Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a computerized control unit for automated sterilization cycles and monitoring, but there is no mention of AI or ML capabilities for learning, adaptation, or complex pattern recognition beyond standard automation.

Therapeutic

No.
The devices are designed for the sterilization of medical and surgical goods, not for therapeutic use on patients. They are used in healthcare facilities to prepare instruments for use, not to treat patients directly.

Diagnostic

No.
The T-Top 10 & T-Top 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical autoclave with numerous hardware components (heating elements, vacuum system, chamber, door, etc.) and the software controls these physical components.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as the "sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities". This describes a process for making medical devices safe for use, not a test performed on biological samples to diagnose a condition.
Device Description: The description details an autoclave that uses steam for sterilization. It focuses on the physical process of sterilization and the features that support this process (vacuum system, heating elements, controls). There is no mention of analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.

The device is a sterilizer, which is a type of medical device used to prepare other medical devices for use. It does not perform in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The T-Top 10 & T-Top 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices).

The T-Top 10 and T-Top 11 devices are validated for use in:

Unwrapped instruments, wrapped instruments and dental handpieces (Class S cycles).
Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads (Class B cycles).

Product codes (comma separated list FDA assigned to the subject device)

FLE

Device Description

The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle. Drying is performed with the door closed).

This autoclave uses steam as a sterilizing agent.

The steam is produced by warming up a controlled amount of water inserted to a pipe heating element, and then to the chamber. This technique saves energy and water consumption.

The autoclave is equipped with a Pipe heating element and with chamber heaters to maintain the steam inside the chamber.

The autoclave is equipped with a vacuum system, which supports and improves:

Removal of residual air from packs and porous load and most kinds of tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle.
Steam penetration into the load; resulting in effective sterilization.
Temperature uniformity.
Post sterilization drying phase

A touchscreen is used for monitoring and control purposes.

The device has 2 built -in USB ports to enable the operation of an external optional barcode printer:

The barcode printer can print labels with a unique cycle ID barcode, operator name, . sterilization and expiry dates
One barcode printer can be connected to the machine.
The printer connection to the machine, by using a USB socket, with a dedicated cable .
Barcode printer power supply voltage can range between 100-240V (external power . supply - not from the USB socket).
A barcode printer is an optional addition to the autoclave

The device features built-in memory to record up to 500 sterilization cycles. These can be exported to a USB device to be transferred to a PC.

The steam for the sterilization process is produced by warming up a controlled amount of demineralized water that is inserted into a pipe heating element and then flows into the chamber as steam. This technique is used as a way of reducing water consumption and saving energy. The autoclave is equipped with a heating element wrapped around the chamber to maintain the required temperatures and steam for the sterilization process. All of these processes are done via the computerized control system of the device.

The door's locking mechanism is designed to allow closing/opening the door, easily, with one hand.

The chamber door has the following features protecting personnel from hazards:

One door micro-switch that indicate that the door is closed. Without this indication steam is . not introduced into the chamber. The micro-switch prevents opening the door while the chamber is pressurized and at the end of cycle until chamber pressure equalizes to room pressure.
An electrical door locking pin that blocks door opening during cycle operation. .

In addition, the following safety devices are installed in the autoclave to optimize its safe operation:

A safety thermostat to prevent over-heating of the chamber heating elements. .
A safety cut-off switch to prevent over heating of the pipe heating element. .
A pressure safety valve to prevent over-pressurizing of the chamber. .

The T-Top 10 autoclave has one configuration only, whereas T-Top 11 has two configurations (available upon request) - a manually filled reservoir of demineralized water or an automatic / direct inlet of demineralized water from the water supply system. The T-Top 10 has a manually filled reservoir of demineralized water only.

There is a demineralized water overflow outlet at the rear, and a demineralized water overflow, and wastewater outlet is located on front.

Automatic water quality checking will alert the user of poor water quality, protecting the autoclave chamber from corrosive minerals found in poor quality water.

The T-Top 10 & T-Top 11 feature a built-in memory to record up to 500 sterilization cycles. The T-Top 10 & T-Top 11 have a built-in USB port to enable exporting this data to a USB device, to be transferred to a PC.

