(368 days)
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.
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.
The Cardinal Spine, LLC STCC is an intervertebral body fusion device. The acceptance criteria for this device are based on passing a series of biomechanical tests as outlined in relevant ASTM standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Passing Requirement) | Reported Device Performance |
|---|---|---|
| Static axial compression (ASTM F2077) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2077) | Met or exceeded biomechanical requirements |
| Dynamic axial compression (ASTM F2077) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2077) | Met or exceeded biomechanical requirements |
| Static torsion (ASTM F2077) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2077) | Met or exceeded biomechanical requirements |
| Dynamic torsion (ASTM F2077) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2077) | Met or exceeded biomechanical requirements |
| Static subsidence (ASTM F2267) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2267) | Met or exceeded biomechanical requirements |
| Static expulsion (ASTM Draft Standard F-04.25.02.02) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM Draft Standard F-04.25.02.02) | Met or exceeded biomechanical requirements |
Note: The provided text explicitly states that the device was "demonstrated to meet or exceed the biomechanical requirements of the intended use" for all listed tests. The specific quantitative acceptance criteria or thresholds for these tests are not detailed in the provided 510(k) summary, but are instead referenced to the respective ASTM standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size (number of devices) used for each biomechanical test.
- Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that these are laboratory biomechanical tests, it's implied that the testing was conducted under controlled laboratory conditions, likely in the US where the manufacturer and consultant are located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable for this device. The "ground truth" for the performance of this intervertebral body fusion device is established through an objective assessment against pre-defined biomechanical standards (ASTM protocols), rather than through expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
This is not applicable for this device. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (like medical images) where human expert consensus is required to establish ground truth. For biomechanical testing, the "adjudication" is inherent in whether the device meets the quantitative pass/fail criteria of the specified ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI/software devices where human readers are involved. The STCC is an implantable medical device, and its performance is evaluated through engineering and biomechanical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the STCC is a physical implantable device, not an algorithm or software. Its performance is inherently "standalone" in a biomechanical sense, meaning its physical properties are tested without human interaction for its functionality, but it is ultimately implanted with human surgical intervention and used in conjunction with human healthcare.
7. The Type of Ground Truth Used
The "ground truth" for the STCC's performance is established by biomechanical engineering standards and test protocols (specifically ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02). The device's ability to withstand specified loads and forces, as defined by these standards, serves as the objective measure of its performance and suitability for its intended use.
8. The Sample Size for the Training Set
This is not applicable for this device. The STCC is a manufactured medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for this device as it does not involve AI or machine learning and thus does not have a "training set" or "ground truth for a training set."
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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 888.3080Class II |
| Product Code: | ODP |
| Classification Panel | Orthopedic and Rehabilitation Devices Panel |
| Reviewing Branch | Orthopedic Spine Devices Branch |
.
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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
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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
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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
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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)
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(Division Sign-Off)
Division of Surgical, Orthopedic, ්යය Restorative Devices
KI00698 510(k) Number_
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§ 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.