(126 days)
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.
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.
The Fort Defiance Industries FRONT-LINE Field Sterilizers FL120 and FL135 are autoclaves designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials. The device's performance was evaluated against the ANSI/AAMI ST55:2016 standard.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Procedure | AAMI ST55:2016 Requirements | Measured Performance |
|---|---|---|
| Sterilizer Temperature Control & Pressure Measurement (TP-5070) | 4.4.2.1 Temperature monitoring4.4.2.2 Relationship between RTD and chamber cold point4.4.2.4 Temperature graduations of 1°C or less4.4.3 -0/+6°F temp control4.4.5.1 Pressure gauge of +/- 3% of full scale, resolution of 1 PSIG or less | PASS |
| Temperature Accuracy (TP-5240) | 4.4.2.3 temperature accuracy of +/- 1℃ over designated range | PASS |
| Air Removal (TP-5080) | 4.6.1 Air removal for dynamic air removal sterilizers | PASS |
| Software Verification and Validation (TP-5100, TP-5110, TP-5120, TP-5130) | 4.4.7 Sterilizer fault conditions4.4.8 Cycle documentation | PASS |
| Biological Performance - Textiles (TP-5141) | 4.5 Biological performance of sterilizers | PASS |
| Biological Performance - Wrapped Instrument (TP-5160) | 4.5 Biological performance of sterilizers | PASS |
| Biological Performance - Dental Handpieces (TP-5170) | 4.5 Biological performance of sterilizers | PASS |
| Moisture Retention – Textiles (TP-5190) | 4.7 Moisture Retention | PASS |
| Moisture Retention – Wrapped Instrument (TP-5200) | 4.7 Moisture Retention | PASS |
| Moisture Retention – Pouches Drying Test (TP-5210) | 4.7 Moisture Retention | PASS |
| Endotoxin and Water Quality (TP-5220) | A.4.2.6 Water supply reservoir | PASS |
| Labeling (TP-5010) (FDI) | AAMI ST55:2016 - 4.1.1 Device MarkingsAAMI ST55:2016 - 4.1.2 Information ManualAAMI ST55:2016 - 4.1.3 Service Manual | PASS |
| Sterilizer Safety (TP-5050) (FDI) | AAMI ST55:2016 - 4.3.1 InterlockAAMI ST55:2016 - 4.3.2 Thermal hazardsAAMI ST55:2016 - 4.3.3 Aborting cycles | PASS |
| General Inspection (TP-5060) (FDI) | 4.2.1 & 4.2.2 Pressure vessel requirements4.2.4 Corrosion resistance4.2.5 Air filters4.2.6 Water supply reservoir4.4.4 Sterilizer exposure timer4.4.6 Cycle completion | PASS |
| 3rd Party Testing Electrical Safety | IEC 61010-1 Edition 3.1 2017-01 | PASS |
| 3rd Party Testing Electrical/Sterilizer Specific Safety | IEC 61010-2-040:2020 | PASS |
| 3rd Party Testing EMC/EMI | IEC 61326-1:2020 | PASS |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a numerical sample size for the test set. However, a series of performance effectiveness tests were conducted for each cycle type (Immediate Use, Textiles, Wrapped Instruments/Pouches, Handpieces) across both FL120 and FL135 models. These tests were performed "by passing 3 successive cycles at half the programmed exposure time." This indicates that at least three runs were conducted for each sterilization cycle condition for both models.
The data provenance is from Fort Defiance Industries LLC itself, conducting validation studies in accordance with AAMI/ANSI ST55:2016. This suggests that the studies were internal, likely prospective laboratory testing. No information on country of origin of the data is provided beyond Fort Defiance Industries being a US company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is established through meeting the sterilizing performance criteria defined by the ANSI/AAMI ST55:2016 standard, specifically achieving a sterility assurance level (SAL) of at least 10^-6, and safety standards like IEC and ASME. This is a technical performance measurement rather than an expert interpretation of data.
4. Adjudication method for the test set
Not applicable. The evaluation is based on objective measurements and compliance with established performance standards for sterilization, rather than subjective interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical sterilizer, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in concept, the performance testing described is "standalone" for the device, meaning the sterilizer's effectiveness is evaluated on its own based on its ability to sterilize according to predefined biological and physical parameters. There is no human-in-the-loop performance aspect for a sterilizer.
