(104 days)
No
The summary describes a bone graft substitute material and its physical and biological properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on material properties and biological response.
Yes
The device is used to fill voids or gaps in the skeletal system and is replaced by bone during the healing process, indicating a therapeutic function.
No
Explanation: The device, Agilon Strip, is described as a "bone graft substitute" used to fill skeletal voids and aid in bone healing. Its function is to facilitate the repair of osseous defects, not to identify or diagnose medical conditions.
No
The device description clearly states it is a physical bone graft substitute composed of granules and collagen fibers, 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 Agilon Strip is for use in voids or gaps of the skeletal system to facilitate bone healing. This is a therapeutic and structural application within the body.
- Device Description: The description details a bone graft substitute material composed of calcium salts and collagen, designed to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. Agilon Strip is a medical device used in vivo (within the body) for a surgical procedure.
N/A
Intended Use / Indications for Use
Agilon Strip is indicated for use in voids or gaps of the skeletal system. i.e., the extremities, pelvis, and posteroateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. Agilon Strip may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Strip 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 Strip is a flexible, resorbable, wicking, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules bound by type I collagen fibers to facilitate shaping and containment of the implant. The osteoSPAN granules in Agilon Strip 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 laver of calcium phosphate throughout its entire porosity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system, extremities, pelvis, 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)
Bench testing of Agilon Strip was performed to verify that the addition of the type 1 collagen does not affect the granule chemistry, crystallinity, porosity, pore diameter, and pore interconnectivity. Sterilization validation and shelf-life aging studies demonstrate the suitability of the packaging system.
A full evaluation of the biocompatibility of Agilon Strip was conducted in accordance with "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." Agilon Strip satisfied a battery of tests assessing the following biological effects: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Bacterial Endotoxins, Subchronic toxicity, Genotoxicity, Implantation.
In vivo testing of Agilon Strip was conducted using a validated, critically sized defect model. Device performance was assessed at multiple time points against the primary predicate and negative controls using histology, histomorphometry, x-ray, and micro-CT analyses. The critical nature of the model was confirmed by the negative controls. No adverse reactions were noted at the implant site or in distant organs; new bone formation, bone remodeling, and implant resorption for the test materials were confirmed with time.
Agilon Strip was also validated in a clinically relevant, single-level posterolateral spinal fusion model. Device performance was evaluated at multiple time points against the primary predicate and positive control 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 events or device-related failures were noted at the implantation site or distant organs for any implant group. No abnormal inflammation, redness, swelling, or discoloration was noted at any time point. New bone formation on the host transverse bone processes, as well as evidence of resorption and remodeling of the graft 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is the Department of Health & Human Services logo. The text is in blue, with "FDA" in a larger font size than the rest of the text.
March 30, 2020
Biogennix, LLC % Elaine Duncan President Paladin Medical, Inc. PO Box 560 Stillwater, Minnesota 55082
Re: K193487
Trade/Device Name: Agilon Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: March 3, 2020 Received: March 4, 2020
Dear Ms. 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 medical devices and radiation-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,
Jesse Muir, Ph.D. 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) K193487
Device Name Agilon Strip
Indications for Use (Describe)
Agilon Strip is indicated for use in voids or gaps of the skeletal system. i.e., the extremities, pelvis, and posteroateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. Agilon Strip may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Strip resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
I. 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: | December 13, 2019 |
II. SUBJECT DEVICE
| Trade Name: | Agilon Strip |
|---|---|
| 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 |
III. PREDICATE DEVICE
The contents of this submission have demonstrated that Agilon Strip is substantially equivalent to its primary predicate Morpheus (K142828) when used as a bone graft substitute in the extremities and pelvis, and as a bone graft extender in the posterolateral spine.
IV. DEVICE DESCRIPTION
Agilon Strip is a flexible, resorbable, wicking, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules bound by type I collagen fibers to facilitate shaping and containment of the implant.
4
The osteoSPAN granules in Agilon Strip 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 laver of calcium phosphate throughout its entire porosity.
V. INDICATIONS FOR USE
Agilon Strip 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. Agilon Strip may be used alone in the extremities or pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Strip resorbs and is replaced with bone during the healing process.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Product | 510(k)
Number | Granules
Composition | Polymer
Binder | Collagen | Osteo-
conductive |
|--------------|--------------------|------------------------------------------------------|-------------------|----------|----------------------|
| Morpheus | K132377
K142828 | Calcium Carbonate/
Calcium Phosphate
composite | Yes | No | Yes |
| Agilon Strip | K193487 | Identical | No | Yes | Yes |
The function, intended use and technological characteristics of the subject device are substantially equivalent to the predicate device cleared under 510(k) premarket notification K142828.
VII. PERFORMANCE DATA
Biogennix followed the "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device: Guidance for Industry and FDA, June 2, 2003, as well as the company's design controls and risk analysis procedures to ensure that Agilon Strip is safe and effective for use.
Bench testing of Agilon Strip was performed to verify that the addition of the type 1 collagen does not affect the granule chemistry, crystallinity, porosity, pore diameter, and pore interconnectivity. Sterilization validation and shelf-life aging studies demonstrate the suitability of the packaging system.
A full evaluation of the biocompatibility of Agilon Strip was conducted in accordance with "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." As a tissue/bone
5
permanent implant device, Agilon Strip satisfied a battery of tests assessing the following biological effects:
- Cytotoxicity
- Sensitization ●
- Intracutaneous Reactivity ●
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity ●
- Bacterial Endotoxins
- Subchronic toxicity
- Genotoxicity ●
- . Implantation
In vivo testing of Agilon Strip was conducted using a validated, critically sized defect model. Device performance was assessed at multiple time points against the primary predicate and negative controls using histology, histomorphometry, x-ray, and micro-CT analyses. The critical nature of the model was confirmed by the negative controls. No adverse reactions were noted at the implant site or in distant organs; new bone formation, bone remodeling, and implant resorption for the test materials were confirmed with time.
Agilon Strip was also validated in a clinically relevant, single-level posterolateral spinal fusion model. Device performance was evaluated at multiple time points against the primary predicate and positive control 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 events or device-related failures were noted at the implantation site or distant organs for any implant group. No abnormal inflammation, redness, swelling, or discoloration was noted at any time point. New bone formation on the host transverse bone processes, as well as evidence of resorption and remodeling of the graft materials, were confirmed with time.
Based on the endpoints and results of these studies, Agilon Strip was concluded to be substantially equivalent to the primary predicate osteoSPAN Morpheus.
VIII. CONCLUSIONS
The non-clinical data presented in this submission demonstrates that Agilon Strip is substantially equivalent to the predicate device osteoSPAN Morpheus.