(90 days)
No
The description focuses on the material composition and physical properties of a bone graft substitute. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML. The performance studies described are based on in vivo testing of the material's biological and mechanical properties.
No
Explanation: The device is a bone graft substitute used to fill voids or gaps in the skeletal system, which resorbs and is replaced by bone during healing. It is not described as treating or curing a disease or condition, but rather as facilitating a natural biological process (bone healing) by providing a scaffold.
No
The device is a bone void filler and a bone graft substitute, indicated for use in voids or gaps of the skeletal system. It facilitates bone formation and remodeling, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical bone graft substitute composed of granules and an organic binder, indicating it is a hardware device, not software.
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 the device is for filling voids or gaps in the skeletal system. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the composition and function of a bone graft substitute, which is used to promote bone healing. This is consistent with a therapeutic device.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.
- Performance Studies: The performance studies focus on bone fusion rates and material resorption, which are relevant to the device's therapeutic function.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is implanted in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Agilon Moldable collagen enhanced bone graft substitute is a moldable, resorbable osteoconductive bone void filler composed of 1-2mm osteoSPAN granules suspended in a biocompatible orqanic binder to facilitate implant mixing, shaping, and containment. The osteoSPAN granules in the product are approximately 65% porous, biphasic calcium salts with interconnected pores having a nominal cross-section of 500 microns. The primary composition of each granule is calcium carbonate, with a thin layer of calcium phosphate throuqhout its entire porosity. The orqanic binder is a combination of a biocompatible polymer and type I collagen fibers to provide enhanced intraoperative handling. The polymer is rapidly absorbed in-situ, leaving behind osteoSPAN granules and collagen fibers as an osteoconductive scaffold.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, pelvis, and posterolateral spine
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)
This submission includes in vivo testing results of the product in a validated, clinically relevant, single-level posterolateral spinal fusion model. Device performance was compared at multiple time points against the predicate and positive control (autograft) using mechanical, histology, histomorphometry, x-ray, and micro-CT analyses. Fusion rates were the same between all treatment groups at each time point and consistent with published literature. No adverse reactions were noted at the implant site or in distant orqans; new bone formation, bone remodeling, and implant resorption for the test materials were confirmed with time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 13, 2020
Biogennix, LLC. % Elaine Duncan President Paladin Medical, Inc PO Box 560 Stillwater, Minnesota 55082
Re: K193168
Trade/Device Name: Agilon Moldable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: November 12, 2019 Received: November 18, 2019
Dear Elaine Duncan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose, PhD Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193168
Device Name Agilon Moldable
Indications for Use (Describe)
Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SUBMITTER
Submitted on behalf of:
| Company Name: | BIOGENNIX, LLC |
|---|---|
| Address: | 1641 McGaw Ave. Irvine, CA 92614 |
| Telephone: | 949-253-0094 |
| Fax: | 949-266-5800 |
| by: | Elaine Duncan, M.S.M.E., RAC President |
| Paladin Medical, Inc. PO Box 560 | |
| Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
| Contact Person: | Elaine Duncan |
| Date Prepared: | November 12, 2019 |
SUBJECT DEVICE
| Trade Name: | Agilon Moldable |
|---|---|
| Common Name(s): | Bone void filler, Bone graft substitute, Bone graft extender |
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Resorbable calcium salt bone void-filler device |
| Product Code: | MQV |
| Regulatory Class: | II |
PREDICATE DEVICE
The contents of this submission have demonstrated that Agilon Moldable is substantially equivalent to Morpheus (K142828) when used as a bone graft extender in the posterolateral spine.
Morpheus-C, cleared to market as a bone graft substitute (K190371) and now marketed as Agilon Moldable, was used as a reference device.
DEVICE DESCRIPTION
Agilon Moldable collagen enhanced bone graft substitute is a moldable, resorbable osteoconductive bone void filler composed of 1-2mm osteoSPAN granules suspended in a biocompatible orqanic binder to facilitate implant mixing, shaping, and containment. The osteoSPAN granules in the product are approximately 65% porous, biphasic calcium salts with interconnected pores having a nominal cross-section of 500 microns. The primary composition of each granule is calcium carbonate, with a thin layer of calcium phosphate throuqhout its entire porosity. The orqanic binder is a combination of a biocompatible polymer and type I collagen fibers to provide enhanced intraoperative handling. The polymer is rapidly absorbed in-situ, leaving behind osteoSPAN granules and collagen fibers as an osteoconductive scaffold.
4
INDICATIONS FOR USE
Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE AND REFERENCE DEVICES
Apart from the type I collagen in the subject device, the function, intended use, and technological characteristics of the subject and predicate devices are identical.
| Product | 510(k)
Number | Granules
Composition | Polymer
Binder | Collagen | Osteo-
conductive |
|---------------------------------------|------------------|------------------------------------------------------|-------------------|----------|----------------------|
| Morpheus
(Predicate Device) | K142828 | Calcium Carbonate/
Calcium Phosphate
composite | Yes | No | Yes |
| Agilon Moldable
(Reference Device) | K190371 | Identical | Identical | Yes | Yes |
PERFORMANCE DATA
Agilon Moldable, the subject device, is IDENTICAL to reference device cleared under K190371. Biogennix followed the "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device: Guidance for Industry and FDA, June 2, 2003", and the company's design controls and risk analysis procedures to ensure the product is safe and effective for use. Biocompatibility testing and other performance characterization prescribed in "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation within a risk management process" was provided in submission K190371.
This submission includes in vivo testing results of the product in a validated, clinically relevant, single-level posterolateral spinal fusion model. Device performance was compared at multiple time points against the predicate and positive control (autograft) using mechanical, histology, histomorphometry, x-ray, and micro-CT analyses. Fusion rates were the same between all treatment groups at each time point and consistent with published literature. No adverse reactions were noted at the implant site or in distant orqans; new bone formation, bone remodeling, and implant resorption for the test materials were confirmed with time.
CONCLUSIONS
The pre-clinical data presented in this submission demonstrate that Agilon Moldable is substantially equivalent to Morpheus when used as an autograft extender in the posterolateral spine.