(27 days)
Not Found
No
The summary describes a test stimulation lead kit, which is a physical device for delivering electrical stimulation. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated as an aid in the management of chronic, intractable pain and delivers electrical stimulation to block pain signals.
No
This device is described as a "test stimulation lead" used to deliver electrical stimulation for pain management, not to diagnose a condition. It is an aid in the management of pain, not a diagnostic tool for identifying the cause of pain. The predicate device is also a "Temporary Screening Lead," which implies a similar function of temporary electrical stimulation, not diagnosis.
No
The device description explicitly states it is a "thin wire covered by an insulative coating" with "small metal electrodes," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an "aid in the management of chronic, intractable, unilateral or bilateral pain associated with..." a list of conditions. This describes a therapeutic or diagnostic procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is described as a "test stimulation lead kit" which is a "thin wire covered by an insulative coating" with "small metal electrodes near its tip through which the ENS delivers electrical stimulation". This is a physical device intended for implantation and electrical stimulation, not for analyzing biological samples.
- No mention of in vitro testing for diagnosis: While there is mention of "In Vitro testing was performed to support substantial equivalence", this refers to testing of the device itself, not testing of patient samples for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
No.
The provided text does not contain any mention of a "Predetermined Change Control Plan" or "PCCP." The information describes a test stimulation lead and its indications for use, device description, and performance studies, but there is no indication that it is authorized under a PCCP.
Intended Use / Indications for Use
The Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads are indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:
- Failed Back Syndrome or Low Back Syndrome or Failed Back;
- Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to . Failed Back Syndrome;
- Post Laminectomy Pain;
- Unsuccessful Disk Surgery;
- Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative . and surgical interventions;
- Peripheral Causalgia; .
- Epidural Fibrosis; .
- Arachnoiditis or Lumbar Adhesive Arachnoiditis; .
- Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy . (RSD) or Causalgia; and,
- Multiple Back Surgeries .
Additional Contraindication: The Medtronic Models 3873 1 x 8 and the 3874 1 x 8 Compact Test Stimulation Leads are contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.
Product codes
GZB
Device Description
The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact are test stimulation lead kits. A test stimulation lead is a thin wire covered by an insulative coating, which is intended to be connected to a screening cable and an external neurostimulator (ENS). The lead has small metal electrodes near its tip through which the ENS delivers electrical stimulation to an area where pain signals will be blocked.
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
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
In Vitro testing was performed to support substantial equivalence to the predicate device. The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits met all specified design and performance requirements.
Key Metrics
Not Found
Predicate Device(s)
Model 3862 Verify Temporary Screening Lead.
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
JUL 2 8 2005
July 2005
051973
Appendix A: 510(K) Summary
Submitter
Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432
| Contact: | Paula Cordero, Regulatory Affairs Specialist |
|---|---|
| Telephone: | (763) 505-0238 |
| Fax: | (763) 505-0258 |
| E-Mail: | paula.cordero@medtronic.com |
| Date Prepared: | July 1st, 2005 |
Name of Device
| Trade Name: | Medtronic Model 3873 1 x 8 and Model 3874
1 x 8 Compact Test Stimulation Leads |
|-----------------|-----------------------------------------------------------------------------------|
| Common Name: | Trialing Leads |
| Classification: | Class II |
| Product Code: | GZB |
Predicate Devices
The predicate device for the Medtronic Model 3873 1 x 8 Test Stimulation Leads and the Model 3874 1 x 8 Compact Test Stimulation Leads is the currently available Model 3862 Verify Temporary Screening Lead.
Device Description
The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact are test stimulation lead kits. A test stimulation lead is a thin wire covered by an insulative coating, which is intended to be connected to a screening cable and an external neurostimulator (ENS). The lead has small metal electrodes near its tip through which the ENS delivers electrical stimulation to an area where pain signals will be blocked.
