(257 days)
No
The summary describes a mechanical implant for vertebral body replacement and does not mention any AI or ML components or functions.
Yes
The device is described as a partial vertebral body replacement device used for the treatment of tumors, trauma, osteomyelitis, or to achieve decompression of the spinal cord and neural tissues, which are all therapeutic interventions aimed at treating a disease or condition.
No
Explanation: The provided text describes the Galileo Vertebral Body Replacement device as a surgical implant for partial vertebral body replacement, not a device used to diagnose medical conditions. Its purpose is to physically replace a resected or excised vertebral body.
No
The device description clearly states it is a surgical grade titanium device, indicating it is a physical implant and not software.
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 replace a portion of a vertebral body in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a surgical implant made of titanium, designed to be placed within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, or tissue) to provide diagnostic information. The device's function is structural support and bone graft containment.
- Performance Studies: The performance studies focus on mechanical properties and clinical utility as a surgical implant, not on diagnostic accuracy.
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
When used as a single-level partial vertebral body replacement devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors, or traumaffracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galileo™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.
Product codes (comma separated list FDA assigned to the subject device)
PLR
Device Description
The Galileo Vertebral Body Replacement device is a surgical grade titanium (Ti-6A1-4V) device and is available in various widths and heights. It has openings of various sizes to allow for the placement of bone graft and for the free flow of cells between the bone graft and the bone of the patient. It is intended for partial vertebral body replacement in a single vertebra and to hold bone graft material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
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)
Mechanical performance tests were conducted following the ASTM F2077 (Test methods for intervertebral body fusion devices) and ASTM F2267 (Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression), and expulsion testing. All tests were passed.
Clinical literature review demonstrates the clinical utility of the device sizes and operative procedure for single level anterior cervical partial vertebrectomy as outlined in the labeling.
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.
Choice Spine Hawkeye VBR system (K183588), Next Spine Matrixx Intervertebral fusion device (K171140), Bengal System (K103488)
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.
Bright Spine Intervertebral Fusion Device (K102449)
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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April 21, 2020
Bright Spine % Bahram Parvinian Founder Lighthouse Regulatory Consulting Group 3 Harrowgate CT Potomac, Maryland 20854
Re: K192145
Trade/Device Name: Galileo Vertebral Body Replacement Device Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR Dated: March 20, 2020 Received: March 24, 2020
Dear Bahram Parvinian:
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,
Brent L. Showalter, Ph.D. Assistant 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) K192145
Device Name Galileo Vertebral Body Replacement Device
Indications for Use (Describe)
When used as a single-level partial vertebral body replacement devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors, or traumaffracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galileo™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.
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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510(k) Summary: Galileo Vertebral Body Replacement Device
In accordance with 21 CFR 807 92 of the Federal Code of Regulations
| Date Prepared | April 16, 2020 |
|---|---|
| Submitted By | Bright Spine LLC |
| Robert Simonson | |
| t 561-289-9378 | |
| r@brightspine.com | |
| Primary Contact | Bahram Parvinian M.S. |
| Principal Consultant | |
| Lighthouse Regulatory Consulting Group LLC | |
| (301)938-7669 | |
| Bahram@lighthouseregulatory.com | |
| Trade Name | Galileo Vertebral Body Replacement Device |
| Common Name | Vertebral body replacement device |
| Classification | |
| Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | PLR |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary | |
| Predicate | |
| Device | Choice Spine Hawkeye VBR system (K183588) |
| Additional | |
| Predicate | |
| Devices | Next Spine Matrixx Intervertebral fusion device (K171140) |
| Bengal System (K103488) | |
| Reference | |
| Predicate | |
| Devices | Bright Spine Intervertebral Fusion Device (K102449) |
| Device Description | The Galileo Vertebral Body Replacement device is a surgical grade titanium (Ti-6A1-4V) |
| device and is available in various widths and heights. It has openings of various sizes to | |
| allow for the placement of bone graft and for the free flow of cells between the bone graft | |
| and the bone of the patient. It is intended for partial vertebral body replacement in a single | |
| vertebra and to hold bone graft material. | |
| Materials | Titanium (Ti-6A1-4V) |
| Intended Use | Partial cervical vertebral body replacement |
| Substantial | |
| Equivalence | |
| Claimed to | |
| Predicate Devices | Galileo Vertebral Body Replacement (VBR) is substantially equivalent to the predicate |
| devices in terms of intended use, design, materials used, mechanical safety and | |
| performances. | |
| Indications for Use | When used as a single-level vertebral body replacement device, the Galileo™ |
| devices are indicated for use in the cervical spine (C2-T1) of skeletally mature | |
| patients for the partial replacement (i.e., partial vertebrectomy) of a vertebral body | |
| resected or excised for the treatment of tumors, or trauma/fracture, or | |
| osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in | |
| cervical degenerative disorders. The device is intended for use with autograft | |
| or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. | |
| When the Galileo™ device is used as a single-level, partial vertebral body | |
| replacement device, supplemental fixation may be used. | |
| Summary of the | |
| technological | |
| characteristics | |
| compared to | |
| predicate | Galileo VBR has the same intended use and similar indication as Choice Spine Hawkeye |
| VBR system (K183588) which is for cervical spine (C2-T1) and is indicated for use with | |
| FDA-cleared supplemental spinal fixation systems. Galileo VBR has the same intended | |
| use as predicate Next Spine Matrixx device (K171140) which includes partial | |
| vertebrectomy and to hold autograft or allograft in place. Galileo VBR uses an identical | |
| surgical procedure to K103488 (Bengal System). | |
| Galileo VBR is indicated for same patient population and same disease condition as |
|
| Non-clinical Test
Summary | Mechanical performance tests were conducted following the ASTM F2077 (Test methods
for intervertebral body fusion devices) and ASTM F2267 (Standard test method for
measuring load induced subsidence of intervertebral body fusion device under static axial
compression), and expulsion testing. All tests were passed. |
| Clinical Test
Summary | Clinical literature review demonstrates the clinical utility of the device sizes and operative
procedure for single level anterior cervical partial vertebrectomy as outlined in the
labeling. |
| SE conclusion | The intended use and technological characteristics of Galileo VBR is the same as the
identified predicates. There are differences in shape and design of Galileo VBR compared
to the predicates, however these differences do not result in new questions of safety and
effectiveness. Where necessary, performance testing has been provided to demonstrate
Galileo VBR is substantially equivalent to the identified predicates. |
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