(145 days)
The Tuttnauer Horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by health care providers to sterilize medical products by means of pressurized steam. The devices that are intended to provide sterilization of heat stable medical devices: wrapped (IUSS) solids, hollow and porous products.
The Tuttnauer horizontal autoclave series models 4472, 5596 and 6690 are dynamic-air-removal autoclaves that are designed for sterilization of heat stable medical devices: wrapped and unwrapped (IUSS) solids, hollow and porous products. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters. The autoclave operates in a temperature range of up to 137 C (279°F) and pressure up to 2.3 bar (34psi).
Each of the mentioned models differ from each other in chamber size and include different 1 or 2 door configurations. The models can come with onboard steam generation capability, but other configurations are used with external steam sources.
Here are the acceptance criteria and details of the study for the Tuttnauer Horizontal autoclave series, extracted and formatted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents acceptance criteria and reported performance (Pass/No Pass) directly within the "PERFORMANCE TESTING" section. No specific numerical results are provided beyond "Pass."
| Test Name | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Electrical Safety | Verifying that device and its components meet electrical safety requirements | Meeting standard specification | Pass |
| EMC | Verifying that the device meets EMC requirements | Meeting standard specification | Pass |
| Pressure vessel testing | Verifying that the pressure vessel used for the 4472, 5596, 6690 and 66120 sterilizers meet the requirements for pressure vessel and is safe for use. | Meeting standard specification | Pass |
| Bowie & Dick test | Verify air removal performance (for dynamic air removal sterilizers) | The Bowie-Dick test indicator sheet shall show a uniform color change | Pass |
| Air-leak-rate (vacuum) test | Verify air removal performance (for dynamic air removal sterilizers) | average leak rate of 1 millimeter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less over the measured time interval. | Pass |
| Empty chamber tests (121°C/132°C) – on wrapped and unwrapped (IUSS) load | to ensure 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 | The temperature shall not exceed more than 3°C above the sterilization temperature. The temperature shall not be below the sterilization temperature. Actual exposure time (Implied to meet the specified sterilization times in the cycle tables). | Pass |
| Full chamber load test (121°C/132°C) – on wrapped and unwrapped (IUSS) load | to ensure 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 | The temperature shall not exceed more than 3°C above the sterilization temperature. The temperature shall not be below the sterilization temperature. Actual exposure time (Implied to meet the specified sterilization times in the cycle tables). | Pass |
| Moisture retention tests - fabric PCD and wrapped instruments PCD | to ensure that the sterilizer is capable of meeting the moisture retention criteria | Moisture retained by the fabric PCD shall cause no more than a 3% increase in pre-sterilization test pack weight, and the pack shall exhibit no wet spots. When examined immediately after completion of the cycle, the wrapped instrument packs shall have no wet spots on the outer wrappers. Moisture retained by the 100% cotton towel shall cause no more than a 20% increase in the pre-sterilization weight of the towel. | Pass |
| Biological performance with a textile PCD | Verifying Biological performance on half sterilization time | Tested cycle has a 10^-6 SAL or an SAL providing a greater assurance of sterility when the textile PCD is used. | Pass |
| Biological performance with wrapped instrument PCD | Verifying biological performance on half sterilization time | Tested cycle has a 10^-6 SAL or an SAL providing a greater assurance of sterility when the wrapped instrument PCD is used. | Pass |
| Biological performance with unwrapped instrument PCD (IUSS) - minimum and maximum load tests | Verifying biological performance on half sterilization time | There shall be no growth observed in the vials containing turbines or in the extraction of any of the turbines, except for the positive controls. No growth shall be observed with the BIs except the positive control BI. Growth should be observed for the positive control turbine and BI. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of cycles performed) for each specific test or the "test set" in terms of physical units. However:
- The tests were conducted on the "Tuttnauer Horizontal autoclave series models: 4472, 5596, 6690, and 66120." It can be inferred that at least one of each model, or selected configurations, underwent these performance tests.
- The nature of sterilization validation studies typically involves multiple runs for each cycle type and load configuration to ensure reproducibility and meet sterility assurance levels.
- Data Provenance: Not explicitly stated regarding country of origin or whether the tests were retrospective or prospective. However, given it's a 510(k) submission, these are typically prospective performance validation studies conducted by the manufacturer according to recognized standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the device is a steam sterilizer, and the "ground truth" for its performance is established by objective physical and biological indicators, not human expert consensus on images or diagnostics. The performance tests rely on meeting physical parameters (temperature, pressure, leak rates, dry weight) and biological sterilisation criteria (no growth of biological indicators).
4. Adjudication Method for the Test Set
This is not applicable. The performance tests for a steam sterilizer involve objective measurements and biological indicator results, not subjective interpretation requiring an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a sterilizer.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable. The device is a physical steam sterilizer, not an AI algorithm. Its performance is inherent to its physical operation and is tested directly. There is no "human-in-the-loop" component in its core sterilization function that would make this distinction relevant.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established through:
- Physical Parameters: Measurements of temperature, pressure, time, and leak rates conforming to specific numerical thresholds (e.g., temperature not exceeding 3°C above sterilization temp, leak rate < 1 mmHg/min).