The built-in USB port also enables the operation of an external, optional barcode printer, by using a dedicated cable - the barcode printer can print labels with a unique cycle ID barcode, operator's name, sterilization and expiry dates. One barcode printer can be connected to the machine.

There is Wi-Fi connection available to customers (optional). If the unit is connected to Wi-Fi, this enables remote diagnostics and issue resolution from Tuttnauer. The software has been validated and cybersecurity has been considered for this option.

The chamber is made of a corrosion-resistant 304L stainless steel, and the door is made of corrosion-resistant 304L stainless steel. The outer covers are made of polycarbonate.

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 T-Top 10 & T-Top 11 Table-Top autoclave 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.

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)

Performance Testing included tests for:

Electrical Safety: Verified that device and its components meet electrical safety requirements based on IEC 61010-1:2010, UL 61010-1:2012, and IEC 61010-2-040:2015. Result: Pass.
EMC: Verified that the device meets EMC requirements based on EN 61326-1:2013 / IEC 61326-1:2012 and FCC part 15, subpart B. Result: Pass.
Software validation: Verified that the SW used meets standard requirements based on IEC 62304-2006+A1:2015. Result: Pass.
Pressure vessel testing: Verified that the pressure vessel used for the T-Edge meets the requirements for pressure vessel and is safe for use based on ASME Boiler and pressure vessel code, Section VIII division 1. Result: Pass.
Device performance tests:
- Bowie & Dick test: Verified air removal performance (for dynamic air removal sterilizers). Acceptance criteria: The Bowie-Dick test indicator sheet shall show a uniform color change. Standard: ANSI/AAMI ST-55. Result: Pass.
- Air-leak-rate (vacuum) test: Verified air removal performance (for dynamic air removal sterilizers). Acceptance criteria: average leak rate of 1 millimeter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less over the measured time interval. Standard: ANSI/AAMI ST-55. Result: Pass.
- Empty chamber tests (250F/273F) – on wrapped and unwrapped load: Ensured 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. Acceptance criteria: 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. Standard: ANSI/AAMI ST-55. Result: Pass.
- Full chamber load test (250F/273F) – on wrapped and unwrapped load: Ensured 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. Acceptance criteria: 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. Standard: ANSI/AAMI ST-55. Result: Pass.
- Biological performance with a textile PCD: Verified biological performance. Acceptance criteria: Tested cycle has a 10-6 SAL or an SAL providing a greater assurance of sterility when the textile PCD is used. Standard: ANSI/AAMI ST-55. Result: Pass.
- Biological performance with wrapped instrument PCD: Verified biological performance. 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. Standard: ANSI/AAMI ST-55. Result: Pass.
- Biological performance with dental handpieces: Verified biological performance. 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. Standard: ANSI/AAMI ST-55. Result: Pass.

The conclusions drawn from the nonclinical tests demonstrate that the subject device, T-Top 10 & T-Top 11, are as safe, as effective, and performs as well as or better than the legally marketed device

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.

K213080

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

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 27, 2023

Tuttnauer U.S.A Co, Ltd Jonathan Lane Global QA RA Manager 25 Power Drive Hauppauge New York, New York 11788

Re: K232658

Trade/Device Name: T-Top (T-Top 10); T-Top (T-Top 11) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: August 4, 2023 Received: August 31, 2023

Dear Jonathan Lane:

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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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,

Christopher K. Dugard -S

Christopher K. Dugard, M.S. Assistant Director

2

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

3

Indications for Use

510(k) Number (if known) K232658

Device Name T-Top 10 & T-Top 11

Indications for Use (Describe)

The T-Top 10 & T-Top 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices).

The T-Top 10 and T-Top 11 devices are validated for use in:

· Unwrapped instruments, wrapped instruments and dental handpieces (Class S cycles).
· Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads (Class B cycles).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the company name in red, with the words "Innovation, Legacy, Partnership" in a smaller font below. Above the company name is a gray diamond shape. The logo is simple and modern, and the colors are eye-catching.