7. The type of ground truth used
The ground truth used for the performance effectiveness of the sterilizer cycles is based on:
- Biological performance: Achieving a sterility assurance level (SAL) of at least 10^-6, demonstrated by the "overkill method" using biological indicators.
- Physical and technical parameters: Compliance with predefined temperature accuracy, pressure measurement, air removal, moisture retention, software functionality, and electrical/safety standards as outlined in ANSI/AAMI ST55:2016, IEC 61010-1, IEC 61326-1, IEC 61010-2-040, and ASME Boiler and Pressure Vessel Code.
8. The sample size for the training set
Not applicable. This device is a medical sterilizer and does not involve machine learning or AI models that require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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
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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
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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 | MAXIMUMLOAD | EXPOSURETEMP (F/C)* | EXPOSURETIME (MIN) | NUMBER OFDYNAMICAIR REMOVALPULSES | DRY TIME(MINUTES) |
|---|---|---|---|---|---|---|
| FL120 | IMMEDIATEUSE (IUSS) | 20 lbs. | 270 / 132 | 4 | 3 | 0 |
| 275 / 135 | 3 | 3 | 0 | |||
| FL120 | TEXTILES | 3 TEXTILEPACKS ** | 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 | IMMEDIATEUSE (IUSS) | 25 lbs | 270 /132 | 4 | 3 | 0 |
| 275 / 135 | 3 | 3 | 0 | |||
| FL135 | TEXTILES | 3 TEXTILEPACKS ** | 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).
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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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1. Device Name
| Trade Name: | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, FortDefiance Industries FRONT-LINE Field Sterilizer FL135 |
|---|---|
| Model Name(s): | FL120 / FL135 |
| Common/usual Name: | Electronic autoclave, steam sterilizer |
| Classification Name: | Steam SterilizerClass 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.
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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 | MaximumLoad | ExposureTemperature¹(°F/°C) | ExposureTime(minutes) | Dry Time(minutes) |
|---|---|---|---|---|---|
| FL120 | Immediate Use(IUSS) | 20 lbs. | 270/132275/135 | 43 | 0 |
| Textiles | 3 Textile Packs² | 250/121270/132275/135 | 3043 | 60 | |
| WrappedInstruments /Pouches | 20 lbs. | 250/121270/132275/135 | 3043 | 60 | |
| FL120 | Handpieces | 12 Handpieces | 270/132 | 4 | 60 |
| 275/135 | 3 | ||||
| FL135 | Immediate Use(IUSS) | 25 lbs. | 270/132275/135 | 43 | 0 |
| Textiles | 3 Textile Packs² | 250/121270/132275/135 | 3043 | 60 | |
| WrappedInstruments /Pouches | 25 lbs. | 250/121270/132275/135 | 3043 | 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.
| Performanceand/or SafetyCharacteristic | New DeviceFort Defiance IndustriesFRONT-LINE Field SterilizersFL120 & FL135K213457 | Predicate DeviceElectronic Tabletop AutoclaveTuttnauer EZ11 PlusK111736 |
|---|---|---|
| Indications forUse | The Fort Defiance IndustriesFRONT-LINE Field Sterilizersare autoclaves designed forsterilizing heat- and moisture-stable medical, dental, andsurgical materials, includingwrapped and unwrapped, solid,porous, and hollow items (e.g.,dental handpieces, suction pipes)in healthcare facilities. | The EZ Plus series of autoclaves areautoclaves designed for sterilizingmedical and surgical goods,including both wrapped andunwrapped, solid, hollow, andporous products and goods definedas hollow (e.g. dental handpieces,suction pipes) in ophthalmic, dental,and medical clinics; in first aidrooms; and in small laboratories. |
