STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)

K181993 · Sturdy Industrial Co., Ltd. · FLE · Nov 1, 2019 · General Hospital

Device Facts

• Record ID: K181993
• Device Name: STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
• Applicant: Sturdy Industrial Co., Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Nov 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.

Device Story

Steam sterilizer (autoclave) using saturated steam at high pressure/temperature to kill bio-organisms; electric heating element generates steam in chamber; operator selects cycle via electronic control system; device automatically fills chamber, heats water, performs four-pulse sterilization, vents steam, and cools; used in clinical/laboratory settings by trained staff; output is sterilized reusable equipment; benefits include effective decontamination of medical/dental instruments.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via ANSI/AAMI ST55:2016 standards, including temperature mapping, Bowie-Dick testing, moisture retention, and biological performance (SAL 10^-6) using half-cycle validation loads.

Technological Characteristics

Dynamic-air-removal steam sterilizer; corrosion-resistant chamber; electric heating element; microcontroller-based control system; power: 120VAC, 60Hz, 12A; pressure vessel/safety valves ASME Section VIII compliant; standards: ANSI/AAMI ST55:2016, IEC 61010-1, IEC 61010-2-040.

Indications for Use

Indicated for sterilization of heat and moisture stable reusable equipment in medical/dental offices, hospitals, clinics, nursing homes, and laboratories. Includes dental handpieces. Not for liquids intended for direct patient contact.

Regulatory Classification

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.

Predicate Devices

• Midmark M11 Ultraclave Steam Sterilizer (K990189)

Submission Summary (Full Text)

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November 1, 2019

Sturdy Industrial Co., Ltd Wolfgang Huang QA Manager No. 168 Sec. 1, Zhongxing Road, Wugu District New Taipei City, 24872 Tw

Re: K181993

Trade/Device Name: STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: September 23, 2019 Received: October 2, 2019

Dear Wolfgang Huang:

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.

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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) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for "STURDY APEX GROUP". The word "STURDY" is in large, green, sans-serif font, with a white plus sign incorporated into the letter "D". Below "STURDY" is the text "APEX GROUP" in a smaller, red, sans-serif font. The logo is simple and modern, with a focus on the company name.

510(k) Premarket

Indications for use statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

### K181993

#### Device Name

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)

Indications for Use (Describe)

The STURDY Autoclave Super Microm (models SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact. Cycle parameters are as follows:

| Cycle | Ster. Temp. | Ster.<br>Pressure | Ster.<br>Time<br>(minutes) | Dry Time<br>(minutes) | Items to be Sterilized<br>(always consult the item manufacturer's<br>recommendation for sterilization) |
|-------------------------------|---------------------|-----------------------|----------------------------|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Un-<br>wrapped | 270 °F<br>(132 °C) | 27.2 psi<br>(186 kPa) | 3 | 30 | ● Instruments loose on a tray.<br>● Loose items manufacturers recommend for<br>exposures at 270 °F (132 °C) for 3 minutes.<br>Note: The sterility of unwrapped items is<br>compromised on exposure to a non-sterile<br>environment. |
| Wrapped<br>(Pouches) | 270 °F<br>(132 °C) | 27.2 psi<br>(186 kPa) | 4 | 30 | ● Pouched or loosely wrapped instruments.<br>● Wrapped trays of loose instrument.<br>● Wrapped items manufacturers recommend<br>for exposures at 270 °F (132 °C ) for 4<br>minutes. |
| Wrapped<br>(Textile<br>Packs) | 250 °F<br>(121 °C) | 15 psi<br>(104 kPa) | 30 | 30 | ● Textiles and surgical packs wrapped for<br>sterilization.<br>● Items except liquids, manufacturers<br>recommend for exposures at 250 °F (121<br>°C ) for 30 minutes. |
| Handpieces | 270 °F<br>(132 ℃ ) | 27.2 psi<br>(186 kPa) | 4 | 30 | Dental handpieces (wrapped)<br>Note: Verify acceptability of sterilization<br>parameters with handpiece manufacturer. |
| Bowie-Dick<br>test | 273 °F<br>(134 °C ) | 29.5 psi<br>(203 kPa) | 3.5 | N/A | N/A |
| Re-Dry | N/A | N/A | N/A | 10 | N/A |
| Pump test | N/A | N/A | N/A | 10 | N/A |

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Image /page/3/Picture/0 description: The image contains a logo for "STURDY APEX GROUP". The word "STURDY" is written in a bold, green font, with a plus sign incorporated into the letter "D". Below "STURDY", the words "APEX GROUP" are written in a smaller, pink font. The logo appears to be for a company or organization.

