(121 days)
Not Found
No
The description focuses on the material composition and physical properties of a bone void filler, with no mention of AI or ML capabilities.
Yes
The device is a bone void filler intended to be replaced by bone during the healing process, which aligns with the definition of a therapeutic device designed to treat or alleviate a condition.
No
The device description clearly states its purpose as a bone void filler and graft scaffold, indicating it is used for treatment and repair rather than diagnosis.
No
The device description clearly states that MicroFuse® Bone Void Filler is a physical implant composed of microspheres, available in various forms like granules, sheets, blocks, and putty. It undergoes physical and biological testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- MicroFuse® Function: MicroFuse® Bone Void Filler is a material intended to be implanted directly into the body to fill bony voids and promote bone healing. It is a surgical implant, not a device used to test samples outside the body.
- Intended Use: The intended use clearly states it's for filling bony voids or gaps in the skeletal system.
- Device Description: The description details the composition and forms of the implantable material.
- Performance Studies: The performance studies mentioned relate to the material's properties, biocompatibility, and degradation within the body, not diagnostic accuracy based on analyzing samples.
Therefore, MicroFuse® Bone Void Filler is a medical device, specifically a bone graft substitute/filler, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MicroFuse® Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse® Bone Void Filler may be combined with autogenous bone marrow aspirate or autograft. MicroFuse® Putty is a bone graft extender to be used with autogenous bone marrow aspirate and autograft. MicroFuse® is intended to be gently packed into bony voids or gaps of the skeletal system (e.g. the spine, pelvis, and extremities). These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse® provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
MicroFuse® Bone Void Filler is a porous bone graft scaffold composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres. MicroFuse® is available with and without a combination of barium sulfate and calcium sulfate. MicroFuse® is provided in a variety of shapes and sizes, in the form of granules, sheets, pre-formed blocks, putty and ST MIS implants. MicroFuse® ST Granules and putty are designed to be gently packed into contained voids or defects. MicroFuse® Sheets are designed to be used with shallow bony defects, or as a bone graft onlay to cover a defect. MicroFuse® Blocks and ST MIS implants are designed to fill an entire defect. MicroFuse® Putty is composed of MicroFuse® ST Granules combined with an inert biodegradable carrier. MicroFuse® implants are available in short-term (ST), mid-term (MT), or long-term (LT) composition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
the spine, pelvis, and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
MicroFuse® additional implants satisfy molecular weight testing, carrier degradation testing, biocompatibility testing, shelf life testing, pH testing, and animal testing, and special controls provided in the Guidance for Industry and FDA, Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device, Issued June 2, 2003.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
510(k) Summary: MicroFuse® Additional Implants
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 415-9000 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.
Director, Clinical Affairs & Regulatory |
| Date Prepared: | August 20, 2010 |
| Device Name(s): | MicroFuse® Putty and MicroFuse® ST MIS |
| Classification: | Per 21 CFR as follows:
§888.3045: Resorbable Calcium Salt Bone Void Filler
Product Code is MQV
Regulatory Class II Panel Code 87. |
| Predicate(s): | MicroFuse® Bone Void Filler (K071187, K082442 and
K083232) |
Purpose:
The purpose of this submission is to add MicroFuse® additional implants (Putty and ST MIS) to the MicroFuse® product line.
DEVICE DESCRIPTION:
MicroFuse® Bone Void Filler is a porous bone graft scaffold composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres. MicroFuse® is available with and without a combination of barium sulfate and calcium sulfate. MicroFuse® is provided in a variety of shapes and sizes, in the form of granules, sheets, pre-formed blocks, putty and ST MIS implants. MicroFuse® ST Granules and putty are designed to be gently packed into contained voids or defects. MicroFuse® Sheets are designed to be used with shallow bony defects, or as a bone graft onlay to cover a defect. MicroFuse® Blocks and ST MIS implants are designed to fill an entire defect. MicroFuse® Putty is composed of MicroFuse® ST Granules combined with an inert biodegradable carrier. MicroFuse® implants are available in short-term (ST), mid-term (MT), or long-term (LT) composition.
Indications for Use:
MicroFuse® Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse® Bone Void Filler may be combined with autogenous bone marrow aspirate or autograft. MicroFuse® Putty is a bone graft extender to be used with autogenous bone marrow aspirate and autograft. MicroFuse® is intended to be gently packed into bony voids or gaps of the skeletal system (e.g. the spine, pelvis, and extremities). These osseous defects may be surgically created or created from traumatic injury to the
1
bone. MicroFuse® provides a bone void filler that resorbs and is replaced with bone during the healing process.
Performance Data:
MicroFuse® additional implants satisfy molecular weight testing, carrier degradation testing, biocompatibility testing, shelf life testing, pH testing, and animal testing, and special controls provided in the Guidance for Industry and FDA, Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device, Issued June 2, 2003,
Basis of Substantial Equivalence:
The MicroFuse® additional implants are similar to the predicate device(s) with respect to design, indications for use and principles of operation. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
DEC 2 2 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Globus Medical Inc. % Kelly J. Baker, Ph.D. Director, Clinical Affairs and Regulatory 2560 General Armistead Avenue Audubon, Pennsylvania 19403
ue
Re: K102392
Trade/Device Name: MicroFuse® Putty and MicroFuse® ST MIS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 24, 2010 Received: November 26, 2010
Dear Dr. Baker:
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
3
Page 2 - Kelly J. Baker, Ph.D.
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 (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/CDRHQffices/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/ReportalProblem/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 vours.
A. B. Rute
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 Statement
510(k) Number: K102392
MicroFuse® Putty and MicroFuse® ST MIS Device Name:
Indications:
MicroFuse® Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse® Bone Void Filler may be combined with autogenous bone marrow aspirate or autograft. MicroFuse Putty is a bone graft extender to be used with autogenous bone marrow aspirate and autograft. MicroFuse® is intended to be gently packed into bony voids or gaps of the skeletal system (e.g. the spine, pelvis, and extremities). These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse® provides a bone void filler that resorbs and is replaced with bone during the healing process.
Prescription Use × (Per 21 CFR §801.109)
OR
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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102392