(145 days)
Not Found
No
The summary describes a standard steam autoclave for sterilization and does not mention any AI or ML capabilities.
No.
The document states that the device is an autoclave intended "to sterilize medical products," not to treat patients.
No
Explanation: The device is an autoclave, intended to sterilize medical products by means of pressurized steam. It is not used for diagnosing medical conditions or diseases.
No
The device description clearly describes a physical autoclave with a sterilization chamber, steam introduction, and pressure/temperature controls. The performance studies also include tests on the physical device and its components (electrical safety, pressure vessel, etc.).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "sterilize medical products by means of pressurized steam." This is a sterilization process for medical devices, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details an autoclave that uses steam for sterilization. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
The device is clearly intended for the sterilization of medical instruments and products, which falls under the category of medical devices used in healthcare settings, but not specifically as an in vitro diagnostic device.
N/A
Intended Use / Indications 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 that are intended to provide sterilization of heat stable medical devices: wrapped (IUSS) solids, hollow and porous products.
Product codes (comma separated list FDA assigned to the subject device)
FLE
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.
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.
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.
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
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 horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by hospital personnel and other medical personnel.
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)
The following non-clinical tests were conducted:
Electrical Safety based on IEC 61010-1:2010 / UL 61010-1:2012 and IEC 61010-2-040:2015. Results: Pass.
EMC based on EN 61326-1:2013 / IEC 61326-1:2012. Results: Pass.
Pressure vessel testing based on ASME Boiler and pressure vessel code, Section VIII division 1. Results: Pass.
Bowie & Dick test to verify air removal performance based on ANSI/AAMI ST-8. Results: Pass.
Air-leak-rate (vacuum) test to verify air removal performance based on ANSI/AAMI ST-8. Results: Pass (average leak rate of 1 millimeter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less over the measured time interval).
Empty chamber tests (121°C/132°C) – on wrapped and unwrapped (IUSS) load to ensure the sterilizer is capable of providing steady-state thermal conditions within the chamber consistent with the desired sterility assurance level (SAL) in the load, based on ANSI/AAMI ST-8. Results: Pass.
Full chamber load test (121°C/132°C) – on wrapped and unwrapped (IUSS) load to ensure the sterilizer is capable of providing steady-state thermal conditions within the chamber consistent with the desired sterility assurance level (SAL) in the load, based on ANSI/AAMI ST-8. Results: Pass.
Moisture retention tests - fabric PCD and wrapped instruments PCD to ensure the sterilizer is capable of meeting the moisture retention criteria, based on ANSI/AAMI ST-8. Results: Pass.
Biological performance with a textile PCD to verify biological performance on half sterilization time, based on ANSI/AAMI ST-8. Acceptance criteria: Tested cycle has a 10-6 SAL or an SAL providing a greater assurance of sterility when the textile PCD is used.
Biological performance with wrapped instrument PCD to verify biological performance on half sterilization time, based on ANSI/AAMI ST-8. Acceptance criteria: Tested cycle has a 10-6 SAL or an SAL providing a greater assurance of sterility when the wrapped instrument PCD is used.
Biological performance with unwrapped instrument PCD (IUSS) - minimum and maximum load tests to verify biological performance on half sterilization time, based on ANSI/AAMI ST-8. Acceptance criteria: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
3
Sterilization Programs for submitted models
| Model 4472 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | ||||
| [°C] | Sterilization | |||
| Time | ||||
| [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 | Sterilization | |||
| temperature | ||||
| [°C] | Sterilization | |||
| Time | ||||
| [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 | Sterilization | |||
| temperature | ||||
| [°C] | Sterilization | |||
| Time | ||||
| [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 |
4
| Model 66120 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | ||||
| [°C] | Sterilization | |||
| Time | ||||
| [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 and | |||||
| 66120 | |||||
| Horizontal | |||||
| Autoclave | FLE | 21CFR880.6880 | Steam | ||
| Sterilizer | 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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Image /page/8/Picture/0 description: The image shows the logo for Tuttnauer. The logo consists of the word "Tuttnauer" in red, with the words "Innovation, Legacy, Partnership" in a smaller font below it. Above the word "Tuttnauer" is a gray star-like shape.
