(29 days)
Not Found
No
The description focuses on pre-programmed electronic control systems and standard sterilization cycle parameters, with no mention of AI or ML capabilities.
No.
This device is an autoclave intended for sterilizing medical and dental equipment, not for direct therapeutic use on patients.
No
Explanation: The device is an autoclave, used for sterilizing equipment by killing infectious bio-organisms using steam, heat, and pressure. It is not used for diagnosing medical conditions or diseases.
No
The device description clearly indicates it is a physical table-top steam sterilizer with hardware components like a sterilization chamber, electric heating element, and electronic control system. While it has software, it is not a software-only device.
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 reusable equipment in various healthcare and laboratory settings. This is a process performed on instruments and materials, not on biological samples taken from the human body for diagnostic purposes.
- Device Description: The device description details a steam sterilizer that uses heat and pressure to kill microorganisms. This is a sterilization process, not a diagnostic test.
- No mention of biological samples or diagnostic testing: The entire document focuses on the sterilization process and the performance of the autoclave in achieving sterility. There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This autoclave does not fit that description.
N/A
Intended Use / 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.
Product codes
FLE
Device Description
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.
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
Non-clinical testing, including ANSI/AAMI ST55:2016 for empty chamber temperature mapping, Bowie-Dick test, Moisture Retention Testing, Biological performance. Safety tests according to UL 61010-1 and IEC 61010-2-040. Electromagnetic Compatibility and Electrical Safety tests according to EN IEC 61326-1:2021. Software verification and validation tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image contains the logo for "Sturdy Wellell Group". The word "Sturdy" is written in a large, bold, teal font. Below "Sturdy" is the text "Wellell Group" written in a smaller, gray font. The logo is simple and modern.
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, New | |
| Taipei City 24872, Taiwan | |
| Phone: +886-2-2981-25245 #601 | |
| 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 |
| (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 steam | |
| sterilizers that uses saturated steam at high pressures and |
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Image /page/5/Picture/0 description: The image contains the logo for "Sturdy Wellell Group". The word "Sturdy" is written in a large, bold, teal font. Below "Sturdy" is the text "Wellell Group" written in a smaller, gray font. The logo is simple and clean, with a focus on the company name.
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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Image /page/6/Picture/0 description: The image contains the logo for "Sturdy Wellell Group". The word "Sturdy" is in a large, teal font. Below that, "Wellell Group" is written in a smaller, gray font. The logo is simple and modern.
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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Image /page/7/Picture/0 description: The image contains the logo for "Sturdy Wellell Group". The word "Sturdy" is in a large, teal-colored font. Below "Sturdy" is the text "Wellell Group" in a smaller, gray font. The logo is simple and clean, with a focus on the company name.
Table 6.1: Technological Characteristics Comparison Table
| Predicate Devices | Modified Device | |
|---|---|---|
| (STURDY Autoclave Super Microm | ||
| models SA-260MA and SA-260MA-R) | (STURDY Autoclave Super Microm | |
| models 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) 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. | Same. | |
| Product Code | FLE | Same |
| C.F.R. code | 880.6880 Steam Sterilizer | Same |
| Class | II | Same |
| Built according to | ||
| standard | ANSI/AAMI ST55 | Same |
| Electrical safety | ||
| standard | IEC 61010-1 | |
| IEC 61010-2-040 | Same | |
| Sterilization type | moist heat sterilization | Same |
| Power Source | Single Phase, | |
| 120VAC, 60Hz, 12A | Same | |
| Water reservoir | ||
| capacity | 1.1 Gallons (4.2 liters) to Full Mark | Same |
