(54 days)
Not Found
Not Found
No
The summary describes a simple electrical cable for connecting components of a neurostimulation system and makes no mention of AI or ML.
No
The Medtronic Model 355531 Multi-Lead Trialing Cable (MLTC) is a connection cable. While it is used with SCS and PNS systems for pain treatment, which are therapeutic, the cable itself does not deliver therapy or have a direct therapeutic effect. It serves as an electrical connection between a power source and a neurostimulation lead.
No
The device is described as an electrical connection between a power source and a neurostimulation lead/extension, used for pain treatment. Its function is to facilitate the delivery of stimulation, not to diagnose a condition.
No
The device description explicitly states it is a "Multi-Lead Trialing Cable" which serves as an "electrical connection" between hardware components (power source and neurostimulation lead/extension). This indicates it is a physical hardware component, not software.
Based on the provided information, the Medtronic Model 355531 Multi-Lead Trialing Cable is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for connecting external power sources to neurostimulation leads for the treatment of pain in the trunk or limbs. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as an electrical connection cable. It facilitates the delivery of electrical stimulation, not the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any interaction with biological samples (blood, urine, tissue, etc.) or any diagnostic purpose (identifying a disease, condition, or state).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Medtronic Model 355531 does not fit this description.
N/A
Intended Use / Indications for Use
The Medtronic Model 355531 Multi-Lead Trialing Cable (MLTC) is indicated for use with Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) systems for the treatment of intractable pain of the trunk or limbs.
Product codes (comma separated list FDA assigned to the subject device)
GZB, GZF
Device Description
The Medtronic Model 355531 Multi-Lead Trialing Cable serves as an electrical connection between an external, temporary power source (e.g. screener or external neurostimulators) and a Medtronic neurostimulation lead or extension.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trunk or limbs (for pain treatment with SCS/PNS systems)
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)
Design Verification and Design Validation: Design Verification Testing and Design Validation Testing were performed to support substantial equivalence to the predicate device. All specified design and performance requirements were met, and the device was found to meet the user needs and intended uses.
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.
The predicate device for the Medtronic Model 355531 Multi-Lead Trialing Cable is the currently available Medtronic Model 3550-03 OR Screener Cable (Twist Lock).
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
K102523
OCT 26 2010
510(k) Summary
| | Applicant's Name/Address: Medtronic Neuromodulation
7000 Central Ave., N.E.
Minneapolis, MN 55432 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Trishia Dwyer
Regulatory Affairs Specialist
Medtronic Neuromodulation
tel: (763) 526-3994
fax: (763) 526-6246
email: trishia.dwyer@medtronic.com |
| Date Prepared: | September 02, 2010 |
| Name of Device: | Medtronic Model 355531 Multi-Lead Trialing Cable |
| Common Name: | Cable |
| Classification Name: | GZB (21 CFR 882.5880)
GZF (21 CFR 882.5870) |
| Predicate Device: | The predicate device for the Medtronic Model 355531 Multi-Lead
Trialing Cable is the currently available Medtronic Model 3550-03
OR Screener Cable (Twist Lock). |
| Device Description: | The Medtronic Model 355531 Multi-Lead Trialing Cable serves as
an electrical connection between an external, temporary power
source (e.g. screener or external neurostimulators) and a Medtronic
neurostimulation lead or extension. |
| Intended Use: | The Medtronic Model 355531 Multi-Lead Trialing Cable (MLTC)
is indicated for use with Spinal Cord Stimulation (SCS) and
Peripheral Nerve Stimulation (PNS) systems for the treatment of
intractable pain of the trunk or limbs. |
| Summary of Testing | Design Verification and Design Validation: Design Verification
Testing and Design Validation Testing were performed to support
substantial equivalence to the predicate device. All specified design
and performance requirements were met, and the device was found
to meet the user needs and intended uses. |
1
Sterilization: The Model 355531 Multi-Lead Trialing Cable is labeled Sterile. The Model 355531 Multi-Lead Trialing Cable will be sterilized using the same 100% Ethylene Oxide (EtO) sterilization process as the predicate device.
Biocompatibility: All.device materials and 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 compliant with ISO 10993-1.
Substantial Equivalence
Testing and supporting documentation have demonstrated that the Model 355531 Multi-Lead Trialing Cable is substantially equivalent to the previously cleared Model 3550-03 OR Cable (Twist-Lock Screening Cable). There is no change to the indications, intended use, or technological characteristics.
A summary of the Device Characteristics is included in the table below:
| Description | Predicate Device:
Cleared 3550-03 OR
Screening Cable | Subject Device: Model
355531 Multi-Lead
Trialing Cable |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Market
Release
Information | K960631 | K102523 (Subject device) |
| Indications
for Use | The Medtronic Model
3550-03 OR Screening
Cable is indicated for use
with Spinal Cord
Stimulation (SCS) and
Peripheral Nerve
Stimulation (PNS)
systems for the treatment
of intractable pain of the
trunk or limbs. | The Medtronic Model
355531 Multi-Lead
Trialing Cable (MLTC) is
indicated for use with
Spinal Cord Stimulation
(SCS) and Peripheral
Nerve Stimulation (PNS)
systems for the treatment
of intractable pain of the
trunk or limbs.
(Equivalent) |
| Fundamental
Technology | External neurostimulation
delivered to the lead
electrodes. | External neurostimulation
delivered to the lead
electrodes.
(Equivalent) |
| Design | Houses a lead to facilitate
electrical connection | Houses multiple leads to
facilitate electrical |
2
| Description | Predicate Device:
Cleared 3550-03 OR
Screening Cable | Subject Device: Model
355531 Multi-Lead
Trialing Cable |
|-------------|------------------------------------------------------------|--------------------------------------------------------------|
| | between the ENS and the
lead. | connection between the
ENS and the leads. |
| Lead Slots | 1 octapolar
-8 active electrodes | 2 octapolar plus 4
quadrapolar
-16 active electrodes |
Conclusion
Through data and information presented, as well as similarity to legally marketed devices, Medtronic, Inc. considers the Model 355531 Multi-Lead Trialing Cable to be substantially equivalent to legally marketed devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCI 2 6 2010
Medtronic Neuromodulation c/o Ms. Trishia Dwyer Regulatory Affairs Specialist 7000 Central Ave., N.E. Minneapolis, MN 55432
Re: K102523
Trade Device Name: Medtronic Model 355531 Multi-Lead Trialing Cable Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Peripheral Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB. GZF Dated: September 24, 2010 Received: September 27, 2010
Dear Ms. Dwyer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
4
Page 2 - Ms. Trishia Dwyer
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Malvina B. Eydelman, MID Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Kio2523
Indications for Use 510(k) Number (if known): K
OCT 2 6 2010
Device Name: Medtronic® Model 355531 Multi-Lead Trialing Cable
Indications for Use: The Medtronic Model 355531 Multi-Lead Trialing Cable (MLTC) is indicated for use with Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) systems for the treatment of intractable pain of the trunk or limbs.
Prescription Use X (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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mythed Hiller
(Division Sign-Off)
Division of Ophosimic, Neurological and Ear, Nose and Throal Lievices
510(k) Number K102523