(484 days)
Not Found
No
The summary describes a passive spinal implant (spacer) and its mechanical properties. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an implantable system for anterior cervical interbody fusion procedures to treat cervical disc disease, which indicates it provides a therapeutic effect.
No
This device is described as an implantable spinal system (PERIMETER® C Spinal System) intended for anterior cervical interbody fusion procedures, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it consists of "spacers of various widths and heights" made of PEEK and tantalum, which are physical hardware components. The performance studies also focus on mechanical testing of these physical implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The PERIMETER® C Spinal System is a physical implant (spacers) designed to be surgically inserted into the cervical spine to provide support and aid in bone fusion. It is a structural device, not a diagnostic test.
- Intended Use: The intended use is for anterior cervical interbody fusion procedures, which is a surgical treatment, not a diagnostic process.
The information provided clearly describes a surgical implant used for treatment, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The PERIMETER® C Spinal System consists of spacers of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures. This device is offered in PEEK-OPTIMA® (i.e., POLYETHERETHERKETONE) with tantalum markers. Medical grade titanium implants and medical grade PEEK implants may be used together. Never use titanium or titanium alloy implants with stainless steel in the same construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-C3 disc to the C7-T1 disc (cervical 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)
For a determination of substantial equivalence, the following non-clinical mechanical tests were performed:
-
Static Torsion Testing per ASTM F2077-03
-
Static Compression Testing per ASTM F2077-03
-
Dynamic Compression Testing per ASTM F2077-03
-
Dynamic Torsion Testing per ASTM F2077-03
-
Static Compression- Shear per ASTM F2077-03
-
Subsidence Testing per ASTM F2267-04
-
Expulsion Testing
Results of non-clinical mechanical tests and an engineering rationale indicate that the acceptance criteria were met demonstrating substantial equivalence of the subject device to the listed 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.
Not Found
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
§ 888.3080 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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AUG - 5 2011
PERIMETER® C Spinal System 510(k) Summary August 2011
Medtronic Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 (901) 346-9738 Fax: Brad Sheals Contact:
Proposed Proprietary Trade Name: PERIMETER® C Spinal System II.
- Classification Name(s): Intervertebral Body Fusion Device (Per 21 CFR Section III. 888.3080); Product Code(s): ODP
- Description: The PERIMETER® C Spinal System is intended to be used for anterior IV. cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and implanted via an open, anterior approach. See the package insert for labeling limitations.
Senior Regulatory Affairs Specialist
The PERIMETER® C Spinal System consists of spacers of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.
This device is offered in PEEK-OPTIMA® (i.e., POLYETHERETHERKETONE) with tantalum markers.
Medical grade titanium implants and medical grade PEEK implants may be used together. Never use titanium or titanium alloy implants with stainless steel in the same construct.
- Indications for Use: The PERIMETER® C Spinal System is intended to be used for V. anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.
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Identification of the Legally Marketed Predicate Devices Use to Claim Substantial VI. Equivalence: The design features, materials and indications for use of the PERIMETER® C Spinal System are substantially equivalent to the previously cleared predicate devices (i.e., K073285, S.E. 05/15/2008; K094042, S.E. 06/30/2010 and K100214, S.E. 06/25/2010). The safety and effectiveness of the subject device is adequately supported by documentation within this premarket notification.
Brief Discussion of the Non-Clinical Tests Submitted VII.
For a determination of substantial equivalence, the following non-clinical mechanical tests were performed:
-
Static Torsion Testing per ASTM F2077-03
-
Static Compression Testing per ASTM F2077-03
-
Dynamic Compression Testing per ASTM F2077-03
-
Dynamic Torsion Testing per ASTM F2077-03
-
Static Compression- Shear per ASTM F2077-03
-
Subsidence Testing per ASTM F2267-04
-
Expulsion Testing
Conclusions Drawn from the Non-Clinical Tests VIII.
Results of non-clinical mechanical tests and an engineering rationale indicate that the acceptance criteria were met demonstrating substantial equivalence of the subject device to the listed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MI) 20993-0002
Medtronic Sofamor Danek USA % Mr. Brad Sheals Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
AUG 5 2011
Re: K100967
Trade/Device Name: PERIMETER® C Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 28, 2011 Received: July 29, 2011
Dear Mr. Sheals:
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
3
Page 2 - Mr. Brad Sheals
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 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,
Mark McKesson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
l00967
510(k) Number (if known): K100967
Device Name: PERIMETER® C Spinal System
Indications for Use:
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR X Per 21 CFR 801.109
Over-The-Counter Use -------
Ame H. H.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
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