(126 days)
Not Found
No
The description focuses on standard autoclave technology, safety features, and adherence to sterilization standards. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an autoclave designed for sterilizing medical materials, not for treating patients.
No
Explanation: The device is an autoclave designed for sterilizing medical, dental, and surgical materials, not for diagnosing medical conditions.
No
The device description clearly outlines physical hardware components such as electrical resistive heaters, a door with a safety locking mechanism and switch, electronic overtemperature and overpressure protection, an independent high temperature cutoff switch, and a pressure safety relief valve. While it includes a touchscreen controller, the core function and components are hardware-based.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "sterilizing heat- and moisturestable medical, dental, and surgical materials... in healthcare facilities." This describes a device used to prepare medical instruments for use, not a device used to perform tests on biological samples from the human body.
- Device Description: The description details an autoclave that uses steam for sterilization. This is a physical process for killing microorganisms, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a sterilizer, which is a type of medical device used in healthcare settings, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisturestable medical, dental, and surgical materials, including wrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities. The devices use electrical resistive heaters to produce steam as the sterilizing agent. The devices adhere to sterilization processes and requirements that are universally accepted sterilization standards for Tabletop Steam Sterilizers. A touchscreen controller is used for monitoring and control of the device.
The devices are equipped with multiple safety features. The door includes a safety locking mechanism and door switch. The door switch does not permit cycle operation unless the door is sealed closed and does not permit the door to be opened until the internal chamber pressure is at atmospheric pressure. Additional safety features include electronic overtemperature and overpressure protection, an independent high temperature cutoff switch, and a pressure safety relief valve for the pressure vessel.
Only United States Food and Drug Administration cleared sterilization accessories should be used with these autoclaves.
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
healthcare facilities.
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)
Fort Defiance Industries conducted validation studies in accordance with AAMI/ANSI ST55:2016 (FDA Recognition Number 14-518). Design outputs and testing demonstrate that the FRONT-LINE Models FL120 and FL135 autoclaves meet all aspects of the standard.
Performance effectiveness of the sterilizer cycles and exposure time recommendations were demonstrated by the overkill method by passing 3 successive cycles at half the programmed exposure time to guarantee a sterility assurance level (SAL) of at least 10 to probability of survival. Fort Defiance Industries validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI). The Fort Defiance Industries FRONT-LINE Field Sterilizers FL120 and FL135 have been validated to meet the requirements of ANSI/AAMI ST55:2016, Tabletop Steam Sterilizers (FDA Recognition Number 14-518).
Performance Testing Summary:
- Sterilizer Temperature Control & Pressure Measurement (TP-5070, TR-5072, TR-5075, TR-5077): PASS
- Temperature Accuracy (TP-5240): PASS
- Air Removal (TP-5080): PASS
- Software Verification and Validation (TP-5100, TP-5110, TP-5120, TP-5130): PASS
- Biological Performance - Textiles (TP-5141): PASS
- Biological Performance - Wrapped Instrument (TP-5160): PASS
- Biological Performance - Dental Handpieces (TP-5170): PASS
- Moisture Retention – Textiles (TP-5190): PASS
- Moisture Retention – Wrapped Instrument (TP-5200): PASS
- Moisture Retention – Pouches Drying Test (TP-5210): PASS
- Endotoxin and Water Quality (TP-5220): PASS
- Labeling (TP-5010): PASS
- Sterilizer Safety (TP-5050): PASS
- General Inspection (TP-5060): PASS
- 3rd Party Testing Electrical Safety: PASS
- 3rd Party Testing Electrical/Sterilizer Specific Safety: PASS
- 3rd Party Testing EMC/EMI: 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
March 2, 2022
Fort Defiance Industries LLC Chris Coleman Quality Management Representative 2411 Maremont Parkway Loudon, Tennessee 37774
Re: K213457
Trade/Device Name: Fort Defiance Industries FRONT-LINE Field Sterilizer FL120. Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: October 26, 2021 Received: October 27, 2021
Dear Chris Coleman:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 (OS) 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).
