(181 days)
No
The document describes a standard automated blood pressure monitor using the oscillometric method, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No.
The device's intended use explicitly states it is for measurement only and does not perform any diagnoses or provide therapeutic intervention. It merely furnishes data for users to consult their personal physicians.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not a diagnostic device".
No
The device description explicitly states it consists of a fixed cuff and measures blood pressure using the oscillometric method, indicating it includes hardware components beyond just software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use explicitly states: "It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians." and "The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician."
- Device Description: Describes a device that measures blood pressure and pulse rate using a physical cuff and the oscillometric method. This is a physiological measurement, not an in vitro test.
- 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 does not involve any such samples.
The Lifeclinic 2400 and LC500 are devices for measuring physiological parameters (blood pressure and pulse rate) directly from the body, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Lifeclinic 2400 is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.
The Lifeclinic LC500 is indicated for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician.
Product codes
74JOE, DXN
Device Description
The Lifeclinic 2400 is an automated system for measuring blood pressure and pulse rate designed to be used by the general public in stores and other places. It is completely automatic, and measures blood pressure by the oscillometric method. The user is guided by a series of interactive screens and voice instructions.
The Lifeclinic 2400 consists of a fixed cuff into which the user inserts an arm. The cuff automatically inflates and then deflates after the user presses a button. The device measures blood pressure using the oscillometric method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General public in stores and other places.
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)
(1) Non-clinical tests
The unit meets all required AAMI tests for such devices.
(2) Clinical tests
Not required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K850893, "BP/Clinic"
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
AUG 3 1 2004
K040562/Si
Page A 2 page 1 of 2
HealthGuard International Inc. Special 510(k) Model 2400 Automatic Blood Pressure Measurement System 510(K) Summary
December 11, 2003
(1) Submitter Information
Name: HealthGuard International Inc..
Address: 255 North Washhington St. Rockville, MD 20850
Telephone Number: 301-279-7300
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703
Date Prepared: February 20, 2004
(2) Name of Device:
Trade Name: Lifeclinic 2400 Common Name: Automated Blood Pressure Monitor. Classification Name: System, measurement, blood pressure, non-invasive, systolic and/or diastolic, 74JOE, 870.1130
(3) Equivalent legally-marketed devices:
K850893, "BP/Clinic"
(4) Description
The Lifeclinic 2400 is an automated system for measuring blood pressure and pulse rate designed to be used by the general public in stores and other places. It is completely automatic, and measures blood pressure by the oscillometric method. The user is guided by a series of interactive screens and voice instructions.
(5) Intended Use
The Lifeclinic 2400 is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.
1
(6) Technological characteristics
The Lifeclinic 2400 consists of a fixed cuff into which the user inserts an arm. The cuff automatically inflates and then deflates after the user presses a button. The device measures blood pressure using the oscillometric method.
(b) Performance data
(1) Non-clinical tests
The unit meets all required AAMI tests for such devices.
(2) Clinical tests
Not required
(3) Conclusions
The Lifeclinic 2400 is equivalent in safety and efficacy to the legally marketed predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Lifeclinic International, Inc. c/o Mr. George H. Myers Medsys, Inc. 377 Route 17 S. Hasbrouck Heights, NJ 07604
Re: K040562 Trade Name: Lifeclinic LC500 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 19, 2004 Received: August 20, 2004
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premained instantially equivalent (for the indications referenced above and nave determined the devices marketed in interstate for use stated in the encrosule) manetoo people the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Foders' Food. Drug commerce prior to May 28, 1776, the enaominen with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provision of the Unite devices that have been iccassified in accessaries with of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the A and Cosment Act (Act) that do not require approvide of the general controls provisions of the Act. The You may, therefore, market me devreet, boojer to the more
general controls provisions of the Act include requirements for annual registration, listing of the general controls provisions of the Field of the rise of the magainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo existing major regulations affecting your device can
may be subject to such additional controls. Existing major and condition ED may be subject to such adultional controlls. Extoung and on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Peacharting your device in the Federal Register.
3
Page 2 – Mr. George H. Myers
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substitive with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decemmanon that your about were Federal agencies. You must or any Federal statutes and regulations daministered of registration and listing (21
comply with all the Act's requirements, including, but not limited to: registration and l comply with an the Act s requirements, merces with the practice requirements as set CFR Part 807), labeling (21 CFR Part 820); good and frapplicable, the electronic forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1 product radiation control provisions (Decicens of Persons of Person Survice as described in Jour Section 5 10(k) I his letter will anow you to begin marketing your avoire of your device to a legally premarket nothication. The PDA miding of backanna virus, permits your device to proceed to the market.
If you desire specific advice for your device on our lated it (21 CFR Part 801), please
s the received in the same of the same of the recults to recults to recultive antitled If you desire specific advice for your do not on our and a more one one the regulation entitled, contact the Office of Comphalled at (501) 991 16 16 (1CFR Part 807.97). You may obtain "Misolanding by reference to premantevisibilities under the Act from the Division of Small other general information on your responsion.com and its toll-free number (800) 638-2041 or Manufacturers, International and Gozess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R. Ogden
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Lifectinic 500 K040562 Added Information
Page 10
Page _________________________________________________________________________________________________________________________________________________________________________
K040562 510(k) Number (if known):__
Device Name: Lifeclinic LC500
Indications for Use:
The Lifeclinic LC500 is indicated for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician.
Prescription Use (Pcr 21 CFR 810.109)
OR
Over-the-Counter Use
(Per 21 CFR 810.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RX
(Division Sign-Off)
Cardiovascular Devices
C
510(k) Number. K040562