(41 days)
Tuttnauer electronic and manual controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 3 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); and liquids (121°C at 30 minutes and 16 psi). In the "E" Series; these cycles are pre-programmed, whereas in the "M" Series the user must manually set the parameters, however, these parameters are recommended in the labeling. These autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.
The Tuttnauer Model M series autoclave is a table-top steam sterilizer that includes as its main components a multi-valve control assembly & timer, water reservoir, heat source and sealed chamber. The M can sterilize unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes). The Model M autoclave is produced in four sizes, the 1730 with a chamber size of 7" x 12"; the 2340 with a chamber size of 9" x 18.5" and the 2540 with a chamber size of 10" x 18.7". The 3870, which has a chamber size of 15" x 27", is not subject to this corrective action.
The provided document describes a 510(k) submission for a corrective action to a previously cleared device, not a new device or an AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design for performance, MRMC studies, standalone performance, and extensive details about ground truth and training sets for an AI/software product is not applicable.
This submission focuses on demonstrating substantial equivalence of a modified version of an existing device (Tuttnauer Manual Autoclave Models M, MK, MP) to its predicate device, primarily due to a change in a single mechanical component: the door closure mechanism's thrust bearing.
Here's an attempt to answer the questions based on the available information, noting where sections are not applicable:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for a Mechanical Modification) | Reported Device Performance |
|---|---|
| Safety: | |
| - Maintain safety profile equivalent to predicate device. | - "Because modification of the thrust bearing on the door closure mechanism does not effect the autoclave's sterilization parameters, the modified Model M series presents an identical sterilization profile." |
- "The Tuttnauer Model M complies with domestic and international safety standards including Underwriter's Laboratories UL 544, Canadian Standards Association (CSA) medical device standards, European TUV standards and Japanese safety standards."
- "The pressure chamber complies with ASME standards for pressure vessels and Canadian CRN requirements."
- "Additionally, each pressure vessel is individually tested for conformance prior to release."
- "Based upon the engineering calculations and ASME testing, the modification to the door closure assembly provides safe operation for these devices." |
| - Conformance to relevant safety and pressure vessel standards (UL 544, CSA, TUV, Japanese safety standards, ASME, CRN). | - Explicitly stated compliance: UL 544, CSA, European TUV, Japanese safety standards. - Pressure chamber complies with ASME standards and Canadian CRN requirements. |
| - Safe operation of the door closure assembly. | - "Based upon the engineering calculations and ASME testing, the modification to the door closure assembly provides safe operation for these devices." |
| Effectiveness: | |
| - Maintain sterilization effectiveness equivalent to predicate device. | - "Because modification of the thrust bearing on the door closure mechanism does not effect the autoclave's sterilization parameters, the modified Model M series presents an identical sterilization profile." - Maintans ability to sterilize unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes), and liquids (121°C at 30 minutes). |
| Substantial Equivalence: | |
| - Demonstrate substantial equivalence to the predicate device (Tuttnauer Model M series autoclave, K833837). | - "It is Tuttnauer USA Co. Ltd.'s conclusion that the modified Model M series autoclave is substantially equivalent to its predicate device, the Tuttnauer Model M series autoclave, 510(k) number K833837." - "With the exception of the change from a ball-type thrust bearing to a solid type thrust bearing in the door closure mechanism, the modified devices are identical to the Model M cleared under K833837."
- "The modified Model M exhibits the same technological characteristics as the Model M, its predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable in the context of an AI/software device performance study. This submission is for a physical device modification.
- The document mentions "individually tested for conformance prior to release" for each pressure vessel, implying a manufacturing quality control process, but not a formal clinical or performance study with a defined sample size for a "test set" in the sense of evaluating an algorithm. The evidence presented appears to be based on engineering calculations and ASME testing of the door closure assembly, and the assumption that changing one mechanical component (the thrust bearing) does not alter the fundamental sterilization parameters of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not an AI/software device requiring expert-established ground truth for a diagnostic performance evaluation. The "ground truth" for a sterilizer is its ability to effectively sterilize, which is evaluated through physical and microbiological validation methods, not expert consensus on images or data. The document does not detail specific microbiological validation studies for this modification, relying instead on the argument that the mechanical change does not affect sterilization parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned or relevant for this type of submission.
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
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of an AI/software device. For this mechanical modification, the "ground truth" for safety and effectiveness is implicitly based on adherence to engineering principles, material specifications, and the established physical and biological performance characteristics of the predicate device. The claim is that the modification does not alter these established characteristics.
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/software device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set as this is not an AI/software device.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as presented for this 510(k) submission):
The "study" or evidence provided to support the substantial equivalence claim for the modified Tuttnauer M series autoclaves is based on:
- Engineering Evaluation: The core argument is that the change from a "ball-type thrust bearing to a solid type thrust bearing in the door closure mechanism" is a minor modification that "does not effect the autoclave's sterilization parameters." This implies an engineering assessment that the mechanical change does not impart new risks or alter the fundamental function related to sterilization.
- Compliance with Established Standards: The device's safety is supported by its compliance with various domestic and international safety standards (UL 544, CSA, European TUV, Japanese safety standards) and pressure vessel standards (ASME, Canadian CRN). The submission asserts that the modification does not compromise this compliance.
- Individual Testing: Each pressure vessel is "individually tested for conformance prior to release."
- Reference to Predicate Device: The modified device is declared "identical to the Model M cleared under K833837" with the single exception of the thrust bearing, and it "exhibits the same technological characteristics." The performance of the predicate device (K833837) implicitly forms the benchmark for the modified device's expected safety and effectiveness, which is claimed to be unchanged.
Essentially, the "study" is a justification that the specific, limited mechanical change does not negate the established safety and effectiveness profile of the original device, relying on engineering principles and continued adherence to standards rather than new performance testing for sterilization efficacy.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).