(168 days)
When used as a cervical intervertebral body fusion device, the Galileo™ Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.
The Bright Spine Galileo™ Spinal Spacer System is an implantable device manufactured from titanium alloy
The provided document is a 510(k) summary for the Bright Spine Galileo™ Spinal Spacer System, which is a cervical intervertebral body fusion device. This type of device is an implantable medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance characteristics commonly found in AI/ML device studies.
Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable to this type of traditional medical device submission.
Here's an adaptation of your request based on the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Manufactured from equivalent materials to the predicate device. | The Bright Spine Galileo™ Spinal Spacer System is manufactured from titanium alloy, which is described as an equivalent material to the predicate Novel® Spinal Spacer System. |
| Dimensional Similarity: Similar dimensions to the predicate device to achieve the same surgical objectives. | The device is described as having similar dimensions to the predicate device, allowing it to achieve the same surgical objectives. |
| Functionality: Functions in a safe and effective manner when used as designed. | The device was shown to be safe and effective and substantially equivalent to the predicate system. |
| Performance Testing (ASTM F2077-03): Includes static and dynamic compression, compressive shear, torsion, and expulsion. | The device complies with ASTM F2077-03. |
| Performance Testing (ASTM F2267-04): Includes subsidence. | The device complies with ASTM F2267-04. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This device's performance was evaluated through mechanical testing against ASTM standards and comparison to a predicate device, not through a clinical "test set" of patients or data in the way AI/ML algorithms are.
- Data Provenance: Not applicable. The performance data comes from mechanical testing, not retrospective or prospective patient data from a specific country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in this context, would be established by the engineering standards themselves (ASTM F2077-03 and ASTM F2267-04) and by the FDA's assessment of substantial equivalence based on the provided technical documentation, not by expert consensus on clinical cases.
4. Adjudication method for the test set
- Not applicable. There was no clinical "test set" requiring adjudication. The assessment was based on comparison to a predicate device and compliance with established engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- Ground Truth: For performance, the "ground truth" is defined by the acceptance criteria specified in the ASTM F2077-03 and ASTM F2267-04 standards. For the overall approval, the "ground truth" is the demonstration of substantial equivalence to the predicate device (Alphatec Spine, Inc. Novel® Spinal Spacer System K081730). This is based on material, dimensional, and functional similarity, as well as adherence to performance standards.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, and no training set was used.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
{0}------------------------------------------------
page 1 of 2
FEB 1 1 20il
510(k) SUMMARY
Submitter's Name:
Submitter's Address:
Contact Person:
Telephone / Facsimile:
Date Prepared:
Device Trade Name:
Device Common Name:
Classification Name:
Classification Number(s)/Product Code(s)
Predicate Device:
Device Description:
Intended Use:
Bright Spine
799 N.E. 71st Street Boca Raton, Florida 33489
Robert E. Simonson
Tel: 561-289-9378 Fax: 561-998-5890
July 22, 2010
Galileo™ Spinal Spacer System
Intervertebral Body Fusion Device
Orthosis, Spinal Intervertebral Fusion with Bone Graft, Cervical
21 CFR 888.3080 (ODP)
Alphatec Spine, Inc. Novel® Spinal Spacer System K081730
The Bright Spine Galileo™ Spinal Spacer System is an implantable device manufactured from titanium alloy
To provide the surgeon with a cervical intervertebral body fusion device, intended for spinal fusion procedures at one level (C2 to TI) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.
{1}------------------------------------------------
K10249
page 2 of 2
Technological Characteristics and Comparison to Predicate:
Performance Data:
The Bright Spine Galileo™ Spinal Spacer System is manufactured from equivalent materials, with similar dimensions, to achieve the same surgical objectives as the predicate Novel® Spinal Spacer System.
When used as designed, the Galileo™ Spinal Spacer System functions in as safe and effective a manner as the predicate device. Complies with ASTM F2077-03 and ASTM F2267-04 Performance Testing.
ASTM F2077-03 Includes:
Static and dynamic compression, compressive shear, torsion and expulsion
ASTM F2267-04 Includes: Subsidence
The Galileo™ Spinal Spacer System was shown to be substantially equivalent to the predicate system.
Clinical Data:
It was determined that Clinical Data was not required to determine substantial equivalence.
The Bright Spine Galileo™ Spinal Spacer System is safe and effective and is Conclusion: substantially equivalent to the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bright Spine, Inc. % Mr. Robert E. Simonson 799 N.E. 71st Street Boca Raton, Florida 33489
FEB 1 1 2GH
Re: K102449
Trade/Device Name: Bright Spine Galileo" Spinal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Invertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 10, 2011 Received: January 11, 2011
Dear Mr. Simonson:
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
{3}------------------------------------------------
Page 2 - Mr. Robert E. Simonson
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
AZ B. R. for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known): _ K102449 '
Device Name: Bright Spine Galileo™ Spinal Spacer System
Indications for Use:
When used as a Cervical Intervertebral Body Fusion Device
When used as a cervical intervertebral body fusion device, the Galileo™ Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Page __ of __ |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K102449 |
Att. 2 -
§ 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.