(259 days)
Not Found
No
The 510(k) summary describes a resorbable bone void filler material and its intended use. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The performance studies described are standard in vivo and biocompatibility testing for this type of device.
Yes.
The device is a bone void filler intended for use in the skeletal system to facilitate bone regeneration during the healing process, falling under the definition of a therapeutic device.
No
The device is a bone void filler intended for structural support and bone regeneration, not for diagnosing medical conditions.
No
The device description clearly states that SIGNIFY™ Bioactive is a material consisting of Bioglass, polyethylene glycol, and glycerol, available in putty, gel, and crunch forms. This indicates a physical substance, 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 states that SIGNIFY™ Bioactive is a bone void filler for surgical repair of bony defects. It is applied directly to the bone within the body.
- Device Description: The description details the material composition and how it functions within the body to guide bone regeneration.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on analysis of these samples.
Therefore, SIGNIFY™ Bioactive is a medical device used in vivo (within the body) for surgical repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SIGNIFY™ Bioactive is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. SIGNIFY™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). SIGNIFY™ Putty and Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). SIGNIFY™ resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
SIGNIFY™ Bioactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When SIGNIFY™ is placed in direct contact with host bone, new bone grows in apposition to the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by SIGNIFY™
SIGNIFY™ consists of Bioglass (per ASTM F1538), polyethylene glycol, and glycerol, and is available in putty, gel, and crunch forms to accommodate surgical and anatomical needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, pelvis, and posterolateral spine), skeletal system (i.e., the extremities and pelvis)
Indicated Patient Age Range
Not Found
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)
In vivo performance testing (tibia defect model and posterolateral spine fusion model) and biocompatibility testing were conducted in accordance with the "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," June 2, 2003. Performance data demonstrates substantial equivalence to the predicate devices.
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.
KINEX® Bioactive (K130392), Vitoss® BA Bioactive Bone Graft Substitute (K103173, K994337), NovaBone® Bioactive Bone Graft (K080009)
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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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K130977 Page 1 of 2
DEC 2 4 2013
510(k) Summary: SIGNIFY™ Bioactive
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Christina Kichula
Group Manager, Regulatory Affairs |
| Date Prepared: | April 5, 2013 |
| Device Name: | SIGNIFY™ Bioactive |
| Classification: | Per 21 CFR as follows:
§888.3045 Resorbable Calcium Salt Bone Void Filler
Device
Product Codes: MQV
Regulatory Class: II, Panel Code 87 |
| Predicate(s): | KINEX® Bioactive (K130392)
Vitoss® BA Bioactive Bone Graft Substitute (K103173,
K994337)
NovaBone® Bioactive Bone Graft (K080009) |
Purpose:
The purpose of this submission is to request clearance of the SIGNIFY™ Bioactive.
Device Description:
SIGNIFY™ Bioactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When SIGNIFY™ is placed in direct contact with host bone, new bone grows in apposition to the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by SIGNIFY™
SIGNIFY™ consists of Bioglass (per ASTM F1538), polyethylene glycol, and glycerol, and is available in putty, gel, and crunch forms to accommodate surgical and anatomical needs.
Indication for Use:
SIGNIFY™ Bioactive is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. SIGNIFY™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). SIGNIFY™ Putty and Gel are intended to be gently packed into bony voids or
1
gaps of the skeletal system (i.e., the extremities and pelvis). SIGNIFY™ resorbs and is replaced with bone during the healing process.
Performance Data:
In vivo performance testing (tibia defect model and posterolateral spine fusion model) and biocompatibility testing were conducted in accordance with the "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," June 2, 2003. Performance data demonstrates substantial equivalence to the predicate devices.
Basis of Substantial Equivalence:
SIGNIFY™ Bioactive is similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device(s). SIGNIFY™ implants are as safe, as effective, and perform as well as or better than the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2013
Globus Medical, Incorporated Ms. Christina Kichula Group Manager, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K130977
Trade/Device Name: SIGNIFY™ Bioactive Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 14, 2013 Received: November 15, 2013
Dear Ms. Kichula:
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 comply with all the Act's requirements, including, but not limited to: registration and Iisting (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
3
Page 2 - Ms. Christina Kichula
requirements as set forth in the quality systems (OS) 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 contact 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. 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
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K130977 510(k) Number:
Device Name: SIGNIFY™ Bioactive
INDICATIONS:
..............................................................................................................................................................................
SIGNIFY™ Bioactive is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. SIGNIFY™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). SIGNIFY™ Putty and Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). SIGNIFY™ resorbs and is replaced with bone during the healing process.
OR Prescription Use X (Per 21 CFR §801.109)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130977