| OperatingPrinciple | Steam Flush Pressure Pulse(SFPP).Steam is the sterilization agent.(traditional method). | Steam Flush Pressure Pulse(SFPP).Steam is the sterilization agent(traditional method). |
| Performanceand SafetyStandardsFollowed | ANSI/AAMI ST55ASME Sec. VIII Div 1IEC 61010-1IEC 61326-1IEC 61010-2-040 | ANSI/AAMI ST55ASME Sec. VIII Div 1UL 61010-1EN 61326-1UL 61010-2-040 |
| Performanceand/or SafetyCharacteristic | New DeviceFort Defiance IndustriesFRONT-LINE Field SterilizersFL120 & FL135K213457 | Predicate DeviceElectronic Tabletop AutoclaveTuttnauer EZ11 PlusK111736 |
| Factory Pre-ProgrammedSteam Flush Pressure Pulse(SFPP) Conditioning Phase | Factory Pre-ProgrammedSteam Flush Pressure Pulse(SFPP) Conditioning Phase | |
| SterilizationCycles | 30 min exposure @ 250°F60 min dry time - Default | 30 min exposure @ 250°F1 min dry time - Default |
| 4 min exposure @ 270°F60 min dry time - Default | 3 or 4 min exposure @ 270°FDry time dependent on load | |
| 3 min exposure @ 275°F60 min dry time - Default | ||
| Chamber Size& Volume | FL12012" dia. X 23" lg.1.6 cf. (45.3 L)FL13513.5" dia. X 24" lg.2.00 cf. (56.35 L) | 11" dia. X 19.8" lg.1.0 cf. (28.5 L) |
| ChamberDesign andConstruction | Single Wall ChamberASME Section VIII, Div. IcertifiedStainless steel (316L) chamberand aluminum door (6061-T6) | Single Wall ChamberASME Section VIII, Div. IcertifiedStainless steel (316L) chamberand stainless-steel door |
| Shelves / Trays | Hard anodized aluminum shelf | Stainless Steel wire trays |
| Steam Source | Internal chamber boiler viapartitioned section | Internal chamber boiler alonglength of chamber |
| SteamGenerationMechanism | Electric resistive heaterssubmerged in chamber boiler | External chamber wall electric bandheaters |
| Dying Process | External air pulled through 0.3-micron HEPA filter then heatedfor drying | External air pulled through 0.2-micron HEPA filter then heatedfor drying |
| ControlTechnology | Electronic controller touch screen(PLC) | Electronic controller touch screen(PLC) |
| Performanceand/or SafetyCharacteristic | New DeviceFort Defiance IndustriesFRONT-LINE Field SterilizersFL120 & FL135 | Predicate DeviceElectronic Tabletop AutoclaveTuttnauer EZ11 PlusK111736 |
| ProcessMonitors | Chamber pressure transmitter.Dual element chambertemperature sensor. | Chamber pressure transmitter.Dual element chambertemperature sensor. |
| Door Failsafe | Automatic Door Interlock | Automatic Door Interlock |
| PrimaryOvertemp andOverpressureControl | PLC Controller -Utilizing RTDs and PressureTransmitter | PLC Controller -Utilizing RTDs and PressureTransmitter |
| SecondaryOvertempControl | Thermocouple TemperatureCut-off Switch (TCO) | Capillary TemperatureCut-off Switch (TCO) |
| SecondaryOverpressureControl | ASME Pressure Safety Valve | ASME Pressure Safety Valve |
| ElectricalInput | 120VAC +/- 10%,1Ø, 50/60 Hz, 15 A230-240VAC +/- 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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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 ST55:2016Requirements | AAMI ST55:2016 Tests | MeasuredPerformance |
|---|---|---|---|
| Sterilizer TemperatureControl&Pressure MeasurementTP-5070Note:TR-5072 reportsSterilizer Resolutions ofTemperatureMeasurementTR-5075 reportsSterilizer PressureMeasurementTR-5077 reports ColdPoint Relationship | 4.4.2.1 Temperature monitoring4.4.2.2 Relationship betweenRTD and chamber cold point4.4.2.4 Temperature graduationsof 1°C or less4.4.3 -0/+6°F temp control4.4.5.1 Pressure gauge of +/- 3%of full scale, resolution of 1PSIG or less | 5.4.2.1 - Verified byinspection5.4.2.2 - Verified byinspection and test 5.4.35.4.2.4 - Verified byinspection5.4.3 - Temperatureinstrumented chamber teststo confirm steady statetemperature control rangeand documentation of coldpoint5.4.5.1 - Verified byinspection and by testingagainst certified standards | PASS |
