(63 days)
No
The device description and intended use focus on mechanical components for spinal surgery and do not mention any AI/ML capabilities or related data processing.
No
Explanation: The device is used to secure graft material after a laminoplasty procedure to prevent expulsion or impingement of the spinal cord, and it does not directly treat a disease or condition for therapeutic purposes. It is a structural support device.
No
The device is described as a system used to hold or buttress graft material in place after a laminoplasty, indicating a structural and supportive function, not a diagnostic one.
No
The device description explicitly states it consists of "various plates and screw configurations" fabricated from "titanium alloy". This indicates a physical hardware device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Life Spine Hinged Laminoplasty System is a surgical implant made of titanium alloy. It is used to hold bone graft material in place during a spinal surgery.
- Intended Use: The intended use is to mechanically support bone graft material in the spine after a laminoplasty procedure. This is a structural and mechanical function within the body, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a device that is surgically implanted to provide structural support, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Life Spine Hinged 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 Hinged Laminoplasty System is used to hold or butresses the allograft or autograft material in place to prevent the graft material from expulsion or impinging the spinal cord.
Product codes
NQW
Device Description
The Life Spine Hinged Laminoplasty System consists of various plates and screw configurations to address surgeon and patient needs. The plates have screw holes at the ends that allow attachment to bone. The center hole of the plate allows it to be affixed to allograft or autograft material. 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 Hinged 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 Screw Pull-Out testing to ASTM F543 was presented to demonstrate the substantial equivalency of the Life Spine Laminoplasty (K181717).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Life Spine Laminoplasty System (K181717), Synthes Arch (K032534), Choice Spine Laminoplasty Fixation System (K173215)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
September 20, 2019
Life Spine, Inc. Angela Batker RA/QA Specialist 13951 South Quality Drive Huntley, Illinois 60142
Re: K191927
Trade/Device Name: Hinged Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: July 16, 2019 Received: July 19, 2019
Dear Ms. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191927
Device Name Hinged Laminoplasty System
Indications for Use (Describe)
The Life Spine Hinged 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 Hinged Laminoplasty System is used to hold or butresses the allograft or autograft material in place to prevent the graft material from expulsion or impinging the spinal cord.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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 Hinged 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: | September 12, 2019 |
| Trade Name: | Life Spine Hinged Laminoplasty System |
| Common Name: | Spinal Interlaminal Fixation Orthosis |
| Classification: | NQW, CFR 888.3050, Class II |
| Primary Predicate: | Life Spine Laminoplasty System (K181717) |
| Additional Predicate: | Synthes Arch (K032534)
Choice Spine Laminoplasty Fixation System (K173215) |
Device Description:
The Life Spine Hinged Laminoplasty System consists of various plates and screw configurations to address surgeon and patient needs. The plates have screw holes at the ends that allow attachment to bone. The center hole of the plate allows it to be affixed to allograft or autograft material. 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 Hinged Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.
Intended Use of the Device:
4
The Life Spine Hinged 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 Hinged Laminoplasty System is used to hold or buttresses the allograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
Technological Characteristics:
The Life Spine Hinged 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 Screw Pull-Out testing to ASTM F543 was presented to demonstrate the substantial equivalency of the Life Spine Laminoplasty (K181717).
Substantial Equivalence:
The Life Spine Hinged 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 Hinged Laminoplasty System.