(63 days)
No
The description details a standard steam sterilization process with pre-defined cycles and parameters. There is no mention of adaptive learning, pattern recognition, or any other characteristic typically associated with AI/ML. The performance studies focus on validating the sterilization parameters against established standards.
No
The device is a sterilizer for medical instruments, not a device used for treating medical conditions in patients.
No
Explanation: The Enbio S is a steam sterilizer intended to sterilize medical products, not to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical steam sterilizer with a chamber, heaters, steam generator, and a touch screen interface. While it includes software for program selection and control, it is fundamentally a hardware device.
Based on the provided information, the Enbio S is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Enbio S is a "table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam." This describes a device used to prepare medical instruments for use, not a device used to perform tests on biological samples or specimens to diagnose, monitor, or treat a disease or condition.
- Device Description: The description focuses on the sterilization process using steam and pressure within a chamber. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies described are related to the efficacy of the sterilization process (vacuum test, Bowie & Dick test, biological indicators), not the accuracy or performance of a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The Enbio S sterilizes instruments that are used on the body, but it does not perform any diagnostic testing itself.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
FLE
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. 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.
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
health care 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)
Non-clinical Bench (Performance) testing was conducted per ANSI AAMI ST55:2016 to validate the performance of the Enbio S '134°C FAST' Immediate Use Steam Sterilization cycle.
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.
Test methods and results:
- Vacuum Test: Verified air removal performance. Acceptance criteria: 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. Results: Pass.
- Bowie & Dick Test: Verified air removal performance. Acceptance criteria: 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. Results: Pass.
- Full Cycle Study: Verified pressure and temperature - to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions during the cycle. Acceptance criteria: 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. Results: Pass.
- Half Cycle Study: Verified pressure and temperature - to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions during the cycle. Acceptance criteria: 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. Results: 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 bv biological challenge. Acceptance criteria: The tested cycle has a 10-6 Sterility Assurance Level (SAL). Results: Pass.
- Full Cycle Biological Indicators: To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biological challenge. Acceptance criteria: The tested cycle has a 10-6 Sterility Assurance Level (SAL). Results: Pass.
- Half Cycle Biological Indicators: To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biological challenge. Acceptance criteria: The tested cycle has a 10-6 Sterility Assurance Level (SAL). Results: Pass.
- Half Cycle Biological Indicators - Turbine: To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biological challenge. Acceptance criteria: The tested cycle has a 10-6 Sterility Assurance Level (SAL). Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Enbio S (K210279)
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.
Statclave G4 Chamber Autoclave (K190062)
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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).
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
2
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.
| Program
Name | Load Description | Sterilization
Temperature | Sterilization
Time | Drying
Time | Maximum
Load |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------|----------------|--------------------|
| 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°C
FAST* | solid objects, non-porous objects, simple instruments (such as
scissors, handles, pliers, chisels, probes, etc.), and dental
handpieces;
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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3
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.
4
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 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°C | |||||
| FAST* | solid objects, non-porous | ||||
| objects, simple instruments | |||||
| (such as scissors, handles, | |||||
| pliers, chisels, probes, etc.), and | |||||
| dental handpieces; unwrapped. | |||||
| *Immediate Use Steam | |||||
| Sterilization cycle | 134°C (273°F) | 4 minutes | N/A | 0.5 Kg/ | |
| 1.1 lbs |
5
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 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 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. | Same | ||
| Sterilization Cycle / | |||
| Program | • 134°C | ||
| • 121°C | |||
| • 134°C FAST (Immediate | |||
| Use Steam Sterilization | |||
| cycle) | • 134°C | ||
| • 121°C | Different | ||
| Water tank | External | External | Same |
| Sterilization | |||
| Chamber Volume | 2.7 L | 2.7 L | Same |
| Sterilization | |||
| Chamber | |||
| Dimensions | 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) | |
| Wireless | |||
| Transmission | |||
| Capability | No | No | Same |
| USB Port | Yes | Yes | Same |
| Sterility and | |||
| Shelf- life | Not provided sterile. | ||
| No shelf-life claimed | Not provided sterile. | ||
| No shelf-life claimed | Same |
6
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.
7
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 AAMI
ST55:2016 Test
Method | Purpose | Acceptance criteria | Results
(see details
provided in
Table 2) |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| 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 | To ensure the efficacy of the
equipment and the lethality of
the recommended processing
parameters bv biological | The tested cycle has a
10-6 Sterility Assurance
Level (SAL) | Pass |
| ANSI AAMI
ST55:2016 Test
Method | Purpose | Acceptance criteria | Results
(see details
provided in
Table 2) |
| with Dental
Turbine | challenge | | |
| 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 |
8
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).