Lexa PLUS RIS-311 by W&H Sterilization s.r.l.

RIS-311 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterm. The RIS-311 has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a steam sterilizer (Lexa PLUS RIS-311), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific aspects like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance is not applicable to this document.

The document describes the device's intended use and performance parameters in a table, but these are specifications for a physical sterilizer, not performance metrics for an algorithm.

Here's a breakdown of why each point is not applicable and what information is provided in the document for the physical device:

A table of acceptance criteria and the reported device performance:
- Not Applicable for AI/ML: This device is a steam sterilizer. Acceptance criteria would relate to its ability to sterilize, usually measured by biological indicators or physical parameters like temperature and pressure profiles, and device reliability.
- Information in document: The table under "Indications for Use" lists operational parameters: Program type (Wrapped, Low Temperature, Unwrapped), Type of Load and Load Weight, Sterilization Temperature, Sterilization Time, and Drying Time (Recommended). These are the designed operating parameters of the sterilizer, not performance results against acceptance criteria in the AI/ML sense. For example, for "Wrapped" program, it has a Sterilization Temperature of 270 °F (132 °C) and Sterilization Time of 4 minutes.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable for AI/ML: There is no "test set" in the context of an algorithm or data-driven model for this physical sterilizer. Performance validation for a sterilizer typically involves microbiology testing and engineering validation.
- Information in document: None of this information is present as it's not relevant to a physical machine clearance.
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 for AI/ML: No ground truth established by experts for a dataset.
- Information in document: None.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable for AI/ML: No adjudication of a test set.
- Information in document: None.
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 for AI/ML: An MRMC study is for evaluating human performance with and without AI assistance in interpretation tasks. This is a sterilization device.
- Information in document: None.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable for AI/ML: This refers to the performance of an AI algorithm alone. The Lexa PLUS RIS-311 is a physical machine.
- Information in document: None.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable for AI/ML: No ground truth in this context. Sterilizer validation relies on scientific principles of microbial inactivation and physical measurements.
- Information in document: None.
The sample size for the training set:
- Not Applicable for AI/ML: No training set for a data-driven model.
- Information in document: None.
How the ground truth for the training set was established:
- Not Applicable for AI/ML: No ground truth or training set for this device.
- Information in document: None.

In summary, the provided text is a standard FDA 510(k) clearance letter for a medical device (a steam sterilizer) which operates based on physical principles, not AI/ML. Therefore, the questions posed, which are tailored for AI/ML device evaluations, do not apply.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 19, 2022

W&H Sterilization s.r.l. % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K213758

Trade/Device Name: Lexa PLUS RIS-311 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: August 16, 2022 Received: August 17, 2022

Dear Angela Blackwell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K213758

Device Name

Lexa PLUS RIS-311

Indications for Use (Describe)

Key program features, including sterilization time, temperature and recommended load type are listed in the following table:

Program	Type of Load and LoadWeight	SterilizationTemperature	Sterilization Time	Drying Time(Recommended)
Wrapped	Pouched Instrumentsand Dental Handpieceson trays 14 lbs (6.3 kg)(trays excluded).	270 °F (132 °C)	4 minutes	22 minutes
	Instruments and dentalhandpieces in wrappedcassettes or in trays andwrapped cassettes 16.5lbs (7.5 kg) (trays andcassettes included).
	Pouched Textile load ontrays 4.4 lbs (2.0 kg)(trays excluded).
Low Temperature	Pouched Instruments(solid instruments) ontrays 14 lbs (6.3 kg)(trays excluded).	250 °F (121 °C)	30 minutes	28 minutes
	Solid instruments inwrapped cassettes or intrays and wrappedcassettes 16.5 lbs (7.5kg) (trays and cassettesincluded).
	Pouched Textile load ontrays 4.4 lbs (2.0 kg)(trays excluded).
Unwrapped	Instruments and dentalhandpieces, up to 18 lbs(8.1 kg).	270°F (132°C)	3.30 minutes	4 minutes

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 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).