(463 days)
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.
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.
This document describes the non-clinical testing performed to demonstrate that the STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) meets specified acceptance criteria.
- Table of Acceptance Criteria and Reported Device Performance:
| Test Method / Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ANSI/AAMI ST55:2016 Empty chamber (Temperature mapping) | 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. | The chamber temperature during the exposure time remains within +3 °C (or +6 °F) and -0 °C (or -0 °F). | Pass for Unwrapped, Wrapped (Pouch), Wrapped (Textile Packs), Handpiece, and Bowie-Dick Test Programs. |
| ANSI/AAMI ST55:2016 - Bowie-Dick test Cycle Program | To verify the air removal performance of the target sterilizer. | The Bowie-Dick test indicator sheet shall show a uniform color change; i.e., the color in the center should be the same as that at the outer edges. | Pass |
| ANSI/AAMI ST55:2016 Moisture Retention Testing for wrapped instrument test trays (wrapped, 270 °F, 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 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 | 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 |
| ANSI/AAMI ST55:2016 Biological Performance with Dental Handpiece | 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 | 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 (for both 250°F and 270°F programs) |
-
Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes (e.g., number of test cycles, specific items tested) for each non-clinical test. It generally describes the "worst-case maximum load condition" for biological performance testing.
The provenance of the data is from non-clinical laboratory testing performed by Sturdy Industrial Co., Ltd. for the purpose of demonstrating substantial equivalence to a predicate device (Midmark M11 Ultraclave Steam Sterilizer, K990189). This is a retrospective evaluation of the device's performance against established standards. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described is non-clinical performance testing against recognized standards rather than human-read image interpretation.
-
Adjudication method for the test set:
Not applicable. The tests are objective measurements against predefined criteria in recognized standards, not subjective interpretations requiring adjudication.
-
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 is a medical device (steam sterilizer) and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a steam sterilizer device. There is no algorithm-only performance to assess.
-
The type of ground truth used:
The ground truth for this device's performance is established by the acceptance criteria defined within the referenced ANSI/AAMI ST55:2016 standard and other relevant standards. These standards specify quantifiable performance metrics (e.g., temperature ranges, moisture retention percentages, biological indicator growth/no growth, uniform color change for Bowie-Dick test).
-
The sample size for the training set:
Not applicable. The device is a steam sterilizer, not a machine learning model, so there is no training set in the context of AI.
-
How the ground truth for the training set was established:
Not applicable for the same reason as point 8.
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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.
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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 (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
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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.Pressure | Ster.Time(minutes) | Dry Time(minutes) | Items to be Sterilized(always consult the item manufacturer'srecommendation for sterilization) |
|---|---|---|---|---|---|
| Un-wrapped | 270 °F(132 °C) | 27.2 psi(186 kPa) | 3 | 30 | ● Instruments loose on a tray.● Loose items manufacturers recommend forexposures at 270 °F (132 °C) for 3 minutes.Note: The sterility of unwrapped items iscompromised on exposure to a non-sterileenvironment. |
| 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 recommendfor exposures at 270 °F (132 °C ) for 4minutes. |
| Wrapped(TextilePacks) | 250 °F(121 °C) | 15 psi(104 kPa) | 30 | 30 | ● Textiles and surgical packs wrapped forsterilization.● Items except liquids, manufacturersrecommend 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 sterilizationparameters with handpiece manufacturer. |