- Biological Indicators (BIs): Lack of growth in BI vials after processing, confirming a Sterility Assurance Level (SAL) of 10^-6 or better.
- Chemical Indicators/Physical Integrity: Uniform color change for Bowie & Dick tests, absence of wet spots and specific weight increase limits for moisture retention tests.
These are objective, quantifiable measures based on scientific principles of sterilization and established industry standards (e.g., ANSI/AAMI ST-8).
8. The Sample Size for the Training Set
This is not applicable. The device is a hardware product (sterilizer) and does not involve machine learning or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2022
Tuttnauer Ltd. Robert Basile Senior Vice President Har-Tuv Industrial Zone Beit-Shemesh, Jerusalem 9910101 Israel
Re: K221227
Trade/Device Name: Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: August 22, 2022 Received: August 22, 2022
Dear Robert Basile:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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,
Clarence W. Murray, III, PhD 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221227
Device Name
Tuttnauer Horizontal autoclave models: 4472, 5596, 6690 and 66120
Indications for Use (Describe)
The Tuttnauer Horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by health care providers to sterilize medical products by means of pressurized steam. The devices that are intended to provide sterilization of heat stable medical devices: wrapped (IUSS) solids, hollow and porous products.
The following tables show the validated cycles, including sterilization time (in minutes), dry time (in minutes) and maximum load for tools (in kilograms) and textile (in packs) for each of the models mentioned:
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)
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FORM FDA 3881 (6/20)
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Sterilization Programs for submitted models
| Model 4472 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilizationtemperature[°C] | SterilizationTime[minute] | Dry Time[minute] | Maximum Load |
| IUSS | 132 | 3 | 2 | Tools – 23 kg (50.7 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile – 4 packs |
| Wrapped | 132 | 4 | 20 | Wrapped Tools – 23 kg (50.7 lbs. |
| IUSS delicate | 121 | 30 | 2 | Tools – 23 kg (50.7 lbs.) |
| Wrapped delicate | 121 | 30 | 20 | Textile – 4 packs |
| Wrapped delicate | 121 | 30 | 20 | Wrapped Tools – 23 kg (50.7 lbs. |
| Bowie and Dick | 134 | 3.5 | 2 | N/A |
| Vacuum test | N/A | N/A | N/A | N/A |
| Table 1: standard cvcles for model 4472 | ||||||
|---|---|---|---|---|---|---|
| -- | -- | ----------------------------------------- | -- | -- | -- | -- |
Table 2: standard cycles for model 5596
| Model 5596 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilizationtemperature[°C] | SterilizationTime[minute] | Dry Time[minute] | Maximum Load |
| IUSS | 132 | 3 | 2 | Tools – 34 kg (75 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile – 6 packs |
| 132 | 4 | 20 | Wrapped Tools – 34 kg (75 lbs.) | |
| IUSS delicate | 121 | 30 | 2 | Tools – 34 kg (75 lbs.) |
| Wrapped delicate | 121 | 30 | 20 | Textile – 6 packs |
| 121 | 30 | 20 | Wrapped Tools – 34 kg (75 lbs.) | |
| Bowie and Dick | 134 | 3.5 | 2 | N/A |
| Vacuum test | N/A | N/A | N/A | N/A |
Table 3: standard cycles for model 6690
| Model 6690 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilizationtemperature[°C] | SterilizationTime[minute] | Dry Time[minute] | Maximum Load |
| IUSS | 132 | 3 | 2 | Tools – 102.1 kg (225 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile – 12 packs |
| 132 | 4 | 20 | Wrapped Tools – 102.1 kg (225 lbs.) | |
| IUSS delicate | 121 | 30 | 2 | Tools – 102.1 kg |
| Wrapped delicate | 121 | 30 | 20 | Textile – 12 Packs |
| 121 | 30 | 20 | Wrapped Tools – 102.1 kg (225 lbs.) | |
| Bowie and Dick | 134 | 3.5 | 2 | N/A |
| Vacuum test | N/A | N/A | N/A | N/A |
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| Model 66120 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilizationtemperature[°C] | SterilizationTime[minute] | Dry Time[minute] | Maximum Load |
| IUSS | 132 | 3 | 2 | Tools – 136 kg (300 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile – 16 packs |
| 132 | 4 | 20 | Wrapped Tools – 136 kg (300 lbs. | |
| IUSS delicate | 121 | 30 | 2 | Tools – 136 kg (300 lbs.) |
| Wrapped delicate | 121 | 30 | 20 | Textile – 16 packs |
| 121 | 30 | 20 | Wrapped Tools – 136 kg (300 lbs. | |
| Bowie and Dick | 134 | 3.5 | 2 | N/A |
| Vacuum test | N/A | N/A | N/A | N/A |
Table 4: standard cycles for model 66120
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Image /page/5/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the company name in red, with the words "Innovation, Legacy, Partnership" written in a smaller font below the name. Above the company name is a gray star-like shape.
