(60 days)
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No
The summary describes a bone void filler composed of biological materials and does not mention any computational or algorithmic components, including AI or ML.
Yes.
AFT is intended for use in the treatment of osseous defects, indicating a therapeutic purpose.
No
The device description clearly states its intended use is as a "bone void filler," indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly states it is composed of physical materials (human demineralized bone matrix, human non-demineralized bone, and sodium hyaluronate) and is provided pre-loaded into a disposable delivery tube, indicating it is a physical medical device, not software-only.
No, 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 used in the extremities, spine, and pelvis for osseous defects. This is a therapeutic use, directly interacting with the patient's body to fill a physical void.
- Device Description: The description details the composition of the material (demineralized bone matrix, non-demineralized bone, sodium hyaluronate) and its form (pre-loaded into a delivery tube). This is consistent with a surgical implant or filler.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a disease or condition. IVDs are used in vitro (outside the body) for diagnostic purposes.
- Performance Studies: The performance studies focus on bone growth support, biocompatibility, sterility, osteoinductivity, and viral inactivation potential. These are all relevant to a device implanted in the body, not a diagnostic test.
In summary, AFT is a therapeutic device used to fill bone voids, not a diagnostic device used to test samples for medical information.
N/A
Intended Use / Indications for Use
AFT is intended for use as a bone void filler in the extremities, spine and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury.
Product codes (comma separated list FDA assigned to the subject device)
MBP
Device Description
AFT is composed of human demineralized bone matrix, human non-demineralized 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, spine and pelvis
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
Biocompatibility of AFT materials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. AFT is single-donor processed using aseptic techniques and is tested for sterility per current USP .
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 osteoinductive potential of the final product. Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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.
0
AFT 510(k) Premarket Notification
MAR 2 1 2006
K 06016/
X. 510(k) SUMMARY OF SAFTEY & EFFECTIVENESS
| PROPREIETARY NAME: | AFT Allograft Filler Tube |
|---|---|
| COMMON NAME: | Bone Void Filler Containing Human Demineralized |
| Bone Matrix (DBM) | |
| PROPOSED REGULATORY | |
| CLASS: | Class II |
| CLASSIFICATION | |
| IDENTIFICATION: | 21 C.F.R. §888.3045 Resorbable calcium salt bone |
| void filler device | |
| PRODUCT 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 in the extremities, spine and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury.
DEVICE DESCRIPTION:
AFT is composed of human demineralized bone matrix, human non-demineralized 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.
Confidential
1
SAFETY AND EFFECTIVENESS INFORMATION:
Biocompatibility of AFT materials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. 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 osteoinductive potential of the final product. Osteoinduction assay results in the athymic mouse model should 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2006
Musculoskeletal Transplant Foundation c/o Ms. Nancy Bennewitz Regulatory Affairs Submission Specialist 125 May Street Edison, New Jersey 08837
Re: K060161
Trade/Device Name: AFT Allograft Filler Tube Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MBP Dated: December 6, 2005 Received: January 20, 2006
Dear Ms. Bennewitz:
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 for abovened as 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 (sec 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
3
Page 2 – Ms. Nancy Bennewitz
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Seeting your device as described in your Section 510(k) This letter will anow you to begin manies.ing of substantial equivalence of your device to a legally premits that hourication. The PDF miamig of cation 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 If you desire specific advice for your ac not our and one one one the regulation entitled, and comact the Office of Compliance at (210) = 6 = 8 = 8 = 8 = 8 = 8 = 8 = 8 = 8 = 8 = 0 = 3 = 0 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = other general information on your responsibilities under the Act from the Division of Small other gelleral International on your responsibilities and 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,
Herbert Lemmerling
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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IV. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: AFT Allograft Filler Tube
Indications for Use:
AFT is intended for use as a bone void filler in the extremities, spine and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury.
AFT is intended for single patient use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR (Pcr 21 CFR 801 Subpart D)
Over-The-Counter Use __ (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helent Lemmerts
Division of General, Restorative, and Neurological Devices
510(k) Number K060161