Sturdy Autoclave Super Microm
Device Facts
| Record ID | K231489 |
|---|---|
| Device Name | Sturdy Autoclave Super Microm |
| Applicant | Sturdy Industrial Co., Ltd. |
| Product Code | FLE · General Hospital |
| Decision Date | Jun 21, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.6880 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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-R) is not recommended for sterilization of liquid intended for direct patient contact.
Device Story
Table-top steam sterilizer; uses saturated steam at high pressure/temperature to kill infectious bio-organisms. Input: reusable heat/moisture stable equipment. Operation: user selects cycle; device automatically fills water, heats to steam, performs steam-flush and pressure-pulses, holds parameters, vents, and cools. Output: sterilized equipment. Used in medical/dental offices, hospitals, clinics, nursing homes, laboratories. Operated by healthcare staff. Provides automated sterilization cycles to ensure equipment safety for patient use.
Clinical Evidence
No clinical data. Bench testing only. Verification included empty chamber temperature mapping, Bowie-Dick air removal testing, moisture retention testing, biological performance (SAL 10^-6), electrical safety (UL 61010-1, IEC 61010-2-040), and EMC testing.
Technological Characteristics
Table-top steam sterilizer; SUS 304/316 stainless steel chamber; 24L capacity. Power: 120VAC, 60Hz. Dynamic-air-removal (2 steam-flush pressure-pulses). Microcontroller-based control system. Complies with ANSI/AAMI ST55, ASME Boiler & Pressure Vessel Code Section VIII Div 1, IEC 61010-1/2-040.
Indications for Use
Indicated for sterilization of heat and moisture stable reusable equipment, including dental handpieces, in medical, dental, clinical, hospital, nursing home, and laboratory settings. Not indicated for sterilization of 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
- STURDY Autoclave Super Microm (K181993)
Submission Summary (Full Text)
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6/21/23
Sturdy Industrial Co., Ltd Wolfgang Huang OA Manager No. 168 Sec. 1, Zhongxing Road, Wugu District New Taipei City, 24872 Taiwan
Re: K231489
Trade/Device Name: Sturdy Autoclave Super Microm Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: Mav 22, 2023 Received: May 23, 2023
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.
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
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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 (OS) 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 mediation-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,
# Christopher K. Dugard -S
for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K231489
Device Name STURDY Autoclave Super Microm
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-R) is not recommended for sterilization of liquid intended for direct patient contact. Cycle parameters are as follows:
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) Premarket Notification STURDY Autoclave Super Microm
### 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92.
| The assigned 510(k) Number: | K231489 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 20 June 2023 |
| 1. Submitter | |
| Mailing Address | STURDY Industrial CO., LTD.<br>No. 168, Sec. 1, Zhongxing Rd, Wugu District, New<br>Taipei City 24872, Taiwan<br>Phone: +886-2-2981-25245 #601<br>Establishment Registration No.: |
| Contact Person | Wolfgang Huang |
| Phone: | +886-2-2981-25245 #601 |
| E-mail: | wolfgang@sturdy.com.tw |
| 2 Device Name | |
| Common or usual name | Steam Sterilizer |
| Trade Name | STURDY Autoclave Super Microm<br>(models SA-260MA and SA-260MA-R) |
| Product Code | FLE |
| Device | Sterilizer, Steam |
| CFR Classification | 21 CFR § 880.6880 |
| Device Class | II |
| Classification Panel | General Hospital |
| 3 Predicate k number | K181993 |
| 4 Device Description: | The STURDY Autoclave Super Microm (models SA-<br>260MA and SA-260MA-R) is a table-top steam<br>sterilizers that uses saturated steam at high pressures and |
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5.
Intended Use:
510(k) Summary
temperatures and kills infectious bio-organisms. The 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 the established time, temperature, and pressure parameters.
Items to be sterilized are placed in the sterilization chamber. The user selects a sterilization cycle, and presses the start switch to initiate the cycle. The sterilizer will automatically fill water into the chamber, heat the water into steam, introduce steam-flush and pressure-pulses, hold at a set pressure, temperature, and time to sterilize the items, and automatically vent the steam and cool the chamber down after the sterilization is complete.
