(23 days)
Not Found
No
The description focuses on electronic circuitry for decoding and converting programming data into stimulation pulses, with no mention of AI or ML terms or functionalities.
Yes.
The "Intended Use / Indications for Use" states that the device is "indicated for the treatment of chronic pain of the trunk and limbs," which directly identifies it as a therapeutic device.
No
The device is described as a treatment device for chronic pain, not a device used to diagnose a condition.
No
The device description explicitly states it contains electronic circuitry and is hermetically encapsulated, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of chronic pain of the trunk and limbs." This is a therapeutic use, not a diagnostic one.
- Device Description: The description details electronic circuitry for generating stimulation pulses, which is consistent with a therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro examination, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is designed to directly treat a condition within the body.
N/A
Intended Use / Indications for Use
ANS Renew Receivers are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Receivers are intended to be used with Advanced Neuromodulation System', leads, extensions, transmitters and antennae.
Product codes
GZB
Device Description
Renew Receiver contains electronic circuitry that decodes and converts programming data into stimulation pulses. The circuitry is hermetically and encapsulated in enoxy. The lead connection adapter, header, on the receiver is covered and sealed with biocompatible silicone rubber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trunk and 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
Non-clinical Testing: Biocompatibility testing of the material is provided in the manufacturer's Master file. Verification testing was performed as required by the risk analysis for this modification. The results demonstrated that the acceptance criteria were met for Impedance testing. Master file biocompatibility information combined with verification testing performed by Advanced Neuromodulation Systems, Inc. demonstrates that the change raises no significant safety or effectiveness questions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the letters 'ANS' in a bold, sans-serif font. To the left of the letters is a square grid pattern, composed of smaller squares. The letters and the grid are all in black, contrasting with the white background.
Page 1 of 3
510 (k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared:
August 16, 1999
Company:
Advanced Neuromodulation Systems, Inc. 6501 Windcrest, Suite 100 Plano, Texas 75024
Contact: Phone: Fax Number:
Katryna Warren 972-309-8000 ext. 8109 972-309-8150
1
Image /page/1/Picture/0 description: The image shows the logo for ANS, which is a professional organization for people in the nuclear industry. The logo consists of a grid of squares on the left, followed by the letters "ANS" in bold, sans-serif font. The grid of squares is likely meant to represent the structure of a nuclear reactor core. The logo is simple and modern, and it effectively communicates the organization's focus on nuclear science and technology.
Page 2 of 3
Renew Receiver 510(k) Summary of Safety and Effectiveness
Device Information:
| Trade Names: | Renew Receiver Model 3408
Renew Receiver Model 3416 |
|----------------------|----------------------------------------------------------------------|
| Common Name: | Spinal Cord Stimulator |
| Classification Name: | Implanted Spinal Cord Stimulator for Pain Relief |
Predicate Device:
Advanced Neuromodulation Systems, Inc., currently markets Octrode Neurostim Receiver under 510(k) # K930536 and Renew Lead Extension under 510(k) # K991784.
Device Description:
Renew Receiver contains electronic circuitry that decodes and converts programming data into stimulation pulses. The circuitry is hermetically and encapsulated in enoxy. The lead connection adapter, header, on the receiver is covered and sealed with biocompatible silicone rubber.
Intended Use:
ANS Renew Receivers are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Receivers are intended to be used with Advanced Neuromodulation System', leads, extensions, transmitters and antennae.
Comparison To Predicate device:
The following table illustrates the comparison between the modified device, and the original legally marketed devices.
000031
2
Image /page/2/Picture/0 description: The image shows the logo for ANS, which is a company or organization. The logo consists of a grid of small squares on the left, followed by the letters "ANS" in a bold, sans-serif font. The letters are large and prominent, making them the focal point of the logo. The grid of squares adds a visual element to the logo, possibly representing a network or structure.
Page 3of 3
| | ANS Predicate Device
510(k) K930536, K991784 | ANS Modified Device
K# Under Review |
|----------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use: | Stimulation of spinal cord for
treatment of chronic pain of
the trunk and limbs. | Stimulation of spinal cord for
treatment of chronic pain of
the trunk and limbs. |
| Materials: | | |
| • Connector Coating: | Silicone, 40076
(K991784)
Silicone
(K930536) | 40076 |
| • Contact Terminal: | Platinum/Iridium
(K991784) | Platinum/Iridium |
| • Connector Header | Silicone | Silicone |
| Design Features: | 4, 8, and 16 Channel
(K930536) | 4,8, and 16 Channel |
| | Percutaneous Introduction
(K930536) | Percutaneous Introduction |
| Dimensions: | 1.75" x .43" | 35mm(1.4") x 11mm (0.414") |
| Sterilization: | 100% ETO | 100% ETO |
| | | |
| | Sterility Assurance Level
(SAL) 1 x $10^{-6}$ | Sterility Assurance Level
(SAL) 1 x $10^{-6}$ |
| Packaging: | Tray w/ Tyvek Lid | Tray w/ Tyvek Lid |
| Labeling: | Labeled as sterile, prescription
device | Labeled as sterile, prescription
device |
Non-clinical Testing:
Biocompatibility testing of the material is provided in the manufacturer's Master file. Verification testing was performed as required by the risk analysis for this modification. The results demonstrated that the acceptance criteria were met for Impedance testing.
Master file biocompatibility information combined with verification testing performed by Advanced Neuromodulation Systems, Inc. demonstrates that the change raises no significant safety or effectiveness questions.
Image /page/2/Picture/7 description: The image shows the number 000032. The numbers are in a bold, sans-serif font. The numbers are black against a white background.
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 depiction of an eagle or bird with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Ms. Katryna Warren Senior Regulatory Specialist Advanced Neuromodulation Systems, Inc. 6501 Windcrest Drive. Suite 100 Plano, Texas 75024
Re: K992946 Trade Name: Renew Receiver Regulatory Class: II Product Code: GZB Dated: August 31, 1999 Received: September 1, 1999
Dear Ms. Warren:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 – Ms. Katryna Warren
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known):
Device Name: Renew Receiver
Indications For Use:
ANS Renew Receivers are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Receivers are intended to be used with Advanced Neuromodulation System', leads, extensions, transmitters and antennae.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992946 |
| Prescription Use (Per 21 CFR 801/109) | X | Or | Over-The-Counter Use | _ |
|---|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- | --- |