(29 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 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.
The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a table-top steam sterilizers that uses saturated steam at high pressures and 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.
This document describes the acceptance criteria and the study that proves the device, STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R), meets those criteria.
Key takeaway: This submission (K231489) is for a modification of an already cleared device (K181993). The primary modifications are a change in the pressure vessel supplier, some operational feature optimizations, and reduced air removal and dry times. The performance claims for sterilization and drying are maintained. Therefore, the acceptance criteria and study primarily focus on demonstrating that these modifications do not negatively impact the previously established safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a modified device, the acceptance criteria are generally that the modified device performs "as well as or better than" the predicate device and meets relevant industry standards. The performance data presented demonstrates this equivalence or improvement.
| Acceptance Criteria / Performance Claim | Reported Device Performance (STURDY Autoclave Super Microm K231489) |
|---|---|
| Sterilization Efficacy (Biological Performance) | Achieves a Sterility Assurance Level (SAL) of 10^-6. Verified through: - No growth at half cycle with validation loads - Includes textile PCD, wrapped instrument PCD, and dental handpieces - Compliance with ANSI/AAMI ST55:2016 |
| Moisture Retention | Meets moisture retention test criteria in ANSI/AAMI ST55:2016 for: - Textile test packs - Wrapped instrument test trays - Paper-plastic peel pouches |
| Empty Chamber Temperature Mapping | Capable of providing steady-state thermal conditions within the chamber consistent with the desired SAL in the load. (Compliance with ANSI/AAMI ST55:2016) |
| Air Removal Performance (Bowie-Dick Test) | Verified air removal performance. (Compliance with ANSI/AAMI ST55:2016) |
| Electrical Safety | Meets all applicable safety requirements for electrical equipment specified in UL 61010-1 3.1 Ed., and IEC 61010-2-040 3rd Ed. 2020-05. |
| Electromagnetic Compatibility (EMC) & Electrical Safety | Meets all applicable electromagnetic compatibility and electrical safety requirements for electrical equipment specified in EN IEC 61326-1:2021 and associated standards. |
| Software Verification & Validation | Software meets safety and functional requirements and fulfills user needs. |
| Cycle Times (Example: Drying Cycle) | Reduced Drying Times: - Unwrapped instruments: 20 minutes (previously 30 min) - Wrapped instruments (pouches): 20 minutes (previously 30 min) - Handpieces: 20 minutes (previously 30 min) Note: Wrapped instruments (Packs) drying cycle remains 30 minutes. The drying performance has been successfully verified using the reduced dry time. |
| Safety (Pressure Relief) Valve Setting | Equivalent to predicate: 40 psi (275.8 kPa) to 41 psi (282.7 kPa) Max. ASME approved. |
| Sterilization Method | Equivalent to predicate: Dynamic-air-removal steam sterilizer with 2 steam-flush pressure-pulses (previously 4). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test (e.g., number of sterilization cycles performed for biological performance, number of Bowie-Dick tests). It refers to compliance with standards like ANSI/AAMI ST55:2016, which would dictate appropriate sample sizes for validation.
The data provenance is not explicitly stated as "country of origin," but given the submitter's address (STURDY Industrial CO., LTD., New Taipei City, Taiwan), it's highly probable the testing was conducted in Taiwan or by a contracted lab following international standards. The studies were retrospective in the sense that they were performed to validate design changes on an existing device, rather than a de novo clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device, a steam sterilizer, does not involve diagnostic interpretation or human-in-the-loop performance. Therefore, "ground truth" is established through objective engineering and microbiology performance metrics (e.g., spore kill, temperature and pressure readings, moisture levels, electrical safety standards compliance). There are no "experts" in the sense of clinicians or radiologists adjudicating results, but rather qualified test engineers and microbiologists performing and analyzing the validation tests according to established international standards (e.g., ANSI/AAMI, IEC, UL). The document does not specify the exact number or individual qualifications of these testing personnel.
