(21 days)
Not Found
No
The 510(k) summary describes a physical implantable device (cervical spinal system) and its materials. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies listed are related to sterilization and pyrogenicity, not algorithmic performance.
Yes
This device is a therapeutic device intended for stand-alone anterior cervical interbody fusion procedures to treat cervical degenerative disc disease, facilitating fusion and stabilizing the vertebral column.
No
Explanation: The device description clearly states that the TOMCAT™ Cervical Spinal System is an anterior cervical spinal fixation system used for stabilizing the cervical vertebral column and facilitating fusion, implying a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a physical implant made from PEEK, titanium alloy, tantalum, and nitinol, and includes bone screws. This is a hardware device, not software.
Based on the provided information, the TOMCAT™ Cervical Spinal System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- TOMCAT™ Function: The TOMCAT™ Cervical Spinal System is an implantable medical device used in surgical procedures to stabilize the cervical spine and facilitate fusion. It is a physical device inserted into the body, not a tool for analyzing biological samples.
The description clearly outlines its use in surgery for treating degenerative disc disease by providing structural support and promoting bone fusion. This is a therapeutic and structural function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
The TOMCATTM Cervical Spinal System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients. The interbody is used with bone screws provided and requires no additional supplementary fixation. The interbody is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies. The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, to facilitate fusion. The device is implanted by an anterior approach. The TOMCATTM implant must be used with the screws included in the TOMCATTM system. This device is to be used in patients who have had six weeks of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The TOMCATTM Cervical Spinal System is an anterior cervical spinal fixation system for an effective means of stabilizing the cervical vertebral column (C2-T1) as an adjunct to fusion of vertebral bodies. The TOMCATTM System will provide an alternative to the more common cervical plate and cervical interbody spacer Anterior Cervical Discectomy & Fusion (ACDF) surgical procedure. The TOMCATTM Cervical Spinal System is a radiolucent and radiopaque intervertebral body fusion device. The interbody is made from PEEK per ASTM F2026 with titanium alloy (Ti-6Al-4V ELI) per ASTM F136, tantalum radiopaque markers per ASTM F560, and nitinol clips per ASTM F2063. This device accepts titanium (Ti-6Al-4V ELI) bone screws that are available in two diameters and multiple lengths.
The system will be composed of a cervical interbody spacer with a zero profile and a hybrid profile design. The hybrid device is implanted anteriorly by inserting two screws, one screw into the anterior face of vertebral body and the other diagonally though the end plate. The zero profile device implants are implanted anteriorly and stabilized by two diagonally placed screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2/C3 disc space to the C7/T1 disc space
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)
Sterilization validation performed in accordance with ISO 11137 Pyrogenicity testing performed in accordance with USP Bacterial Endotoxin Test (BET) and ANSI/AAMI ST72.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2017
Choice Spine, LP Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K170953
Trade/Device Name: TOMCAT™ Cervical Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: March 29, 2017 Received: March 31, 2017
Dear Ms. Finch:
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
1
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/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,
Vincent J. Devlin -S
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
K170953 Page 1 of 1
Device Name
TOMCATTM Cervical Spinal System
Indications for Use (Describe)
The TOMCAT™ Cervical Spinal System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients. The interbody is used with bone screws provided and requires no additional supplementary fixation. The interbody is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies. The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, to facilitate fusion. The device is implanted by an anterior approach. The TOMCAT™ implant must be used with the screws included in the TOMCAT™ system. This device is to be used in patients who have had six weeks of non-operative treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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7. 510(k) Summary
I. Submitter
Choice Spine, LP.
400 Erin Drive
Knoxville, TN 37919
Phone: 865-246-3333
Fax: 865-246-3334
Contact Person: Kim Finch, Manager of Regulatory Affairs
Contact Email: kfinch@choicespine.com
Date Prepared: March 30, 2017
II. Device
Name of Device: TOMCAT™ Cervical Spinal System
Classification Name: Intervertebral Body Fusion Device
Product Class: Class II
Regulatory Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Product Code: OVE
Panel Code: 87- Orthopedics Devices
III. Predicate Device
The TOMCAT™ Cervical Spinal System K152515 is the primary predicate device provided for this submission.
IV. Device Description
The TOMCAT™ Cervical Spinal System is an anterior cervical spinal fixation system for an effective means of stabilizing the cervical vertebral column (C2-T1) as an adjunct to fusion of vertebral bodies. The TOMCAT™ System will provide an alternative to the more common cervical plate and cervical interbody spacer Anterior Cervical Discectomy & Fusion (ACDF) surgical procedure. The TOMCAT™ Cervical Spinal System is a radiolucent and radiopaque intervertebral body fusion device. The interbody is made from PEEK per ASTM F2026 with titanium alloy (Ti-6Al-4V ELI) per ASTM F136, tantalum radiopaque markers per ASTM F560, and nitinol clips per ASTM F2063. This device accepts titanium (Ti-6Al-4V ELI) bone screws that are available in two diameters and multiple lengths.
The system will be composed of a cervical interbody spacer with a zero profile and a hybrid profile design. The hybrid device is implanted anteriorly by inserting two screws,
4
one screw into the anterior face of vertebral body and the other diagonally though the end plate. The zero profile device implants are implanted anteriorly and stabilized by two diagonally placed screws.
V. Indications for Use
The TOMCAT™ Cervical Spinal System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients. The interbody is used with bone screws provided and requires no additional supplementary fixation. The interbody is inserted between the vertebral bodies into the disc space at one level from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies. The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and for corticocancellous bone graft, to facilitate fusion. The device is implanted by an anterior approach. The TOMCAT™ implant must be used with the screws included in the TOMCAT™ system. This device is to be used in patients who have had six weeks of non-operative treatment.
VI. Comparison of Technological Characteristics with the Predicate Device
The device design remains unchanged from the original 510(k) submission (K152515).
VII. Performance Data
Sterilization validation performed in accordance with ISO 11137 Pyrogenicity testing performed in accordance with USP Bacterial Endotoxin Test (BET) and ANSI/AAMI ST72.
VII. Conclusions
The purpose of this submission is to gain clearance for an additional method of sterilization for the TOMCAT™ Interbodies of the TOMCAT™ Cervical Spinal System. The indications for use and design characteristics of the system devices have not changed. Therefore, it can be concluded that the subject device is substantially equivalent to the predicate.