Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120

K221227 · Tuttnauer , Ltd. · FLE · Sep 20, 2022 · General Hospital

Device Facts

• Record ID: K221227
• Device Name: Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
• Applicant: Tuttnauer , Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Sep 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

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.

Device Story

Horizontal steam sterilizers (models 4472, 5596, 6690, 66120) for hospital/medical use; utilize pressurized steam for sterilization of heat-stable medical devices (solids, hollow, porous). Features include dynamic air removal (vacuum pump or ejector), steam jacket, and digital control system. Configurations include 1 or 2 doors (sliding or hinged) and various steam sources (onboard generator, external, or steam-to-steam). Operators (hospital/medical personnel) select programs via digital interface; system provides automated cycle control and printed documentation. R.PC.R application enables remote data/trend reporting. Emergency stop and automatic sleep mode included. Benefits include effective sterilization of increased load capacities for wrapped/unwrapped instruments.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 61010-1/2-040), EMC (EN 61326-1), pressure vessel integrity (ASME Section VIII), and performance validation per ANSI/AAMI ST-8. Performance tests included Bowie & Dick, air-leak-rate, empty/full chamber thermal distribution, moisture retention, and biological performance (SAL 10^-6) for wrapped and IUSS loads.

Technological Characteristics

Chamber materials: 316/304 stainless steel. Energy: electrical grid. Vacuum: pump or ejector. Control: electronic computer. Standards: IEC 61010-1, IEC 61010-2-040, EN 61326-1, ASME Boiler and Pressure Vessel Code Section VIII, ANSI/AAMI ST-8. Connectivity: Remote PC Reporting (R.PC.R) application.

Indications for Use

Indicated for use by healthcare providers to sterilize heat-stable medical devices, including wrapped and unwrapped (IUSS) solids, hollow, and porous products via pressurized steam.

Regulatory Classification

Identification

A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

Predicate Devices

• 4472, 5596, 6690 and 66120 Horizontal Autoclave (K181456)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[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<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[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<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[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<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[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

{5}------------------------------------------------

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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image contains the logo for Tuttnauer. The logo features the word "Tuttnauer" in a bold, red font. Below the name are the words "Innovation, Legacy, Partnership" in a smaller, gray font. Above the name is a gray, star-like shape.

## Date Prepared: September 19, 2022

# 1. SUBMITTER

Tuttnauer USA Co. Ltd. 25 Power Drive Hauppauge, NY 11788 Phone: [phone] Fax: [phone]

## Contact Person:

Robert Basile Sr. Vice President Tuttnauer USA Co. Ltd. Tel: [phone] Ext: 137 Fax: [phone] E-mail: [e-mail]

# 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,<br>6690 and<br>66120<br>Horizontal<br>Autoclave | FLE | 21CFR880.6880 | Steam<br>Sterilizer | II | K181456 |

{7}------------------------------------------------

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.

{8}------------------------------------------------

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.

{9}------------------------------------------------

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<br>no. | Device description |
|--------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4472 | 4472-1V<br>4472-2V<br>4472-1R<br>4472-2R<br>4472-1V-L-USA<br>4472-1V-R-USA | An autoclave with a chamber volume of 120L, operating in 1Ph<br>115V/60Hz or 3Ph 220V/60Hz depending on the configuration<br>(see device manual).<br><br>This device can come with:<br>• one or two vertical sliding doors (1V or 2V) configuration, or<br>• one or two manual hinged doors configuration (1R or 2R).<br>With the piping to the left or right side of the device and,<br><br>Several steam generation options:<br>• EP – Electric Power – onboard steam generator<br>• SP - Steam comes from external source<br>• STS - Steam to Steam option, a unit supplied with the<br>configuration that cleans the external industrial steam. |
| Device model | Device catalog<br>no. | Device description |
| 5596 | 5596-1V<br>5596-2V<br>5596-1R<br>5596-2R<br>5596-2V-USA<br>5596-1V-L-USA<br>5596-1V-R-USA<br>5596-1R-L-USA<br>5596-1R-R-USA | An autoclave with a chamber volume of 250L, operating in 1Ph<br>115V/60Hz or 3Ph 400V/60Hz depending on the configuration<br>(see device manual).<br><br>This device can come with:<br>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,<br><br>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<br>6690-2A<br>6690LM-1V-USA<br>6690LM-2V-USA | An autoclave with a chamber volume of 430L, operating in 1Ph<br>115V/60Hz or 3Ph 208V/60Hz or 3Ph 400V/60Hz depending on<br>the configuration (see device manual).<br><br>This device can come with:<br>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,<br><br>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<br>66120-2V | An autoclave with a chamber volume 530L, operating in 1Ph<br>115V/60Hz or 1Ph 120V/60Hz depending on the configuration<br>(see device manual).<br><br>This device can come with:<br>one or two vertical sliding doors (1V or 2V) configuration With the piping to the left or right side of the device and,<br><br>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

