Cassette Autoclave (ACA5)

K250164 · Guangzhou Ajax Medical Equipment Co., Ltd. · FLE · Aug 14, 2025 · General Hospital

Device Facts

• Record ID: K250164
• Device Name: Cassette Autoclave (ACA5)
• Applicant: Guangzhou Ajax Medical Equipment Co., Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Aug 14, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The Cassette Autoclave (ACA5) is suitable for the sterilization of dental and medical instruments designed to withstand steam sterilization. The Cassette Autoclave (ACA5) has not been designed to sterilize liquids, bio- medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. Please refer to below sterilization cycles for Program Name / Load Description/Sterilization Temperature/Sterilization Time/Drying Time and Load Weight.: 1)Program Name: 134 °C Load Description: Solid objectssmall porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped. Sterilization Temperature : 134 °C273°F Sterilization Time: 4 minutes Drying Time: 60minutes Load Weight: 0.9 kg 2)Program Name: 121°C Load Description: Solid objectssmall porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped. Sterilization Temperature : 121 °C250°F Sterilization Time: 30 minutes Drying Time: 60 minutes Load Weight: 0.9 kg

Device Story

Dynamic-air-removal (pre-vacuum) table-top steam sterilizer; used by healthcare providers to sterilize medical/dental instruments. Device modules: water supply, disinfection, air dry, exhaust steam processing, control system. Operation: distilled water supplied to steam generator; electric heating element produces saturated steam at 121°C or 134°C; steam enters sealed disinfection box; excess steam condensed in exhaust module; air dry cycle provides ventilation. Output: dry, sterile instruments. Healthcare providers use the device to ensure instrument sterility for clinical procedures, reducing infection risk.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via ANSI AAMI ST55:2016 vacuum tests, Bowie-Dick tests, temperature/pressure control verification, moisture retention analysis, and biological indicator (BI) testing (overkill method, 10^-6 lethality). Electrical safety and EMC verified per IEC 61010-1, IEC 61010-2-040, and IEC 61326-1.

Technological Characteristics

Dynamic-air-removal (pre-vacuum) table-top steam sterilizer. 5.1L chamber volume. Internal water reservoir (4L). Electric heating element. Operating temp: 121°C–134°C. Max pressure: 212kPa. Relief valve: 300kPa. Connectivity: USB port. Power: 110V, 60Hz, 1300VA. Non-continuous operation (max 6 cycles/hr). Software developed per IEC 62304.

Indications for Use

Indicated for sterilization of dental and medical instruments designed to withstand steam sterilization. Not indicated for liquids, bio-medical waste, or materials incompatible with steam sterilization.

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

• Enbio S (K210279)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 14, 2025

Guangzhou Ajax Medical Equipment Co., Ltd.
% Iris Fung
Regulation Manager
SGS-CSTC Standards Technical Services Co., Ltd.
198 KEZHU Road SCIENTECH Park Guangzhou Economic
& Technology Development District
GuangZhou, Guangdong 510000
China

Re: K250164
Trade/Device Name: Cassette Autoclave (ACA5)
Regulation Number: 21 CFR 880.6880
Regulation Name: Steam Sterilizer
Regulatory Class: Class II
Product Code: FLE
Dated: July 15, 2025
Received: July 15, 2025

Dear Iris Fung:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250164 - Iris Fung
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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-

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K250164 - Iris Fung
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

PAULO LARANJEIRA -S

Digitally signed by PAULO LARANJEIRA -S
Date: 2025.08.14 14:05:37
-04'00'

for: Stephen Anisko
Acting Assistant 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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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) K250164 | |
| Device Name Cassette Autoclave (ACA5 | |
| Indications for Use (Describe) The Cassette Autoclave (ACA5 is suitable for the sterilization of dental and medical instruments designed to withstand steam sterilization. The Cassette Autoclave (ACA5) has not been designed to sterilize liquids, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. Please refer to below sterilization cycles for Program Name / Load Description/Sterilization Temperature/Sterilization Time/Drying Time and Load Weight.: | |
| 1)Program Name: 134 °C Load Description: Solid objectssmall porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped. Sterilization Temperature : 134 °C273°F Sterilization Time: 4 minutes Drying Time: 60minutes Load Weight: 0.9 kg | |
| 2)Program Name: 121°C Load Description: Solid objectssmall porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped. Sterilization Temperature : 121 °C250°F Sterilization Time: 30 minutes Drying Time: 60 minutes Load Weight: 0.9 kg | |
| 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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "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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510(k) Summary K250164

In accordance with the requirement of 21 CFR 807.92.

