(29 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.
The provided text is a 510(k) summary for the fiXate Tissue Band and does not contain detailed information about specific acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy. The summary focuses on demonstrating substantial equivalence to a predicate device.
However, based on the information provided, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or detailed performance metrics are reported in this document. The document states "Biocompatibility and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band." This indicates that some form of testing was done to ensure safety and effectiveness, but the specific criteria and results are not detailed.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document does not describe a clinical study or a test set involving patient data where such information would typically be relevant. The testing mentioned appears to be bench testing and biocompatibility testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No expert review or ground truth establishment relevant to an AI/diagnostic device performance study is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document does not describe an MRMC study or any study where human readers' performance with and without AI assistance was evaluated.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. The fiXate Tissue Band is a physical medical device (an accessory to Spinal Cord Stimulator systems), not an algorithm or AI device. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used:
Not applicable. As this is not an AI/diagnostic device, the concept of "ground truth" in that context does not apply. The "ground truth" for a physical device like this would be its physical properties, biocompatibility, and mechanical performance, established through bench testing and material analyses.
8. The Sample Size for the Training Set:
Not applicable. As this is a physical medical device, not an algorithm or AI device, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set is involved.
Summary of what is available from the document regarding "acceptance criteria" and "study":
- Acceptance Criteria (Implied): The implied acceptance criteria for the fiXate Tissue Band are related to its safety and effectiveness, as demonstrated through biocompatibility and bench testing. The key "acceptance" was the FDA's determination of substantial equivalence to existing predicate devices (K111462 and K112849). This means the device was found to be as safe and effective as the previously cleared devices.
- Study: The document mentions that "Biocompatibility and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band." This refers to non-clinical studies evaluating the material properties and mechanical performance of the physical device. Specific details about these tests, their protocols, or results are not included in this summary.
In essence, this 510(k) summary focuses on demonstrating that the fiXate Tissue Band is a modified version of an already cleared device and meets the necessary non-clinical standards for safety and performance, rather than presenting a clinical study with detailed performance metrics.
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DEC 1 6 2011
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: 952.224.5417E-Mail: rkennedy@anulex.com |
| Date Prepared: | November 15, 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 device: |
| Device Description: | Anulex Technologies fiXate Tissue Band(K111462 cleared September 8, 2011 and K112849cleared October 27, 2011) 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/1 description: The image shows the seal for the Department of Health & Human Services (USA). The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract image of an 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 and Quality Systems 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
Re: K113400
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 Code: GZB, GAT Dated: November 16, 2011 Received: November 17, 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.
DEC 1 6 2011
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Page 2 - Ms. Rachel Kennedy
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/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/ReportaProblem/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. Felder, Jr.
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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- Andications 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 on ipters. spinous/supra-spinous ligament.
| Prescription Use | X |
|---|---|
| Use |
(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
510(k) Number_11 3 4 00
§ 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).