(63 days)
The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.
Please refer to the table below for program name, load description, sterilization temperature, exposure time, drying time and maximum load.
| ProgramName | Load Description | SterilizationTemperature | SterilizationTime | DryingTime | MaximumLoad |
|---|---|---|---|---|---|
| 134°C | solid objects, small porous objects, simple objects recessed,narrow-clearance items, dental handpieces, and textiles;wrapped and unwrapped | 134°C (273°F) | 4 minutes | 3 minutes | 0.5 Kg/1.1 lbs |
| 121°C | solid objects, small porous objects, simple objects recessed,narrow-clearance items, dental handpieces, textiles, and plastics;wrapped and unwrapped | 121°C (250°F) | 30 minutes | 5 minutes | 0.5 Kg/1.1 lbs |
| 134°CFAST* | solid objects, non-porous objects, simple instruments (such asscissors, handles, pliers, chisels, probes, etc.), and dentalhandpieces;unwrapped*Immediate Use Steam Sterilization cycle | 134°C (273°F) | 4 minutes | N/A | 0.5 Kg/1.1 lbs |
The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It has a hermetically sealed, heated chamber made from aluminum, with two heaters sink inside chamber walls. Inside this chamber, the sterilized load is placed on a special perforated tray. After closing the chamber, the user selects the appropriate sterilization program through the TFT touch screen. The actual sterilization phase starts after the pre-vacuum phase. The aluminum steam generator produces superheated steam and applies it inside the chamber. That steam penetrates the sterilized instruments. The set temperature is maintained inside the chamber depending on the selected sterilization cycle (121C° or 134°C), during a specified time (30 minutes or 4 minutes). After that time all the steam accumulated inside the chamber is pumped out and the drying cycle begins. Enbio S also features an additional sterilization cycle referred to as '134°C FAST' which is an immediate use steam sterilization cycle without drying. When sterilization is finished, device displays to the user that process is completed, and that the load is sterile.
The provided text is a 510(k) summary for the Enbio S steam sterilizer. It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, particularly for the addition of a new sterilization cycle ('134°C FAST').
Here's the breakdown of acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and reported device performance:
The device performance is consistently reported as "Pass" for all tests.
| ANSI AAMI ST55:2016 Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Vacuum Test | Verify air removal performance | Average leak rate shall be equal to or less than 1 mmHg (i.e. 0.13 kPa or 0.019 psia) per minute over the measured time interval | Pass |
| Bowie & Dick Test | Verify air removal performance | The Bowie-Dick test indicator sheet shall show a uniform color change; i.e., the color in the center should be the same as that at the outer edges. | Pass |
| Full Cycle Study | Verify pressure and temperature - to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions during the cycle | Temperature recorded shall be between +3°C /-0°C of the sterilization temperature for specified program. Pressure recorded shall be within ±0.3 bar of the equipment's specified pressure | Pass |
| Half Cycle Study | Verify pressure and temperature - to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions during the cycle | Temperature recorded shall be between +3°C /-0°C of the sterilization temperature for specified program. Pressure recorded shall be within ±0.3 bar of the equipment's specified pressure | Pass |
| Half Cycle Study, Over-Kill Biological Performance with Dental Turbine | To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biological challenge | The tested cycle has a 10-6 Sterility Assurance Level (SAL) | Pass |
| Full Cycle Biological Indicators | To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biological challenge | The tested cycle has a 10-6 Sterility Assurance Level (SAL) | Pass |
| Half Cycle Biological Indicators | To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biological challenge | The tested cycle has a 10-6 Sterility Assurance Level (SAL) | Pass |
| Half Cycle Biological Indicators - Turbine | To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biological challenge | The tested cycle has a 10-6 Sterility Assurance Level (SAL) | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific number of runs or samples used for each test (e.g., number of Vacuum Tests, Bowie & Dick Tests, or biological indicator challenge runs). It simply states that tests were "conducted per ANSI AAMI ST55:2016." This standard would typically specify the required test replicates.
