(270 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, biomedical waste or materials not compatible with sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.
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. When sterilization is finished, device displays to the user that process is completed, and that the load is sterile.
This document is a 510(k) summary for the Enbio S steam sterilizer. It outlines the acceptance criteria and the non-clinical bench testing conducted to prove that the device meets these criteria. Since this is a sterilizer, the relevant acceptance criteria and studies revolve around its ability to achieve sterilization.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ANSI AAMI ST55:2016 Vacuum Test | Verify air removal performance | Average leak rate of 1 millimeter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less | 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 |
| ANSI AAMI ST55:2016 Empty Chamber Study (134°C in 4 min & 121°C in 30 min) | Verify pressure and temperature – to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions within the chamber | +3°C/-0°C, ±0.3 bar | Pass |
| ANSI AAMI ST55:2016 Full Cycle Study (134°C in 4 min & 121°C in 30 min) | Verify pressure and temperature - to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions | +3°C/-0°C, ±0.3 bar | Pass |
| ANSI AAMI ST55:2016 Half Cycle Study (134°C in 4 min & 121°C in 30 min) | Verify pressure and temperature – to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions during the cycle | +3°C/-0°C, ±0.3 bar | Pass |
| ANSI AAMI ST55:2016 Full Cycle Biological Indicators (134°C in 4 min) | To verify biological sterilization performance | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Full Cycle Biological Indicators (121°C in 30 min) | To verify biological sterilization performance | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Half Cycle Biological Indicators (134°C in 2 min) | 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 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Half Cycle Biological Indicators (121°C in 15 min) | 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 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Half Cycle Study / Textile PCD (134°C in 2 min) | Verify half-cycle sterilization of BI inside textile PCD | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Half Cycle Study / Textile PCD (121°C in 15 min) | Verify half-cycle sterilization of BI inside textile PCD | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| IEC 61010-1, 61010-2 | Verify electrical safety | Meets specifications of standard | Pass |
| IEC 60601-1-2, IEC 61326-1, 47 CFR 15 Subpart B | Verify electromagnetic compatibility | Meets specifications of standards | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical bench (performance) testing, not a test set in the sense of patient data or algorithm performance. Therefore, typical "sample size" and "data provenance" (country of origin, retrospective/prospective) don't directly apply here.
The tests conducted are physical performance tests on the sterilizer as a device. The "sample size" would refer to the number of sterilization cycles performed or units tested to demonstrate consistency and adherence to parameters. This specific detail is not provided in text, but it's implied that sufficient tests were run to determine a "Pass" for each criterion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable for the given document. The "ground truth" for a steam sterilizer's performance is established by well-defined physical and biological standards (e.g., temperature/pressure tolerances, biological indicator kill rates). There isn't a need for human expert consensus in the same way there would be for a diagnostic imaging AI, for example.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of human-interpreted data (e.g., medical images). The tests performed on the sterilizer yield objective, measurable results (e.g., temperature readings, biological indicator color changes, leak rates) which do not require human adjudication in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The submission does not contain any data from clinical testing." MRMC studies are typically for evaluating the impact of an AI on human reader performance for diagnostic tasks. This device is a mechanical sterilizer, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, in a sense, a "standalone" evaluation was done. The tests performed are directly on the performance of the sterilizer itself, without human interaction impacting the sterilization efficacy. For example, the biological indicator tests verify the sterilizer's ability to kill microorganisms on its own. While a human initiates the cycle, the effectiveness of the sterilization process is tested independently.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on established scientific and regulatory standards for sterilization, specifically:
- Physical Parameters: Defined temperature and pressure ranges, leak rates, and cycle times as specified in ANSI AAMI ST55:2016.
- Biological Efficacy: The 10^-6 Sterility Assurance Level (SAL), verified using biological indicators (BIs) which contain highly resistant bacterial spores (e.g., Geobacillus stearothermophilus). A successful sterilization run means the BIs show no growth, indicating a 1 in a million chance of a non-sterile item.
- Electrical Safety & EMC: Compliance with international safety and electromagnetic compatibility standards (IEC, CFR).
8. The Sample Size for the Training Set:
This information is not applicable. This device is a traditional medical device (steam sterilizer), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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October 29, 2021
Enbio Group AG Lukasz Rogowski Corporate Quality Manager Eichengasse 3 Oensingen, CH-4702 Switzerland
Re: K210279
Trade/Device Name: Enbio S Regulation Number: 21 CFR 880.6880 Regulation Name: Steam sterilizer Regulatory Class: Class II Product Code: FLE Dated: September 24, 2021 Received: September 27, 2021
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
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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, Ph.D. Assistant Director THT4B1:Sterility Devices Team DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K210279
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 sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with 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 porousobjects, simple objectsrecessed, narrow-clearanceitems, dental handpieces,and textiles; 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 |
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 K210279
Sponsor/ Applicant 1.
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: October 29, 2021
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
Statclave G4 Chamber Autoclave (K190062)
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. When sterilization is finished, device displays to the user that process is completed, and that the load is sterile.
