(105 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.
Here's an analysis of the provided information regarding the fiXate Tissue Band (K111462) from the perspective of acceptance criteria and supporting studies:
Based on the provided K111462 summary, there is no specific performance study involving a test set, ground truth established by experts, or AI performance reported. This device clearance is based on substantial equivalence to predicate devices, supported by functional and safety (benchtop) testing and biocompatibility assessments.
Therefore, I cannot populate most of the requested fields as they pertain to clinical or algorithm performance studies that were not conducted or reported in this 510(k) summary.
However, I can extract information relevant to the device's functional and safety testing, which implicitly serves as the "study that proves the device meets acceptance criteria" within the context of a 510(k) based on substantial equivalence.
Acceptance Criteria and Device Performance (Based on Provided Information)
| Acceptance Criteria (Implied by Substantial Equivalence and Testing) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Biocompatibility: Device materials must be biocompatible and safe for implantation. | Biocompatibility testing was completed and supports the safety of the fiXate Tissue Band. (Specific results or standards not detailed in summary). |
| Functional Performance (Bench Testing): Device must perform as intended (e.g., secure lead, maintain integrity). | Bench testing was completed and supports the safety and effectiveness of the fiXate Tissue Band. (Specific tests, acceptance criteria, or quantitative results not detailed in summary). |
| Similar Intended Use: Must have the same intended use as predicate devices. | The fiXate Tissue Band has the same intended use as the predicate Advanced Neuromodulation Systems Swift-Lock Anchor (K092371). |
| Similar Materials: Must use similar materials to predicate devices. | The fiXate Tissue Band is similar in materials to the predicate Versaclose and Xclose Plus Tissue Repair Systems. |
| Similar Design: Must have a similar design to predicate devices. | The fiXate Tissue Band is similar in design to the predicate Versaclose and Xclose Plus Tissue Repair Systems. |
| Similar Performance Characteristics: Must exhibit similar performance to predicate devices. | The fiXate Tissue Band is similar in performance characteristics to the predicate Versaclose and Xclose Plus Tissue Repair Systems. |
Explanation of "Acceptance Criteria" in this Context: For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are generally met when the new device can demonstrate that it is as safe and effective as a legally marketed predicate device. This is primarily achieved through showing similarity in intended use, technology, design, materials, and performance characteristics, often supported by bench testing and biocompatibility studies rather than complex clinical efficacy trials. The "reported device performance" is essentially the conclusion that these similarities have been demonstrated.
Additional Study Information (Based on Provided Document)
- Sample size used for the test set and the data provenance: Not applicable. The summary mentions "bench testing" but does not provide details on sample sizes or data provenance. This is typical for bench-top mechanical/functional tests, which are not usually reported with "test sets" in the clinical sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert-established ground truth was reported.
- Adjudication method for the test set: Not applicable. No clinical test set requiring adjudication was reported.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device, and no MRMC study was reported.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device, and no algorithm-only performance study was reported.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was used or reported. The "ground truth" for this device's clearance is its demonstrated equivalence to known safe and effective predicate devices, supported by engineering tests.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
Summary of Device Evaluation for K111462:
The fiXate Tissue Band received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (Anulex Technologies Versaclose, Anulex Technologies Xclose™ Tissue Repair System, and Advanced Neuromodulation Systems Swift-Lock Anchor). The "study" proving it meets acceptance criteria consists of:
- Bench Testing: To assess functional performance, safety, and mechanical properties.
- Biocompatibility Testing: To ensure the materials are safe for implantation.
- Comparative Analysis: A detailed comparison of the new device's intended use, materials, design, and performance characteristics with those of the predicate devices.
The conclusion drawn by the FDA is that these tests and comparisons demonstrate the new device is as safe and effective as the predicates, thereby meeting the requirements for 510(k) clearance. Clinical studies involving human subjects with defined test sets, expert ground truth, or AI performance metrics were not part of this submission's basis for clearance.
{0}------------------------------------------------
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SEP - 8 2011
ﺮ
ones no version contract controllation of the contribution and the comments of the comments of the lines of the lines of the lines of the lines of the line of the lines of th
Appendix 3: 510(k) Summary
As Required by 21 CFR 807.92
..............................................................................................................................................................................
| Submitter: | Anulex Technologies, Inc. |
|---|---|
| 5600 Rowland Road, Suite 280 | |
| Minnetonka, MN 55343 | |
| Contact Person: | Rachel Kennedy |
| Director, Regulatory Affairs and Quality Systems | |
| Anulex Technologies, Inc. | |
| Direct: 952.224.4034Fax: 952.224.4040E-Mail: rkennedy@anulex.com | |
| Date Prepared: | May 25, 2011 |
| Trade Name: | fiXate Tissue Band |
| Classification: | II |
| Product Code: | GZB |
| 21 CFR 882.5880 | |
| Predicate Device(s): | The subject device is substantially equivalent to the followingpredicate devices: |
| ● Anulex Technologies Versaclose(K100572 cleared March 17, 2010)● Anulex Technologies Xclose™ Tissue Repair System(K091432 cleared June 12, 2009)● Advanced Neuromodulation Systems Swift-Lock Anchor(K092371 cleared December 23, 2009) | |
| 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. |
{1}------------------------------------------------
Conclusion:
The fiXate Tissue Band is similar in intended use, materials, design, and performance characteristics to the Versaclose and Xclose Plus Tissue Repair Systems (K100572 and K091432) and has the same intended use as Advanced Neuromodulation Systems Swift-Lock Anchor (K092371). Substantial equivalence is demonstrated through the detailed device description, performance testing and conformance with voluntary performance standards.
S - 55 - 5
{2}------------------------------------------------
Image /page/2/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 lines representing its wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Anulex Technologies, Inc. c/o Ms. Rachel Kennedy Director of Regulatory Affairs & Quality Systems 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
- 8 2011
Re: K111462
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: August 2, 2011 Received: August 3, 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.
{3}------------------------------------------------
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 (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/CDRH0ffices/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.
Melvin R. Feldheim, M.D.
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
{4}------------------------------------------------
.
Indications for Use Form
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 inter-spinous/supra-spinous/ligament.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KRISTEN OW SHER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(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).