cuff itself and its equivalence to other blood pressure cuffs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.
Product codes
74 DXQ
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
upper arm
Indicated Patient Age Range
neonate, pediatric and adult patients.
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
The device was tested per ISO 10993 series standards to evaluate its biocompatibility Testing Summary and AAMI SP10:2002+A1:2003+A2:2006 to evaluate its perfromance
Key Metrics
Not Found
Predicate Device(s)
Disposable Blood Pressure Cuff.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).
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7
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Premarket Notification Traditional Section 510(k) Submission . The device was tested per ISO 10993 series standards to evaluate its biocompatibility Testing Summary and AAMI SP10:2002+A1:2003+A2:2006 to evaluate its perfromance The proposed devices, Disposable blood Pressure Cuff, are claimed to be SE Conclusion Substantially Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff.
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Image /page/2/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 lines forming its body and wings. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wuxi Medical Instruments Factory c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai 200237 CHINA
JAN - 7 2011
Re: K102823
Trade/Device Name: Disposable Blood Pressure Cuff Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ Dated: September 28, 2010 Received: September 29, 2010
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 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 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. Diana Hong
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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/ucm115809.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,
S Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Traditional Section 510(k) Submission
Attachment I Indication for Use Statement
510(k) Number: K102823 Device Name: Disposable blood Pressure Cuff
- 7 2011 JAN
Indications for Use:
Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __x (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 1
W.A. West.
in-Off) ardiovascular Devices
510(k) Number K102823