(43 days)
No
The device description and intended use are for a passive implant (bone plate and screws) and there is no mention of any software, algorithms, or data processing that would suggest AI/ML.
Yes
This device is intended for temporary stabilization of the anterior spine during the development of a cervical spinal fusion for various medical conditions, indicating a therapeutic purpose.
No
The device description indicates it is an implantable plate system for spinal fusion, not a tool for diagnosing medical conditions. It is used to stabilize the spine during the development of a cervical spinal fusion in patients who have already been diagnosed with specific conditions.
No
The device description explicitly states that the device consists of "anterior cervical bone plates and screws" manufactured from "implant grade titanium alloy". This indicates a physical, implantable hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical fixation of the cervical spine during fusion procedures. This is a direct intervention on the patient's body.
- Device Description: The device consists of implants (plates and screws) made of titanium alloy. These are physical components designed to be surgically placed within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies mentioned are biomechanical tests, which assess the physical properties and strength of the implant, not its ability to perform a diagnostic test.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Life Spine Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with:
-
- Degenerative disease, DDD (as defined by neck pain of discogenic origin with degeneration of dise confirmed by patient history and radiographic studies);
-
- Spondvlolisthesis
-
- Trauma (including fractures or dislocations);
-
- Spinal cord stenosis;
-
- Deformity or curvatures (i.e. kyphosis, lordosis and/or scollosis);
-
- Tumors:
-
- Pseudarthrosis:
-
- Failed previous fusions.
Nota Benet This device system is intended for anterior cervical interverterbral body fusions only.
WARNING: This device is not approved for serew attachment to the posterior clements (pedicles) of the cervical, thoracic, or lumbar spine.
- Failed previous fusions.
Product codes
KWQ
Device Description
The Life Spine Anterior Cervical Plate consists of various sizes of anterior cervical bone plates and screws. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The Life Spine Anterior Cervical Plate components will be supplied clean and "NON-STERILE'.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2 to T1
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
Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Life Spine NEO ™ Cervical Plating System K040844, Life Spine KINETIC ® Anterior Cervical Plate K062643
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
070285
MAR 1 3 2007
510(k) Summary
510(k) Summary - Life Spine Anterior Cervical Plate System
| Submitted By: | Life Spine
2400 Hassell Road, Suite 370
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Rebecca M. Brooks
Life Spine
2400 Hassell Road, Suite 370
Hoffman Estates, IL 60195
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | January 26, 2007 |
| Trade Name: | Life Spine Anterior Cervical Plate System |
| Common Name: | Spinal Fixation System |
| Classification: | KWQ 888.3060 - Spinal Intervertebral Body Fixation
Orthosis
21 CFR 888.3060
Class II |
| Device Product Code: | KWQ |
| Predicate Device: | Life Spine NEO ™ Cervical Plating System K040844
Life Spine KINETIC ® Anterior Cervical Plate K062643 |
Device Description:
The Life Spine Anterior Cervical Plate consists of various sizes of anterior cervical bone plates and screws. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The Life Spine Anterior Cervical Plate components will be supplied clean and "NON-STERILE'.
1
070285 Page 2 of 2
Intended Use of the Device:
The Life Spine Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with:
-
- Degenerative disease, DDD (as defined by neck pain of discogenic origin with degeneration of dise confirmed by patient history and radiographic studies);
-
- Spondvlolisthesis
-
- Trauma (including fractures or dislocations);
-
- Spinal cord stenosis;
-
- Deformity or curvatures (i.e. kyphosis, lordosis and/or scollosis);
-
- Tumors:
-
- Pseudarthrosis:
-
- Failed previous fusions.
Nota Benet This device system is intended for anterior cervical interverterbral body fusions only.
WARNING: This device is not approved for serew attachment to the posterior clements (pedicles) of the cervical, thoracic, or lumbar spine.
Muterial:
The Life Spine Anterior Cervical Plate System is manufactured from medical grade itlanium alloy described by ASTM F136 (Ti 6A1-4V-ELI).
Performance Data:
Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
Substantial Equivalence:
The Life Spine Anterior Cervical Plate System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Life Spine LLC % Ms. Rebecca Brooks Project Coordinator 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195
MAR 1 3 2007
Re: K070285
Trade/Device Name: Life Spine Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: January 26, 2007 Received: January 29, 2007
Dear Ms. Brooks:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); 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.
3
Page 2 - Ms. Rebecca Brooks
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the words "Life Spine" in a bold, sans-serif font. The word "Life" is in a larger font size than the word "Spine". There is a registered trademark symbol next to the word "Spine". A curved line is underneath the words, adding a design element to the logo.
Indications for Use
510(k) number (if known): _K070285
Device Name: Life Spine Anterior Cervical Plate System
The Life Spine Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with (1) degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) trauma (including fractures or dislocations), (4) spinal cord stenosis, (5) deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis), (6) tumors, (7) pseudarthrosis, (8) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use _x (Part 21 CFR 801 Subpart D) And/Or
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Salvare Bonetur
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K070285