510k Summary
Submission: K221227 Device Models: 4472, 5596, 6690, 66120
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Date Prepared: September 19, 2022
1. SUBMITTER
Tuttnauer USA Co. Ltd. 25 Power Drive Hauppauge, NY 11788 Phone: (631) 737 4850 Fax: (631) 737 0720
Contact Person:
Robert Basile Sr. Vice President Tuttnauer USA Co. Ltd. Tel: 631 737 4850 Ext: 137 Fax: 631 737 1034 E-mail: bob@tuttnauerusa.com
2. DEVICE
Trade Name: Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690 and 66120 Common Name: Horizontal Steam Sterilizer
Classification:
| Regulation description: | Steam sterilizer |
|---|---|
| Regulation medical specialty: | General hospital |
| Product code: | FLE |
| Regulation number: | 880.6880 |
| Device class: | II |
3. PREDICATE DEVICE
Primary Predicate: Tuttnauer 4472, 5596, 6690 and 66120 Horizontal Autoclave Models
| Predicate Name | Product Code | Regulation Number | Regulation Name | Class | 510k No. |
|---|---|---|---|---|---|
| 4472, 5596,6690 and66120HorizontalAutoclave | FLE | 21CFR880.6880 | SteamSterilizer | II | K181456 |
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Image /page/7/Picture/0 description: The image contains the logo for Tuttnauer. The logo features the company name in a bold, red font, with the words "Innovation, Legacy, Partnership" written in a smaller font underneath. Above the company name is a gray, star-like graphic.
4. DEVICE DESCRIPTION
The Tuttnauer horizontal autoclave series models 4472, 5596 and 6690 are dynamic-air-removal autoclaves that are designed for sterilization of heat stable medical devices: wrapped and unwrapped (IUSS) solids, hollow and porous products. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters. The autoclave operates in a temperature range of up to 137 C (279°F) and pressure up to 2.3 bar (34psi).
Each of the mentioned models differ from each other in chamber size and include different 1 or 2 door configurations. The models can come with onboard steam generation capability, but other configurations are used with external steam sources.
The various configurations are provided as follows:
A. Door configurations:
Door configuration can be manual or automatic hinged or sliding, one door or two doors:
| Number of doors in the autoclave | ||
|---|---|---|
| Door type | 1 door | 2 doors |
| Vertical sliding | 1V | 2V |
| Horizontal sliding | 1H | 2H |
| Manual hinged | 1R | 2R |
| Automatic hinged | 1A | 2A |
The vertical sliding door is operated by two hydro-pneumatic cylinders, mounted laterally on both sides of the door. Each cylinder contains an integrated and separated oil system. The operation of the cylinders is performed by an air pressure and the oil system acts as a speed control system. An adjustable restrictor controls the flow of oil from one side to the other side on each cylinder, controlling the speed movement of the door.
The horizontal sliding door is operated by a hydro-pneumatic cylinder mounted above the door that is adjusted to operate in either the opening or closing direction. The cylinder contains an integrated and separated oil system. The operation of the cylinder is performed by air pressure and the oil system acts as a speed control system. An adjustable restrictor on the cylinder controls the flow of oil from one side to the other, controlling the speed movement of the door.
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The manual hinged door is locked by rotating a wheel located on the front of the door. The closing mechanism incorporates a safety lock which locks the door in the closed position, preventing the door mechanism from opening. The door will only open if conditions in the chamber allow the locking mechanism to open the door.
The automatic hinged door is closed manually and is locked by an automatic pneumatic mechanism. Similarly, at the end of a cycle, the door is unlocked and can be opened manually.
The interlock system of the door is based on the following opening conditions:
- The door cannot be opened while the autoclave is in operation. .
- The door cannot be opened if the chamber is under pressure.
- . The door cannot be opened if there is liquid in the chamber.
- . The door cannot be opened at the end of the cycle if the chamber temperature is higher than the pre-set final temperature.
- B. Steam generation configuration:
- o EP Electric Power onboard steam generator
- o SP Steam comes from External source
- o STS Steam to Steam option, a unit supplied with the configuration that cleans the external industrial steam.
The horizontal autoclave models 4472, 5596, 6690 and 66120 include main components: a pressure vessel with steam jacket, a vacuum pump, a water pump and generator, depending on the configuration of the device. The vacuum pump can be replaced by an ejector, which is installed as part of the piping of the device and operates in a similar way to create vacuum.
An emergency stop-push button that is mounted on the front panel is an available option for customers with specific needs. This feature is designed to prevent hazards to humans, and accidents due to equipment breakdown. When the emergency switch is activated, the key must be used to allow the switch to return to the operating position.
The autoclave has an automatic shutdown system. If there are no operations for four hours, the autoclave goes into SLEEP mode.