| Predicate Devices | ||
| (STURDY Autoclave Super Microm | ||
| models SA-260MA and SA-260MA-R) | STURDY Autoclave Super Microm | |
| Modified Device | ||
| (STURDY Autoclave Super Microm | ||
| models SA-260MA and SA-260MA-R) | ||
| Models | ||
| 510(k) Number | K181993 | K231489 |
| Pressure vessel | ||
| Chamber design | ||
| standard | ASME Boiler & Pressure Vessel Code, | |
| Section VIII, Division 1. | Same | |
| Chamber size | 10.2 in. diameter × 17.7 in. depth (26cm x | |
| 45cm) | Same | |
| Chamber capacity | 6.3 Gallons (24 liters) | Same |
| Materials of the | ||
| chamber | Corrosion-resistance materials (SUS 304 | |
| or SUS 316) | Same | |
| Safety (pressure | ||
| relief) valve setting | 40 psi (275.8 kPa) | |
| ASME approved | Equivalent | |
| 40 psi (275.8 kPa) to 41 psi (282.7 kPa) | ||
| Max. | ||
| ASME approved | ||
| Sterilization | ||
| method | Dynamic-air-removal steam sterilizer | |
| 4 steam-flush pressure-pulse | Equivalent | |
| Dynamic-air-removal steam sterilizer | ||
| 2 steam-flush pressure-pulse | ||
| Control | ||
| technology | Microcontrollers | Same |
| Sterilization | ||
| process | ||
| monitoring | Temperature sensor for exposure | |
| condition monitoring | Same | |
| Models | Predicate Devices | |
| (STURDY Autoclave Super Microm | ||
| models SA-260MA and SA-260MA-R) | Modified Device | |
| (STURDY Autoclave Super Microm | ||
| models SA-260MA and SA-260MA-R) | ||
| 510(k) Number | K181993 | K231489 |
| Process control | Automatic operation through all phases of | |
| sterilization cycle | Same | |
| Models | Predicate Devices | |
| (STURDY Autoclave Super Microm | ||
| models SA-260MA and SA-260MA-R) | Modified Device | |
| (STURDY Autoclave Super Microm | ||
| models SA-260MA and SA-260MA-R) | ||
| 510(k) Number | K181993 | K231489 |
| Cycle phases | Factory predefined cycles are provided as | |
| standardized sterilizing cycles, including: | ||
| Unwarpped instruments: | ||
| Temp.: 270°F (132°C) | ||
| Pressure: 27.1psi (186 kPa) | ||
| Sterilize: 3 minutes | ||
| Drying cycle: 30 minutes Wrapped instruments (Packs): | ||
| Temp.: 250° F(121° C) | ||
| Pressure: 15 psi (104 kPa) | ||
| Sterilize: 30 minutes | ||
| Drying cycle: 30 minutes Wrapped instruments (pouches): | ||
| Temp.: 270°F (132°C) | ||
| Pressure: 27.1psi (186 kPa) | ||
| Sterilize: 4 minutes | ||
| Drying cycle: 30 minutes Handpieces: | ||
| Temp.: 270°F (132°C) | ||
| Pressure: 27.1psi (186 kPa) | ||
| Sterilize: 6 minutes | ||
| Drying cycle: 30 minutes | Equivalent. | |
| The drying performance has been | ||
| successfully verified using the reduced dry | ||
| time. | ||
| Factory predefined cycles are provided as | ||
| standardized sterilizing cycles, including: | ||
| Unwarpped instruments: | ||
| Temp.: 270°F (132°C) | ||
| Pressure: 27.1psi (186 kPa) | ||
| Sterilize: 3 minutes | ||
| Drying cycle: 20 minutes Wrapped instruments (Packs): | ||
| Temp.: 250° F(121° C) | ||
| Pressure: 15 psi (104 kPa) | ||
| Sterilize: 20 minutes | ||
| Drying cycle: 30 minutes Wrapped instruments (pouches): | ||
| Temp.: 270°F (132°C) | ||
| Pressure: 27.1psi (186 kPa) | ||
| Sterilize: 4 minutes | ||
| Drying cycle: 20 minutes Handpieces: | ||
| Temp.: 270°F (132°C) | ||
| Pressure: 27.1psi (186 kPa) | ||
| Sterilize: 6 minutes | ||
| Drying cycle: 20 minutes | ||
| Predicate Devices | ||
| (STURDY Autoclave Super Microm | ||
| models SA-260MA and SA-260MA-R) | Modified Device | |
| (STURDY Autoclave Super Microm | ||
| models SA-260MA and SA-260MA-R) | ||
| Models | ||
| 510(k) Number | K181993 | K231489 |
| Cycle end | Cycle completion indications are | |
| monitored both audibly and visually | Same | |
| Steam generator | Electrical heaters | Same |
| Control valve | Actuated by electric solenoid | Same |
| Recorder | SA-260MA: NA | |
| SA-260MA-R: Digital recorder | Same | |
| Biological | ||
| performance | SAL of 10-6 | |
| Through achievement of no growth at half | ||
| cycle with validation loads, including | ||
| textile PCD, wrapped instrument PCD, | ||
| and dental handpieces, in compliance with | ||
| ANSI/AAMI ST55:2016 | Same | |
| Moisture retention | Meet the moisture retention test criteria in | |
| ANSI/AAMI ST55:2016 for textile test | ||
| packs, wrapped instrument test trays, and | ||
| paper-plastic peel pouches | Same | |
| Maximum loading | ||
| capacities | Solid items: 150 instruments – 9.0lbs | |
| (4082 grams) | ||
| Handpieces: 9 handpieces in a rack and 75 | ||
| instruments | ||
| Packs: 930 in³( |