(262 days)
Not Found
Not Found
No
The summary describes a steam sterilizer and does not mention any AI or ML components or functionalities.
No
This device sterilizes medical products; it does not directly treat or diagnose a patient's condition.
No
The description states that the device is a steam sterilizer intended to sterilize medical products. It does not mention any function related to diagnosing medical conditions.
No
The device is described as a "dynamic-air-removal (pre-vacuum) table-top steam sterilizer," which is a physical piece of equipment, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a steam sterilizer for medical products and instruments. This is a sterilization process, not a diagnostic test performed on samples taken from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device's function is to sterilize medical equipment, which is a crucial step in preventing the spread of infection in a healthcare setting, but it does not perform any diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Key program features, including sterilization time, temperature and recommended load type are listed in the following table:
| Program | Type of Load and Load
Weight | Sterilization
Temperature | Sterilization Time | Drying Time
(Recommended) |
|---|---|---|---|---|
| Wrapped | Pouched Instruments
and Dental Handpieces
on trays 14 lbs (6.3 kg)
(trays excluded). | 270 °F (132 °C) | 4 minutes | 22 minutes |
| | Instruments and dental
handpieces in wrapped
cassettes or in trays and
wrapped cassettes 16.5
lbs (7.5 kg) (trays and
cassettes included). | | | |
| | Pouched Textile load on
trays 4.4 lbs (2.0 kg)
(trays excluded). | | | |
| Low Temperature | Pouched Instruments
(solid instruments) on
trays 14 lbs (6.3 kg)
(trays excluded). | 250 °F (121 °C) | 30 minutes | 28 minutes |
| | Solid instruments in
wrapped cassettes or in
trays and wrapped
cassettes 16.5 lbs (7.5
kg) (trays and cassettes
included). | | | |
| | Pouched Textile load on
trays 4.4 lbs (2.0 kg)
(trays excluded). | | | |
| Unwrapped | Instruments and dental
handpieces, 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)
Product codes
FLE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
Lexa PLUS RIS-311
Indications for Use (Describe)
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.
Key program features, including sterilization time, temperature and recommended load type are listed in the following table:
| Program | Type of Load and Load
Weight | Sterilization
Temperature | Sterilization Time | Drying Time
(Recommended) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------|------------------------------|
| Wrapped | Pouched Instruments
and Dental Handpieces
on trays 14 lbs (6.3 kg)
(trays excluded). | 270 °F (132 °C) | 4 minutes | 22 minutes |
| | Instruments and dental
handpieces in wrapped
cassettes or in trays and
wrapped cassettes 16.5
lbs (7.5 kg) (trays and
cassettes included). | | | |
| | Pouched Textile load on
trays 4.4 lbs (2.0 kg)
(trays excluded). | | | |
| Low Temperature | Pouched Instruments
(solid instruments) on
trays 14 lbs (6.3 kg)
(trays excluded). | 250 °F (121 °C) | 30 minutes | 28 minutes |
| | Solid instruments in
wrapped cassettes or in
trays and wrapped
cassettes 16.5 lbs (7.5
kg) (trays and cassettes
included). | | | |
| | Pouched Textile load on
trays 4.4 lbs (2.0 kg)
(trays excluded). | | | |
| Unwrapped | Instruments and dental
handpieces, 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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