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Image /page/9/Picture/0 description: The image contains the logo for Tuttnauer. The logo is red and has the word "Tuttnauer" in a bold font. Below the word "Tuttnauer" are the words "Innovation, Legacy, Partnership" in a smaller font. Above the word "Tuttnauer" is a star-like symbol.
The selected program, the main phases of the cycle and the status of the machine are controlled and displayed on digital readouts. For process documentation, the important information concerning operation is printed.
The Remote PC Reporting application, (R.PC.R), is used to generate Data and Trends reports on cycle data.
The electronic circuitry and software programming of the programmable control system are designed to operate:
- . Programs for Un-wrapped Loads
- . Programs for Wrapped Loads.
- . Two Test Programs: The Bowie & Dick Test and the Vacuum Test
The control system of the sterilizer is based on microcomputer technology. The computerized control unit ensures a fully automatic operation through the entire cycle. For all models mentioned, the software and controller are the same.
5. LIST OF DEVICES
The following table is a list of devices models for which this 510(k) clearance is requested in this submission:
| Device model | Device catalogno. | Device description |
|---|---|---|
| 4472 | 4472-1V4472-2V4472-1R4472-2R4472-1V-L-USA4472-1V-R-USA | An autoclave with a chamber volume of 120L, operating in 1Ph115V/60Hz or 3Ph 220V/60Hz depending on the configuration(see device manual).This device can come with:• one or two vertical sliding doors (1V or 2V) configuration, or• one or two manual hinged doors configuration (1R or 2R).With the piping to the left or right side of the device and,Several steam generation options:• EP – Electric Power – onboard steam generator• SP - Steam comes from external source• STS - Steam to Steam option, a unit supplied with theconfiguration that cleans the external industrial steam. |
| Device model | Device catalogno. | Device description |
| 5596 | 5596-1V5596-2V5596-1R5596-2R5596-2V-USA5596-1V-L-USA5596-1V-R-USA5596-1R-L-USA5596-1R-R-USA | An autoclave with a chamber volume of 250L, operating in 1Ph115V/60Hz or 3Ph 400V/60Hz depending on the configuration(see device manual).This device can come with:one or two vertical sliding doors (1V or 2V) configuration, or one or two manual hinged doors (1R or 2R) configuration With the piping to the left or right side of the device and,Several steam generation options: EP - Electric Power - onboard steam generator SP - Steam comes from external source STS - Steam to Steam option, a unit supplied with the configuration that cleans the external industrial steam. |
| 6690 | 6690-1A6690-2A6690LM-1V-USA6690LM-2V-USA | An autoclave with a chamber volume of 430L, operating in 1Ph115V/60Hz or 3Ph 208V/60Hz or 3Ph 400V/60Hz depending onthe configuration (see device manual).This device can come with:one or two vertical sliding doors (1V or 2V) configuration, or one or two doors automatic hinged doors (1A or 2A) configuration. With the piping to the left or right side of the device and,Several steam generation options: EP - Electric Power - onboard steam generator SP - Steam comes from external source STS - Steam to Steam option, a unit supplied with the configuration that cleans the external industrial steam. |
| 66120 | 66120-1V66120-2V | An autoclave with a chamber volume 530L, operating in 1Ph115V/60Hz or 1Ph 120V/60Hz depending on the configuration(see device manual).This device can come with:one or two vertical sliding doors (1V or 2V) configuration With the piping to the left or right side of the device and,Several steam generation options: EP - Electric Power - onboard steam generator SP - Steam comes from external source STS - Steam to Steam option, a unit supplied with the configuration that cleans the external industrial steam. |
Table 1: List of devices models in the current submission
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Image /page/11/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name are the words "Innovation, Legacy, Partnership" in a smaller font. Above the name is a gray, diamond-shaped graphic.
6. INDICATION FOR USE
The Tuttnauer horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by health care providers to sterilize medical products by means of pressurized steam. The devices are autoclaves that are intended to provide sterilization of heat stable medical devices: wrapped and unwrapped (IUSS) solids, hollow and porous products.
The following tables show the preprogramed standard cycles for each of the mentioned models, including sterilization temperature, sterilization time (in minutes), dry time (in minutes) and maximum load for tools (in kilograms) and textile (in packs) for each of the models mentioned:
Table 2: standard cycles for model 4472
| Model 4472 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilizationtemperature[°C] | SterilizationTime[minute] | Dry Time[minute] | Maximum Load |
| IUSS* | 132 | 3 | 2 | Tools – 23 kg (50.7 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile – 4 packs |
| 132 | 4 | 20 | Wrapped Tools – 23 kg (50.7 lbs.) | |
| IUSS delicate* | 121 | 30 | 2 | Tools – 23 kg (50.7 lbs.) |
| Wrapped delicate | 121 | 30 | 20 | Textile – 4 packs |
| 121 | 30 | 20 | Wrapped Tools – 23 kg (50.7 lbs.) | |
| Bowie and Dick | 134 | 3.5 | 2 | N/A |
| Vacuum test | N/A | N/A | N/A | N/A |
Notes:
- IUSS – means immediate use steam sterilization
Table 3: standard cycles for model 5596
| Model 5596 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilizationtemperature[°C] | SterilizationTime[minute] | Dry Time[minute] | Maximum Load |
| IUSS* | 132 | 3 | 2 | Tools – 34 kg (75 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile – 6 packs |
| 132 | 4 | 20 | Wrapped Tools – 34 kg (75 lbs.) | |
| IUSS delicate* | 121 | 30 | 2 | Tools – 34 kg (75 lbs.) |
| 121 | 30 | 20 | Textile – 6 packs | |
| Wrapped delicate | 121 | 30 | 20 | Wrapped Tools – 34 kg (75 lbs.) |
| Bowie and Dick | 134 | 3.5 | 2 | N/A |
| Vacuum test | N/A | N/A | N/A | N/A |
Notes:
- IUSS – means immediate use steam sterilization
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Image /page/12/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name are the words "Innovation, Legacy, Partnership" in a smaller font. Above the company name is a gray, star-like shape.
