(32 days)
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.
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.
Here's the analysis of the provided text regarding the Cardiocom Commander III device, focusing on its acceptance criteria and the study used to prove it meets them:
Disclaimer: The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It is not generally a detailed clinical study report and thus may not contain all the specific metrics and methodologies typically found in such a report. Many of the requested details (like specific statistical measures for performance, sample sizes for training data, expert qualifications, etc.) are not explicitly stated in this type of regulatory submission and would be found in the actual studies conducted by the manufacturer, which are summarized or referenced here.
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Cardiocom Commander III does not define explicit, quantitative acceptance criteria for its performance. Instead, the core of this submission is a demonstration of substantial equivalence to a predicate device (Cardiocom LLC Commander II). This means the acceptance criterion is implicitly that the new device is "as safe and effective" as the predicate device.
The reported device performance, in this context, is that the new device maintains the same functionalities and performance characteristics as the predicate, especially regarding its core function of oscillometric automated blood pressure monitoring.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Safety and Effectiveness (as safe and effective as the predicate device) | The results of bench, laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate device. |
| Operating Principle (same as predicate) | Oscillometric automated blood pressure monitoring (SAME as predicate) |
| Intended Use (same as predicate) | For use by patients to collect and transmit general health questions and patient vital sign data (weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site. (SAME as predicate) |
| Measurements (capable of measuring same vital signs as predicate) | Blood pressure, Pulse oximeter, Peak flow meter, Glucose, Weight (SAME as predicate) |
| Electrical Safety (compliance with same standards as predicate) | UL/IEC 60601-1 (SAME as predicate) |
| Electromagnetic Compatibility (compliance with same standards as predicate) | IEC 60601-1-2 (SAME as predicate) |
| No significant technological differences leading to new safety/effectiveness concerns (Implicit) | Built-in NIBP meter (compared to external A&D Medical UA-767PC), and minor interface changes with selection buttons. The submission asserts these changes do not introduce new safety or effectiveness issues. |
Study Details
The submission refers to "bench, laboratory, and clinical testing data" to support its claim of substantial equivalence. However, the details of these studies are very brief, which is typical for a 510(k) summary.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document simply mentions "clinical testing data."
- Data Provenance: Not specified (e.g., country of origin). The document does not indicate if the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not mentioned.
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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 is not applicable to this device. The Cardiocom Commander III is a non-invasive automated blood pressure monitor and a data collection/transmission system. It does not involve human "readers" interpreting medical images or data in a way that an AI would assist.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, for the blood pressure measurement component, the device would have undergone standalone performance testing against reference standards, as required for blood pressure devices. The submission states, "The Commander III has a built in NIBP meter," and this component's accuracy would have been validated. However, the specific results of this standalone performance (e.g., mean difference, standard deviation compared to a reference sphygmomanometer as per ISO standards) are not provided in this summary. The summary broadly states "bench, laboratory, and clinical testing data."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the blood pressure meter component, the ground truth would typically be a simultaneous measurement by a trained observer using a calibrated mercury sphygmomanometer or an equivalent reference standard, adhering to recognized protocols for blood pressure device validation (e.g., ANSI/AAMI/ISO 81060-2). For the other vital sign inputs (glucometers, pulse oximeters, peak flow meters), the ground truth would be established by the respective reference devices' measurements, as the Commander III acts as a data collector and transmitter for these, not the primary measurement device (except for the built-in NIBP).
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The sample size for the training set:
- Not applicable/Not mentioned. This device does not appear to employ a machine learning or AI model that requires a "training set" in the conventional sense of AI algorithms that learn from data. It's a hardware device with embedded firmware for data collection and transmission.
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How the ground truth for the training set was established:
- Not applicable. As above, there's no indication of a machine learning "training set" being used for this device.
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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.
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- 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.
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- Comparison Table
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| Comparisonmatrix - newvs. PredicatedeviceCharacteristic | K043096 Cardiocom LLCPredicate Device | Submission Device |
|---|---|---|
| OperatingPrinciple | Oscillometric automated bloodpressure monitoring | SAME |
| Product Name | Commander II | Commander III |
| ClassificationName | Noninvasive blood pressuremeasurement system | Noninvasive blood pressuremeasurement system |
| Description | The Commander II is an automateddevice that connects to the user'stelephone system at home. It has adisplay that asks the user healthrelated questions and has inputs fordevices such as weight scales,blood pressure meters, and othervital sign measurement devices. | The Commander III is anautomated device that connectsto the user's telephone system athome. It has a display that asksthe user health related questionsand has inputs for devices suchas weight scales, Glucometers,and other vital sign measurementdevices. The Commander III hasa built in NIBP meter. |
| Intended Use | The Commander II device is foruse by patients to collect andtransmit general health questionsand patient vital sign data (such asweight, blood pressure, glucose,pulse oximetry, peak flow)between the patient, typically athome, and a health careprofessional at a remote site. | The Commander III device is foruse by patients to collect andtransmit general health questionsand patient vital sign data (suchas weight, blood pressure,glucose, pulse oximetry, peakflow) between the patient,typically at home, and a healthcare professional at a remotesite. |
| Blood PressureMeter | A&D Medical UA-767PC BloodPressure Monitor forTelemonitoring | BUILT IN Blood Pressure Meterdesigned by Cardiocom. |
| Transmission | Telephone line | Telephone line |
| Intended Users | Home users and health careprofessionals | Home users and health careprofessionals |
| 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 andPatient database | embedded Firmware andPatient database |
| Case | Plastic Wedge shape | Plastic Wedge shape |
| User interface | Keypad overlay with YES, NO up | Keypad overlay with YES, NO up |
| Comparisonmatrix - newvs. PredicatedeviceCharacteristic | K043096 Cardiocom LLCPredicate Device | Submission Device |
| arrow and down arrow | up arrow , down arrow, andselection buttons | |
| Communication | Multiple serial RS-232 ports andtelephone modem Part 68approved | Multiple serial RS-232 ports andtelephone modem Part 68approved |
| Power supply | External AC to DC supply | External AC to DC supply |
| ElectricalSafety | UL/IEC 60601-1 | UL/IEC 60601-1 |
| Electromagneticcompatibility | IEC 60601-1-2 | IEC 60601-1-2 |
..
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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.
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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.
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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
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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
Page 1 of 1
§ 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).