CARDIOCOM COMMANDER III

K053303 · Cardiocom, LLC · DXN · Dec 30, 2005 · Cardiovascular

Device Facts

• Record ID: K053303
• Device Name: CARDIOCOM COMMANDER III
• Applicant: Cardiocom, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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 care.

Device Story

Commander III is a home-based telemonitoring system; functions like a PC with a modem. Device connects to home telephone lines; features a display for patient health questionnaires and an integrated oscillometric blood pressure meter. Includes RS232 ports for external vital sign peripherals (weight scales, glucometers, peak flow meters, pulse oximeters). Patient interacts via keypad; device stores and transmits data to remote healthcare professionals. System provides no medical interpretation or treatment recommendations; clinical judgment required by provider to interpret transmitted data. Benefits include remote patient monitoring and improved access to health data for clinicians.

Clinical Evidence

Bench, laboratory, and clinical testing performed. No specific performance metrics (e.g., sensitivity, specificity) provided in the summary. Testing concluded the device is as safe and effective as the predicate.

Technological Characteristics

Oscillometric NIBP measurement; telephone modem transmission; RS232 connectivity for peripherals. Plastic wedge-shaped housing. Power: External AC to DC supply. Safety standards: UL/IEC 60601-1; EMC: IEC 60601-1-2. Software: Embedded firmware and patient database.

Indications for Use

Indicated for patients at home to collect and transmit vital signs (weight, blood pressure, glucose, pulse oximetry, peak flow) and answer health-related questions for review by remote healthcare professionals. Not for medical diagnosis or treatment recommendations.

Regulatory Classification

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.

Predicate Devices

• Cardiocom LLC Commander II (K043096)

Submission Summary (Full Text)

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DEC 3 0 2005

K053303

## EXHIBIT 2

510K Summary Cardiocom 1260 Park Road Chanhassen, MN 55317 Toll-Free: 888-243-8881 Tel: [phone] Fax: [phone] 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.
- 5. 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.
- 6. Comparison Table

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| Comparison<br>matrix - new<br>vs. Predicate<br>device<br>Characteristic | K043096 Cardiocom LLC<br>Predicate Device | Submission Device |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating<br>Principle | Oscillometric automated blood<br>pressure monitoring | SAME |
| Product Name | Commander II | Commander III |
| Classification<br>Name | Noninvasive blood pressure<br>measurement system | Noninvasive blood pressure<br>measurement system |
| Description | The Commander II is an automated<br>device that connects to the user's<br>telephone system at home. It has a<br>display that asks the user health<br>related questions and has inputs for<br>devices such as weight scales,<br>blood pressure meters, and other<br>vital sign measurement devices. | The Commander III is an<br>automated device that connects<br>to the user's telephone system at<br>home. It has a display that asks<br>the user health related questions<br>and has inputs for devices such<br>as weight scales, Glucometers,<br>and other vital sign measurement<br>devices. The Commander III has<br>a built in NIBP meter. |
| Intended Use | The Commander II device is for<br>use by patients to collect and<br>transmit general health questions<br>and patient vital sign data (such as<br>weight, blood pressure, glucose,<br>pulse oximetry, peak flow)<br>between the patient, typically at<br>home, and a health care<br>professional at a remote site. | The Commander III device is for<br>use by patients to collect and<br>transmit general health questions<br>and patient vital sign data (such<br>as weight, blood pressure,<br>glucose, pulse oximetry, peak<br>flow) between the patient,<br>typically at home, and a health<br>care professional at a remote<br>site. |
| Blood Pressure<br>Meter | A&D Medical UA-767PC Blood<br>Pressure Monitor for<br>Telemonitoring | BUILT IN Blood Pressure Meter<br>designed by Cardiocom. |
| Transmission | Telephone line | Telephone line |
| Intended Users | Home users and health care<br>professionals | Home users and health care<br>professionals |
| Site of Use | Home: Clinic or remote site | Home: Clinic or remote site |
| Measurements | - Blood pressure<br>- Pulse oximeter<br>- Peak flow meter<br>- Glucose<br>- Weight | - Blood pressure<br>- Pulse oximeter<br>- Peak flow meter<br>- Glucose<br>- Weight |
| Software | Embedded Firmware and<br>Patient database | embedded Firmware and<br>Patient database |
| Case | Plastic Wedge shape | Plastic Wedge shape |
| User interface | Keypad overlay with YES, NO up | Keypad overlay with YES, NO up |
| Comparison<br>matrix - new<br>vs. Predicate<br>device<br>Characteristic | K043096 Cardiocom LLC<br>Predicate Device | Submission Device |
| | arrow and down arrow | up arrow , down arrow, and<br>selection buttons |
| Communication | Multiple serial RS-232 ports and<br>telephone modem Part 68<br>approved | Multiple serial RS-232 ports and<br>telephone modem Part 68<br>approved |
| Power supply | External AC to DC supply | External AC to DC supply |
| Electrical<br>Safety | UL/IEC 60601-1 | UL/IEC 60601-1 |
| Electromagnetic<br>compatibility | 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 [phone]. 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 [phone] or [phone] 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

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