(86 days)
The Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) is an autoclave designed for sterilizing heat- and moisture-stable 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 Sterilizer, model FL135, is an autoclave 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 device uses electrical resistive heaters to produce steam as the sterilizing agent. The device adheres 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 provided text describes the 510(k) summary for the Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) and its modifications. The key changes involve reducing the dry times for wrapped instruments, textiles, and handpieces cycles. The study provided focuses on the sterilizer's performance and safety and is not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML studies (such as MRMC studies, number of experts for ground truth, sample sizes for training sets, etc.) are not applicable to this submission.
The acceptance criteria and performance data are primarily based on the sterilizer's ability to achieve and maintain sterility, as well as its moisture retention characteristics, according to the AAMI ST55:2016 standard.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are derived from ANSI/AAMI ST55:2016. The reported device performance is indicated by "PASS" for each test.
| Acceptance Criteria (from AAMI ST55:2016 Requirements) | Reported Device Performance |
|---|---|
| Sterilizer Temperature Control & Pressure Measurement 4.4.3 -0/+6°F temp control | PASS (5.4.3 - Temperature instrumented chamber tests to confirm steady state temperature control range and documentation of cold point) |
| Software Verification and Validation 4.4.7 Sterilizer fault conditions | PASS (5.4.7 - Verified by inspection, TP-5110: Sterilizer Fault Conditions, TP-5120: General Functions, TP-5130: Full Cycle Verification) |
| Biological Performance - Wrapped Instrument 4.5 Biological performance of sterilizers | PASS (5.5.4 Biological performance with wrapped instruments) |
| Moisture Retention - Textiles 4.7 Moisture Retention | PASS (5.7.1 Textile test packs) |
| Moisture Retention - Wrapped Instrument 4.7 Moisture Retention | PASS (5.7.2 Wrapped Instr. Test trays) |
| Moisture Retention - Pouches 4.7 Moisture Retention | PASS (5.7.3 Paper-plastic peel pouches) |
| Safety - Electrical Safety | PASS (3rd Party test protocol per IEC 61010-1 Edition 3.1 2017-01) |
| Safety - EMC/EMI | PASS (3rd Party test protocol per IEC 61326-1:2020) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "3 successive cycles at half the programmed exposure time" for the overkill method to guarantee a sterility assurance level (SAL) of at least 10^-6. It also mentions validation studies were conducted. However, the exact sample sizes for each specific test (e.g., number of textile packs, wrapped instruments, or handpieces tested) are not explicitly stated in the provided summary.
- Data Provenance: The studies were conducted by Fort Defiance Industries LLC which is based in Loudon, Tennessee, USA. The studies appear to be prospective validation studies performed to support the 510(k) submission for the device modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a hardware medical device (steam sterilizer) and the ground truth is established through physical and biological indicators, not human expert consensus on interpretations of images or data. The validation is against established engineering and sterilization standards (ANSI/AAMI ST55:2016).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is not an AI/ML or diagnostic study requiring human expert adjudication. The performance is objectively measured against physical and biological parameters.
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 is not an AI/ML device, and no human reader comparative effectiveness studies were performed or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML algorithm. The performance is the standalone performance of the sterilizer itself. The summary evaluates the device's ability to sterilize and dry items on its own, based on programmed cycles.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for sterilizer performance is based on established industry standards and scientific principles of sterilization. This includes:
- Biological Indicators: Used in the "overkill method" to demonstrate a Sterility Assurance Level (SAL) of at least 10^-6. This typically involves challenging the sterilizer with a high concentration of resistant microorganisms, and "ground truth" is established by their survival or inactivation.
- Physical Parameters: Temperature and pressure measurements throughout the cycle, as defined by ANSI/AAMI ST55:2016 (e.g., -0/+6°F temp control).
- Moisture Retention: Empirical measurements of water remaining on processed items, compared against defined limits in the AAMI standard.
