FIXATE TISSUE BAND

K112849 · Anulex Technologies, Inc. · GZB · Oct 27, 2011 · Neurology

Device Facts

• Record ID: K112849
• Device Name: FIXATE TISSUE BAND
• Applicant: Anulex Technologies, Inc.
• Product Code: GZB · Neurology
• Decision Date: Oct 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5880
• Device Class: Class 2

Indications for Use

The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

Device Story

The fiXate Tissue Band is a mechanical fixation device used to secure spinal cord stimulator leads to patient tissue. It consists of an adjustable loop of non-absorbable 2-0 suture with two attached T-anchors. The device is provided sterile and preloaded on a disposable delivery instrument. During a surgical procedure, a physician uses the delivery instrument to place the T-anchors into the sub-layer of the fascia or inter-spinous/supra-spinous ligament. This secures the lead in place, preventing migration and potentially improving the long-term efficacy of the spinal cord stimulation therapy. The device is intended for use by clinicians in a surgical setting.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Non-absorbable 2-0 suture loop with two T-anchors; disposable delivery instrument; sterile; mechanical fixation principle.

Indications for Use

Indicated for use as an accessory to spinal cord stimulator leads to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

Regulatory Classification

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.

Predicate Devices

• Anulex Technologies fiXate Tissue Band (K111462)

Submission Summary (Full Text)

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K112849

OCT 2 7 2011

## Section 5 - 510(k) Summary

As Required by 21 CFR 807.92

. .

| Submitter: | Anulex Technologies, Inc.<br>5600 Rowland Road, Suite 280<br>Minnetonka, MN 55343 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rachel Kennedy<br>Director, Regulatory Affairs and Quality Systems<br>Anulex Technologies, Inc.<br>Direct: 952.224.4034<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Prepared: | September 27, 2011 |
| Trade Name: | fiXate Tissue Band |
| Classification: | II |
| Product Code: | GZB<br>21 CFR 882.5880 |
| Predicate Device(s): | The subject device is substantially equivalent to the following<br>predicate device: |
| | • Anulex Technologies fiXate Tissue Band<br>(K111462 cleared September 8, 2011) |
| Device Description: | The fiXate Tissue Band consists of an adjustable loop of non-<br>absorbable 2-0 suture with two (2) attached anchors. The<br>construct is provided sterile and preloaded on a disposable<br>delivery instrument. The instrument's needle facilitates<br>placement of the suture by positioning the T-anchors in the sub-<br>layer of tissue. |
| Indications for Use: | The fiXate Tissue Band is intended to be an accessory to the<br>leads component of Spinal Cord Stimulator systems functioning<br>to secure the lead to the fascia or inter-spinous/supra-spinous<br>ligament. |
| Functional and Safety<br>Testing: | Biocompatibility and bench testing were completed and support<br>the safety and effectiveness of the fiXate Tissue Band. |
| Conclusion: | The fiXate Tissue Band is similar in materials, design, and<br>performance characteristics and has the same intended use as the<br>original fiXate Tissue Band (K111462). Substantial equivalence<br>is demonstrated through the detailed device description,<br>performance testing and conformance with voluntary<br>performance standards. |

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Image /page/1/Picture/11 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its head. The text "DEPARTMENT OF HEALTH & HU" is arranged vertically along the left side of the logo.

Food and-Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 27 2011

Ms. Rachel Kennedy Director of Regulatory Affairs & Ouality Systems Anulex Technologies, Inc. 5600 Rowland Road, Suite 280 Minnetonka, MN 55343

Re: K112849

Trade/Device Name: fiXate Tissue Band Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Codes: GZB and GAT Dated: September 28, 2011 Received: September 29, 2011

Dear Ms. Kennedy:

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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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 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/ucm115809.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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eula Tenenbaum

Malvina B. Eydelman, M.D. 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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K112849

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## Indications for Use Statement

Device Name: fiXate Tissue Band

## Indications for Use:

The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or interspinous/supra-spinous ligament.

| Prescription Use | X |
|-------------------------------|---|
| (Part 21 CFR 801 Subpart D C) | |

AND/OR

| Over-The-Counter | |
|---------------------|--|
| (21 CFR 801 Subpart | |

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

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Kristen Bowsher

Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K 112849 SI((k) Number_