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 catalog
no. | Device description |
|--------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4472 | 4472-1V
4472-2V
4472-1R
4472-2R
4472-1V-L-USA
4472-1V-R-USA | An autoclave with a chamber volume of 120L, operating in 1Ph
115V/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 the
configuration that cleans the external industrial steam. |
| Device model | Device catalog
no. | Device description |
| 5596 | 5596-1V
5596-2V
5596-1R
5596-2R
5596-2V-USA
5596-1V-L-USA
5596-1V-R-USA
5596-1R-L-USA
5596-1R-R-USA | An autoclave with a chamber volume of 250L, operating in 1Ph
115V/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 | 6690-1A
6690-2A
6690LM-1V-USA
6690LM-2V-USA | An autoclave with a chamber volume of 430L, operating in 1Ph
115V/60Hz or 3Ph 208V/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 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 | 66120-1V
66120-2V | An autoclave with a chamber volume 530L, operating in 1Ph
115V/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/10/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, black font. Above the name is a gray, star-like symbol.
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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 | Sterilization | |||
| temperature | ||||
| [°C] | Sterilization | |||
| Time | ||||
| [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 | Sterilization | |||
| temperature | ||||
| [°C] | Sterilization | |||
| Time | ||||
| [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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Table 4: standard cycles for model 6690
| Model 6690 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | ||||
| [°C] | Sterilization | |||
| Time | ||||
| [minute] | Dry Time | |||
| [minute] | Maximum Load | |||
| IUSS* | 132 | 3 | 2 | Tools - 102.1 kg (225 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile - 12 packs |
| Wrapped Tools – 102.1 kg (225 lbs.) | ||||
| IUSS delicate* | 121 | 30 | 2 | Tools - 102.1 kg (225 lbs.) |
| Wrapped delicate | 121 | 30 | 20 | Textile - 12 Packs |
| 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 |
Notes:
- IUSS – means immediate use steam sterilization
Table 5: standard cycles for model 66120
| Model 6690 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | ||||
| [°C] | Sterilization | |||
| Time | ||||
| [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 autoclave
model 4472 is intended for
use by health care
providers to sterilize
medical products by means
of pressurized steam. The
device is an autoclave that
is intended to provide
sterilization of heat stable
medical devices: wrapped
and unwrapped (IUSS)
solids, hollow and porous
products. | The horizontal autoclave
model 4472 is intended for
use by health care
providers to sterilize
medical products by means
of pressurized steam. The
device is an autoclave that
is intended to provide
sterilization of heat stable
medical devices: wrapped
solids, hollow and porous
products. | 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 |
| Operating
Principle /
sterilization method | Sterilization using steam as
sterilizing agent | Sterilization using steam as
sterilizing agent | Same |
| Sterilization cycle
types | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| Chamber Materials | 316 or 304 grade stainless
steal | 316 or 304 grade stainless
steal | Same |
| Energy source | The device can be operated
only while connected to an
electrical source (the
electrical grid).
It has no internal power
source (batteries). | The device can be operated
only while connected to an
electrical source (the
electrical grid).
It has no internal power
source (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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Table 7: model 5596 – Comparison of technological characteristics with predicate device
| Parameter | 5596 -
K221227 | 5596 -
under K181456 | Comparison |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for use | The horizontal autoclave
model 5596 is intended for
use by health care
providers to sterilize
medical products by means
of pressurized steam. The
device is an autoclave that
is intended to provide
sterilization of heat stable
medical devices: wrapped
and unwrapped (IUSS)
solids, hollow and porous
products. | The horizontal autoclave
model 5596 is intended for
use by health care
providers to sterilize
medical products by means
of pressurized steam. The
device is an autoclave that is
intended to provide
sterilization of heat stable
medical devices: wrapped
solids, hollow and porous
products. | 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 |
| Operating
Principle /
sterilization method | Sterilization using steam
as sterilizing agent | Sterilization using steam
as sterilizing agent | Same |
| Sterilization cycle
types | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| Chamber
Materials | 316 or 304 grade stainless
steal | 316 or 304 grade stainless
steal | Same |
| Energy source | The device can be
operated only while
connected to an electrical
source (the electrical grid).
It has no internal power
source (batteries). | The device can be
operated only while
connected to an electrical
source (the electrical grid).
