(109 days)
Not Found
No
The description focuses on the mechanical and operational aspects of a steam sterilizer, with no mention of AI or ML capabilities.
No
The device is a sterilizer for medical devices, not a device used to provide therapy to a patient.
No
Explanation: The device is a steam sterilizer intended for sterilizing medical devices, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, steam-heated sterilizer (autoclave) with hardware components like a steam generator, vacuum system, and door mechanisms. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as sterilizing heat stable medical devices. This is a process performed on medical devices themselves, not on biological specimens from the human body for diagnostic purposes.
- Device Description: The description details a steam sterilizer (autoclave) used for physical sterilization. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
- Measuring analytes
The device is a medical device used in healthcare settings for the reprocessing of other medical devices. Its function is to render medical devices sterile, not to perform diagnostic tests.
N/A
Intended Use / Indications for Use
The pre-vacuum steam sterilizer models 3870HSG and 3870HSG-WS are in hospitals and other healthcare facilities (e.g. hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices) for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The autoclave models 3870HSG-WS and the 3870HSG are dynamic-air-removal steam-heated sterilizers that are using steam as the sterilizing agent, which are suitable for large medical centers, dental clinics and operating rooms for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.
The model 3870HSG-WS has an automatic door and is designed to be a fast cycle sterilizer that is mobile and can operate independent of building utilities due to its internal water reservoirs. The autoclave includes the option of water recycling, which allows the operator to manually fill the tap water reservoir with water that will be reused for 10 cycles, after which the reservoir is automatically drained and, in case the device is connected to a water inlet connection, be refilled automatically.
The model 3870HSG has an automatic door and is designed to be a fast cycle sterilizer. Contrary to the 3870HSG-WS, the 3870HSG need to be connected to the building utilities system (the water system). For both autoclave configurations (HSG/HSG-WS) a 9kW built-in steam generator is used to supply the steam for the sterilization process.
The autoclaves are Class B devices equipped with a vacuum system that allows:
- . 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.
- . Better steam penetration into the load; resulting in effective sterilization.
- . Better temperature uniformity.
- . Post sterilization drying phase - during the drying stage draws air through a HEPA filter (0.2um) and pushes that air through the heated chamber to remove moisture and facilitate the drying operation. Drying is performed with the door closed.
The autoclave models 3870HSG-WS and 3870HSG are stand-alone devices that do not need to interact with other devices or to interact with any person(s) or patient(s) besides the current device operator.
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
Intended Use / Indications for Use: in hospitals and other healthcare facilities (e.g. hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices)
Intended User: The autoclave models 3870HSG-WS and 3870HSG 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 non-clinical tests include:
Electrical Safety Testing: Verifying 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. Results: Pass.
EMC Testing: Verifying that the device meets EMC requirements based on EN 61326-1:2013 / IEC 61326-1:2012. Results: Pass.
Pressure Vessel Testing: Verifying that the pressure vessel used meets the requirements for pressure vessel and is safe for use based on ASME Boiler and pressure vessel code, Section VIII division 1. Results: Pass.
Bowie & Dick Test: Verify air removal performance (for dynamic air removal sterilizers) based on ANSI/AAMI ST-8. Acceptance criteria: The Bowie-Dick test indicator sheet shall show a uniform color change. Results: Pass.
Air-leak-rate (vacuum) test: Verify air removal performance (for dynamic air removal sterilizers) based on ANSI/AAMI ST-8. 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. Results: 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 based on ANSI/AAMI ST-8. 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. Results: 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 based on ANSI/AAMI ST-8. 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. Results: Pass.
Moisture retention tests - fabric PCD and wrapped instruments PCD: to ensure that the sterilizer is capable of meeting the moisture retention criteria based on ANSI/AAMI ST-8. Acceptance criteria: Moisture retained by the fabric PCD shall cause no more than a 3% increase in pre-sterilization test pack weight, and the pack shall exhibit no wet spots. When examined immediately after completion of the cycle, the wrapped instrument packs shall have no wet spots on the outer wrappers. Moisture retained by the 100% cotton towel shall cause no more than a 20% increase in the pre-sterilization weight of the towel. Results: Pass.