Table 4: standard cycles for model 6690
| Model 6690 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilizationtemperature[°C] | SterilizationTime[minute] | Dry Time[minute] | Maximum Load |
| IUSS* | 132 | 3 | 2 | Tools - 102.1 kg (225 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile - 12 packsWrapped Tools – 102.1 kg (225 lbs.) |
| IUSS delicate* | 121 | 30 | 2 | Tools - 102.1 kg (225 lbs.) |
| Wrapped delicate | 121 | 30 | 20 | Textile - 12 PacksWrapped Tools – 102.1 kg (225 lbs.) |
| Bowie and Dick | 134 | 3.5 | 2 | N/A |
| Vacuum test | N/A | N/A | N/A | N/A |
Notes:
- IUSS – means immediate use steam sterilization
Table 5: standard cycles for model 66120
| Model 6690 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilizationtemperature[°C] | SterilizationTime[minute] | Dry Time[minute] | Maximum Load |
| IUSS* | 132 | 3 | 2 | Tools – 136 kg (300 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile – 16 packs |
| Wrapped | 132 | 4 | 20 | Wrapped Tools – 136 kg (300 lbs.) |
| IUSS delicate* | 121 | 30 | 2 | Tools – 136 kg (300 lbs.) |
| Wrapped delicate | 121 | 30 | 20 | Textile – 16 Packs |
| Wrapped delicate | 121 | 30 | 20 | Wrapped Tools – 136 kg (300 lbs.) |
| Bowie and Dick | 134 | 3.5 | 2 | N/A |
| Vacuum test | N/A | N/A | N/A | N/A |
Notes:
- IUSS – means immediate use steam sterilization
Intended user
The horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by hospital personnel and other medical personnel.
All autoclave users must receive training in proper usage from an experienced employee. Every new employee must undergo a training period under an experienced employee.
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7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following technological characteristics will be compared between the subject horizontal autoclave models 4472, 5596. 6690 and 66120 and the cleared predicate horizontal autoclave models 4472, 5596, 6690 and 66120 under K181456:
- . Indication for use
- General design of device: chamber volume, dimensions;
- Materials; ●
- Energy source; ●
- Performance: operation principle, sterilization cycle type, sterilization time, controls; ●
- . Sterilization parameters
- . Maximum load
Reason for the 510(k):
Increasement of the maximum load that can be sterilized in the Wrapped tools and Unwrapped tools (IUSS) cycles, and replacing the definition of the allowable maximum load in the Textile cycles from kilograms to number of packs for the horizontal autoclave models 4472, 5596, 6690 and 66120.
| Parameter | 4472 –K221227 | 4472 –under K181456 | Comparison |
|---|---|---|---|
| Indication for use | The horizontal autoclavemodel 4472 is intended foruse by health careproviders to sterilizemedical products by meansof pressurized steam. Thedevice is an autoclave thatis intended to providesterilization of heat stablemedical devices: wrappedand unwrapped (IUSS)solids, hollow and porousproducts. | The horizontal autoclavemodel 4472 is intended foruse by health careproviders to sterilizemedical products by meansof pressurized steam. Thedevice is an autoclave thatis intended to providesterilization of heat stablemedical devices: wrappedsolids, hollow and porousproducts. | Different |
| Parameter | 4472 -K221227 | 4472 -under K181456 | Comparison |
| Chamber dimensions | 16" x 16" x 29" | 16" x 16" x 29" | Same |
| Chamber volume | 4.24 ft³ (120 L) | 4.24 ft³ (120 L) | Same |
| OperatingPrinciple /sterilization method | Sterilization using steam assterilizing agent | Sterilization using steam assterilizing agent | Same |
| Sterilization cycletypes | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| Chamber Materials | 316 or 304 grade stainlesssteal | 316 or 304 grade stainlesssteal | Same |
| Energy source | The device can be operatedonly while connected to anelectrical source (theelectrical grid).It has no internal powersource (batteries). | The device can be operatedonly while connected to anelectrical source (theelectrical grid).It has no internal powersource (batteries). | Same |
| Controls | Electronic computer control | Electronic computer control | Same |
| Maximum Load | Tools (solids) – 23 kg (50.7 lbs.) Textile – 4 packs | Tools (solids) – 23 kg (50.7 lbs.) Textile – 11.1 kg | Different |
| Cycle parameters | IUSS – sterilization temp. of 132°C / 270°F for 3min, dry time of 2min. Wrapped - sterilization temp. of 132°C / 270°F for 4min, dry time of 20min. IUSS delicate – sterilization temp. of 121°C / 250°F for 30min, dry time for 2min. Wrapped delicate - sterilization temp of 121°C / 250°F for 30min, dry time of 20min. | IUSS – sterilization temp. of 132°C / 270°F for 3min, dry time of 1min. Wrapped-sterilization temp. of 132°C / 270°F for 4min, dry time of 20min. IUSS delicate – sterilization temp. of 121°C / 250°F for 30min, dry time for 1min. Wrapped delicate - sterilization temp of 121°C / 250°F for 30min, dry time of 20min. | Different |
Table 6: model 4472 – Comparison of technological characteristics with predicate device
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Image /page/14/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name, the words "Innovation, Legacy, Partnership" are written in a smaller font. Above the company name is a gray, star-like shape.
