(30 days)
The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.
The Cook® Biodesign® Otologic Repair Graft is a porous, absorbable, multi-layer biomaterial composed of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). SIS is obtained from the intestine using a process that retains the natural composition of matrix molecules such as collagen (Types I, III, VI), glycosaminoglycans (hyaluronic acid, chondroitin sulfate A and B, heparin, and heparin sulfate), proteoglycans, and fibronectin. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.
This document describes a 510(k) premarket notification for the Biodesign Otologic Repair Graft (K161000). The key information revolves around a packaging change and the demonstration of substantial equivalence to a predicate device (K150594).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Preamble Testing | Demonstration of sterility maintenance over the product's shelf life. | "Sterilization adoption" was performed, implying the sterilization method remains effective with the new packaging configuration. The document states, "Any potential new risks associated with the change in device packaging have been identified by appropriate risk analysis techniques. These potential new risks have been addressed with verification and validation activities in a manner satisfactory to the pre-determined acceptance criteria to ensure that no change to device safety has occurred." |
| Packaging Integrity | The new packaging (snap-top container) must maintain its integrity and protect the device throughout its intended shelf life and under various transport/storage conditions. | "Package performance testing for accelerated aged devices in the snap-top container packaging" was performed, suggesting the new packaging meets performance requirements for integrity and protection. |
| Biocompatibility | The new packaging component (snap-top tray) must not introduce cytotoxins or other harmful substances that could leach into the device or patient. | "Cytotoxicity testing of the snap-top tray" was performed, indicating the material of the new packaging is biocompatible and does not pose a cytotoxic risk. |
| Material Composition | The device's material composition should remain identical to the predicate device. | The document explicitly states the "material composition... of both subject and predicate devices are identical." The device is composed of "laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS)." |
| Intended Use | The intended use of the device should remain unchanged from the predicate device. | The document states, "This intended use is identical to that previously cleared under K150594 for the predicate device." |
| Sterilization Method | The sterilization method should remain consistent and effective. | The document confirms the sterilization method is "Ethylene Oxide," which is the same as the predicate. |
| Single Use | The device remains intended for single use. | The document confirms the device is intended for "single use," same as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for the "sterilization adoption," "package performance testing," or "cytotoxicity testing." It only mentions that these tests were "performed to demonstrate substantial equivalence."
- Data Provenance: The studies were conducted by Cook Biotech Incorporated, as part of their 510(k) submission. The data is retrospective in the sense that these tests were performed on the device and its new packaging configuration to demonstrate equivalence, rather than being part of a prospective clinical trial. The country of origin of the data is implied to be the USA, where Cook Biotech Incorporated is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not pertain to studies requiring expert adjudication for ground truth (e.g., medical image interpretation). The testing described here is related to device engineering, materials science, and packaging performance. The "ground truth" for these tests would be established through defined scientific methodologies and standards (e.g., ISO standards for biocompatibility or ASTM standards for package testing), rather than expert consensus on a clinical outcome or image.
4. Adjudication Method for the Test Set
Not applicable as this is not a study involving human reader interpretation or clinical outcomes that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This submission is for a material and packaging change, not an AI or diagnostic device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a surgical graft, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests would be based on:
- Scientific Standards: For sterilization adoption, it would be demonstration of sterility in accordance with established standards (e.g., ISO 11135 for ethylene oxide sterilization).
- Engineering Standards: For package performance, it would be meeting pre-defined physical and barrier property requirements based on industry standards (e.g., ASTM F1980 for accelerated aging, various ASTM standards for package integrity like peel strength, burst tests, etc.).
- Biological Standards: For cytotoxicity, it would be meeting the requirements of recognized biocompatibility standards (e.g., ISO 10993-5 for in vitro cytotoxicity).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
§ 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.