(109 days)
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 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.
The provided text describes the acceptance criteria and the results of a study conducted for the Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS. This is a medical device (a sterilizer), and the study focuses on its performance in sterilizing medical devices.
Here's an breakdown of the information requested based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
| Test Name | Purpose | Acceptance Criteria (from document) | Reported Device Performance (Results) |
|---|---|---|---|
| Electrical Safety | Verifying that device and its components meet electrical safety requirements. | Meeting standard specification | Pass |
| EMC | Verifying that the device meets EMC requirements. | Meeting standard specification | Pass |
| Pressure vessel testing | Verifying that the pressure vessel used for the T-Edge meets the requirements for pressure vessel and is safe for use. | Meeting standard specification | Pass |
| Bowie & Dick test | Verify air removal performance (for dynamic air removal sterilizers). | The Bowie-Dick test indicator sheet shall show a uniform color change. | Pass |
| Air-leak-rate (vacuum) test | Verify air removal performance (for dynamic air removal sterilizers). | Average leak rate of 1 millimeter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less over the measured time interval. | Pass |
| Empty chamber tests (121°C/132°C) - on wrapped and unwrapped (IUSS) load | To ensure that the sterilizer is capable of providing steady-state thermal conditions within the chamber consistent with the desired sterility assurance level (SAL) in the load. | The temperature shall not exceed more than 3°C above the sterilization temperature. The temperature shall not be below the sterilization temperature. Actual exposure time. | 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. | Pass |
| Moisture retention tests - fabric PCD and wrapped instruments PCD | To ensure that the sterilizer is capable of meeting the moisture retention criteria. | Moisture retained by the fabric PCD shall cause no more than a 3% increase in pre-sterilization test pack weight, and the pack shall exhibit no wet spots. When examined immediately after completion of the cycle, the wrapped instrument packs shall have no wet spots on the outer wrappers. Moisture retained by the 100% cotton towel shall cause no more than a 20% increase in the pre-sterilization weight of the towel. | Pass |
| Biological performance with a textile PCD | Verifying biological performance on half sterilization time. | Tested cycle has a 10⁻⁶ SAL or an SAL providing a greater assurance of sterility when the textile PCD is used. | Pass |
| Biological performance with wrapped instrument PCD | Verifying biological performance on half sterilization time. | Tested cycle has a 10⁻⁶ SAL or an SAL providing a greater assurance of sterility when the wrapped instrument PCD is used. | Pass |
| Biological performance with unwrapped instrument PCD (IUSS) – minimum and maximum load tests | Verifying biological performance on half sterilization time. | There shall be no growth observed in the vials containing turbines or in the extraction of any of the turbines, except for the positive controls. No growth shall be observed with the BIs except the positive control BIs. Growth should be observed for the positive control turbine and BI. | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document describes "tests" and "cycles" but does not explicitly state a quantitative sample size (e.g., number of sterilization runs) for each specific test. It implies multiple trials were conducted to meet each acceptance criterion, as performance tests like "Empty chamber tests" or "Biological performance" would typically involve multiple runs to demonstrate consistency and reliability. However, no specific quantitative sample size is provided in the document for the test set.
- Data Provenance: The document does not specify the country of origin of the data. It is a submission to the U.S. Food & Drug Administration (FDA) by Tuttnauer LTD. based in Jerusalem, Israel, implying the tests were conducted by the manufacturer or a contracted lab. The tests are described as non-clinical tests, which means they are laboratory-based and simulated scenarios, not directly from patient data. The context suggests these were prospective tests performed specifically for this 510(k) submission, rather than retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention human expert involvement in establishing ground truth for the test set. The tests described are objective, quantitative performance measurements of a sterilizer (e.g., temperature, pressure, leak rate, biological indicator growth). Ground truth is established by physical measurements and the absence/presence of microbial growth, not by expert consensus on interpretations.
4. Adjudication method for the test set
Not applicable. As noted above, the ground truth is established by objective physical and biological measurements, not through human interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done.
- This device is a steam sterilizer, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Therefore, the concepts of human readers, AI assistance, or MRMC studies are not relevant to this type of device and its performance evaluation as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence, standalone performance was assessed. The device itself is an automated sterilizer. Its "performance" refers to its ability to achieve specific physical parameters (temperature, pressure, dry time) and biological outcomes (sterility assurance level, lack of growth). The tests described (e.g., Bowie & Dick test, air-leak-rate test, empty/full chamber load tests, biological performance tests) directly measure the sterilizer's function without human intervention during the cycle itself. Human operators set up and observe the results, but the "performance" being evaluated is the device's independent operation.
