Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
Device Facts
| Record ID | K222608 |
|---|---|
| Device Name | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS |
| Applicant | Tuttnauer , Ltd. |
| Product Code | FLE · General Hospital |
| Decision Date | Dec 16, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6880 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Dynamic-air-removal steam sterilizer (autoclave) for heat-stable medical devices; uses steam as sterilizing agent. Models 3870HSG (requires building water connection) and 3870HSG-WS (mobile, internal water reservoir, water recycling option). Features 9kW built-in steam generator; vacuum system for air removal from packs/porous loads; HEPA-filtered post-sterilization drying. Operated by hospital/medical personnel via integrated keypad and digital display. Computerized control unit monitors physical parameters; prints cycle data; supports USB export/PC reporting. Benefits include effective sterilization, temperature uniformity, and moisture removal. Used in hospitals, clinics, and surgical centers.
Clinical Evidence
Bench testing only. Conducted electrical safety (IEC 61010-1/2-040), EMC (EN 61326-1), pressure vessel integrity (ASME Section VIII), and performance testing per ANSI/AAMI ST-8. Performance tests included Bowie & Dick, vacuum leak rate, empty/full chamber thermal distribution, moisture retention, and biological performance (SAL 10^-6) for all cycle types.
Technological Characteristics
Class II steam sterilizer; 316/304 stainless steel chamber; 85L volume; 9kW steam generator; vacuum-assisted air removal; HEPA filter (0.2um); electronic computer control; integrated printer/USB connectivity. Standards: IEC 61010-1, IEC 61010-2-040, EN 61326-1, ASME Boiler and Pressure Vessel Code, ANSI/AAMI ST-8.
Indications for Use
Indicated for sterilization of heat-stable medical devices including wrapped/unwrapped solids (IUSS), hollow, and porous products in hospitals, clinics, and surgical centers.
Regulatory Classification
Identification
A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.
Predicate Devices
- Tuttnauer pre-vacuum horizontal autoclave model 5075HSG (K143311)
Submission Summary (Full Text)
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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 | Sterilization<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[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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### 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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# 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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## 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<br>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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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<br><br>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<br><br>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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| Cycle name | Sterilization<br>temperature<br>[°C] | Sterilization<br>Time<br>[minute] | Dry Time<br>[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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## 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<br>K143311 | Comparison |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Indication for use | The pre-vacuum<br>steam sterilizer<br>models 3870HSG and<br>3870HSG-WS are<br>intended for use in<br>hospitals and other<br>health-care facilities<br>(e.g. hospitals,<br>nursing homes,<br>extended-care<br>facilities, freestanding<br>surgical centers,<br>clinics, and medical<br>and dental offices) for<br>the purpose of<br>sterilizing heat stable<br>medical devices:<br>wrapped and<br>unwrapped solids<br>(IUSS), hollow and<br>porous products. | The pre-vacuum<br>steam sterilizer<br>models 3870HSG<br>and 3870HSG-WS<br>are intended for use<br>in hospitals and<br>other health-care<br>facilities (e.g.<br>hospitals, nursing<br>homes, extended-<br>care facilities,<br>freestanding<br>surgical centers,<br>clinics, and medical<br>and dental offices)<br>for the purpose of<br>sterilizing heat<br>stable medical<br>devices: wrapped<br>and unwrapped<br>solids (IUSS),<br>hollow and porous<br>products. | The model 5075 is a<br>horizontal autoclave<br>designed for<br>sterilization of<br>wrapped and<br>unwrapped<br>instruments and<br>related items found<br>in dental, medical<br>and veterinary<br>clinics, first aid<br>rooms and<br>hospitals. | Different |