Biological performance with a textile PCD: Verifying 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. Results: Pass.
Biological performance with wrapped instrument PCD: Verifying 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. Results: Pass.
Biological performance with unwrapped instrument PCD (IUSS) – minimum and maximum load tests: Verifying 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 BIs. Growth should be observed for the positive control turbine and BI. Results: Pass.
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.
December 16, 2022
Tuttnauer LTD. Robert Basile Senior Vice President Har-Tuv Industrial Zone Beit-Shemesh. Jerusalem 9910101 Israel
Re: K222608
Trade/Device Name: Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: August 29, 2022 Received: August 29, 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).
Sincerelv.
Christopher K. Dugard -S
for Clarence W. Murray, III, Ph.D. 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
Indications for Use
510(k) Number (if known) K222608
Device Name
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
Indications for Use (Describe)
The pre-vacuum steam sterilizer models 3870HSG and 3870HSG-WS are in hospitals and other healthcare facilities (e.g. hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices) for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.
The following table show the preprogrammed cycles, including sterilization time (in minutes). dry time (in minutes) and maximum load:
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|× | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Cycle name | Sterilization
temperature
[°C] | Sterilization
Time
[minute] | Dry Time
[minute] | Maximum Load |
|------------------|--------------------------------------|-----------------------------------|----------------------|------------------------------------|
| IUSS | 134 | 4 | 2 | Tools - 12 kg (26.46 lbs.) |
| Wrapped | 134 | 4 | 20 | Textile - 2 packs |
| | 134 | 4 | 20 | Wrapped Tools - 12 kg (26.46 lbs.) |
| IUSS delicate | 121 | 20 | 2 | Tools - 12 kg (26.46 lbs.) |
| Wrapped delicate | 121 | 20 | 20 | Textile - 2 packs |
| | 121 | 20 | 20 | Wrapped Tools - 12 kg (26.46 lbs.) |
| Bowie and Dick | 134 | 3.5 | 2 | N/A |
| Vacuum test | N/A | N/A | N/A | N/A |
Table 1: standard cycles for model 3870HSG & 3870HSG-WS
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Image /page/4/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the company name in a bold, red font. Above the name is a gray, star-like shape. Below the name is the text "Innovation * Legacy * Partnership" in a smaller, gray font.
K222608 510(k) Summary
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
Date
August 29, 2022
Prepared:
2. DEVICE
Trade Name: Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
Common Name: Electronic Pre-vacuum Steam sterilizer (autoclave)
Classification:
| Regulation description: | Steam sterilizer |
|---|---|
| Regulation medical specialty: | General hospital |
| Product code: | FLE |
| Regulation number: | 880.6880 |
| Device class: | II |
3. PREDICATE DEVICES:
- Tuttnauer pre-vacuum horizontal autoclave model 5075HSG, which was cleared under ● K143311.
Product Code: FLE Regulation Number: 21CFR 880.6880
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Image /page/5/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, black font. Above the company name, there is a gray, star-like graphic.
4. DEVICE DESCRIPTION
The autoclave models 3870HSG-WS and the 3870HSG are dynamic-air-removal steam-heated sterilizers that are using steam as the sterilizing agent, which are suitable for large medical centers, dental clinics and operating rooms for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.
The model 3870HSG-WS has an automatic door and is designed to be a fast cycle sterilizer that is mobile and can operate independent of building utilities due to its internal water reservoirs. The autoclave includes the option of water recycling, which allows the operator to manually fill the tap water reservoir with water that will be reused for 10 cycles, after which the reservoir is automatically drained and, in case the device is connected to a water inlet connection, be refilled automatically.