Date of the summary prepared: August 14, 2025

1. Submitter’s Information

Sponsor
- Company Name: Guangzhou Ajax Medical Equipment Co., Ltd.
- Address: Building No.2, Dagang Industrial Zone, Shilou Town, Panyu District, Guangzhou City, Guangdong Province, 511447, P.R. China
- Phone: [phone]
- Contact Person (including title): Dien Wang Registered Engineer
- E-mail: [e-mail]

Application Correspondent
- Company: SGS-CSTC Standards Technical Services Co., Ltd.
- Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic &
Technology Development District, Guangzhou, Guangdong, CHINA
- Tel: [phone]
- Email: [e-mail]

2. Subject Device Information
- Type of 510(k) submission: Traditional
- Common Name: Steam sterilizer
- Trade Name: Cassette Autoclave (ACA5)
- Classification Name: Dental Operative Unit and Accessories
- Review Panel: General Hospital
- Product Code: FLE
- Regulation Number: 880.6880
- Regulation Class: II

3. Predicate Device Information

| | Predicate Device |
| --- | --- |
| Sponsor | Enbio Group AG |
| Device Name | Enbio S |
| 510(k) Number | K210279 |
| Product Code | FLE |

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# 4. Device Description

The Cassette Autoclave (ACA5) is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. The Cassette Autoclave (ACA5) consists of five modules: water supply, disinfection, air dry, exhaust steam processing and control system.

The main working principle is as follows: The water supply module supplies clean distilled water to the disinfection module. Inside the steam generator, the electric heating element generates high-temperature saturated steam at $121^{\circ}\mathrm{C}$ for a period of 4 minutes and $134^{\circ}\mathrm{C}$ for a period of 30 minutes. This steam is then utilized within a sealed disinfection box to sterilize instruments. During sterilization, excess high-temperature steam is condensed in the exhaust steam processing module. After the sterilization, high-temperature steam and coolant water remain inside the disinfection box. Air dry cycle works for ventilation and drying. Ultimately, you can get the dry and sterile instruments.

Basic parameters/use conditions/power supply specifications are as follows:

| Name | Cassette Autoclave (ACA5) | |
| --- | --- | --- |
| Machine Dimensions (A*B*C) | 650mm*416mm*200mm | |
| Cassette Sizes (D*E*F) | 495mm*196mm*78.5mm | |
| Maximum Load for a Single Sterilization | 1.5kg | |
| Sterilization Chamber Volume | 5.1L | |
| Weight (Without water) | 43KG | |
| Rated Operating Temperature | 134°C | |
| Rated Working Pressure | 212kPa (Gauge Pressure) | |
| Relief Valve Pressure Setting | Pressure set: 300kpa (relative pressure), pressure release when exceeded | |
| Operating Temperature Range | 121°C~134°C | |
| Reservoir Volume | 4L | |
| Input Voltage | a.c.110v, 60Hz | |
| Rated Power | 1300VA | |
| Fuse(250VH15AT) | 10A | |
| Working Medium | Steam | |
| Illumination level | (215±15) lx to (1500±15) lx | |
| Operating Mode | Non-continuous operation, with a maximum of 6 cycles per hour. | |
| Water Supply | Purified water | |

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# 5. Intended Use / Indications for Use

The Cassette Autoclave (ACA5) is suitable for the sterilization of dental and medical instruments designed to withstand steam sterilization. The Cassette Autoclave (ACA5) has not been designed to sterilize liquids, bio- medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

Please refer to below sterilization cycles for Program Name / Load Description/Sterilization Temperature/Sterilization Time/Drying Time and Load Weight.:

| Program Name | Load Description | Sterilization Temperature | Sterilization Time | Drying time | Max load |
| --- | --- | --- | --- | --- | --- |
| 134 °C | Solid objects, small porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped. | 134 °C (273°F) | 4 minutes | 60 minutes | 0.9 kg |
| 121 °C | Solid objects, small porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped. | 121 °C (250°F) | 30 minutes | 60 minutes | 0.9 kg |

# 6. Comparison to predicate device

| Elements of Comparison | Subject Device | Predicate Device I | Verdict |
| --- | --- | --- | --- |
| 510(k) Number | K250164 | K210279 | -- |
| Device Name | Cassette Autoclave (ACA5) | Enbio S(K210279) | -- |
| Product Code | FLE | FLE | Same |
| Regulation Number | 21 CFR 880.6880 | 21 CFR 880.6880 | Same |
| Regulation Class | II | II | Same |
| Prescription | Over-The-Counter | Over-The-Counter | Same |

