(162 days)
No.
The device description indicates a "computerized control system" for automated processes, records, and displays. However, there is no mention of "AI," "DNN," or "ML" within the document, nor any description of functions that would require or explicitly suggest the use of an AI model, such as complex pattern recognition, learning, or adaptive decision-making beyond pre-programmed sterilization cycles.
No.
This device is a sterilizer intended to disinfect medical instruments, not to provide therapy or treatment to a patient.
No
This device is a steam sterilizer, designed to sterilize medical instruments and goods, not to diagnose medical conditions or diseases.
No
The device is a physical tabletop steam sterilizer that uses hardware components like a heating element, chamber, door, and external ports for USB and printing, none of which are software-only. The software component controls the hardware and processes but is not the sole component of the device.
No
The device is a steam sterilizer for medical and surgical goods, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 2545D tabletop Steam Sterilizer is designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices).
The 2545D was validated for use in:
Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads.
Key Cycles of subject device
| # | Cycle name | Sterilization temperature (F°/℃) | Sterilization time(min) | Numbers of vacuum pulses | Dry time (min) | Load type | Max load(kg) |
|---|---|---|---|---|---|---|---|
| 1 | Quick 273 | 273/134 | 4 | 1 | 4 | Unwrapped solid material | 5.00 |
| 2 | Universal 273 | 273/134 | 4 | 3 | 20 | Unwrapped solid material | 5.00 |
| 4 | wrapped solid or hollow material | 50 | |||||
| Unwrapped porous material | 1.25 | ||||||
| wrapped porous material | 1.10 | ||||||
| 3 | Universal 250 | 250/121 | 30 | 3 | 20 | Unwrapped solid material | 5.00 |
| 4 | wrapped solid or hollow material | 50 | |||||
| Unwrapped porous material | 1.25 | ||||||
| wrapped porous material | 1.10 | ||||||
| 4 | BD TEST 273 | 273/134 | 3.5 | 3 | 20 | / | / |
| 5 | Vacuum test | / | / | / | / | / | / |
Product codes
FLE
Device Description
The subject device (model: 2545D) is a table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
The 2545D uses steam as a sterilizing agent. The steam for the sterilization process is produced by warming up a controlled amount of demineralized water that is inserted into a pipe heating element and then flows into the chamber as steam. This technique is used as a way of reducing water consumption and saving energy. The subject device is equipped with a heating element wrapped around the chamber to maintain the required temperatures and steam for the sterilization process. All of these processes are done via the computerized control system of the device.
The 2545D Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject device extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. Once the cycle is selected and the operator presses "Start," the sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying. Sterilization parameters and process status also displayed on the screen.
The 2545D is designed with some external port and printing function:
- The device features one built-in USB ports to enable the operation of an external USB device to record sterilization cycles.
- The device features built-in report printer to print the sterilization records;
- The device features built-in memory to record up to 16000 sterilization cycles; these can be exported to a USB device to be transferred to a PC;
- The device features built-in label printer to print labels with a unique cycle ID barcode, Program name, and expiry dates.
The label printer and report printer are optional additions to the subject device
Device specifications are provided below:
| Specification | Value |
|---|---|
| Chamber size (mm) | 250x450 |
| Overall dimensions (mm) | 490(W) x 455(H) x 690(D) |
| Net Weight (kg) | 50 |
| Nominal power (VA) | 1750 |
| Rated Voltage (V) | 120 |
| Rated frequency (Hz) | 60 |
| Capacity of the distilled water tank (L) | 4.0 L (Water at level Max.) Approx. 0.8L (Water at level Min.) Approx. |
| Operation temperature (°C) | 5-40 |
| Operation relative humidity | Max. 80%, non-condensing |
| Atmospheric pressure (kPa) | 76-106 |
| Max. allowed working pressure (MPa) | ~0.28 |
| Relief valve (MPa) | ~0.28 |
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
health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data Evaluations were conducted to confirm compliance with performance requirements.