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.
Special Conditions for Use Statement(s):
N/A
#### 6. Technological Characteristics Comparison
Modifications in the pressure vessel supplier and several operational features optimization, and the reduced overall air removal time and dry time while the air removal, drying, and sterilization performance remained
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510(k) Summary
Special 510(k) Premarket Notification STURDY Autoclave Super Microm
Comparison with Predicate:
intact. These modifications applied to both models of the previously 510(k) cleared devices (K181993), the model numbers are SA-260MA and SA-260MA-R.
A comparison of the device features, intended use, and other information summarized in Table 6.1.
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### Table 6.1: Technological Characteristics Comparison Table
| | Predicate Devices | Modified Device |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) | (STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) |
| Models | | |
| 510(k) Number | K181993 | K231489 |
| Intended Use | The STURDY Autoclave Super Microm<br>(models SA-260MA and SA-260MA-R) is<br>intended to be used in medical and dental<br>offices, hospitals, clinics, nursing homes,<br>laboratories, and other facilities to sterilize<br>heat and moisture stable reusable<br>equipment. Dental handpieces can be<br>sterilizer in the SA-260MA and SA-<br>260MA-R. The STURDY Autoclave Super<br>Microm (models SA-260MA and SA-<br>260MA-R) is not recommended for<br>sterilization of liquid intended for direct<br>patient contact. | Same. |
| Product Code | FLE | Same |
| C.F.R. code | 880.6880 Steam Sterilizer | Same |
| Class | II | Same |
| Built according to<br>standard | ANSI/AAMI ST55 | Same |
| Electrical safety<br>standard | IEC 61010-1<br>IEC 61010-2-040 | Same |
| Sterilization type | moist heat sterilization | Same |
| Power Source | Single Phase,<br>120VAC, 60Hz, 12A | Same |
| Water reservoir<br>capacity | 1.1 Gallons (4.2 liters) to Full Mark | Same |
| | Predicate Devices<br>(STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) | STURDY Autoclave Super Microm<br>Modified Device<br>(STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) |
| Models | | |
| 510(k) Number | K181993 | K231489 |
| Pressure vessel | | |
| Chamber design<br>standard | ASME Boiler & Pressure Vessel Code,<br>Section VIII, Division 1. | Same |
| Chamber size | 10.2 in. diameter × 17.7 in. depth (26cm x<br>45cm) | Same |
| Chamber capacity | 6.3 Gallons (24 liters) | Same |
| Materials of the<br>chamber | Corrosion-resistance materials (SUS 304<br>or SUS 316) | Same |
| Safety (pressure<br>relief) valve setting | 40 psi (275.8 kPa)<br>ASME approved | Equivalent<br>40 psi (275.8 kPa) to 41 psi (282.7 kPa)<br>Max.<br>ASME approved |
| Sterilization<br>method | Dynamic-air-removal steam sterilizer<br>4 steam-flush pressure-pulse | Equivalent<br>Dynamic-air-removal steam sterilizer<br>2 steam-flush pressure-pulse |
| Control<br>technology | Microcontrollers | Same |
| Sterilization<br>process<br>monitoring | Temperature sensor for exposure<br>condition monitoring | Same |
| Models | Predicate Devices<br>(STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) | Modified Device<br>(STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) |
| 510(k) Number | K181993 | K231489 |
| Process control | Automatic operation through all phases of<br>sterilization cycle | Same |
| Models | Predicate Devices<br>(STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) | Modified Device<br>(STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) |
| 510(k) Number | K181993 | K231489 |
