COMMANDER II

K043096 · Cardiocom · DXN · Nov 24, 2004 · Cardiovascular

Device Facts

• Record ID: K043096
• Device Name: COMMANDER II
• Applicant: Cardiocom
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Commander II 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.

Device Story

Commander II is an automated home-based system connecting to telephone lines. It functions as a data collection and transmission hub; it displays health-related questions to the patient and provides inputs for peripheral vital sign measurement devices (e.g., weight scales, blood pressure meters, pulse oximeters). The device transmits collected patient data and survey responses to a remote healthcare professional. It is operated by the patient in a home setting. The healthcare provider receives the transmitted data at a remote site to monitor patient status. The device does not perform medical interpretations or treatment recommendations; clinical judgment is required by the provider to interpret the transmitted information.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including EMC emissions and immunity (EN60601-1-2, EN61000-3-2), telephone network connection compliance (FCC Part 68), and UL safety standards.

Technological Characteristics

Automated data collection and transmission system; connects to standard telephone networks. Includes inputs for peripheral vital sign measurement devices. Tested to EN60601-1-2, EN61000-3-2, FCC Part 68, and UL safety standards.

Indications for Use

Indicated for patients requiring remote collection and transmission of vital sign data (weight, blood pressure, glucose, pulse oximetry, peak flow) and health survey responses to healthcare professionals. Not intended as a substitute for medical care; makes no medical judgments 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

• Home Care Monitoring System, AvidCare Corp. (K010029)

Submission Summary (Full Text)

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NOV 2 4 2004

K043096
page 1 of 2

# SECTION 5. SUMMARY AND CERTIFICATION

## A. DEVICE SUMMARY

### Summary of Safety and Effectiveness

The following information constitutes the summary for the Commander II.

| SUBMITTERS NAME: | Cardiocom, LLC. |
|--------------------|---------------------------------------------|
| ADDRESS: | 1260 Park Road, Chanhassen, Minnesota 55317 |
| CONTACT PERSON: | Constance G. Bundy |
| TELEPHONE NUMBER: | [phone] |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION | Prepared October 15th, 2004 |

#### 1. Identification of device

Proprietary Name: Commander II Common Name: Noninvasive blood pressure measurement system Classification Status: Class II per regulations 870.1130 Product Code: DXN

#### 2. Description of the Device

The Commander II is an automated device that connects to the user's telephone system at home. It has a display that asks the user health related questions and has inputs for devices such as weight scales, blood pressure meters, and other vital sign measurement devices.

#### 3. Intended use

The Commander II 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.

#### 4. Technological characteristics, comparison to predicate device.

The Commander II is substantially equivalent to: Home Care Monitoring System, AvidCare Corp., K010029. The Commander II device and its predicate system have the same general use to provide the capability for health care professionals to monitor the vitals signs of their patients from remote locations.

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#### 5. Discussion of functional and safety testing.

The device has been tested according to the following standards:

- EN60601-1-2, 2001 .
- . EN61000-3-2
- . FCC Part 68
- . UL and C-UL Listing Mark

EMC Emissions EMC Immunity Limits for Harmonic Current Emissions Connection of Terminal Equipment to the Telephone Network UL Safety Standards

Verification and validation testing was conducted to establish performance and reliability characteristics of the device.

#### 6. Conclusion

Based on the low risk device type, internal and external performance testing, it is Cardiocom's conclusion that Commander II presents no significant concerns about safety and effectiveness.

## B. TRUTH AND ACCURACY CERTIFICATION

I certify that, in my capacity as President, I believe, to the best of my knowledge, that all data and information maintained on file are truthful and accurate, and that no material fact has been omitted.

Qul. (A 10/15/4

Daniel L. Cosentino, MBA President

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract, wing-like shapes stacked on top of each other, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

Cardiocom c/o Mr. Pedro E. Gonzales Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K043096 Trade Name: Commander II Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: November 03, 2004 Received: November 09, 2004

Dear Mr. Gonzales:

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 for association 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. Pedro E. Gonzales

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/dsma/dsmamain.html

Sincerely yours,

Duma R. Wachner

A 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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K043096

Page 1 of 1

### B. INDICATIONS FOR USE

KD43096 510(k) Number_

Device Name: Commander II

### Indications for Use:

The Commander II 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 II device makes no interpretation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander II is not intended as a substitute for medical care.

Prescription Use _ (Per 21 CFR 801.109)

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Lachner

(Division Sign-Off) Division of Cardiovascular Devices

510(K) Number_K 6430 9 6