(125 days)
The Space Vision® PLIF (Posterior Lumbar Interbody Fusion® TLIF (Transforaminal Lumbar Interbody Fusion) and Space Vision® OLIF (Oblique Lumbar Interbody Fusion) systems are intervertebral body fusion devices indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Space Vision® PLIF, SpaceVision® TLIF systems. These devices are to be filled with autogenous bone graft material. These devices can be implanted via posterior or transforaminal approaches. SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.
The SpaceVision® PLIF system (Posterior Lumbar Interbody Fusion), the SpaceVision® OLIF system (Oblique Lumbar Interbody Fusion) and the SpaceVision® TLIF system (Transforaminal Lumbar Interbody Fusion) are intended as an internal spacer between the vertebral bodies of the lumbar (L2-S1) spine to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain. The design of the cages is adapted to the vertebral anatomy. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF systems consist of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages. The systems are supplied sterile or non-sterile. The SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF cages are made from PEEK Optima (Invibio, Inc.) ASTM F2026 and ASTM F560 Tantalum wire. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF implants are supplied with their specific instrumentation and trial spacers.
The provided document describes the SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF systems, which are intervertebral body fusion devices. This is a 510(k) premarket notification, indicating the device's substantial equivalence to legally marketed predicate devices, not requiring extensive clinical trials to demonstrate effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This is primarily achieved through mechanical testing to show comparable properties.
| Acceptance Criteria (Demonstrates Substantial Equivalence in Mechanical Properties) | Reported Device Performance |
|---|---|
| Conformity to Class II Special Controls Guidance Document: Intervertebral Body Fusion Device (June 12, 2007) | Conformity affirmed. The device states it "conforms to Class II Special Controls Guidance Document: Intervertebral Body Fusion Device- Document issued on: June 12, 2007." |
| Mechanical testing according to ASTM F2077-14 (Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear) | Testing performed and results demonstrated comparability. "Mechanical testing includes static axial compression, dynamic axial compression, static compression shear, dynamic compression shear, performed according to ASTM F2077-14." |
| Subsidence testing according to ASTM F2267-04 | Testing performed and results demonstrated comparability. "subsidence testing performed according to ASTM F2267-04." |
| Expulsion testing according to DRAFT ASTM F-04.25.02.02 (ENDOLAB PI-52 protocol) | Testing performed and results demonstrated comparability. "expulsion testing performed according to DRAFT ASTM F-04.25.02.02 (ENDOLAB PI-52 protocol)." |
| Overall Mechanical Properties Comparable to Predicate Device | Affirmed comparability. "Results demonstrate comparable mechanical properties to the predicate device." The conclusion states, "SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF Devices are substantially equivalent to the primary predicate Phantom PLIF (K082801 - US Spine) in terms of intended use, material, design, mechanical properties and function." And also "substantially equivalent to the additional predicates BAK-L (P950002 - Zimmer) and Brantigan Cage (P960025 - DePuy Spine) in terms of intended use and mechanical properties." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or data provenance in the context of typical clinical studies for performance evaluation. For a 510(k) submission based on substantial equivalence, the "test set" primarily refers to the physical devices undergoing mechanical testing, not a patient cohort.
- Sample Size: Not specified for the mechanical testing. For physical device testing, usually a statistically appropriate number of devices are tested, but the exact count isn't in this summary.
- Data Provenance: Not applicable in the sense of retrospective or prospective patient data from a specific country, as "No clinical data has been presented." The data provenance for the mechanical testing would be the testing facility (ENDOLAB PI-52 protocol is mentioned) and the specific ASTM standards used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as "No clinical data has been presented." The "ground truth" here is the adherence to mechanical performance standards and comparability to predicate devices, not clinical diagnoses made by experts.
4. Adjudication Method for the Test Set
This information is not applicable as "No clinical data has been presented" and no human expert review or adjudication of a "test set" in the clinical sense was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical data has been presented." Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical intervertebral body fusion system, not a diagnostic algorithm or AI-powered tool. The concept of "algorithm only" performance is not relevant to this type of medical device submission.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established mechanical performance standards (ASTM standards) and the mechanical properties of the legally marketed predicate devices. The goal is to demonstrate that the SpaceVision® systems meet these standards and are comparable. There is no expert consensus, pathology, or outcomes data used as ground truth for this specific submission, as clinical data was not presented.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical implant, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set mentioned, the method for establishing its ground truth is irrelevant.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2016
SpineVision® S.A. Sylvain CAVAILLES Operations Director 10 rue de la Renaissance, Bâtiment E 92160 Antony FRANCE
Re: K153783
Trade/Device Name: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 31, 2016 Received: April 12, 2016
Dear Sylvain CAVAILLES:
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
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(21 CFR Part 807); labeling (21 CFR Parts 801); medical device 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 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 yours,
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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Indications for Use
510(k) Number (if known) K153783
Device Name
SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
Indications for Use (Describe)
The Space Vision® PLIF (Posterior Lumbar Interbody Fusion® TLIF (Transforaminal Lumbar Interbody Fusion) and Space Vision® OLIF (Oblique Lumbar Interbody Fusion) systems are intervertebral body fusion devices indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Space Vision® PLIF, SpaceVision® TLIF systems. These devices are to be filled with autogenous bone graft material. These devices can be implanted via posterior or transforaminal approaches. SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.
