(94 days)
The STATIM 600B are dynamic air removal (pre-vacuum) table-top steam sterilizers that are intended for use by a healthcare provider to sterilize medical products by means of pressurized steam.
The STATIM 6000B are suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATIM 6000B has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such in incomplete sterlization and/or damage to the autoclave.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a steam sterilizer (autoclave). It does not contain information about an AI/ML powered device, its acceptance criteria, or the study used to validate its performance. The document focuses on establishing substantial equivalence for the sterilizer, specifying its indications for use, and providing a table of sterilization cycles, temperatures, times, and load descriptions.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a different type of medical device.
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March 31, 2022
SciCan Ltd. Teresa Boyce Director of Regulatory Affairs 1440 Don Mills Road Toronto, Ontario M3B 3P9 Canada
Re: K214057
Trade/Device Name: STATIM 6000B Vacuum Autoclave Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: January 5, 2022 Received: January 6, 2022
Dear Teresa Boyce:
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
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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 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).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K214057
Device Name STATIM 6000B VACUUM AUTOCLAVE
Indications for Use (Describe)
The STATIM 600B are dynamic air removal (pre-vacuum) table-top steam sterilizers that are intended for use by a healthcare provider to sterilize medical products by means of pressurized steam.
The STATIM 6000B are suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATIM 6000B has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such in incomplete sterlization and/or damage to the autoclave.
A table describing the STATIM 6000B programs, cycle times, temperatures and dry times is available on the next page.
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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| PROGRAM NAME | STERILIZATIONTEMPERATUREAND TIME | DRYINGTIME (min)(*) | CYCLETIME MAX.LOAD 120V(min.) (***) | CYCLETIMEMAX.LOAD240V(min.) (***) | MAXIMUMLOAD(***) | LOAD DESCRIPTION (**) |
|---|---|---|---|---|---|---|
| SOLIDUNWRAPPED | 132°C / 270°F4 minutes | 1 | 19.3min | 14.5min | 1kg | Unwrapped solidinstruments (mirrors,explorers), hingedinstruments (hemostats) ontrays |
| HOLLOWUNWRAPPED | 132°C / 270°F4 minutes | 1 | 20.5min | 27.7min | 1kg | UnwrappedSolid instruments,handpieces, hollow orlumen instruments (mirrors,explorers), hingedinstruments (hemostats) ontrays |
| SOLID WRAPPED | 132°C / 270°F4 minutes | 11 | 33min | 29.3min | 2.6kg | Double-wrapped IMScassettes with solidinstruments or single-pouched solid instrumentson a tray or pouch rack |
| HOLLOWWRAPPED | 132°C / 270°F4 minutes | 11 | 31.1min | 17.3min | 2.6kg | Wrapped SolidInstruments, handpieces,hollow or lumeninstruments (mirrors,explorers), hingedinstruments (hemostats) ontrays |
| RUBBER &PLASTICWRAPPED | 121°C / 250°F20 minutes | 5 ,* | 48.2min | 44.1min | 1kg | Wrapped orUnwrapped solid or hollowinstruments constructed ofmetal, rubber and plastic. |
| TEXTILES/POROUSWRAPPED | 132°C / 270°F4 minutes | 11 ,* | 37min | 28.5min | 1.4kg | Unwrapped or wrappedtextiles |
(*) Default drying time, but the drying time can be manually increased.
() If the material is sterilized "unwrapped" the sterilized material shall be used immediately after sterilization (the cycle shall be considered as an Immediate Use Steam Sterilization (IUSS) cycle). (*) Depending on the type of load, it may be necessary to optimize drying using the extra drying function.
§ 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).