- Data Provenance: The data comes from non-clinical bench testing. The country of origin for the testing itself is not specified, but the applicant, Enbio Group AG, is based in Oensingen, Switzerland. The testing is a component of a 510(k) submission to the U.S. FDA, implying it needs to meet U.S. regulatory standards. All tests are inherently "prospective" in the sense that they are conducted specifically for this submission to validate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This submission concerns a physical medical device (steam sterilizer) and its performance in achieving sterility, not an AI/ML-based diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of radiologists or similar clinical experts does not apply here. The "ground truth" for sterilization is established by well-defined physical and biological parameters and internationally recognized standards (ANSI AAMI ST55:2016) which dictate acceptable levels of microbial inactivation (Sterility Assurance Level - SAL).
4. Adjudication method for the test set:
Not applicable, as this is bench testing of a physical device against defined technical and biological standards, not an assessment requiring human interpretation and adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This submission pertains to a steam sterilizer, which is a therapeutic/sterilization device, not a diagnostic one.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, in a sense. The performance testing evaluates the sterilizer's ability to achieve validated sterilization parameters independently of human intervention beyond operating the device. The device's efficacy is measured against objective criteria (temperature, pressure, leak rate, biological indicator kill) as outlined in the standards. There is no AI algorithm being evaluated in this specific FDA submission beyond the operational software/firmware of the sterilizer itself, which was validated using the same methodology as the predicate device.
7. The type of ground truth used:
The ground truth used for evaluating the Enbio S sterilizer is:
- Physical Parameters: Defined temperature and pressure ranges, and leak rates as specified by ANSI AAMI ST55:2016.
- Biological Inactivation: A 10^-6 Sterility Assurance Level (SAL), demonstrated through biological indicator challenges. This means that the probability of a single viable microorganism remaining on an item after sterilization is one in a million.
8. The sample size for the training set:
Not applicable. This is a physical device submission demonstrating performance based on engineering and biological testing, not an AI/Machine Learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no AI/Machine Learning training set.
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February 22, 2022
Enbio Group AG Lukasz Rogowski Corporate Quality Manager Eichengasse 3 Oensingen. CH-4702 Switzerland
Re: K213991
Trade/Device Name: Enbio S Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: January 25, 2022 Received: January 26, 2022
Dear Lukasz Rogowski:
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
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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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213991
Device Name Enbio S
Indications for Use (Describe)
The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterm. The Enbio S 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.
Please refer to the table below for program name. load description, sterilization temperature, exposure time, drying time and maximum load.
| ProgramName | Load Description | SterilizationTemperature | SterilizationTime | DryingTime | MaximumLoad |
|---|---|---|---|---|---|
| 134°C | solid objects, small porous objects, simple objects recessed,narrow-clearance items, dental handpieces, and textiles;wrapped and unwrapped | 134°C (273°F) | 4 minutes | 3 minutes | 0.5 Kg/1.1 lbs |
| 121°C | solid objects, small porous objects, simple objects recessed,narrow-clearance items, dental handpieces, textiles, and plastics;wrapped and unwrapped | 121°C (250°F) | 30 minutes | 5 minutes | 0.5 Kg/1.1 lbs |
| 134°CFAST* | solid objects, non-porous objects, simple instruments (such asscissors, handles, pliers, chisels, probes, etc.), and dentalhandpieces;unwrapped*Immediate Use Steam Sterilization cycle | 134°C (273°F) | 4 minutes | N/A | 0.5 Kg/1.1 lbs |
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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510(k) Summary - 213991
1. Sponsor/ Applicant
Enbio Group AG Eichengasse 3 CH-4702 Oensingen, Switzerland
Mr. Lukasz Rogowski Corporate Quality Manager Email: lukasz.rogowski@enbio.com Phone: +48 605 058 629
Summary Preparation Date: January 25, 2022
2. Device
| Trade Name | Enbio S |
|---|---|
| Classification | Class 2 |
| Classification Name | Steam Sterilizer |
| Product Code | FLE |
| Regulation Number | 21 CFR 880.6880 |
| Review Panel | General Hospital |
3. Predicate Device
Enbio S (K210279)
4. Device Description
The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It has a hermetically sealed, heated chamber made from aluminum, with two heaters sink inside chamber walls. Inside this chamber, the sterilized load is placed on a special perforated tray. After closing the chamber, the user selects the appropriate sterilization program through the TFT touch screen.
