(68 days)
No
The summary describes a data collection and transmission device, similar to a simple computer with a modem. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The submission is focused on adding a new accessory (pulse oximeter) to an existing cleared device.
No
The device collects and transmits patient data and does not provide therapy or treatment.
No
The device collects and transmits vital sign data; it does not analyze or interpret the data to diagnose a condition. It acts as a data relay.
No
The device description explicitly states it is "similar to a simple personal computer with a modem" and is cleared for use with various hardware medical devices (pulse oximeter, weight scale, glucose meter, peak flow meter, blood pressure cuff). The submission also seeks to add a new hardware pulse oximeter. This indicates it is a hardware device that interacts with other hardware devices, not a software-only device.
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 (weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient and a healthcare professional. This involves collecting data from the patient's body or from devices that measure physiological parameters, not from in vitro examination of specimens derived from the human body.
- Device Description: The description highlights its function as a data collection and transmission device, similar to a computer with a modem. It connects to various medical devices that measure vital signs.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device facilitates the transmission of data from other medical devices.
Therefore, the Commander III falls under the category of a medical device used for remote patient monitoring and data transmission, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Commander III 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA
Device Description
The Commander III is an FDA cleared device (K053303, K053304). It is similar to a simple personal computer with a modem that stores and transmits data to remote locations. The Commander III is cleared for use with a pulse oximeter, a weight scale, a glucose meter, a peak flow meter and a blood pressure cuff. This premarket submission seeks to add an additional pulse oximeter, the PO100, for use with the Commander III. The PO100 is a reusable pulse oximeter that connects to the Cardiocom Commander III via a cable in the same manner as the currently cleared pulse oximeter.
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)
Functional and Safety Testing: To verify that device design met its functional and performance requirements, representative samples of the device underwent electrical, mechanical and clinical testing in accordance with applicable industry standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1091821
Section 5-510(k) Summary
AUG 2 $ 2009 Cardiocom. LLC Submitter: 7980 Century Boulevard, Chanhassen, MN 55317 Daniel Cosentino, CEO, President, Cardiocom, LLC Contact Person: 612-669-5890(C) 888-320-8881(F) June 17, 2009 Date Prepared: Commander III Trade Name: Class II Classification: Noninvasive Blood Pressure Measurement System - 21 CFR $870.1130 Oximeter - 21 CFR §870.2700 Product Code: DXN, DQA The subject device is equivalent to the following device: Predicate Device(s): Cardiocom Commander III, K053303 The Commander III is an FDA cleared device (K053303, Device Description: K053304). It is similar to a simple personal computer with a modem that stores and transmits data to remote locations. The Commander III is cleared for use with a pulse oximeter, a weight scale, a glucose meter, a peak flow meter and a blood pressure cuff. This premarket submission seeks to add an additional pulse oximeter, the PO100, for use with the Commander III. The PO100 is a reusable pulse oximeter that connects to the Cardiocom Commander III via a cable in the same manner as the currently cleared pulse oximeter. The Commander III is for use by patients to collect and transmit Intended Use: 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. Functional and To verify that device design met its functional and performance Safety Testing: requirements, representative samples of the device underwent electrical, mechanical and clinical testing in accordance with applicable industry standards. Cardiocom considers the Commander III to be equivalent to the Conclusion: predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
1
Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 2 5 2009
Cardiocom, LLC c/o Mr. Daniel Cosentino CEO, President 7980 Century Blvd. Chanhassen, MN 55317
Re: K091821
Trade/Device Name: Commander 111, Model CD300-CD399 Regulation Number: 21 CFR 870.1130 Regulation Name: System, Measurement, Blood Pressure, Non-invasive Regulatory Class: Class II (two) Product Code: DXN, DOA Dated: July 27, 2009 Received: July 29, 2009
Dear Mr. Cosentino:
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.
2
Page 2 - Mr. Daniel Cosentino
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/CDRH0ffices/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zukkerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use Statement
Device Name: Commander III
The Commander III 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.
Prescription Use X (Part 21 CFR 801 Subpart D
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | E091821 |
Special Premarket Notification for the Cardiocom Commander III
CONFIDENTIAL