(168 days)
Not Found
No
The document describes a physical implantable device and its mechanical performance testing. There is no mention of software, algorithms, image processing, or AI/ML terms.
Yes
The device is described as an "implantable device" used for "spinal fusion procedures" to treat "degenerative disc disease," which indicates it is used for therapeutic purposes.
No
The device is an implantable spinal spacer system used for fusion procedures, not for diagnosing medical conditions. Its purpose is treatment, not diagnosis.
No
The device description explicitly states it is an "implantable device manufactured from titanium alloy," indicating it is a physical hardware device, not software only.
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 for spinal fusion. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as an "implantable device manufactured from titanium alloy." This is consistent with a surgical implant, not a diagnostic tool used on biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Bright Spine Galileo™ Spinal Spacer System is an implantable device manufactured from titanium alloy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2 to T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeon
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)
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.
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.
Not Found
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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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
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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
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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
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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)
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| 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 -