(168 days)
The Idys™ LIF Cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by FDA for use in the lumbar spine.
The Idys™ LIF Cages consist of PEEK lumbar cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Idys™ LIF Cages also feature markers made of Tantalum according to ASTM F560.
The Idys™ LIF Cages have different anatomic shapes and dimensions based on the surgical approach: PLIF (posterior lumbar interbody fusion); TLIF (transforaminal lumbar interbody fusion); and PTLIF (posterior approach and oblique-TLIF approach).
The Idys™ PLIF Cage is a hollow spacer with openings for autograft on the top, bottom, and sides of the device.
the Idys™ TLIF Cage has a bullet tip to facilitate introduction. The TLIF Cage Holder instrument has a clamp that affixes to the axle to enable rotation of the device during its introduction in situ.
The Idys™ PTLIF Cage is inserted in an oblique position. It can be introduced with a PLIF approach or a TLIF approach to the convenience of the surgeon and with taking into account the profile of the patient.
The Idys™ LIF Cage procedures are performed using a set of surgical instruments common for PLIF and TLIF approaches. Most of the instruments provided are common surgical tools used in these types of interbody fusion procedures. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21 CFR 888.4540.
This document describes the acceptance criteria and the study that proves the device meets those criteria for CLARIANCE's Idys™ LIF Cages.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance (as stated in the document) |
|---|---|
| Static axial compression testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Dynamic axial compression testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Static compression shear testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Dynamic compression shear testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Subsidence testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Expulsion testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Wear testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the performance tests (static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion, and wear testing). It only mentions that performance testing was conducted per ASTM F2077 and ASTM F2267.
The data provenance is not specified beyond indicating that the studies were performed by CLARIANCE, a French company. It does not state whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For this type of device (intervertebral body fusion cages), the "ground truth" is typically established through recognized industry standards for mechanical performance rather than expert consensus on medical images or patient outcomes. The document indicates that performance testing was conducted per ASTM F2077 and ASTM F2267. These ASTM standards define the methodologies and acceptance criteria for mechanical testing of spinal intervertebral body fusion devices. Therefore, the "experts" in this context would be those who interpreted and conducted the tests according to these established standards. The document does not specify the number or qualifications of the individuals who performed or interpreted these tests.
4. Adjudication Method for the Test Set
Not applicable for a device performance study based on engineering standards. The performance is objectively measured against the criteria defined by ASTM F2077 and ASTM F2267, rather than requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess human performance with and without AI, not for mechanical devices like intervertebral body fusion cages.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only without human-in-the-loop performance) study was done. This concept is not applicable to an intervertebral body fusion device, which is a physical implant, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's performance was the mechanical performance standards specified in ASTM F2077 and ASTM F2267. This includes metrics like static and dynamic axial compression, static and dynamic compression shear, subsidence, expulsion, and wear.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not an AI model that requires a training set. The term "training set" is typically used in the context of machine learning and artificial intelligence.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
510(k) SUMMARY
CLARIANCE's Idys™ LIF Cages
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
CLARIANCE 17 rue James WATT - 2A F-62000 Dainville, FRANCE
Phone: +33 (0)3 2116 1215 Facsimile: +33 (0)3 2115 5073
Contact Person: Pascal Rokegem, Chief Technology Officer
Date Prepared: October 9, 2013
Name of Device and Name/Address of Sponsor
CLARIANCE - Idys™ LIF Cages
Common or Usual Name
Lumbar Intervertebral Body Fusion Device
Classification Name
21 C.F.R. 888.3080 - Intervertebral body fusion device
Product Code
MAX
Predicate Devices
Eisertech, LLC's PLIF Cage
K2M, Inc.'s Aleutian IBF System
Synthes Spine's OPAL Spacer
Intended Use / Indications for Use
The Idys™ LIF Cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by FDA for use in the lumbar spine.
OCT 10 2013
{1}------------------------------------------------
Device Description
:
The Idys™ LIF Cages consist of PEEK lumbar cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Idys™ LIF Cages also feature markers made of Tantalum according to ASTM F560.