Sincerely,
for Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213457
Device Name
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135
Indications for Use (Describe)
The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisturestable medical, dental, and surgical materials, including wrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
| MODEL | CYCLE | MAXIMUM
LOAD | EXPOSURE
TEMP (F/C)* | EXPOSURE
TIME (MIN) | NUMBER OF
DYNAMIC
AIR REMOVAL
PULSES | DRY TIME
(MINUTES) |
|-------|----------------------------------|-----------------------|-------------------------|------------------------|-----------------------------------------------|-----------------------|
| FL120 | IMMEDIATE
USE (IUSS) | 20 lbs. | 270 / 132 | 4 | 3 | 0 |
| | | | 275 / 135 | 3 | 3 | 0 |
| FL120 | TEXTILES | 3 TEXTILE
PACKS ** | 250 / 121 | 30 | 3 | 60 |
| | | | 270 / 132 | 4 | 3 | 60 |
| | | | 275 / 135 | 3 | 3 | 60 |
| FL120 | WRAPPED INSTRUMENTS
/ POUCHES | 20 lbs. | 250 / 121 | 30 | 3 | 60 |
| | | | 270 / 132 | 4 | 3 | 60 |
| | | | 275 / 135 | 3 | 3 | 60 |
| FL120 | HANDPIECES | 12 HANDPIECES | 270 / 132 | 4 | 5 | 60 |
| | | | 275 / 135 | 3 | 5 | 60 |
| FL135 | IMMEDIATE
USE (IUSS) | 25 lbs | 270 /132 | 4 | 3 | 0 |
| | | | 275 / 135 | 3 | 3 | 0 |
| FL135 | TEXTILES | 3 TEXTILE
PACKS ** | 250 / 121 | 30 | 3 | 60 |
| | | | 270 / 132 | 4 | 3 | 60 |
| | | | 275 / 135 | 3 | 3 | 60 |
| FL135 | WRAPPED INSTRUMENTS
/ POUCHES | 25 lbs | 250 / 121 | 30 | 3 | 60 |
| | | | 270 / 132 | 4 | 3 | 60 |
| | | | 275 / 135 | 3 | 3 | 60 |
| FL135 | HANDPIECES | 12 HANDPIECES | 270 / 132 | 4 | 5 | 60 |
| | | | 275 / 135 | 3 | 5 | 60 |
NOTES:
- THE ANSI/AAMI ST55:2016 MINIMUM TEMPERATURE IS LISTED FOR ALL CYCLES.
** AAMI STANDARD TEXTILE PACK (9 TOWELS - ST 55 SECTION 5.7.1.1).
3
Prescription Use (Part 21 CFR 801 Subpart D)
- X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for FDI in orange. The logo is made up of the letters F, D, and I. The letters are all capitalized and in a sans-serif font. The logo is simple and modern. The color is bright and eye-catching.
510(k) Summary for Fort Defiance Industries FRONT-LINE Field Sterilizer FL120 & FL135 K213457
Submitter / 510(k) Owner: Fort Defiance Industries LLC 2411 Maremont Parkway Loudon, TN 37774 Phone: (865) 408-0100 Fax No: (866) 732-8086
Contact: Chris Coleman Quality Management Representative Fort Defiance Industries LLC Phone: (865) 657-6108 (866) 732-8086 Fax:
Submission Date: March 2nd, 2022
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Image /page/5/Picture/0 description: The image shows the logo for FDI in orange. The letters are large and bold. There are white lines that cut through the letters, giving the logo a modern look.
1. Device Name
| Trade Name: | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort
Defiance Industries FRONT-LINE Field Sterilizer FL135 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Model Name(s): | FL120 / FL135 |
| Common/usual Name: | Electronic autoclave, steam sterilizer |
| Classification Name: | Steam Sterilizer
Class II Device - 21 CFR 880.6880 Product Code FLE |
2. Predicate Device
K111736, Tuttnauer EZ11 Plus Electronic Tabletop Autoclave, product code FLE, cleared December 8, 2011
3. Description of Device
The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities. The devices use electrical resistive heaters to produce steam as the sterilizing agent. The devices adhere to sterilization processes and requirements that are universally accepted sterilization standards for Tabletop Steam Sterilizers. A touchscreen controller is used for monitoring and control of the device.
The devices are equipped with multiple safety features. The door includes a safety locking mechanism and door switch. The door switch does not permit cycle operation unless the door is sealed closed and does not permit the door to be opened until the internal chamber pressure is at atmospheric pressure. Additional safety features include electronic overtemperature and overpressure protection, an independent high temperature cutoff switch, and a pressure safety relief valve for the pressure vessel.
Only United States Food and Drug Administration cleared sterilization accessories should be used with these autoclaves.
