(133 days)
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No
The provided text describes a steam sterilizer with pre-defined sterilization cycles based on load type and temperature. There is no mention of AI, ML, image processing, or any adaptive or learning capabilities. The device operates based on fixed parameters.
No.
The Lexa MINI is a sterilizer for medical products, not a device used to treat a disease or medical condition.
No
The device is a sterilizer for medical and dental instruments, not a device used to diagnose 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, the Lexa MINI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to sterilize medical products (instruments) by means of pressurized steam. This is a process performed on medical devices themselves, not on biological samples or specimens from the human body.
- Definition of IVD: IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Lexa MINI does not perform this function.
The Lexa MINI is a medical device, specifically a sterilizer, used in a healthcare setting to prepare other medical devices for use.
N/A
Intended Use / Indications for Use
Lexa MINI 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 sterilized by steam. The Lexa MINI 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:
-
Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs); wrapped Porous/ Textile load (0.22 lbs)
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Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs)
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Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs)
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
May 5, 2023
W&H Sterilization S.r.l. Paola Zampino Regulatory Affairs Manager Via Bolgara, 2 Brusaporto, 24060 Italy
Re: K223858
Trade/Device Name: Lexa MINI (RIS-303, RIS-305) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: March 31, 2023 Received: March 31, 2023
Dear Paola Zampino:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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).
Sincerelv.
Christopher K. Dugard -2
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
Submission Number (if known)
Device Name
Lexa MINI (RIS-303, RIS-305)
Indications for Use (Describe)
Lexa MINI 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 sterilized by steam. The Lexa MINI 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:
-
Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs); wrapped Porous/ Textile load (0.22 lbs)
-
Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs)
-
Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs)
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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