(129 days)
The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue where weakness exists, in plastic and reconstructive surgery of the nipple. The cylinder is supplied sterile and is intended for one-time use.
The Biodesign Nipple Reconstruction Cylinder is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material is identical to the predicates SurgiSIS® Mesh (K980431, K062696), SIS Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cylinder is a rolled SIS mesh and available in sizes from 0.7 cm in diameter and 1.0 cm to 2.5 cm in length. The cylinder is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The device is implanted using a skin flap procedure that prevents migration of the device. A PET marking template (Class I, 21 CFR 888.4800) and silicone (35A durometer) nipple shield (Class I, 21 CFR 880.5630 ) to be placed over the cylinder post-operatively, are included with the device. The use of the Biodesign Nipple Recosntruction Cylinder, an off-the-shelf graft, is advantageous in that a donor site is no longer necessary.
Here's a breakdown of the acceptance criteria and study information for the Biodesign® Nipple Reconstruction Cylinder, based on the provided 510(k) summary:
This device's submission is for substantial equivalence to existing predicate devices, not for a de novo marketing authorization. Therefore, the "acceptance criteria" are not defined as specific performance thresholds, but rather the demonstration that the new device performs similarly to
its predicates across various tests, without raising new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be performance comparable to the predicate devices. The reported device performance is presented as demonstrating this comparability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Suture Retention Strength | Performed similarly to predicate devices. |
| Ultimate Tensile Strength | Performed similarly to predicate devices. |
| Biocompatibility | |
| Genotoxicity | Met biocompatibility requirements of ISO 10993-1. |
| Direct Contact In Vitro | Met biocompatibility requirements of ISO 10993-1. |
| Hemolysis | |
| Cytotoxicity | Met biocompatibility requirements of ISO 10993-1. |
| Muscle Implantation | Met biocompatibility requirements of ISO 10993-1. |
| Acute Intracutaneous | Met biocompatibility requirements of ISO 10993-1. |
| Reactivity | |
| ISO Sensitization | Met biocompatibility requirements of ISO 10993-1. |
| Acute Systemic Toxicity | Met biocompatibility requirements of ISO 10993-1. |
| Pyrogenicity | Met biocompatibility requirements of ISO 10993-1. |
| LAL Endotoxins | Met biocompatibility requirements of ISO 10993-1. |
| Subchronic Systemic Toxicity | Met biocompatibility requirements of ISO 10993-1. |
| Animal Performance | |
| Tissue Integration/Response | Performed adequately with minimal inflammation and provided increased soft |
| tissue volume at 5 months. | |
| Clinical Performance | |
| Equivalence in Application | Substantially equivalent to its predicates. |
| Complications | Device extrusion occurred (number not given). |
2. Sample Sizes and Data Provenance
- Bench Testing: The sample sizes for suture retention strength and ultimate tensile strength are not specified. The tests were performed on "finished, terminally sterilized SurgiSIS® mesh" which forms the device.
- Biocompatibility Testing: The sample sizes for each specific biocompatibility test are not specified. The tests were performed on "sterilized SurgiSIS Mesh."
- Animal Testing: The sample size is not explicitly stated beyond "an animal study" in "a guinea pig model." It is implied to include multiple animals to assess performance over 5 months.
- Data Provenance: The study was an animal study, likely conducted in a controlled laboratory setting. The country of origin is not specified but presumed to be within the Cook Biotech research facilities or contracted labs. The data is prospective within the context of the animal study.
- Clinical Testing:
- Sample Size: 2 case studies and anecdotal evidence of 186 device implants (totaling 188 implants).
- Data Provenance: The document does not specify the country of origin. The data appears to be retrospective (anecdotal evidence from past implants) and possibly some prospective observation for the "2 case studies."
3. Number of Experts and Qualifications for Ground Truth for Test Set
This device's submission relies on demonstrating substantial equivalence to already approved predicate devices. Thus, there isn't a "test set" in the traditional sense of a diagnostic algorithm where expert ground truth is established for novel readings.
- For the clinical testing, the "ground truth" implicitly comes from the clinical outcomes and observations made by the surgeons/clinicians performing the implants and follow-ups. The number of experts and their specific qualifications are not reported. Their assessment of "substantially equivalent to its predicates in its application" is based on their clinical experience.
4. Adjudication Method for the Test Set
Given the nature of the submission (substantial equivalence for a physical implant), there is no mention of an adjudication method in the context of expert review of data from a "test set" for a diagnostic algorithm. The clinical "data" comprises case studies and anecdotal evidence from implants managed by various clinicians.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. This type of study is typical for diagnostic AI devices, not for assessing the substantial equivalence of a physical implant. The focus here is on the material, design, and performance characteristics compared to predicates.
6. Standalone Performance Study
This concept of "standalone performance" typically applies to diagnostic algorithms operating independently. Since this is a physical implant, it doesn't have a "standalone" algorithm-only performance. Its performance is assessed through its material properties, biological interaction (in animals), and clinical outcomes (in humans).
7. Type of Ground Truth Used
- Bench Testing: The "ground truth" is based on objective mechanical measurements (suture retention strength, ultimate tensile strength) and comparison to established predicate device performance or industry standards.
- Biocompatibility Testing: The "ground truth" is adherence to ISO 10993-1 standards for various biological responses.
- Animal Testing: The "ground truth" is histopathological analysis and observation of tissue response (minimal inflammation, increased soft tissue volume) in the guinea pig model, compared to expected healthy tissue response and the known behavior of SIS material.
- Clinical Testing: The "ground truth" is based on clinical outcomes, observations, and anecdotal evidence from patients who received the implant. This includes assessment of its ability to reinforce soft tissue in nipple reconstruction, functional outcomes, and reported complications. This is closer to outcomes data and expert clinical assessment rather than a single objective "ground truth" like pathology for a diagnostic image.
8. Sample Size for the Training Set
This submission does not involve a machine learning algorithm, so there is no "training set" in the context of AI. The development of the device (implant) relies on established knowledge of SIS material, previous predicate devices, and pre-clinical/clinical testing.
9. How Ground Truth for the Training Set was Established
As there is no training set for an AI model, this question is not applicable. The underlying "knowledge base" for the device's design and expected performance comes from decades of research and clinical use of SIS extracellular matrix material.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.