(97 days)
Not Found
No
The summary describes a mechanical interbody fusion device and its intended use, with no mention of AI or ML capabilities.
No
Explanation: The device is an interbody fusion device intended to facilitate fusion, which is a surgical procedure to join bones, not a therapeutic treatment in itself. Its purpose is to support bone fusion by allowing bone to grow into and around it, rather than directly treating a disease or condition with curative or palliative properties like medication or radiation.
No.
The device is an interbody fusion device designed for treatment of Degenerative Disc Disease, not for diagnosing it.
No
The device description clearly states it is an "Interbody Fusion Device" with physical components (spiral support arches, roughened surfaces) intended for surgical implantation, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for spinal fusion in patients with Degenerative Disc Disease. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an "Interbody Fusion Device" designed to be implanted in the spine to facilitate bone fusion. This is a medical device used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Camber Spine Technologies SPIRA Open Matrix LLIF 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 LLIF is intended to be used with additional FDA-cleared systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft material.
Product codes
MAX
Device Description
The Camber Spine Technologies SPIRA Open Matrix LLIF 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 roughened 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
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 performed indicate that the SPIRA Open Matrix LLIF 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K162986, K083894, K112316, K080699, K090782
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Camber Spine Technologies LLC % Barry Sands Senior Regulatory/ Quality Consultant ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K180724
Trade/Device Name: SPIRA Open Matrix LLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 12, 2018 Received: June 18, 2018
Dear Mr. Sands:
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
June 25, 2018
1
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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -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) K180724
Device Name SPIRA Open Matrix LLIF
Indications for Use (Describe)
The Camber Spine Technologies SPIRA Open Matrix LLIF 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 LLF is intended to be used with additional FDA-cleared systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft material.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K180724 Page 1 of 2
510(k) Summary
| Device Trade Name: | SPIRA Open Matrix LLIF |
|---|---|
| Manufacturer: | Camber Spine Technologies |
| 418 E. Lancaster Ave. | |
| Wayne, PA 19087 | |
| Contact: | Mr. Sean Bishop |
| Product Development Engineer | |
| Institute for Musculoskeletal Science and Education | |
| Phone: (484) 420.4286 | |
| Prepared by: | Barry Sands |
| RQMIS. Inc. | |
| 110 Haverhill Road, Suite 526 | |
| Haverhill, MA 01913 | |
| Phone: (978)-477-0206 | |
| barrysands@rqmis.com | |
| Date Prepared: | October 25, 2016 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX |
| Primary Predicate: | SPIRA Open Matrix ALIF (K162986) |
| Additional Predicate(s): | 4WEB Medical LATERAL Spinal Truss System |
| (K083894,K112316), Alphatec Spine Novel (K080699, K090782) | |
| and Camber Spine SPIRA Open Matrix ALIF (K162986) |
Indications For Use:
The Camber Spine Technologies SPIRA Open Matrix LLIF 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 LLIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft material.
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K180724 Page 1 of 2
Device Description:
The Camber Spine Technologies SPIRA Open Matrix LLIF 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 roughened surface to help prevent movement of the device while fusion takes place.
Predicate Device:
The subject SPIRA Open Matrix LLIF device is substantially equivalent to predicates SPIRA Open Matrix ALIF (K162986), 4WEB Medical LATERAL Spinal Truss System (K083894, K112316), and the Alphatec Spine Novel (K080699, K090782) with respect to indications, design, materials, function, manufacturing, and/or performance.
Performance Testing Summary:
Testing performed indicate that the SPIRA Open Matrix LLIF 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 LLIF device was demonstrated to be substantially equivalent to predicates SPIRA Open Matrix ALIF (K162986), 4WEB Medical LATERAL Spinal Truss System (K083894, K112316), and the Alphatec Spine Novel (K080699, K090782) with respect to indications, design, materials, function, manufacturing, and/or performance.
Conclusion:
Camber Spine Technologies provided sufficient information to demonstrate the SPIRA Open Matrix LLIF is substantially equivalent to predicates SPIRA Open Matrix ALIF (K162986), 4WEB Medical LATERAL Spinal Truss System (K083894, K112316), and the Alphatec Spine Novel (K080699, K090782) with respect to indications, design, materials, function, manufacturing, and/or performance.