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.

Typical applications:

Metal Medical Instruments (Unwrapped) Metal Medical Instruments (Wrapped) Glassware (Unwrapped) Hand Pieces (Pouches)

The electronic control has four pre-programmed sterilization cycles.

The four pre-programmed sterilization cycles are for:

Cycle 1; Metal Medical Instruments (Unwrapped); 134°C for 3 minutes; Drying Time 15 minutes

Cycle 2: Metal Medical Instruments (Wrapped); 134°C for 4 minutes; Drying time 30 minutes

Cycle 3: Glassware (Unwrapped); 121°C for 30 minutes; Drying time 15 minutes

Cycle 4; Hand pieces; (Pouches) 134°C for 4 minutes; Drying time 15 minutes

Device Description

The Astell Scientific range of UMB benchtop steam sterilizers are designed to offer convenience and flexibility in the sterilization of medical and surgical instruments.

Instruments for sterilization include wrapped and unwrapped Metal Medical instruments, unwrapped Glassware and pouched dental hand pieces.

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. Autoclaves/sterilizers heat water to generate steam as the sterilization agent, producing steam in the chamber to create a gravity displacement, pulsed dynamic air removal sterilization environment.

Steam sterilization is a widely used sterilization process due to its versatility and speed. The sterilizers include as its main components a pre-programmed electronic control module, autofill water reserve, electronic heaters and an auto-drain sterilization chamber.

The free-steaming phase of the sterilization process incorporates a 20-minute dynamic air removal program pulsing at low; 1200 mbar/ high;1600 mbar

The autoclaves are equipped with multiple safety features. The door contains a safety locking mechanism that does not permit operation unless the door is closed and locked, and does not permit the door to be opened until the internal chamber pressure is no greater than 100mbar above atmospheric pressure. Additional safety features include an automatic safety shutoff to prevent the chamber overheating; two (2) thermostats; one to detect overheating of the heaters and one to prevent opening of the door if the chamber temperature is unsafe to do so (80 °C). There is also a safety valve for the pressure vessel.

A touch screen digital display with a user log, data archiving for up to 5000 cycles and multiple user access levels and multi-level password protection is used for precision control and monitoring purposes.

The differences between the UMB Autoclaves/Sterilizers in this submission is the chamber volumes:

UMB 220 (Total volume 33 Litres) UMB 230 (Total volume 43 Litres) UMB 240 (Total volume 63 Litres)

There is an optional printer available to record cycle parameters.

Only United States Food and Drug Administration cleared accessories such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes should be used with this Autoclave.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Astell UMB 220, 230, 240 Autoclaves/Sterilizers). This document primarily focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (Tuttnauer EZ Plus Series Autoclaves), rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner one would see for a novel AI device or a device with complex performance metrics like diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria and a study proving device performance (especially those related to AI, human readers, ground truth, and training data) are not applicable to this type of submission. The document outlines technical performance standards and safety criteria that the device must meet, and then demonstrates through non-clinical testing and comparison that it achieves these.

Here's how to interpret the document in the context of your request:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a sterilizer are not typically framed in terms of metrics like sensitivity or specificity, but rather in meeting established physical and microbiological performance standards for sterilization. The study proving these criteria are met is the non-clinical testing conducted according to recognized standards.

Table of Acceptance Criteria (based on relevant standards) and Reported Device Performance:

Acceptance Criteria (from ANSI/AAMI ST55:2010 and other standards)	Reported Device Performance (Astell UMB series)	Notes
Sterilizer Temperature Control (e.g., within -0°C and +3°C of target)	Passed for both 121°C and 134°C cycles	Demonstrated compliance with 5.4.3 of ANSI/AAMI ST55:2010.
Biological Performance of Sterilizers (ability to kill target microorganisms)	Passed	Demonstrated compliance with 5.5 of ANSI/AAMI ST55:2010. This is the core proof of sterilization efficacy.
Mechanical Air Removal (effective removal of air from the chamber)	Passed	Demonstrated compliance with 5.6 of ANSI/AAMI ST55:2010, which indicates effective steam penetration.
Moisture Retention (items sufficiently dry after cycle)	Passed	Demonstrated compliance with 5.7 of ANSI/AAMI ST55:2010. Important for preventing recontamination.
Electrical Safety (e.g., per IEC 61010, IEC 61010-2-040)	Compliant (through gap analysis reports and self-certification)	Testing conducted to demonstrate safety with electrical components as per the standard.
Electromagnetic Compatibility (EMC) (e.g., per IEC 61326)	Compliant (through gap analysis reports)	Device does not interfere with or is not affected by other electronic devices.
Application of Risk Management (per BS EN ISO 14971)	Compliant (through self-certification validated by Notified Body)	Process in place to identify, evaluate, and control risks associated with the device.
Application of Usability (per IEC 62366)	Compliant (through self-certification validated by Notified Body)	Designed for safe and effective use by operators.
Software Life Cycle Processes (per IEC 62304)	Compliant (through self-certification validated by Notified Body)	Software development and maintenance follows recognized standards.
Functional Equivalence to Predicate Device (e.g., design, components, safety features, sterilization cycles)	Similar/Same across multiple parameters (Tables 1, 2, 3A, 3B, 4, 5)	Demonstrated by direct comparison tables against the predicate device (K111736).

Study Information (as applicable to a sterilizer 510(k))

Sample size used for the test set and the data provenance:
- The "test set" here refers to the sterilizer units themselves and the test loads used within them. The document does not specify an exact number of units or test cycles beyond stating that "All testing was conducted in accordance with the requirements of AAMI/ANSI ST55:2010 inclusive of physical and microbiological performance requirements."
- Data Provenance: The testing was conducted by Astell Scientific (the manufacturer) and certified by a Notified Body (SGS). The standards applied are international (ANSI/AAMI, IEC, BS EN, ISO). This is non-clinical lab testing. The data is prospective, in the sense that the tests were specifically performed to demonstrate compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not directly applicable. "Ground truth" for a sterilizer's performance is established by the physical and microbiological tests outlined in standards like AAMI/ANSI ST55:2010. These involve:
  - Physical: Temperature probes, pressure sensors, timers, etc., to verify cycle parameters.
  - Microbiological: Use of biological indicators (BIs) containing resistant spores (e.g., Geobacillus stearothermophilus) which are processed in the sterilizer. The "ground truth" of successful sterilization for BIs is validated by absence of growth after incubation under controlled laboratory conditions, indicating spore kill.
- The "experts" involved would be microbiologists and engineers who design and execute these tests, and the auditors/certifiers from SGS who verify compliance with the standards. Their qualifications are inherent in their roles within testing labs and notified bodies for medical devices.
Adjudication method for the test set:
- Not applicable in the sense of human reader adjudication. Test results (e.g., temperature/pressure readings, bacterial growth/no growth in BIs) are objective and determined by laboratory protocols.
If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an autoclave/sterilizer, not an AI-powered diagnostic or assistive tool. There are no "human readers" in the context of its performance evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the autoclave has an electronic control system, it doesn't perform diagnostic functions or involve an "algorithm" in the sense of AI. Its performance is evaluated as a complete electromechanical system via the physical and microbiological tests mentioned.
The type of ground truth used:
- Scientific Standards and Objective Measurement: The ground truth for a sterilizer's performance is ultimately derived from the established scientific principles of sterilization (time, temperature, pressure, steam saturation) and empirically proven methods for demonstrating microbial inactivation. This is primarily established through:
  - Physical parameters: Direct measurement (e.g., temperature, pressure, time) and comparison against specified acceptance limits.
  - Microbiological indicators: The known resistance of specific bacterial spores and the absence of their growth after a sterilization cycle.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI models, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is irrelevant.