| Bowie-Dicktest | 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 |
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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(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 | SolidInstrument | 9.0 lbs(4080 grams) | - | - | - |
| Textile Packs | - | 2.9 lbs(1300 grams) | - | - | |
| Pouches | - | - | 2.9 lbs(1300 grams) | - | |
| Handpieces | - | - | - | 9 handpieces withother instruments4.5 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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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 TaipeiCity 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 § 880.6880FLE: 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.Pressure | Ster.Time(minutes) | Dry Time(minutes) | Items to be Sterilized(always consult the item manufacturer'srecommendation for sterilization) |
|---|---|---|---|---|---|
| Un-wrapped | 270 °F(132 °C) | 27.2 psi(186 kPa) | 3 | 30 | Instruments loose on a tray. Loose items manufacturers recommend forexposures at 270 °F (132 °C) for 3 minutes. Note: The sterility of unwrapped items iscompromised on exposure to a non-sterileenvironment. |
| 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 recommendfor exposures at 270 °F (132 °C) for 4minutes. |
| Wrapped(TextilePacks) | 250 °F(121 °C) | 15 psi(104 kPa) | 30 | 30 | Textiles and surgical packs wrapped forsterilization. Items except liquids, manufacturersrecommend 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 sterilizationparameters with handpiece manufacturer. |
| Bowie-Dicktest | 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 |
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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(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 | |
| SolidInstrument | 9.0 lbs(4080 grams) | - | - | - | |
| Max.load | Textile Packs | - | 2.9 lbs(1300 grams) | - | - |
| Pouches | - | - | 2.9 lbs(1300 grams) | - | |
| Handpieces | - | - | - | 9 handpieces withother instruments4.5 lbs(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:
| DeviceCharacteristic | STURDY Autoclave Super Microm(K181993) | PredicateMidMark 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 toStandard | ANSI/AAMI ST55:2016 | ANSI/AAMI ST55:2010/(R)2014 | Similar | |
| Sterilization type | moist heat sterilization | moist heat sterilization | Same | |
| DeviceCharacteristic | STURDY Autoclave Super Microm(K181993) | PredicateMidMark M11 (K990189) | Comment | |
| SA-260MASA-260MA-R | ||||
| Power Source | Single Phase,120VAC, 60Hz, 12 A | Single Phase,115VAC, 60Hz, 12 A | Similar | |
| Water ReservoirCapacity | 1.1 Gallons (4.2 liters) to Full Mark | 1.4 Gallons (5.3 liters) to Full Mark | Similar | |
| Electrical safetystandard | IEC 61010-1, 3rd EditionIEC 61010-2-040:2015 | UL 61010-1, 2nd EditionIEC 61010-2-040, 1st Edition | Similar | |
| Certification | ASME Boiler & Pressure Vessel Code,Section VIII, Division 1. | ASME Boiler & Pressure VesselCode, Section VIII, Division 1. | Same | |
| Pressure vessel | ||||
| Chamber designstandard | ASME Boiler & Pressure Vessel Code,Section VIII, Division 1. | ASME Boiler & Pressure VesselCode, Section VIII, Division 1. | Same | |
| Material ofchamber | corrosion-resistant properties | corrosion-resistant properties | Same | |
| Safety ValveSetting | 40 psi (275.8 kPa) | 40 psi (275.8 kPa) | Same | |
| Safety (pressurerelief) valves | ASME approved | ASME approved | Same | |
| Control system | ||||
| SterilizationMethod | Dynamic-air-removal steam sterilizer | Dynamic-air-removal steamsterilizer | Same | |
| ControlTechnology | Microcontrollers | Microcontrollers | Same | |
| Sterilizationprocess | Temperature sensor for exposure temperaturemonitoring | Temperature sensor for exposuretemperature monitoring | Same | |
| DeviceCharacteristic | STURDY Autoclave Super Microm(K181993) | PredicateMidMark M11 (K990189) | Comment | |
| SA-260MA | SA-260MA-R | |||
| monitoring | Automatic operation through all phases ofsterilization cycle, | Automatic operation through all phases ofsterilization cycle, | Same | |
| Control devices | electrical heaters | electrical heaters | electrical heaters | Same |
| Performance: | ||||
| Biologicalperformance | SAL of 10 -6Through achievement of no growth at half cyclewith validation loads. | SAL of 10 -6Through achievement of no growth at half cyclewith validation loads. | SAL of 10 -6Through achievement of no growthat 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 shallbe less than 2 %. | The gain in weight due to moisture content shallbe less than 2 %. | The gain in weight due to moisturecontent shall be less than 2 %. | Similar |