Date Prepared: August 01, 2023

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

Regulation Name:

Trade Name: T-Top 10 & T-Top 11 Common Name: Electronic autoclave Classification Name: Steam Sterilizer Classification: Product Code FLE Regulatory Class: II Regulation Number: 21CFR 880.6880

3. PREDICATE DEVICES

Primary predicate: T-Edge 10 & T-Edge 11 autoclave

Steam Sterilizer

Predicate name	Product Code	Regulation Number
T-Edge 10 &
T-Edge 11	FLE	21CFR
880.6880	Steam
Sterilizer	Class II	K213080

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Image /page/5/Picture/1 description: The image contains the logo for Tuttnauer. The logo features the company name in bold, red lettering. Below the name are the words "Innovation, Legacy, Partnership" in a smaller, dark font. Above the company name is a gray, diamond-shaped graphic.

4. DEVICE DESCRIPTION

The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle. Drying is performed with the door closed).

This autoclave uses steam as a sterilizing agent.

The steam is produced by warming up a controlled amount of water inserted to a pipe heating

element, and then to the chamber. This technique saves energy and water consumption.

The autoclave is equipped with a Pipe heating element and with chamber heaters to maintain the steam inside the chamber.

The autoclave is equipped with a vacuum system, which supports and improves:

. Removal of residual air from packs and porous load and most kinds of tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle.
. Steam penetration into the load; resulting in effective sterilization.
. Temperature uniformity.
. Post sterilization drying phase

A touchscreen is used for monitoring and control purposes.

The device has 2 built -in USB ports to enable the operation of an external optional barcode printer:

The barcode printer can print labels with a unique cycle ID barcode, operator name, . sterilization and expiry dates
. One barcode printer can be connected to the machine.
The printer connection to the machine, by using a USB socket, with a dedicated cable .
Barcode printer power supply voltage can range between 100-240V (external power . supply - not from the USB socket).
. A barcode printer is an optional addition to the autoclave

The device features built-in memory to record up to 500 sterilization cycles. These can be exported to a USB device to be transferred to a PC.

The following tables show the cycles that were validated for Class-B and Class-S, including sterilization temperature, sterilization time in minutes and dry time in minutes:

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Image /page/6/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the company name in red, with the words "Innovation, Legacy, Partnership" in a smaller font below. Above the company name is a gray, star-like shape. The logo is simple and modern, and the red color is eye-catching.

Table 1: Class B key cycles

#	Cycle Name	Sterilization temperature [°F/°C]	Sterilization time [min]	Dry Time [min]		Max load 10" [Kg]	Max load 11" [Kg]
				10"	11"
1	Unwrapped instruments 273F	273.2°F (134°C)	4	2	2	6	9
2	Wrapped Pouches 273F	273.2°F (134°C)	4	22	26	Instruments – 3.6
Textile – 1.5	Instruments – 5.4
Textile – 2
Handpieces – 5 units
3	Wrapped Pouches 273F / 2kg	273.2°F (134°C)	4	15	15	Instruments – 1.8
Textile – 0.75	Instruments – 2.7
Textile – 1
Handpieces – 3 units
4	Unwrapped Delicate 250F	249.8°F (121°C)	20	2	2	6	9
5	Wrapped Delicate 250F	249.8°F (121°C)	20	25	30	Instruments – 3.6
Textile – 1.5	Instruments – 5.4
Textile – 2
6	B&D Test	273.2°F (134°C)	3.5	2		-	-
7	Vacuum Test	NA	NA	NA		-	-
8	System Clean	NA	NA	NA		-	-

*Wrapped pouches 273F partial load will not be tested because this is the same program as Wrapped pouches 273F, except for a different drying time. Wrapped pouches 273F was tested at full load and this is the worst case. Therefore, in this cycle, only dryness will be tested.

#	Cycle Name	Sterilization temperature [°F/°C]	Sterilization time [min]	Dry Time [min]		Max load 10" [Kg]	Max load 11" [Kg]
				10"	11"
1	Unwrapped instruments 270F	269.6°F (132°C)	4	2	2	5	8
2	Wrapped Pouches 270F	269.6°F (132°C)	4	25	26	3.6	4.5
3	Wrapped Pouches 270F / 2kg	269.6°F (132°C)	4	15	15	1.8	2.3
4	Unwrapped Delicate 250F	249.8°F (121°C)	20	2	2	5	8
5	Handpieces 270F	269.6°F (132°C)	4	22	26	5 units	5 units

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Image /page/7/Picture/1 description: The image contains 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 steam for the sterilization process is produced by warming up a controlled amount of demineralized water that is inserted into a pipe heating element and then flows into the chamber as steam. This technique is used as a way of reducing water consumption and saving energy. The autoclave is equipped with a heating element wrapped around the chamber to maintain the required temperatures and steam for the sterilization process. All of these processes are done via the computerized control system of the device.

