(84 days)
Not Found
No
The document describes a physical intervertebral body fusion device and its mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for intervertebral body fusion procedures to treat degenerative disc disease, which directly addresses a medical condition.
No.
The SteriSpine™LC device is indicated for intervertebral body fusion procedures and is designed to be an implant, not a tool for diagnosis. It is used in patients already diagnosed with degenerative disc disease.
No
The device description clearly states that the SteriSpine™LC is a physical intervertebral body fusion device made of Zeniva ZA-500 with Tantalum markers. It is a hardware implant, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- SteriSpine™LC Function: The SteriSpine™LC is an implantable medical device designed for surgical implantation into the spine to facilitate bone fusion. It is a physical structure that is placed within the body, not a device that analyzes samples taken from the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebrae, not a diagnostic test performed on a sample.
- Device Description: The description details the materials and design of a physical implant, not a diagnostic assay or instrument.
The mention of "radiographic studies" in the Indications for Use refers to imaging techniques used to assess the patient's condition and confirm the diagnosis, which is a separate process from the function of the SteriSpine™LC device itself. The tantalum markers are for visualizing the implant's position during or after surgery using imaging, not for diagnostic testing of a sample.
N/A
Intended Use / Indications for Use
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.
Product codes
MAX
Device Description
The SteriSpine™LC cages are intervertebral body fusion devices with a central cavity that is filled with bone graft (autograft) to facilitate fusion. The SteriSpine™LC is available either in straight rectangular shape for transforaminal (TLIF) or posterior (PLIF) approach and in curved shape for transforaminal (TLIF) approach. The SteriSpine™LC is made of (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
from L2 to 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)
The following non-clinical tests were conducted on SteriSpineTMLC : Static axial compression, Dynamic axial compression, Static compression shear testing and Dynamic compression shear testing according to ASTM F2077, subsidence testing according to ASTM F2267 and and expulsion testing according to in-house protocol. Results demonstrate that SteriSpineTMLC performs as safely and effectively as previsoulsy cleared devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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K133893 Page 1 of 2
Abbreviated 510k STERISPINE® LC Lumbar Cage
:
SafeOrthopaedics
510(k) Summary
| Safe Orthopaedics | |
|---|---|
| Submitted by | Parc des Bellevues |
| Allée R. Luxembourg - Le Californie | |
| 95610 Eragny sur Oise - FRANCE | |
| Contacts | QARA Director : Pierre DUMOUCHEL |
| p.dumouchel@safeorthopaedics.com | |
| +33 (0) 1 34 21 50 00 | |
| Regulatory contact Isabelle Drubaix | |
| idee-consulting@nordnet.fr | |
| +33 (0)3 21 05 64 23 | |
| Date Prepared | December 9th 2013 |
| Common Name | Intervertebral body fusion device |
| Trade Name | SteriSpine™LC Lumbar 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 | STERISPINE™ LC manufactured by Safe Orthopaedics and cleared under |
| K122021, Crescent manufactured by Medtronic and cleared under K094025 and | |
| Lumbar I/F cage manufactured by Depuy and cleared under P960025 | |
| Indications for use | 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. | |
| Description of the device | The SteriSpine™LC cages are intervertebral body fusion devices with a central |
| cavity that is filled with bone graft (autograft) to facilitate fusion. The | |
| SteriSpine™LC is available either in straight rectangular shape for | |
| transforaminal (TLIF) or posterior (PLIF) approach and in curved shape for | |
| transforaminal (TLIF) approach. The SteriSpine™LC is made of (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. |
1
K133893 Page 2 of 2
:
:
| Technological
Characteristics | The SteriSpineTMLC straight cages are available in 8 heights (from 7 to 14 mm)
and six lengths (from 22 to 32 mm) with a 4° lordosis. The SteriSpineTMLC
curved cages are available in 8 heights (from 7 to 14 mm) and three lengths
(from 28 to 32 mm) with a 4° lordosis.
The SteriSpineTMLC range of products is supplied sterile with a sterile single-use
set of surgical instruments. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion of Testing | The following non-clinical tests were conducted on SteriSpineTMLC : Static axial
compression, Dynamic axial compression, Static compression shear testing and
Dynamic compression shear testing according to ASTM F2077, subsidence
testing according to ASTM F2267 and and expulsion testing according to in-
house protocol. Results demonstrate that SteriSpineTMLC performs as safely and
effectively as previsoulsy cleared devices. |
| Conclusion | The SteriSpineTMLC devices enclosed within the present submission are
substantially equivalent to previously cleared SteriSpineTMLC devices in terms of
intended use, material, design, mechanical properties and function. The subject
and predicate devices have nearly identical technological characteristics and the
minor differences do not raise any new issues of safety and effectiveness. Non
clinical performance testing demonstrates that SteriSpineTMLC is as safe, as
effective, and performs as safely and effectively as its predicate devices. |
. .
and the comments of the comments of
. .
.
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing or protecting another form, possibly representing health and well-being.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2014
Safe Orthopaedics Mr. Pierre Dumouchel QARA Director Parc des Bellevues Allée R. Luxembourg - Le Californie 95610 Eragny sur Oise - FRANCE
Re: K133893
Trade/Device Name: SteriSpine™ LC Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 17, 2013 Received: December 20, 2013
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Pierre Dumouchel
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" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K133893 Page 1 of 1
INDICATIONS FOR USE
K133893 510(k) Number (if known):
Device Name: SterlSpine™LC
Indications for Use:
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.
| Prescription Use | AND/OR | Over-The-Counter Use _ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiologicial Health (CDRH)
Colin O'Neill
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133893