(68 days)
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.
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.
The provided text is a 510(k) summary for the Cardiocom Commander III, seeking to add an additional pulse oximeter (PO100) for use with the device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, much of the requested information cannot be extracted from this document, as it describes a regulatory submission focused on substantial equivalence rather than a detailed performance study with acceptance criteria.
However, based on the provided text, here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission states: "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." However, it does not specify the numerical acceptance criteria or the quantitative results of these tests for the Commander III or the PO100.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "representative samples of the device" were tested, but no details on the sample size or the nature of the data are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The submission does not detail any expert-driven ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided and is not applicable. The device described (Commander III with PO100) is a medical device for collecting and transmitting vital sign data, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not explicitly detailed in the context of specific performance metrics. The submission focuses on the Commander III's ability to "store and transmit data to remote locations" and its use with various sensors, including the new PO100 pulse oximeter. The "functional and safety testing" mentioned implies testing the device's standalone performance in accordance with industry standards, but no specific results are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. Given the nature of the device (a data collection and transmission system), ground truth would typically refer to the accuracy of the vital sign measurements provided by the connected sensors (like the pulse oximeter) compared to a gold standard, but this is not discussed in the summary.
8. The sample size for the training set
This information is not applicable/provided. The device is not an AI/machine learning algorithm requiring a "training set" in the conventional sense. Its functionality is to collect and transmit data from established medical sensors.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as point 8.
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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.
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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.
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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
§ 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).