(250 days)
The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Arena-L, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.
The SpineFrontier Ti-Coated Lumbar Interbody Fusion Device System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of titanium coated PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant.
The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.
The provided document describes a 510(k) premarket notification for the SpineFrontier Lumbar Interbody Fusion Device System. This document is a regulatory submission for a medical device and, as such, does not contain information about the performance of an AI/ML powered device, nor does it include a study that proves a device meets acceptance criteria in the context of an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics and non-clinical mechanical performance testing. The 'Performance Data' section lists various ASTM standards used for mechanical testing of the device and its coating, but these are related to the physical properties and durability of the implantable device, not the performance of an AI/ML algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2015
SpineFrontier, Incorporated % Ms. Meredith Mav Senior Manager Empirical Consulting 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K142504
Trade/Device Name: SpineFrontier Lumbar Interbody Fusion Device System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 15, 2015 Received: April 16, 2015
Dear Ms. May:
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Meredith May
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement on last page. |
|---|---|
| ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
| 510(k) Number (if known) | K142504 |
|---|---|
| Device Name | SpineFrontier Lumbar Interbody Fusion Device System |
| Indications for Use (Describe) | The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT,Dorado ELIFT, Arena-L, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) isintended for intervertebral body fusion of the spine of skeletally mature patients, usingautogenous bone graft to facilitate fusion. The device is indicated for use in patients withdegenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. TheseDDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involvedlevel(s). |
| Degenerative disc disease is defined as discogenic back pain with degeneration of the discconfirmed by history or radiographic studies. These patients should be skeletally mature andhave had six months of non-operative treatment. | |
| The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be usedwith supplemental spinal fixation system(s) cleared for use in the lumbar spine. |
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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5.510(K) SUMMARY
| Submitter's Name: | SpineFrontier |
|---|---|
| Submitter's Address: | 500 Cummings Center, Suite 3500Beverly, MA 01915 |
| Submitter's Telephone: | 978.232.3990 x252 |
| Company Contact Person: | Manthan Damani, MSRASr. Regulatory Affairs Associate |
| Official Contact Person: | Meredith L. May, MSEmpirical Testing Corp.719.337.7579 |
| Date Summary was Prepared: | 15-Apr-15 |
| Trade or Proprietary Name: | SpineFrontier Lumbar Interbody Fusion Device System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedic DevicesOrthopaedic and Rehabilitation Panel |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SpineFrontier Ti-Coated Lumbar Interbody Fusion Device System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of titanium coated PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant.
The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.
INDICATIONS FOR USE
The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Arena-L, Dorado TLIFT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and
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have had six months of non-operative treatment.
The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.
TECHNOLOGICAL CHARACTERISTICS
Lumbar Interbody Fusion Device System is made from PEEK Optima® LT1 with Titanium Coating. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of manufacture
- o Structural support mechanism
- Principles of operation ●
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K111553 | Lumbar Interbody Fusion Device System | SpineFrontier | Primary |
| K071724,K110632 | Lucent PLIF System | Spinal Element | Reference |
| K130573 | Interbody System | Tyber Medical | Reference |
PERFORMANCE DATA
The SpineFrontier Lumbar Interbody Fusion Device System has been tested and its coating characterized in the following test modes:
- o Static axial compression per ASTM F2077
- Static compressive shear per ASTM F2077 ●
- Static torsion per ASTM F2077 ●
- o Dynamic axial compression per ASTM F2077
- Dynamic compressive shear per ASTM F2077
- Percent Porosity per ASTM F1854-09
- Coating Thickness per ASTM F1854-09
- Static Shear per ASTM F1044-05
- Static Tensile per ASTM F1147-05
- Shear Fatigue per ASTM F1160-05 ●
- Abrasion per ASTM F1978-00 ●
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The results of this non-clinical testing show that the strength of the Lumbar Interbody Fusion Device System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the SpineFrontier Lumbar Interbody Fusion Device System is substantially equivalent to the predicate device.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.