(34 days)
Not Found
No
The summary describes implantable leads for spinal cord stimulation, which are passive components of a neurostimulation system. There is no mention of any computational or algorithmic processing, let alone AI/ML.
Yes
The device is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, which is a therapeutic purpose.
No
Explanation: The device description states that the leads are used to deliver stimulation to the spinal cord for pain management, which is a therapeutic function, not a diagnostic one. While fluoroscopy is mentioned for identification purposes, the device itself does not perform any diagnostic measurements or analyses.
No
The device description clearly details physical components including leads, electrodes, and a power source, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- Device Function: The provided description clearly states that the Medtronic Pisces Z Quad Leads are implantable leads used in Spinal Cord Stimulation (SCS) systems. These systems deliver electrical stimulation directly to the spinal cord to manage chronic pain.
- Mechanism of Action: The device works by delivering electrical signals to the spinal cord, not by analyzing biological specimens.
- Intended Use: The intended use is "as an aid in the management of chronic, intractable pain of the trunk and/or limbs," which is a therapeutic application, not a diagnostic one based on in vitro analysis.
The device is an implantable medical device used for neuromodulation (specifically, spinal cord stimulation).
N/A
Intended Use / Indications for Use
The Medtronic Pisces Z Quad® Model 3890, Pisces Z Quad Compact™ Model 3891, and Pisces Z Quad Plus® Model 3892 Leads for Spinal Cord Stimulation (SCS) are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs.
Product codes (comma separated list FDA assigned to the subject device)
GZB
Device Description
The function of the Medtronic Mattrix and X-trel® Neurostimulation Systems is accomplished with a power source, extension (for X-trel only) and lead (electrode). The power source generates and controls the stimulation, which is delivered to the spinal cord via electrodes at the end of the lead.
The Models 3890, 3891 and 3892 Leads are lower impedance percutaneous quadripolar, implantable leads. The proximal end provides in-line fourconductor contacts that connect to the Mattrix receiver or Medtronic extension (which connects to the X-trel receiver). The proximal ends and lead bodies of all three leads are identical. Each lead model has four platinum iridium electrodes on the distal end but with variable electrode length and spacing. The electrode spacing and electrode lengths of the Models 3890, 3891, and 3892 Leads are identical to the current Models 3487A, 3887, 3888 Leads, respectively. A radio-opaque marker band at the tip of the Model 3892 Lead enhances identification when viewed in fluoroscopy. The Models 3890, 3891 and 3892 Leads are available in lengths from 10 cm to 100 cm. The Medtronic Models 3890, 3891, and 3892 Leads are packaged, sterilized, and labeled for single use only (disposable).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal cord, trunk and/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 (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
§ 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
OCT 3 0 2003
K033016
10F2
510(k) Summary Medtronic Models 3890, 3891, and 3892 Leads
A. General Provisions
| Submitter's Name: | Medtronic, Inc. |
|---|---|
| Submitter's Address: | Sullivan Lake Facility |
| 800 53rd Avenue Northeast | |
| Columbia Heights, MN 55421 | |
| Contact Person: | Pam Schaub |
| Principal Regulatory Affairs Specialist | |
| Classification Name: | Implanted Spinal Cord Stimulator for Pain |
| Relief | |
| 21 CFR Section 882.5880 | |
| Common or usual Name: | N/A |
| Proprietary Names: | Pisces Z Quad® Model 3890 Lead, |
| Pisces Z Quad Compact™ Model 3891 Lead, | |
| Pisces Z Quad Plus® Model 3892 Lead |
B. Name of Predicate Devices
| Medtronic Neurological | Models 3487A and 3887 Leads | K923931 |
|---|---|---|
| Medtronic Neurological | Model 3888 Lead | K923567 |
C. Device Description
The function of the Medtronic Mattrix and X-trel® Neurostimulation Systems is accomplished with a power source, extension (for X-trel only) and lead (electrode). The power source generates and controls the stimulation, which is delivered to the spinal cord via electrodes at the end of the lead.
The Models 3890, 3891 and 3892 Leads are lower impedance percutaneous quadripolar, implantable leads. The proximal end provides in-line fourconductor contacts that connect to the Mattrix receiver or Medtronic extension (which connects to the X-trel receiver). The proximal ends and lead bodies of all three leads are identical. Each lead model has four platinum iridium electrodes on the distal end but with variable electrode length and spacing. The electrode spacing and electrode lengths of the Models 3890, 3891, and 3892 Leads are identical to the current Models 3487A, 3887, 3888 Leads, respectively. A radio-opaque marker band at the tip of the Model 3892 Lead enhances identification when viewed in fluoroscopy. The Models 3890, 3891 and 3892 Leads are available in lengths from 10 cm to 100 cm. The Medtronic Models 3890, 3891, and 3892 Leads are packaged, sterilized, and labeled for single use only (disposable).
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's authority and commitment to public health.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2003
Pam Schaub Principal Regulatory Affairs Specialist 710 Medtronic Parkway NE Minneapolis, Minnesota 55432-5604
Re: K033016
Trade/Device Name: Models 3890, 3891 and 3892 Leads Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: September 25, 2003 Received: September 26, 2003
Dear Ms. Schaub:
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.
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
2
Page 2 - Ms. Pam Schaub
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
fo Mark N Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | K033016 |
|---|---|
| --------------------------- | --------- |
Medtronic Models 3890, 3891, and 3892 Leads Device Name:
INDICATIONS FOR USE:
The Medtronic Pisces Z Quad® Model 3890, Pisces Z Quad Compact™ Model 3891, and Pisces Z Quad Plus® Model 3892 Leads for Spinal Cord Stimulation (SCS) are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________ OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Mark N. Millerson
sion Sign-Off) Division of General, Restorative and Neurological Dev
್ 10(k) Number_