### SA-260MA and SA-260MA-R

510(k) Premarket

Indications for use statement

#### Maximum load:

| | | Program | | | |
|--------------|---------------------------------|-------------------------|-------------------------|-------------------------|-------------------------------------------------------------------|
| | | Unwrapped | Wrapped | Wrapped | Handpieces |
| Temperature | | 270 °F (132 °C) | 250 °F (121 °C) | 270 °F (132 °C) | 270 °F (132 °C) |
| Pressure | | 27.2 psi<br>(186 kPa) | 15 psi<br>(104 kPa) | 27.2 psi<br>(186 kPa) | 27.2 psi<br>(186 kPa) |
| | Sterilization time<br>(minutes) | 3 | 30 | 4 | 4 |
| | Dry time (minutes) | 30 | 30 | 30 | 30 |
| Max.<br>load | Solid<br>Instrument | 9.0 lbs<br>(4080 grams) | - | - | - |
| | Textile Packs | - | 2.9 lbs<br>(1300 grams) | - | - |
| | Pouches | - | - | 2.9 lbs<br>(1300 grams) | - |
| | Handpieces | - | - | - | 9 handpieces with<br>other instruments<br>4.5 lbs<br>(2040 grams) |

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image contains the word "STURDY" in large, green, bold letters. To the right of the "Y" in "STURDY" is a green plus sign. Below "STURDY" are the words "APEX GROUP" in smaller, pink letters.

# 510(k)Summary (K181993)

The information required by 21 CFR § 807.92 is listed below.

| Submitter: | STURDY Industrial CO., LTD.<br>No. 168, Sec. 1, Zhongxing Rd, Wugu District, New Taipei<br>City 24872, Taiwan |
|-----------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Wolfgang Huang<br>[phone] #601 |
| Date prepared: | December 24, 2018 |
| Device Names: | Proprietary: STURDY Autoclave Super Microm<br>(models SA-260MA and SA-260MA-R) |
| | Common: Steam sterilizer |
| | Classification: 21 CFR § 880.6880<br>FLE: Sterilizer, steam |
| | Class II |

## Predicate Device Information:

Midmark M11 Ultraclave Steam Sterilizer, K990189.

## General Description:

The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature and pressure parameters.

Devices to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle and presses the appropriate switch. The sterilizer automatically fills the chamber, heats the water into steam,

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STURDY

four times pulse sterilizes the items, and automatically vents the steam and cools the chamber after sterilization is complete.

## Indications for Use:

The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA and SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact. Cycle parameters are as follows:

| Cycle | Ster. Temp. | Ster.<br>Pressure | Ster.<br>Time<br>(minutes) | Dry Time<br>(minutes) | Items to be Sterilized<br>(always consult the item manufacturer's<br>recommendation for sterilization) |
|-------------------------------|---------------------|-----------------------|----------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Un-<br>wrapped | 270 °F<br>(132 °C) | 27.2 psi<br>(186 kPa) | 3 | 30 | Instruments loose on a tray. Loose items manufacturers recommend for<br>exposures at 270 °F (132 °C) for 3 minutes. Note: The sterility of unwrapped items is<br>compromised on exposure to a non-sterile<br>environment. |
| Wrapped<br>(Pouches) | 270 °F<br>(132 °C) | 27.2 psi<br>(186 kPa) | 4 | 30 | Pouched or loosely wrapped instruments. Wrapped trays of loose instrument. Wrapped items manufacturers recommend<br>for exposures at 270 °F (132 °C) for 4<br>minutes. |
| Wrapped<br>(Textile<br>Packs) | 250 °F<br>(121 °C) | 15 psi<br>(104 kPa) | 30 | 30 | Textiles and surgical packs wrapped for<br>sterilization. Items except liquids, manufacturers<br>recommend for exposures at 250 °F (121<br>°C) for 30 minutes. |
| Handpieces | 270 °F<br>(132 °C ) | 27.2 psi<br>(186 kPa) | 4 | 30 | Dental handpieces (wrapped)<br>Note: Verify acceptability of sterilization<br>parameters with handpiece manufacturer. |
| Bowie-Dick<br>test | 273 °F<br>(134 °C ) | 29.5 psi<br>(203 kPa) | 3.5 | N/A | N/A |
| Re-Dry | N/A | N/A | N/A | 10 | N/A |
| Pump test | N/A | N/A | N/A | 10 | N/A |

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Image /page/6/Picture/0 description: The image shows the logo for "STURDY APEX GROUP". The word "STURDY" is in large, green, bold letters. To the right of the "D" in "STURDY" is a white medical cross. Below "STURDY" is the text "APEX GROUP" in smaller, red letters.