8. The sample size for the training set
- Not Applicable. This device uses pre-programmed cycles based on engineering design and validation against recognized standards, not machine learning models that require a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set for an AI/ML model.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for 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 text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
March 7, 2025
Fort Defiance Industries LLC Chris Coleman Quality Management Representative 2411 Maremont Parkway Loudon, Tennessee 37774
Re: K243801
Trade/Device Name: FRONT-LINE Field Sterilizer (FL135) Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: February 12, 2025 Received: February 12, 2025
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
{2}------------------------------------------------
Sincerely,
Stephen A. Anisko -S
Digitally signed by Stephen A. Anisko -S Date: 2025.03.07 16:32:38 -05'00'
for: Christopher K. Dugard Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K243801
Device Name
FRONT-LINE Field Sterilizer (FL135)
Indications for Use (Describe)
The Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
| CYCLE | MAXIMUMLOAD | EXPOSURETEMP* (°F/°C) | EXPOSURETIME(MINUTES) | DRY TIME(MINUTES) |
|---|---|---|---|---|
| IMMEDIATEUSE (IUSS) | 25 LBS. | 270 / 132 | 4 | 0 |
| 275 / 135 | 3 | 0 | ||
| TEXTILES | 3 TEXTILEPACKS** | 250 / 121 | 30 | 15 |
| 270 / 132 | 4 | 15 | ||
| 275 / 135 | 3 | 15 | ||
| WRAPPEDINSTR./POUCHES | 25 LBS. | 250 / 121 | 30 | 35 |
| 270 / 132 | 4 | 30 | ||
| 275 / 135 | 3 | 30 | ||
| HANDPIECES | 12 HANDPIECES | 270 / 132 | 4 | 30 |
| 275 / 135 | 3 | 30 |
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).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{4}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for FDI. The logo is orange and consists of the letters "FDI" in a bold, sans-serif font. A white line cuts through the top of the letters, giving the logo a modern and dynamic look. The logo is simple and memorable, and the orange color gives it a sense of energy and enthusiasm.
510(k) Summary for Fort Defiance Industries FRONT-LINE Field Sterilizer Model FL135 K243801
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:
Revised: 12 FEB 2025
{6}------------------------------------------------
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 connected and have a modern, geometric design. The logo is simple and eye-catching.
1. Device Name
| Trade Name: | FRONT-LINE Field Sterilizer (FL135) |
|---|---|
| Model Name(s): | FL135 |
| Common/usual Name: | Electronic autoclave, steam sterilizer |
| Classification Name: | Steam SterilizerClass II Device - 21 CFR 880.6880Product Code FLE |
2. Predicate Device
K213457, FRONT-LINE Field Sterilizer, Model FL135, product code FLE, cleared March 2, 2022
3. Descrintion of Device
This change to the FRONT-LINE Field Sterilizer, model FL135, reduces the dry times of the wrapped instrument, textiles, and handpieces cycles from the original dry times to the following new dry times.
| Model | Cycle | ExposureTemperature (°F) | Original DryTime (mins) | New DryTime (mins) |
|---|---|---|---|---|
| FL135 | Immediate Use SteamSterilization(IUSS) | 270 & 275 | 0 | 0 |
| Textiles | 250, 270, & 275 | 60 | 15 | |
| Wrapped Instruments/Pouches | 250 | 60 | 35 | |
| 270 & 275 | 60 | 30 | ||
| Handpieces | 270 & 275 | 60 | 30 |
To allow for the reduction in dry time, the dry rate of the sterilizer was increased by the following changes: (1) added a surface heater on the outside of the chamber to increase heat delivered to the chamber and load, (2) replaced the existing chamber load rack with an improved rack that allows for better heat and mass transfer, (3) implemented a new valve control scheme to improve condensate drainage and air flow during drying, and (4) increased the speed of the air pump to increase airflow through the chamber during drying. FDA consensus standard, AAMI ST55:2016, was referenced to validate dry performance of the predicate and new device. Acceptance criteria were also derived from the above standard.
{7}------------------------------------------------
Image /page/7/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 connected and have a modern, geometric design. The logo is simple and eye-catching.
The Fort Defiance Industries FRONT-LINE Field Sterilizer, model FL135, is an autoclave 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 device uses electrical resistive heaters to produce steam as the sterilizing agent. The device adheres 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 device is 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 and does not permit the door to be opened until the chamber gauge pressure is near zero. Additional safety features include electronic overtemperature and overpressure protection, independent thermal cutoffs, and a pressure safety relief valve for the chamber.
Only United States Food and Drug Administration cleared sterilization accessories should be used with this autoclave.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for FDI in orange. The logo is a stylized version of the letters FDI. The letters are bold and sans-serif. The logo is simple and modern.
4. Design and Materials
The FRONT-LINE Field Sterilizer, model FL135, is a steam sterilizer 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 device is electronically controlled and includes 10 preprogrammed sterilization cycles. All materials in the sterilization system and plumbing system are deemed acceptable for steam sterilizers.
