Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on standard sterilization processes controlled by pre-programmed parameters, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No
This device is an autoclave used for sterilizing medical and dental equipment, not for treating patients.

Diagnostic

No

The device is an autoclave, used for sterilization of medical equipment by killing bio-organisms with saturated steam. It does not perform any diagnostic functions like detecting, characterizing, or monitoring diseases or conditions in patients.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical hardware device (autoclave) that uses steam, pressure, and temperature for sterilization. While it has an electronic control system, it is an integral part of the hardware and not a standalone software device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to sterilize heat and moisture stable reusable equipment in various healthcare and laboratory settings. This is a sterilization process for medical devices, not a diagnostic test performed on biological samples.
Device Description: The device description details a steam sterilization process, which is a method for killing microorganisms on instruments. It does not describe any process for analyzing biological samples to diagnose a condition.
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.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases

The device is clearly intended for the sterilization of medical instruments, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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: Unwrapped
Ster. Temp.: 270 °F (132 °C)
Ster. Pressure: 27.2 psi (186 kPa)
Ster. Time (minutes): 3
Dry Time (minutes): 30
Items to be Sterilized: Instruments loose on a tray. Loose items manufacturers recommend for exposures at 270 °F (132 °C) for 3 minutes. Note: The sterility of unwrapped items is compromised on exposure to a non-sterile environment.

Cycle: Wrapped (Pouches)
Ster. Temp.: 270 °F (132 °C)
Ster. Pressure: 27.2 psi (186 kPa)
Ster. Time (minutes): 4
Dry Time (minutes): 30
Items to be Sterilized: Pouched or loosely wrapped instruments. Wrapped trays of loose instrument. Wrapped items manufacturers recommend for exposures at 270 °F (132 °C ) for 4 minutes.

Cycle: Wrapped (Textile Packs)
Ster. Temp.: 250 °F (121 °C)
Ster. Pressure: 15 psi (104 kPa)
Ster. Time (minutes): 30
Dry Time (minutes): 30
Items to be Sterilized: Textiles and surgical packs wrapped for sterilization. Items except liquids, manufacturers recommend for exposures at 250 °F (121 °C ) for 30 minutes.

Cycle: Handpieces
Ster. Temp.: 270 °F (132 ℃ )
Ster. Pressure: 27.2 psi (186 kPa)
Ster. Time (minutes): 4
Dry Time (minutes): 30
Items to be Sterilized: Dental handpieces (wrapped) Note: Verify acceptability of sterilization parameters with handpiece manufacturer.

Cycle: Bowie-Dick test
Ster. Temp.: 273 °F (134 °C )
Ster. Pressure: 29.5 psi (203 kPa)
Ster. Time (minutes): 3.5
Dry Time (minutes): N/A
Items to be Sterilized: N/A

Cycle: Re-Dry
Ster. Temp.: N/A
Ster. Pressure: N/A
Ster. Time (minutes): N/A
Dry Time (minutes): 10
Items to be Sterilized: N/A

Cycle: Pump test
Ster. Temp.: N/A
Ster. Pressure: N/A
Ster. Time (minutes): N/A
Dry Time (minutes): 10
Items to be Sterilized: N/A

Product codes (comma separated list FDA assigned to the subject device)

FLE

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

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

medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities

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)

Summary of Non-Clinical Testing:
Tests were conducted to demonstrate that the subject device met the acceptance criteria for the following standards:

ANSI/AAMI ST55:2016 Empty chamber (Temperature mapping)
- Purpose: To ensure that the sterilizer is capable of providing steady-state thermal conditions within the chamber consistent with the desired sterility assurance level (SAL) in the load.
- Acceptance Criteria: The chamber temperature during the exposure time remains within +3 ℃ (or +6 °F) and -0 ℃ (or -0 °F).
- Results:
  - Unwrapped Program, 270 °F (132 °C), sterilization time 3 minutes, dry time 30 minutes: Pass
  - Wrapped (Pouch) Program, 270 °F (132 °C), sterilization time 4 minutes, dry time 30 minutes: Pass
  - Wrapped (Textile Packs) Program, 250 °F (121 °C), sterilization time 30 minutes, dry time 30 minutes: Pass
  - Handpiece Program, 270 °F (132 °C), sterilization time 4 minutes, dry time 30 minutes: Pass
  - Bowie-Dick Test Program, 273 °F (134 °C), sterilization time 3.5 minutes, dry time 0 minutes: Pass
ANSI/AAMI ST55:2016 Bowie-Dick test Cycle Program
- Purpose: To verify the air removal performance of target sterilizer.
- 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
ANSI/AAMI ST55:2016 Moisture Retention Testing for wrapped instrument test trays (Wrapped, 270 °F (132 °C), Ster. time 4 minutes, Dry time 30 minutes)
- Purpose: To verify the presence of any residual moisture of wrapped instrument test trays.
- Acceptance Criteria: No evidence of condensed moisture (visible droplets) is allowed. The gain in weight due to moisture content shall be less than 0.5%.
- Results: Pass
ANSI/AAMI ST55:2016 Moisture Retention Testing for wrapped instrument test trays (for paper-plastic peel pouches) (Wrapped 270 °F (132 °C) Cycle to perform sterilization time 4 minutes and the dry time 30 minutes)
- Purpose: To verify the presence of any residual moisture of wrapped instrument test trays.
- Acceptance Criteria: No evidence of condensed moisture (visible droplets) is allowed.
- Results: Pass
ANSI/AAMI ST55:2016 Moisture Retention Testing for Textile test pack (Wrapped (Textile Packs) Program, 250 °F (121 °C), sterilization time 30 minutes, dry time 30 minutes)
- Purpose: To verify the presence of any residual moisture of textile test pack.
- Acceptance Criteria: No evidence of condensed moisture (visible droplets) is allowed. The gain in weight due to moisture content shall be less than 2.0%.
- Results: Pass
ANSI/AAMI ST55:2016 Biological performance with wrapped instrument PCD (BI test tray)
- Purpose: To verify the Biological performance with wrapped instrument PCD (BI test tray).
- Acceptance Criteria: The recommended cycle has a 10^-6 SAL PCD is used.
- Results: Pass for three consecutive cycles run at one-half the recommended holding time, e.g. 132°C for 2 minutes, under worst-case maximum load condition.
ANSI/AAMI ST55:2016 Biological Performance with Dental Handpiece (one-half the recommended holding time, e.g. 132°C for 2 minutes)
- Purpose: To verify the biological performance with instrument PCD.
- Acceptance Criteria: No growth observed in the vials containing turbines or in the extraction of any of the turbines, except for the positive controls. No growth shall be observed with the BIs except the positive control BI. If growth is observed for test or negative control vials/extractions/BIs, the presence of the test organism shall be verified via Gram stain, or equivalent. Growth should be observed for the positive control turbine and BI.
- Results: Pass
ANSI/AAMI ST55:2016 Biological performance with a textile PCD (Program Wrapped (Packs): Cycle Program: Wrapped (Packs) Sterilization Temperature: 250°F (121°C) Exposure Time: 15 minutes (half cycles) Dry Time: 30 minutes and Program Wrapped (Packs): Sterilization Temperature: 270°F (132°C) Exposure Time: 2 minutes (half cycles) Dry Time: 30 minutes)
- Purpose: To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biologically challenged.
- Acceptance Criteria: The recommended cycle has a 10^-6 SAL.
- Results: Pass for both programs.

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.

Midmark M11 Ultraclave Steam Sterilizer, K990189.

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.

Not Found

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

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).

Summary

0

Image /page/0/Picture/0 description: The image contains 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.

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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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

3

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
(186 kPa)	15 psi
(104 kPa)	27.2 psi
(186 kPa)	27.2 psi
(186 kPa)
	Sterilization time
(minutes)	3	30	4	4
	Dry time (minutes)	30	30	30	30
Max.
load	Solid
Instrument	9.0 lbs
(4080 grams)	-	-	-
	Textile Packs	-	2.9 lbs
(1300 grams)	-	-
	Pouches	-	-	2.9 lbs
(1300 grams)	-
	Handpieces	-	-	-	9 handpieces with
other instruments
4.5 lbs
(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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4

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.
No. 168, Sec. 1, Zhongxing Rd, Wugu District, New Taipei
City 24872, Taiwan |
|-----------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Wolfgang Huang
+886-2-2981-25245 #601 |
| Date prepared: | December 24, 2018 |
| Device Names: | Proprietary: STURDY Autoclave Super Microm
(models SA-260MA and SA-260MA-R) |
| | Common: Steam sterilizer |
| | Classification: 21 CFR § 880.6880
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,

5

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

6

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
(186 kPa)	15 psi
(104 kPa)	27.2 psi
(186 kPa)	27.2 psi
(186 kPa)
	Sterilization time
(minutes)	3	30	4	4
	Dry time (minutes)	30	30	30	30
	Solid
Instrument	9.0 lbs
(4080 grams)	-	-	-
Max.
load	Textile Packs	-	2.9 lbs
(1300 grams)	-	-
	Pouches	-	-	2.9 lbs
(1300 grams)	-
	Handpieces	-	-	-	9 handpieces with
other instruments
4.5 lbs
(2040 grams)