SA-260MA / SA-260MA-R

# 510(k) Premarket Notification
510(k) Summary

### Maximum load:

| | | Program | | | |
|--------------|---------------------------------|-------------------------|-------------------------|-------------------------|-------------------------------------------------------------------|
| | | Unwrapped | Wrapped | Wrapped | Handpieces |
| | Temperature | 270 °F (132 °C) | 250 °F (121 °C) | 270 °F (132 °C) | 270 °F (132 °C) |
| Pressure | | 27.2 psi<br>(186 kPa) | 15 psi<br>(104 kPa) | 27.2 psi<br>(186 kPa) | 27.2 psi<br>(186 kPa) |
| | Sterilization time<br>(minutes) | 3 | 30 | 4 | 4 |
| | Dry time (minutes) | 30 | 30 | 30 | 30 |
| | Solid<br>Instrument | 9.0 lbs<br>(4080 grams) | - | - | - |
| Max.<br>load | Textile Packs | - | 2.9 lbs<br>(1300 grams) | - | - |
| | Pouches | - | - | 2.9 lbs<br>(1300 grams) | - |
| | Handpieces | - | - | - | 9 handpieces with<br>other instruments<br>4.5 lbs<br>(2040 grams) |

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Image /page/7/Picture/0 description: The image shows the logo for "STURDY APEX GROUP". The word "STURDY" is in large, green, sans-serif font, with a plus sign incorporated into the letter "D". Below "STURDY" is the text "APEX GROUP" in a smaller, red, sans-serif font.

## Technological Characteristics:

Shown below is the technological characteristic comparison of the STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) with the predicate device, MidMark M11:

| Device<br>Characteristic | STURDY Autoclave Super Microm<br>(K181993) | | Predicate<br>MidMark M11 (K990189) | Comment |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | SA-260MA | SA-260MA-R | | |
| Intended Use | The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilizer in the SA-260MA and SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact. | | The M11UltraClave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilizer in the M11 in the Pouches cycle. This device is not recommended for sterilization of liquid intended for direct patient contact. | Similar |
| Product code | FLE | | FLE | Same |
| Regulation | 880.6880 Steam Sterilizer | | 880.6880 Steam Sterilizer | |
| Class | Class II | | Class II | |
| Built according to<br>Standard | ANSI/AAMI ST55:2016 | | ANSI/AAMI ST55:2010/(R)2014 | Similar |
| Sterilization type | moist heat sterilization | | moist heat sterilization | Same |
| Device<br>Characteristic | STURDY Autoclave Super Microm<br>(K181993) | Predicate<br>MidMark M11 (K990189) | Comment | |
| | SA-260MA<br>SA-260MA-R | | | |
| Power Source | Single Phase,<br>120VAC, 60Hz, 12 A | Single Phase,<br>115VAC, 60Hz, 12 A | Similar | |
| Water Reservoir<br>Capacity | 1.1 Gallons (4.2 liters) to Full Mark | 1.4 Gallons (5.3 liters) to Full Mark | Similar | |
| Electrical safety<br>standard | IEC 61010-1, 3rd Edition<br>IEC 61010-2-040:2015 | UL 61010-1, 2nd Edition<br>IEC 61010-2-040, 1st Edition | Similar | |
| Certification | ASME Boiler & Pressure Vessel Code,<br>Section VIII, Division 1. | ASME Boiler & Pressure Vessel<br>Code, Section VIII, Division 1. | Same | |
| Pressure vessel | | | | |
| Chamber design<br>standard | ASME Boiler & Pressure Vessel Code,<br>Section VIII, Division 1. | ASME Boiler & Pressure Vessel<br>Code, Section VIII, Division 1. | Same | |
| Material of<br>chamber | corrosion-resistant properties | corrosion-resistant properties | Same | |
| Safety Valve<br>Setting | 40 psi (275.8 kPa) | 40 psi (275.8 kPa) | Same | |
| Safety (pressure<br>relief) valves | ASME approved | ASME approved | Same | |
| Control system | | | | |
| Sterilization<br>Method | Dynamic-air-removal steam sterilizer | Dynamic-air-removal steam<br>sterilizer | Same | |
| Control<br>Technology | Microcontrollers | Microcontrollers | Same | |
| Sterilization<br>process | Temperature sensor for exposure temperature<br>monitoring | Temperature sensor for exposure<br>temperature monitoring | Same | |
| Device<br>Characteristic | STURDY Autoclave Super Microm<br>(K181993) | | Predicate<br>MidMark M11 (K990189) | Comment |
| | SA-260MA | SA-260MA-R | | |
| monitoring | Automatic operation through all phases of<br>sterilization cycle, | | Automatic operation through all phases of<br>sterilization cycle, | Same |
| Control devices | electrical heaters | electrical heaters | electrical heaters | Same |
| Performance: | | | | |
| Biological<br>performance | SAL of 10 -6<br>Through achievement of no growth at half cycle<br>with validation loads. | SAL of 10 -6<br>Through achievement of no growth at half cycle<br>with validation loads. | SAL of 10 -6<br>Through achievement of no growth<br>at half cycle with validation loads. | Similar |
| Comply with | ANSI/AAMI ST55:2016 | | ANSI/AAMI ST55:2010/(R)2014 | |
| Moisture retention | | | | |
| Textile test packs | The gain in weight due to moisture content shall<br>be less than 2 %. | The gain in weight due to moisture content shall<br>be less than 2 %. | The gain in weight due to moisture<br>content shall be less than 2 %. | Similar |
| Comply with<br>Wrapped<br>instrument test<br>trays | ANSI/AAMI ST55:2016<br>The gain in weight due to moisture content shall<br>be less than 0.5% | | ANSI/AAMI ST55:2010/(R)2014<br>The gain in weight due to moisture<br>content shall be less than 0.5 % | Same |
| Comply with | ANSI/AAMI ST55:2016 | | ANSI/AAMI ST55:2010/(R)2014 | |
| Maximum Loading capacities | | | | |
| Factory predefined cycles | | | | |
| Unwrapped | Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 3 minutes | Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 3 minutes | Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 3 minutes | Similar |
| Device<br>Characteristic | STURDY Autoclave Super Microm<br>(K181993) | | Predicate<br>MidMark M11 (K990189) | Comment |
| | SA-260MA | SA-260MA-R | | |
| | Drying cycle: 30 minutes | | Drying cycle: 30 minutes (Dry time<br>can be changed from 0 to 60<br>minutes.) | |
| Pouches | Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 4 minutes<br>Drying cycle: 30 minutes | | Temp.: 270°F (132°C)<br>Pressure:27.1psi (186 kPa)<br>Sterilize: 5 minutes<br>Drying cycle: 30 minutes (Dry time<br>can be changed from 0 to 60<br>minutes.) | Similar |
| Packs | Temp.: 250° F(121° C)<br>Pressure: 15 psi (104 kPa)<br>Sterilize: 30 minutes<br>Drying cycle: 30 minutes | | Temp.: 250° F(121° C)<br>Pressure: 15 psi (104 kPa)<br>Sterilize: 30 minutes<br>Drying cycle: 30 minutes (Dry time<br>can be changed from 0 to 60<br>minutes.) | Similar |
| Handpieces | Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 4 minutes<br>Drying cycle: 30 minutes | | Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 6 minutes<br>Drying cycle: 30 minutes (Dry time<br>can be changed from 0 to 60<br>minutes.) | Similar |

