(97 days)
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No
The summary focuses on packaging and sterilization of accessories, with no mention of AI/ML or related concepts.
No
The document describes "spinal cord and peripheral nerve stimulation lead accessories," which are components for treatments but not therapeutic devices themselves. The focus is on their nonsterile packaging and instructions for sterilization by the user.
No
The document describes packaging for spinal cord and peripheral nerve stimulation lead accessories, focusing on their non-sterile nature and instructions for sterilization. There is no mention of the device being used for diagnosis or imaging.
No
The device description focuses entirely on the packaging of physical accessories (spinal cord and peripheral nerve stimulation lead accessories) and instructions for their sterilization. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for packaging of accessories for spinal cord and peripheral nerve stimulation leads. This relates to implantable medical devices used for therapeutic purposes, not for testing samples from the human body to diagnose conditions.
- Device Description: The description focuses on the packaging of nonsterile accessories and instructions for sterilization. This is related to the handling and preparation of medical devices for use in or on the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Medtronic considers nonsterile packaging of spinal cord and peripheral nerve stimulation lead accessories with appropriate labeling and instructions for sterilization by the user to be substantially equivalent in design, function, materials, and intended use to previous accessory devices.
Product codes
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Device Description
Packaging of the nonsterile accessories will be either in kits, as separate piece parts or in bulk packaging that in no way resembles sterile packaging. The word "Nonsterile " will be obviously displayed on the packaging and instructions for sterilization will be included in the labeling.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
spinal cord and peripheral nerve
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve 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
February 12, 1996
MAY 2 1 1996
RE: 510(k) Notification: Medtronic Model 3550 Accessories
In order to comply with the Safe Medical Devices Act of 1990, this one page will provide safety and effectiveness information to interested persons.
SUMMARY OF SAFETY AND EFFECTIVENESS
Medtronic considers nonsterile packaging of spinal cord and peripheral nerve stimulation lead accessories with appropriate labeling and instructions for sterilization by the user to be substantially equivalent in design, function, materials, and intended use to previous accessory devices. Packaging of the nonsterile accessories will be either in kits, as separate piece parts or in bulk packaging that in no way resembles sterile packaging. The word "Nonsterile " will be obviously displayed on the packaging and instructions for sterilization will be included in the labeling.
Sincerely,
MEDTRONIC, INC. Neurological Business
Juan Prather
Jean Prather Senior Clinical Research Associate