7

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
Characteristic | STURDY Autoclave Super Microm
(K181993) | | Predicate
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
Standard | ANSI/AAMI ST55:2016 | | ANSI/AAMI ST55:2010/(R)2014 | Similar |
| Sterilization type | moist heat sterilization | | moist heat sterilization | Same |
| Device
Characteristic | STURDY Autoclave Super Microm
(K181993) | Predicate
MidMark M11 (K990189) | Comment | |
| | SA-260MA
SA-260MA-R | | | |
| Power Source | Single Phase,
120VAC, 60Hz, 12 A | Single Phase,
115VAC, 60Hz, 12 A | Similar | |
| Water Reservoir
Capacity | 1.1 Gallons (4.2 liters) to Full Mark | 1.4 Gallons (5.3 liters) to Full Mark | Similar | |
| Electrical safety
standard | IEC 61010-1, 3rd Edition
IEC 61010-2-040:2015 | UL 61010-1, 2nd Edition
IEC 61010-2-040, 1st Edition | Similar | |
| Certification | ASME Boiler & Pressure Vessel Code,
Section VIII, Division 1. | ASME Boiler & Pressure Vessel
Code, Section VIII, Division 1. | Same | |
| Pressure vessel | | | | |
| Chamber design
standard | ASME Boiler & Pressure Vessel Code,
Section VIII, Division 1. | ASME Boiler & Pressure Vessel
Code, Section VIII, Division 1. | Same | |
| Material of
chamber | corrosion-resistant properties | corrosion-resistant properties | Same | |
| Safety Valve
Setting | 40 psi (275.8 kPa) | 40 psi (275.8 kPa) | Same | |
| Safety (pressure
relief) valves | ASME approved | ASME approved | Same | |
| Control system | | | | |
| Sterilization
Method | Dynamic-air-removal steam sterilizer | Dynamic-air-removal steam
sterilizer | Same | |
| Control
Technology | Microcontrollers | Microcontrollers | Same | |
| Sterilization
process | Temperature sensor for exposure temperature
monitoring | Temperature sensor for exposure
temperature monitoring | Same | |
| Device
Characteristic | STURDY Autoclave Super Microm
(K181993) | | Predicate
MidMark M11 (K990189) | Comment |
| | SA-260MA | SA-260MA-R | | |
| monitoring | Automatic operation through all phases of
sterilization cycle, | | Automatic operation through all phases of
sterilization cycle, | Same |
| Control devices | electrical heaters | electrical heaters | electrical heaters | Same |
| Performance: | | | | |
| Biological
performance | SAL of 10 -6
Through achievement of no growth at half cycle
with validation loads. | SAL of 10 -6
Through achievement of no growth at half cycle
with validation loads. | SAL of 10 -6
Through achievement of no growth
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
be less than 2 %. | The gain in weight due to moisture content shall
be less than 2 %. | The gain in weight due to moisture
content shall be less than 2 %. | Similar |
| Comply with
Wrapped
instrument test
trays | ANSI/AAMI ST55:2016
The gain in weight due to moisture content shall
be less than 0.5% | | ANSI/AAMI ST55:2010/(R)2014
The gain in weight due to moisture
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)
Pressure: 27.1psi (186 kPa)
Sterilize: 3 minutes | Temp.: 270°F (132°C)
Pressure: 27.1psi (186 kPa)
Sterilize: 3 minutes | Temp.: 270°F (132°C)
Pressure: 27.1psi (186 kPa)
Sterilize: 3 minutes | Similar |
| Device
Characteristic | STURDY Autoclave Super Microm
(K181993) | | Predicate
MidMark M11 (K990189) | Comment |
| | SA-260MA | SA-260MA-R | | |
| | Drying cycle: 30 minutes | | Drying cycle: 30 minutes (Dry time
can be changed from 0 to 60
minutes.) | |
| Pouches | Temp.: 270°F (132°C)
Pressure: 27.1psi (186 kPa)
Sterilize: 4 minutes
Drying cycle: 30 minutes | | Temp.: 270°F (132°C)
Pressure:27.1psi (186 kPa)
Sterilize: 5 minutes
Drying cycle: 30 minutes (Dry time
can be changed from 0 to 60
minutes.) | Similar |
| Packs | Temp.: 250° F(121° C)
Pressure: 15 psi (104 kPa)
Sterilize: 30 minutes
Drying cycle: 30 minutes | | Temp.: 250° F(121° C)
Pressure: 15 psi (104 kPa)
Sterilize: 30 minutes
Drying cycle: 30 minutes (Dry time
can be changed from 0 to 60
minutes.) | Similar |
| Handpieces | Temp.: 270°F (132°C)
Pressure: 27.1psi (186 kPa)
Sterilize: 4 minutes
Drying cycle: 30 minutes | | Temp.: 270°F (132°C)
Pressure: 27.1psi (186 kPa)
Sterilize: 6 minutes
Drying cycle: 30 minutes (Dry time
can be changed from 0 to 60
minutes.) | Similar |

8

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.

9

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.