The door's locking mechanism is designed to allow closing/opening the door, easily, with one hand.

The chamber door has the following features protecting personnel from hazards:

One door micro-switch that indicate that the door is closed. Without this indication steam is . not introduced into the chamber. The micro-switch prevents opening the door while the chamber is pressurized and at the end of cycle until chamber pressure equalizes to room pressure.
An electrical door locking pin that blocks door opening during cycle operation. .

In addition, the following safety devices are installed in the autoclave to optimize its safe operation:

A safety thermostat to prevent over-heating of the chamber heating elements. .
A safety cut-off switch to prevent over heating of the pipe heating element. .
A pressure safety valve to prevent over-pressurizing of the chamber. .

The T-Top 10 autoclave has one configuration only, whereas T-Top 11 has two configurations (available upon request) - a manually filled reservoir of demineralized water or an automatic / direct inlet of demineralized water from the water supply system. The T-Top 10 has a manually filled reservoir of demineralized water only.

There is a demineralized water overflow outlet at the rear, and a demineralized water overflow, and wastewater outlet is located on front.

Automatic water quality checking will alert the user of poor water quality, protecting the autoclave chamber from corrosive minerals found in poor quality water.

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Image /page/8/Picture/1 description: The image shows the logo for Tuttnauer. The logo features the company name in red, with the words "Innovation, Legacy, Partnership" in a smaller font below. Above the company name is a gray, diamond-like shape.

The T-Top 10 & T-Top 11 feature a built-in memory to record up to 500 sterilization cycles. The T-Top 10 & T-Top 11 have a built-in USB port to enable exporting this data to a USB device, to be transferred to a PC.

The built-in USB port also enables the operation of an external, optional barcode printer, by using a dedicated cable - the barcode printer can print labels with a unique cycle ID barcode, operator's name, sterilization and expiry dates. One barcode printer can be connected to the machine.

There is Wi-Fi connection available to customers (optional). If the unit is connected to Wi-Fi, this enables remote diagnostics and issue resolution from Tuttnauer. The software has been validated and cybersecurity has been considered for this option - see software reports in the 510(k) file.

The chamber is made of a corrosion-resistant 304L stainless steel, and the door is made of corrosion-resistant 304L stainless steel. The outer covers are made of polycarbonate.

The properties of the T-Top 10 & T-Top 11 are as described in the following table:

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Image /page/9/Picture/0 description: The image contains the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name, there is a tagline that reads "Innovation · Legacy · Partnership" in a smaller, gray font. Above the company name, there is a gray, star-like shape.

