(48 days)
Coaptite™ Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Coaptite™ Tissue Marker is a sterile, nonpyrogenic, flexible, semi-solid, cohesive implant used as a single use tissue marker. The principle component of the Coaptite™ Tissue Marker is synthetic calcium hydroxylapatite, a radiopaque biomaterial with over twenty years of use in orthopedics, neurosurgery, dentistry, otolaryngology, and ophthalmology. The product is available in two particle size ranges to allow different needle sizes for percutaneous placement. Coaptite™ Tissue Marker (0008025-1 and 0008026-1) has a size range of 75-125 microns. Coaptite™ FN Tissue Marker (0008027-1 and 0008028-1) has a size range of 25-45 microns. The calcium hydroxylapatite beads are clearly visible on standard radiographs as well as CT scan, MRI, and ultrasound. The cohesive semi-solid, elastic nature of the Coaptite™ Tissue Marker is created by physical bonds formed with sodium carboxymethylcellulose (NaCMC). NaCMC has also been used safely as a biomaterial for over twenty years. Coaptite™ Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. There is no ferrous material used in the formulation for Coaptite™ Tissue Marker and therefore it is MRI compatible.
This 510(k) submission for the Coaptite™ Tissue Marker (K012955) does not include a study with acceptance criteria and reported device performance in the way a typical AI/ML device submission would. The document is for a physical implantable tissue marker, not an AI/ML software device.
Therefore, many of the requested categories in your prompt are not applicable to this submission. I will address the relevant sections of your prompt based on the provided text, and explicitly state when information is not available or not applicable for this type of medical device submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This type of information (e.g., sensitivity, specificity, accuracy) is not applicable to this physical device submission. The acceptance criteria for the Coaptite™ Tissue Marker are inherent in its design, materials, and manufacturing processes, aiming for safety and effectiveness through biocompatibility, sterilization, and visible radiographic marking.
| Acceptance Criteria Category (Derived from document intent) | Reported Device Performance (Summary) |
|---|---|
| Material Biocompatibility | Nonantigenic, nonirritant, nontoxic. No concerns for long-term safety issues based on 36-month data. Proven record of excellent biocompatibility for synthetic dense calcium hydroxylapatite (ASTM-1185). USP grade pharmaceutical excipients (glycerin, NaCMC) have extensive safe use. |
| Radiographic Visibility | Clearly visible on standard radiographs, CT scan, MRI, and ultrasound. |
| MRI Compatibility | MRI compatible (no ferrous material). |
| Sterilization Efficacy | Sterilized using steam, validated autoclave system with overkill methodology to 10⁻⁶ SAL. |
| Long-Term Safety (Clinical) | Subjects from a clinical study (Robert Mayer, M.D.) are more than five years out from implant placement with no long-term concerns. |
| Substantial Equivalence to Predicates | Determined substantially equivalent to Durasphere Tissue Marker (K001807), Gel Mark Biopsy Site Marker (K000060), and Auto Suture Site Marker staple (K983400) for radiographic soft tissue marking. |
2. Sample size used for the test set and the data provenance
- Sample Size (Pre-clinical): The document mentions "in vivo tests" for sensitization, tissue reaction, systemic reactions, and long-term safety issues, conducted under GLP guidelines. However, the exact sample size (number of animals or test subjects) for these in vivo tests is not specified.
- Sample Size (Clinical): "Subjects from the clinical study by Robert Mayer, M.D." are mentioned, but the exact number of subjects is not provided.
- Data Provenance: The preclinical tests were "in vitro and in vivo" based on Tripartite and Biocompatibility guidelines and ISO10993, using historically accepted test methods. These tests were conducted under GLP (Good Laboratory Practice) guidelines, suggesting a controlled experimental environment. The clinical study by Dr. Robert Mayer would inherently be prospective in nature for assessing long-term outcomes, but the original study design details are not in this 510(k) summary. The country of origin for these studies is not specified, though BioForm, Inc. is located in Wisconsin, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to this physical device submission. "Ground truth" in the context of material biocompatibility and radiographic visibility is established through objective scientific testing (e.g., chemical analysis, imaging studies) and established medical understanding of materials, rather than expert consensus on diagnostic interpretations. The document refers to "pre-clinical and clinical experience" and Dr. Robert Mayer's clinical study, implying medical expertise in evaluating outcomes, but no specific number or qualification of "experts establishing ground truth for a test set" on device performance in the AI sense is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to this device type. Adjudication methods are typically used in clinical studies for diagnostic devices where subjective interpretation (e.g., by radiologists) needs to be reconciled to establish a consensus ground truth. For a physical tissue marker, its presence and visibility are objectively verifiable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical tissue marker, not an AI or diagnostic imaging device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical tissue marker.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the Coaptite™ Tissue Marker is based on:
- Biomaterial Science and Standards: Compliance with ASTM-1185 for calcium hydroxylapatite, and established safe use records for excipients (USP grade glycerin and sodium carboxymethylcellulose).
- Pre-clinical In Vivo Testing: Direct measurement and observation of tissue reactions (sensitization, irritation, toxicity) in animal models, and long-term safety assessments (36-month data).
- Radiographic Visibility: Objective imaging (X-ray, CT, MRI, ultrasound) to confirm the marker's presence and clarity.
- Clinical Outcomes Data: "Long-term concerns" from subjects in a clinical study (Robert Mayer, M.D.) are considered. This refers to the real-world performance and safety in human subjects over an extended period.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. Refer to point 8.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.