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The actual sterilization phase starts after the pre-vacuum phase. The aluminum steam generator produces superheated steam and applies it inside the chamber. That steam penetrates the sterilized instruments. The set temperature is maintained inside the chamber depending on the selected sterilization cycle (121C° or 134°C), during a specified time (30 minutes or 4 minutes). After that time all the steam accumulated inside the chamber is pumped out and the drying cycle begins. Enbio S also features an additional sterilization cycle referred to as '134°C FAST' which is an immediate use steam sterilization cycle without drying. When sterilization is finished, device displays to the user that process is completed, and that the load is sterile.
Indications for Use 5.
The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.
Please refer to the table below for program name, load description, sterilization temperature, exposure time, drying time and maximum load.
| Program | Load Description | Sterilization | Sterilization | Drying | Maximum |
|---|---|---|---|---|---|
| Name | Temperature | Time | Time | Load | |
| 134°C | solid objects, small porousobjects, simple objectsrecessed, narrow-clearanceitems, dental handpieces, andtextiles; wrapped andunwrapped | 134°C (273°F) | 4 minutes | 3 minutes | 0.5 Kg/1.1 lbs |
| 121°C | solid objects, small porousobjects, simple objectsrecessed, narrow-clearanceitems, dental handpieces,textiles, and plastics;wrapped and unwrapped | 121°C (250°F) | 30 minutes | 5 minutes | 0.5 Kg/1.1 lbs |
| 134°CFAST* | solid objects, non-porousobjects, simple instruments(such as scissors, handles,pliers, chisels, probes, etc.), anddental handpieces; unwrapped.*Immediate Use SteamSterilization cycle | 134°C (273°F) | 4 minutes | N/A | 0.5 Kg/1.1 lbs |
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Technological Characteristics Comparison Table 6.
Provided below is a technological comparison of the subject device with the predicate device.
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Trade Name | Enbio S | Enbio S (K210279) | |
| Submitter | Enbio Group AG | Enbio Group AG | Same |
| Product Code | FLE | FLE | Same |
| Regulation Number | 21 CFR 880.6880 | 21 CFR 880.6880 | Same |
| Device Class | Class 2 | Class 2 | Same |
| Prescription / Over-The-Counter Use | Over-The-Counter | Over-The-Counter | Same |
| Intended Use | The Enbio S is an air-removal(pre-vacuum) table-top steamsterilizer intended for use by ahealth care provider tosterilize medical products bymeans of pressurized steam.It is suitable for thesterilization of dental andmedical instruments that arevalidated to be sterilized bysteam. The Enbio S has notbeen designed to sterilizeliquid loads, bio-medicalwaste or materials notcompatible with steamsterilization. The processingof such loads may result inincomplete sterilization and/ordamage to the autoclave. | The Enbio S is an air-removal(pre-vacuum) table-top steamsterilizer intended for use by ahealth care provider tosterilize medical products bymeans of pressurized steam.It is suitable for thesterilization of dental andmedical instruments that arevalidated to be sterilized bysteam. The Enbio S has notbeen designed to sterilizeliquid loads, bio-medicalwaste or materials notcompatible with steamsterilization. The processingof such loads may result inincomplete sterilization and/ordamage to the autoclave. | Same |
| Sterilization Cycle /Program | • 134°C• 121°C• 134°C FAST (ImmediateUse Steam Sterilizationcycle) | • 134°C• 121°C | Different |
| Water tank | External | External | Same |
| SterilizationChamber Volume | 2.7 L | 2.7 L | Same |
| SterilizationChamberDimensions | 292 x 192 x 45 mm(L x W x H) | 292 x 192 x 45 mm (L x W x H) | Same |
| Device Dimensions(L x W x H) | 561 x 252 x 162 mm | 561 x 252 x 162 mm | Same |
| Weight | 15 kg (approximately) | 15 kg (approximately) | Same |
| Power Rating | 110-120 V, 60Hz, 15A | 110-120 V, 60Hz, 15A | Same |
| Subject Device | Predicate Device | Comparison | |
| Trade Name | Enbio S | Enbio S (K210279) | |
| WirelessTransmissionCapability | No | No | Same |
| USB Port | Yes | Yes | Same |
| Sterility andShelf- life | Not provided sterile.No shelf-life claimed | Not provided sterile.No shelf-life claimed | Same |
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The intended use, fundamental scientific technology, design, construction, materials, and electrical characteristics of the proposed Enbio S are identical to the Enbio S cleared under K210279.