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| Intended Use | The Cassette Autoclave (ACA5) is suitable for the sterilization of dental and medical instruments designed to withstand steam sterilization. The Cassette Autoclave (ACA5) has not been designed to sterilize liquids, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. | The Enbio S is an air - removal (pre - vacuum) table - top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, bio - medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. | Similar |
| --- | --- | --- | --- |
| Water tank | Internal reservoir | External | Different |
| Sterilization Chamber Volume | 5.1 L | 2.7 L | Different |
| Sterilization Chamber Dimensions (L x W x H) | 495mm*196mm*78.5mm | 292 x 192 x 45 mm (L x W x H) | Different |
| Device Dimensions (L x W x H) | 650mm*416mm*200mm | 561 x 252 x 162 mm | Different |
| Weight | 43KG | 15 kg (approximately) | Different |
| Power Rating | a.c.110v, 60Hz, 10A | 110 - 120 V, 60Hz, 15A | Similar |
| Wireless Transmission Capability | No | No | Same |
| USB Port | Yes | Yes | Same |
| Sterility and Shelf - life | Not provided sterile. No shelf - life claimed | Not provided sterile. No shelf - life claimed | Same |

## 7. Non-clinical Bench (Performance) testing

The device had been validated to comply with the following bench testing:

| Test Method | Purpose | Acceptance criteria | Result |
| --- | --- | --- | --- |
| ANSI AAMI ST55:2016 Vacuum Test | Verify air removal performance | Average leak rate of 1 milliliter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less | Pass |
| Bowie Dick Test | Verify air removal performance | The Bowie - Dick - test indicator sheet shall show a uniform color change, i.e., the color in the center should be the same as that at the outer edges. | Pass |
| Hollow unwrapped (S) 134°C/4min | Verify temperature control performance | The chamber temperature during the exposure time remains within +3 °C and -0 °C of the selected sterilization exposure temperature. | Pass |
| Solid unwrapped(N) 134°C/4min | | | |
| Hollow wrapped(S) 134°C/4min | | | |
| Rubber/plastic(S) 121°C/30min | | | |

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| Test Method | Purpose | Acceptance criteria | Result |
| --- | --- | --- | --- |
| Hollow unwrapped(S) 134°C/4min | Verify pressure control performance | The chamber pressure is within ±0.3 bar within the chamber. | Pass |
| Solid unwrapped(N) 134°C/4min | | | |
| Hollow wrapped(S) 134°C/4min | | | |
| Rubber/plastic(S) 121°C/30min | | | |
| Hollow unwrapped(S) 134°C/4min/dry 60min | Verify Moisture retention performance | There shall be no visible moisture present on the outside of loads or on the instruments contained inside. In addition, weighing before and after sterilization shall reveal less than 2% moisture gain in the PCD (textile test pack) and less than 0.5% moisture gain in the PCD (wrapped instrument test tray). | Pass |
| Solid unwrapped(N) 134°C/4min/dry 60min | | | |
| Hollow wrapped(S) 134°C/4min/dry 60min | | | |
| Rubber/plastic(S) 121°C/30min/dry 60min | | | |
| Hollow unwrapped(S) 134°C/4min/dry 60min | Verify Biological performance | When the sterilizer is tested, biological indicators (BIs) and spore suspensions shall show no growth of the test spores. The recommended exposure time shall have a sufficient lethality to reduce a microbial population having a D121 °C value of at least 1.0 minute (min) to a 10-6 probability of a surviving organism—that is, an overkill method shall be used, and the test results shall otherwise meet the acceptance criteria defined in the particular test. | Pass |
| Solid unwrapped(N) 134°C/4min/dry 60min | | | |
| Hollow wrapped(S) 134°C/4min/dry 60min | | | |
| Rubber/plastic(S) 121°C/30min/dry 60min | | | |
| IEC61010-1:2010/AMD1:2016 IEC 61010-2-040:2020 | Verify electrical safety | Meets specifications of standard | Pass |
| IEC 61326-1:2020 | Verify electromagnetic compatibility | Meets specifications of standards | Pass |

## Test Summary

The Cassette Autoclave (ACA5) was evaluated for conformance to recognized international standards. The following is a list of these evaluations and tests that were found to be in conformance:

- Electrical safety test
IEC 61010-1:2010/AMD1:2016 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61010-2-040:2020 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

- Table-top steam sterilizers test
ANSI/AAMI ST55:2016/(R)2023 Table-top steam sterilizers

- Software verification and validation test
FDA “Guidance for Premarket Submissions and for Software Contained in Medical Devices”

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- Software Life Cycle Processes
IEC 62304:2006+AMD1:2015 Medical Device Software

## 8. Summary for clinical test
Clinical performance is not deemed necessary.

## 9. Conclusion
The nonclinical test result demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device, K210279.

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