In summary, this 510(k) submission details non-clinical laboratory testing and comparisons to predicate devices to prove the safety and effectiveness of a steam sterilizer against recognized performance and safety standards, rather than through a clinical study involving human users or AI performance metrics.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 2, 2018

Astell Scientific Limited Gary Doughty Quality and Compliance Manager 19-21 Powerscroft Rd Sidcup, Kent DA14 5DT United Kingdom

Re: K170304

Trade/Device Name: Astell UMB 220, UMB 240 Autoclaves/Sterilizers Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: January 24, 2018 Received: January 26, 2018

Dear Gary Doughty:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170304

Device Name

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

Indications for Use (Describe)

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.

Typical applications:

Metal Medical Instruments (Unwrapped) Metal Medical Instruments (Wrapped) Glassware (Unwrapped) Hand Pieces (Pouches)

The electronic control has four pre-programmed sterilization cycles.

The four pre-programmed sterilization cycles are for:

Cycle 1; Metal Medical Instruments (Unwrapped); 134°C for 3 minutes; Drying Time 15 minutes

Cycle 2: Metal Medical Instruments (Wrapped); 134°C for 4 minutes; Drying time 30 minutes

Cycle 3: Glassware (Unwrapped); 121°C for 30 minutes; Drying time 15 minutes

Cycle 4; Hand pieces; (Pouches) 134°C for 4 minutes; Drying time 15 minutes

The four pre-programmed cycles are for:

Cycle 1; Metal Medical Instruments (Unwrapped); 134°C for 3 minutes; Drying Time 15 minutes Maximum Load: Shelf rack can accommodate 4 instruments they have to be layered down in an open position. All instruments have to remain apart with a minimum distance of 1 cm. Maximum weight/tray: 2.5 kg, Maximum load/cycle: 10 kg

Cycle 2; Metal Medical Instruments (Wrapped); 134°C for 4 minutes; Drying time 30 minutes Maximum Load: Shelf rack can accommodate 2 pouch racks. Pouches have to stand on their side and not touching each other. Leave at least 2 cm between each item. Maximum weight/rack: 2.5 kg Maximum load/cycle: 5 kg

Cycle 3; Glassware (Unwrapped); 121°C for 30 minutes; Drying time 15 minutes Shelf rack can accommodate 4 trays. Glassware have to be placed upside down with a minimum distance of 1 cm. Maximum weight/tray: 2.5 kg Maximum load/cycle: 10 kg

Cycle 4; Hand pieces; (Pouches) 134°C for 4 minutes; Drying time 15 minutes Maximum Load; Shelf rack can accommodate 2 pouch racks. Pouches have to stand on their side and not touching each other. Leave at least 2 cm between each item. Maximum weight/rack: 2.5 kg Maximum load/cycle: 5 kg.

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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the word "Astell" in blue font, followed by a blue circle with a blue triangle inside. There is also a yellow circle that is slightly offset from the blue circle. The logo is simple and clean, with a focus on the company name and a geometric symbol.

Astell Scientific Ltd Powerscroft Road Sidcup, Kent DA14 5DT United Kingdom

Tel: 0208 309 2031 Fax: 0208 300 2247

e-mail: info@astell.com
website: http://www.astell.com

510(K) Number K170304 Summary

Submitter:	Astell Scientific Limited19-21 Powerscroft RoadSidcupKentDA14 5DTTelephone: +44 020 8309 2003Email: gdoughty@astell.com
Contact:	G Doughty
Date:	28TH February 2018
Common Name:	Steam Sterilizer
Product Code:	FLE
Device Trade Name:	Astell UMB 220, UMB 230, UMB 240 Autoclaves/Sterilizers
Classification Name:	Steam Sterilizer: Class II Device-21 C.F.R. § 880.6880
Predicate Device 510(k) No:	K111736
Predicate Device Trade Name:	Tuttnauer EZ Plus Series Electronic Table Top Autoclaves (EZ9 Plus,EZ11 Plus, EZ 15 Plus.
Classification Name:	Steam Sterilizer Class II Device-21 C.F.R § 880.6880

Image /page/4/Picture/6 description: The image shows a logo with a crown on top of a circle. Inside the circle are two mirrored symbols that resemble a sideways "K" or a stylized lightning bolt. Below the circle is the text "UKAS" in a sans-serif font, and below that is the word "CALIBRATION" in a smaller font size.