The only modification is the addition of a '134°C FAST' program, which is an Immediate Use Steam Sterilization (IUSS) cycle with following parameters. The indications for use are modified to describe this new program/ sterilization cycle. The labeling (User Manual), software and firmware are also updated to support this additional program.
The Enbio S cleared under K210279 did not have a '134°C FAST' IUSS cycle; however the following previously 510(k) cleared device serves as 'reference device' to support the addition of the IUSS cycle.
- Statclave G4 Chamber Autoclave (K190062) .
The Statclave G4 Chamber Autoclave has IUSS cycle parameters of 132°C for 4 minutes (and no drying) whereas the proposed Enbio S has '134°C FAST' IUSS cycle parameters of 134°C for 4 minutes (and no drying). Although, their IUSS cycle temperatures are slightly different, the performance and effectiveness of the Enbio S 134°C FAST program has been validated per AAMI ANSI ST55:2016. In addition, the updated software and firmware have been validated using the same methodology that was used to validate the software and firmware of Enbio S cleared under K210279.
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7. Non-clinical Bench (Performance) testing
Below table includes a summary of the performance test conducted per ANSI AAMI ST55:2016 to validate the performance of the Enbio S '134°C FAST' Immediate Use Steam Sterilization cycle.
In addition, the updated software and firmware have been validated using the same methodology that was used to validate the software and firmware of Enbio S previously cleared under K210279.
| ANSI AAMIST55:2016 TestMethod | Purpose | Acceptance criteria | Results(see detailsprovided inTable 2) |
|---|---|---|---|
| Vacuum Test | Verify air removalperformance | Average leak rate shallbe equal to or less than1 mmHg (i.e. 0.13 kPa or0.019 psia) per minuteover the measured timeinterval | Pass |
| Bowie & Dick Test | Verify air removalperformance | The Bowie-Dick testindicator sheet shallshow a uniform colorchange; i.e., the color inthe center should be thesame as that at theouter edges. | Pass |
| Full Cycle Study | Verify pressure andtemperature - to ensure thatthe sterilizer is capable ofproviding steady-state thermaland pressure conditionsduring the cycle | Temperature recordedshall be between +3°C /-0°C of the sterilizationtemperature for specifiedprogram.Pressure recorded shallbe within ±0.3 bar of theequipment's specifiedpressure | Pass |
| Half Cycle Study | Verify pressure andtemperature - to ensure thatthe sterilizer is capable ofproviding steady-state thermaland pressure conditionsduring the cycle | Temperature recordedshall be between +3°C /-0°C of the sterilizationtemperature for specifiedprogram.Pressure recorded shallbe within ±0.3 bar of theequipment's specifiedpressure | Pass |
| Half Cycle Study,Over-KillBiologicalPerformance | To ensure the efficacy of theequipment and the lethality ofthe recommended processingparameters bv biological | The tested cycle has a10-6 Sterility AssuranceLevel (SAL) | Pass |
| ANSI AAMIST55:2016 TestMethod | Purpose | Acceptance criteria | Results(see detailsprovided inTable 2) |
| with DentalTurbine | challenge | ||
| Full CycleBiologicalIndicators | To ensure the efficacy of theequipment and the lethality ofthe recommended processingparameters by biologicalchallenge | The tested cycle has a10-6 Sterility AssuranceLevel (SAL) | Pass |
| Half Cycle BiologicalIndicators | To ensure the efficacy of theequipment and the lethality ofthe recommended processingparameters by biologicalchallenge | The tested cycle has a10-6 Sterility AssuranceLevel (SAL) | Pass |
| Half Cycle BiologicalIndicators - Turbine | To ensure the efficacy of theequipment and the lethality ofthe recommended processingparameters by biologicalchallenge | The tested cycle has a10-6 Sterility AssuranceLevel (SAL) | Pass |
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8. Clinical Testing
The submission does not contain any data from clinical testing.
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the Enbio S is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Enbio S (K210279).
§ 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).