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Image /page/8/Picture/0 description: The image shows the logo for "STURDY APEX GROUP". The word "STURDY" is in large, green, bold letters. Below "STURDY" is the text "APEX GROUP" in smaller, red letters. The plus sign in the word "STURDY" is a green cross.

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Image /page/9/Picture/0 description: The image shows the logo for "STURDY APEX GROUP". The word "STURDY" is in large, green, bold letters. Below "STURDY" is the text "APEX GROUP" in smaller, red letters. The plus sign in the word "STURDY" is a green cross.

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Image /page/10/Picture/0 description: The image shows the logo for "STURDY APEX GROUP". The word "STURDY" is in large, green, bold letters. Below "STURDY" is the phrase "APEX GROUP" in smaller, red letters. The "+" in "STURDY" is stylized as a medical cross.

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Image /page/11/Picture/0 description: The image shows the logo for "STURDY APEX GROUP". The word "STURDY" is written in green, with a plus sign incorporated into the letter "D". Below "STURDY" is the text "APEX GROUP" in a smaller font size and a reddish-pink color.

SA-260MA / SA-260MA-R

## Summary of Non-Clinical Testing:

Shown below the standards that were used to demonstrate that the subject device met the acceptance criteria for the standards listed below:

| Test Method / | Purpose | Acceptance | Results |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Name | | Criteria | |
| ANSI/AAMI | To ensure that the | the chamber | Pass |
| ST55:2016 | sterilizer is capable | temperature during | |
| Empty chamber | of providing | the exposure time | |
| (Temperature | steady-state | remains within +3 | |
| mapping) | thermal conditions | ℃ (or +6 °F) and -0 | |
| | within the chamber | ℃ (or -0 °F) | |
| - Unwrapped | consistent with the | | |
| Program, 270 °F | desired sterility | | |
| (132 °C), | assurance level | | |
| sterilization time 3 | (SAL) in the load |…