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.

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.

AI/ML Overview

The provided submission describes the Medtronic Model 355531 Multi-Lead Trialing Cable and its substantial equivalence to a predicate device. The primary focus of the testing detailed is on verifying design and performance requirements, as well as biocompatibility and sterilization, rather than clinical performance metrics in the way an AI/ML device would be evaluated.

Here's an analysis based on the information provided, addressing your requested categories where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Design Verification Testing	All specified design and performance requirements were met.
Design Validation Testing	The device was found to meet user needs and intended uses.
Sterilization (100% Ethylene Oxide (EtO))	The device is labeled Sterile and will use the same 100% Ethylene Oxide (EtO) sterilization process as the predicate device.
Biocompatibility (consistent with ISO 10993)	All device materials and components were assessed and found to be compliant with ISO 10993-1.
Indications for Use	The indications for use are equivalent to the predicate device: treatment of intractable pain of the trunk or limbs via SCS and PNS systems.
Fundamental Technology	The fundamental technology is equivalent to the predicate device: external neurostimulation delivered to lead electrodes.
Lead Slots/Design	The subject device facilitates electrical connection between ENS and multiple leads (2 octapolar plus 4 quadrapolar; 16 active electrodes), which is a design difference from the predicate's single octapolar lead (8 active electrodes), but this difference does not negate substantial equivalence based on the provided text.

2. Sample size used for the test set and the data provenance

The document indicates "Design Verification Testing and Design Validation Testing were performed," and "All materials were found to be compliant with ISO 10993-1" for biocompatibility. However, no specific sample sizes for these tests are mentioned. The provenance of this test data (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This submission describes a medical device (a cable) for which performance is assessed through engineering and biological testing (sterilization, biocompatibility), rather than clinical performance requiring expert ground truth in the context of diagnoses or interpretations. Therefore, this question is not applicable in the context of this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

As the study focuses on design verification, validation, and material compliance rather than clinical interpretation or diagnostic accuracy, an adjudication method for a test set (like 2+1) is not applicable. The "ground truth" for these tests would be established by engineering standards, material specifications, and regulatory requirements (e.g., ISO 10993).

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

No MRMC comparative effectiveness study was done. This device is a passive electrical cable, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance. Therefore, this question is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No standalone performance study of an algorithm was done. This is a hardware device (a cable), and the concept of an "algorithm only" performance is not relevant. Therefore, this question is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" for evaluation is based on:

Engineering specifications and performance requirements: For design verification and validation testing.
International standards (e.g., ISO 10993-1): For biocompatibility.
Established sterilization protocols: For sterilization efficacy.

It does not rely on expert consensus, pathology, or outcomes data in the clinical sense, as it is a component device and not a diagnostic or treatment system with direct clinical interpretative output.

8. The sample size for the training set

This device is not an AI/ML model, so the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established

This device is not an AI/ML model, so the concept of a "training set ground truth" is not applicable.

Summary

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K102523
OCT 26 2010

510(k) Summary

	Applicant's Name/Address: Medtronic Neuromodulation7000 Central Ave., N.E.Minneapolis, MN 55432
Contact:	Trishia DwyerRegulatory Affairs SpecialistMedtronic Neuromodulationtel: (763) 526-3994fax: (763) 526-6246email: 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-LeadTrialing Cable is the currently available Medtronic Model 3550-03OR Screener Cable (Twist Lock).
Device Description:	The Medtronic Model 355531 Multi-Lead Trialing Cable serves asan electrical connection between an external, temporary powersource (e.g. screener or external neurostimulators) and a Medtronicneurostimulation lead or extension.
Intended Use:	The Medtronic Model 355531 Multi-Lead Trialing Cable (MLTC)is indicated for use with Spinal Cord Stimulation (SCS) andPeripheral Nerve Stimulation (PNS) systems for the treatment ofintractable pain of the trunk or limbs.
Summary of Testing	Design Verification and Design Validation: Design VerificationTesting and Design Validation Testing were performed to supportsubstantial equivalence to the predicate device. All specified designand performance requirements were met, and the device was foundto meet the user needs and intended uses.

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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 ORScreening Cable	Subject Device: Model355531 Multi-LeadTrialing Cable
MarketReleaseInformation	K960631	K102523 (Subject device)
Indicationsfor Use	The Medtronic Model3550-03 OR ScreeningCable is indicated for usewith Spinal CordStimulation (SCS) andPeripheral NerveStimulation (PNS)systems for the treatmentof intractable pain of thetrunk or limbs.	The Medtronic Model355531 Multi-LeadTrialing Cable (MLTC) isindicated for use withSpinal Cord Stimulation(SCS) and PeripheralNerve Stimulation (PNS)systems for the treatmentof intractable pain of thetrunk or limbs.(Equivalent)
FundamentalTechnology	External neurostimulationdelivered to the leadelectrodes.	External neurostimulationdelivered to the leadelectrodes.(Equivalent)
Design	Houses a lead to facilitateelectrical connection	Houses multiple leads tofacilitate electrical

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Description	Predicate Device:Cleared 3550-03 ORScreening Cable	Subject Device: Model355531 Multi-LeadTrialing Cable
	between the ENS and thelead.	connection between theENS and the leads.
Lead Slots	1 octapolar-8 active electrodes	2 octapolar plus 4quadrapolar-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.

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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.

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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

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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

Regulation Number and Section

§ 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).