{10}------------------------------------------------

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.

{11}------------------------------------------------

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 | Sterilization<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[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<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[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

{12}------------------------------------------------

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 | Sterilization<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[minute] | Maximum Load |
| IUSS* | 132 | 3 | 2 | Tools - 102.1 kg (225 lbs.) |
| Wrapped | 132 | 4 | 20 | Textile - 12 packs<br>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<br>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<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[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.

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for Tuttnauer. The logo is red and has the word "Tuttnauer" in a bold, sans-serif font. Below the name is the text "Innovation - Legacy - Partnership" in a smaller font. Above the name is a star-like symbol.

# 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 –<br>K221227 | 4472 –<br>under K181456 | Comparison |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for use | The horizontal autoclave<br>model 4472 is intended for<br>use by health care<br>providers to sterilize<br>medical products by means<br>of pressurized steam. The<br>device is an autoclave that<br>is intended to provide<br>sterilization of heat stable<br>medical devices: wrapped<br>and unwrapped (IUSS)<br>solids, hollow and porous<br>products. | The horizontal autoclave<br>model 4472 is intended for<br>use by health care<br>providers to sterilize<br>medical products by means<br>of pressurized steam. The<br>device is an autoclave that<br>is intended to provide<br>sterilization of heat stable<br>medical devices: wrapped<br>solids, hollow and porous<br>products. | Different |
| Parameter | 4472 -<br>K221227 | 4472 -<br>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<br>Principle /<br>sterilization method | Sterilization using steam as<br>sterilizing agent | Sterilization using steam as<br>sterilizing agent | Same |
| Sterilization cycle<br>types | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| Chamber Materials | 316 or 304 grade stainless<br>steal | 316 or 304 grade stainless<br>steal | Same |
| Energy source | The device can be operated<br>only while connected to an<br>electrical source (the<br>electrical grid).<br>It has no internal power<br>source (batteries). | The device can be operated<br>only while connected to an<br>electrical source (the<br>electrical grid).<br>It has no internal power<br>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

{14}------------------------------------------------

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.

{15}------------------------------------------------

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 -<br>K221227 | 5596 -<br>under K181456 | Comparison |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for use | The horizontal autoclave<br>model 5596 is intended for<br>use by health care<br>providers to sterilize<br>medical products by means<br>of pressurized steam. The<br>device is an autoclave that<br>is intended to provide<br>sterilization of heat stable<br>medical devices: wrapped<br>and unwrapped (IUSS)<br>solids, hollow and porous<br>products. | The horizontal autoclave<br>model 5596 is intended for<br>use by health care<br>providers to sterilize<br>medical products by means<br>of pressurized steam. The<br>device is an autoclave that is<br>intended to provide<br>sterilization of heat stable<br>medical devices: wrapped<br>solids, hollow and porous<br>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<br>Principle /<br>sterilization method | Sterilization using steam<br>as sterilizing agent | Sterilization using steam<br>as sterilizing agent | Same |
| Sterilization cycle<br>types | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| Chamber<br>Materials | 316 or 304 grade stainless<br>steal | 316 or 304 grade stainless<br>steal | Same |
| Energy source | The device can be<br>operated only while<br>connected to an electrical<br>source (the electrical grid).<br>It has no internal power<br>source (batteries). | The device can be<br>operated only while<br>connected to an electrical<br>source (the electrical grid).<br>It has no internal power<br>source (batteries). | Same |
| Controls | Electronic computer control | Electronic computer control | Same |
| Maximum load | · Tools (solids) - 34 kg (75<br>lbs.)<br>· Textile - 6 packs | • Tools (solids) – 23 kg<br>(50.7 lbs.)<br>• Textile – 22.2 kg | Different |
| Parameter | 5596 –<br>K221227 | 5596 –<br>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 |