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Image /page/6/Picture/0 description: The image shows the logo for FDI in orange. The logo is made up of the letters F, D, and I. The letters are all capitalized and in a sans-serif font. The logo is simple and modern. The color is bright and eye-catching.
4. Design and Materials
The FRONT-LINE Field Sterilizers, models FL120 and FL135, are steam sterilizers composed of a stainless-steel chamber, an aluminum chamber door, electric resistive heaters, a plumbing system with a clean water tank, control system, and an aluminum frame providing a housing for all components. The devices are electronically controlled, and each device includes 10 pre-programmed sterilization cycles. All materials in the sterilization system and plumbing system are deemed acceptable for steam sterilizers.
న. Technology
The FRONT-LINE series of autoclaves are steam sterilizers composed of a pressure vessel that utilizes electric resistive heaters to produce the sterilizing agent, steam, from a chamber boiler. The autoclaves contain an electronic control system that automatically initiates programmed Steam Flush Pressure Pulse (SFPP) phases to purge atmospheric air from the chamber followed by a timed steam exposure and drying phase. Exhaust air purged during the dry phase passes through a heat exchanger to condense water vapor and reclaim as much condensate as possible for reuse.
7
Image /page/7/Picture/0 description: The image shows the logo for FDI. The logo is orange and features the letters "FDI" in a bold, sans-serif font. The letters are connected to each other, and there are white lines running through the letters, creating a sense of movement. The logo is simple and modern, and the orange color is eye-catching.
6. Intended Use
The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
| Model | Cycle | Maximum
Load | Exposure
Temperature¹
(°F/°C) | Exposure
Time
(minutes) | Dry Time
(minutes) |
|-------|-------------------------------------|------------------|-------------------------------------|-------------------------------|-----------------------|
| FL120 | Immediate Use
(IUSS) | 20 lbs. | 270/132
275/135 | 4
3 | 0 |
| | Textiles | 3 Textile Packs² | 250/121
270/132
275/135 | 30
4
3 | 60 |
| | Wrapped
Instruments /
Pouches | 20 lbs. | 250/121
270/132
275/135 | 30
4
3 | 60 |
| FL120 | Handpieces | 12 Handpieces | 270/132 | 4 | 60 |
| | | | 275/135 | 3 | |
| FL135 | Immediate Use
(IUSS) | 25 lbs. | 270/132
275/135 | 4
3 | 0 |
| | Textiles | 3 Textile Packs² | 250/121
270/132
275/135 | 30
4
3 | 60 |
| | Wrapped
Instruments /
Pouches | 25 lbs. | 250/121
270/132
275/135 | 30
4
3 | 60 |
| FL135 | Handpieces | 12 Handpieces | 270/132 | 4 | 60 |
| | | | 275/135 | 3 | |
1 The ANSI/AAMI ST55:2016 minimum temperature is listed for all cycles.
2 AAMI Standard Textile Pack (9 towels - ST 55 section 5.7.1.1).
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Image /page/8/Picture/0 description: The image shows the logo for FDI. The logo is orange and features the letters "FDI" in a bold, sans-serif font. The "F" and "D" are connected by a horizontal line, and there is a diagonal line cutting through the top right corner of the "I". The logo is simple and modern.
7. Comparison of Technology
The previously cleared device and the FRONT-LINE Field Sterilizers FL120 and FL135 are traditional steam sterilizers of similar chamber size using AAMI approved Steam Flush Pressure Pulse (SFPP) dynamic air removal cycles. The previously cleared device and the FRONT-LINE series sterilizers use electric heaters to generate steam and touchscreen controllers for cycle control. Based on the information provided below, there are negligible differences noted between the FRONT-LINE series and the predicate with regards to chamber size, cycle parameters, and configuration of steam generation. The differences do not affect safety or effectiveness of the new devices compared to the predicate. Table 1 provides a summary of performance and safety characteristics of the proposed new devices and the predicate.
| Performance
and/or Safety
Characteristic | New Device
Fort Defiance Industries
FRONT-LINE Field Sterilizers
FL120 & FL135
K213457 | Predicate Device
Electronic Tabletop Autoclave
Tuttnauer EZ11 Plus
K111736 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Fort Defiance Industries
FRONT-LINE Field Sterilizers
are autoclaves designed for
sterilizing heat- and moisture-
stable medical, dental, and
surgical materials, including
wrapped and unwrapped, solid,
porous, and hollow items (e.g.,
dental handpieces, suction pipes)
in healthcare facilities. | The EZ Plus series of autoclaves are
autoclaves designed for sterilizing
medical and surgical goods,
including both wrapped and
unwrapped, solid, hollow, and
porous products and goods defined
as hollow (e.g. dental handpieces,
suction pipes) in ophthalmic, dental,
and medical clinics; in first aid
rooms; and in small laboratories. |
| Operating
Principle | Steam Flush Pressure Pulse
(SFPP).