న. Technology
The FRONT-LINE FL135 autoclave is a steam sterilizer composed of a pressure vessel that utilizes electric resistive heaters to produce the sterilizing agent, steam, from a chamber boiler. The autoclave contains an electronic control system that automatically initiates programmed Steam Flush Pressure Pulse (SFPP) phases to purge atmospheric air from the chamber followed by a temperature-controlled, timed steam exposure. A final drying phase, assisted by chamber internal and external heaters, completes the sterilization cycle. 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.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for FDI. The logo is orange and consists of the letters F, D, and I. The letters are connected and have a modern, geometric design. The logo is simple and eye-catching.
6. Intended Use
The Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) is an autoclave 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) |
|---|---|---|---|---|---|
| FL135 | Immediate Use(IUSS) | 25 lbs. | 270/132 | 4 | 0 |
| 275/135 | 3 | ||||
| FL135 | Textiles | 3 Textile Packs2 | 250/121 | 30 | 15 |
| 270/132 | 4 | ||||
| 275/135 | 3 | ||||
| FL135 | WrappedInstruments /Pouches | 25 lbs. | 250/121 | 30 | 30 |
| 270/132 | 4 | ||||
| 275/135 | 3 | ||||
| FL135 | Handpieces | 12 Handpieces | 270/132 | 4 | 30 |
| 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).
{10}------------------------------------------------
Image /page/10/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 is a white line running through the middle of each letter. The logo is simple and modern, and the orange color is eye-catching.
7. Comparison of Technology
The previously cleared device and the FRONT-LINE Field Sterilizer model 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 new FL135 sterilizer 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 new FL135 and the predicate with regards to chamber size, cycle parameters, and configuration of steam generation. The differences do not affect the safety or effectiveness of the new device compared to the predicate. Table 1 provides a summary of performance and safety characteristics of the proposed new device and the predicate.
| Performanceand/or SafetyCharacteristic | New DeviceFort Defiance IndustriesFRONT-LINE Field SterilizerModel FL135 K243801 | Predicate DeviceFort Defiance Industries FRONT-LINE Field SterilizerModel FL135 (K213457) |
|---|---|---|
| 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 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. |
| OperatingPrinciple | Steam Flush Pressure Pulse(SFPP).Steam is the sterilization agent(traditional method).ANSI/AAMI ST55 | Steam Flush Pressure Pulse(SFPP).Steam is the sterilization agent(traditional method).ANSI/AAMI ST55 |
| Performanceand SafetyStandardsFollowed | ASME Sec. VIII Div 1UL 61010-1EN 61326-1UL 61010-2-040 | ASME Sec. VIII Div 1UL 61010-1EN 61326-1UL 61010-2-040 |
| Performanceand/or SafetyCharacteristic | New DeviceFort Defiance IndustriesFRONT-LINE Field SterilizerModel FL135 K243801 | Predicate DeviceFort Defiance Industries FRONT-LINE Field SterilizerModel FL135 (K213457) |
| Factory Pre-Programmed | Factory Pre-Programmed | |
| Steam Flush Pressure Pulse(SFPP) Conditioning Phase | Steam Flush Pressure Pulse(SFPP) Conditioning Phase | |
| SterilizationCycles | 30 min exposure @ 250°F Drytime dependent on load | 30 min exposure @ 250°F Drytime dependent on load |
| 4 min exposure @ 270°FDry time dependent on load | 4 min exposure @ 270°FDry time dependent on load | |
| 3 min exposure @ 275°FDry time dependent on load | 3 min exposure @ 275°FDry time dependent on load | |
| Dry Times -Wrapped | 275°F: 30 min270°F: 30 min250°F: 35 min | 60 min(all temperatures) |
| Dry Times -Textiles | 15 min(all temperatures) | 60 min(all temperatures) |
| Dry Times -Handpieces | 30 min(all temperatures) | 60 min(all temperatures) |
| Chamber Size& Volume | FL13513.5" dia. X 24" lg.2.00 cf. (56.35 L) | FL13513.5" dia. X 24" lg.2.00 cf. (56.35 L) |
| ChamberDesign andConstruction | Single Wall Chamber ASMESection VIII, Div. I certifiedStainless steel (316L) chamberand aluminum door (6061-T6) | Single Wall Chamber ASMESection VIII, Div. I certifiedStainless steel (316L) chamberand aluminum door (6061-T6) |
| Shelves / Trays | Stainless Steel wire tray | Aluminum tray |
| Steam Source | Internal chamber boiler viapartitioned section | Internal chamber boiler viapartitioned section |
| SteamGenerationMechanism | Electric resistive heaterssubmerged in chamber boiler | Electric resistive heaterssubmerged in chamber boiler |