| Evaluation | Standards Used | Results |
|---|---|---|
| Safety | ANSI/UL 61010-1 Third Edition 5/12/2012 / Revised 7/19/2019, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements. IEC 61010-2-040:2020 Edition 3.0 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 2-040: Particular requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials. ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| EMC | IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances – Requirements and tests | Passed; the results of the evaluation demonstrate compliance of the device to the standards |
| Software | IEC 62304- 2006+A1:2015 Medical device software - Software life cycle processes | Meeting standard specification |
| Performance- Bowie & Dick | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify air removal performance | Passed, the Bowie-Dick test indicator sheet showed a uniform color change |
| Performance- Air leaks | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify air removal performance | Passed, the average leak rate is 0.0133kPa/min |
| Performance- Temperature control | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify 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 | Passed. The chamber temperature during the exposure time remains within +3℃ and -0℃ of selected sterilization exposure temperature for cycles Quick 273, Universal 273 and Universal 250 |
| Performance- Biological performance | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify biological performance with textile PCD, wrapped instrument PCD and dental handpieces | Passed. The results showed that the tested cycle has a 10-6 SAL or an SAL providing a greater assurance of sterility. There shall be no growth observed in the vials containing turbines or in the extraction of any of the turbines. |
| Performance- Moisture retention | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify the drying performance for cycles Quick 273, Universal 273 and Universal 250 with Textile PCD, wrapped instruments and paper-plastic pouch | Passed. The results showed that the gain in weight less than 2% and 0.5% for Textile PCD and wrapped instruments respectively, no water droplets for paper-plastic pouch. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
FDA 510(k) Clearance Letter - Steam Sterilizer (2545D)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 6, 2025
Ningbo Ican Machines Co., Ltd.
℅ Lord Guo
Regulatory Director
Orscene (shanghai) Medical Technology Co., Ltd.
Room 118, Building 20, No. 1-42, Lane 83, Hongxiang North Rd
Lingang New Zone, China (Shanghai) Pilot Free Trade Zone
Shanghai, Shanghai
China
Re: K243994
Trade/Device Name: Steam Sterilizer (2545D)
Regulation Number: 21 CFR 880.6880
Regulation Name: Steam Sterilizer
Regulatory Class: Class II
Product Code: FLE
Dated: May 5, 2025
Received: May 5, 2025
Dear Lord Guo:
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 (the 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 available 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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K243994 - Lord Guo Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243994 - Lord Guo Page 3
assistance/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,
Stephen A. Anisko -S Digitally signed by Stephen A. Anisko -S Date: 2025.06.06 14:53:47 -04'00'
for: Christopher K. Dugard, M.S.
Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243994
Device Name: Steam Sterilizer (2545D)
Indications for Use (Describe)
The 2545D tabletop Steam Sterilizer is designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices).
The 2545D was validated for use in:
Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads.
Key Cycles of subject device
| # | Cycle name | Sterilization temperature (F°/℃) | Sterilization time(min) | Numbers of vacuum pulses | Dry time (min) | Load type | Max load(kg) |
|---|---|---|---|---|---|---|---|
| 1 | Quick 273 | 273/134 | 4 | 1 | 4 | Unwrapped solid material | 5.00 |
| 2 | Universal 273 | 273/134 | 4 | 3 | 20 | Unwrapped solid material | 5.00 |
| 4 | wrapped solid or hollow material | 50 | |||||
| Unwrapped porous material | 1.25 | ||||||
| wrapped porous material | 1.10 | ||||||
| 3 | Universal 250 | 250/121 | 30 | 3 | 20 | Unwrapped solid material | 5.00 |
| 4 | wrapped solid or hollow material | 50 | |||||
| Unwrapped porous material | 1.25 | ||||||
| wrapped porous material | 1.10 | ||||||
| 4 | BD TEST 273 | 273/134 | 3.5 | 3 | 20 | / | / |
| 5 | Vacuum test | / | / | / | / | / | / |
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ 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:
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"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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
K243994 Page 1 of 8
510(k) Summary
1. ADMINISTRATIVE INFORMATION
Applicant Name: Ningbo Ican Machines Co., Ltd.
