(125 days)
K082801, P950002, P960025
K082801, P950002, P960025
No
The summary describes a passive intervertebral body fusion device made of PEEK and Tantalum, with no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as an "intervertebral body fusion device" intended to "stabilize spinal segment to promote fusion in order to restrict motion and decrease pain" in patients with Degenerative Disc Disease (DDD), which directly addresses a disease state and aims to restore function and alleviate symptoms.
No
The device is an intervertebral body fusion device (spacer) used in surgical procedures, not for diagnosing conditions. Its purpose is to stabilize spinal segments and promote fusion, not to confirm or identify a disease.
No
The device description explicitly states that the system consists of "cages" made from PEEK and Tantalum wire, which are physical implants, along with "ancillary products for placement of the cages" and "specific instrumentation and trial spacers." This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Space Vision® systems are implants designed to be surgically placed within the lumbar spine to promote fusion and stabilize the spinal segment. They are used in conjunction with bone graft material.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The device itself is a physical implant.
- Input Imaging Modality: The input imaging modality is radiographic studies (X-ray), which are used to assess the patient's anatomy and the placement of the implant, not to analyze biological specimens.
Therefore, the Space Vision® PLIF, TLIF, and OLIF systems fall under the category of medical devices (specifically, spinal implants), but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The SpaceVision® PLIF (Posterior Lumbar Interbody Fusion), the SpaceVision® TLIF (Transforaminal Lumbar Interbody Fusion) and SpaceVision® 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 SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF 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.
Product codes
MAX
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, Lumbar (L2-S1)
Indicated Patient Age Range
skeletally mature patients
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)
SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF Devices 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 axial compression, static compression shear, dynamic compression shear, performed according to ASTM F2077-14, subsidence testing performed according to ASTM F2267-04 and expulsion testing performed according to DRAFT ASTM F-04.25.02.02 (ENDOLAB PI-52 protocol).
Results demonstrate comparable mechanical properties to the predicate device. No clinical data has been presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082801 Phantom PLIF manufactured by US Spine, P950002 BAK-L manufactured by Zimmer, P960025 Brantigan Cage manufactured by DePuy Spine
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
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
1
(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® PLIF |
| SpaceVision® OLIF | |
| SpaceVision® TLIF | |
| Classification Name | Intervertebral body fusion device |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | Orthopedic |
| Legally marketed | |
| predicate devices | Primary Predicate |
| K082801 Phantom PLIF manufactured by US Spine | |
| Additional Predicates | |
| P950002 BAK-L manufactured by Zimmer | |
| P960025 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 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 | |
| Indications for use | The SpaceVision® PLIF (Posterior Lumbar Interbody Fusion), the |
| SpaceVision® TLIF (Transforaminal Lumbar Interbody Fusion) and | |
| SpaceVision® 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 | |
| SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF | |
| 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. | |
| Performance data | SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF |
| Devices conform to Class II Special Controls Guidance Document: | |
| Intervertebral Body Fusion Device- Document issued on: June 12, |
Mechanical testing includes static axial compression, dynamic axial
compression, static compression shear, dynamic compression shear,
performed according to ASTM F2077-14, subsidence testing
performed according to ASTM F2267-04 and expulsion testing
performed according to DRAFT ASTM F-04.25.02.02 (ENDOLAB PI-52
protocol).
Results demonstrate comparable mechanical properties to the
predicate device. No clinical data has been presented. |
| Substantial
equivalence | 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.
SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF
Devices are substantially equivalent to the additional predicates BAK-
L (P950002 - Zimmer) and Brantigan Cage (P960025 - DePuy
Spine)in terms of intended use and mechanical properties. |
| Conclusion | SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF
Devices are substantially equivalent to the predicate devices. |
| Date | 2016-04-27 |
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