(9 days)
Not Found
Not Found
No
The summary describes a standard blood pressure monitor and lacks any mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device is designed to measure blood pressure and pulse rate, which are diagnostic or monitoring functions, not therapeutic interventions.
Yes
The device is designed to measure blood pressure (diastolic & systolic) and pulse rate, which are key vital signs used in diagnosing various medical conditions.
No
The device description is not found, but the intended use clearly describes a device that measures blood pressure and pulse rate using an arm cuff, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients. This is a physiological measurement taken directly from the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device operates by applying a cuff to the arm and measuring pressure changes, which is a direct measurement on the patient, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to measure blood pressure (diastolic & systolic) and pulse rate in adult patients with arm circumference ranging from 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).
Product codes
DXN
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text "Public Health Service" in bold, black font. The text is presented on a white background. The words are stacked on top of each other, with "Public Health" on the first line and "Service" on the second line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2001
A & D Engineering Inc. c/o Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298
Re: K010828
Trade Name: Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP Regulatory Class: II (two) Product Code: DXN Dated: March 19, 2001 Received: March 20, 2001
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the energismere to regarly maxical Device Amendments, or to devices that prior to rid) 20, 1978, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Sourisions 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Mr. Robert Mosenkis
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Hypt Rhodes
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP Digital Blood Pressure Monitors
Indications for Use:
The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to The A&D Mcdroal Dirocodice 11:2 & systolic) and pulse rate in adult patients with arm measure brood probare (shares 1 inches (13.0 cm) to 17.7 inches (45.0 cm).
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hyat Qude
Division Of Cardiovascular & Respiratory Devices
510(k) Number K010828
Prescription Use
Or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X
(Optional Format 1-2-96)