(231 days)
Not Found
No
The summary describes a mechanical implant for vertebral body replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a replacement device for a vertebral body resected or excised for treatment of various medical conditions, indicating a therapeutic purpose.
No
The device is a partial vertebral body replacement device used in surgery, not for diagnosis. Its intended use is for treatment and replacement of resected vertebral bodies.
No
The device description explicitly states it is a surgical grade titanium device, indicating it is a physical hardware implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Galileo™ device is a surgical implant made of titanium intended for the partial replacement of a vertebral body in the cervical spine. It is used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Galileo™ device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a single-level partial 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 osteomvelitis, 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 Galleo ™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.
Product codes
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). All tests were passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 13, 2023
Bright Spine % Bahram Parvinian Founder & Principal Consultant Lighthouse Regulatory Consulting Group 5801 Nicholson Lane, Apt. 1705 North Bethesda, Maryland 20852
Re: K221542
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: December 14, 2022 Received: December 19, 2022
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.
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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) 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 (QS) 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 medical devices and radiation-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.
Katherine D. Kavlock -S
for Brent Showalter, Ph.D. Assistant Director 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
Submission Number (if known)
Device Name
Galileo Vertebral Body Replacement Device
Indications for Use (Describe)
When used as a single-level partial 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 osteomvelitis, 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 Galleo ™ 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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| Date Prepared | May 5, 2022 |
|---|---|
| Submitted By | Bright Spine LLC |
| Robert Simonson | |
| t 561-289-9378 | |
| r@brightspine.com | |
| Primary Contact | Bahram Parvinian PhD, |
| Founder and 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 | Galileo Vertebral Body Replacement Device (K192145) |
| 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 |
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| Substantial
Equivalence
Claimed to
Predicate Device | Galileo VBR is substantially equivalent to the predicate device 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 Indications For Use as K192145. The
Galileo VBR includes four additional sizes: | | | | | | | | | | | | | | | | | | | | |
| | A (width) B (height) C (depth) 7 mm 7 mm 12 mm 8 mm 8 mm 12 mm 9 mm 9 mm 12 mm 10 mm 10 mm 12 mm | | | | | | | | | | | | | | | | | | | | |
| | There were no changes made to the device design, materials, or manufacturing
method. | | | | | | | | | | | | | | | | | | | | |
| Non-clinical Test
Summary | Mechanical performance tests were conducted following the ASTM F2077 (Test
methods for intervertebral body fusion devices). All tests were passed. | | | | | | | | | | | | | | | | | | | | |
| Clinical Test
Summary | Not Applicable | | | | | | | | | | | | | | | | | | | | |
| SE conclusion | The intended use and technological characteristics of Galileo VBR is the same
as the identified predicate. The Galileo VBR has additional sizes compared to
the predicate; however, these new device sizes do not result in new questions
of safety and effectiveness. Based on the required design verification and
validation activities, Galileo VBR is substantially equivalent to the identified
predicate. | | | | | | | | | | | | | | | | | | | | |