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Image /page/15/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the word "Tuttnauer" in a bold, red font. Below the name is the tagline "Innovation - Legacy - Partnership" in a smaller font. Above the name is a gray, star-like symbol.
Table 7: model 5596 – Comparison of technological characteristics with predicate device
| Parameter | 5596 -K221227 | 5596 -under K181456 | Comparison |
|---|---|---|---|
| Indication for use | The horizontal autoclavemodel 5596 is intended foruse by health careproviders to sterilizemedical products by meansof pressurized steam. Thedevice is an autoclave thatis intended to providesterilization of heat stablemedical devices: wrappedand unwrapped (IUSS)solids, hollow and porousproducts. | The horizontal autoclavemodel 5596 is intended foruse by health careproviders to sterilizemedical products by meansof pressurized steam. Thedevice is an autoclave that isintended to providesterilization of heat stablemedical devices: wrappedsolids, hollow and porousproducts. | Different |
| Chamber dimensions | 20" x 20" x 38" | 20" x 20" x 38" | Same |
| Chamber volume | 8.83 ft3 (250 L) | 8.83 ft3 (250 L) | Same |
| OperatingPrinciple /sterilization method | Sterilization using steamas sterilizing agent | Sterilization using steamas sterilizing agent | Same |
| Sterilization cycletypes | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| ChamberMaterials | 316 or 304 grade stainlesssteal | 316 or 304 grade stainlesssteal | Same |
| Energy source | The device can beoperated only whileconnected to an electricalsource (the electrical grid).It has no internal powersource (batteries). | The device can beoperated only whileconnected to an electricalsource (the electrical grid).It has no internal powersource (batteries). | Same |
| Controls | Electronic computer control | Electronic computer control | Same |
| Maximum load | · Tools (solids) - 34 kg (75lbs.)· Textile - 6 packs | • Tools (solids) – 23 kg(50.7 lbs.)• Textile – 22.2 kg | Different |
| Parameter | 5596 –K221227 | 5596 –under K181456 | Comparison |
| Cycle parameters | IUSS – sterilization temp. of 132°C / 270°F for 3min, dry time of 2min. Wrapped – sterilization temp. of 132°C / 270°F for 4min, dry time of 20min. IUSS delicate – sterilization temp. of 121°C / 250°F for 30min, dry time for 2min. Wrapped delicate – sterilization temp of 121°C / 250°F for 30min, dry time of 20min. | IUSS – sterilization temp. of 132°C / 270°F for 3min, dry time of 1min. Wrapped – sterilization temp. of 132°C / 270°F for 4min, dry time of 20min. IUSS delicate – sterilization temp. of 121°C / 250°F for 30min, dry time for 1min. Wrapped delicate – sterilization temp of 121°C / 250°F for 30min, dry time of 20min. | Different |
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Image /page/16/Picture/0 description: The image shows the logo for Tuttnauer. The logo consists of the word "Tuttnauer" in a bold, red font. Below the name is the text "Innovation - Legacy - Partnership" in a smaller font. Above the name is a gray, star-like shape.
