(136 days)
Not Found
Not Found
No
The summary describes a bone graft substitute kit consisting of calcium sulfate powder and mixing solution, used as a bone void filler. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The device is a physical material for surgical use.
Yes
The device is described as a "bone void filler that resorbs and is replaced with bone during the healing process," indicating a therapeutic purpose to aid in bone healing and regeneration.
No
The device is a bone graft substitute, designed to fill bone voids and resorbs over time, being replaced by bone. It is therapeutic rather than diagnostic.
No
The device description clearly outlines physical components (calcium sulfate powder, mixing solution, tools) that are mixed to form a paste/pellets, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ProFusion® Bone Graft Substitute Kits are used in vivo (within the body) to fill bone voids and gaps. They are a physical material implanted into the skeletal system to aid in bone healing.
- Intended Use: The intended use clearly describes the device being injected, packed, or molded and placed directly into bone voids or gaps within the skeletal system. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The description focuses on the physical properties of the material, its placement within the body, and its role in the bone healing process. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
The paste made with the ProFusion® Bone Graft Substitute Kits are intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.
ProFusion® paste cured in situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.
ProFusion® Bone Graft Substitute Kits are provided sterile for single use only. Because the devices are biodegradable and biocompatible, they may be used at an infected site.
Product codes
MQV
Device Description
ProFusion® Bone Graft Substitute Kits consist of pre-measured medical grade calcium sulfate powder and pre-measured mixing solution, and the tools necessary to mix the components into a paste. The device is provided sterile for single use only. When its components are mixed according to the instructions, the ProFusion Kits produce biodegradable, radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling.
After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). These bone voids or gaps may be either surgically created or result from traumatic injury. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. long bones, extremities, spine 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)
Testing demonstrated that the performance of the ProFusion® Bone Graft Substitute Kits are substantially equivalent to the performances of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ProFusion® Graft Substitute Devices Wright Medical Kits
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
OCT 3 0 2003
510(K) SUMMARY (As required by section 21 CFR 807.92(c))
Submitter's name: Submitter's address: Submitter's telephone number: Contact Person: Submission date: Trade Name: Common Name: Classification Name: Device Product Code and Panel Code: Legally marketed predicate devices:
BioGeneration®, Inc. 9160 Highway 64, Suite 12, Lakeland, TN 38002 (901) 380-9411 Bernard F. Grisoni June 12, 2003 ProFusion® Bone Graft Substitute Kits Calcium Sulfate Unclassified Orthopedics/87/MQV ProFusion® Graft Substitute Devices Wright Medical Kits
Device description:
ProFusion® Bone Graft Substitute Kits consist of pre-measured medical grade calcium sulfate powder and pre-measured mixing solution, and the tools necessary to mix the components into a paste. The device is provided sterile for single use only. When its components are mixed according to the instructions, the ProFusion Kits produce biodegradable, radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling.
After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). These bone voids or gaps may be either surgically created or result from traumatic injury. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
Intended Uses/Indications:
The paste resulting from ProFusion® Bone Graft Substitute Kits is intended to be injected. digitally packed into bone voids or gaps to cure in-situ; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). These bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.
ProFusion® paste cured in situ provides an bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.
ProFusion® Bone Graft Substitute Kit s are provided sterile for single use only. Because the device is biodegradable and biocompatible, ProFusion® Bone Graft Substitute Kits may be used at an infected site.
Technological characteristics:
ProFusion® Bone Graft Substitute Kits have the equivalent chemical composition and technological characteristics to the predicate devices.
Performance data:
Testing demonstrated that the performance of the ProFusion® Bone Graft Substitute Kits are substantially equivalent to the performances of the predicate devices.
Basis for substantial equivalence:
The ProFusion® Bone Graft Substitute Kits are safe and effective because they are equivalent to the predicate devices in terms of chemical composition, indication of use, performances and design features.
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 caduceus, which is a symbol often associated with healthcare. The caduceus is composed of three diagonal lines that curve and merge together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
OCT 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bernard Grisoni, Ph.D Technical Service Director BioGeneration, Inc. 9160 Highway 64, Suite 12 Lakeland. TN 38002
Re: K031838
Trade Name: ProFusion™ Bone Graft Substitute Kits Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 8, 2003 Received: October 9, 2003
Dear Dr. Grisoni:
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.
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 1000-1050.
2
Page 2 - Bernard Grisoni, 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K03/838
Device Name: ProFusion® Bone Graft Substitute Kits
Indications For Use:
The paste made with the ProFusion® Bone Graft Substitute Kits are intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.
ProFusion® paste cured in situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.
ProFusion® Bone Graft Substitute Kits are provided sterile for single use only. Because the devices are biodegradable and biocompatible, they may be used at an infected site.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
la Mark N. Milkeson
ral. Restorative
510(k) Number K031838
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)