Steam is the sterilization agent.
(traditional method). | Steam Flush Pressure Pulse
(SFPP).
Steam is the sterilization agent
(traditional method). |
| Performance
and Safety
Standards
Followed | ANSI/AAMI ST55
ASME Sec. VIII Div 1
IEC 61010-1
IEC 61326-1
IEC 61010-2-040 | ANSI/AAMI ST55
ASME Sec. VIII Div 1
UL 61010-1
EN 61326-1
UL 61010-2-040 |
| Performance
and/or Safety
Characteristic | New Device
Fort Defiance Industries
FRONT-LINE Field Sterilizers
FL120 & FL135
K213457 | Predicate Device
Electronic Tabletop Autoclave
Tuttnauer EZ11 Plus
K111736 |
| | Factory Pre-Programmed
Steam Flush Pressure Pulse
(SFPP) Conditioning Phase | Factory Pre-Programmed
Steam Flush Pressure Pulse
(SFPP) Conditioning Phase |
| Sterilization
Cycles | 30 min exposure @ 250°F
60 min dry time - Default | 30 min exposure @ 250°F
1 min dry time - Default |
| | 4 min exposure @ 270°F
60 min dry time - Default | 3 or 4 min exposure @ 270°F
Dry time dependent on load |
| | 3 min exposure @ 275°F
60 min dry time - Default | |
| Chamber Size
& Volume | FL120
12" dia. X 23" lg.
1.6 cf. (45.3 L)
FL135
13.5" dia. X 24" lg.
2.00 cf. (56.35 L) | 11" dia. X 19.8" lg.
1.0 cf. (28.5 L) |
| Chamber
Design and
Construction | Single Wall Chamber
ASME Section VIII, Div. I
certified
Stainless steel (316L) chamber
and aluminum door (6061-T6) | Single Wall Chamber
ASME Section VIII, Div. I
certified
Stainless steel (316L) chamber
and stainless-steel door |
| Shelves / Trays | Hard anodized aluminum shelf | Stainless Steel wire trays |
| Steam Source | Internal chamber boiler via
partitioned section | Internal chamber boiler along
length of chamber |
| Steam
Generation
Mechanism | Electric resistive heaters
submerged in chamber boiler | External chamber wall electric band
heaters |
| Dying Process | External air pulled through 0.3-
micron HEPA filter then heated
for drying | External air pulled through 0.2-
micron HEPA filter then heated
for drying |
| Control
Technology | Electronic controller touch screen
(PLC) | Electronic controller touch screen
(PLC) |
| Performance
and/or Safety
Characteristic | New Device
Fort Defiance Industries
FRONT-LINE Field Sterilizers
FL120 & FL135 | Predicate Device
Electronic Tabletop Autoclave
Tuttnauer EZ11 Plus
K111736 |
| Process
Monitors | Chamber pressure transmitter.
Dual element chamber
temperature sensor. | Chamber pressure transmitter.
Dual element chamber
temperature sensor. |
| Door Failsafe | Automatic Door Interlock | Automatic Door Interlock |
| Primary
Overtemp and
Overpressure
Control | PLC Controller -
Utilizing RTDs and Pressure
Transmitter | PLC Controller -
Utilizing RTDs and Pressure
Transmitter |
| Secondary
Overtemp
Control | Thermocouple Temperature
Cut-off Switch (TCO) | Capillary Temperature
Cut-off Switch (TCO) |
| Secondary
Overpressure
Control | ASME Pressure Safety Valve | ASME Pressure Safety Valve |
| Electrical
Input | 120VAC +/- 10%,
1Ø, 50/60 Hz, 15 A
230-240VAC +/- 10%,
1Ø, 50/60 Hz, 15 A | 120VAC +/- 5%, 60 Hz |
Table 1: Comparison of Technology
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Image /page/9/Picture/0 description: The image shows the logo for FDI in orange. The logo is made up of the letters F, D, and I. The letters are all capitalized and in a sans-serif font. There is a white line that cuts through the top of the letters.
