(107 days)
Not Found
No
The summary describes a physical implant and surgical system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is a cervical spinal system used for fusion procedures in patients with degenerative disc disease, which falls under the definition of a therapeutic device.
No
Explanation: The device is a cervical spinal system intended for fusion procedures to treat cervical degenerative disc disease, not for diagnostic purposes.
No
The device description clearly states it is a physical implant made of PEEK and Titanium, designed for surgical implantation. It also mentions bone screws and performance testing related to mechanical properties.
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.
- TOMCAT™ Cervical Spinal System Function: The TOMCAT™ Cervical Spinal System is a surgical implant designed to stabilize the cervical spine and facilitate fusion. It is physically implanted into the patient's body.
The provided text clearly describes a surgical implant used for spinal fusion, not a device that analyzes biological samples outside the body.
N/A
Intended Use / 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 /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.
Product codes
OVE
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 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-OPTIMA® HA, PEEK per ASTM F2026 with Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136, Tantalum radiopaque markers per ASTM F560. 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 device is implanted anteriorly by inserting two screws, one screw into the anterior face of vertebral body and the other diagonally through the end plate. The zero profile device is 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
cervical vertebral column (C2-T1)
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 TOMCAT™ Cervical Spinal System has been tested by an independent laboratory in accordance to the following standard:
Static Axial Compression per ASTM F2077
Static Torsion per ASTM F2077
Static Compression Shear per ASTM F2077
Dynamic Axial Compression per ASTM F2077
Dynamic Torsion per ASTM F2077
Dynamic Compression Shear per ASTM F2077
Static Testing in Subsidence per ASTM F2267
Static Testing in Expulsion per ASTM Draft Standard F-04.25.02.02
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102606, K142026, K122630, K150053, P980048
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
Image /page/0/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 design featuring a symbol that resembles a human figure or a caduceus, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
Choice Spine, LP. Ms. Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K152515
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: December 8, 2015 Received: December 9, 2015
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Kim Finch
forth in the quality systems (OS) 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
510(k) Number (if known) K152515
Device Name TOMCAT™ 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 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 /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)
| Prescription (Part 21 CFR 201.66) - Select Drug |
|---|
| Over-The-Counter - Select Drug |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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| 8.0 510(k) Summary | |
|---|---|
| Date Prepared: | December 8, 2015 |
| Submitter Name: | Choice Spine, LP |
| 400 Erin Drive, Knoxville, TN 37919 | |
| Tel: 865.246.3333 Fax: 865.246.3334 | |
| Regulatory Contact: | Kim Finch, Manager of Regulatory Affairs |
| Trade Name: | TOMCAT™ Cervical Spinal System |
| Product Class: | Class II |
| Regulation Number: | 21 CFR 888.3080 |
| Regulation Name: | Intervertebral body fusion device |
| Product Code: | OVE |
| Panel Code: | 87 – Orthopedics Devices |
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 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-OPTIMA® HA, PEEK per ASTM F2026 with Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136, Tantalum radiopaque markers per ASTM F560. 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 device is implanted anteriorly by inserting two screws, one screw into the anterior face of vertebral body and the other diagonally through the end plate. The zero profile device is implanted anteriorly and stabilized by two diagonally placed screws.
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 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.
Predicate Device(s):
The primary predicate is AVS Anchor-C, Stryker Inc., K102606. Other predicates are: Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device, SpineFrontier Inc., K142026 SpineSmith IN: C2 Spinal Fixation System, SpineSmith Partners LLP, K122630 STALIF C® & STALIF-C Ti™, Centinel Spine, Inc., K150053 BAK/Cervical Interbody System, Centerpulse Spine, PMA# P980048
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Performance Standards:
The TOMCAT™ Cervical Spinal System has been tested by an independent laboratory in accordance to the following standard:
Static Axial Compression per ASTM F2077 Static Torsion per ASTM F2077 Static Compression Shear per ASTM F2077 Dynamic Axial Compression per ASTM F2077 Dynamic Torsion per ASTM F2077 Dynamic Compression Shear per ASTM F2077 Static Testing in Subsidence per ASTM F2267 Static Testing in Expulsion per ASTM Draft Standard F-04.25.02.02
The performance testing required is the equivalent for the predicate devices.
Substantial Equivalence:
The characteristics of the TOMCAT™ Cervical Spinal System are similar to the predicate devices Spine Frontier (K142026) Arena-C System, Stryker (K102606) AVS- Anchor-C, Spinesmith (K122630) IN:C2 and Centinel Spine (K150053) STALIF C & STALIF C -- Ti.
Equivalence is based on the similarities of the intended use, implant design, physical characteristics when compared to the predicates, and manufacturing materials. Choice Spine concludes that the TOMCAT™ Spinal System is substantially equivalent when compared to the predicate legally marketed devices.