Applicant Address: No. 77 Yunlin East Road, Gulin Town, Haishu District Ningbo Zhejiang 315000 China
Applicant Contact Telephone: 0574-89011155
Applicant Contact: Mr. HUI LIN
Applicant Contact Email: Sales@icanclave.com
Correspondent Name: Orscene (shanghai) Medical Technology Co., Ltd.
Correspondent Address: Room 118, Building 20, No. 1-42, Lane 83, Hongxiang North Road Lingang New Zone, China (Shanghai) Pilot Free Trade Zone shanghai shanghai China
Correspondent Contact Telephone: 18521500818
Correspondent Contact: Mr. Lord Guo
Correspondent Contact Email: lord.guo@orscene.net
Date summary prepared: June 3, 2025
2. SUBJECT DEVICE
Device Trade Name: Steam Sterilizer (2545D)
Common Name: Steam sterilizer
Classification Name: Sterilizer, Steam
Regulatory Number: 880.6880
Product Code: FLE
3. PREDICATE DEVICE
Manufacturer: Shinva Medical Instrument Co., Ltd.
Device name: MOST-T Autoclave
510(K) number: K220102
Product Code: FLE
4. DEVICE DESCRIPTION
The subject device (model: 2545D) is a table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
The 2545D uses steam as a sterilizing agent. The steam for the sterilization process is produced by warming up a controlled amount of demineralized water that is inserted into a pipe heating element and then flows
Page 6
K243994 Page 2 of 8
into the chamber as steam. This technique is used as a way of reducing water consumption and saving energy. The subject device is equipped with a heating element wrapped around the chamber to maintain the required temperatures and steam for the sterilization process. All of these processes are done via the computerized control system of the device.
The 2545D Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject device extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. Once the cycle is selected and the operator presses "Start," the sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying. Sterilization parameters and process status also displayed on the screen.
The 2545D is designed with some external port and printing function:
- The device features one built-in USB ports to enable the operation of an external USB device to record sterilization cycles.
- The device features built-in report printer to print the sterilization records;
- The device features built-in memory to record up to 16000 sterilization cycles; these can be exported to a USB device to be transferred to a PC;
- The device features built-in label printer to print labels with a unique cycle ID barcode, Program name, and expiry dates.
The label printer and report printer are optional additions to the subject device
Device specifications are provided below:
| Specification | Value |
|---|---|
| Chamber size (mm) | 250x450 |
| Overall dimensions (mm) | 490(W) x 455(H) x 690(D) |
| Net Weight (kg) | 50 |
| Nominal power (VA) | 1750 |
| Rated Voltage (V) | 120 |
| Rated frequency (Hz) | 60 |
| Capacity of the distilled water tank (L) | 4.0 L (Water at level Max.) Approx. 0.8L (Water at level Min.) Approx. |
| Operation temperature (°C) | 5-40 |
| Operation relative humidity | Max. 80%, non-condensing |
| Atmospheric pressure (kPa) | 76-106 |
| Max. allowed working pressure (MPa) | ~0.28 |
| Relief valve (MPa) | ~0.28 |
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K243994 Page 3 of 8
5. INDICATIONS FOR USE
The 2545D tabletop Steam Sterilizer is designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities. (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices).
The 2545D was validated for use in:
Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads.
Key cycles of subject device
| # | Cycle name | Sterilization temperature (F°/℃) | Sterilization time (min) | Numbers of vacuum pulses | Dry time (min) | Load type | Max. load(kg) |
|---|---|---|---|---|---|---|---|
| 1 | Quick 273 | 273/134 | 4 | 1 | 4 | Unwrapped solid material | 5.00 |
| 2 | Universal 273 | 273/134 | 4 | 3 | 20 | Unwrapped solid material | 5.00 |
| wrapped solid or hollow material | 4.50 | ||||||
| Unwrapped porous material | 1.25 | ||||||
| wrapped porous material | 1.10 | ||||||
| 3 | Universal 250 | 250/121 | 30 | 3 | 20 | Unwrapped solid material | 5.00 |
| wrapped solid or hollow material | 4.50 | ||||||
| Unwrapped porous material | 1.25 | ||||||
| wrapped porous material | 1.10 | ||||||
| 4 | BD TEST 273 | 273/134 | 3.5 | 3 | 20 | / | / |
| 5 | Vacuum test | / | / | / | / | / | / |
6. TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO THE PREDICATE
The following tables provide a side-by-side comparison of the 2545D to the predicate device to support this pre-market notification.
