(71 days)
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No
The document describes a lead extension for a spinal cord stimulation system and does not mention any AI or ML capabilities.
Yes
The device is described as a component of a spinal cord stimulation system used for the treatment of chronic pain, which is a therapeutic application.
No
The device is described as a lead extension component for a spinal cord stimulation system used in the treatment of chronic pain. Its function is to facilitate stimulation, not to diagnose a condition.
No
The device description explicitly states it is a "Lead Extension" and lists compatible hardware components (leads, receiver, transmitter), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a lead extension for a spinal cord stimulation system used in the treatment of chronic pain. This is a therapeutic device that is implanted in the body to deliver electrical stimulation.
- Device Description: The description details its use with other components of a spinal cord stimulation system, all of which are therapeutic devices.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such testing or analysis of biological samples.
Therefore, the ANS® A127 Lead Extension is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ANS® A127 Lead Extension is designed to be utilized as the lead extension component of a spinal cord stimulation system (SCS) and is indicated for spinal cord stimulation in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The A127 Lead Extension Models 2341, 2342, 2343 and 2346 are designed to be used with the following devices:
Micronet Axxess™ Lead Model 8000, 8100 and 8200 series
Medtronic Pisces Quad® Lead Model 3487
Medtronic Pisces Quad® Plus Lead Model 3888
Medtronic Pisces Quad® Compact Lead Model 3887
Medtronic SpecifyTM Lead Model 3998
Medtronic Resume® II Lead Model 3587A
ANS Renew® Receiver Model 3408
ANS Renew® Transmitter Model 3508
Product codes
GZB
Device Description
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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
Trunk and limbs (for chronic pain treatment via spinal cord stimulation)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2003
Rashmi Moza Regulatory Affairs Specialist Advanced Neuromodulation Systems, Inc. 6501 Windcrest Drive, Suite 100 Plano, Texas 75024
Re: K030461
Trade/Device Name: A127 Lead Extension Models 2341, 2342, 2343 and 2346 Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: February 11, 2003 Received: February 12, 2003
Dear Ms. Moza:
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
1
Page 2 - Ms. Rashmi Moza
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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
h Mark n Millenn
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
2
510(k) Number:
Device Name: A127 Lead Extension
Indications for Use:
The ANS® A127 Lead Extension is designed to be utilized as the lead extension component of a spinal cord stimulation system (SCS) and is indicated for spinal cord stimulation in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The A127 Lead Extension Models 2341, 2342, 2343 and 2346 are designed to be used with the following devices:
Micronet Axxess™ Lead Model 8000, 8100 and 8200 series Medtronic Pisces Quad® Lead Model 3487 Medtronic Pisces Quad® Plus Lead Model 3888 Medtronic Pisces Quad® Compact Lead Model 3887 Medtronic SpecifyTM Lead Model 3998 Medtronic Resume® II Lead Model 3587A ANS Renew® Receiver Model 3408 ANS Renew® Transmitter Model 3508
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use y (Per 21 CFR 801.109)
O
Over-The-Counter Use
h Mark N Milkers
Division Sign-Off
ion of General, Restorative and Neurological Devices
Or
510(k) Number K030461