| Comply withWrappedinstrument testtrays | ANSI/AAMI ST55:2016The gain in weight due to moisture content shallbe less than 0.5% | ANSI/AAMI ST55:2010/(R)2014The gain in weight due to moisturecontent 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 |
| DeviceCharacteristic | STURDY Autoclave Super Microm(K181993) | PredicateMidMark M11 (K990189) | Comment | |
| SA-260MA | SA-260MA-R | |||
| Drying cycle: 30 minutes | Drying cycle: 30 minutes (Dry timecan be changed from 0 to 60minutes.) | |||
| Pouches | Temp.: 270°F (132°C)Pressure: 27.1psi (186 kPa)Sterilize: 4 minutesDrying cycle: 30 minutes | Temp.: 270°F (132°C)Pressure:27.1psi (186 kPa)Sterilize: 5 minutesDrying cycle: 30 minutes (Dry timecan be changed from 0 to 60minutes.) | Similar | |
| Packs | Temp.: 250° F(121° C)Pressure: 15 psi (104 kPa)Sterilize: 30 minutesDrying cycle: 30 minutes | Temp.: 250° F(121° C)Pressure: 15 psi (104 kPa)Sterilize: 30 minutesDrying cycle: 30 minutes (Dry timecan be changed from 0 to 60minutes.) | Similar | |
| Handpieces | Temp.: 270°F (132°C)Pressure: 27.1psi (186 kPa)Sterilize: 4 minutesDrying cycle: 30 minutes | Temp.: 270°F (132°C)Pressure: 27.1psi (186 kPa)Sterilize: 6 minutesDrying cycle: 30 minutes (Dry timecan be changed from 0 to 60minutes.) | 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 | ||
| 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 Notification510(k) Summary | ||
| - Bowie-Dick testCycle Program,273 °F (134 °C),sterilization time3.5 minutes, drytime 0 | performance oftarget sterilizer | show a uniformcolor change; i.e.,the color in thecenter should be thesame as that at theouter edges. | Pass |
| ANSI/AAMIST55:2016Moisture RetentionTesting forwrapped instrumenttest traysWrapped, 270 °F(132 °C), Ster. time4 minutes, Drytime 30 minutes | To verify thepresence of anyresidual moistureof wrappedinstrument testtrays | No evidence ofcondensed moisture(visible droplets) isallowed.The gain in weightdue to moisturecontent shall be lessthan 0.5%. | Pass |
| ANSI/AAMIST55:2016Moisture RetentionTesting forwrapped instrumenttest trays(for paper-plasticpeel pouches)- Wrapped 270 °F(132 °C) Cycle toperformsterilization time 4minutes and the drytime 30 minutes | To verify thepresence of anyresidual moistureof wrappedinstrument testtrays | No evidence ofcondensed moisture(visible droplets) isallowed. | Pass |
| ANSI/AAMIST55:2016Moisture RetentionTesting for Textiletest pack- Wrapped (TextilePacks) Program,250 °F (121 °C),sterilization time30 minutes, drytime 30 minutes | To verify thepresence of anyresidual moistureof textile test pack | No evidence ofcondensed moisture(visible droplets) isallowed.The gain in weightdue to moisturecontent shall be lessthan 2.0% | Pass |
| ANSI/AAMIST55:2016Biologicalperformance withwrapped instrumentPCD (BI test tray) | To verify theBiologicalperformance withwrapped instrumentPCD (BI test tray) | The recommendedcycle has a 10-6 SALPCD is used | Pass |
| SA-260MA / SA-260MA-R | 510(k) Premarket Notification510(k) Summary | ||
| - three consecutivecycles run at one-half therecommendedholding time, e.g.132°C for 2minutes, underworst-casemaximum loadcondition | |||
| ANSI/AAMIST55:2016BiologicalPerformance withDental Handpiece- one-half therecommendedholding time, e.g.132°C for 2minutes | To verify thebiologicalperformance withinstrument PCD | No growth observedin the vialscontaining turbinesor in the extractionof any of theturbines, except forthe positive controls.No growth shall beobserved with theBIs except thepositive control BI.If growth isobserved for test ornegative controlvials/extractions/BIs,the presence of thetest organism shallbe verified via Gramstain, or equivalent.Growth should beobserved for thepositive controlturbine and BI | Pass |
| ANSI/AAMIST55:2016Biologicalperformance with atextile PCD-Program Wrapped(Packs):Cycle Program:Wrapped (Packs)SterilizationTemperature:250°F (121°C)Exposure Time: 15minutes (half | To ensure theefficacy of theequipment and thelethality of therecommendedprocessingparameters bybiologicallychallenged | The recommendedcycle has a 10-6SAL | Pass |
| STURDYAPEX GROUPcycles) Dry Time: 30minutes | SA-260MA / SA-260MA-R | 510(k) Premarket Notification510(k) Summary | |
| -Program Wrapped(Packs):SterilizationTemperature:270°F (132°C)Exposure Time: 2minutes (halfcycles)Dry Time: 30minutes | Pass |
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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).
§ 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).