Image /page/4/Picture/7 description: The image contains two logos. The first logo is the ISO 9001 system certification logo with an orange checkmark inside a circle. The text "SGS" is written below the circle. The second logo is the UKAS Quality Management logo, which features a crown above a checkmark. The text "UKAS QUALITY MANAGEMENT" is written below the checkmark.

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General Description /Technology:

The Astell Scientific range of UMB benchtop steam sterilizers are designed to offer convenience and flexibility in the sterilization of medical and surgical instruments.

Instruments for sterilization include wrapped and unwrapped Metal Medical instruments, unwrapped Glassware and pouched dental hand pieces.

The free-steaming phase of the sterilization process incorporates a 20-minute dynamic air removal program pulsing at low; 1200 mbar/ high;1600 mbar

The differences between the UMB Autoclaves/Sterilizers in this submission is the chamber volumes:

UMB 220 (Total volume 33 Litres) UMB 230 (Total volume 43 Litres) UMB 240 (Total volume 63 Litres)

There is an optional printer available to record cycle parameters.

Design and Materials:

Astell Scientific Autoclaves are designed and manufactured in accordance with the requirements of European Medical Devices Directive 93/42/EEC, BS EN 13060:2014, ANSI/AAMI ST55:2010 and the appropriate Pressure Vessel Directive 2014/68/EU or ASME Boiler and Pressure Vessel Code Rules, Section VIII, Division 1. The manufacturing principles specified in these directives and standards are followed for the products in this submission.

The UMB range of Autoclaves sterilization chamber is manufactured from Stainless Steel Grade 316 with the internal bore electro polished. The range are fitted with electronic heating elements, an autofill water reservoir and an electronic control system. The control system is pre-programmed

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with four sterilization cycles and up to a further 50 cycles available. There is also a safety valve test cycle.

Non-Clinical Testing:

The Astell Scientific range of Autoclave/Sterilizers within this submission are certified by a Notified Body (SGS) to be compliant with the requirements of MDD 93/42/EEC inclusive of BS EN 13060:2014, similar in scope and content to the requirements of AAMI/ANSI ST55:2010.

All testing was conducted in accordance with the requirements of AAMI/ANSI ST55:2010 inclusive of physical and microbiological performance requirements.

Model UMB240 have a total capacity of 63 litres which is larger than the 56.63 litre specification of AAMI/ANSI ST55:2010. The useable capacity of this model is 50 litres. It is therefore considered they should be evaluated as compliant with the capacity specification of AAMI/ANSI ST55:2010.

There are not any patient contacting components within this range of Autoclaves/Sterilizers.

When used as intended by competent trained personnel any patient contact will be with sterilized products.

Indications for use.

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.

Typical applications include:

Metal Medical Instruments (Unwrapped) Metal Medical Instruments (Wrapped) Glassware (Unwrapped) Hand pieces (Pouches)

The electronic control has four pre-programmed sterilization cycles.

The four pre-programmed cycles are for:

Cycle 4; Hand pieces; (Pouches) 134°C for 4 minutes; Drying time 15 minutes Maximum Load: Shelf rack can accommodate 2 pouches have to stand on their side and not touching each other. Leave at least 2 cm between each item. Maximum weight/rack: 2.5 kg Maximum load/cycle: 5 kg.

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Technical Standards:

The Astell Scientific UMB series of autoclaves have been assessed to be compliant with the requirements of the following FDA recognised standards:

ANSI/AAMI ST55:2010: Tabletop Steam Sterilizers

BS EN 13060 is the European equivalent of ANSI/AAMI ST55:2010. The Astell range of AMB/UMB sterilizers have been certified by SGS as compliant with BS EN 13060. Astell conducted additional testing to the following ANSI/AAMI ST55:2010 specifications:

5.4.3; Sterilizer temperature control
5.5 Biological performance of sterilizers
5.6 Mechanical air removal
5.7 Moisture retention
5.8 Sterilizer performance certification and record keeping.

