(140 days)
The Consolidated HC Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities using saturated steam as the sterilizing agent. They are equipped with factory programmed cycles. The factory programmed cycles, the chamber and overall dimensions, and the number of standard test items per AAMI ST8:2013 for all models of the HC Series steam sterilizers are provided below.
The 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 (reference 21 CFR Part 880.6880). Three models have been selected for the Consolidated HC Sterilizer product line: Model 3AV-HC, Model 26AV-HC, and Model 26BV-HC. The sterilizer will be targeted for sale into Ambulatory Surgery Centers (ASCs), Clinics, and Hospitals.
The Consolidated HC Steam Sterilizers are for general purpose gravity, vacuum, or liquid steam sterilization of heat and moisture-stabile medical goods, surgical instruments, and supplies. All models utilize both gravity/downward air displacement with positive-pressure pulse conditioning and pressure/vacuum pulsing for dynamic air removal. The programmed cycles are easily accessed and are password protected. All cycle phases are sequenced and monitored by a PLC-based control system, providing both audible and visual notification of deviation from critical operating parameters. These sterilizers can either be supplied for connection to direct building steam supply of 50-80 PSI of steam pressure or come equipped with an integral, electrically heated steam generator.
Here's a breakdown of the acceptance criteria and study information for the Consolidated HC Steam Sterilizer, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance | Meets requirements of AAMI ST8: 2013/(R)2018 | Pass |
| General Electrical Safety | Meets requirements of UL 61010-1, 3rd Edition | Pass |
| Sterilizer Electrical Safety | Meets requirements of UL 61010-2-040 | Pass |
| Electromagnetic Compatibility | Meets requirements of IEC 61326-1:2020, FCC Part 15 subpart b, and Table 9 Per IEC 60601-1-2:2014 | Pass |
| Pressure Vessel Safety | Meets requirements of Section VIII, ASME Boiler & Pressure Vessel Code, 2019 | Pass |
| Generator Safety | Meets requirements of Section I, ASME Boiler & Pressure Vessel Code, 2019 | Pass |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 (stated under Technological Characteristics) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical tests against various standards. It does not provide specific sample sizes for these tests in terms of the number of devices tested or the number of sterilization cycles performed for each criterion. The provenance of this data is internal testing conducted by Consolidated Machine Corp. (the manufacturer) to demonstrate compliance with recognized industry standards. The data is reported as part of a premarket notification to the FDA. It is prospective data generated specifically for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For non-clinical tests based on engineering and performance standards (like AAMI, UL, IEC, ASME), the "ground truth" is typically established by fulfilling the defined criteria and measurement methodologies specified within those standards. This would involve calibrated equipment and trained technicians/engineers, rather than a panel of clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable in the context of the provided non-clinical testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessment (e.g., image reading), not for objective performance tests against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was used in support of this submission." This device is a medical sterilizer, and its effectiveness is determined by its ability to achieve a Sterility Assurance Level (SAL) through validated physical and biological parameters, not by human interpretation of results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a steam sterilizer, not an AI algorithm. Its performance is inherent to its mechanical and control systems.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on established industry standards and regulatory requirements. For example:
- Performance: AAMI ST8:2013 (R)2018 (a standard for steam sterilization in healthcare facilities). This standard outlines the microbiological and physical requirements for effective sterilization, often involving the use of biological indicators that demonstrate a defined kill rate.
- Safety (Electrical, EMC, Pressure Vessel, Generator): UL, IEC, and ASME standards, which define objective measurement criteria for electrical safety, electromagnetic compatibility, and structural integrity under pressure.
- Sterility Assurance Level (SAL): Defined as 10^-6, meaning there is a 1 in 1,000,000 probability of a viable microorganism being present on a sterilized item. This is a universally accepted microbiological standard for sterilization.
