(1192 days)
The Solidence Multipockets is a sterilization pouch intended to provide dentists with an effective method to enclose stainless steel dental burs of up to 0.5 grams intended for sterilization in steam autoclaves. The validated gravity steam sterilization cycle parameters are 10 minutes at 275°F (135°C), 30 minutes drying time, with a maximum weight of 18 grams, with no more than one bur in each pocket. The sterilization pockets maintain the sterility of the enclosed devices for one year post sterilization.
The Solidence Multipockets is a single use sterilization pouch that features 36 pockets, designed to be used by dentists to enclose small medical devices intended for sterilization in steam autoclaves. The design of the Solidence Multipockets allows the dentists to sterilize 36 dental burs individually, using one sterilization pouch. Each pocket can then be opened independently, without compromising the sterility of the items contained in the other pockets of the sterilization pouch.
The provided text is a 510(k) Summary for a medical device called "Solidence Multipockets," a sterilization pouch. This document details non-clinical testing performed to demonstrate the device's safety and effectiveness compared to a predicate device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "SUMMARY OF NON-CLINICAL TESTING" section directly provides this information.
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Sterilization efficacy half cycle sterilization | Demonstrate adequate sterilization performance | No growth | Pass |
| Full cycle sterilization | Demonstrate adequate sterilant penetration | No growth | Pass |
| Drying time | Demonstrate adequate drying performance | The mass of the device after sterilization shall not be increased more than 3%. | Pass |
| ASTM 10993-5 (Cytotoxicity) | Demonstrate pouch contact during sterilization will not produce a cytotoxic effect in sterilized devices | Under the conditions of the testing, non-cytotoxic | Pass |
| ASTM F88 Seal Strength | Demonstrate adequate sealing performance | Seal strength greater than 0.57 lbf/in | Pass |
| ASTM F1929 Dye Penetration | Demonstrate adequate resistance to seal leakage | No channels detected | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test (e.g., how many pouches were tested for seal strength). It only states that the tests were performed and passed.
Data Provenance:
- Country of Origin of the Data: Not explicitly stated, though the manufacturer is Solidence Surgical Corporation in San Fernando, California, USA, and the representative/consultant is Acknowledge Regulatory Strategies, LLC. The testing itself could have been conducted in a variety of locations.
- Retrospective or Prospective: All non-clinical testing described (sterilization efficacy, drying time, seal strength, dye penetration, biocompatibility, accelerated aging) is inherently prospective testing, as it involves newly manufactured devices undergoing specific controlled procedures to assess their performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The information provided describes non-clinical, laboratory-based testing, not studies involving human experts establishing ground truth for medical image interpretation or similar AI applications. Therefore, this question is not applicable to this document. The "ground truth" for these tests comes from the physical and chemical properties of the materials and the validated performance metrics for sterilization and packaging.
4. Adjudication Method for the Test Set
Since this is non-clinical performance testing for a physical device (sterilization pouch), rather than an AI or diagnostic imaging study requiring expert interpretation and potential disagreement, there is no adjudication method described or necessary in the context of this document. The results are based on objective measurements and established standards (e.g., "no growth," "mass not increased more than 3%," "no channels detected").
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was used in support of this submission." MRMC studies are typically performed for diagnostic devices (e.g., AI for medical imaging) to assess reader performance with and without AI assistance. This device is a sterilization pouch.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical sterilization pouch, not an algorithm or AI system.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" for the non-clinical testing is based on:
- Objective Laboratory Measurements: e.g.,
- Absence/presence of microbial growth (for sterilization efficacy)
- Change in mass (for drying time)
- Force measurements (for seal strength)
- Visual inspection for dye penetration (for seal leakage)
- Cell viability assays (for cytotoxicity/biocompatibility)
- Established Industry Standards and Protocols: The tests reference ASTM and ISO standards (e.g., ASTM F88, ASTM F1929, ISO 10993-1, ISO 11138-1), indicating that the methodologies and criteria are widely accepted and validated within the medical device industry for sterilization and packaging.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical medical device, not an AI model that requires a training set and corresponding ground truth establishment.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).