The model 3870HSG has an automatic door and is designed to be a fast cycle sterilizer. Contrary to the 3870HSG-WS, the 3870HSG need to be connected to the building utilities system (the water system). For both autoclave configurations (HSG/HSG-WS) a 9kW built-in steam generator is used to supply the steam for the sterilization process.
The autoclaves are Class B devices equipped with a vacuum system that allows:
- . 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.
- . Better steam penetration into the load; resulting in effective sterilization.
- . Better temperature uniformity.
- . Post sterilization drying phase - during the drying stage draws air through a HEPA filter (0.2um) and pushes that air through the heated chamber to remove moisture and facilitate the drying operation. Drying is performed with the door closed.
The autoclave models 3870HSG-WS and 3870HSG are stand-alone devices that do not need to interact with other devices or to interact with any person(s) or patient(s) besides the current device operator.
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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 smaller black font underneath. Above the company name is a gray, four-pointed star-like shape.
The following tables show the properties for autoclave models 3870HSG-WS and 3870HSG:
| Property | Values |
|---|---|
| Chamber | Diam. ~15" (38cm) |
| Depth ~27" (68.5cm) | |
| Chamber volume | 3ft³ (85liters) |
| Max. Allowable Working pressure (MAWP) | ~40.6psi (2.8bar) |
| Net weight | ~701lbs (318kg) |
| Shipping weight | ~750lbs (340kg) |
| Floor loading requirements | According to the Overall weight and floor requirements |
| Max load | Fabric - 2 packs |
| Instruments - ~26.5 lbs. (12 kg) | |
| Tray dimensions | Big ~14" x ~26" x ~1" (35 x 67 x 2.5 cm) |
| Small ~11" x ~26" x ~1" (28 x 67 x 2.5 cm) | |
| No. of trays | 2 |
| Load No. counter | Counting from 0 to 999 and nullifies. |
Table 1: properties of model 3870HSG-WS and 3870HSG
Both autoclaves offer a choice of automatic programs designed to match the material to be sterilized. The programs included in the device are:
- . Programs for Un-wrapped Loads
- Programs for Wrapped Loads. .
- Two Test Programs: The Bowie & Dick Test and the Vacuum Test
A computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and printing of sterilization data. The selected program, the main phases of the cycle and the status of the machine are displayed on digital display. The device can display the pressure in psia, psig, or in kPa according to the operator's requirements. The operation of the autoclave is done via integrated keypad located below the screen.
For process documentation, the information concerning the cycles is printed from an integrated printer. By using the Remote PC Reporting application (R.PC.R) it is possible to generate Data and Trends reports on cycle data from the cycle data downloaded from the
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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. Above the name is a gray, star-like graphic. Below the name is the text "Innovation · Legacy · Partnership".
autoclave. Both models feature a built-in memory to record up to 100 sterilization cycles. These can be reprinted on the printer or exported to a USB device to be transferred to a PC (using the R.PC.R application).
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 |
|---|---|---|
| 3870HSG-WS | 3870HSG-WS-230-D | An autoclave with a chamber volume of 85L, operating in 3Ph 230V 50/60Hz with a generator of 9kW |
The autoclave is a stand-alone device with an internal water recycle system to allow several runs before replacing/filling the water |
| 3870HSG | 3870HSG-230-D | An autoclave with a chamber volume of 85L, operating in 3Ph 230V 50/60Hz with a generator of 9kW
The autoclave is a stand-alone device that needs to be connected to the site's water system to operate. |
Table 2: List of devices models in the current submission
6. INDICATION FOR USE
The pre-vacuum steam sterilizer models 3870HSG-WS and 3870HSG are intended for use in hospitals and other health-care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices) for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.
