(29 days)
Not Found
No
The summary describes a purely mechanical device for securing leads and makes no mention of AI or ML.
No.
The device is described as an "accessory to the leads component of Spinal Cord Stimulator systems" and functions to secure the lead. It does not directly provide therapy or affect the body's function in a therapeutic way itself.
No
The provided text explicitly states the device 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." This describes a supportive, mechanical function, not one involved in diagnosing a medical condition.
No
The device description clearly states it consists of a physical suture, anchors, and a delivery instrument, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to a Spinal Cord Stimulator system, functioning to secure a lead to tissue. This is a surgical/implantable device intended for use in vivo (within the body).
- Device Description: The description details a suture and anchors for tissue fixation, which is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
GZB, GAT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
DEC 1 6 2011
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: 952.224.5417
E-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 following
predicate device: |
| Device Description: | Anulex Technologies fiXate Tissue Band
(K111462 cleared September 8, 2011 and K112849
cleared October 27, 2011) 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. |
| 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. |
| Functional and Safety
Testing: | Biocompatibility and bench testing were completed and support
the safety and effectiveness of the fiXate Tissue Band. |
| Conclusion: | 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. |
1
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
2
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
3
- 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