COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM

K053304 · Cardiocom, LLC · DXN · Dec 30, 2005 · Cardiovascular

Device Facts

• Record ID: K053304
• Device Name: COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
• Applicant: Cardiocom, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 30, 2005
• Decision: SESE
• Submission Type: Traditional
• 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 functions as a telemonitoring hub; collects patient vital signs via RS232-connected peripheral devices (scales, blood pressure meters, glucometers, peak flow meters, pulse oximeters); prompts users with health-related questions via display; stores and transmits data via telephone modem to remote clinical monitoring stations. Operated by patients at home; data reviewed by healthcare professionals. Device performs no medical interpretation or treatment recommendations; clinical judgment required for data review. Benefits include remote patient monitoring and improved data transmission between home and clinical settings.

Clinical Evidence

Bench, laboratory, and clinical testing performed. Results indicate the device is as safe and effective as the predicate device.

Technological Characteristics

Electronic printed circuit boards in ABS enclosure. Oscillometric blood pressure measurement principle. Connectivity via multiple RS-232 ports and telephone modem (Part 68 approved). Power source: AC adapter. Dimensions: 2.7" x 6.8" x 8.9". Memory: 200 measurements. Complies with UL/IEC 60601-1 and IEC 60601-1-2. Patient contact materials: Nylon cuff.

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 questions for remote review by healthcare professionals. Not for use as a substitute for medical care.

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

• A&D Medical UA-767PC Digital Blood Pressure Monitor (K982481)

Submission Summary (Full Text)

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K053304

DEC 3 0 2005

## 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

- 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
- 2. Equivalent legally marketed devices This product is similar in function and design to predicate K982481 A&D Medical UA-767PC Digital Blood Pressure Monitor
- 3. 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
- 4. 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.

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| Designation | K982481 A&D Medical UA-767PC<br>Digital Blood Pressure Monitor | Commander III |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | Oscillometric automated blood pressure<br>monitoring | SAME |
| Indications | The UA-767PC is designed to be used by end<br>users who are eighteen (18) years and older at<br>home and doctor/nurse office to monitor their<br>blood pressure (systolic and diastolic) and pulse<br>rate. At the end of each measurement, the<br>results will be stored in the UA-767PC<br>memory. UA-767PC through its<br>communications port can also transfer the<br>measurements stored in memory to other<br>electronic devices, such as a PC, a modem, or a<br>printer. | The Commander III device is for use by<br>patients to collect and transmit general<br>health questions and patient vital sign data<br>(such as weight, blood pressure, glucose,<br>pulse oximetry, peak flow) between the<br>patient, typically at home, and a health<br>care professional at a remote site.<br>Contraindications, Precautions and<br>Warnings: The Commander III device<br>makes no interpretation, evaluation,<br>medical judgments or recommendations<br>for treatment. Clinical judgment and<br>experience are required to check and<br>interpret the information transmitted. The<br>Commander III is not intended as a<br>substitute for medical care |
| Display | LCD: Systolic, Diastolic, Pulse | SAME |
| Controls | Start, pressure select | Yes, No, Up-arrow, Down-arrow, Four<br>"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<br>sent over the phone line. |
| Weight | 0.32 kg without batteries | 0.8kg without Blood Pressure cuff |
| Cuff Arm<br>Circumference Range | 5.1 inches -17.7 inches (small, medium, large<br>cuff sizes) | 7 inches-16.5 inches (small, medium, large<br>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<br>compatibility | IEC 60601-1-2 | IEC 60601-1-2 |
| Patient Contact<br>Materials | Nylon Cuff | SAME |
| Designation | K982481 A&D Medical UA-767PC<br>Digital Blood Pressure Monitor | Commander III |
| Description | This home blood pressure monitor<br>communicates with your information hub<br>through a serial communication cable and port.<br>Real-time communication is achieved by sending<br>the blood pressure measurement to the<br>information hub immediately. The UA-767PC<br>can also operate in a batch-mode to send up to<br>126 measurements with time and date in a single<br>request command. System integrators can<br>provide units to remotely located patients<br>enabling them to monitor their blood pressure at<br>home. Combine this blood pressure monitor and<br>the LifeSource™ UC-321 personal scale and you<br>have a foundation for a complete telemonitoring<br>system. | The Commander III device is for use by<br>patients to collect and transmit general<br>health questions and the following patient<br>vital signs data: Non-invasive blood<br>pressure measurement, Non-invasive blood<br>oxygen saturation measurement using pulse<br>oximetry, In vitro diagnostic quantitative<br>measurement of glucose in fresh capillary<br>whole blood, Non-invasive measurement of<br>lung peak flow, and Patient weight using a<br>stand-on electronic scale. The results of<br>these measurements are transmitted to a<br>computer monitoring station in a clinical<br>setting via common telephone lines from<br>the patient's home setting. For sale by or on<br>the order of a physician. |
| Communication<br>capability | Serial RS-232 with PC | Multiple serial RS-232 ports and telephone<br>modem Part 68 approved |
| Measurement Range | Pressure: 20 mmHg to 280 mmHg; Pulse: 40 to<br>200 pulses/minute | SAME (from AAMI) |
| Accuracy | Pressure: ±3 mmHg or ±2%, whichever is<br>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

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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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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.

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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.

Bhimmar 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 × (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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