Search Results
Found 1 results
510(k) Data Aggregation
(266 days)
TISSUE REGENERATION SYSTEMS, INC.
TRS Cranial Bone Void Filler is intended for use in the repair of 13mm neurosurgical cranial burr holes. It should be gently packed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.
TRS Cranial Bone Void Filler (TRS C-BVF) is a synthetic, porous, osteoconductive, bone void filler made from PCL polycaprolactone (CaH100-)X which will degrade and resorb fully in vivo by hydrolysis and is subsequently metabolized by the body, and hydroxylapatite (Ca10(PO4)6.(OH)2) with a calcium phosphate bone mineral coating (Hydroxylapatite and Octacalcium phosphate). TRS BVF has an interconnected porous structure that acts as an osteoconductive matrix for the ingrowth of bone.
TRS C-BVF is available in single size, which is a 13mm diameter x 5mm "plug" with a 20mm diameter x .90mm thick flange.
TRS C-BVF is manufactured using a laser sintering process and is then coated with the calcium phosphate bone mineral coating. The product is shipped to a contract manufacturer who packages, labels and sterilizes the C-BVF devices. They are then returned to TRS and inventoried as Finished Goods.
Acceptance Criteria and Study for TRS Cranial Bone Void Filler (TRS C-BVF)
This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Tissue Regeneration Systems Cranial Bone Void Filler (TRS C-BVF) to its predicate devices, as presented in 510(k) Premarket Notification K123633.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for TRS C-BVF were not explicitly stated as numerical thresholds for specific performance metrics in the provided document. Instead, the study aimed to demonstrate "comparable performance" or "similar performance" to predicate devices across various tests. Therefore, the "acceptance criteria" are implied by the demonstration of substantial equivalence to already cleared devices.
The reported device performance is summarized in the table below, based on the non-clinical testing performed.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (TRS C-BVF) |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-sensitizer, non-irritant, no acute systemic toxicity, non-mutagenic, non-clastogenic, non-pyrogenic, no evidence of systemic toxicity, non-hemolytic, minimal activator of intrinsic coagulation pathway. (Demonstrate compliance with ISO 10993 standards akin to predicate devices). | Cytotoxicity (ISO 10993-5): No cytotoxicity or cell lysis, reactivity grade 0. Sensitization (ISO 10993-10): No evidence of causing delayed dermal contact sensitization. Intracutaneous Reactivity (ISO 10993-10): No erythema/edema or very slight with difference from control ≤ 1.0. Systemic Toxicity (Acute) (ISO 10993-11): No mortality or evidence of systemic toxicity. Genotoxicity (Gene mutation) (ISO 10993-3): Non-mutagenic. Genotoxicity (in-vivo) (ISO 10993-3): Non-clastogenic. Genotoxicity (Mouse Lymphoma) (ISO 10993-3): Non-mutagenic. Local effects (2wks) (ISO 10993-6): Non-irritant compared to negative control (HDPE) and ChronOS. Local effects (6wks) (ISO 10993-6): Non-irritant compared to ChronOS, slight irritant compared to HDPE. Pyrogen study (USP) (ISO 10993-11): Non-pyrogenic after retest. Sub-chronic toxicity (13wks) (ISO 10993-11): No evidence of systemic toxicity, local reaction not significant compared to HDPE. Chronic toxicity (26wks) (ISO 10993-11): No evidence of systemic toxicity, local reaction not significant compared to HDPE, moderate irritant compared to HDPE (expected mild macrophage/giant cell response). Hemolysis (ASTM F756): Non-hemolytic. PTT (ASTM F2382): Averaged 77% of negative control (passed as minimal activator). C3a/SC5b-9 Complement Activation (ISO 10993-4): Statistically significantly higher than controls (attributed to surface-related phenomenon, not a direct blood-contacting device). |
| Material Degradation | Comparable degradation mechanism and profile to ChronOS predicate; qualitatively similar polymeric material components to Osteopore PCL Scaffold predicate. | Polymer degradation (ISO 10993-13): Similar PCL degradation mechanism (hydrolysis). TRS C-BVF lost 10-23% molecular weight and 0.26-0.47% mass at 365-730 days. ChronOS showed faster degradation (57% reduction at 30 days, 90% at 90 days, completely degraded by 540 days). TRS device is in the first stage of degradation. Ceramic degradation (ISO 10993-14): Both extreme and simulation tests demonstrated ceramic component is calcium and phosphate. Heavy metal elements within acceptable limits. FTIR Analysis: FTIR results showed strong peaks consistent with PCL for both TRS C-BVF and Osteopore PCL Scaffold, indicating PCL as a major component. Degradation for Osteopore material (and thus TRS C-BVF) presumed similar to TRS C-BVF. |
| Mechanical Properties | Comparable compressive mechanical properties and push-out force to predicate devices (chronOS and Osteopore PCL). | Bench testing showed comparable performance in compressive mechanical properties and push-out force to chronOS and Osteopore devices. |
| Bone Ingrowth/Healing | Similar performance to predicate ChronOS device in new bone formation in an animal model, demonstrating facilitation of constant, sustained bony healing response. | Rabbit Calvarial Defect Testing: Similar performance to predicate ChronOS device with respect to new bone formation. Total bone formation approximately equal by 26 weeks, nearly identical bone volumes by 78 weeks (CT). |
Note: The FDA's 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than meeting predefined, quantitative acceptance criteria for novel claims. The reported performance aims to show that the new device is as safe and effective as the predicate.