8. The Sample Size for the Training Set
This question is not applicable. This device is a physical sterilizer, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this type of 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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
August 1, 2022
Consolidated Machine Corp. Arthur Trapotsis CEO 3 Enterprise Rd, Suite C Billerica, Massachusetts 01821
Re: K220736
Trade/Device Name: Consolidated HC Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: June 28, 2022 Received: June 30, 2022
Dear Arthur Trapotsis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
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) K220736
Device Name Consolidated HC Steam Sterilizer
Indications for Use (Describe)
The Consolidated HC Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities using saturated steam as the sterilizing agent. They are equipped with factory programmed cycles. The factory programmed cycles, the chamber and overall dimensions, and the number of standard test items per AAMI ST8:2013 for all models of the HC Series steam sterilizers are provided below.
Table 1: Validated Sterilization Cycles
| Cycle Type | SterilizationTemperature | SterilizationTime | Dry Time | Load Type |
|---|---|---|---|---|
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Fabric Packs |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double Wrapped InstrumentTrays Maximum weight pertray: 25lbs (11.3 kg) |
| Gravity - IUSS | 270°F (132°C) | 3 minutes | 1 minutes | Single Unwrapped TrayMaximum weight per tray: 25lbs(11.3 kg) |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double Wrapped InstrumentTrays Maximum weight pertray: 25lbs (11.3 kg) |
| Pre-Vacuum -IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Single Unwrapped TrayMaximum weight per tray: 25lbs(11.3 kg) |
| Pre-Vacuum | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs |
| Pre-Vacuum | 270°F (132°C) | 4 minutes | 30 minutes | Double Wrapped InstrumentTrays Maximum weight pertray: 25lbs (11.3 kg) |
| Pre-Vacuum | 275°F (135°C) | 3 minutes | 30 minutes | Double Wrapped InstrumentTrays Maximum weight pertray: 25lbs (11.3 kg) |
| Pre-Vacuum | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack and SingleUnwrapped Tray Maximumweight per tray: 25lbs (11.3 kg) |
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Table 1 (cont.): Validated Sterilization Cycles
| Liquids | 250°F (121°C) | 30 minutes | N/A | 1L Liquid Volumes |
|---|---|---|---|---|
| Bowie Dick Test | 273°F (134°C) | 3.5 minutes | 0 minutes | Bowie Dick Test Pack |
| Vacuum LeakTest | 270°F (132°C) | N/A | N/A | Empty Chamber |
| Warm Up | 270°F (132°C) | 3 minutes | 1 minutes | Empty Chamber |
Table 2: Load Size
| Model | SterilizerChamber Size | DoubleWrappedInstrumentTrays1 | FabricPacks2 | Number ofLiquidContainers3 |
|---|---|---|---|---|
| 26AV-HC | 26" X 26" X39" | 9, maximumweight 25lbeach | 12 | 70, 1 LiterVolume PerContainer |
| 26BV-HC | 26" X 26" X49" | 12, maximumweight 25lbeach | 16 | 90, 1 LiterVolume PerContainer |
| 3AV-HC | 20" X 20" X38" | 3, maximumweight 25lbeach | 9 | 28, 1 LiterVolume PerContainer |
1 For instrument trays, the maximum weight per tray is 25lbs (11.3 kg).
2 The weight of each fabric pack should be limited to aproximately 3.2 lbs (1.4 kg) with a density of 11.3 lb/ft3 (181 kg/m3) or less. 3 For liquid containers, the maximum volume of liquid per container is 1,000 ml. Please note, liquid loads processed in the sterlizer are inappropriate for direct patient contact.
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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)
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510(k) Summary for Consolidated HC Steam Sterilizer
Consolidated Sterilizer Systems 3 Enterprise Road, Suite C Billerica, MA 01821
Contact: Arthur Trapotsis Phone: 617-782-6072 ext2200 Email: Arthur@consteril.com
Premarket Notification Number: K220736 Date of Preparation: July 27, 2022
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Device Name
| Trade Name: | Consolidated HC Steam Sterilizer |
|---|---|
| Device Class: | Class II |
| Common Name: | Steam Sterilizer/Autoclave |
| Classification Name: | Sterilizer, Steam |
| Classification Number: | 21 CFR 880.6880 |
| Product Code: | FLE |
Predicate Device
| K183410 AMSCO 600 Steam Sterilizer | ||
|---|---|---|
| Device Class: | Class II | |
| Common Name: | Steam Sterilizer/Autoclave | |
| Classification Name: | Sterilizer, Steam | |
| Classification Number: | 21 CFR 880.6880 | |
| Product Code: | FLE |
Description of Device
The 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 (reference 21 CFR Part 880.6880). Three models have been selected for the Consolidated HC Sterilizer product line: Model 3AV-HC, Model 26AV-HC, and Model 26BV-HC. The sterilizer will be targeted for sale into Ambulatory Surgery Centers (ASCs), Clinics, and Hospitals.