| Temperature AccuracyTP-5240 | 4.4.2.3 temperature accuracy of+/- 1℃ over designated range | 5.4.2.3 - Verified by testingagainst calibrated standards | PASS |
| Air RemovalTP-5080 | 4.6.1 Air removal for dynamicair removal sterilizers | A.4.6.1 - Alternate test forSteam Flush Pressure PulseSterilizers | PASS |
| Software Verificationand ValidationTP-5100: Sterilizer LogVerificationTP-5110: Sterilizer FaultConditionsTP-5120: GeneralFunctionsTP-5130: Full CycleVerification | 4.4.7 Sterilizer fault conditions4.4.8 Cycle documentation | 5.4.7 - Verified by inspection5.4.8 - Verified by inspection | PASS |
| Biological Performance- TextilesTP-5141 | 4.5 Biological performance ofsterilizers | 5.5.2 Biological performancewith a textile pack | PASS |
| Biological Performance- Wrapped InstrumentTP-5160 | 4.5 Biological performance ofsterilizers | 5.5.4 Biological performancewith wrapped instruments | PASS |
| Biological Performance- Dental HandpiecesTP-5170 | 4.5 Biological performance ofsterilizers | 5.5.5 Biological performancewith dental handpieces | PASS |
| Test Procedure | AAMI ST55:2016Requirements | AAMI ST55:2016 Tests | MeasuredPerformance |
| Moisture Retention –TextilesTP-5190 | 4.7 Moisture Retention | 5.7.1 Textile test packs | PASS |
| Moisture Retention –Wrapped InstrumentTP-5200 | 4.7 Moisture Retention | 5.7.2 Wrapped Instr. Testtrays | PASS |
| Moisture Retention –Pouches Drying TestTP-5210 | 4.7 Moisture Retention | 5.7.3 Paper-plastic peelpouches | PASS |
| Endotoxin and WaterQualityTP-5220 | A.4.2.6 Water supply reservoir | A.4.2.6 Water supplyreservoir | PASS |
| FDI Test Procedure or3rd Party | Standard | Tests | MeasuredPerformance |
| LabelingTP-5010(FDI) | AAMI ST55:2016 - 4.1.1Device MarkingsAAMI ST55:2016 - 4.1.2Information ManualAAMI ST55:2016 - 4.1.3Service Manual | AAMI ST55:2016 - 5.1 Visualinspection only | PASS |
| Sterilizer SafetyTP-5050(FDI) | AAMI ST55:2016 - 4.3.1InterlockAAMI ST55:2016 - 4.3.2Thermal hazardsAAMI ST55:2016 - 4.3.3Aborting cycles | AAMI ST55:2016 - 5.3.1Interlock functions underconditions describedAAMI ST55:2016 - 5.3.2Thermal hazard testing per UL-61010AAMI ST55:2016 - 5.3.3Verified by inspection | PASS |
| General InspectionTP-5060(FDI) | 4.2.1 & 4.2.2 Pressure vesselrequirements4.2.4 Corrosion resistance4.2.5 Air filters4.2.6 Water supply reservoir4.4.4 Sterilizer exposure timer4.4.6 Cycle completion | AAMI ST55:2016 - 5.2.1Verified by compliance toASME BPVC Section VIIIDivision 1 Code, requirementsin UL 61010-1 and IEC 61010-2-040AAMI ST55:2016 - 5.2.4Material corrosion resistancereviewAAMI ST55:2016 - 5.2.5 Airfilter inspection necessaryfiltration efficiency and filterreadily accessibleAAMI ST55:2016 - 5.2.6Verified by inspectionAAMI ST55:2016 - 5.4.4Verified by inspection andtimer testing to NIST standardAAMI ST55:2016 - 5.6.6Verified by inspection | PASS |
| 3rd Party TestingElectrical Safety | IEC 61010-1 Edition 3.12017-01 | 3rd Party test protocol | PASS |
| 3rd Party TestingElectrical/SterilizerSpecific Safety | IEC 61010-2-040:2020 | 3rd Party test protocol | PASS |
| 3rd Party TestingEMC/EMI | IEC 61326-1:2020 | 3rd Party test protocol | PASS |
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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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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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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).
§ 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).