Table 4: T-Top 10 & T-Top 11 properties

Property	Value	T-Top 10	T-Top 11
External size	Width	~18" (46.2 cm)	~19.5" (49.7 cm)
	Height	~18" (46 cm)	~17.5" (44.7 cm)
	Depth	~23.5" (58.5 cm) (supporting common install base carry a ~23" (60 cm) countertop)
Chamber	Diameter	~9.8" (249 cm)	~11" (28 cm)
	Depth	~17.7" (45 cm)	~17.7" (45.2 cm)
	Volume	~732 Ounces (20.8 Lit)	~936 Ounces (26.6 Lit)
	Usable chamber space	75% (~549 Ounces/~15.6 Lit)	75% (~685 Ounces/~20 Lit)
Max. Allowable Working pressure (MAWP)		~40.6 PSI (2.8 bar)
Safety relief valve		~40 PSI (2.8 bar)
Net weight		~99 lbs (45 kg)	~115 lbs (52 kg)
Shipping weight		~112 lbs (51 kg)	~125.6 lbs (57 kg)
Floor loading requirements		~165 lbs (75 kg)
Max load	Solid /Unwrapped	~13 lbs (6 kg)	~19.8 lbs (9 kg)
	Solid /Wrapped	~7.7 lbs (3.5 kg)	~11.9 lbs (5.4 kg)
	Textile	~3.3 lbs (1.5 kg)	~4.4 lbs (2 kg)
Maximum load per tray	Unwrapped	~2.67 lbs (1.2 kg)	~4 lbs (1.8 kg)
	Wrapped	~1.6 lbs (0.72 kg)	~2.4 lbs (1.08 kg)
Tray dimensions		~14.7" x ~7.3" x ~0.6"
(37.5 cm x 18.5cm x 1.5 cm)	~14.7" x ~8.14" x ~0.6"
(37.5 cm x 20.7cm x 1.5 cm)
No. of trays		4
Mineral-free water reservoir	Max. water volume	~122 Ounces (3.6 Lit)
Overflow ~237 Ounces (7 Lit)
	Min. water volume	~45.6 Ounces (1.35 Lit) (up to the float)
Used (waste) water reservoir	Max. water volume	~127 Ounces / (3.75 Lit) – up to float
~182.5 Ounces (182.5 Lit.) - overflow
Load No. counter		Counting from 0 to 500 and nullifies

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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 are the words "Innovation, Legacy, Partnership" in a smaller font. Above the name is a gray, star-like shape.

Only United States Food and Drug Administration cleared accessories such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes should be used with this autoclave.

5. LIST OF DEVICES

Table 5: List of devices models in the current submission

Device model	Device catalogue no.	Device description
T-Top 10 230V PED /
ASME	T-Top-10-230V-PED /
ASME	An autoclave with a 10" diameter chamber and with a volume of 20.8L (~732 Oz), operating in 230V/1Ph (50/60Hz).
The demineralized water is supplied by a manually filled reservoir.
T-Top 10 120V PED /
ASME	T-Top-10-120V-PED /
ASME	An autoclave with a 10" diameter chamber and with a volume of 20.8L (~732 Oz), operating in 120V/1Ph (50/60Hz).
The demineralized water is supplied by a manually filled reservoir.
T-Top 11 230V PED /
ASME	T-Top-11-230V-PED /
ASME	An autoclave with a 11" diameter chamber and with a volume of 26.6L (~936 Oz), operating in 230V/1Ph (50/60Hz).
The demineralized water is supplied by a manually filled reservoir. There is also an option to have automatic filled via demineralized water inlet.

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Device model	Device catalogue no.	Device description
T-Top 11 120V PED /
ASME	T-Top-11-120V-PED /
ASME	An autoclave with a 11" diameter chamber and with a volume of 26.6L (~936 Oz), operating in 120V/1Ph (50/60Hz). The demineralized water is supplied by a manually filled reservoir. There is also an option to have automatic filled via demineralized water inlet.

All products if provided with a Printer will have a -P at the end of the product catalogue number.

6. INDICATION FOR USE

The T-Top 10 & T-Top 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices).

The T-Top 10 and T-Top 11 devices are validated for use in:

Unwrapped instruments, wrapped instruments and dental handpieces (Class S cycles).
. Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads (Class B cycles).

Intended user

The T-Top 10 & T-Top 11 Table-Top autoclave 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 T-Top family (T-Top 10 & T-Top 11) and the cleared predicate devices, the T-Edge 10 and T-Edge 11:

General design of device: chamber volume, control system;
Indication for use and intended users .
Materials: ●
Energy source; ●
Performance;
Sterilization parameters ●

Reason for the 510(k):

Modification of a legally marketed device that would not otherwise qualify for a Special 510(k). The T-Top 10 & T-Top 11 are class II device, equivalent to the predicate cleared devices, T-Edge 10 and T-Edge 11 (K213080) but changes made exceeds the limitations for a special 510(k) and thus the device requires a traditional 510(k).

The Operating system of T-Top devices is based on Linux (using Java as the programing language) which is the same as in the predicate device T-Edge.

The T-Top 10 and T-Top 11 offers a half-load cycle with adjusted drying time, whereas the T-Edge 10 and T-Edge 11 does not have this cycle.