The Idys™ LIF Cages have different anatomic shapes and dimensions based on the surgical approach: PLIF (posterior lumbar interbody fusion); TLIF (transforaminal lumbar interbody fusion); and PTLIF (posterior approach and oblique-TLIF approach).
The Idys™ PLIF Cage is a hollow spacer with openings for autograft on the top, bottom, and sides of the device.
the Idys™ TLIF Cage has a bullet tip to facilitate introduction. The TLIF Cage Holder instrument has a clamp that affixes to the axle to enable rotation of the device during its introduction in situ.
The Idys™ PTLIF Cage is inserted in an oblique position. It can be introduced with a PLIF approach or a TLIF approach to the convenience of the surgeon and with taking into account the profile of the patient.
The Idys™ LIF Cage procedures are performed using a set of surgical instruments common for PLIF and TLIF approaches. Most of the instruments provided are common surgical tools used in these types of interbody fusion procedures. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21 CFR 888.4540.
| CLARIANCE'sIdys™ LIF, Cages | Eisertech, LLC'sPLIF Cage(K113478) | K2M, Inc.'sAleutian IBF System(K082698) | Synthes Spine'sSynthes OPALSpacer(K072791) | |
|---|---|---|---|---|
| Anatomicalsites | L2 to S1 | L2 to S1 | L2 to S1 | L2 to S1 |
| Material | INVIBIO PEEKOPTIMA LT1 | INVIBIO PEEKOPTIMA or ZenivaPEEK | INVIBIO PEEKOPTIMA LT1 | PEEK |
| RadiographicMarkerComponents | Tantalum markers;ASTM F136 Titaniumalloy cage axle (TLIFCage only) | Commercially puretitanium markers grade2, per ASTM F67 | Tantalum markers | N/A |
| SurgicalApproaches | PLIF, TLIF, PTLIF | PLIF | PLIF, TLIF, PTLIF | PTLIF |
| PLIFDimensions | Length: 20, 25 mmHeight: 8-14 mmWidth: 11 mm | Length: 20-30 mmHeight: 7-16 mmWidth:8-12 mm | Length: 22, 26 mmHeight: 7-17 mmWidth: 10 mm | N/A |
| TLIFDimensions | Length: 29 mmHeight: 7-14 mmWidth: 11 mm | N/A | Length: 27 mmHeight: 7-17 mmWidth: 10 mm | N/A |
| PTLIFDimensions | Length: 28, 32 mmHeight: 8-14 mmWidth: 11 mm | N/A | Length: 28, 32, 36 mmHeight: 7-15 mmWidth: 10, 12 mm | Length: 28, 32 mmHeight: 7-17 mmWidth: 10 mm |
Comparison of Technical Characteristics
{2}------------------------------------------------
Performance Data
Performance testing was conducted per ASTM F2077 and ASTM F2267. Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, and wear testing. The results of these studies were determined to be substantially equivalent to legally marketed devices.
Substantial Equivalence
The Idys™ LIF Cages are substantially equivalent to Eisertech, LLC's PLIF Cage (K113478), K2M, Inc.'s Aleutian IBF System (K082698), and Synthes Spine's OPAL Spacer (K072791). The Idys™ LIF Cages have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the Idys™ LIF Cages and its predicate devices raise no new issues. Performance data demonstrate that the Idys™ LIF Cages are substantially equivalent to the predicate devices.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public I lealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
October 10, 2013
CLARIANCE % Janice M. Hogan, Esq. Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K131178
Trade/Device Name: Idys™ LIF Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 30. 2013 Received: August 30, 2013
Dear Esquire Hogan:
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 docs 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 (reporting of medical
{4}------------------------------------------------
Page 2 - Janice Hogan, Esq.
device-related adverse events) (21 CFR 803); good manufacturing practive 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/Safetv/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 Small Manufacturers, International and Consumer Assistance 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.
Sincercly yours.
Erin I. Keith
for
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): ____K131178
Device Name: Idys™ LIF Cages
Indications for Use:
The Idys™ LIF Cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
Page __ of
§ 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.