(15 days)
Not Found
No
The summary describes a device for collecting and transmitting patient data, but there is no mention of AI or ML being used for analysis, interpretation, or any other function. The device appears to be a data collection and transmission tool.
No
The device is described as collecting and transmitting health data and vital signs, not as providing therapy or treatment.
No
Explanation: The device collects and transmits general health questions and vital sign data. There is no indication that it analyzes or interprets this data to diagnose a condition. It acts as a data collection and transmission tool.
No
The device description explicitly states it is an "automated device" that "connects to the user's telephone system" and "has a display" and "inputs for devices," indicating it includes hardware components beyond just software.
Based on the provided information, the Commander II device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Commander II Function: The Commander II device collects and transmits general health questions and patient vital sign data (weight, blood pressure, glucose, pulse oximetry, peak flow). This data is collected from the patient directly or from connected devices, not from samples taken from the body.
- No Mention of Sample Analysis: The description does not mention any analysis of biological samples.
The Commander II is a remote patient monitoring device used for collecting and transmitting health information, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients, typically at home, and a health care professional at a remote site.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing was conducted to establish performance and reliability characteristics of the device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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: | (763) 574-1976 |
| 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.
1
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
2
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.
3
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 (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/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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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