(32 days)
No
The description focuses on data collection and transmission, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device functions as a data collection and transmission tool for health information and vital signs, but it does not directly provide therapy or treatment to the patient. It facilitates communication between the patient and a healthcare professional, who would then determine and administer any necessary therapy.
No
The device collects and transmits data and asks health-related questions, but it does not interpret or diagnose based on the data. It acts as a data collection and transmission hub, not a diagnostic tool. The description explicitly states it collects and transmits data "between the patient ... and a health care professional at a remote site," implying that the professional, not the device, performs any diagnostic interpretation.
No
The device description explicitly states it is a personal computer with a modem, a display, an integrated blood pressure meter, and inputs for other physical medical devices, indicating it is a hardware device with software functionality.
Based on the provided information, the Commander III device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect and transmit general health questions and patient vital sign data. This data is collected from the patient's body (e.g., blood pressure, weight, glucose from a glucometer, pulse oximetry, peak flow).
- Device Description: The device acts as a data collection and transmission hub. While it integrates a blood pressure meter and connects to other devices that measure physiological parameters (glucometer, pulse oximeter, etc.), it does not perform any tests on samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analysis of biological samples, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Commander III focuses on collecting and transmitting in vivo (within the living body) measurements and patient-reported information.
N/A
Intended Use / Indications for Use
The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Contraindications, Precautions and Warnings: The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.
Product codes
DXN
Device Description
Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commender III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It contains an integrated blood pressure meter. It also has inputs for devices such as weight scales, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.
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
Home users and health care professionals; Home: Clinic or remote site
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)
The results of bench, laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
DEC 3 0 2005
EXHIBIT 2
510K Summary Cardiocom 1260 Park Road Chanhassen, MN 55317 Toll-Free: 888-243-8881 Tel: 952-474-4149 Fax: 952-474-4372 Contact: Daniel Cosentino, President Date: November 19, 2005
- 【. Identification of the device Proprietary-Trade Name: Cardiocom Commander III Non-Invasive Automated Blood Pressure Monitor Classification Name: DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, Common/Usual Name: Noninvasive Blood Pressure Measurement System
- Equivalent legally marketed devices 2. This product is similar in function and design to predicate K043096 Cardiocom LLC Commander II.
- Indications for Use (intended use). The Commander III device is for use by patients to 3. collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site. Contraindications, Precautions and Warmings: The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care
- Description of the Device. Commander III is similar to a simple personal computer with a 4. modem that stores and transmits data. Commender III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It contains an integrated blood pressure meter. It also has inputs for devices such as weight scales, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.
-
- Safety and Effectiveness, comparison to predicate device The results of bench, laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate device.
-
- Comparison Table
1
| Comparison
matrix - new
vs. Predicate
device
Characteristic | K043096 Cardiocom LLC
Predicate Device | Submission Device |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
Principle | Oscillometric automated blood
pressure monitoring | SAME |
| Product Name | Commander II | Commander III |
| Classification
Name | Noninvasive blood pressure
measurement system | Noninvasive blood pressure
measurement system |
| Description | The Commander II is an automated
device that connects to the user's
telephone system at home. It has a
display that asks the user health
related questions and has inputs for
devices such as weight scales,
blood pressure meters, and other
vital sign measurement devices. | The Commander III is an
automated device that connects
to the user's telephone system at
home. It has a display that asks
the user health related questions
and has inputs for devices such
as weight scales, Glucometers,
and other vital sign measurement
devices. The Commander III has
a built in NIBP meter. |
| Intended Use | The Commander II device is for
use by patients to collect and
transmit general health questions
and patient vital sign data (such as
weight, blood pressure, glucose,
pulse oximetry, peak flow)
between the patient, typically at
home, and a health care
professional at a remote site. | The Commander III device is for
use by patients to collect and
transmit general health questions
and patient vital sign data (such
as weight, blood pressure,
glucose, pulse oximetry, peak
flow) between the patient,
typically at home, and a health
care professional at a remote
site. |
| Blood Pressure
Meter | A&D Medical UA-767PC Blood
Pressure Monitor for
Telemonitoring | BUILT IN Blood Pressure Meter
designed by Cardiocom. |
| Transmission | Telephone line | Telephone line |
| Intended Users | Home users and health care
professionals | Home users and health care
professionals |
| Site of Use | Home: Clinic or remote site | Home: Clinic or remote site |
| Measurements | - Blood pressure
- Pulse oximeter
- Peak flow meter
- Glucose
- Weight | - Blood pressure
- Pulse oximeter
- Peak flow meter
- Glucose
- Weight |
| Software | Embedded Firmware and
Patient database | embedded Firmware and
Patient database |
| Case | Plastic Wedge shape | Plastic Wedge shape |
| User interface | Keypad overlay with YES, NO up | Keypad overlay with YES, NO up |
| Comparison
matrix - new
vs. Predicate
device
Characteristic | K043096 Cardiocom LLC
Predicate Device | Submission Device |
| | arrow and down arrow | up arrow , down arrow, and
selection buttons |
| Communication | Multiple serial RS-232 ports and
telephone modem Part 68
approved | Multiple serial RS-232 ports and
telephone modem Part 68
approved |
| Power supply | External AC to DC supply | External AC to DC supply |
| Electrical
Safety | UL/IEC 60601-1 | UL/IEC 60601-1 |
| Electromagnetic
compatibility | IEC 60601-1-2 | IEC 60601-1-2 |
..
.
2
7. Conclusion
After analyzing bench, test laboratory, and clinical testing data, it is the conclusion of Cardiocom that the Cardiocom Commander III is as safe and effective as the predicate device, has essentially no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2005
Cardiocom LLC c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K053303
Trade Name: Cardiocom Commander III Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 12, 2005 Received: December 13, 2005
Dear Mr. Job:
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 such 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.
4
Page 2 - Mr. Mark Job
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); 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, This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhummer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known) _________________
Device Name: Cardiocom Commander III
Indications For Use:
The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Contraindications, Precautions and Warnings:
The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Zimmerman
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K05 330 3
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