2. Sample Sizes and Data Provenance
The document does not explicitly state a general "test set" sample size in the context of a single uniform study. Instead, different sample sizes were used for various non-clinical tests:
- Biocompatibility Tests (ISO 10993 series):
- Cytotoxicity (ISO 10993-5): Not specified, but standard in-vitro test.
- Sensitization (Guinea pig maximization test) (ISO 10993-10): "All animals" (implies a typical number for this test, usually around 10-20 guinea pigs for a maximization test).
- Intracutaneous Reactivity (ISO 10993-10): Not specified.
- Systemic Toxicity (Acute) (ISO 10993-11): "Mice" (implies a typical number for acute toxicity, often 3-5 mice per extract).
- Genotoxicity (Bacterial Reverse Mutation) (ISO 10993-3): Standard in-vitro assay using specific Salmonella typhimurium and Escherichia coli tester strains, not a sample size of devices.
- Genotoxicity (in-vivo; Mouse Peripheral Blood Micronucleus Study) (ISO 10993-3): "Mice" (implies a typical number, usually 5-6 mice per group).
- Genotoxicity (Mouse Lymphoma Assay) (ISO 10993-3): Standard in-vitro assay using L5178Y/TK+/- cell line.
- Local effects after Implantation (Muscle implantation study in rabbits) (ISO 10993-6): "Rabbits" for 2 and 6-week studies (typically small groups, e.g., 3-5 rabbits per group).
- Pyrogen study (USP) (ISO 10993-11): Initial test: 3 animals. Retest: 5 additional animals (total 8 rabbits).
- Sub-chronic toxicity (13 week study) (ISO 10993-11): "Rats" (small groups, e.g., 5-10 rats per sex/group).
- Chronic toxicity (26 week study) (ISO 10993-11): "Rats" (similar to sub-chronic, small groups).
- ASTM F756 Hemolysis Test: Standard in-vitro test, not a patient sample size.
- Partial Thromboplastin Time (PTT): Standard in-vitro test, not a patient sample size.
- C3a/SC5b-9 Complement Activation Assay: Standard in-vitro test, not a patient sample size.
- Polymer degradation (ISO 10993-13): Samples of TRS C-BVF and ChronOS incubated over various time points (30, 90, 180, 365, 540, 730 days), likely duplicate/triplicate samples per time point.
- Ceramic degradation (ISO 10993-14): Coated and uncoated discs tested in extreme and simulation solutions.
- Bench Testing: Not specified, but involved multiple samples of TRS C-BVF and predicate devices for mechanical property measurements.
- Animal Testing (Rabbit Calvarial Defect testing): "Rabbits" (implies a typical number for animal models, usually in groups of 6-12 animals per test/control arm).
Data Provenance: The studies described are pre-clinical (in-vitro and animal). The country of origin for the studies is not explicitly stated, but they are generally performed in GLP-certified labs, often in the US or other countries with established regulatory testing standards. The data is prospective in the sense that these tests were specifically conducted to support this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
This type of submission (510(k) for a bone void filler) does not typically involve human expert readers establishing ground truth in the way defined for image-based diagnostic AI devices. The ground truth for the pre-clinical studies was established through:
- Laboratory assays and measurements: For biocompatibility, mechanical properties, and degradation, the "ground truth" is the objective result of the standardized test method (e.g., cell viability count, force measurement, chemical analysis, animal health observations).
- Histopathological evaluation: For the animal (rabbit) study, the "ground truth" for new bone formation would have been established by a pathologist (likely a veterinary pathologist or a pathologist specializing in bone/tissue histomorphometry) examining tissue samples from the defect sites. The number of pathologists and their specific years of experience are not mentioned in this summary but would be part of the full study report.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "test set" consists of laboratory and animal study results, not a set of human-interpreted cases requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is designed for diagnostic imaging devices where multiple human readers interpret cases to assess diagnostic accuracy, often with and without AI assistance. TRS C-BVF is a bone void filler, not a diagnostic device, so this type of study is not relevant to its clearance.
6. Standalone (Algorithm Only) Performance
No. This device is a physical medical implant, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. Type of Ground Truth Used
The ground truth for the various studies includes:
- Standardized laboratory measurements and observations: For biocompatibility (e.g., cell counts, dermal reactions, organ weights, histopathology, chemical analysis).
- Mechanical engineering data: For bench testing (e.g., force/stress measurements).
- Histological and imaging evaluation (CT): For animal studies, assessing new bone formation and volume.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML algorithm involved, there is no training set or associated ground truth establishment process.
Ask a specific question about this device
Page 1 of 1