(228 days)
No
The document describes a physical interbody fusion device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an Interbody Fusion Device used to treat Degenerative Disc Disease, which is a medical condition, making it a therapeutic device.
No
The device description indicates it is an interbody fusion device designed to facilitate fusion, not to diagnose a condition.
No
The device description clearly states it is an "Interbody Fusion Device" with physical characteristics (spiral support arches, rough surfaces) and is intended for surgical implantation, indicating it is a physical medical device, not software.
Based on the provided information, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Camber Spine Technologies SPIRA™ Open Matrix ALIF is an Interbody Fusion Device intended for surgical implantation in the spine (L2-S1) to facilitate fusion in patients with Degenerative Disc Disease. It is a physical implant used within the body, not a device that analyzes samples outside the body.
The information provided aligns with a surgically implanted medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Camber Spine Technologies SPIRA™ Open Matrix ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA™ Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies SPIRA™ Open Matrix ALIF system must be used with autogenous graft material.
Product codes
MAX
Device Description
The Camber Spine Technologies SPIRA Open Matrix ALIF is an Interbody Fusion Device that has spiral support arches 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
L2-S1 (lumbar spine)
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
Testing performed indicate that the SPIRA Open Matrix ALIF is as mechanically sound as predicate devices. Testing included static compression-static compression-shear, dynamic compression, dynamic compression-shear, expulsion, 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
Not Found
Predicate Device(s)
4WEB Medical ALIF Spinal Truss System (K083894, K112316), Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), Scient'x Tribeca Cage (K080588)
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 is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of a human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2017
Camber Spine Technologies % Justin Eggleton Senior Director, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001
Re: K162986
Trade/Device Name: SPIRATM Open Matrix ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 8, 2017 Received: May 10, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K162986 Page 1 of 1
Device Name SPIRA™ Open Matrix ALIF
Indications for Use (Describe)
The Camber Spine Technologies SPIRA™ Open Matrix ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA™ Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies SPIRA™ Open Matrix ALIF system must be used with autogenous graft material.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(k) Summary
| Device Trade Name: | SPIRA™ Open Matrix ALIF |
|---|---|
| Manufacturer: | Camber Spine Technologies |
| 418 E. Lancaster Ave. | |
| Wayne, PA 19087 | |
| Contact: | Mr. Michael Black |
| Director of Engineering | |
| Phone: (855) 899.9869 | |
| Prepared by: | Justin Eggleton |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| jeggleton@mcra.com | |
| Date Prepared: | June 9, 2017 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX |
| Primary Predicate: | 4WEB Medical ALIF Spinal Truss System (K083894, |
| K112316) | |
| Additional Predicate(s): | Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix |
| Anterior Lumbar System (K132790, K143297), and Scient'x | |
| Tribeca Cage (K080588). |
Indications For Use:
The Camber Spine Technologies SPIRA Open Matrix ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix ALIF system must be used with autogenous graft material.
4
Device Description:
The Camber Spine Technologies SPIRA Open Matrix ALIF is an Interbody Fusion Device that has spiral support arches 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 Open Matrix ALIF device is substantially equivalent to predicates 4WEB Medical ALIF Spinal Truss System (K083894, K112316), Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient'x Tribeca Cage (K080588) with respect to indications, design, materials, function, manufacturing, and/or performance.
Performance Testing Summary:
Testing performed indicate that the SPIRA Open Matrix ALIF is as mechanically sound as predicate devices. Testing included static compression-static compression-shear, dynamic compression, dynamic compression-shear, expulsion, 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 Open Matrix ALIF device was demonstrated to be substantially equivalent to predicates 4WEB Medical ALIF Spinal Truss System (K083894, K112316), Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient'x Tribeca Cage (K080588) with respect to indications, design, materials, function, manufacturing, and/or performance.
Conclusion:
Camber Spine Technologies provided sufficient information to demonstrate the SPIRA Open Matrix ALIF is substantially equivalent to predicates 4WEB Medical ALIF Spinal Truss System (K083894, K112316), Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient'x Tribeca Cage (K080588) with respect to indications, design, materials, function, manufacturing, and/or performance.