Search Results
Found 2 results
510(k) Data Aggregation
(193 days)
Vocalis and Vocalis SM are indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication. The product is intended to be durable for a period of one month.
Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principle durable component is synthetic calcium hydroxylapatite. The semi-sold nature is created by suspending the calcium hydroxylapatite particles in a durable high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the Carbopol 974P NF (USP).
The provided text is a 510(k) summary for the Vocalis and Vocalis SM vocal fold implants. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document focuses on:
- Intended Use: Vocal fold medialization and vocal fold insufficiency to improve phonation, with a durability of one month.
- Product Description: Sterile, latex-free, non-pyrogenic, semi-solid, cohesive subdermal implant with synthetic calcium hydroxylapatite suspended in a thixotropic gel.
- Substantial Equivalence: Lists several predicate devices (K013243, K070090, K071663, K080956).
- Pre-Clinical Tests: Biocompatibility, sterilization, and general in vivo/in vitro tests for irritation, sensitization, cytotoxicity, toxicity, genotoxicity, and hemolysis. These tests concluded the device is non-irritant, non-toxic, and has no long-term safety concerns.
- Risk Assessment: Identified primary risks associated with nasopharyngoscopy and injection laryngoplasty.
- Summary: Concludes the device is safe and effective as a space-filling material for soft tissue augmentation in laryngeal procedures.
Therefore, I cannot extract the requested information, as the document does not contain details about acceptance criteria, specific performance studies with sample sizes, expert involvement, or ground truth establishment for clinical effectiveness. The review is a premarket notification centered on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.
Ask a specific question about this device
(114 days)
BioForm's Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:
- · Periodontal Defects
- · Ridge Augmentation
- · Extraction Sites
- · Craniofacial Augmentation
- · Cystic Defects
Calcium Hydroxylapatite Implant is a sterile, non-pyrogenic, flexible, semi-solid, cohesive paste containing calcium hydroxylapatite particles. Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects. Calcium Hydroxylapatite Implant contains calcium hydroxylapatite particles in a pasty gel of glycerin, water and sodium carboxymethylcellulose that acts as a binder for the particles. The calcium hydroxylapatite meets ASTM F1185. The gel ingredients are pharmacoutical grade excipients and are listed as GRAS materials.
Here's an analysis of the provided text regarding the Calcium Hydroxylapatite Implant, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) Premarket Notification Summary from 2003. This type of submission primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo acceptance criteria through rigorous performance studies against predefined metrics. Therefore, the information provided below will reflect this regulatory context. Direct "acceptance criteria" as you might find in a performance study with specific quantitative targets and "reported device performance" against those targets are not explicitly presented in this type of submission. Instead, the "performance" is demonstrated through equivalence to predicates.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, there are no explicit quantitative acceptance criteria defined for the Calcium Hydroxylapatite Implant. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
| Category | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as demonstrated by argument of equivalence) |
|---|---|---|
| Intended Use | Same intended use as predicate devices. | "Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: Periodontal Defects, Ridge Augmentation, Extraction Sites, Craniofacial Augmentation, Cystic Defects." This is stated to be the "same intended use" as the cited predicate devices. |
| Technological Characteristics | Similar composition, mechanism of action, and material properties to predicate devices (e.g., osteoconductivity, biocompatibility, form). | "Calcium Hydroxylapatite Implant is a sterile, non-pyrogenic, flexible, semi-solid, cohesive paste containing calcium hydroxylapatite particles... The CaHA Implant functions as an osteoconductive scaffold for bone infiltration, the same mechanism of action as the predicate devices." |
| "The principal component of the Calcium Hydroxylapatite Implant, calcium hydroxylapatite is identical to the calcium hydroxylapatite used in most of the predicates and is very similar to the calcium phosphate glasses used in the rest of the predicate devices. All of these meet the same biocompatibility requirements." | ||
| The device's "premixed and ready to use characteristic" is presented as an advantage/convenience feature compared to predicates that require mixing. The binder formulation is described as a technological characteristic providing controlled porosity for bone ingrowth and reducing migration, while still being a composite of resorbable/non-resorbable components like predicates. The gel ingredients are pharmaceutical grade excipients and GRAS materials. | ||
| Safety and Effectiveness | As safe and effective as the predicate devices. BioForm also asserts advantages in convenience and reduced contamination risk. | "The Calcium Hydroxylapatite Implant is substantially equivalent in intended use, technical characteristics and are as safe as the predicate devices cited." |
| "In terms of risk versus benefit, BioForm believes that the CaHA Implant has obvious advantages compared to the predicate devices. The CAHA implant is provided as a sterile and ready to use paste that is more convenient for the physician, minimizes the potential for contamination during the mixing processes required by other devices, eliminates the risk and pain associated with drawing blood and is more convenient to place." | ||
| "The components used in the Calcium Hydroxylapatite Implant and the predicate devices are biocompatible, based on the history use in many medical devices as well as from preclinical testing and clinical experience." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical performance study with a "test set" in the traditional sense (i.e., a group of patients receiving the device for evaluation against specific clinical endpoints). The submission is based on substantial equivalence to predicate devices, which are already legally marketed.
- Sample Size: Not applicable for a traditional test set in this 510(k) submission.
- Data Provenance: The 'data' supporting equivalence comes from:
- Descriptions and regulatory filings of the cited predicate devices (e.g., K882682, K852742, K852765, etc.).
- General understanding of the biocompatibility and mechanism of action of calcium hydroxylapatite and similar bone graft materials, often based on "history of use in many medical devices as well as from preclinical testing and clinical experience" of the material itself.
- Assertions about the device's characteristics and how they compare to predicates.
- The document does not refer to prospective or retrospective clinical data collected specifically for this device's performance demonstration.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no "test set" in a clinical study sense where expert adjudication of ground truth was required for the Calcium Hydroxylapatite Implant.
4. Adjudication Method for the Test Set
Not applicable. No "test set" and no adjudication of ground truth for performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed or described in this document. This submission is for a material implant, not an imaging AI diagnostic device. The concept of "human readers" and "AI assistance" improving performance is not relevant to this type of medical device submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a bone graft material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in the context of this 510(k) is the established safety and effectiveness profile of the predicate devices and the general scientific understanding of calcium hydroxylapatite as a bone graft material. The submission argues that the Calcium Hydroxylapatite Implant shares fundamental characteristics with these predicates, making it equally safe and effective.
- Ground Truth Sources (Implied):
- Regulatory history and approvals of predicate devices.
- Preclinical and clinical experience with similar materials (calcium hydroxylapatite, calcium phosphate glasses) cited indirectly.
- ASTM standard F1185 for the calcium hydroxylapatite.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an AI/ML device.
Ask a specific question about this device
Page 1 of 1