(62 days)
Not Found
No
The summary describes a mechanical device for securing leads/catheters and does not mention any AI/ML components or functions.
No
The device is described as an "accessory to the leads/catheter component" functioning to "secure the lead to the fascia or inter-spinous/supra-spinous ligament," indicating it plays a structural role in the placement of other therapeutic devices (Spinal Cord Stimulator/Pain Pump systems), rather than providing therapeutic action itself.
No
The device is an accessory (tissue band) intended to secure leads/catheters for Spinal Cord Stimulator/Pain Pump systems, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components made of suture material and anchors, and mentions a disposable delivery instrument. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the fiXate Tissue Band is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to secure leads/catheters of Spinal Cord Stimulator/Pain Pump systems to tissue (fascia or ligaments). This is a surgical accessory used in vivo (within the body) during a medical procedure.
- Device Description: The device is a physical construct (suture and anchors) designed for implantation and mechanical fixation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The fiXate Tissue Band does not perform any such function. It does not analyze biological samples or provide diagnostic information.
Therefore, the fiXate Tissue Band is a medical device used for surgical fixation, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GZB, GAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fascia or inter-spinous/supra-spinous ligament
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was completed in accordance with ISO 10993-1 standards. Tensile testing was performed to verify compliance with USP suture requirements and a comparison of fixation strength was completed to support the safety and effectiveness of the fiXate Tissue Band.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Anulex Technologies fiXate Tissue Band, FB-100-01 (K111462), Anulex Technologies fiXate Tissue Band, FB-101-01 (K112849), Anulex Technologies fiXate Tissue Band, FB-102-01 (K113400)
Reference Device(s)
Ethicon, Inc., Ethibond Suture
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Band | |
| Anulex Technologies, Inc. | |
| Confidential | Traditional 510(k) Premarket Notification |
| Page 50 |
1
| Functional and Safety
Testing: | Biocompatibility testing was completed in accordance with ISO
10993-1 standards. Tensile testing was performed to verify
compliance with USP suture requirements and a comparison of
fixation strength was completed to support the safety and
effectiveness of the fiXate Tissue Band. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate: | The fiXate Tissue Band that is the subject of this submission has
identical technological characteristics in comparison to the
previously cleared fiXate Tissue Band. The intended use is
unchanged, fixation of implant components to the fascia or inter-
spinous/supra-spinous ligament. |
| Conclusion: | Substantial equivalence is demonstrated through the detailed
device description, performance testing and conformance with
voluntary performance standards. |
.
2
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.
3
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
4
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
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