(208 days)
No
The document describes a physical interbody fusion device and its intended use, with no mention of AI or ML technology in its design, function, or intended use. The performance study mentioned is a Finite Element Analysis (FEA), which is a simulation technique, not an AI/ML method.
Yes
These devices are interbody fusion devices used to treat Degenerative Disc Disease (DDD) and facilitate bone growth, which are direct medical interventions.
No
This device is an interbody fusion device, indicated for treatment of degenerative disc disease, not for diagnosis.
No
The device description clearly states it is an "interbody fusion device" with a physical structure ("open matrix design consisting primarily of arched support members" and "spiral support members"). This is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The SPIRA Open Matrix ALIF and LLIF are described as "interbody fusion devices" with an "open matrix design" intended to "permit bone growth (i.e., interbody fusion) throughout the implant." These are physical implants placed within the body.
- Intended Use: The intended use is for treating Degenerative Disc Disease (DDD) by facilitating spinal fusion. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological specimens, diagnostic testing, or providing diagnostic information based on laboratory results.
The device is a surgical implant used for spinal fusion, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
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 radios. Patients should have received 6 months of nonoperative 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 bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
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 radios. Patients should have received 6 months of nonoperative 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 supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
SPIRA Open Matrix ALIF is an interbody fusion device with an open matrix design consisting primarily of arched support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA Open Matrix ALIF. With the exception of the perimeter, all surfaces have a roughened texture to help prevent movement of the device.
SPIRA Open Matrix LLIF is an interbody fusion device with an open matrix design consisting primarily of spiral support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA-L Open Matrix LLIF
The purpose of this submission is the addition of the allogenic bone graft indication to both SPIRA ALIF and SPIRA LLIF devices that have been cleared under K162986 and K180724 respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radios
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)
A Finite Element Analysis (FEA) was performed to evaluate the effects of design changes to the SPIRA Open Matrix LLIF on the worst-case implant and determine if the design changes created new worst-case scenarios. The testing performed was static axial compression shear, and surface area comparison (subsidence and expulsion equivalence). Testing proved that the new design did not create a new worst-case under any testing condition.
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.
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.
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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
September 23, 2019
Camber Spine Technologies % Matthew Carey Junior Regulatory Affairs/Quality Consultant RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K190483
Trade/Device Name: SPIRA Open Matrix ALIF and LLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 16, 2019 Received: August 27, 2019
Dear Matthew Carey:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190483
Device Name SPIRA Open Matrix ALIF and LLIF
Indications for Use (Describe) SPIRA Open Matrix ALIF
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 radios. Patients should have received 6 months of nonoperative 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 bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
SPIRA Open Matrix LLIF
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 radios. Patients should have received 6 months of nonoperative 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 supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF 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) | ||
|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K190483 Page 1 of 3
510(k) SUMMARY
Camber Spine Technologies SPIRA Open Matrix ALIF and LLIF
SUBMITTER l.
Camber Spine Technologies 501 Allendale Road King of Prussia, PA 19406
Phone: 484.427.7060
Contact Person: Matthew Carey RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 Phone: 1-(978) 834-5703 Fax: 1 (978) 477-0206
Date Prepared: 19 September 2019
II. DEVICE
| Trade/Device Name: | SPIRA Open Matrix ALIF and SPIRA Open Matrix LLIF |
|---|---|
| Common or Usual Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification Name: | Intervertebral body fusion device |
| Regulation Number: | 21 CFR 888.3080 |
| Regulatory Class: | Class II |
| Product codes | MAX |
lll. PREDICATE DEVICES
| Primary Predicates: | SPIRA Open Matrix LLIF (K180724)
SPIRA Open Matrix ALIF (K162986) |
|-----------------------|-------------------------------------------------------------------------------------------|
| Additional Predicate: | Centinel Spine STALIF TT70, STALIF MIDLINE®, MIDLINE II™, and
MIDLINE II-Ti™ (K150643) |
| Reference Predicate: | SPIRA-C Open Matrix Cervical Interbody, Camber Spine
Technologies (K172446) |
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IV. DEVICE DESCRIPTION
SPIRA Open Matrix ALIF is an interbody fusion device with an open matrix design consisting primarily of arched support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA Open Matrix ALIF. With the exception of the perimeter, all surfaces have a roughened texture to help prevent movement of the device.
SPIRA Open Matrix LLIF is an interbody fusion device with an open matrix design consisting primarily of spiral support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA-L Open Matrix LLIF
The purpose of this submission is the addition of the allogenic bone graft indication to both SPIRA ALIF and SPIRA LLIF devices that have been cleared under K162986 and K180724 respectively.
Indications for Use:
SPIRA™ Open Matrix ALIF
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 nonoperative 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 bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
SPIRA™ Open Matrix LLIF
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 nonoperative 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 or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
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V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject SPIRA Open Matrix LLIF and SPIRA Open Matrix ALIF device was demonstrated to be substantially equivalent to primary predicates SPIRA Open Matrix LLIF (K180724) and SPIRA Open Matrix ALIF (K162986) with respect to indications, design, materials, function, manufacturing, and/or performance.
VI. PERFORMANCE DATA
A Finite Element Analysis (FEA) was performed to evaluate the effects of design changes to the SPIRA Open Matrix LLIF on the worst-case implant and determine if the design changes created new worst-case scenarios. The testing performed was static axial compression shear, and surface area comparison (subsidence and expulsion equivalence). Testing proved that the new design did not create a new worst-case under any testing condition.
VII. CONCLUSION
Camber Spine Technologies provided sufficient information to demonstrate the SPIRA Open Matrix LLF and SPIRA Open Matrix ALIF device is substantially equivalent to predicates SPIRA Open Matrix LLIF (K180724), SPIRA Open Matrix ALIF (K162986), and Centinel Spine STALIF TT70, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ (K150643) with respect to indications, design, materials, function, manufacturing, and performance.