(341 days)
The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is intended for use during and after ENT surgeries for the control of minimal to moderate bleeding by tamponande effect, blood absorption and platelet aggregation.
The Gel-Sponge ENT is a sterile, absorbable gelatin sponge, USP available in sizes ranging from a 1.5 cm disk to a 100 cm rectangular size. It is able to absorb and hold within its interstices, many times its weight of blood and other fluids. The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. Hemostasis is achieved by the physiological coagulation-inducing properties of the absorbable gelatin sponge. USP, The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied dry or is wetted before use with sterile water for injection or saline (not provided),
The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP, as described in the provided 510(k) summary, did not involve specific acceptance criteria in the typical sense of quantitative performance thresholds for a clinical study. Instead, the device's suitability for its intended use was established through a demonstration of substantial equivalence to existing predicate devices (Gelita-Spon Absorbable Gelatin Sponge, USP and ThrombiGel® thrombin/gelatin foam hemostat). This means the device was shown to be as safe and effective as a legally marketed device for which a PMA was not required.
The study that "proves" the device meets the acceptance criteria is implicitly the demonstration of substantial equivalence through non-clinical testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a substantially equivalent device, the "acceptance criteria" are primarily implied by the predicate device's performance and the successful completion of specific non-clinical tests to demonstrate that the new device shares similar characteristics and performs as expected. No specific quantitative performance metrics like sensitivity, specificity, or reduction in bleeding time were reported with acceptance thresholds.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Physical Properties | Pepsin Digestion | Suitable digestion properties (comparable to predicate) | Confirmed suitability for intended use |
| Absorption | Ability to absorb and hold blood/fluids (comparable to predicate) | Confirmed suitability for intended use | |
| Residue on Ignition | Acceptable residue levels (comparable to predicate) | Confirmed suitability for intended use | |
| pH Testing | Acceptable pH range (comparable to predicate) | Confirmed suitability for intended use | |
| Formaldehyde Residual | Acceptable formaldehyde levels (comparable to predicate) | Confirmed suitability for intended use | |
| Biocompatibility | MEM Elution | Non-cytotoxic | Biocompatible |
| Systemic Injection Test | Non-systemically toxic | Biocompatible | |
| Kligman Skin Sensitization | Non-sensitizing | Biocompatible | |
| Intracutaneous Injection Test | Non-irritating | Biocompatible | |
| Rabbit Pyrogen Test | Non-pyrogenic | Biocompatible | |
| Ames Reverse Mutation Assay | Non-mutagenic | Biocompatible | |
| Short Term Subcutaneous Implantation Testing | Acceptable tissue reaction for short-term implantation | Biocompatible | |
| Clinical Equivalence | N/A (Clinical Testing Not Required) | Substantially equivalent to predicate in terms of indications for use and technological characteristics | Demonstrated substantial equivalence to K060878 and K063860 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set involving human subjects was used. The "test set" for non-clinical testing refers to samples of the device itself. The specific quantities of samples used for each bench and biocompatibility test are not provided in this summary.
- Data Provenance: Not applicable, as no human data was collected. The testing was laboratory-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As no human clinical data was collected, there was no need for experts to establish ground truth for a test set of patient cases. The "ground truth" for the non-clinical tests would be established by standard laboratory methods and validated testing protocols.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. A MRMC comparative effectiveness study was not performed. The 510(k) summary explicitly states: "No human clinical testing was required for this device."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done
- Not applicable. This device is a physical medical device (absorbable gelatin sponge), not an AI algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
- Bench Testing: Ground truth established by validated laboratory standards and measurements for physical properties (e.g., pH, absorption capacity, formaldehyde residual).
- Biocompatibility Testing: Ground truth established by in-vitro and in-vivo (animal model, for some tests like pyrogen and sensitization) toxicology and biocompatibility standards (e.g., ISO 10993 series).
- For the overall product, the "ground truth" for its safety and effectiveness was assessed against the predicate devices through substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm, so there is no "training set" in the machine learning sense. The manufacturing process of the device itself can be seen as a form of "training" to achieve consistent product characteristics, but this is not reported as a data set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI algorithm.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.