(129 days)
Drill Stop Kit is intended to be used to enclose drill stops that are to be sterlized by a health care provider. Drill Stop Kit is intended to allow sterilization of the enclosed medical devices. Drill Stop Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Drill Stop Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum)- Exposure at 132 °C for 4 minutes and 20 minutes dry time. Drill Stop Kit is intended for sterilization of non-porous loads.
Drill Stop Kit is recommended not to be stacked during sterilization.
The combined weight of the Drill Stop Kit and the associated devices is 199.8 grams.
The weight of the empty Drill Stop Kit is 192.6 grams.
Prosthetic Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Prosthetic Kit is intended to allow sterilization of the enclosed medical devices.
Prosthetic Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Prosthetic Kit is to be enclosed in a sterlization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time. Prosthetic Kit is intended for sterilization of non-porous loads.
Prosthetic Kit is recommended not to be stacked during sterilization.
The combined weight of the Prosthetic Kit and the associated instruments is 178.8 grams.
The weight of the empty Prosthetic Kit is 141.8 grams
Healing Screws Kit is intended to be used to enclose healing screws that are to be sterilized by a health care provider. Healing Screws Kit is intended to allow sterilization of the enclosed medical devices. Healing Screws Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Healing Screws Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) - Exposure at 132 °C for 4 minutes and 20 minutes dry time.
Healing Screws Kit is intended for sterilization of non-porous loads.
Healing Screws Kit is recommended not to be stacked during sterilization.
The combined weight of the Healing Screws Kit and the associated instruments is 203.1 grams.
The weight of the empty kit Healing Screws Kit is 168.9 grams.
Kit for Healing Screws Kontat Perio Level is intended to be used to enclose healing screws that are to be sterilized by a health care provider. Kit for Healing Screws Kontat Perio Level is intended to allow sterilization of the enclosed medical devices. Healing Screws Kit, Perio Level requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Kit for Healing Screws Kontat Perio Level in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time. Kit for Healing Screws Kontat Perio Level is intended for sterilization of non-porous loads.
Kit for Healing Screws Kontat Perio Level is recommended not to be stacked during sterilization.
The combined weight of the Kit for Healing Screws Kontat Perio Level and the associated instruments is 200.0 grams. The weight of the empty Kit for Healing Screws Kontat Perio Level is 169.0 grams.
Scanbodies Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Scanbodies Kit is intended to allow sterilization of the enclosed medical devices.
Scanbodies Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Scanbodies Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time. Scanbodies Kit is intended for sterilization of non-porous loads.
Scanbodies Kit is recommended not to be stacked during sterilization.
The combined weight of the Scanbodies Kit and the associated instruments is 259.7 grams.
The weight of the empty Scanbodies Kit is 233.9 grams.
Pick-up Impression Coping Cica Kit is intended to be used to enclose pick-up impression copings that are to be sterilized by a health care provider. Pick-up Impression Coping Cica Kit is intended to allow sterilization of the enclosed medical devices. Pick-up Impression Coping Cica Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Pick-up Impression Coping Cica Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time. Pick-up Impression Coping Cica Kit is intended for sterilization of non-porous loads.
Pick-up Impression Coping Cica Kit is recommended not to be stacked during sterilization.
The combined weight of the Pick-up Impression Coping Cica Kit and the associated instruments is 338.0 grams.
The weight of the empty tray Pick-up Impression Coping Cica Kit is 291.4 grams.
Pop-up Impression Coping Cica Kit is intended to be used to enclose pop-up impression copings that are to be sterilized by a health care provider. Pop-up Impression Coping Cica Kit is intended to allow sterilization of the enclosed medical devices. Pop-up Impression Coping Cica Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.)
Pop-up Impression Coping Cica Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) = Exposure at 132 °C for 4 minutes and 20 minutes dry time. Pop-up Impression Coping Cica Kit is intended for sterilization of non-porous loads.
Pop-up Impression Coping Cica Kit is recommended not to be stacked during sterilization.
The combined weight of the Pop-up Impression Coping Cica Kit and the associated instruments is 317.1 grams.
The weight of the empty kit Pop-up Impression Coping Cica Kit is 270.9 grams.
Multi Kontact Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Multi Kontact Surgical is intended to allow sterilization of the enclosed medical devices. Multi Kontact Surgical requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.) Multi Kontact Surgical is to be enclosed in a sterlization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time.
Multi Kontact Surgical is intended for sterilization of non-porous loads.
Multi Kontact Surgical is recommended not to be stacked during sterilization.
The combined weight of the Multi Kontact Surgical and the associated instruments is 580.7 grams.
The weight of the empty Multi Kontact Surgical is 449.6 grams.
Try-in Abutment Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Try-in Abutment Kit is intended to allow sterilization of the enclosed medical devices. Try-in Abutment Kit requires the use of a double pouch to maintain the sterlity of the enclosed devices (pouch must be FDA cleared in the U.S.). Try-in Abutment Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time.
Trv-in Abutment Kit is intended for sterilization of non-porous loads.
Try-in Abutment Kit is recommended not to be stacked during sterilization.
The combined weight of the Try-in Abutment Kit and the associated devices is 469.5 grams.
The weight of the empty Try-in Abutment Kit is 463.8 grams
AtlaSurgery Guided Surgery Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. AtlaSurgery Guided Surgery Kit is intended to allow sterilization of the enclosed medical devices. AtlaSurgery Guided Surgery Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
AtlaSurgery Guided Surgery Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) = Exposure at 132 °C for 4 minutes and 20 minutes dry time.
AtlaSurqery Guided Surgery Kit is intended for sterilization of non-porous loads.
AtlaSurgery Guided Surgery Kit is recommended not to be stacked during sterilization.
