(62 days)
The fiXate Tissue Band is intended to be an accessory to the leads/catheter component of Spinal Cord Stimulator/Pain Pump 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 (UHMWPE or PET (coated or uncoated) ) with two (2) attached anchors (PEEK Optima LT1 or PET). 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 a breakdown of the acceptance criteria and study information for the fiXate Tissue Band, based on the provided K113805 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K113805) describes functional and safety testing as part of the submission to demonstrate substantial equivalence, rather than setting specific numerical acceptance criteria for a direct comparison table. Instead, it relies on conformance to established standards and comparison to a predicate device.
| Acceptance Criteria Category | Description of Performance/Testing Conducted |
|---|---|
| Biocompatibility | Completed in accordance with ISO 10993-1 standards. |
| Tensile Strength | Performed to verify compliance with USP suture requirements. |
| Fixation Strength | Comparison completed to support the safety and effectiveness of the fiXate Tissue Band against the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state a specific sample size for the "test set." It mentions "tensile testing" and "comparison of fixation strength," which implies testing on a certain number of devices or components. However, the exact number is not provided.
- Data Provenance: The nature of the tests (biocompatibility, tensile, and fixation strength) suggests these were prospective bench tests performed in a laboratory setting. There is no indication of country of origin for test data, but given the US submission, it's reasonable to assume the testing was conducted per US regulatory guidance or by labs compliant with such. There is no mention of patient data (retrospective or prospective) for this specific submission as it appears to be focused on physical and material properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This type of information is generally not applicable to the non-clinical, bench testing described in this 510(k). The "ground truth" for biocompatibility is conformance to ISO standards, for tensile strength it's USP suture requirements, and for fixation strength, it's a comparative assessment against a predicate device's established performance. These are objective measures rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set:
Not applicable. The tests described are objective physical and chemical evaluations, not subjective clinical assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The fiXate Tissue Band is a surgical accessory, and its evaluation relies on bench testing and comparison of its physical properties to predicate devices.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant/accessory, not a software algorithm or AI-driven system.
7. Type of Ground Truth Used:
- Biocompatibility: Conformance to ISO 10993-1 standards.
- Tensile Strength: Compliance with USP (United States Pharmacopeia) suture requirements.
- Fixation Strength: Comparative data against the previously cleared fiXate Tissue Band (predicate devices) to demonstrate comparable safety and effectiveness.
Essentially, the "ground truth" for these tests are established engineering and material science standards, and the performance characteristics of an already cleared, substantially equivalent device.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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FEB 2 3 2012
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: 952.224.4034 | |
| Fax: 952.224.4040 | |
| E-Mail: rkennedy@anulex.com | |
| Date Prepared: | February 21, 2012 |
| 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 following predicate devices: |
| Anulex Technologies fiXate Tissue Band, FB-100-01 (K111462 cleared September 8, 2011)Anulex Technologies fiXate Tissue Band, FB-101-01 (K112849 cleared October 27, 2011)Anulex Technologies fiXate Tissue Band, FB-102-01 (K113400 cleared December 16, 2011)Ethicon, Inc., Ethibond Suture | |
| Device Description: | The fiXate Tissue Band consists of an adjustable loop of non- absorbable 2-0 suture (UHMWPE or PET (coated or uncoated) ) with two (2) attached anchors (PEEK Optima LT1 or PET). 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. |
| Indications for Use: | The fiXate Tissue Band is intended to be an accessory to the leads/catheter component of Spinal Cord Stimulator/Pain Pump systems functioning to secure the lead to the fascia or inter- spinous/supra-spinous ligament. |
| fiXate Tissue BandAnulex Technologies, Inc.Confidential | Traditional 510(k) Premarket NotificationPage 50 |
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| Functional and SafetyTesting: | Biocompatibility testing was completed in accordance with ISO10993-1 standards. Tensile testing was performed to verifycompliance with USP suture requirements and a comparison offixation strength was completed to support the safety andeffectiveness of the fiXate Tissue Band. |
|---|---|
| Comparison to Predicate: | The fiXate Tissue Band that is the subject of this submission hasidentical technological characteristics in comparison to thepreviously cleared fiXate Tissue Band. The intended use isunchanged, fixation of implant components to the fascia or inter-spinous/supra-spinous ligament. |
| Conclusion: | Substantial equivalence is demonstrated through the detaileddevice description, performance testing and conformance withvoluntary performance standards. |
.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized emblem featuring three horizontal bars that curve downwards, resembling a stylized human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 3 2012
Anulex Technologies, Inc. % Ms. Rachel Kennedy Director, Regulatory Affairs and Quality Systems 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
Re: K113805
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: December 22, 2011 Received: December 23, 2011
Dear Ms. Kennedy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the 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, do need that have been require approval of a premarket approval application (PMA). und Cosmetter Free (110) in the device, subject to the general controls provisions of the Act. The I va may , ateres, and seconding of the Act include requirements for annual registration, listing of general voltarely provincities, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Trious now, 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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Page 2 - Ms. Rachel Kennedy
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devised that i Drivision that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must or any I edelar statures and regaranents, 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 de rice-related daverse overses (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality of trovisions (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 11 you desire specific ad 1100 to 100 for your contrices/CDRH/CDRHOffices/ucm115809.htm for go to hap. W . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation onlined, "ins 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 Tou may 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K113805
p. 1 of 1
Appendix 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/catheter component of Spinal The I risue Pana Danaman functioning to secure the lead to the fascia or interspinous/supra-spinous ligament.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)
Daniel Kramer MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113805
Traditional 510(k) Premarket Notification
fiXate Tissue Band Anulex Technologies, Inc. Confidential
Page 52
§ 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).