It has no internal power
source (batteries). | Same |
| Controls | Electronic computer control | Electronic computer control | Same |
| Maximum load | · Tools (solids) - 34 kg (75
lbs.)
· 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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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 autoclave
model 6690 is intended for
use by health care
providers to sterilize
medical products by means
of pressurized steam. The
device is an autoclave that
is intended to provide
sterilization of heat stable
medical devices: wrapped
and unwrapped (IUSS)
solids, hollow and porous
products. | The horizontal autoclave
model 6690 is intended for
use by health care
providers to sterilize
medical products by means
of pressurized steam. The
device is an autoclave that
is intended to provide
sterilization of heat stable
medical devices: wrapped
solids, hollow and porous
products. | 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 steam
as sterilizing agent | Sterilization using steam
as sterilizing agent | Same |
| Sterilization cycle
types | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| Chamber
Materials | 316 or 304 grade stainless
steal | 316 or 304 grade stainless
steal | Same |
| Energy source | The device can be
operated only while
connected to an electrical
source (the electrical grid).
It has no internal power
source (batteries). | The device can be
operated only while
connected to an electrical
source (the electrical grid).
It has no internal power
source (batteries). | Same |
| Controls | Electronic computer
control, not programmable | Electronic computer
control, 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 – 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 |
| Parameter | 66120 –
K221227 | 66120 –
under K181456 | Comparison |
| Indication for use | The horizontal autoclave
model 66120 is intended
for use by health care
providers to sterilize
medical products by means
of pressurized steam. The
device is an autoclave that
is intended to provide
sterilization of heat stable
medical devices: wrapped
and unwrapped (IUSS)
solids, hollow and porous
products. | The horizontal autoclave
model 66120 is intended
for use by health care
providers to sterilize
medical products by means
of pressurized steam. The
device is an autoclave that
is intended to provide
sterilization of heat stable
medical devices: wrapped
solids, hollow and porous
products. | 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 |
| Operating
Principle /
sterilization method | Sterilization using steam
as sterilizing agent | Sterilization using steam
as sterilizing agent | Same |
| Sterilization cycle
types | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| Chamber
Materials | 316 or 304 grade stainless
steel | 316 or 304 grade stainless
steel | Same |
| Energy source | The device can be
operated only while
connected to an electrical
source (the electrical grid).
It has no internal power
source (batteries). | The device can be
operated only while
connected to an electrical
source (the electrical grid).
It has no internal power
source (batteries). | Same |
| Controls | Electronic computer
control, not programmable | Electronic computer
control, 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 – sterilization
temp. of 132°C / 270°F
for 3min, dry time of
2min. | • IUSS – sterilization
temp. of 132°C / 270°F
for 3min, dry time of
1min. | Different |
| | • Wrapped – sterilization
temp. of 132°C / 270°F
for 4min, dry time of
20min. | • 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. | • 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. | • Wrapped delicate –
sterilization temp of
121°C / 250°F for 30min,
dry time of 20min. | |
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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 / No
Pass) |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------|
| Electrical Safety | Verifying that
device and its
components meet
electrical safety
requirements | Meeting standard
specification | • IEC 61010-
1:2010
/UL 61010-
1:2012
• IEC 61010-2-
040:2015 | Pass |
| EMC | Verifying that the
device meets EMC
requirements | Meeting standard
specification | • EN 61326-
1:2013 / IEC
61326-1:2012 | 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 | • ASME Boiler
and pressure
vessel code,
Section VIII
division 1 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results
(Pass / No
Pass) |
| Device performance tests | | | | |
| Bowie & Dick
test | Verify air removal
performance (for
dynamic air
removal sterilizers) | The Bowie-Dick test
indicator sheet shall
show a uniform
color change | • ANSI/AAMI
ST-8 | 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. | • ANSI/AAMI
ST-8 | 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 | • ANSI/AAMI
ST-8 | 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 | • ANSI/AAMI
ST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results
(Pass / No
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 | • ANSI/AAMI
ST-8 | Pass |
| | | 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. | | |
| 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. | • ANSI/AAMI
ST-8 | |
| 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. | • ANSI/AAMI
ST-8 | |
| 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. | • ANSI/AAMI
ST-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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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.