(110 days)
No
The 510(k) summary describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is a pedicle screw fixation system indicated as an adjunct to fusion for various spinal pathologies, which makes it a therapeutic device designed to treat medical conditions.
No
The device is described as a pedicle screw fixation system used as an adjunct to fusion for treating spinal pathologies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is composed of rods, pedicle screws, and a transverse link, all made of titanium alloy. It also mentions surgical instruments. These are all physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Erisma®-LP Spinal System is a surgical implant used to stabilize the spine during fusion procedures. It is composed of physical components like rods and screws made of titanium alloy.
- Intended Use: The intended use describes the system as an "adjunct to fusion" for various spinal pathologies. This involves physically fixing the spine, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The device is clearly a surgical implant/instrumentation system used for structural support and stabilization within the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma®-LP Spinal System is indicated as an adjunct to fusion for the following indications:
- Degenerative disc disease (discogenic pain with degeneration of the disc confirmed by history and radiographic studies);
- Degenerative spondylolisthesis with objective evidence of neurologic impairment:
- Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; ●
- Fracture; ●
- Dislocation:
- . Scoliosis:
- Kyphosis: .
- Spinal tumor: .
- Failed previous fusion (pseudarthrosis). ●
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH
Device Description
The Erisma®-LP instrumentation is designed for the surgical treatment of spinal pathologies. The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.
The Erisma®-LP system is composed of rods fixed on the spine with pedicle screws. The Erisma®-LP includes monoaxial and polyaxial screws cannulated or not and monoaxial and polyaxial screws with or without breaking tabs, as well as a transverse link which connects two rods altogether.
The implants used in the Erisma®-LP system are made of ISO 5832-3 or ASTM F136 medical grade titanium alloy.
The Erisma®-LP procedures are performed using a set of surgical instruments common for posterior spinal fixation approach. Most of the instruments provided are common surgical tools used in these types of posterior fixation of the spine. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21CFR 888.4540.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to establish equivalence included:
- Dynamic ASTM F1717-15 testing: ●
- . Pull-Out ASTM F543 testing.
Performance data demonstrates that the Erisma® LP is substantially equivalent to its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
CLARIANCE, SAS % Ms. Janice M. Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K153326
Trade/Device Name: Erisma®-LP Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: February 12, 2016 Received: February 12, 2016
Dear Ms. 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 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
March 8, 2016
1
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/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 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 Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
K153326
Device Name Erisma®-LP Spinal Fixation System
Indications for Use (Describe)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma®-LP Spinal System is indicated as an adjunct to fusion for the following indications:
- Degenerative disc disease (discogenic pain with degeneration of the disc confirmed by history and radiographic studies);
- Degenerative spondylolisthesis with objective evidence of neurologic impairment:
- Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; ●
- Fracture; ●
- Dislocation:
- . Scoliosis:
- Kyphosis: .
- Spinal tumor: .
- Failed previous fusion (pseudarthrosis). ●
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
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510(k) SUMMARY
CLARIANCE's Modified Erisma® - LP Spinal Fixation System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
CLARIANCE, SAS 18 rue Robespierre 62217 Beaurains, France
| Phone: | +33(0)3 2116 1215 |
|---|---|
| Facsimile: | +33(0)3 2115 5073 |
Contact Person: Pascal ROKEGEM, Chief Technology Officer
Date Prepared: November 18, 2015
Name of Device and Name/Address of Sponsor
CLARIANCE - Erisma®-LP Spinal Fixation System 18 rue Robespierre 62217 Beaurains, France
Common or Usual Name
Non cervical pedicle spine System
Classification Name
Class III, 21 CFR 888.3070, NKB Class II, 21 CFR 888.3070, MNH and MNI
Predicate and Reference Devices
Erisma LP manufactured by CLARIANCE SAS (K120469) (Primary Predicate) Xia Spine System manufactured by Howmedica Osteonics Corp (now Stryker) (K001272) (Reference Device) Xia 3 Spine System manufactured by Stryker Spine (K142381) (Reference Device) CD Horizon LEGACY manufactured by Medtronic (K143569) (Reference Device)
Purpose of the Special 510(k) notice.
The Erisma®-LP is a modification to the cleared Erisma®-LP to add screws with breaking tabs, improve screw/head fixation, and change from single to double thread, as well as add additional screw dimensions and instrument modifications.
4
Indications
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma®-LP Spinal System is indicated as an adjunct to fusion for the followinq indications:
- Degenerative disc disease (discogenic pain with degeneration of the disc confirmed o by history and radiographic studies);
- Degenerative spondylolisthesis with objective evidence of neurologic impairment; O
- Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) O vertebral joint;
- Fracture; O
- Dislocation; O
- Scoliosis; O
- Kyphosis; O
- Spinal tumor: O
- Failed previous fusion (pseudarthrosis). O
Device Description
The Erisma®-LP instrumentation is designed for the surgical treatment of spinal pathologies. The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.
The Erisma®-LP system is composed of rods fixed on the spine with pedicle screws. The Erisma®-LP includes monoaxial and polyaxial screws cannulated or not and monoaxial and polyaxial screws with or without breaking tabs, as well as a transverse link which connects two rods altogether.
The implants used in the Erisma®-LP system are made of ISO 5832-3 or ASTM F136 medical grade titanium alloy.
The Erisma®-LP procedures are performed using a set of surgical instruments common for posterior spinal fixation approach. Most of the instruments provided are common surgical tools used in these types of posterior fixation of the spine. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21CFR 888.4540.
Technological Characteristics comparison
The modified device is made from the same materials as the company's cleared predicate device. The slight differences between the predicate and modified device include the addition of breaking tabs, improved polyaxial screw assembly fixation strength, and change in screw threading. None of these changes raise different types of safety or effectiveness questions and are present in reference devices.
Performance Data
Bench testing was performed to establish equivalence included:
- Dynamic ASTM F1717-15 testing: ●
- . Pull-Out ASTM F543 testing.
5
Substantial Equivalence
The Erisma®-LP has the same intended use and indications for use, as well as very similar principles of operation and technological characteristics as the cleared Erisma® LP. The minor differences in the technological characteristics do not raise different questions of safety or effectiveness. Performance data demonstrates that the Erisma® LP is substantially equivalent to its predicate devices.
Conclusion
The Erisma® LP is substantially equivalent to the predicate devices.