The chamber volume of the T-Top 10 corresponds to the 10" chamber. It is different as the T-Edge 10 holds for 23L whereas the T-Top 10 holds 20.8L. The chamber volume of the T-Top 11 corresponds to the 11" chamber. It is different as the T-Edge 11 holds for 27.2L whereas the T-Top 11 holds 26.6L.

| Parameter | T-Edge
K213080 | T-Top | Comparison |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chamber volume | This device is a single
door table-top
autoclave with a
chamber volume of: | This device is a single
door table-top
autoclave with a
chamber volume of: | Different. |
| Parameter | T-Edge
K213080 | T-Top | Comparison |
| | 23L (~778 ounces) for
the T-Edge 10
27.2L (~913 ounces)
for the T-Edge11. | 20.8L (~732 ounces)
for the T-Top 10
26.6L (~936 ounces)
for the T-Top 11. | The 10" T-Edge holds
23L whereas the 10"
T-Top holds 20.8L
The 11" T-Edge holds
27.2L whereas the 11"
T-Top holds 26.6L |
| Control system | The device is
software controlled
with electronic
control panel that
permits automatic
usage. | The device is software
controlled with
electronic control
panel that permits
automatic usage. | Same |
| | The device is non-
programmable. | The device is non-
programmable. | Same |
| | The Operating system
is Linux (programming
language is Java). | The Operating system
is Linux (programming
language is Java). | Same |
| Indication for use | The T-Edge 10 & T-
Edge 11 are tabletop
autoclaves designed
for the sterilization of
medical and surgical
goods such as
wrapped and
unwrapped solid,
hollow, and porous
loads used in health
care facilities (e.g.,
hospitals, nursing
homes, extended-care
facilities, freestanding
surgical centers,
clinics, and medical
and dental offices). | The T-Top 10 & T-
Top 11 are tabletop
autoclaves designed
for the sterilization of
medical and surgical
goods such as
wrapped and
unwrapped solid,
hollow, and porous
loads used in health
care facilities (e.g.,
hospitals, nursing
homes, extended-care
facilities, freestanding
surgical centers,
clinics, and medical
and dental offices). | Same |
| Parameter | T-Edge
K213080 | T-Top | Comparison |
| Materials | The outer cover of the
device is made of
polycarbonate. | The outer cover of the
device is made of
polycarbonate. | Same |
| | The chamber is made
of 316L stainless
steel. | The chamber is made
of 304L stainless
steel. | Different.
304L is a different
grade of stainless steel
however the material
holds the required
properties for an
autoclave chamber. |
| | The door is made of
304L stainless steel. | The door is made of
304L 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 | The device can be
operated only while
connected to an
electrical source (the
electrical grid).
It has no internal
power source | Same |
| | (batteries). | (batteries). | |
| Performance | The operation
principle is
sterilization by
heating a controlled
amount of
demineralized water
to generate steam as
the sterilization
reagent and
maintaining its
temperature by using
a heating element
surrounding the | The operation
principle is
sterilization by
heating a controlled
amount of
demineralized water
to generate steam as
the sterilization
reagent and
maintaining its
temperature by using
a heating element
surrounding the | Same |
| | chamber. The water is | chamber. The water is | |
| Parameter | T-Edge
K213080 | T-Top | Comparison |
| | drawn from a built-in
water reservoir. | drawn from a built-in
water reservoir. | |
| | The heating of the
water to generate the
steam is done by
using a water pipe
heater and the heating
element used is metal
jacket. | The heating of the
water to generate the
steam is done by
using a water pipe
heater and the heating
element used is metal
jacket. | Same |
| | The T-Edge 10 & T-
Edge 11 have a
vacuum mechanism to
allow better air
removal of air pockets
in the load for an
effective sterilization
(i.e., pre-vacuum) and
to allow drying of the
load at the end of the
sterilization process.
This possibility exists
as the T-Edge 10 &
T-Edge 11 can be
switched between S-
class cycles and B-
class cycles. | The T-Top 10 & T-
Top 11 have a
vacuum mechanism to
allow better air
removal of air pockets
in the load for an
effective sterilization
(i.e., pre-vacuum) and
to allow drying of the
load at the end of the
sterilization process.
This possibility exists
as the T-Edge 10 & T-
Edge 11 can be
switched between S-
class cycles and B-
class cycles. | Same |
| Sterilization
parameters | The T-Edge 10 & T-
Edge 11 have both
Class-B and Class-S
cycles and it can be
switched between
modes.
The sterilization
parameters for the
Class-B cycles (see
Table 1 Section 4 in | The T-Top 10 & T-
Top 11 have both
Class-B and Class-S
cycles and it can be
switched between
modes.
The sterilization
parameters for the
Class-B cycles (see
Table 1 Section 4 in | Same |
| Parameter | T-Edge
K213080 | T-Top | Comparison |
| | - Unwrapped
instruments: temp.
134°C/273.2°F for
4 minutes. | - Unwrapped
instruments: temp.
134°C/273.2°F for
4 minutes. | |
| | - Wrapped pouches:
temp.
134°C/273.2°F for
4 minutes. | - Wrapped pouches:
temp.
134°C/273.2°F for
4 minutes. | |
| | - Unwrapped
delicate: temp.
121°C/249.8°F for
20 minutes. | - Unwrapped
delicate: temp.
121°C/249.8°F for
20 minutes. | |
| | - Wrapped delicate:
temp.
121°C/249.8°F for
20 minutes. | - Wrapped delicate:
temp.
121°C/249.8°F for
20 minutes. | |
| | The sterilization
parameters for the
Class-S cycles (see
Table 2 Section 4 in
this document): | The sterilization
parameters for the
Class-S cycles (see
Table 2 Section 4 in
this document): | |
| | - Unwrapped
instruments: temp.
132°C/269.6°F for
4 minutes | - Unwrapped
instruments: temp.
132°C/269.6°F for
4 minutes | |
| | - Wrapped pouches:
temp.
132°C/269.6°F for
4 minutes | - Wrapped pouches:
temp.
132°C/269.6°F for
4 minutes | |
| | - Unwrapped
delicate: temp.
121°C/249.8°F for
20 minutes | - Unwrapped
delicate: temp.
121°C/249.8°F for
20 minutes | |
| Parameter | T-Edge
K213080 | T-Top | Comparison |
| | - Handpieces: temp.
132°C/269.6°F for
4 minutes | Handpieces: temp.
132°C/269.6°F for
4 minutes | |

