(43 days)
No
The device description focuses on the material composition and physical form of a bone void filler, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "bone void filler" intended "for use in filling bony voids or gaps" and resorbs to be "replaced with bone during the healing process," clearly indicating a therapeutic purpose to aid in bone healing and regeneration.
No
MicroFuse™ Bone Void Filler is described as a bone graft scaffold intended for filling bony voids, which is a therapeutic rather than a diagnostic function. It is replaced by bone during healing, indicating it plays a role in the treatment and repair process.
No
The device description clearly states that MicroFuse™ Bone Void Filler is a physical product composed of microspheres, available in various shapes and sizes (granules, sheets, blocks). It is a physical implant intended to fill bony voids.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MicroFuse™ Function: MicroFuse™ Bone Void Filler is a material implanted directly into the body to fill bone defects and promote bone healing. It does not analyze specimens taken from the body.
The description clearly indicates it's a surgical implant used for structural support and bone regeneration within the body, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities and pelvis 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. 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, and pre-formed blocks. MicroFuse™ granules 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 are designed to fill an entire defect. MicroFuse™ implants are available in short-term (ST), mid-term (MT), or long-term (LT) compositions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities and pelvis
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 888.3045 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™ Bone Void Filler
6082442
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 415-9000 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.
Director, Clinical Affairs & Regulatory |
| Device Name: | MicroFuse™ Bone Void Filler |
| Classification: | Per 21 CFR §888.3045: Resorbable Calcium Salt Bone
Void Filler. Class II. The Product Code is MQV. The Panel
Code is 87. |
| Predicate(s): | MicroFuse™ Bone Void Filler K071187 |
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, and pre-formed blocks. MicroFuse™ granules 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 are designed to fill an entire defect. MicroFuse™ implants are available in short-term (ST), mid-term (MT), or long-term (LT) compositions.
Intended Use:
MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities and pelvis 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. MicroFuse™ provides a bone void filler that resorbs and is replaced with bone during the healing process.
Basis of Substantial Equivalence:
The MicroFuse™ Bone Void Filler is similar to the predicate device with respect to design, indications for use, principles of operation, and performance.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, clutching a caduceus in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
OCT 0 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Globus Medical Inc. % Kelly J. Baker, Ph.D. Director, Clinical Affairs & Regulatory 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Rc: K082442
Trade/Device Name: MicroFuse™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: September 24, 2008 Received: September 25, 2008
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, Dr to 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, its inc. A devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 100-1050.
2
Page 2 -- Kelly J. Baker, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse vents. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millham
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use Statement
| 510(k) Number: | K082442 |
|---|---|
| ---------------- | --------- |
MicroFuse™ Bone Void Filler Device Name:
Indications:
MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities and pelvis 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. 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)
D
De De 10/2/16
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K682442