(32 days)
No
The description explicitly states the device makes no interpretation, evaluation, medical judgments or recommendations, and functions as a data collection and transmission tool. There is no mention of AI/ML terms or functionalities.
No
The device collects and transmits data but explicitly states that it "makes no interpretation, evaluation, medical judgments or recommendations for treatment" and "is not intended as a substitute for medical care," indicating it does not provide therapy.
No
The device collects and transmits vital sign data and responses to health questions but explicitly states it makes "no interpretation, evaluation, medical judgments or recommendations for treatment." Its function is data collection and transmission, not diagnosis. Clinical judgment is required to interpret the information transmitted.
No
The device description explicitly states it is a "simple personal computer with a modem" and has physical inputs for connecting to other medical devices, indicating it is a hardware device with software functionality, not a software-only device.
Based on the provided information, the Commander III device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The Commander III collects and transmits data from external devices (weight scales, blood pressure meters, etc.) and patient responses to questions. It does not analyze biological samples like blood, urine, or tissue.
- The device description focuses on data collection and transmission. It explicitly states that the functionality of the connected devices (which might be IVDs themselves, like a glucometer) has not been modified. The Commander III acts as a data hub and communication tool.
- The intended use is for collecting and transmitting general health questions and vital sign data. This is a data management and communication function, not a diagnostic test performed on a biological specimen.
- The contraindications and warnings emphasize that the device makes no interpretation or medical judgments. This further reinforces that it's not performing a diagnostic analysis.
Therefore, the Commander III falls outside the definition of an In Vitro Diagnostic device.
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. Commander III connects to a user's telephonel winn 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 also has inputs for devices such as weight scales, blood pressure meters, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices 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
patients, typically at home, and a health care professional at a 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)
K982481 A&D Medical UA-767PC Digital Blood Pressure Monitor
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
- 1 . 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 This product is similar in function and design to predicate K982481 A&D Medical UA-767PC Digital Blood Pressure Monitor
-
- Indications for Use (intended 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 cars in o
-
- Description of the Device. Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commander III connects to a user's telephonel winn 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 also has inputs for devices such as weight scales, blood pressure meters, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices not been modified; they are used as supplied from the manufacturer.
న్. 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.
1
| Designation | K982481 A&D Medical UA-767PC
Digital Blood Pressure Monitor | Commander III |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | Oscillometric automated blood pressure
monitoring | SAME |
| Indications | The UA-767PC is designed to be used by end
users who are eighteen (18) years and older at
home and doctor/nurse office to monitor their
blood pressure (systolic and diastolic) and pulse
rate. At the end of each measurement, the
results will be stored in the UA-767PC
memory. UA-767PC through its
communications port can also transfer the
measurements stored in memory to other
electronic devices, such as a PC, a modem, or a
printer. | 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 |
| Display | LCD: Systolic, Diastolic, Pulse | SAME |
| Controls | Start, pressure select | Yes, No, Up-arrow, Down-arrow, Four
"selection buttons" |
| Power supply | 4-A A alkaline batteries | AC Adapter only |
| External dimensions | 2.7" tall 4.4" deep 6.5" wide | 2.7" tall 6.8" deep 8.9" wide |
| Memory | 126 measurements | 200 measurements. Last measurement is
sent over the phone line. |
| Weight | 0.32 kg without batteries | 0.8kg without Blood Pressure cuff |
| Cuff Arm
Circumference Range | 5.1 inches -17.7 inches (small, medium, large
cuff sizes) | 7 inches-16.5 inches (small, medium, large
cuff sizes) |
| OTC or prescription | OTC | Prescription |
| Standard | ANSI/AAMI SP10: 1992+A1 | SAME |
| Electrical Safety | UL/IEC 60601-1 | UL/IEC 60601-1 |
| Electromagnetic
compatibility | IEC 60601-1-2 | IEC 60601-1-2 |
| Patient Contact
Materials | Nylon Cuff | SAME |
| Designation | K982481 A&D Medical UA-767PC
Digital Blood Pressure Monitor | Commander III |
| Description | This home blood pressure monitor
communicates with your information hub
through a serial communication cable and port.
Real-time communication is achieved by sending
the blood pressure measurement to the
information hub immediately. The UA-767PC
can also operate in a batch-mode to send up to
126 measurements with time and date in a single
request command. System integrators can
provide units to remotely located patients
enabling them to monitor their blood pressure at
home. Combine this blood pressure monitor and
the LifeSource™ UC-321 personal scale and you
have a foundation for a complete telemonitoring
system. | The Commander III device is for use by
patients to collect and transmit general
health questions and the following patient
vital signs data: Non-invasive blood
pressure measurement, Non-invasive blood
oxygen saturation measurement using pulse
oximetry, In vitro diagnostic quantitative
measurement of glucose in fresh capillary
whole blood, Non-invasive measurement of
lung peak flow, and Patient weight using a
stand-on electronic scale. The results of
these measurements are transmitted to a
computer monitoring station in a clinical
setting via common telephone lines from
the patient's home setting. For sale by or on
the order of a physician. |
| Communication
capability | Serial RS-232 with PC | Multiple serial RS-232 ports and telephone
modem Part 68 approved |
| Measurement Range | Pressure: 20 mmHg to 280 mmHg; Pulse: 40 to
200 pulses/minute | SAME (from AAMI) |
| Accuracy | Pressure: ±3 mmHg or ±2%, whichever is
greater; Pulse: ±5% | SAME (from AAMI) |
| Pressurization | Automatic, using micropump | Automatic |
| Operating Environment | 50° - 104° F (10° to 40° C) | SAME (from AAMI) |
Electronic printed circuit boards inside an ABS
enclosure
Comparison matrix – new vs. Predicate device 6.
Construction
Electronic printed circuit boards inside an
A BS enclosure
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol.
DEC 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiocom LLC c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K053304
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.
Bhimmar 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 × (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. L. Zimmerman
Division Supt. O.S.
Division of Cardiovascular Devices
510(k) Number K053304
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