The combined weight of the AtlaSurgery Guided Surgery Kit and the associated instruments is 689.2 grams.
The weight of the empty AtlaSurgery Guided Surgery Kit is 476.0 grams.
Pilot Drills Kit for Guided Surgery is intended to be used to group other medical devices that are to be sterilized by a health care provider. Pilot Drills Kit for Guided Surgery is intended to allow sterlization of the group medical devices. Pilot Drills Kit for Guided Surgery requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.).
Pilot Drills Kit for Guided Surgery is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time.
Pilot Drills Kit for Guided Surgery is intended for sterilization of non-porous loads.
Pilot Drills Kit for Guided Surgerv is recommended not to be stacked during sterilization.
The combined weight of the Pilot Kit for Guided Surgery and the associated instruments is 39.4 grams.
The weight of the empty Pilot Drills Kit for Guided Surgery is 36.8 grams.
The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner trav (if applicable), and a lid (cover). The subject device trays are to be used to organize and protect the dental healing screws, try-in abutments, instruments, and accessories that are sterilized in the trays by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared pouch to maintain sterility.
The subject device includes a total of 10 sizes (same lid and base and enclosed volumes), and a total of 11 tray configurations. The subject device has seven (7) trays that are 2-piece plastic trays manufactured from Polyphenylsulfone (Radel® R-5000) for the lid and Polypropylene (PPHS) or Polysulfone for the base. The subject device has three (3) trays that are 3-piece plastic trays manufactured from Polyphenylsulfone (Radel R-5000) with silicone grommets. The subject device has one (1) tray that is a 2-piece metal tray manufactured from stainless steel.
This document is a 510(k) Premarket Notification for Biotech Dental Kits, which are instrument sterilization trays. It details the device's indications for use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices.
Acceptance Criteria and Device Performance Study for Biotech Dental Kits
The review focuses on the "Summary of Non-Clinical Testing" section, specifically the table and the text indicating how the device meets acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Automated Cleaning Validation (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 2015) | To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective. | Protein assay: less than 6.4 µg/cm² (Assay quantitation limits: 5.0 µg/mL) | |
| TOC assay: less than 2.010 mg/L (Assay quantitation limits: 2.010 mg/L) | Pass | ||
| Sterilization Validation (including sterilant penetration and dry time validation) (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2) | To validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents. | 3 consecutive half-cycles performed for each of the two sizes of trays will demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10⁻⁶ is achieved if the Instructions for Use are followed | Pass |
| Dry time | To validate that the sterilization instructions listed in the Instructions for Use appropriately dry the pouched tray for storage. | Using pre-cycle and post-cycle weights, the weight gain after drying will not exceed ± 3% | Pass |
| Life Cycle / Simulated Use Life Validation (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 2015) | To validate the service life of the trays as stated in the Instructions for Use. | Visual inspection, component dimensional fit verification, functional closure/latch verification for 100 use cycles | Pass |
| Biocompatibility of Subject Device (by cytotoxicity testing) (ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) | To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay. | Non-cytotoxic if ≤ 30% reduction of NRU cell viability after exposure to extract of the device | Pass |
2. Sample size used for the test set and data provenance:
The document describes non-clinical performance testing.
- Cleaning Validation: The sample size isn't explicitly stated as a numerical count of individual units tested, but it refers to the cleaning validation of "the tray." The number of cycles performed for the cleaning validation is not specified in the summary.
- Sterilization Validation: "3 consecutive half-cycles performed for each of the two sizes of trays." This implies a total of 6 cycles across two representative sizes (one representing the most challenging to sterilize).
- Dry Time: Not explicitly stated, but performed in conjunction with sterilization validation.
- Life Cycle / Simulated Use Life Validation: "100 use cycles" are performed for this validation.
- Biocompatibility: The acceptance criteria reference "extract of the device," implying testing on material samples representative of the device.
The data provenance is not explicitly stated as country of origin, nor is it categorized as retrospective or prospective. However, given that these are non-clinical performance tests (e.g., cleaning, sterilization efficacy, material compatibility, and durability) conducted as part of a premarket submission, they are inherently prospective tests performed in a controlled laboratory environment to evaluate the device's design and manufacturing parameters.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document states that no clinical data were included in this submission. Therefore, no human experts (e.g., radiologists) were used to establish ground truth in the context of clinical interpretation or diagnosis. The ground truth for these non-clinical tests is based on established scientific and engineering principles, and validated laboratory methodologies and standards (e.g., ISO, AAMI, FDA guidance). The "experts" involved would be the engineers, microbiologists, and other technical personnel who perform these tests and interpret the results against the defined acceptance criteria. Their qualifications are implicit in the adherence to the referenced standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No adjudication method is relevant or described as these are non-clinical, objective performance tests against established quantitative and qualitative criteria (e.g., protein residue levels, sterility assurance level, weight gain, visual inspection for integrity). There is no subjective human reading or interpretation of "cases" that would require adjudication.
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:
No MRMC comparative effectiveness study was done. This device is a medical instrument sterilization tray, not an AI-powered diagnostic or assistive technology for human readers. The submission explicitly states, "No clinical data were included in this submission."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical sterilization tray, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As these are non-clinical tests, the "ground truth" is defined by:
- Established industry standards: ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12.
- FDA guidance documents: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015)."
- Validated laboratory methodologies: Protein assays (Micro BCA Protein Assay), TOC assays, biologic indicator inactivation, weight measurements, visual inspections.
The ground truth is therefore based on meeting specific, measurable, and objective physical, chemical, and microbiological endpoints defined by regulatory and consensus standards.
8. The sample size for the training set:
Not applicable. This device is a physical product and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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).