IEC 61010:2010: Electrical safety for laboratory equipment

EN 61010-1 1993/A2:1995; Report 071-607596-00; Test date 05/15/2002

IEC 61010:2010; Report 071-75934461-000; Test date 05/06/2016

IEC 61010:2010; Report 071-071-75935721; Test date 08/08/2016

The above tests were conducted on 50L useable volume sterilizers. The models with a useable volume of 50 litres are AMB/UMB 240 Total volume 63L.

Models UMB 220, 230 and 240 are electrically identical (utilizing the same electrical components).

Original compliance testing report 071-607596-00 was conducted to EN 61010-1 1993/A2:1995. Test reports 071-75934461-000 and 071-071-75935721 are gap analysis reports to demonstrate compliance with IEC 61010:2010. Testing was only conducted on the elements which had changed in the standard revision process.

The original test report and the subsequent gap analysis reports demonstrate all models in this application are compliant with the content of IEC 61010:2010.

IEC 61010-2-040: Safety requirements for electrical equipment for measurement, control, and laboratory use. Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

Particular requirements for sterilizers and washer-disinfectors used to treat medical materials is an element within the Medical Devices Directive 93/42 EEC. Compliance is demonstrated by selfcertification completion of an Electrical Safety checklist validated by Notified Body SGS.

IEC 61326:2013: Electrical equipment for measurement, control and laboratory use. EMC requirements. General requirements

EMC testing in accordance with the requirements of IEC 61326:2013

EN 61326-1:2006; Report 02-556/3886/1/09; Test date 16th – 23 February 2009

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EN 61326-1:2013; Report 04/8557-2-16; Test date 13th April 2016

The above tests were conducted on AMB/UMB 230 with a total volume of 43L and an AMB/UMB 220 with a total volume of 33L.

Models UMB 220, 230 and 240 are electrically identical (utilizing the same electrical components).

Original compliance testing report 02-556/3886/1/09 was conducted to EN 61326-1:2006. Test report 04/8557-2-16 is a gap analysis to demonstrate compliance with EN 61326-1:2013. Testing was only conducted on the elements which had changed in the standard revision process.

The original test report and the subsequent gap analysis report demonstrates all models in this application are compliant with the content of EN 61326-1:2013.

BS EN ISO 14971:2012: Application of Risk Management to Medical Devices

IEC 62366:2015: Application of Usability to Medical Devices

Requirements for Medical Devices is an element within the Medical Devices Directive 93/42 EEC. Compliance is demonstrated by self-certification completion of an Electrical Safety checklist validated by Notified Body SGS.

IEC 62304: 2006: Software Life Cycle Processes

Technical Directives

Medical Devices Directive; 93/42/EEC

Pressure Equipment Directive 2014/68/EU

Quality Management Systems

Astell Scientific's Quality Management system is compliant with the following standards which are annually audited by Notified Body SGS.

ISO EN 13485: 2012

ISO 9001:2008

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Technological Characteristics Comparison Tables

Table 1: Technological characteristics Comparison
Description	K170304	K111736	Substantially Equivalence Comparison
Sterilization cycles operate by gravity displacement	Yes	Yes	Same
Sterilizing Medical and Surgical goods	Yes	Yes	Same
316 Stainless Steel Chamber	Yes	Yes	Same
Chamber Diameter	13.8"	9"-15"	Similar
Chamber Depth	14.2-26"	19.8-30"	Similar
Chamber Volume Range	8.7 -16.6 US Gal	5.2-22 US Gal	Similar
Pre-programmed Sterilization Cycles	4	4	Same
Electrically generated steam	Yes	Yes	Same
Multiple Safety Features	Yes	Yes	Same
Door Safety Locking Mechanism	Yes	Yes	Same
Automatic Safety Shutoff	Yes	Yes	Same
Two overheating Thermostats	Yes	Yes	Same
Safety Pressure Valve	Yes	Yes	Same
Digital Display	Yes	Yes	Same
Optional Printer	Yes	Yes	Same

