(356 days)
OSTEOSET®, Exactech Resorbable Bone Paste
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No
The summary describes a bone void filler composed of biological materials and a delivery system. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on biological efficacy (bone growth).
Yes
AFT is intended for use as a bone void filler for voids or gaps in bony structures, treating surgically-created osseous defects or those from traumatic injury, which clearly defines a therapeutic purpose.
No
Explanation: The AFT device is described as a bone void filler intended for treatment of osseous defects, functioning as a resorbable material that supports new bone growth. It does not mention any diagnostic capabilities or functions.
No
The device description clearly states it is composed of physical materials (demineralized bone matrix, nondemineralized bone, sodium hyaluronate) and is provided in a disposable delivery tube, indicating it is a physical medical 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 states that AFT is a "bone void filler" for surgical and traumatic osseous defects. This describes a device used in vivo (within the body) to treat a physical condition.
- Device Description: The description details the composition of the device (bone matrix, bone, sodium hyaluronate) and its form (pre-loaded into a delivery tube). This aligns with a surgical implant or filler, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. AFT is a therapeutic device used to fill bone voids directly in the patient's body.
N/A
Intended Use / Indications for Use
AFT is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. It is indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. AFT is for single patient use only.
Product codes
MQV
Device Description
AFT is composed of human demineralized bone matrix, human nondemineralized bone and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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 testing in the athymic mouse model has demonstrated that AFT materials can effectively support new bone growth in osseous defects.
AFT is osteoconductive, and has been shown to have osteoinductivity potential in an athymic mouse.
The method for processing the DBM and CBM (cortical cancellous) contained in the AFT was evaluated for its viral inactivation potential.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OSTEOSET®, Exactech Resorbable Bone Paste
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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JUL 2 8 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| PROPRIETRY NAME: | AFT |
|---|---|
| COMMON NAME: | Bone Void Filler Containing Human |
| Demineralized Bone Matrix (DBM) | |
| PROPOSED REGULATORY | |
| CLASS: | Class II |
| CLASSIFICATION | |
| IDENTIFICATION: | 21 CFR §888.3045 |
| Resorbable calcium salt bone void filler | |
| device | |
| PRODUCT CODE: | MQV |
| PANEL CODE: | 87 - Orthopedic Devices |
| SPONSOR: | Musculoskeletal Transplant Foundation |
| 125 May Street | |
| Edison, NJ 08837 | |
| 732-661-0202 |
INDICATIONS FOR USE:
AFT is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. It is indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. AFT is for single patient use only.
DEVICE DESCRIPTION:
AFT is composed of human demineralized bone matrix, human nondemineralized bone and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.
SUBSTANTIAL EQUIVALENCE INFORMATION:
AFT shares the same function and intended use and therefore is substantially equivalent to OSTEOSET® and Exactech Resorbable Bone Paste. In vivo testing in the athymic mouse model has demonstrated that AFT materials can effectively support new bone growth in osseous defects.
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SAFETY AND EFFECTIVENESS INFORMATION:
Biocompatibility of AFT materials has been established through their long Diocompanier of rective clinical use, further supported by laboratory testing mstory of sare and 20093. AFT is single-donor processed using aseptic techniques and is tested for sterility per current USP .
OSTEOINDUCTIVITY POTENTIAL
AFT is osteoconductive, and has been shown to have osteoinductivity potential in an athymic mouse. Every lot of final product will be tested to ensure the m an anymis a other inal product. Osteoinduction assay results in the ostcomative possible not be interpreted to predict clinical performance in human subjects.
VIRAL CLEARANCE AND INACTIVATION
The method for processing the DBM and CBM (cortical cancellous) contained in the AFT was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses. The CBM processing methods were determined to provide some viral inactivation potential for a wide range of viruses. In comparison, the CBM processing methods provided less viral inactivation potential than the DBM processing methods; therefore, the risk of disease transmission for the CBM component is greater than the DBM component. However, the risk for disease transmission for these components remains low due to the multiple safeguards employed, i.e., donor selection, laboratory testing, and material processing.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2005
Ms. Karen Hardwick Manager, Regulatory Affairs Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837
Re: K042125
AFT Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: May 31, 2005 Received: June 3, 2005
Dear Ms. Hardwick:
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 (fix 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 segmisms.
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Page 2 - Ms. Karen Hardwick
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.
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Mark N Allman
Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: K042125
Device Name: AFT
Indications for Use:
AFT is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. AFT is indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
AFT is intended for single patient use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Koy 2125
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Miller
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number __