5. Indications for Use
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 porousobjects, simple objectsrecessed, narrow-clearanceitems, dental handpieces,and textiles; 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 |
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Technological Characteristics Comparision 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 | STATCLAVE G4 ChamberAutoclave (K190062) | |
| Submitter | Enbio Group AG | SciCan Ltd. | - |
| 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 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. | The STATCLAVE G4 is a dynamic-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 STATCLAVE G4 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. | Same |
| Water tank | External | Internal reservoir | Different |
| Sterilization Chamber Volume | 2.7 L | 26 L | Different |
| Sterilization Chamber Dimensions | 292 x 192 x 45 mm(L x W x H) | Diameter: 280 mmDepth: 381 mm | Different |
| Device Dimensions (L x W x H) | 561 x 252 x 162 mm | 635 x 450 x 495 mm | Different |
| Weight | 15 kg (approximately) | 62.7kg (approximately) | Different |
| Power Rating | 110-120 V, 60Hz, 15A | 120V, 60Hz, 12 A | Similar |
| WirelessTransmissionCapability | No | Yes | Different |
| USB Port | Yes | Yes | Same |
| Sterility and Shelf-life | Not provided sterile.No shelf-life claimed | Not provided sterile.No shelf-life claimed | Same |
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Non-clinical Bench (Performance) testing 7.
Provided below is the non-clinical testing to demonstrated the subject device meets the specification and accpetance criteria found in the Standards and test method listed below.
| Test Method | Purpose | Acceptance criteria | Result |
|---|---|---|---|
| ANSI AAMI ST55:2016Vacuum Test | Verify air removalperformance | Average leak rate of 1millimeter of mercury(mmHg) (0.13 kPa) (0.019psia) per min or less | Pass |
| Bowie Dick Test | Verify air removalperformance | The Bowie-Dick testindicator sheet shall showa uniform color change;i.e., the color in the centershould be the same asthat at the outer edges. | Pass |
| ANSI AAMI ST55:2016Empty Chamber Study• 134°C (273°F) in 4 minutes | Verify pressure andtemperature – to ensurethat the sterilizer iscapable of providingsteady-state thermaland pressure conditionswithin the chamber | +3°C/-0°C±0.3 bar | Pass |
| ANSI AAMI ST55:2016Empty Chamber Study• 121°C (250°F) in 30 minutes | Verify pressure andtemperature - to ensurethat the sterilizer iscapable of providingsteady-state thermaland pressure conditionswithin the chamber | Pass | |
| ANSI AAMI ST55:2016Full Cycle Study• 134°C (273°F) in 4minutes | Verify pressure andtemperature - to ensurethat the sterilizer iscapable of providingsteady-state thermaland pressure conditions | +3°C/-0°C±0.3 bar | Pass |
| ANSI AAMI ST55:2016Full Cycle Study• 121°C (250°F) in 30minutes | Verify pressure andtemperature - to ensurethat the sterilizer iscapable of providingsteady-state thermaland pressure conditionsduring the cycle | Pass | |
| ANSI AAMI ST55:2016Half Cycle Study• 134°C (273°F) in 4minutes | Verify pressure andtemperature – to ensurethat the sterilizer iscapable of providing | +3°C/-0°C±0.3 bar | Pass |
| ANSI AAMI ST55:2016Half Cycle Study• 121°C (250°F) in 30 minutes | steady-state thermaland pressure conditionsduring the cycle | Pass | |
| ANSI AAMI ST55:2016Full Cycle BiologicalIndicators• 134°C (273°F) in 4 minutes | To verify biologicalsterilization performance | The tested cycle has a10-6 SAL | Pass |
| ANSI AAMI ST55:2016Full Cycle BiologicalIndicators• 121°C (250°F) in 30 minutes | Pass | ||
| ANSI AAMI ST55:2016Half Cycle BiologicalIndicators• 134°C (273°F) in 2 minutes | To ensure the efficacy ofthe equipment and thelethality of therecommendedprocessing parametersby biological challenge | The tested cycle has a10-6 SAL | Pass |
| ANSI AAMI ST55:2016Half Cycle BiologicalIndicators• 121°C (250°F) in 15 minutes | Pass | ||
| ANSI AAMI ST55:2016Half Cycle Study /Textile PCD• 134°C (273°F) in 2 minutes | Verify half-cyclesterilization of BI insidetextile PCD | The tested cycle has a10-6 SAL | Pass |
| ANSI AAMI ST55:2016Half Cycle Study /Textile PCD• 121°C (250°F) in 15 minutes | Pass | ||
| IEC 61010-1, 61010-2 | Verify electrical safety | Meets specifications ofstandard | Pass |
| IEC 60601-1-2,IEC 61326-1,47 CFR 15 Subpart B, | Verify electromagneticcompatibility | Meets specifications ofstandards | 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, STATCLAVE G4 Chamber Autoclave (K190062).
§ 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).