{16}------------------------------------------------

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 –<br>K221227 | 6690 –<br>under K181456 | Comparison |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for use | The horizontal autoclave<br>model 6690 is intended for<br>use by health care<br>providers to sterilize<br>medical products by means<br>of pressurized steam. The<br>device is an autoclave that<br>is intended to provide<br>sterilization of heat stable<br>medical devices: wrapped<br>and unwrapped (IUSS)<br>solids, hollow and porous<br>products. | The horizontal autoclave<br>model 6690 is intended for<br>use by health care<br>providers to sterilize<br>medical products by means<br>of pressurized steam. The<br>device is an autoclave that<br>is intended to provide<br>sterilization of heat stable<br>medical devices: wrapped<br>solids, hollow and porous<br>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 –<br>K221227 | 6690 –<br>under K181456 | Comparison |
| Operating Principle /<br>sterilization method | Sterilization using steam<br>as sterilizing agent | Sterilization using steam<br>as sterilizing agent | Same |
| Sterilization cycle<br>types | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| Chamber<br>Materials | 316 or 304 grade stainless<br>steal | 316 or 304 grade stainless<br>steal | Same |
| Energy source | The device can be<br>operated only while<br>connected to an electrical<br>source (the electrical grid).<br>It has no internal power<br>source (batteries). | The device can be<br>operated only while<br>connected to an electrical<br>source (the electrical grid).<br>It has no internal power<br>source (batteries). | Same |
| Controls | Electronic computer<br>control, not programmable | Electronic computer<br>control, not programmable | Same |
| Maximum load | • Tools (solids) – 102.1 kg<br>(225 lbs.)<br>• Textile - 12 packs | • Tools (solids) - 46 kg<br>(101.4 lbs.)<br>• Textile - 33.3 kg | Different |
| Cycle parameters | • IUSS – sterilization<br>temp. of 132°C / 270°F<br>for 3min, dry time of<br>2min.<br>• Wrapped – sterilization<br>temp. of 132°C / 270°F<br>for 4min, dry time of<br>20min.<br>• IUSS delicate –<br>sterilization temp. of<br>121°C / 250°F for 30min,<br>dry time for 2min.<br>• Wrapped delicate –<br>sterilization temp of<br>121°C / 250°F for 30min,<br>dry time of 20min. | • IUSS – sterilization<br>temp. of 132°C / 270°F<br>for 3min, dry time of<br>1min.<br>• Wrapped – sterilization<br>temp. of 132°C / 270°F<br>for 4min, dry time of<br>20min.<br>• IUSS delicate –<br>sterilization temp. of<br>121°C / 250°F for 30min,<br>dry time for 1min.<br>• Wrapped delicate –<br>sterilization temp of<br>121°C / 250°F for 30min,<br>dry time of 20min. | Different |
| Parameter | 66120 –<br>K221227 | 66120 –<br>under K181456 | Comparison |
| Indication for use | The horizontal autoclave<br>model 66120 is intended<br>for use by health care<br>providers to sterilize<br>medical products by means<br>of pressurized steam. The<br>device is an autoclave that<br>is intended to provide<br>sterilization of heat stable<br>medical devices: wrapped<br>and unwrapped (IUSS)<br>solids, hollow and porous<br>products. | The horizontal autoclave<br>model 66120 is intended<br>for use by health care<br>providers to sterilize<br>medical products by means<br>of pressurized steam. The<br>device is an autoclave that<br>is intended to provide<br>sterilization of heat stable<br>medical devices: wrapped<br>solids, hollow and porous<br>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<br>Principle /<br>sterilization method | Sterilization using steam<br>as sterilizing agent | Sterilization using steam<br>as sterilizing agent | Same |
| Sterilization cycle<br>types | Pre & post vacuum | Pre & post vacuum | Same |
| Vacuum system | Vacuum pump or ejector | Vacuum pump | Different |
| Chamber<br>Materials | 316 or 304 grade stainless<br>steel | 316 or 304 grade stainless<br>steel | Same |
| Energy source | The device can be<br>operated only while<br>connected to an electrical<br>source (the electrical grid).<br>It has no internal power<br>source (batteries).…