Comparison Table of the Subject Device and Predicate Device
Intended Use / Indications for Use Comparison
Page 8
K243994 Page 4 of 8
| Comparison Elements | Subject Device | Predicate Device K220102 | Comments |
|---|---|---|---|
| Indications for Use | The 2545D tabletop Steam Sterilizer is designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices). | The MOST-T Autoclave is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, medical clinics; and in first aid rooms. | Same |
Comparison Statement
Both the subject device and predicate devices are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities.
Technological and Performance Characteristics Comparison
| Comparison Elements | Subject Device K243994 | Predicate Device K220102 | Comments |
|---|---|---|---|
| Sterilization cycles | Quick 273 for Unwrapped solid material 4 min/134℃/4min |
Universal 273 for Unwrapped solid material, wrapped solid or hollow material, Unwrapped or wrapped porous material 4 min/134℃/20min
Universal 250 for Unwrapped solid material, wrapped solid or hollow material, Unwrapped or wrapped porous material 30 min/121℃/20min | N-QUICK for single unwrapped solid instrument 4 min/134℃/1min
B-QUICK for single unwrapped hollow instrument 4 min/134℃/1min
B134UNIV for Packaged or unpackaged instrument or textile 4 min/134℃/20min
B121UNIV for Packaged or unpackaged instrument or textile 20 min/121℃/20min
USER for Packaged or unpackaged instrument 4 min/134℃/20min | Similar See note 1 |
| Max. load | Unwrapped solid material: 5kg
wrapped solid or hollow material: 4.5kg
Unwrapped porous material: 1.25kg
wrapped porous material:1.10kg | Max. weight of instrument: 5.5kg
Max. weight of textile: 0.8kg | Similar See note 1 |
| Chamber volume/size | This device is a single door tabletop autoclave with a chamber volume of: 22L; Size:Φ250mm×450mm | This device is a single door tabletop autoclave with a chamber volume of: 24L; Size:Φ250mm×450mm | Similar See note 1 |
Page 9
K243994 Page 5 of 8
| Comparison Elements | Subject Device | Predicate Device K220102 | Comments |
|---|---|---|---|
| Control system | The device is software controlled with electronic control panel that permits automatic usage. The device is nonprogrammable. | The device is software controlled with electronic control panel that permits automatic usage. The device is nonprogrammable. | Same |
| Materials | The chamber and door are made of a corrosion-resistant 304L stainless steel. | The chamber and door are made of a corrosion-resistant 304L stainless steel. | Same |
| User Interface | LCD Display and touch pad | LCD Display Screen and key pad | Same |
| Door Gaskets | High Temperature Silicon Rubber | High Temperature Silicon Rubber | Same |
| Door lock | Manual to drive the door lock hook rotation, the door lock hook directly pull the door tightly locked structure | Door motor work to drive the door lock hook rotation, the door lock hook directly pull the door tightly locked structure | Different See note 2 |
| Door safety interlock | the sterilizer can start the working procedure only when the door is closed in place; the door cannot be opened when the inner chamber is under pressure | the sterilizer can start the working procedure only when the door is closed in place; the door cannot be opened when the inner chamber is under pressure | Same |
| Overpressure valve | ASME pressure relief valve | ASME pressure relief valve | Same |
| Overheat Protection | Thermostat@250°C | Automatic overheat protection | Similar |
| Energy source | The device can be operated only while connected to an electrical source (the electrical grid). AC 120V 60 Hz 1750VA | The device can be operated only while connected to an electrical source (the electrical grid). AC 120V 60 Hz 1.5KVA | Similar |
| Operation principle | The operation principle is sterilization by heating a controlled amount of demineralized water to generate steam as the sterilization reagent and maintaining its temperature by using a heating element surrounding the chamber. The water is drawn from a built-in water reservoir. The subject device has a vacuum mechanism to allow better air removal of air pockets in the load for an effective sterilization and to allow drying of the load at the end of the sterilization process. | The operation principle is sterilization by heating a controlled amount of demineralized water to generate steam as the sterilization reagent and maintaining its temperature by using a heating element surrounding the chamber. The water is drawn from a built-in water reservoir. The predicate device has a vacuum mechanism to allow better air removal of air pockets in the load for an effective sterilization and to allow drying of the load at the end of the sterilization process. | Same |