| Drying Process | External air pulled through 0.3-micron HEPA filter then heatedby internal cartridge heaters andexternal chamber wall heater fordrying | External air pulled through 0.3-micron HEPA filter then heatedby internal cartridge heaters fordrying |
| Performanceand/or SafetyCharacteristic | New DeviceFort Defiance IndustriesFRONT-LINE Field SterilizerModel FL135 K243801 | Predicate DeviceFort Defiance Industries FRONT-LINE Field SterilizerModel FL135 (K213457) |
| ControlTechnology | Electronic controller touchscreen (PLC) | Electronic controller touch screen(PLC) |
| 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 - UtilizingRTDs and PressureTransmitter | PLC Controller - Utilizing RTDsand PressureTransmitter |
| SecondaryOvertempControl | Thermocouple TemperatureCut-off Switch (TCO) | Thermocouple TemperatureCut-off Switch (TCO) |
| SecondaryOverpressureControl | ASME Pressure Safety Valve | ASME Pressure Safety Valve |
| ElectricalInput | 120VAC ± 10%,1Φ, 50/60 Hz, 15 A230-240VAC ± 10%,1Φ, 50/60 Hz, 15 A | 120VAC ± 10%,1Φ, 50/60 Hz, 15 A230-240VAC ± 10%,1Φ, 50/60 Hz, 15 A |
Table 1: Comparison of Technology
{11}------------------------------------------------
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 all capitalized and in a sans-serif font. The logo is simple and modern.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for FDI in orange. The logo is a stylized version of the letters FDI. The letters are bold and sans-serif. The letter D is incomplete, with a diagonal line cutting through the upper right corner. The letter I also has a diagonal line cutting through the upper right corner.
8. Summarv 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 Model FL135 sterilizer meets all requirements 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 10t6 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 FL135 Sterilizer has been validated to meet the requirements of ANSI/AAMI ST55:2016, Tabletop Steam Sterilizers (FDA Recognition Number 14-518). Table 2 summarizes the FL135 effectiveness testing and results performed by Fort Defiance Industries.
{13}------------------------------------------------
Image /page/13/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 have a modern, geometric design. The logo is simple and eye-catching.
Table 2: Performance Testing Summary
| Test Procedure | AAMI ST55:2016 Requirements | AAMI ST55:2016 Tests | Measured Performance |
|---|---|---|---|
| Sterilizer Temperature Control & Pressure MeasurementTP-5070 | 4.4.3 -0/+6°F temp control | 5.4.3 - Temperature instrumented chamber tests to confirm steady state temperature control range and documentation of cold point | PASS |
| Software Verification and Validation | 4.4.7 Sterilizer fault conditions | 5.4.7 - Verified by inspection | |
| TP-5110: Sterilizer Fault Conditions | |||
| TP-5120: General Functions | PASS | ||
| TP-5130: Full Cycle Verification | |||
| Biological Performance - Wrapped InstrumentTP-5160 | 4.5 Biological performance of sterilizers | 5.5.4 Biological performance with wrapped instruments | PASS |
| 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. Test trays | PASS |
| Moisture Retention - PouchesTP-5210 | 4.7 Moisture Retention | 5.7.3 Paper-plastic peel pouches | PASS |
{14}------------------------------------------------
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 connected to each other and have a modern, geometric design. The logo is simple and eye-catching.
9. Safety
The Fort Defiance FRONT-LINE Field Sterilizer FL135 has 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 Laboratorv 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, 2023 Edition, . Rules for Construction of Pressure Vessels (General Use)
Table 3 summarizes FRONT-LINE Field Sterilizer FL135 safety testing results performed by Fort Defiance Industries or a Third Party where indicated.
| FDI Test Procedure or3rd Party | Standard | Tests | MeasuredPerformance |
|---|---|---|---|
| 3rd Party TestingElectrical Safety | IEC 61010-1 Edition 3.12017-01 | 3rd Party test protocol | PASS |
| 3rd Party TestingEMC/EMI | IEC 61326-1:2020 | 3rd Party test protocol | PASS |
Table 3: Safety Testing Summary
{15}------------------------------------------------
Image /page/15/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 connected and have a modern, geometric design. The logo is simple and eye-catching.
10. Conclusion
The conclusion drawn from the nonclinical test results demonstrates that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device, K213457, 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).