| Chamber<br>dimensions | ~15" (38cm) ID X<br>~27" (68.5cm) length | ~15" (38cm) ID X<br>~27" (68.5cm)<br>length | ~26" (49.4cm) ID X<br>~29.5" (75cm)<br>length | Different |
| Chamber volume | 3ft3 (85liters) | 3ft3 (85liters) | 5.65ft3 (160liters) | Different |
| Operating<br>Principle /<br>sterilization<br>method | Sterilization using<br>steam as sterilizing<br>agent | Sterilization using<br>steam as sterilizing<br>agent | Sterilization using<br>steam as sterilizing<br>agent | Same |
| Sterilization cycle<br>types | Pre & post vacuum | Pre & post vacuum | Pre & post vacuum | Same |
| Parameter | 3870HSG | 3870HSG-WS | 5075HSG – under<br>K143311 | Comparison |
| Chamber<br>Materials/water<br>path materials | 316 or 304 grade<br>stainless steal | 316 or 304 grade<br>stainless steal | 316 or 304 grade<br>stainless steal | Same |
| Energy source | The device can be<br>operated only while<br>connected to an<br>electrical source<br>(the electrical grid).<br>It has no internal<br>power source<br>(batteries). | The device can be<br>operated only while<br>connected to an<br>electrical source<br>(the electrical grid).<br>It has no internal<br>power source<br>(batteries). | The device can be<br>operated only while<br>connected to an<br>electrical source<br>(the electrical grid).<br>It has no internal<br>power source<br>(batteries). | Same |
| Controls | Electronic computer<br>control | Electronic computer<br>control | Electronic computer<br>control | Same |
| Door mechanism | Automatic door | Automatic door | Manual door | Different |
| Water utilities | The device needs to<br>be connected to the<br>building water<br>utilities. | The device has<br>internal water<br>reservoirs that allow<br>it to be mobile and<br>independent of water<br>utilities | The device needs to<br>be connected to the<br>building water<br>utilities. | Same for the<br>3870HSG model<br>Different for the<br>3870HSG-WS<br>model. |
| Maximum load | • Tools (solids) –<br>12kg (26.46lbs.)<br>• Textile – 2 packs | • Tools (solids) –<br>12kg (26.46lbs.)<br>• Textile – 2 packs | • Tools (solids) –<br>15kg (33.07lbs.)<br>• Textile – 14kg<br>(30.86lbs.) | Different |
| Cycle parameters | • IUSS –<br>sterilization temp.<br>of 134°C / 273°F<br>for 4min, dry time<br>of 2min. | • IUSS –<br>sterilization temp.<br>of 134°C / 273°F<br>for 4min, dry time<br>of 1min. | • Unwrapped<br>instruments –<br>sterilization temp.<br>of 134°C / 273°F<br>for 4min, dry time<br>of 1min. | Different |
| | • Wrapped –<br>sterilization temp.<br>of 134°C / 273°F<br>for 4min, dry time<br>of 20min. | • Wrapped –<br>sterilization temp.<br>of 134°C / 273°F<br>for 4min, dry time<br>of 20min. | • Wrapped –<br>sterilization temp.<br>of 134°C / 273°F<br>for 4min, dry time<br>of 20min. | |
| | • IUSS delicate –<br>sterilization temp | • IUSS delicate –<br>sterilization temp | | |
| Parameter | 3870HSG | 3870HSG-WS | 5075HSG - under<br>K143311 | Comparison |
| | of 121°C / 250°F<br>for 20min, dry<br>time for 2min.<br><br>• Wrapped delicate<br>– sterilization<br>temp of 121°C /<br>250°F for 20min,<br>dry time of<br>20min. | of 121°C / 250°F<br>for 20min, dry<br>time for 1min.<br><br>• Wrapped delicate<br>– sterilization<br>temp of 121°C /<br>250°F for 20min,<br>dry time of<br>20min. | • Unwrapped<br>delicate<br>instruments –<br>sterilization temp.<br>of 121°C / 250°F<br>for 20min, dry<br>time for 1min.<br><br>Wrapped delicate –<br>sterilization temp of<br>121°C / 250°F for<br>20min, dry time of<br>20min. | |
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Image /page/11/Picture/0 description: The image contains the logo for Tuttnauer. The logo features the company name in a bold, red font. Below the name is the tagline "Innovation * Legacy * Partnership" in a smaller, black font. Above the company name is a gray, star-like shape.
