(106 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural support provided by the titanium plates and screws, with no mention of AI or ML.
Yes
The Life Spine Laminoplasty System is a therapeutic device because its intended use is to hold or buttress an allograft in place after a laminoplasty to prevent expulsion or impingement on the spinal cord, which directly treats a medical condition.
No
The device is a surgical implant designed to hold or buttress an allograft in place after a laminoplasty, which is a treatment rather than a diagnostic procedure.
No
The device description explicitly states it consists of physical components (plates and screws) made from titanium alloy, which are hardware, not software.
Based on the provided information, the Life Spine Laminoplasty System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to hold or buttress an allograft in place after a laminoplasty procedure in the spine. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device consists of plates and screws made of titanium alloy, which are typical components of surgical implants.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Life Spine Laminoplasty System is clearly an in vivo surgical device.
N/A
Intended Use / Indications for Use
The Life Spine Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Laminoplasty System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Product codes (comma separated list FDA assigned to the subject device)
NQW
Device Description
The Life Spine Laminoplasty System consists of plates screws in various diameters and lengths to support a laminoplasty procedure. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3-T3)
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)
Testing according to ASTM F2193-02 included Static and Dynamic Four Point Bending Test & Static Screw Pull-Out testing to ASTM F543 was presented to demonstrate the substantial equivalency of the Medtronic Centerpiece (K050082).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medtronic Centerpiece (K050082), Stryker Escalate (K113802), Synthes Arch (K032534)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services-USA logo. The second logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Life Spine Inc. Angela Batker RA/QA Specialist 13951 S Quality Drive Huntley, Illinois 60142
Re: K181717
Trade/Device Name: Life Spine Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: NQW Dated: August 28, 2018 Received: August 30, 2018
Dear Angela Batker:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
October 12, 2018
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181717
Device Name Life Spine Laminoplasty System
Indications for Use (Describe)
The Life Spine Laminoplasty System is indicated for use in the lower thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Laminoplasty System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Type of Use (Select one or both, as applicable):
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Life Spine Laminoplasty System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Batker
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | June 18, 2018 |
| Trade Name: | Life Spine Laminoplasty System |
| Common Name: | Spinal Interlaminal Fixation Orthosis |
| Classification: | NQW, CFR 888.3050, Class II |
| Primary Predicate: | Medtronic Centerpiece (K050082) |
| Secondary Predicate: | Stryker Escalate (K113802)
Synthes Arch (K032534) |
Device Description:
The Life Spine Laminoplasty System consists of plates screws in various diameters and lengths to support a laminoplasty procedure. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.
4
Intended Use of the Device:
The Life Spine Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Laminoplasty System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Technological Characteristics:
The Life Spine Laminoplasty System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
Material:
This submission seeks clearance of a device made from implant grade (Ti-6AL-4V) Titanium alloy according to F136. This this is the same material used in the predicate devices.
Performance Data:
Testing according to ASTM F2193-02 included Static and Dynamic Four Point Bending Test & Static Screw Pull-Out testing to ASTM F543 was presented to demonstrate the substantial equivalency of the Medtronic Centerpiece (K050082).
Substantial Equivalence:
The Life Spine Laminoplasty System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
Conclusion:
The information presented demonstrates the substantial equivalency of The Life Spine Laminoplasty System.