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
| Submitter | SpineVision, S.A. |
|---|---|
| 10 rue de la Renaissance | |
| Bâtiment E | |
| 92160 Antony - France | |
| Contacts | Sylvain CAVAILLES |
| Operations Director | |
| +33 (0)1 53 33 25 98 | |
| +33 (0)1.53.33.25.39 (Fax) | |
| corp.quality@spinevision.com | |
| Trade Name | SpaceVision® PLIFSpaceVision® OLIFSpaceVision® TLIF |
| Classification Name | Intervertebral body fusion device |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | Orthopedic |
| Legally marketedpredicate devices | Primary PredicateK082801 Phantom PLIF manufactured by US Spine |
| Additional Predicates | |
| P950002 BAK-L manufactured by ZimmerP960025 Brantigan Cage manufactured by DePuy Spine | |
| Description | The SpaceVision® PLIF system (Posterior Lumbar Interbody Fusion),the SpaceVision® OLIF system (Oblique Lumbar Interbody Fusion)and the SpaceVision® TLIF system (Transforaminal Lumbar InterbodyFusion) are intended as an internal spacer between the vertebralbodies of the lumbar (L2-S1) spine to stabilize spinal segment topromote fusion in order to restrict motion and decrease pain.The design of the cages is adapted to the vertebral anatomy.SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIFsystems consist of cages differentiated by their approach, withvarying dimensions and ancillary products for placement of the cages. |
| The systems are supplied sterile or non-sterile. | |
| The SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIFcages are made from PEEK Optima (Invibio, Inc.) ASTM F2026 andASTM F560 Tantalum wire. | |
| X-ray markers system on the cages permits the identification of cageposition and allows post-operative assessment.SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIFimplants are supplied with their specific instrumentation and trialspacers | |
| Indications for use | The SpaceVision® PLIF (Posterior Lumbar Interbody Fusion), theSpaceVision® TLIF (Transforaminal Lumbar Interbody Fusion) andSpaceVision® OLIF (Oblique Lumbar Interbody Fusion) systems areintervertebral body fusion devices indicated for use with autogenousbone graft in skeletally mature patients with Degenerative DiscDisease (DDD) at one or two continuous levels from L2-S1. DDD isdefined as discogenic back pain with degeneration of the discconfirmed by patient history and radiographic studies. These DDDpatients may also have up to Grade I spondylolisthesis orretrolisthesis at the involved level(s). Patients should have received atleast 6 months of non-operative treatment prior to treatment withSpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIFsystems. These devices are to be filled with autogenous bone graftmaterial. These devices can be implanted via posterior ortransforaminal approaches. SpaceVision® PLIF, SpaceVision® TLIF orSpaceVision® OLIF systems must be used in combination withsupplemental internal spinal fixation which has been cleared by theFDA for use in the lumbar spine. |
| Performance data | SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIFDevices conform to Class II Special Controls Guidance Document:Intervertebral Body Fusion Device- Document issued on: June 12,2007.Mechanical testing includes static axial compression, dynamic axialcompression, static compression shear, dynamic compression shear,performed according to ASTM F2077-14, subsidence testingperformed according to ASTM F2267-04 and expulsion testingperformed according to DRAFT ASTM F-04.25.02.02 (ENDOLAB PI-52protocol).Results demonstrate comparable mechanical properties to thepredicate device. No clinical data has been presented. |
| Substantialequivalence | SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIFDevices are substantially equivalent to the primary predicate PhantomPLIF (K082801 - US Spine) in terms of intended use, material, design,mechanical properties and function.SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIFDevices are substantially equivalent to the additional predicates BAK-L (P950002 - Zimmer) and Brantigan Cage (P960025 - DePuySpine)in terms of intended use and mechanical properties. |
| Conclusion | SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIFDevices are substantially equivalent to the predicate devices. |
| Date | 2016-04-27 |
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§ 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.