The following table show the preprogrammed cycles for each of the mentioned models, including sterilization temperature, sterilization time (in minutes), dry time (in minutes) and maximum load:
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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 a bold, red font. Above the word is a gray, star-like shape. Below the word are the words "Innovation · Legacy · Partnership" in a smaller, black font.
| Cycle name | Sterilization
temperature
[°C] | Sterilization
Time
[minute] | Dry Time
[minute] | Maximum Load |
|------------------|--------------------------------------|-----------------------------------|----------------------|------------------------------------|
| IUSS | 134 | 4 | 2 | Tools - 12 kg (26.46 lbs.) |
| Wrapped | 134 | 4 | 20 | Textile - 2 packs |
| | 134 | 4 | 20 | Wrapped Tools - 12 kg (26.46 lbs.) |
| IUSS delicate* | 121 | 20 | 2 | Tools - 12 kg (26.46 lbs.) |
| Wrapped delicate | 121 | 20 | 20 | Textile - 4 packs |
| | 121 | 20 | 20 | Wrapped Tools – 12 kg (26.46 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 models 3870HSG-WS and 3870HSG
Intended user
The autoclave models 3870HSG-WS and 3870HSG 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.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following technological characteristics will be compared between the subject horizontal autoclave models 3870HSG-WS and 3870HSG and the cleared predicate horizontal autoclave model 5075HSG under K143311:
- Indication for use
- General design of device: chamber volume, dimensions, door mechanism;
- Materials; ●
- Energy source; ●
- Performance: operation principle, sterilization cycle type, sterilization time, controls;
- Utilities .
- Sterilization parameters .
- Maximum load ●
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Image /page/9/Picture/0 description: The image contains the logo for Tuttnauer. The word "Tuttnauer" is written in large, red font. Below the name are the words "Innovation, Legacy, Partnership" in a smaller, black font. Above the name is a gray, star-like shape.
Reason for the 510(k):
Submission of a new device that is not marketed in the US.
| Table 4: Comparison of technological characteristics with predicate device |
|---|
| ---------------------------------------------------------------------------- |
| Parameter | 3870HSG | 3870HSG-WS | 5075HSG - under
K143311 | Comparison |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Indication for use | The pre-vacuum
steam sterilizer
models 3870HSG and
3870HSG-WS are
intended for use in
hospitals and other
health-care facilities
(e.g. hospitals,
nursing homes,
extended-care
facilities, freestanding
surgical centers,
clinics, and medical
and dental offices) for
the purpose of
sterilizing heat stable
medical devices:
wrapped and
unwrapped solids
(IUSS), hollow and
porous products. | The pre-vacuum
steam sterilizer
models 3870HSG
and 3870HSG-WS
are intended for use
in hospitals and
other health-care
facilities (e.g.
hospitals, nursing
homes, extended-
care facilities,
freestanding
surgical centers,
clinics, and medical
and dental offices)
for the purpose of
sterilizing heat
stable medical
devices: wrapped
and unwrapped
solids (IUSS),
hollow and porous
products. | The model 5075 is a
horizontal autoclave
designed for
sterilization of
wrapped and
unwrapped
instruments and
related items found
in dental, medical
and veterinary
clinics, first aid
rooms and
hospitals. | Different |
| Chamber
dimensions | ~15" (38cm) ID X
~27" (68.5cm) length | ~15" (38cm) ID X
~27" (68.5cm)
length | ~26" (49.4cm) ID X
~29.5" (75cm)
length | Different |
| Chamber volume | 3ft3 (85liters) | 3ft3 (85liters) | 5.65ft3 (160liters) | Different |
| Operating
Principle /
sterilization
method | Sterilization using
steam as sterilizing
agent | Sterilization using
steam as sterilizing
agent | Sterilization using
steam as sterilizing
agent | Same |
| Sterilization cycle
types | Pre & post vacuum | Pre & post vacuum | Pre & post vacuum | Same |
| Parameter | 3870HSG | 3870HSG-WS | 5075HSG – under
K143311 | Comparison |
| Chamber
Materials/water
path materials | 316 or 304 grade
stainless steal | 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). | 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 | Electronic computer
control | Same |
| Door mechanism | Automatic door | Automatic door | Manual door | Different |
| Water utilities | The device needs to
be connected to the
building water
utilities. | The device has
internal water
reservoirs that allow
it to be mobile and
independent of water
utilities | The device needs to
be connected to the
building water
utilities. | Same for the
3870HSG model
Different for the
3870HSG-WS
model. |
| Maximum load | • Tools (solids) –
12kg (26.46lbs.)