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Image /page/10/Picture/0 description: The image shows the logo for FDI, which is an acronym. The letters are orange and have a unique design. The letters are connected by a white line that runs through the top of the letters.
8. Summary of Non-Clinical Testing
Fort Defiance Industries conducted validation studies in accordance with AAMI/ANSI ST55:2016 (FDA Recognition Number 14-518). Design outputs and testing demonstrate that the FRONT-LINE Models FL120 and FL135 autoclaves meet all aspects of the standard.
Performance effectiveness of the sterilizer cycles and exposure time recommendations were demonstrated by the overkill method by passing 3 successive cycles at half the programmed exposure time to guarantee a sterility assurance level (SAL) of at least 10 to probability of survival. Fort Defiance Industries validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI). The Fort Defiance Industries FRONT-LINE Field Sterilizers FL120 and FL135 have been validated to meet the requirements of ANSI/AAMI ST55:2016, Tabletop Steam Sterilizers (FDA Recognition Number 14-518). Table 2 summarizes FRONT-LINE Field Sterilizer FL120 and FL135 effectiveness testing and results performed by Fort Defiance Industries.
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Image /page/11/Picture/0 description: The image shows the logo for FDI in orange. The logo is made up of the letters F, D, and I. The letters are connected to each other, and there is a white line running through the top of the letters. The logo is simple and modern.
Table 2: Performance Testing Summary
| Test Procedure | AAMI ST55:2016
Requirements | AAMI ST55:2016 Tests | Measured
Performance |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Sterilizer Temperature
Control
&
Pressure Measurement
TP-5070
Note:
TR-5072 reports
Sterilizer Resolutions of
Temperature
Measurement
TR-5075 reports
Sterilizer Pressure
Measurement
TR-5077 reports Cold
Point Relationship | 4.4.2.1 Temperature monitoring
4.4.2.2 Relationship between
RTD and chamber cold point
4.4.2.4 Temperature graduations
of 1°C or less
4.4.3 -0/+6°F temp control
4.4.5.1 Pressure gauge of +/- 3%
of full scale, resolution of 1
PSIG or less | 5.4.2.1 - Verified by
inspection
5.4.2.2 - Verified by
inspection and test 5.4.3
5.4.2.4 - Verified by
inspection
5.4.3 - Temperature
instrumented chamber tests
to confirm steady state
temperature control range
and documentation of cold
point
5.4.5.1 - Verified by
inspection and by testing
against certified standards | PASS |
| Temperature Accuracy
TP-5240 | 4.4.2.3 temperature accuracy of
+/- 1℃ over designated range | 5.4.2.3 - Verified by testing
against calibrated standards | PASS |
| Air Removal
TP-5080 | 4.6.1 Air removal for dynamic
air removal sterilizers | A.4.6.1 - Alternate test for
Steam Flush Pressure Pulse
Sterilizers | PASS |
| Software Verification
and Validation
TP-5100: Sterilizer Log
Verification
TP-5110: Sterilizer Fault
Conditions
TP-5120: General
Functions
TP-5130: Full Cycle
Verification | 4.4.7 Sterilizer fault conditions
4.4.8 Cycle documentation | 5.4.7 - Verified by inspection
5.4.8 - Verified by inspection | PASS |
| Biological Performance
- Textiles
TP-5141 | 4.5 Biological performance of
sterilizers | 5.5.2 Biological performance
with a textile pack | PASS |
| Biological Performance - Wrapped Instrument
TP-5160 | 4.5 Biological performance of
sterilizers | 5.5.4 Biological performance
with wrapped instruments | PASS |
| Biological Performance - Dental Handpieces
TP-5170 | 4.5 Biological performance of
sterilizers | 5.5.5 Biological performance
with dental handpieces | PASS |
| Test Procedure | AAMI ST55:2016
Requirements | AAMI ST55:2016 Tests | Measured
Performance |
| Moisture Retention –
Textiles
TP-5190 | 4.7 Moisture Retention | 5.7.1 Textile test packs | PASS |
| Moisture Retention –
Wrapped Instrument
TP-5200 | 4.7 Moisture Retention | 5.7.2 Wrapped Instr. Test
trays | PASS |
| Moisture Retention –
Pouches Drying Test
TP-5210 | 4.7 Moisture Retention | 5.7.3 Paper-plastic peel