Device Model: 4472, 5596, 6690, 66120
Table 8: model 6690 – Comparison of technological characteristics with predicate device
| Parameter | 6690 –K221227 | 6690 –under K181456 | Comparison |
|---|---|---|---|
| Indication for use | The horizontal autoclavemodel 6690 is intended foruse by health careproviders to sterilizemedical products by meansof pressurized steam. Thedevice is an autoclave thatis intended to providesterilization of heat stablemedical devices: wrappedand unwrapped (IUSS)solids, hollow and porousproducts. | The horizontal autoclavemodel 6690 is intended foruse by health careproviders to sterilizemedical products by meansof pressurized steam. Thedevice is an autoclave thatis intended to providesterilization of heat stablemedical devices: wrappedsolids, hollow and porousproducts. | Different |
| Chamber dimensions | 26" x 26" x 39" | 26" x 26" x 39" | Same |
| Chamber volume | 15.19 ft3 (430 L) | 15.19 ft3 (430 L) | Same |
| Parameter | 6690 –K221227 | 6690 –under K181456 | Comparison |
| Operating Principle /sterilization method | Sterilization using steamas sterilizing agent | Sterilization using steamas sterilizing agent | Same |
| Sterilization cycletypes | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| ChamberMaterials | 316 or 304 grade stainlesssteal | 316 or 304 grade stainlesssteal | Same |
| Energy source | The device can beoperated only whileconnected to an electricalsource (the electrical grid).It has no internal powersource (batteries). | The device can beoperated only whileconnected to an electricalsource (the electrical grid).It has no internal powersource (batteries). | Same |
| Controls | Electronic computercontrol, not programmable | Electronic computercontrol, not programmable | Same |
| Maximum load | • Tools (solids) – 102.1 kg(225 lbs.)• Textile - 12 packs | • Tools (solids) - 46 kg(101.4 lbs.)• Textile - 33.3 kg | Different |
| Cycle parameters | • IUSS – sterilizationtemp. of 132°C / 270°Ffor 3min, dry time of2min.• Wrapped – sterilizationtemp. of 132°C / 270°Ffor 4min, dry time of20min.• IUSS delicate –sterilization temp. of121°C / 250°F for 30min,dry time for 2min.• Wrapped delicate –sterilization temp of121°C / 250°F for 30min,dry time of 20min. | • IUSS – sterilizationtemp. of 132°C / 270°Ffor 3min, dry time of1min.• Wrapped – sterilizationtemp. of 132°C / 270°Ffor 4min, dry time of20min.• IUSS delicate –sterilization temp. of121°C / 250°F for 30min,dry time for 1min.• Wrapped delicate –sterilization temp of121°C / 250°F for 30min,dry time of 20min. | Different |
| Parameter | 66120 –K221227 | 66120 –under K181456 | Comparison |
| Indication for use | The horizontal autoclavemodel 66120 is intendedfor use by health careproviders to sterilizemedical products by meansof pressurized steam. Thedevice is an autoclave thatis intended to providesterilization of heat stablemedical devices: wrappedand unwrapped (IUSS)solids, hollow and porousproducts. | The horizontal autoclavemodel 66120 is intendedfor use by health careproviders to sterilizemedical products by meansof pressurized steam. Thedevice is an autoclave thatis intended to providesterilization of heat stablemedical devices: wrappedsolids, hollow and porousproducts. | Different |
| Chamber dimensions | 26" x 26" x 49" | 26" x 26" x 49" | Same |
| Chamber volume | 18.72 ft³ (530 L) | 18.72 ft³ (530 L) | Same |
| OperatingPrinciple /sterilization method | Sterilization using steamas sterilizing agent | Sterilization using steamas sterilizing agent | Same |
| Sterilization cycletypes | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| ChamberMaterials | 316 or 304 grade stainlesssteel | 316 or 304 grade stainlesssteel | Same |
| Energy source | The device can beoperated only whileconnected to an electricalsource (the electrical grid).It has no internal powersource (batteries). | The device can beoperated only whileconnected to an electricalsource (the electrical grid).It has no internal powersource (batteries). | Same |
| Controls | Electronic computercontrol, not programmable | Electronic computercontrol, not programmable | Same |
| Maximum load | • Tools (solids) – 136 kg(300 lbs.)• Textile - 16 packs | • Tools (solids) - 46 kg(101.4 lbs.)• Textile – 33.3 kg | Different |
| Parameter | 66120 –K221227 | 66120 –under K181456 | Comparison |
| Cycle parameters | • IUSS – sterilizationtemp. of 132°C / 270°Ffor 3min, dry time of2min. | • IUSS – sterilizationtemp. of 132°C / 270°Ffor 3min, dry time of1min. | Different |
| • Wrapped – sterilizationtemp. of 132°C / 270°Ffor 4min, dry time of20min. | • Wrapped – sterilizationtemp. of 132°C / 270°Ffor 4min, dry time of20min. | ||
| • IUSS delicate –sterilization temp. of121°C / 250°F for 30min,dry time for 2min. | • IUSS delicate –sterilization temp. of121°C / 250°F for 30min,dry time for 1min. | ||
| • Wrapped delicate –sterilization temp of121°C / 250°F for 30min,dry time of 20min. | • Wrapped delicate –sterilization temp of121°C / 250°F for 30min,dry time of 20min. |
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Image /page/17/Picture/0 description: The image shows the logo for Tuttnauer. The logo is red and has the word "Tuttnauer" in large, bold letters. Below the name are the words "Innovation, Legacy, Partnership" in a smaller font. Above the name is a gray star-like shape.
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Image /page/18/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name is the tagline "Innovation - Legacy - Partnership" in a smaller font. Above the name is a gray, star-like symbol.