7. The type of ground truth used
The ground truth used for these tests is based on:
- Physical measurements: Temperature (within a specified range), pressure (leak rate), weight change (moisture retention). These are objectively measurable physical properties.
- Biological outcomes: The absence of microbial growth in biological indicators (BIs) or test turbines after sterilization, demonstrating a sterility assurance level (SAL) of 10⁻⁶. Positive controls are used to confirm test viability. This is an objective biological outcome.
- Visual inspection: Uniform color change for the Bowie-Dick test, absence of wet spots for moisture retention.
8. The sample size for the training set
This document describes the validation of a physical device (a steam sterilizer). It is not an AI/ML device, so there is no "training set" in the context of machine learning model development. The device operates based on preprogrammed cycles and physical principles, not on learned data.
9. How the ground truth for the training set was established
Since this is not an AI/ML device, there is no training set and therefore no ground truth established for a training set. The performance is assessed against established engineering and biological standards for sterilization.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
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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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| Cycle name | Sterilizationtemperature[°C] | SterilizationTime[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 packsInstruments - ~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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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 9kWThe 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 9kWThe 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 | Sterilizationtemperature[°C] | SterilizationTime[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 - underK143311 | Comparison |
|---|---|---|---|---|
| Indication for use | The pre-vacuumsteam sterilizermodels 3870HSG and3870HSG-WS areintended for use inhospitals and otherhealth-care facilities(e.g. hospitals,nursing homes,extended-carefacilities, freestandingsurgical centers,clinics, and medicaland dental offices) forthe purpose ofsterilizing heat stablemedical devices:wrapped andunwrapped solids(IUSS), hollow andporous products. | The pre-vacuumsteam sterilizermodels 3870HSGand 3870HSG-WSare intended for usein hospitals andother health-carefacilities (e.g.hospitals, nursinghomes, extended-care facilities,freestandingsurgical centers,clinics, and medicaland dental offices)for the purpose ofsterilizing heatstable medicaldevices: wrappedand unwrappedsolids (IUSS),hollow and porousproducts. | The model 5075 is ahorizontal autoclavedesigned forsterilization ofwrapped andunwrappedinstruments andrelated items foundin dental, medicaland veterinaryclinics, first aidrooms andhospitals. | Different |
| Chamberdimensions | ~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 |
| OperatingPrinciple /sterilizationmethod | Sterilization usingsteam as sterilizingagent | Sterilization usingsteam as sterilizingagent | Sterilization usingsteam as sterilizingagent | Same |
| Sterilization cycletypes | Pre & post vacuum | Pre & post vacuum | Pre & post vacuum | Same |
| Parameter | 3870HSG | 3870HSG-WS | 5075HSG – underK143311 | Comparison |
| ChamberMaterials/waterpath materials | 316 or 304 gradestainless steal | 316 or 304 gradestainless steal | 316 or 304 gradestainless steal | Same |
| Energy source | The device can beoperated only whileconnected to anelectrical source(the electrical grid).It has no internalpower source(batteries). | The device can beoperated only whileconnected to anelectrical source(the electrical grid).It has no internalpower source(batteries). | The device can beoperated only whileconnected to anelectrical source(the electrical grid).It has no internalpower source(batteries). | Same |
| Controls | Electronic computercontrol | Electronic computercontrol | Electronic computercontrol | Same |
| Door mechanism | Automatic door | Automatic door | Manual door | Different |
| Water utilities | The device needs tobe connected to thebuilding waterutilities. | The device hasinternal waterreservoirs that allowit to be mobile andindependent of waterutilities | The device needs tobe connected to thebuilding waterutilities. | Same for the3870HSG modelDifferent for the3870HSG-WSmodel. |
| 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°Ffor 4min, dry timeof 2min. | • IUSS –sterilization temp.of 134°C / 273°Ffor 4min, dry timeof 1min. | • Unwrappedinstruments –sterilization temp.of 134°C / 273°Ffor 4min, dry timeof 1min. | Different |
| • Wrapped –sterilization temp.of 134°C / 273°Ffor 4min, dry timeof 20min. | • Wrapped –sterilization temp.of 134°C / 273°Ffor 4min, dry timeof 20min. | • Wrapped –sterilization temp.of 134°C / 273°Ffor 4min, dry timeof 20min. | ||
| • IUSS delicate –sterilization temp | • IUSS delicate –sterilization temp | |||
| Parameter | 3870HSG | 3870HSG-WS | 5075HSG - underK143311 | Comparison |
| of 121°C / 250°Ffor 20min, drytime for 2min.• Wrapped delicate– sterilizationtemp of 121°C /250°F for 20min,dry time of20min. | of 121°C / 250°Ffor 20min, drytime for 1min.• Wrapped delicate– sterilizationtemp of 121°C /250°F for 20min,dry time of20min. | • Unwrappeddelicateinstruments –sterilization temp.of 121°C / 250°Ffor 20min, drytime for 1min.Wrapped delicate –sterilization temp of121°C / 250°F for20min, dry time of20min. |
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Image /page/10/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.
