(270 days)
Not Found
No
The description focuses on standard sterilization processes and hardware components, with no mention of AI/ML terms or functionalities.
No.
The device is a sterilizer for medical products, not a device used for treating disease or injury.
No
The device is a sterilizer, used to sterilize medical products and instruments. It does not diagnose any condition or disease.
No
The device description clearly outlines physical hardware components such as a heated chamber, heaters, a perforated tray, a TFT touch screen, and a steam generator. The performance studies also include testing related to electrical safety and electromagnetic compatibility, which are relevant to hardware.
Based on the provided information, the Enbio S 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 applied to medical devices themselves, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The description details a steam sterilizer that uses heat and pressure to kill microorganisms on instruments. It does not describe any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The Enbio S is a medical device used in a healthcare setting to prepare other medical devices for use. Its function is sterilization, not diagnosis.
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 sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.
Product codes
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. 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
Non-clinical Bench (Performance) testing was conducted to demonstrate the subject device meets the specifications and acceptance criteria.
Test methods included:
- ANSI AAMI ST55:2016 Vacuum Test: Result Pass
- Bowie Dick Test: Result Pass
- ANSI AAMI ST55:2016 Empty Chamber Study (134°C in 4 minutes and 121°C in 30 minutes): Result Pass for both
- ANSI AAMI ST55:2016 Full Cycle Study (134°C in 4 minutes and 121°C in 30 minutes): Result Pass for both
- ANSI AAMI ST55:2016 Half Cycle Study (134°C in 4 minutes and 121°C in 30 minutes): Result Pass for both
- ANSI AAMI ST55:2016 Full Cycle Biological Indicators (134°C in 4 minutes and 121°C in 30 minutes): Result Pass for both (10^-6 SAL)
- ANSI AAMI ST55:2016 Half Cycle Biological Indicators (134°C in 2 minutes and 121°C in 15 minutes): Result Pass for both (10^-6 SAL)
- ANSI AAMI ST55:2016 Half Cycle Study / Textile PCD (134°C in 2 minutes and 121°C in 15 minutes): Result Pass for both (10^-6 SAL)
- IEC 61010-1, 61010-2 (Verify electrical safety): Result Pass
- IEC 60601-1-2, IEC 61326-1, 47 CFR 15 Subpart B (Verify electromagnetic compatibility): Result Pass
No clinical testing was conducted.
Key Metrics
- Average leak rate of 1 millimeter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less (for Vacuum Test)
- Uniform color change (for Bowie-Dick test)
- +3°C/-0°C and ±0.3 bar (for pressure and temperature verification)
- 10^-6 SAL (Sterility Assurance Level) (for Biological Indicators)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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.
| 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 |
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 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.
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. 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.
| 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 |
5
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 Chamber | |
| Autoclave (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 mm | ||
| Depth: 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 |
| Wireless | |||
| Transmission | |||
| Capability | 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 |
6
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 ST55:2016 | |||
| 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 (273°F) in 4 minutes | 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 | |||
| Empty Chamber Study | |||
| • 121°C (250°F) in 30 minutes | Verify pressure and | ||
| temperature - to ensure | |||
| that the sterilizer is | |||
| capable of providing | |||
| steady-state thermal | |||
| and pressure conditions | |||
| within the chamber | Pass | ||
| ANSI AAMI ST55:2016 | |||
| Full Cycle Study | |||
| • 134°C (273°F) in 4 | |||
| minutes | 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 | |||
| Full Cycle Study | |||
| • 121°C (250°F) in 30 | |||
| minutes | Verify pressure and | ||
| temperature - to ensure | |||
| that the sterilizer is | |||
| capable of providing | |||
| steady-state thermal | |||
| and pressure conditions | |||
| during the cycle | Pass | ||
| ANSI AAMI ST55:2016 | |||
| Half Cycle Study | |||
| • 134°C (273°F) in 4 | |||
| minutes | Verify pressure and | ||
| temperature – to ensure | |||
| that the sterilizer is | |||
| capable of providing | +3°C/-0°C | ||
| ±0.3 bar | Pass | ||
| ANSI AAMI ST55:2016 | |||
| Half Cycle Study | |||
| • 121°C (250°F) in 30 minutes | steady-state thermal | ||
| and pressure conditions | |||
| during the cycle | Pass | ||
| ANSI AAMI ST55:2016 | |||
| Full Cycle Biological | |||
| Indicators | |||
| • 134°C (273°F) in 4 minutes | To verify biological | ||
| sterilization performance | The tested cycle has a | ||
| 10-6 SAL | Pass | ||
| ANSI AAMI ST55:2016 | |||
| Full Cycle Biological | |||
| Indicators | |||
| • 121°C (250°F) in 30 minutes | Pass | ||
| ANSI AAMI ST55:2016 | |||
| Half Cycle Biological | |||
| Indicators | |||
| • 134°C (273°F) in 2 minutes | 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 | Pass | ||
| ANSI AAMI ST55:2016 | |||
| Half Cycle Biological | |||
| Indicators | |||
| • 121°C (250°F) in 15 minutes | Pass | ||
| ANSI AAMI ST55:2016 | |||
| Half Cycle Study / | |||
| Textile PCD | |||
| • 134°C (273°F) in 2 minutes | Verify half-cycle | ||
| sterilization of BI inside | |||
| textile PCD | The tested cycle has a | ||
| 10-6 SAL | Pass | ||
| ANSI AAMI ST55:2016 | |||
| Half Cycle Study / | |||
| Textile PCD | |||
| • 121°C (250°F) in 15 minutes | 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 |
7
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).