(53 days)
The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.
The SteriSpine™LC cages are intervertebral body fusion devices with a central cavity available either in straight rectangular shape for transforaminal (TLIF) or posterior (PLIF) approach and in curved shape for transforaminal (TLIF) approach. The SteriSpine™LC cages are made of PEEK (Zeniva ZA-500) conforming to ASTM F2026 with Tantalum markers conforming ASTM F560 to visualize the position of the implant in the disc space. The SteriSpine™LC cages are available in several sizes to adapt to anatomical variations. The SteriSpine™LC range of products is supplied sterile with a sterile single-use set of surgical instruments.
The provided text is a 510(k) summary for the STERISPINE™ LC CAGE device. It largely focuses on demonstrating substantial equivalence to predicate devices, particularly concerning changes to surgical instruments and packaging, rather than presenting a performance study for the device itself or an AI component.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in this document. The device in question is an intervertebral body fusion device, not an AI/ML powered device. The document describes non-clinical tests conducted to support substantial equivalence for modifications to the device's instruments and packaging, not a study to prove meeting acceptance criteria for a device's performance in a clinical setting.
Below is an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for the STERISPINE™ LC CAGE device in the context of clinical performance. | Non-clinical testing results demonstrate that the performance of the subject device system is substantially equivalent to the cited predicates. Specifically, testing conducted for modifications (new or modified raw materials for instruments, packaging, and sterilization revalidation) confirmed compliance with relevant ISO standards. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not available for the type of testing described (non-clinical tests for substantial equivalence of device modifications, not a clinical performance study with a test set of data). The testing was for biocompatibility, packaging validation, and sterilization revalidation of materials and processes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not available. The document refers to non-clinical tests (biocompatibility, packaging, sterilization) and not a study requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable and not available. The testing described does not involve an adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for an intervertebral body fusion device and did not involve an AI component or analysis of human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done. This submission is for an intervertebral body fusion device and did not involve an algorithm or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. The non-clinical tests (biocompatibility, packaging, sterilization) did not utilize ground truth in the context of clinical expert consensus, pathology, or outcomes data. Ground truth, in this context, would be compliance with the specified ISO standards for the respective tests.
8. The Sample Size for the Training Set
This information is not applicable and not available. The document describes non-clinical tests for device modifications, not an AI/ML model for which a training set would be used.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not available. As there is no AI/ML model or training set, the concept of establishing ground truth for a training set does not apply.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
Safe Orthopaedics Mr. Pierre Dumouchel QARA Director Parc des Bellevues Allée R. Luxembourg - Bat. Californie 95610 Eragny Sur Oise France
Re: K151756
Trade/Device Name: STERISPINETM LC Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 25, 2015 Received: June 29, 2015
Dear Mr. Dumouchel:
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 (reporting of medical
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Page 2 - Mr. Pierre Dumouchel
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K151756
Device Name STERISPINE™ LC CAGE
Indications for Use (Describe)
The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
2 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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STERISPINE™ LC CAGE
Image /page/3/Picture/1 description: The image shows the logo for SafeOrthopaedics. The logo features a stylized letter 'S' in a light green color, with a small dot to the right of the 'S'. Below the 'S', the text 'SafeOrthopaedics' is written in a sans-serif font, with the word 'Safe' in a lighter shade of green than the word 'Orthopaedics'.
510(k) SUMMARY
| 510k | Traditional |
|---|---|
| Submitted by | Safe OrthopaedicsParc des BellevuesAllée R. Luxembourg - Le Californie95610 Eragny sur Oise - FRANCE |
| Contacts | Pierre DUMOUCHEL Industrialization Director / QARA Directorp.dumouchel@safeorthopaedics.com+33 (0) 1 34 21 50 00Isabelle Drubaix Regulatory contactidee-consulting@nordnet.fr+33 (0)3 21 05 64 23 |
| Date Prepared | June 3rd 2015 |
| Common Name | Intervertebral body fusion device |
| Trade Name | STERISPINET™ LC CAGE |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | Primary predicate device: STERISPINET™ LC CAGE manufactured by SafeOrthopaedics cleared under K133893Additional predicate device: STERISPINE™ LC CAGE manufactured bySafe Orthopaedics cleared under K122021 |
| Indications for use | The SteriSpine™LC device is indicated for intervertebral body fusionprocedures at one or two contiguous levels from L2 to S1 in skeletallymature patients with degenerative disc disease (DDD) with up to Grade Ispondylolisthesis at the involved level(s). DDD is defined as discogenicback pain with degeneration of the disc confirmed by patient history andradiographic studies. Patients should have at least six (6) months ofnon-operative treatment prior to treatment with an intervertebral cage.This device is to be used with autogenous bone graft to facilitate fusionand is intended for use with SteriSpine™ PS, a supplemental fixationsystem cleared by the FDA for use in the lumbar spine. |
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| Description of the device | The SteriSpine™LC cages are intervertebral body fusion devices with acentral cavity available either in straight rectangular shape fortransforaminal (TLIF) or posterior (PLIF) approach and in curved shapefor transforaminal (TLIF) approach. The SteriSpine™LC cages are madeof PEEK (Zeniva ZA-500) conforming to ASTM F2026 with Tantalummarkers conforming ASTM F560 to visualize the position of the implantin the disc space. The SteriSpine™LC cages are available in several sizesto adapt to anatomical variations. The SteriSpine™LC range of productsis supplied sterile with a sterile single-use set of surgical instruments. |
|---|---|
| TechnologicalCharacteristics | There have been no changes made to the SteriSpine™LC implants(K122021 and K133893). The purpose of this 510(k) submission is toobtain clearance for added bifunctional instruments to theSteriSpine™LC sterile single-use set of surgical instruments, and for aredesigned quick change handle. Additionally, sulfate barium has beenadded in the raw material of the dual trial and the dual spreader in orderto improve visibility. Finally, a "window" has been added to the externalpackaging of SteriSpine™LC devices supplied sterile. This new packagingwill be used for all devices manufactured by Safe Orthopaedics. |
| Discussion of Testing | The following non-clinical tests were conducted: biocompatibility testingaccording to ISO 10993-5, ISO 10993-10 and ISO 10993-11 for the newor modified raw materials; packaging validation according to ISO 11607-1 and 11607-2 and sterilization revalidation according to ISO 11137-1,11137-2 and 11137-3. Results demonstrate that the performance of thesubject device system is substantially equivalent to the cited predicates. |
| Conclusion | Non clinical performance testing demonstrates that the added ormodified surgical instruments are substantially equivalent to predicatedevices in terms of intended use, materials, design and function. |
§ 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.