pouches | PASS |
| Endotoxin and Water
Quality
TP-5220 | A.4.2.6 Water supply reservoir | A.4.2.6 Water supply
reservoir | PASS |
| FDI Test Procedure or
3rd Party | Standard | Tests | Measured
Performance |
| Labeling
TP-5010
(FDI) | AAMI ST55:2016 - 4.1.1
Device Markings
AAMI ST55:2016 - 4.1.2
Information Manual
AAMI ST55:2016 - 4.1.3
Service Manual | AAMI ST55:2016 - 5.1 Visual
inspection only | PASS |
| Sterilizer Safety
TP-5050
(FDI) | AAMI ST55:2016 - 4.3.1
Interlock
AAMI ST55:2016 - 4.3.2
Thermal hazards
AAMI ST55:2016 - 4.3.3
Aborting cycles | AAMI ST55:2016 - 5.3.1
Interlock functions under
conditions described
AAMI ST55:2016 - 5.3.2
Thermal hazard testing per UL-
61010
AAMI ST55:2016 - 5.3.3
Verified by inspection | PASS |
| General Inspection
TP-5060
(FDI) | 4.2.1 & 4.2.2 Pressure vessel
requirements
4.2.4 Corrosion resistance
4.2.5 Air filters
4.2.6 Water supply reservoir
4.4.4 Sterilizer exposure timer
4.4.6 Cycle completion | AAMI ST55:2016 - 5.2.1
Verified by compliance to
ASME BPVC Section VIII
Division 1 Code, requirements
in UL 61010-1 and IEC 61010-
2-040
AAMI ST55:2016 - 5.2.4
Material corrosion resistance
review
AAMI ST55:2016 - 5.2.5 Air
filter inspection necessary
filtration efficiency and filter
readily accessible
AAMI ST55:2016 - 5.2.6
Verified by inspection
AAMI ST55:2016 - 5.4.4
Verified by inspection and
timer testing to NIST standard
AAMI ST55:2016 - 5.6.6
Verified by inspection | PASS |
| 3rd Party Testing
Electrical Safety | IEC 61010-1 Edition 3.1
2017-01 | 3rd Party test protocol | PASS |
| 3rd Party Testing
Electrical/Sterilizer
Specific Safety | IEC 61010-2-040:2020 | 3rd Party test protocol | PASS |
| 3rd Party Testing
EMC/EMI | IEC 61326-1:2020 | 3rd Party test protocol | PASS |
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Image /page/12/Picture/0 description: The image shows the logo for FDI in orange. The logo is made up of the letters F, D, and I. The letters are connected to each other, and the letter D is in the center. There is a white line that cuts through the top of the letters F and D. The logo is simple and modern.
9. Safety
The Fort Defiance FRONT-LINE Field Steam Sterilizers have been designed, constructed, and tested to meet the safety and performance requirements of various national safety codes and standards. The device complies with the following standards:
- ANSI/AAMI ST55:2016, Tabletop Steam Sterilizers (FDA Recognition Number 14-518).
- IEC 61010-1 Edition 3.1 2017-01, "Safety Requirements for Electrical Equipment ● for Measurement, Control and Laboratory Use - Part 1 General Requirements". (FDA Recognition Number 19-34)
- IEC 61326-1:2020, "Electrical Equipment for Measurement, Control, and . Laboratory Use – EMC Requirements – Part 1: General Requirements" (General Use)
- . IEC 61010-2-040:2020, "Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-040: Particular Requirements for Sterilizers and Washer-disinfectors used to Treat Medical Materials" (General Use)
- ASME Boiler and Pressure Vessel Code, Section VIII, Division I, 2019 Edition, . Rules for Construction of Pressure Vessels (General Use)
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Image /page/13/Picture/0 description: The image shows the logo for FDI in orange. The letters are large and bold. A white line cuts through the top right corner of the D and the I.
Table 3 summarizes FRONT-LINE Field Sterilizer FL120 and FL135 safety testing results performed by Fort Defiance Industries or a Third Party where indicated.
Table 3: Safety Testing Summary
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Image /page/14/Picture/0 description: The image shows the logo for FDI in orange. The logo is made up of the letters F, D, and I. The letters are all capitalized and in a sans-serif font. The logo is simple and modern. The color is bright and eye-catching.
10. Conclusion
The conclusion drawn from the nonclinical testing demonstrates that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device, K111736, Class II (21 CFR 880.6880, Product code FLE).