4. Adjudication Method for the Test Set
Not applicable. As described above, the acceptance is based on objective measurements against pre-defined engineering and microbiological standards, not subjective human interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a steam sterilizer, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire performance evaluation for this device is effectively "standalone" in the sense of the sterilizer's function without continuous human intervention during a sterilization cycle. The device's performance (sterilization efficacy, drying, etc.) is objectively measured and validated against standards, independent of human operators' real-time judgment during the sterilizing process.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on:
- Microbiological Standards: Demonstrated sterility (SAL of 10^-6) through biological indicator challenges and growth/no-growth results, a fundamental requirement for sterilizers.
- Physical Parameters: Objective measurements of temperature, pressure, and time profiles within the sterilization chamber during cycles, ensuring they meet the required conditions for sterilization.
- Engineering Standards: Compliance with relevant safety (electrical, pressure vessel), electromagnetic compatibility, and performance standards (e.g., ANSI/AAMI ST55:2016 for sterilizer performance, IEC and UL for electrical safety).
- Performance Metrics: Measurements of residual moisture content and verification of clean air removal (Bowie-Dick test).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. The "training" for such a device would be its historical design and manufacturing processes, which are validated through adherence to quality systems and standards, not a specific data training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/machine learning device requiring a discrete training data set with established ground truth. The "ground truth" for the predicate device's design (K181993) and the modifications in K231489 are established through adherence to recognized consensus standards for medical device design, manufacturing, and performance.
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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.No. 168, Sec. 1, Zhongxing Rd, Wugu District, NewTaipei City 24872, TaiwanPhone: +886-2-2981-25245 #601Establishment 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(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-260MA and SA-260MA-R) is a table-top steamsterilizers that uses saturated steam at high pressures and |
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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 Micrommodels SA-260MA and SA-260MA-R) | (STURDY Autoclave Super Micrommodels SA-260MA and SA-260MA-R) | |
| Models | ||
| 510(k) Number | K181993 | K231489 |
| Intended Use | The STURDY Autoclave Super Microm(models SA-260MA and SA-260MA-R) isintended to be used in medical and dentaloffices, hospitals, clinics, nursing homes,laboratories, and other facilities to sterilizeheat and moisture stable reusableequipment. Dental handpieces can besterilizer in the SA-260MA and SA-260MA-R. The STURDY Autoclave SuperMicrom (models SA-260MA and SA-260MA-R) is not recommended forsterilization of liquid intended for directpatient contact. | Same. |
| Product Code | FLE | Same |
| C.F.R. code | 880.6880 Steam Sterilizer | Same |
| Class | II | Same |
| Built according tostandard | ANSI/AAMI ST55 | Same |
| Electrical safetystandard | IEC 61010-1IEC 61010-2-040 | Same |
| Sterilization type | moist heat sterilization | Same |
| Power Source | Single Phase,120VAC, 60Hz, 12A | Same |
| Water reservoircapacity | 1.1 Gallons (4.2 liters) to Full Mark | Same |
| Predicate Devices(STURDY Autoclave Super Micrommodels SA-260MA and SA-260MA-R) | STURDY Autoclave Super MicromModified Device(STURDY Autoclave Super Micrommodels SA-260MA and SA-260MA-R) | |
| Models | ||
| 510(k) Number | K181993 | K231489 |
| Pressure vessel | ||
| Chamber designstandard | ASME Boiler & Pressure Vessel Code,Section VIII, Division 1. | Same |
| Chamber size | 10.2 in. diameter × 17.7 in. depth (26cm x45cm) | Same |
| Chamber capacity | 6.3 Gallons (24 liters) | Same |
| Materials of thechamber | Corrosion-resistance materials (SUS 304or SUS 316) | Same |
| Safety (pressurerelief) valve setting | 40 psi (275.8 kPa)ASME approved | Equivalent40 psi (275.8 kPa) to 41 psi (282.7 kPa)Max.ASME approved |