Intended Use
The Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads are indicated as an aid is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:
- Failed Back Syndrome or Low Back Syndrome or Failed Back; ●
Image /page/0/Picture/16 description: The image shows the Medtronic logo. The logo consists of a symbol on the left and the word "Medtronic" on the right. Below the word "Medtronic" is the word "Confidential".
1
- Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to . Failed Back Syndrome;
- Post Laminectomy Pain; ●
- Unsuccessful Disk Surgery; ◆
- Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative . and surgical interventions;
- Peripheral Causalgia; .
- Epidural Fibrosis; .
- Arachnoiditis or Lumbar Adhesive Arachnoiditis; .
- Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy . (RSD) or Causalgia; and,
- Multiple Back Surgeries .
Additional Contraindication: The Medtronic Models 3873 1 x 8 and the 3874 1 x 8 Compact Test Stimulation Leads are contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.
Summary of Studies
In Vitro testing was performed to support substantial equivalence to the predicate device. The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits met all specified design and performance requirements.
Sterilization
The Medtronic Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits are labeled STERILE. The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits will be sterilized using the same 100% Ethylene Oxide (EtO) sterilization process as the predicate device.
Biocompatibility
All device materials / components were assessed for biocompatibility consistent with ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". All materials were found to be biocompatible and in compliance to ISO 10993-1.
Conclusion
Through data and information presented, as well as similarity to legally marketed devices, Medtronic, Inc. considers the Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits to be substantially equivalent to legally marketed predicate devices.
Image /page/1/Picture/20 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. Below the logo, the word "Confidential" is written in a smaller, non-bold font. To the left of the word "Medtronic" is a graphic of a person with outstretched arms.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2005
Ms. Paula Cordero Regulatory Affairs Specialist Medtronic, Inc., Neurological Division 710 Medtronic Parkway NE Minneapolis, Minnesota 55432-5604
Re: K051773
Trade/Device Name: Medtronic® Model 38731 x 8 and Model 38741 x 8 Compact Test Stimulation Leads Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: II Product Code: GZB Dated: June 30, 2005 Reccived: July 5, 2005
Dear Ms. Cordero:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 use stated in the encreations of the enactment date of the Medical Device Amendments. Or to commerce provise that have been reclassified in accordance with the provisions of the Federal Food. Drug. de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (. 10.) that the device, subject to the general controls provisions of the Act. The r ou may, morely williams of the Act include requirements for annual registration. Iisting of general controlo proficturing 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 If your device is elabsition it controls. Existing major regulations affecting your device can may oe subject to back as a sateral Regulations, Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devised that i bring that your device complies with other requirements of the Act that + Dr Are I statutes and regulations administered by other Federal agencies. You must or any I vath 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Paula Cordero
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and wyours organism diagrof substantial equivalence of your device to a legally prematter nedicate 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 n Joa abon's 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,
Mark McMullen
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use
510(k) Number (if known): N/A
Device Name: Medtronic® Model 3873 1 x 8 and Model 3874 1 x 8 Compact Tcst Stimulation Leads
Indications For Use: The Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads are indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:
- Failed Back Syndrome or Low Back Syndrome or Failed Back; �
- Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed . Back Syndrome;
- Post Laminectomy Pain; .
- Unsuccessful Disk Surgery; .
- Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and . surgical interventions;
- Peripheral Causalgia; .
- . Epidural Fibrosis;
- Arachnoiditis or Lumbar Adhesive Arachnoiditis; .
- Complex Regional Pain Syndtome (CRPS) or Reflex Sympathetic Dystrophy (RSD) . or Causalgia; and,
- . Multiple Back Surgenes
Additional Contraindication: The Medtronic Models 3873 1 x 8 and the 3874 1 x 8 Compact Test Stimulation Leads are contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.
Prescription Use _ _ >> (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
__, and I'm sorry, but I cannot fulfill that request.
Division Sign-Off) Division of General, Restorative and Heurological Devices
Number_