| Performance | Comply with AAMI ST55:2016 requirements | Comply with AAMI ST55:2016 requirements | Same |
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Comparison Statement
Note 1:
-
The subject device and predicate device have similar sterilization cycles:
- The subject device has Universal 250 with the holding time 30min which is longer than the predicate device B121 UNIV's 20min, this holding time difference cannot rise safety and effectiveness concerns based on performance tests according to AAMI ST55;
- The subject device's Quick 273 cycle has a drying time 4min which is longer than the predicate device's N-QUICK and B-QUICK's 1min, this drying time difference cannot rise safety and effectiveness concerns based on performance tests according to AAMI ST55.
-
The subject device has similar rated max. load
- The rated max. load difference cannot rise safety and effectiveness concerns based on performance tests according to AAMI ST55.
-
The subject device has same chamber size but smaller rated volume with a difference 2L, this rated chamber volume difference cannot rise safety and effectiveness concerns based on performance tests according to AAMI ST55.
Note 2:
- The subject device uses manual force via handle to lock the door, and the Predicate device uses motor driving. These two measures both meet safety requirements of UL 61010-1, IEC 61010-2-040 and AAMI ST55. This different does not rise safety and effectiveness concerns.
7. SUMMARY OF TESTING and PERFORMANCE STANDARDS
To establish the technical equivalency of the Steam Sterilizer, evaluations were conducted to confirm compliance with performance requirements, including
Non-Clinical Performance Data
| Evaluation | Standards Used | Results |
|---|---|---|
| Safety | ANSI/UL 61010-1 Third Edition 5/12/2012 / Revised 7/19/2019, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements |
IEC 61010-2-040:2020 Edition 3.0 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 2-040: Particular requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials
ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| EMC | IEC 60601-1-2 Edition 4.1 2020-09 | Passed; the results of the |
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K243994 Page 7 of 8
| Evaluation | Standards Used | Results |
|---|---|---|
| Consolidated Version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances – Requirements and tests | evaluation demonstrate compliance of the device to the standards | |
| Software | IEC 62304- 2006+A1:2015 Medical device software - Software life cycle processes | Meeting standard specification |
| Performance- Bowie & Dick | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify air removal performance | Passed, the Bowie-Dick test indicator sheet showed a uniform color change |
| Performance- Air leaks | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify air removal performance | Passed, the average leak rate is 0.0133kPa/min |
| Performance- Temperature control | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify 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 | Passed. The chamber temperature during the exposure time remains within +3℃ and -0℃ of selected sterilization exposure temperature for cycles Quick 273, Universal 273 and Universal 250 |
| Performance- Biological performance | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify biological performance with textile PCD, wrapped instrument PCD and dental handpieces | Passed. The results showed that the tested cycle has a 10-6 SAL or an SAL providing a greater assurance of sterility. There shall be no growth observed in the vials containing turbines or in the extraction of any of the turbines. |
| Performance- Moisture retention | ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers To verify the drying performance for cycles Quick 273, Universal 273 and Universal 250 with Textile PCD, wrapped instruments and paper-plastic pouch | Passed. The results showed that the gain in weight less than 2% and 0.5% for Textile PCD and wrapped instruments respectively, no water droplets for paper-plastic pouch. |
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K243994 Page 8 of 8
8. Conclusion:
The conclusion drawn from the testing demonstrates that the subject device is at least as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220102, Class II (21 CFR 880.6880, Product Code FLE).