(85 days)
No
The 510(k) summary describes a physical implant (a cage) for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The testing described is mechanical performance testing.
Yes
The device is used to treat degenerative disk disease and facilitate spinal fusion, which are therapeutic actions.
No
The provided text describes a medical implant (Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody) used to facilitate spinal fusion in patients with degenerative disk disease. Its purpose is to stabilize and support the cervical spine, not to identify or diagnose a condition.
No
The device description clearly states it is a "Cage" and describes its physical characteristics and materials, indicating it is a hardware implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to facilitate spinal fusion in the cervical spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical cage designed to be implanted in the body and packed with bone graft. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
- Performance Studies: The performance studies focus on mechanical testing of the device's structural integrity, which is relevant for a surgical implant, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in Skeletally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
Product codes
ODP
Device Description
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is a Cage that has spiral supports to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C3-C7
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 performed indicate that the SPIRA-C Open Matrix Cervical Interbody is as mechanically sound as predicate devices. Testing included static compression-shear, static torsion, dynamic compression, dynamic compression-shear, dynamic torsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
November 7, 2017
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
Camber Spine Technologies % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K172446
Trade/Device Name: SPIRA-C Open Matrix Cervical Interbody Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: August 10, 2017 Received: August 14, 2017
Dear Mr. Eggleton:
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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 (DICE) 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 (DICE) 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,
Katherine D. Kavlock -S
for
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) K172446
Device Name SPIRA-C Open Matrix Cervical Interbody
Indications for Use (Describe)
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in sketally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Device Trade Name: | SPIRA-C Open Matrix Cervical Interbody |
|---|---|
| Manufacturer: | Camber Spine Technologies |
| 418 E. Lancaster Ave. | |
| Wayne, PA 19087 | |
| Contact: | Mr. Daniel Pontecorvo |
| CEO | |
| Phone: (484)-427-7060 | |
| Prepared by: | Justin Eggleton |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: (202) 552-5800 | |
| jeggleton@mcra.com | |
| Date Prepared: | October 12, 2017 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | ODP |
| Primary Predicate: | Camber Spine Coveris (K133529) |
| Additional Predicate(s): | 4WEB Medical CERVICAL CAGE Spinal Truss System |
| (K142112, K121741) | |
| Reference Device | Camber Spine Technologies SPIRA Open Matrix ALIF (K162986) |
Indications For Use:
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is intended to be used with additional FDA-cleared supplementary fixation systems.
4
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
Device Description:
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is a Cage that has spiral supports to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place.
Predicate Device:
The subject SPIRA-C Open Matrix Cervical Interbody is substantially equivalent to primary predicate, Camber Spine Coveris (K133529), and additional predicate 4WEB Medical CERVICAL CAGE Spinal Truss System (K121741)
Performance Testing Summary:
Testing performed indicate that the SPIRA-C Open Matrix Cervical Interbody is as mechanically sound as predicate devices. Testing included static compression-shear, static torsion, dynamic compression, dynamic compression-shear, dynamic torsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Substantial Equivalence:
The subject SPIRA-C Open Matrix Cervical Interbody device was demonstrated to be substantially equivalent to primary predicate, Camber Spine Coveris (K133529), and additional predicate 4WEB Medical CERVICAL CAGE Spinal Truss System (K142112, K121741) with respect to indications, design, materials, function, manufacturing, and/or performance. Additionally, the subject 510(k) referenced Camber Spine Technologies SPIRA Open Matrix ALIF (K162986) to establish equivalent biocompatibility.
Conclusion:
Camber Spine Technologies provided sufficient information to demonstrate the SPIRA-C Open Matrix Cervical Interbody is substantially equivalent to primary predicate, Camber Spine Coveris (K133529), and additional predicate 4WEB Medical CERVICAL CAGE Spinal Truss System (K121741) with respect to indications, design, materials, function, manufacturing, and/or performance.