(28 days)
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.
The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.
This 510(k) pertains to a medical device, the fiXate Tissue Band, which is an accessory to Spinal Cord Stimulator systems. This type of device does not typically involve AI/ML components or require the extensive validation studies for diagnostic accuracy that are common in AI/ML submissions. Therefore, many of the requested elements (e.g., test set sample size, ground truth establishment, MRMC studies, training set details) are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" for diagnostic performance, as it is a physical medical device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device through functional and safety testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Completed and supports safety and effectiveness |
| Bench Testing | Completed and supports safety and effectiveness |
| Materials | Similar to predicate device (K111462) |
| Design | Similar to predicate device (K111462) |
| Performance Characteristics | Similar to predicate device (K111462) |
| Intended Use | Same as predicate device (K111462) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a physical medical device submission, not a diagnostic algorithm. Performance was evaluated through biocompatibility and bench testing, not through a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this device. Safety and effectiveness are evaluated through engineering and biological testing.
4. Adjudication Method for the Test Set
Not applicable. See above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This device is not an AI/ML diagnostic tool, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
Not applicable. Evaluation relies on established engineering and biocompatibility standards, not diagnostic ground truth.
8. The Sample Size for the Training Set
Not applicable. This device does not involve an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See above.
Study Proving the Device Meets Acceptance Criteria:
The submission states: "Biocompatibility and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band." It further concludes: "The fiXate Tissue Band is similar in materials, design, and performance characteristics and has the same intended use as the original fiXate Tissue Band (K111462). Substantial equivalence is demonstrated through the detailed device description, performance testing and conformance with voluntary performance standards."
The study that proves the device meets the (implied) acceptance criteria is the biocompatibility and bench testing. The details of these tests (e.g., specific protocols, results, number of samples tested for each bench test) are not provided in this 510(k) summary but would have been submitted to the FDA as part of the full application. The key outcome presented is that these tests confirmed the device is safe and effective and that it is substantially equivalent to its predicate device (K111462).
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OCT 2 7 2011
Section 5 - 510(k) Summary
As Required by 21 CFR 807.92
. .
| Submitter: | Anulex Technologies, Inc.5600 Rowland Road, Suite 280Minnetonka, MN 55343 |
|---|---|
| Contact Person: | Rachel KennedyDirector, Regulatory Affairs and Quality SystemsAnulex Technologies, Inc.Direct: 952.224.4034Fax: 952.224.4040E-Mail: rkennedy@anulex.com |
| Date Prepared: | September 27, 2011 |
| Trade Name: | fiXate Tissue Band |
| Classification: | II |
| Product Code: | GZB21 CFR 882.5880 |
| Predicate Device(s): | The subject device is substantially equivalent to the followingpredicate device: |
| • Anulex Technologies fiXate Tissue Band(K111462 cleared September 8, 2011) | |
| Device Description: | The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. Theconstruct is provided sterile and preloaded on a disposabledelivery instrument. The instrument's needle facilitatesplacement of the suture by positioning the T-anchors in the sub-layer of tissue. |
| Indications for Use: | The fiXate Tissue Band is intended to be an accessory to theleads component of Spinal Cord Stimulator systems functioningto secure the lead to the fascia or inter-spinous/supra-spinousligament. |
| Functional and SafetyTesting: | Biocompatibility and bench testing were completed and supportthe safety and effectiveness of the fiXate Tissue Band. |
| Conclusion: | The fiXate Tissue Band is similar in materials, design, andperformance characteristics and has the same intended use as theoriginal fiXate Tissue Band (K111462). Substantial equivalenceis demonstrated through the detailed device description,performance testing and conformance with voluntaryperformance 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 (800) 638-2041 or (301) 796-7100 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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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)
Kristen Bowsher
Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K 112849 SI((k) Number_
§ 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).