10

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
minutes, dry time
30 minutes.
- Wrapped (Pouch)			Pass
Program, 270 °F
(132 °C),
sterilization time 4
minutes, dry time
30 minutes.
- Wrapped (Textile			Pass
Packs) Program,
250 °F (121 °C),
sterilization time
30 minutes, dry
time 30 minutes.
- Handpiece			Pass
Program, 270 °F
(132 °C),
sterilization time 4
minutes, dry time
30 minutes.
- Bowie-Dick Test			Pass
Program, 273 °F
(134 °C),
sterilization time
3.5 minutes, dry
time 0 minutes.
ANSI/AAMI	To verify the air	The Bowie-Dick test	Pass
ST55:2016	removal	indicator sheet shall
	SA-260MA / SA-260MA-R		510(k) Premarket Notification
510(k) Summary
- Bowie-Dick test
Cycle Program,
273 °F (134 °C),
sterilization time
3.5 minutes, dry
time 0	performance of
target sterilizer	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
Moisture Retention
Testing for
wrapped instrument
test trays
Wrapped, 270 °F
(132 °C), Ster. time
4 minutes, Dry
time 30 minutes	To verify the
presence of any
residual moisture
of wrapped
instrument test
trays	No evidence of
condensed moisture
(visible droplets) is
allowed.
The gain in weight
due to moisture
content shall be less
than 0.5%.	Pass
ANSI/AAMI
ST55:2016
Moisture Retention
Testing for
wrapped instrument
test trays
(for paper-plastic
peel pouches)

Wrapped 270 °F
(132 °C) Cycle to
perform
sterilization time 4
minutes and the dry
time 30 minutes | To verify the
presence of any
residual moisture
of wrapped
instrument test
trays | No evidence of
condensed moisture
(visible droplets) is
allowed. | Pass |
| ANSI/AAMI
ST55:2016
Moisture Retention
Testing for Textile
test pack
Wrapped (Textile
Packs) Program,
250 °F (121 °C),
sterilization time
30 minutes, dry
time 30 minutes | To verify the
presence of any
residual moisture
of textile test pack | No evidence of
condensed moisture
(visible droplets) is
allowed.
The gain in weight
due to moisture
content shall be less
than 2.0% | Pass |
| ANSI/AAMI
ST55:2016
Biological
performance with
wrapped instrument
PCD (BI test tray) | To verify the
Biological
performance with
wrapped instrument
PCD (BI test tray) | The recommended
cycle has a 10-6 SAL
PCD is used | Pass |
| | SA-260MA / SA-260MA-R | | 510(k) Premarket Notification
510(k) Summary |
| - three consecutive
cycles run at one-
half the
recommended
holding time, e.g.
132°C for 2
minutes, under
worst-case
maximum load
condition | | | |
| ANSI/AAMI
ST55:2016
Biological
Performance with
Dental Handpiece
one-half the
recommended
holding time, e.g.
132°C for 2
minutes | To verify the
biological
performance with
instrument PCD | No growth observed
in the vials
containing turbines
or in the extraction
of any of the
turbines, except for
the positive controls.
No growth shall be
observed with the
BIs except the
positive control BI.
If growth is
observed for test or
negative control
vials/extractions/BIs,
the presence of the
test organism shall
be verified via Gram
stain, or equivalent.
Growth should be
observed for the
positive control
turbine and BI | Pass |
| ANSI/AAMI
ST55:2016
Biological
performance with a
textile PCD
-Program Wrapped
(Packs):
Cycle Program:
Wrapped (Packs)
Sterilization
Temperature:
250°F (121°C)
Exposure Time: 15
minutes (half | To ensure the
efficacy of the
equipment and the
lethality of the
recommended
processing
parameters by
biologically
challenged | The recommended
cycle has a 10-6
SAL | Pass |
| STURDY
APEX GROUP
cycles) Dry Time: 30
minutes | SA-260MA / SA-260MA-R | | 510(k) Premarket Notification
510(k) Summary |
| -Program Wrapped
(Packs):
Sterilization
Temperature:
270°F (132°C)
Exposure Time: 2
minutes (half
cycles)
Dry Time: 30
minutes | | | Pass |

12

13

14

Shown below are a listing of Standards used in the non-clinical testing of the subject devices

Item	Standards
1	ANSI/AAMI ST55:2016
2	EN ISO 14971:2012
3	ISO 13485:2016
4	IEC/EN 61010-1:2010 (Third Edition)
5	IEC 61010-2-040:2015
6	American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels Ed. 2015

Clinical Data:

No clinical data is required for this device classification submission.

CONCLUSION:

Based on the conclusions drawn from the nonclinical tests that demonstrate that the STURDY Steam Sterilizers models SA-260MA and SA-260MA-R is as safe, as effective, and performs as well as or better than the legally marketed predicate device, MidMark M11 (K990189).