| Sterilizationmethod | Dynamic-air-removal steam sterilizer4 steam-flush pressure-pulse | EquivalentDynamic-air-removal steam sterilizer2 steam-flush pressure-pulse |
| Controltechnology | Microcontrollers | Same |
| Sterilizationprocessmonitoring | Temperature sensor for exposurecondition monitoring | Same |
| Models | Predicate Devices(STURDY Autoclave Super Micrommodels SA-260MA and SA-260MA-R) | Modified Device(STURDY Autoclave Super Micrommodels SA-260MA and SA-260MA-R) |
| 510(k) Number | K181993 | K231489 |
| Process control | Automatic operation through all phases ofsterilization cycle | Same |
| Models | Predicate Devices(STURDY Autoclave Super Micrommodels SA-260MA and SA-260MA-R) | Modified Device(STURDY Autoclave Super Micrommodels SA-260MA and SA-260MA-R) |
| 510(k) Number | K181993 | K231489 |
| Cycle phases | Factory predefined cycles are provided asstandardized sterilizing cycles, including:Unwarpped instruments:Temp.: 270°F (132°C)Pressure: 27.1psi (186 kPa)Sterilize: 3 minutesDrying cycle: 30 minutes Wrapped instruments (Packs):Temp.: 250° F(121° C)Pressure: 15 psi (104 kPa)Sterilize: 30 minutesDrying cycle: 30 minutes Wrapped instruments (pouches):Temp.: 270°F (132°C)Pressure: 27.1psi (186 kPa)Sterilize: 4 minutesDrying cycle: 30 minutes Handpieces:Temp.: 270°F (132°C)Pressure: 27.1psi (186 kPa)Sterilize: 6 minutesDrying cycle: 30 minutes | Equivalent.The drying performance has beensuccessfully verified using the reduced drytime.Factory predefined cycles are provided asstandardized sterilizing cycles, including:Unwarpped instruments:Temp.: 270°F (132°C)Pressure: 27.1psi (186 kPa)Sterilize: 3 minutesDrying cycle: 20 minutes Wrapped instruments (Packs):Temp.: 250° F(121° C)Pressure: 15 psi (104 kPa)Sterilize: 20 minutesDrying cycle: 30 minutes Wrapped instruments (pouches):Temp.: 270°F (132°C)Pressure: 27.1psi (186 kPa)Sterilize: 4 minutesDrying cycle: 20 minutes Handpieces:Temp.: 270°F (132°C)Pressure: 27.1psi (186 kPa)Sterilize: 6 minutesDrying cycle: 20 minutes |
| Predicate Devices(STURDY Autoclave Super Micrommodels SA-260MA and SA-260MA-R) | Modified Device(STURDY Autoclave Super Micrommodels SA-260MA and SA-260MA-R) | |
| Models | ||
| 510(k) Number | K181993 | K231489 |
| Cycle end | Cycle completion indications aremonitored both audibly and visually | Same |
| Steam generator | Electrical heaters | Same |
| Control valve | Actuated by electric solenoid | Same |
| Recorder | SA-260MA: NASA-260MA-R: Digital recorder | Same |
| Biologicalperformance | SAL of 10-6Through achievement of no growth at halfcycle with validation loads, includingtextile PCD, wrapped instrument PCD,and dental handpieces, in compliance withANSI/AAMI ST55:2016 | Same |
| Moisture retention | Meet the moisture retention test criteria inANSI/AAMI ST55:2016 for textile testpacks, wrapped instrument test trays, andpaper-plastic peel pouches | Same |
| Maximum loadingcapacities | Solid items: 150 instruments – 9.0lbs(4082 grams)Handpieces: 9 handpieces in a rack and 75instrumentsPacks: 930 in³(<= 2 in. thick)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- Empty chamber temperaturemapping | to ensure that the modified device is capable of providingsteady-state thermal conditions within the chamberconsistent with the desired sterility assurance level (SAL)in the load |
| ANSI/AAMI ST55:2016- Bowie-Dick test | to verify the air removal performance of the modifieddevice |
| ANSI/AAMI ST55:2016Moisture Retention Testing | to verify the presence of any residual moisture |
| ANSI/AAMI ST55:2016Biological performance | to verify the Biological performance to achieve therequired sterility assurance level |
| Safety tests according to UL 61010-13.1 Ed., and IEC 61010-2-040 3rdEd. 2020-05 | To verify that the modified device meets all theapplicable safety requirements for electrical equipmentspecified in the standard |
| Electromagnetic Compatibility andElectrical Safety tests according toEN IEC 61326-1:2021, andassociated standards | To verify that the modified device meets all theapplicable electromagnetic compatibility and electricalsafety requirements for electrical equipment specifiedin the standard |
| Software verification and validationtests | To verify that software of the modified device meetsthe safety and functional requirements and fulfills theuser 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.
§ 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).