# 8. PERFORMANCE TESTING
The following shows the non-clinical tests conducted:
| Test name | Purpose | Acceptance criteria | Standards used | Results<br>(Pass /<br>No Pass) |
|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------|
| Electrical Safety | Verifying that<br>device and its<br>components meet<br>electrical safety<br>requirements | Meeting standard<br>specification | • IEC 61010-<br>1:2010<br>/UL 61010-<br>1:2012<br>• IEC 61010-2-<br>040:2015 | Pass |
| EMC | Verifying that the<br>device meets EMC<br>requirements | Meeting standard<br>specification | • EN 61326-<br>1:2013 / IEC<br>61326-1:2012 | Pass |
| Pressure vessel<br>testing | Verifying that the<br>pressure vessel<br>used for the T-<br>Edge meets the<br>requirements for<br>pressure vessel and<br>is safe for use. | Meeting standard<br>specification | • ASME Boiler<br>and pressure<br>vessel code,<br>Section VIII<br>division 1 | Pass |
| Device performance tests | | | | |
| Bowie & Dick<br>test | Verify air removal<br>performance (for | The Bowie-Dick test<br>indicator sheet shall | • ANSI/AAMI<br>ST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results<br>(Pass /<br>No Pass) |
| | dynamic air<br>removal sterilizers) | show a uniform<br>color change | | |
| Air-leak-rate<br>(vacuum) test | Verify air removal<br>performance (for<br>dynamic air<br>removal sterilizers) | average leak rate of<br>1 millimeter of<br>mercury<br>(mmHg) (0.13 kPa)<br>(0.019 psia) per min<br>or less over the<br>measured time<br>interval. | • ANSI/AAMI<br>ST-8 | Pass |
| Empty chamber<br>tests<br>(121°C/132°C) -<br>on wrapped and<br>unwrapped<br>(IUSS) load | to ensure that<br>the sterilizer is<br>capable of<br>providing steady-<br>state thermal<br>conditions within<br>the chamber<br>consistent with the<br>desired sterility<br>assurance level<br>(SAL) in the load | The temperature<br>shall not exceed<br>more than 3°C above<br>the sterilization<br>temperature.<br>The temperature<br>shall not be below<br>the sterilization<br>temperature<br>Actual exposure<br>time | • ANSI/AAMI<br>ST-8 | Pass |
| Full chamber load<br>test<br>(121°C/132°C) -<br>on wrapped and<br>unwrapped<br>(IUSS) load | to ensure that<br>the sterilizer is<br>capable of<br>providing steady-<br>state thermal<br>conditions within<br>the chamber<br>consistent with the<br>desired sterility<br>assurance level<br>(SAL) in the load | The temperature<br>shall not exceed<br>more than 3°C above<br>the sterilization<br>temperature.<br>The temperature<br>shall not be below<br>the sterilization<br>temperature<br>Actual exposure<br>time | • ANSI/AAMI<br>ST-8 | Pass |
| Moisture<br>retention tests -<br>fabric PCD and<br>wrapped<br>instruments PCD | to ensure that<br>the sterilizer is<br>capable of meeting<br>the moisture<br>retention criteria | Moisture retained by<br>the fabric PCD shall<br>cause no more than a<br>3% increase in pre-<br>sterilization test pack<br>weight, and the pack | • ANSI/AAMI<br>ST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results<br>(Pass /<br>No Pass) |
| | | shall exhibit no wet<br>spots. | | |
| | | When examined<br>immediately after<br>completion of the<br>cycle, the wrapped<br>instrument packs<br>shall have no wet<br>spots on the outer<br>wrappers. Moisture<br>retained by the 100%<br>cotton towel shall<br>cause no more than a<br>20% increase in the<br>pre-sterilization<br>weight of the towel. | | |
| Biological<br>performance with<br>a textile PCD | Verifying<br>biological<br>performance on<br>half sterilization<br>time | Tested cycle has a<br>$10^{-6}$ SAL or an SAL<br>providing a greater<br>assurance of sterility<br>when the textile<br>PCD is used. | • ANSI/AAMI<br>ST-8 | Pass |
| Biological<br>performance with<br>wrapped<br>instrument PCD | Verifying<br>biological<br>performance on<br>half sterilization<br>time | Tested cycle has a<br>$10^{-6}$ SAL or an SAL<br>providing a greater<br>assurance of sterility<br>when the wrapped<br>instrument PCD is<br>used. | • ANSI/AAMI<br>ST-8 | Pass |
| Biological<br>performance with<br>unwrapped<br>instrument PCD<br>(IUSS) –<br>minimum and<br>maximum load<br>tests | Verifying<br>biological<br>performance on<br>half sterilization<br>time | There shall be no<br>growth observed in<br>the vials containing<br>turbines or in the<br>extraction of any of<br>the turbines, except<br>for the positive<br>controls. No growth<br>shall be observed<br>with the BIs except<br>the positive control<br>BIs. Growth should | • ANSI/AAMI<br>ST-8 | Pass |
| Test name | Purpose | Acceptance criteria | Standards used | Results<br>(Pass /<br>No Pass) |
| | | be observed for the<br>positive control<br>turbine and BI. | | |
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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.