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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 thatdevice and itscomponents meetelectrical safetyrequirements | Meeting standardspecification | • IEC 61010-1:2010/UL 61010-1:2012• IEC 61010-2-040:2015 | Pass |
| EMC | Verifying that thedevice meets EMCrequirements | Meeting standardspecification | • EN 61326-1:2013 / IEC61326-1:2012 | Pass |
| Pressure vesseltesting | Verifying that thepressure vesselused for the T-Edge meets therequirements forpressure vessel andis safe for use. | Meeting standardspecification | • ASME Boilerand pressurevessel code,Section VIIIdivision 1 | Pass |
| Device performance tests | ||||
| Bowie & Dicktest | Verify air removalperformance (for | The Bowie-Dick testindicator sheet shall | • ANSI/AAMIST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results(Pass /No Pass) |
| dynamic airremoval sterilizers) | show a uniformcolor change | |||
| Air-leak-rate(vacuum) test | Verify air removalperformance (fordynamic airremoval sterilizers) | average leak rate of1 millimeter ofmercury(mmHg) (0.13 kPa)(0.019 psia) per minor less over themeasured timeinterval. | • ANSI/AAMIST-8 | Pass |
| Empty chambertests(121°C/132°C) -on wrapped andunwrapped(IUSS) load | to ensure thatthe sterilizer iscapable ofproviding steady-state thermalconditions withinthe chamberconsistent with thedesired sterilityassurance level(SAL) in the load | The temperatureshall not exceedmore than 3°C abovethe sterilizationtemperature.The temperatureshall not be belowthe sterilizationtemperatureActual exposuretime | • ANSI/AAMIST-8 | Pass |
| Full chamber loadtest(121°C/132°C) -on wrapped andunwrapped(IUSS) load | to ensure thatthe sterilizer iscapable ofproviding steady-state thermalconditions withinthe chamberconsistent with thedesired sterilityassurance level(SAL) in the load | The temperatureshall not exceedmore than 3°C abovethe sterilizationtemperature.The temperatureshall not be belowthe sterilizationtemperatureActual exposuretime | • ANSI/AAMIST-8 | Pass |
| Moistureretention tests -fabric PCD andwrappedinstruments PCD | to ensure thatthe sterilizer iscapable of meetingthe moistureretention criteria | Moisture retained bythe fabric PCD shallcause no more than a3% increase in pre-sterilization test packweight, and the pack | • ANSI/AAMIST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results(Pass /No Pass) |
| shall exhibit no wetspots. | ||||
| When examinedimmediately aftercompletion of thecycle, the wrappedinstrument packsshall have no wetspots on the outerwrappers. Moistureretained by the 100%cotton towel shallcause no more than a20% increase in thepre-sterilizationweight of the towel. | ||||
| Biologicalperformance witha textile PCD | Verifyingbiologicalperformance onhalf sterilizationtime | Tested cycle has a$10^{-6}$ SAL or an SALproviding a greaterassurance of sterilitywhen the textilePCD is used. | • ANSI/AAMIST-8 | Pass |
| Biologicalperformance withwrappedinstrument PCD | Verifyingbiologicalperformance onhalf sterilizationtime | Tested cycle has a$10^{-6}$ SAL or an SALproviding a greaterassurance of sterilitywhen the wrappedinstrument PCD isused. | • ANSI/AAMIST-8 | Pass |
| Biologicalperformance withunwrappedinstrument PCD(IUSS) –minimum andmaximum loadtests | Verifyingbiologicalperformance onhalf sterilizationtime | There shall be nogrowth observed inthe vials containingturbines or in theextraction of any ofthe turbines, exceptfor the positivecontrols. No growthshall be observedwith the BIs exceptthe positive controlBIs. Growth should | • ANSI/AAMIST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results(Pass /No Pass) |
| be observed for thepositive controlturbine and BI. |
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Image /page/12/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the word "Tuttnauer" in large, red font. Above the word is a gray, star-like shape. Below the word are the words "Innovation, Legacy, Partnership" in a smaller, gray font.
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Image /page/13/Picture/0 description: The image shows the logo for Tuttnauer. The logo features the company name in bold, red letters. Above the name is a gray, star-like shape. Below the name is the text "Innovation · Legacy · Partnership".
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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.
§ 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).