Table 9: model 66120 – Comparison of technological characteristics with predicate device
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Device Model: 4472, 5596, 6690, 66120
8. PERFORMANCE TESTING
The following shows the non-clinical tests conducted:
| Test name | Purpose | Acceptance criteria | Standards used | Results(Pass / NoPass) |
|---|---|---|---|---|
| Electrical Safety | Verifying thatdevice and itscomponents meetelectrical safetyrequirements | Meeting standardspecification | • IEC 61010-1:2010/UL 61010-1:2012• IEC 61010-2-040:2015 | Pass |
| EMC | Verifying that thedevice meets EMCrequirements | Meeting standardspecification | • EN 61326-1:2013 / IEC61326-1:2012 | Pass |
| Pressure vesseltesting | Verifying that thepressure vessel usedfor the 4472, 5596,6690 and 66120sterilizers meet therequirements forpressure vessel andis safe for use. | Meeting standardspecification | • ASME Boilerand pressurevessel code,Section VIIIdivision 1 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results(Pass / NoPass) |
| Device performance tests | ||||
| Bowie & Dicktest | Verify air removalperformance (fordynamic airremoval sterilizers) | The Bowie-Dick testindicator sheet shallshow a uniformcolor change | • ANSI/AAMIST-8 | Pass |
| Air-leak-rate(vacuum) test | Verify air removalperformance (fordynamic airremoval sterilizers) | average leak rate of1 millimeter ofmercury (mmHg)(0.13 kPa) (0.019psia) per min or lessover the measuredtime interval. | • ANSI/AAMIST-8 | Pass |
| Empty chambertests(121°C/132°C) –on wrapped andunwrapped(IUSS) load | to ensure that thesterilizer is capableof providingsteady- statethermal conditionswithin the chamberconsistent with thedesired sterilityassurance level(SAL) in the load | The temperatureshall not exceedmore than 3°C abovethe sterilizationtemperature.The temperatureshall not be belowthe sterilizationtemperatureActual exposuretime | • ANSI/AAMIST-8 | Pass |
| Full chamber loadtest(121°C/132°C) –on wrapped andunwrapped(IUSS) load | to ensure that thesterilizer is capableof providingsteady- statethermal conditionswithin the chamberconsistent with thedesired sterilityassurance level(SAL) in the load | The temperatureshall not exceedmore than 3°C abovethe sterilizationtemperature.The temperatureshall not be belowthe sterilizationtemperatureActual exposure time | • ANSI/AAMIST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results(Pass / NoPass) |
| Moistureretention tests -fabric PCD andwrappedinstruments PCD | to ensure thatthe sterilizer iscapable of meetingthe moistureretention criteria | Moisture retained bythe fabric PCD shallcause no more than a3% increase in pre-sterilization test packweight, and the packshall exhibit no wetspots.When examined | • ANSI/AAMIST-8 | Pass |
| immediately aftercompletion of thecycle, the wrappedinstrument packsshall have no wetspots on the outerwrappers. Moistureretained by the 100%cotton towel shallcause no more than a20% increase in thepre-sterilizationweight of the towel. | ||||
| Biologicalperformance witha textile PCD | Verifying Biologicalperformance on halfsterilization time | Tested cycle has a10-6 SAL or an SALproviding a greaterassurance of sterilitywhen the textilePCD is used. | • ANSI/AAMIST-8 | |
| Biologicalperformance withwrappedinstrument PCD | Verifying biologicalperformance on halfsterilization time | Tested cycle has a10-6 SAL or an SALproviding a greaterassurance of sterilitywhen the wrappedinstrument PCD isused. | • ANSI/AAMIST-8 | |
| Biologicalperformance withunwrappedinstrument PCD(IUSS) - minimumand maximum loadtests | Verifying biologicalperformance on halfsterilization time | There shall be nogrowth observed inthe vials containingturbines or in theextraction of any ofthe turbines, exceptfor the positivecontrols. | • ANSI/AAMIST-8 | |
| Test name | Purpose | Acceptance criteria | Standards used | Results(Pass / No Pass) |
| No growth shall be observed with the BIs except the positive control BI. Growth should be observed for the positive control turbine and BI |
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Image /page/20/Picture/1 description: The image shows the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name is the tagline "Innovation - Legacy - Partnership" in a smaller, black font. Above the company name is a gray, star-like shape.
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Image /page/21/Picture/1 description: The image shows the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name is the tagline "Innovation - Legacy - Partnership" in a smaller font. Above the company name is a gray star-like symbol.
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Image /page/22/Picture/0 description: The image contains the logo for Tuttnauer. The logo is red and has the word "Tuttnauer" in large letters. Below the name are the words "Innovation, Legacy, Partnership" in a smaller font. Above the name is a gray star-like shape.
Device Model: 4472, 5596, 6690, 66120
9. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the subject device, the horizontal autoclaves models 4472, 5596, 6690 and 66120, are as safe, as effective, and performs as well as or better than the legally marketed device cleared under K181456.
§ 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).