(368 days)
Not Found
No
The summary describes a passive, implantable intervertebral body fusion device made of titanium alloy. There is no mention of software, algorithms, image processing, or any other components typically associated with AI/ML in medical devices. The performance studies focus on biomechanical testing, not algorithmic performance.
Yes
The device is intended to be used as an adjunct to spinal fusion procedures for degenerative disc disease, which indicates it provides a therapeutic benefit.
No
The device description clearly states it is an "implantable intervertebral body fusion device manufactured from titanium alloy," designed to be implanted in the spine to aid fusion, not to diagnose a condition.
No
The device description explicitly states it is an "implantable intervertebral body fusion device manufactured from titanium alloy" and describes its physical characteristics and intended placement, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implantable intervertebral body fusion device used in spinal fusion procedures. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implant made of titanium alloy, designed to be placed within the body. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The performance studies focus on biomechanical properties, which are relevant to surgical implants, not diagnostic tests.
Therefore, the STCC is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STCC is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an anterior approach and used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
STCC is an implantable intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V) and is available in a variety of different sizes to suit the individual anatomic and clinical circumstances of each patient. Intended for placement via an anterior approach, the device has a trapezoidal cross section with a hollow interior designed to accommodate the placement of autologous bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, 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)
Testing was performed on the STCC following protocols outlined in ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices", ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression" and in ASTM Draft Standard F-04.25.02.02 "Static Push-out Test Method for Intervertebral Body Fusion Devices" Draft #2 -- August 29, 2000. The following tests were conducted in which the STCC was demonstrated to meet or exceed the biomechanical requirements of the intended use:
Static axial compression (ASTM F2077)
Dynamic axial compression (ASTM F2077)
Static torsion (ASTM F2077)
Dynamic torsion (ASTM F2077)
Static subsidence (ASTM F2267)
Static expulsion (ASTM Draft Standard F-04.25.02.02)
Conclusion: The STCC is capable of meeting the biomechanical requirements of the intended use.
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.
0
510(k) Summary
STCC K100698
510(k) Summary
Cardinal Spine, LLC STCC
MAR 1 4 2011
November 2, 2010
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Cardinal Spine, LLC |
|---|---|
| 12307 Old LaGrange Rd. Ste. 105 | |
| Louisville, KY 40245 | |
| Telephone: | +1 (502) 777-4788 |
| Fax: | +1 (502) 245-5768 |
| Official Contact: | Natasha Lonnon |
| Vice President | |
| Representative/Consultant: | David J. Collette, MD |
| Floyd G. Larson | |
| PaxMed International, LLC | |
| 11234 El Camino Real, Suite 200 | |
| San Diego, CA 92130 | |
| Telephone: | +1 (858) 792-1235 |
| Fax: | +1 (858) 792-1236 |
| email: | dcollette@paxmed.com |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
.'
| Trade/Proprietary Name: | STCC |
|---|---|
| Common Name: | Intervertebral body fusion device |
| Classification Regulations: | 21 CFR 888.3080 |
| Class II | |
| Product Code: | ODP |
| Classification Panel | Orthopedic and Rehabilitation Devices Panel |
| Reviewing Branch | Orthopedic Spine Devices Branch |
.
・・
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Se 1 of 2
1
INTENDED USE
The STCC is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an anterior approach and used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
DEVICE DESCRIPTION
STCC is an implantable intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V) and is available in a variety of different sizes to suit the individual anatomic and clinical circumstances of each patient. Intended for placement via an anterior approach, the device has a trapezoidal cross section with a hollow interior designed to accommodate the placement of autologous bone graft.
PERFORMANCE DATA
Testing was performed on the STCC following protocols outlined in ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices", ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression" and in ASTM Draft Standard F-04.25.02.02 "Static Push-out Test Method for Intervertebral Body Fusion Devices" Draft #2 -- August 29, 2000. The following tests were conducted in which the STCC was demonstrated to meet or exceed the biomechanical requirements of the intended use:
Static axial compression (ASTM F2077) Dynamic axial compression (ASTM F2077) Static torsion (ASTM F2077) Dynamic torsion (ASTM F2077) Static subsidence (ASTM F2267) Static expulsion (ASTM Draft Standard F-04.25.02.02)
Conclusion: The STCC is capable of meeting the biomechanical requirements of the intended use.
EQUIVALENCE TO MARKETED DEVICE
Cardinal Spine, LLC has submitted information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the STCC is substantially equivalent in indications, design principles, materials and performance to the following predicate devices: the LDR Spine Cervical Interbody Fusion System (K091088) from LDR Spine USA, the Synthes Zero-P (K072981) from Synthes Spine, and the Novel® Spinal Spacer System (K081730) from Alphatec Spine, Inc.
Page 52 of 59
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 4 2011
Cardinal Spine, LLC % PaxMed International, LLC David J. Collette, MD 11234 El Camino Real, Suite 200 ... - -San Diego, California 92130
Re: K100698
Trade/Device Name: STCC Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 08, 2011 Received: March 09, 2011
Dear Dr. Collette:
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 - David J. Collette, MD
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.fdagov/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,
A
B. n he
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: STCC
Indications for Use:
The STCC is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the devices are intended to be implanted via an anterior approach and used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
(Division Sign-Off)
Division of Surgical, Orthopedic, ්යය Restorative Devices
KI00698 510(k) Number_
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