(53 days)
Not Found
No
The 510(k) summary describes a physical intervertebral body fusion device made of PEEK and Tantalum. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies focus on biocompatibility, packaging, and sterilization, not algorithmic performance.
Yes
The device is intended for intervertebral body fusion procedures to treat degenerative disc disease, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
The device description indicates it is an intervertebral body fusion device (a cage) used for surgical procedures, not for diagnosing conditions.
No
The device description clearly states the device is an intervertebral body fusion cage made of PEEK with Tantalum markers, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The SteriSpine™LC device is an implantable surgical device used for intervertebral body fusion. It is placed within the patient's body, not used to test samples taken from the body.
- The intended use describes a surgical procedure. The description clearly outlines its use in spinal fusion surgery, not in a laboratory setting for diagnostic testing.
- The device description details a physical implant. It describes the materials, shapes, and sizes of the cage, which are characteristics of a surgical implant, not a diagnostic test kit or instrument.
- The performance studies are related to biocompatibility, packaging, and sterilization. These are typical tests for implantable medical devices, not performance metrics like sensitivity, specificity, or AUC which are common for IVDs.
The SteriSpine™LC device is a surgical implant, specifically an intervertebral body fusion device.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (vertebral levels in the lumbar spine)
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
Non-clinical tests were conducted: biocompatibility testing according to ISO 10993-5, ISO 10993-10 and ISO 10993-11 for the new or 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 the subject device system is substantially equivalent to the cited predicates.
Key Metrics
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.
0
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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
1
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
2
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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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 Orthopaedics |
| Parc des Bellevues | |
| Allée R. Luxembourg - Le Californie | |
| 95610 Eragny sur Oise - FRANCE | |
| Contacts | Pierre DUMOUCHEL Industrialization Director / QARA Director |
| p.dumouchel@safeorthopaedics.com | |
| +33 (0) 1 34 21 50 00 | |
| Isabelle Drubaix Regulatory contact | |
| idee-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 Safe |
| Orthopaedics cleared under K133893 | |
| Additional predicate device: STERISPINE™ LC CAGE manufactured by | |
| Safe Orthopaedics cleared under K122021 | |
| 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. |
4
| Description of the device | 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. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | There have been no changes made to the SteriSpine™LC implants
(K122021 and K133893). The purpose of this 510(k) submission is to
obtain clearance for added bifunctional instruments to the
SteriSpine™LC sterile single-use set of surgical instruments, and for a
redesigned quick change handle. Additionally, sulfate barium has been
added in the raw material of the dual trial and the dual spreader in order
to improve visibility. Finally, a "window" has been added to the external
packaging of SteriSpine™LC devices supplied sterile. This new packaging
will be used for all devices manufactured by Safe Orthopaedics. |
| Discussion of Testing | The following non-clinical tests were conducted: biocompatibility testing
according to ISO 10993-5, ISO 10993-10 and ISO 10993-11 for the new
or 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 the
subject device system is substantially equivalent to the cited predicates. |
| Conclusion | Non clinical performance testing demonstrates that the added or
modified surgical instruments are substantially equivalent to predicate
devices in terms of intended use, materials, design and function. |