Table 6: Comparison of technological characteristics with predicate devices

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8. PERFORMANCE TESTING

| 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
• FCC part 15,
subpart B | Pass |
| Software
validation | Verifying that the
SW used meets
standard
requirements | Meeting standard
specification | • IEC 62304-
2006+A1:2015 | Pass |
| Pressure vessel
testing | Verifying that the
pressure vessel
used for the T-
Edge meets the
requirements for
pressure vessel and
is safe for use. | Meeting standard
specification | • ASME Boiler
and pressure
vessel code,
Section VIII
division 1 | 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-55 | 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-55 | Pass |
| Empty chamber
tests (250F/273F) | to ensure that | The temperature
shall not exceed | • ANSI/AAMI
ST-55 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results
(Pass /
No Pass) |
| – on wrapped and
unwrapped load | the sterilizer is
capable of
providing steady-
state thermal
conditions within
the chamber
consistent with the
desired sterility
assurance level
(SAL) in the load | more than 3°C above
the sterilization
temperature.
The temperature
shall not be below
the sterilization
temperature
Actual exposure
time | | |
| Full chamber load
test (250F/273F)
– on wrapped and
unwrapped 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-55 | Pass |
| Biological
performance with
a textile PCD | Verifying
biological
performance | 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-55 | Pass |
| Biological
performance with
wrapped
instrument PCD | Verifying
biological
performance | 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-55 | Pass |
| Biological
performance with
dental handpieces | Verifying
biological
performance | There shall be no
growth observed in
the vials containing
turbines or in the
extraction of any of
the turbines, except | • ANSI/AAMI
ST-55 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results
(Pass /
No Pass) |
| | | 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. | | |

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510(k) Summary K232658 Device name: T-Top

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9. CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the subject device, T-Top 10 & T-Top 11, are as safe, as effective, and performs as well as or better than the legally marketed device