Table 1; Technological characteristics Comparison

Table 2; volumetric characteristics Comparison

Model	Capacity (Litres)	Chamber (Dia x Depth-mm)	Model	Capacity (Litres)	Useable Capacity (Litres)	Chamber (Dia x Depth-mm)	Substantially Equivalence Comparison
EZ9 Plus	19.8	230 x 504	UMB 220	33	23	350 x 360	Similar
EZ11 Plus	28.5	280 x 504	UMB 230	43	33	350 x 460	Similar
EZ15 Plus	84	380 x 760	UMB 240	63	50	350 x 660	Similar

Table 3A; Tuttnauer Indication for Use

K111736
Recommended Use	Devicefunctions	SterilizationTemperature	SterilizationTime(Minutes)	Dry Time	SubstantiallyEquivalence
Instruments(Unwrapped)	EZ9 (G)EZ11 (1A)EZ15 (1A)	132°C	3	1	Similar
Instruments (Wrapped)	EZ9 (1A)EZ11 (1A)EZ15 (1A)	132°C	4	30	Similar
Glassware (Unwrapped)	EZ9 (G)EZ11 (1A)EZ15 (1A)	121°C	30	1	Similar
Hand pieces	EZ9 (7A)EZ11 (7A)EZ15 (5A)	132°C	4	30	Similar

(G) = Gravity displacement: (A) = Dynamic Air Removal Pulse

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K170304
RecommendedUse	Devicefunctions	SterilizationTemperature	SterilizationTime(Minutes)	DryTime	SubstantiallyEquivalenceComparison	Maximum Load
Metal MedicalInstruments(Unwrapped)		134°C	3	15	Similar	Shelf rack can accommodate 4instrument trays instrumentsthey have to be layered downin an open position. Allinstruments have to remainapart with a minimumdistance of 1cm. Maximumweight/tray: 2.5kg Maximumload/cycle: 10 kg.
Metal MedicalInstruments(Wrapped)	UMB 220(P)UMB 230(P)UMB 240(P)	134°C	4	30	Similar	Shelf rack can accommodate 2pouch racks. Pouches have tostand on their side and nottouching each other. Leave atleast 2cm between each itemMaximum weight/rack: 2.5 kgMaximum load/cycle: 5 kg.
Glassware(Unwrapped)	UMB 240(P)	121°C	30	15	Similar	Shelf rack can accommodate 4trays. Glassware have to beplaced upside down with aminimum distance of 1 cmMaximum weight/tray: 2.5kgMaximum load/cycle: 10 kg.
Hand pieces(Pouches)		134°C	4	30	Similar	Shelf rack can accommodate 2pouch racks. Pouches have tostand on their side and nottouching each other. Leave atleast 2cm between each itemMaximum weight/rack: 2.5 kgMaximum load/cycle: 5 kg.

Table 3B; Astell Indications for Use

Table 4: Technical Standards Comparison

Standard Title	K170304	K111736	SubstantiallyEquivalence
ANSI/AAMI ST55:2010	✓	✓	Same
ASME Section VIII Division 1	✓	✓	Same
IEC 61010:2010	✓	✓	Same
IEC 61010-2-040	✓	✓	Same
IEC 61326:2013	✓	×	Similar
BS EN ISO 14971:2012	✓	×	Similar
IEC 62366:2015	✓	×	Similar
IEC 62304: 2006	✓	×	Similar
ISO EN 13485: 2012	✓	✓	Same
ISO 9001:2008	✓	✓	Same
Canada Standards: CMDR	×	✓	Same
ISO 17665-1:2006	×	✓	Same

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Table 5: Thermal Profiling Comparison

Sterilization TemperatureTolerance	K170304	K111736	SubstantiallyEquivalenceComparison
-0°c and + 3°c	Cycle 121°c; Passed	Cycle 121°c; Passed	Same
-0°c and + 3°c	Cycle 134°c Passed	Cycle 132°c; Passed	Similar

Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well or better than the legally marketed predicate device, K111736

Regulation Number and Section

§ 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).