(183 days)
Model 3627 Screener, Model 3210 Transmitter
K/DEN number: Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on combining existing, non-AI/ML components.
No.
The device is indicated for use in trial screening for SCS and PNS, which are therapeutic interventions, but the device itself is for screening purposes rather than delivering therapy.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "indicated for use in trial screening for SCS and PNS for chronic intractable pain of the trunk or limbs." This describes a screening or evaluation tool for candidacy related to pain management therapies, not a device used to diagnose a medical condition.
No
The device description explicitly states it is a combination of two existing hardware products (Model 3627 Screener and Model 3210 Transmitter) and allows the patient to carry "one unit rather than two," indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "trial screening for SCS and PNS for chronic intractable pain of the trunk or limbs." This describes a device used on the patient's body to deliver electrical stimulation, not a device used to test samples from the body (like blood, urine, or tissue) in a lab setting.
- Device Description: The description details a "Screener" and "Transmitter" that are combined. This further supports the idea of an external device used for therapy or screening, not an in vitro test.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information about a patient's health status based on sample analysis.
Therefore, the Medtronic Model 3628 Screener, as described, is a medical device used for electrical stimulation screening, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic Model 3628 Screener is indicated for use in trial screening for SCS and PNS for chronic intractable pain of the trunk or limbs, as is the Model 3627 Screener and the Model 3210 Transmitter.
Product codes
Not Found
Device Description
The Model 3628 Screener is a combination of the Model 3627 Screener and the Model 3210 Transmitter. Electrically and functionally, it is the same as the two current products combined. The new Screener allows the patient to carry one unit rather than two during the screening period.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The trunk or limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Model 3627 Screener, Model 3210 Transmitter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).
0
Medtronic
K95529/
MN 55440-9087 (612) 572-5078
MAY 17 1996
November 15, 1995
RE: 510(k) Notification: Medtronic Model 3628 Screener
In order to comply with the Safe Medical Devices Act of 1990, this page will provide safety and effectiveness information to interested persons.
SUMMARY OF SAFETY AND EFFECTIVENESS
The Medtronic Model 3628 Screener is indicated for use in trial screening for SCS and PNS for chronic intractable pain of the trunk or limbs, as is the Model 3627 Screener and the Model 3210 Transmitter. The Model 3628 Screener is a combination of the Model 3627 Screener and the Model 3210 Transmitter. Electrically and functionally, it is the same as the two current products combined. The new Screener allows the patient to carry one unit rather than two during the screening period.
There are only minor differences between the Model 3628 Screener and the commercially available Model 3627/3210 units, which are as follows:
- A larger liquid crystal display (LCD); used to display parameter information. 1.
-
- The antenna and receiver coil in the current products have been replaced with a RF transformer .
-
- Several items (pushbuttons, switches, etc.) have been relocated for improved ease of use.
Therefore, the Model 3628 Screener is substantially equivalent to current Model 3627/3210 units.
Sincerely,
MEDTRONIC, INC. Neurological Division
Sennis H. Comer
Dennis H. Crane Principal Regulation Manager