| Cycle phases | Factory predefined cycles are provided as<br>standardized sterilizing cycles, including:<br>Unwarpped instruments:<br>Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 3 minutes<br>Drying cycle: 30 minutes Wrapped instruments (Packs):<br>Temp.: 250° F(121° C)<br>Pressure: 15 psi (104 kPa)<br>Sterilize: 30 minutes<br>Drying cycle: 30 minutes Wrapped instruments (pouches):<br>Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 4 minutes<br>Drying cycle: 30 minutes Handpieces:<br>Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 6 minutes<br>Drying cycle: 30 minutes | Equivalent.<br>The drying performance has been<br>successfully verified using the reduced dry<br>time.<br>Factory predefined cycles are provided as<br>standardized sterilizing cycles, including:<br>Unwarpped instruments:<br>Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 3 minutes<br>Drying cycle: 20 minutes Wrapped instruments (Packs):<br>Temp.: 250° F(121° C)<br>Pressure: 15 psi (104 kPa)<br>Sterilize: 20 minutes<br>Drying cycle: 30 minutes Wrapped instruments (pouches):<br>Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 4 minutes<br>Drying cycle: 20 minutes Handpieces:<br>Temp.: 270°F (132°C)<br>Pressure: 27.1psi (186 kPa)<br>Sterilize: 6 minutes<br>Drying cycle: 20 minutes |
| | Predicate Devices<br>(STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) | Modified Device<br>(STURDY Autoclave Super Microm<br>models SA-260MA and SA-260MA-R) |
| Models | | |
| 510(k) Number | K181993 | K231489 |
| Cycle end | Cycle completion indications are<br>monitored both audibly and visually | Same |
| Steam generator | Electrical heaters | Same |
| Control valve | Actuated by electric solenoid | Same |
| Recorder | SA-260MA: NA<br>SA-260MA-R: Digital recorder | Same |
| Biological<br>performance | SAL of 10-6<br>Through achievement of no growth at half<br>cycle with validation loads, including<br>textile PCD, wrapped instrument PCD,<br>and dental handpieces, in compliance with<br>ANSI/AAMI ST55:2016 | Same |
| Moisture retention | Meet the moisture retention test criteria in<br>ANSI/AAMI ST55:2016 for textile test<br>packs, wrapped instrument test trays, and<br>paper-plastic peel pouches | Same |
| Maximum loading<br>capacities | Solid items: 150 instruments – 9.0lbs<br>(4082 grams)<br>Handpieces: 9 handpieces in a rack and 75<br>instruments<br>Packs: 930 in³(<= 2 in. thick)<br>15240 cm³ (<= 5 cm thick) | Same |
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Special 510(k) Premarket Notification STURDY Autoclave Super Microm
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Special 510(k) Premarket Notification STURDY Autoclave Super Microm
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Special 510(k) Premarket Notification STURDY Autoclave Super Microm
# 7. Summary of non-clinical testing
The modified device has passed the following non-clinical testing to verify its safety and effectiveness.
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| Test Method / Name | Purpose |
|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI ST55:2016<br>- Empty chamber temperature<br>mapping | to ensure that the modified device is capable of providing<br>steady-state thermal conditions within the chamber<br>consistent with the desired sterility assurance level (SAL)<br>in the load |
| ANSI/AAMI ST55:2016<br>- Bowie-Dick test | to verify the air removal performance of the modified<br>device |
| ANSI/AAMI ST55:2016<br>Moisture Retention Testing | to verify the presence of any residual moisture |
| ANSI/AAMI ST55:2016<br>Biological performance | to verify the Biological performance to achieve the<br>required sterility assurance level |
| Safety tests according to UL 61010-1<br>3.1 Ed., and IEC 61010-2-040 3rd<br>Ed. 2020-05 | To verify that the modified device meets all the<br>applicable safety requirements for electrical equipment<br>specified in the standard |
| Electromagnetic Compatibility and<br>Electrical Safety tests according to<br>EN IEC 61326-1:2021, and<br>associated standards | To verify that the modified device meets all the<br>applicable electromagnetic compatibility and electrical<br>safety requirements for electrical equipment specified<br>in the standard |
| Software verification and validation<br>tests | To verify that software of the modified device meets<br>the safety and functional requirements and fulfills the<br>user need |
### 8. Clinical data
No clinical data is required to verify the modified device and demonstrate the substantial equivalence.
### 9. Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device K181993.
