(72 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 STERISPINET™ PS a supplemental fixation system cleared, by the FDA for use in the lumbar spine
SteriSpine™LC range of products consists of lumbar Interbody fusion devices available in sizes to adapt to anatomical variations. SteriSpine™LC is dedicated to transforaminal approach and is manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of tantalum conforming to ASTM F560-08 are used to visualize the position of the implant in the disc space. STERISPINE LC Lumbar Interbody Devices are supplied sterile with a single-use set of surgical instruments.
Here's an analysis of the provided text regarding the STERISPINE LC device's acceptance criteria and study information:
Key Takeaway: The STERISPINE LC device's acceptance criteria and studies are focused on demonstrating mechanical equivalence to predicate devices. There is no clinical data presented in this 510(k) summary, meaning no studies assessing AI performance, human reader improvement, or standalone algorithm performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Shearing (ASTM F2077-03) | "Results demonstrate comparable mechanical properties to the predicate device." |
| Compression (ASTM F2077-03) | "Results demonstrate comparable mechanical properties to the predicate device." | |
| Torsion (ASTM F2077-03) | "Results demonstrate comparable mechanical properties to the predicate device." | |
| Subsidence (ASTM F2267-04) | "Results demonstrate comparable mechanical properties to the predicate device." | |
| Expulsion Testing | "Results demonstrate comparable mechanical properties to the predicate device." | |
| Instrumentation Evaluation | Cadaver Testing | "Cadaver testing performed to validate the instrumentation have been presented." (No specific quantitative results provided for acceptance criteria). |
Note: The acceptance criteria are implicitly met by achieving "comparable mechanical properties to the predicate device." The submission does not specify numerical thresholds for these properties but rather relies on a comparative assessment.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The provided document details mechanical and cadaveric testing, not clinical studies or AI model evaluations with a "test set" of patient data.
- Data Provenance: Not applicable. The studies are non-clinical mechanical tests and cadaveric studies, not involving patient data from specific countries or types of studies (retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus. For cadaver testing, the "ground truth" would be the successful validation of instrument function, likely assessed by surgeons or relevant technical personnel, but no specific number or qualifications are mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is relevant for clinical or diagnostic studies involving human interpretation or consensus, which are not described here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study Done? No. The submission explicitly states: "No clinical data has been presented." Therefore, no MRMC study assessing human reader improvement with or without AI assistance was performed or presented.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Study Done? No. This device is an intervertebral body fusion device (an implantable medical device), not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- For Mechanical Testing: The ground truth is based on established engineering standards (ASTM F2077-03, ASTM F2267-04) and the mechanical properties of the legally marketed predicate devices (Lumbar I/F cage manufactured by Depuy Acromed and Zavation IBF System manufactured by Zavation LLC).
- For Cadaver Testing: The ground truth is the successful validation of the instrumentation's function in a simulated surgical environment (cadavers).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI algorithm, so there is no training set mentioned or relevant in this context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.
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STERISPINE LC
SEP 2 0 2012
510(k) SUMMARY
Sunorthopaccics
| Safe Orthopaedics | |
|---|---|
| Parc des Bellevues | |
| Submitter | Allée R. Luxembourg - Le Californie95610 Eragny sur Oise - France |
| Regulatory contact Isabelle Drubaix | |
| idee-consulting@nordnet.fr | |
| Contacts | +33 (0)3 21 05 64 23 |
| QARA Director : Pierre DUMOUCHELp.dumouchel@safeorthopaedics.com | |
| +33 (0) 1 34 21 50 00 | |
| Trade Name | SteriSpine™LC |
| Classification Name | Intervertebral body fusion device |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | Orthopedic |
| Legally marketedpredicate devices | Lumbar I/F cage (P960025) manufactured by Depuy AcromedZavation IBF System (K112664) manufactured by Zavation LLC |
| Description | SteriSpine™LC range of products consists of lumbar Interbodyfusion devices available in sizes to adapt to anatomical variations. |
| SteriSpine™LC is dedicated to transforaminal approach and ismanufactured as single solid-machined piece made of PEEK | |
| conforming ASTM F2026. Markers made of tantalum conforming toASTM F560-08 are used to visualize the position of the implant in | |
| the disc space. STERISPINE LC Lumbar Interbody Devices aresupplied sterile with a single-use set of surgical instruments. | |
| Indications for use | SteriSpine™LC device is indicated for intervertebral body fusionprocedures at one or two contiguous levels from L2 to S1 inskeletally mature patients with degenerative disc disease (DDD)with up to Grade I spondylolisthesis at the involved level(s). DDD isdefined as discogenic back pain with degeneration of the discconfirmed by patient history and radiographic studies. Patientsshould have at least six (6) months of non-operative treatment priorto treatment with an intervertebral cage. |
| This device is to be used with autogenous bone graft to facilitatefusion and is intended for use with STERISPINET™ PS a supplementalfixation system cleared, by the FDA for use in the lumbar spine | |
| SteriSpine™LC Lumbar Interbody Device conforms to Class IISpecial Controls Guidance Document: Intervertebral Body FusionDevice- Document issued on: June 12, 2007. | |
| Performance data | Mechanical testing includes shearing, compression and torsionperformed according to ASTM F2077-03, subsidence testingperformed according to ASTM F2267-04 and expulsion testing. |
| Results demonstrate comparable mechanical properties to thepredicate device. Cadaver testing performed to validate theinstrumentation have been presented. No clinical data has beenpresented. | |
| Substantialequivalence | SteriSpine™LC is substantially equivalent to its predicate devices interms of intended use, material, design, mechanical properties andfunction. Non clinical performance testing according to specialcontrol demonstrate that SteriSpine™ LC is as safe, as effective, andperforms as safely and effectively as its predicate devices. |
| Date | 2012July06 |
..
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 20 2012
Safe Orthopaedics % Mr. Pierre Dumouchel QARA Director Parc des Bellevues Allée R. Luxembourg - Le Californie 95610 Eragny sur Oise - France
Re: K122021
Trade/Device Name: STERISPINE LC Lumbar Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 6, 2012 Received: July 10, 2012
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours
Sincerely yours,
for Ditte
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STERISPINE LC
Image /page/3/Picture/1 description: The image shows a logo with a stylized letter "S" at the top, followed by the word "Orthopaedics" in a simple, sans-serif font. The letter "S" is drawn in a cursive style with a loop at the top. The text is positioned below the letter, suggesting that "S" might be an initial or a symbol representing the orthopaedics practice or company.
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: STERISPINE LC Lumbar Interbody Device
Indications for Use:
The STERISPINE™ LC device is indicated for intervertebral body fusion procedures at one The STERISPINE™ LC device is indicated in Thicated patients with degenerative disc
or two contiguous levels from L2 to S1 in skeletally mature patients of neders or two contiguous levels from L2 to 31 in skeculity includived level(s). DDD is defined
disease (DDD) with up to Grade I spondylolisthesis at the involved by and disease (DDD) with up to Grade I Spondionsticsio di confirmed by patient history and as discogenic back pain with degeneration of the arse commed a parties of non-operative Tadlographic 'studies: 'Fother with an intervertebral cage.
treatment prior to treatment with an liner version case.
This device is to be used with autogenous bone graft to facilitates and is intended for This device is to be used with autogenous bone grant to facilities and the FDA for use in the lumbar spine
Prescription Use く AND/OR (Part 21 CFR 801 Subpart D)
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)
Cal-Of-
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_K/2202/
§ 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.