(140 days)
Not Found
No
The summary describes a data transmission system and does not mention any analytical or interpretive functions that would typically involve AI/ML.
No
The device acts as a data transmission system for personal monitoring devices, sending data to a health management database. It does not provide any therapy or direct medical treatment.
No
The text indicates that "MediCompass Connect serves as an interface or a gateway between personal monitoring devices and a general purpose personal health management database." It transmits data from monitoring devices but does not analyze or interpret the data to diagnose a condition.
No
The device description explicitly states it is a "system that transmits data from personal monitoring devices" and mentions using standard communication methods like "telephone lines or wireless, or transmits data by using a PC that has a connection to the Internet." While software is a key component for data transmission and interfacing, the description implies the system includes hardware components (e.g., interfaces for telephone lines, wireless communication, or a PC connection) to facilitate the data transfer from the monitoring devices. It is not solely software.
Based on the provided information, the MediCompass Connect is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that MediCompass Connect transmits data from personal monitoring devices (like blood glucose monitors, blood pressure cuffs, scales, etc.) to a database. It does not directly analyze biological samples.
- The function is data transmission and management. The device acts as an interface or gateway to move data from monitoring devices to a database. It doesn't perform any diagnostic testing or analysis on the data itself to determine a medical condition.
The device's purpose is to facilitate the collection and transmission of health data from various monitoring devices, which is a different function than an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
MediCompass Connect serves as an interface or a gateway between personal monitoring devices and a general purpose personal health management database. Monitoring devices that can interface to the MediCompass Connect include, but are not limited to:
- Blood glucose monitor
- Blood pressure cuffs I
- Insulin pumps
- Spirometers
- . Scales
MediCompass Connect is designed for professional healthcare settings and home use.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
MediCompass Connect is a system that transmits data from personal monitoring devices using standard communication methods such as telephone lines or wireless, or transmits data by using a PC that has a connection to the Internet. MediCompass Connect transmits the data from a personal monitoring devices, such as a blood pressure cuff, to a remote general-purpose personal health management database.
- Blood pressure cuffs .
- . Blood glucose meters
- Insulin pumps .
- Spirometers .
- . Scales
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
professional healthcare settings and home use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2005
iMetrikus, Inc. c/o Mr. Curtis M. Egan Chief Operations Officer Certified Software Solutions, Inc. 5770 Armada Drive, Suite 100 Carlsbad, CA 92008
Re: K042768 MediCompass Connect Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: February 14,2005 Received: February 16,2005
Dear Mr. Egan;
This letter corrects our substantially equivalent letter of February 22, 2005, regarding the incorrect year cited for the date of your submission. Please see the above date for the correction.
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 (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 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.
1
Page 2 - Mr. Curtis M. Egan
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 continue 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- _ . 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dmra R. Kochner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure 1. E-mail correspondance dated March 2,2005
2
Indications for Use
510(k) Number (if known): K042768
Device Name: MediCompass Connect
Indications for Use:
MediCompass Connect serves as an interface or a gateway between personal monitoring devices and a general purpose personal health management database. Monitoring devices that can interface to the MediCompass Connect include, but are not limited to:
- Blood glucose monitor
- Blood pressure cuffs I
- Insulin pumps
- Spirometers
- . Scales
MediCompass Connect is designed for professional healthcare settings and home use.
Prescription Use (Per 21 CFR 801 109) OR
Over-the-counter U s e - X ____
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.L. Ammons
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042768
Page I of 1
01210
3
FEB 2 2 2005
510(k) Summary
| Date prepared: | September 29, 2004 |
|---|---|
| Submitter/Owner: | iMetrikus, Inc. |
| 5770 Armada Drive, Suite 100 | |
| Carlsbad, CA 92008 | |
| Contact person: | Dan Olivier |
| 16787 Bernardo Center Drive, Suite A-1 | |
| San Diego, CA 92128 | |
| Phone number: | (858)675-8200 |
| Fax number: | (858)675-8201 |
| Proprietary name: | MediCompass Connect |
| Common name: | Data Transfer System |
| Classification: | Class II. 870.1130. Noninvasive blood pressure measurement |
| system | |
| Product Code: | DXN |
Substantial equivalence claimed to:
Health Buddy® with BuddyLink 1. K040086 -
Description:
MediCompass Connect is a system that transmits data from personal monitoring devices using standard communication methods such as telephone lines or wireless, or transmits data by using a PC that has a connection to the Internet. MediCompass Connect transmits the data from a personal monitoring devices, such as a blood pressure cuff, to a remote general-purpose personal health management database.
- Blood pressure cuffs .
- . Blood glucose meters
- Insulin pumps .
- Spirometers .
- . Scales
4
Comparison of technological characteristics with predicate device:
MediCompass Connect is a system to transmit data that is substantially equivalent to the currently marketed Health Buddy with BuddyLink (K040086). Both systems are for the communication of general purpose personal health management information.
Devices validated for use with MediCompass Connect
| Brand | Personal Monitoring
Devices | Model |
|-----------------------------------|----------------------------------------|----------------------------------------------|
| Roche | Blood glucose monitor | Accu-Chek® Advantage |
| Bayer | Blood glucose monitor | Ascensia Elite™ XL (model number
3901G) |
| Abbott | Blood glucose monitor | TheraSense FreeStyle™ (A)** |
| LifeScan | Blood glucose monitor | One Touch® II® |
| LifeScan | Blood glucose monitor | One Touch® Profile® |
| LifeScan | Blood glucose monitor | One Touch® Ultra® |
| Becton, Dickinson,
and Company | Blood glucose monitor | BD Logic™ |
| Roche | Blood glucose monitor | Accu-Chek® Compact |
| Abbott | Blood glucose monitor | MediSense® Precision Xtra™ |
| Abbott | Blood glucose monitor | MediSense® Precision Q-I-D® |
| Bayer | Blood glucose monitor | Ascencia® Breeze™ |
| Roche | Blood glucose monitor | Accu-Chek® Complete |
| HDI (Home
Diagnostics, Inc. | Blood glucose monitor | Prestige IQ™ |
| A&D Medical | Blood pressure monitor
(arm cuff) | LifeSource™ UA-767PC |
| LifeScan | Blood glucose monitor | One Touch® SureStep® |
| Omron Healthcare | Blood pressure monitor
(arm cuff) | HEM 705CP |
| Omron Healthcare | Blood pressure monitor
(wrist cuff) | HEM 637 |
| Becton, Dickinson,
and Company | Blood glucose monitor | BD Paradigm Link™ |
| LifeScan | Blood glucose monitor | InDuo® |
| Abbott | Blood glucose monitor | TheraSense FreeStyle™ (C)** |
| LifeScan | Blood glucose monitor | One Touch® Basic® |
| Roche | Blood glucose monitor | Accu-Chek® Active |
| Bayer | Blood glucose monitor | Glucometer Elite™ XL (model number
3901B) |
| iMetrikus | Personal respiratory
monitor | AirWatch® |
| Roche | Insulin pump | Disetronic D-TRON™ plus |
| HDI | Blood glucose monitor | TrueTrack Smart System™ |
| Bayer | Blood glucose monitor | Ascensia® DEX™ |
- Typically referred to as the (A) model, the serial number of this TheraSense Freesty'e begins with A.
** Typically referred to as the (C) model, the serial number of this TheraSense Freestyle meter begins with C.