(244 days)
The Medtronic CareLink™ USB Connector is indicated for use by patients at home and clinicians in a medical office setting to facilitate communication between Medtronic diabetes ther apy management devices that use Paradigm-compatible RF telemetry and a personal computer that uses data management application software.
The Medtronic MiniMed CareLink USB Connector is an accessory device that facilitates wireless communication between compatible Medtronic MiniMed radiofrequency telemetry devices and a personal computer. The hardware component of the CareLink USB Connector consists of a radio-frequency (RF) transceiver enclosed in a plastic housing and one USB connector that is compatible with a type A (female) USB port of a personal computer (PC) or a USB hub. The CareLink USB Connector has a form factor similar to a USB flash memory stick and will by recognized by the PC as a USB device. The CareLink USB Connector is designed for use with Medtronic MiniMed devices that use Paradigm radiofrequency telemetry. Data is transferred between Medtronic MiniMed Paradigm RF compatible devices and a personal computer (PC) using select Medtronic MiniMed data management software applications.
The provided text is related to a 510(k) premarket notification for the Medtronic MiniMed CareLink™ USB Connector (Model MMT-7305). This device is an accessory that facilitates wireless communication between Medtronic MiniMed radiofrequency telemetry devices and a personal computer. The 510(k) summary focuses on comparing this new device to a predicate device (Com-Link Communication System, Model MMT-7304) and asserting substantial equivalence.
Crucially, this document does not describe any performance acceptance criteria for the device itself, nor does it detail any study that proves the device meets such criteria in terms of clinical or diagnostic accuracy. The focus is on the device's technological features and its intended use as a communication facilitator, not on a diagnostic or therapeutic output that would require a performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or directly stated based on the given document:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (such as sensitivity, specificity, accuracy, etc.) are mentioned in the provided text. The submission is a 510(k) for substantial equivalence based on technological features and intended use, not clinical performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No performance study data is presented. The submission focuses on device design and comparison to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment or expert review for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication methods for a test set are mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a communication connector, not an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for performance evaluation is mentioned.
8. The sample size for the training set
Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is mentioned.
Summary:
The provided document is a regulatory submission (510(k)) focused on demonstrating substantial equivalence of a new medical device (a USB connector for data transfer) to an existing predicate device. The primary argument for equivalence is based on similar function and technology, with the main difference being the physical connection type (USB vs. serial port). This type of submission typically does not involve extensive clinical performance studies or the establishment of ground truth for diagnostic accuracy, as the device's function is data communication rather than a diagnostic or therapeutic intervention itself. Therefore, the requested information regarding acceptance criteria and performance studies is not present in the given text.
{0}------------------------------------------------
Medtronic MiniMed Premarket Notification - 510(k) Medtronic MiniMed CareLink USB Connector
007 1 7 2007
SECTION 2.0 - 510(k) SUMMARY
In accordance with the requirements of 21 CFR 807.92, this 510(k) Summary is provided:
Submitter: Medtronic MiniMed 18000 Devonshire St. Northridge, CA 91325
Contact: Jodie Rogers, (818) 576-5708
Date: February 13, 2007
Name of Device: Medtronic MiniMed CareLink™ USB Connector, Model MMT-7305
Predicate Device: Com-Link Communication System, Model MMT-7304
Description of the Device: The Medtronic MiniMed CareLink USB Connector is an accessory device that facilitates wireless communication between compatible Medtronic MiniMed radiofrequency telemetry devices and a personal computer.
The hardware component of the CareLink USB Connector consists of a radio-frequency (RF) transceiver enclosed in a plastic housing and one USB connector that is compatible with a type A (female) USB port of a personal computer (PC) or a USB hub. The CareLink USB Connector has a form factor similar to a USB flash memory stick and will by recognized by the PC as a USB device.
The CareLink USB Connector is designed for use with Medtronic MiniMed devices that use Paradigm radiofrequency telemetry. Data is transferred between Medtronic MiniMed Paradigm RF compatible devices and a personal computer (PC) using select Medtronic MiniMed data management software applications.
Intended Use of the Device: The Medtronic CareLink USB Connector is indicated for use by patients at home and clinicians in a medical office setting to facilitate communication between Medtronic diabetes therapy management devices that use Paradigm-compatible RF telemetry and a personal computer that uses data management application software.
Comparison of the Technological Features of the New Device and Predicate Device: The modified device and the lawfully marketed predicate devices provide similar function, and use radiofrequency technology to communicate. The primary difference between the two devices is physical, in that, the new device is designed to connect to the computer's USB port instead of a serial port. These modifications do not affect the safety or effectiveness of the device.
Jodie Rogers Regulatory Affairs Medtronic MiniMed
Date
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines representing its 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
OCT 1 7 2007
Ms. Jodie Rogers Senior Regulatory Affairs Specialist Medtronic MiniMed, Incorporated 18000 Devonshire Street Northridge, California 91325
Re: K070438
Trade/Device Name: Medtronic MiniMed CareLink™ USB Connector (Model: MMT-7305) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: October 4, 2007 Received: October 5, 2007
Dear Ms. Rogers:
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.
{2}------------------------------------------------
Page 2 - Ms. Rogers
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/industry/support/index.html.
Sincerely vours,
Chris R.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K070438
Device Name: Medtronic MiniMed CareLink™ USB Connector (Model: MMT-7305)
Indications For Use: The Medtronic CareLink™ USB Connector is indicated for use by patients at home and clinicians in a medical office setting to facilitate communication between Medtronic diabetes ther apy management devices that use Paradigm-compatible RF telemetry and a personal computer that uses data management application software.
escription Use art 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF EEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
474438 510(k) Number:
Page 1 of 1
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).