• Textile – 2 packs | • Tools (solids) –
12kg (26.46lbs.)
• Textile – 2 packs | • Tools (solids) –
15kg (33.07lbs.)
• Textile – 14kg
(30.86lbs.) | Different |
| Cycle parameters | • IUSS –
sterilization temp.
of 134°C / 273°F
for 4min, dry time
of 2min. | • IUSS –
sterilization temp.
of 134°C / 273°F
for 4min, dry time
of 1min. | • Unwrapped
instruments –
sterilization temp.
of 134°C / 273°F
for 4min, dry time
of 1min. | Different |
| | • Wrapped –
sterilization temp.
of 134°C / 273°F
for 4min, dry time
of 20min. | • Wrapped –
sterilization temp.
of 134°C / 273°F
for 4min, dry time
of 20min. | • Wrapped –
sterilization temp.
of 134°C / 273°F
for 4min, dry time
of 20min. | |
| | • IUSS delicate –
sterilization temp | • IUSS delicate –
sterilization temp | | |
| Parameter | 3870HSG | 3870HSG-WS | 5075HSG - under
K143311 | Comparison |
| | of 121°C / 250°F
for 20min, dry
time for 2min.
• Wrapped delicate
– sterilization
temp of 121°C /
250°F for 20min,
dry time of
20min. | of 121°C / 250°F
for 20min, dry
time for 1min.
• Wrapped delicate
– sterilization
temp of 121°C /
250°F for 20min,
dry time of
20min. | • Unwrapped
delicate
instruments –
sterilization temp.
of 121°C / 250°F
for 20min, dry
time for 1min.
Wrapped delicate –
sterilization temp of
121°C / 250°F for
20min, dry time of
20min. | |
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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 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 | The Bowie-Dick test
indicator sheet shall | • ANSI/AAMI
ST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results
(Pass /
No Pass) |
| | dynamic air
removal sterilizers) | show a uniform
color change | | |
| 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 |
| 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 | • ANSI/AAMI
ST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results
(Pass /
No Pass) |
| | | shall exhibit no wet
spots. | | |
| | | When examined
immediately after
completion of the
cycle, the wrapped
instrument packs
shall have no wet
spots on the outer
wrappers. Moisture
retained by the 100%
cotton towel shall
cause no more than a
20% increase in the
pre-sterilization
weight of the towel. | | |
| 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 | Pass |
| Biological
performance with
wrapped
instrument PCD | Verifying
biological
performance on
half sterilization
time | Tested cycle has a
$10^{-6}$ SAL or an SAL
providing a greater
assurance of sterility
when the wrapped
instrument PCD is
used. | • ANSI/AAMI
ST-8 | Pass |
| Biological
performance with
unwrapped
instrument PCD
(IUSS) –
minimum and
maximum load
tests | Verifying
biological
performance on
half sterilization
time | There shall be no
growth observed in
the vials containing
turbines or in the
extraction of any of
the turbines, except
for the positive
controls. No growth
shall be observed
with the BIs except
the positive control
BIs. Growth should | • ANSI/AAMI
ST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results
(Pass /
No Pass) |
| | | be observed for the
positive control
turbine and BI. | | |
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Image /page/14/Picture/0 description: The image is a logo for Tuttnauer. The logo features the word "Tuttnauer" in a bold, red font. Above the word is a gray, star-like shape. Below the word are the words "Innovation · Legacy · Partnership" in a smaller, black font.
9. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the subject device, the autoclaves models 3870HSG and 3870HSG-WS, are as safe, as effective, and performs as well as or better than the legally marketed device cleared under K143311.