The Consolidated HC Steam Sterilizers are for general purpose gravity, vacuum, or liquid steam sterilization of heat and moisture-stabile medical goods, surgical instruments, and supplies. All models utilize both gravity/downward air displacement with positive-pressure pulse conditioning and pressure/vacuum pulsing for dynamic air removal. The programmed cycles are easily accessed and are password protected. All cycle phases are sequenced and monitored by a PLC-based control system, providing both audible and visual notification of deviation from critical operating parameters. These sterilizers can either be supplied for connection to direct building steam supply of 50-80 PSI of steam pressure or come equipped with an integral, electrically heated steam generator.
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Indications for Use
The Consolidated HC Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities using saturated steam as the sterilizing agent. They are equipped with factory programmed cycles. The factory programmed cycles, the chamber and overall dimensions, and the number of standard test items per AAMI ST8:2013 R2018 for all models of the HC Series steam sterilizers are provided below.
| Cycle Type | SterilizationTemperature | SterilizationTime | Dry Time | Load Type |
|---|---|---|---|---|
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Fabric Packs |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double Wrapped Instrument TraysMaximum weight per tray: 25lbs(11.3 kg) |
| Gravity - IUSS | 270°F (132°C) | 3 minutes | 1 minutes | Single Unwrapped TrayMaximum weight per tray: 25lbs(11.3 kg) |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double Wrapped Instrument TraysMaximum weight per tray: 25lbs(11.3 kg) |
| Pre-Vacuum -IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Single Unwrapped Tray Maximumweight per tray: 25lbs (11.3 kg) |
| Pre-Vacuum | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs |
| Pre-Vacuum | 270°F (132°C) | 4 minutes | 30 minutes | Double Wrapped Instrument TraysMaximum weight per tray: 25lbs(11.3 kg) |
| Pre-Vacuum | 275°F (135°C) | 3 minutes | 30 minutes | Double Wrapped Instrument TraysMaximum weight per tray: 25lbs(11.3 kg) |
| Pre-Vacuum | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack and SingleUnwrapped Tray Maximum weightper tray: 25lbs (11.3 kg) |
| Liquids | 250°F (121°C) | 30 minutes | N/A | 1L Liquid Volumes |
| Bowie Dick Test | 273°F (134°C) | 3.5 minutes | 0 minutes | Bowie Dick Test Pack |
| Vacuum Leak Test | 270°F (132°C) | N/A | N/A | Empty Chamber |
| Warm Up | 270°F (132°C) | 3 minutes | 1 minutes | Empty Chamber |
Table 1: Validated Sterilization Cycles
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Table 2: Load Size
| Model | SterilizerChamber Size | Double WrappedInstrument Trays1 | FabricPacks2 | Number of LiquidContainers3 |
|---|---|---|---|---|
| 26AV-HC | 26" X 26" X 39" | 9, maximumweight 25lb each | 12 | 70, 1 Liter Volume PerContainer |
| 26BV-HC | 26" X 26" X 49" | 12, maximumweight 25lb each | 16 | 90, 1 Liter Volume PerContainer |
| 3AV-HC | 20" X 20" X 38" | 3, maximumweight 25lb each | 9 | 28, 1 LiterVolume PerContainer |
1 For instrument trays, the maximum weight per tray is 25lbs (11.3 kg).
2 The weight of each fabric pack should be limited to approximately 3.2 lbs (1.4 kg) with a density of 11.3 lb/ft3 (181 kg/m3) or less.
3 For liquid containers, the maximum volume of liquid per container is 1,000 ml. Please note, liquid loads processed in the sterilizer are inappropriate for direct patient contact.
Technological Characteristics
Table 3: Comparison of the Proposed Device and the Predicate Device
| Feature | Consolidated HC Steam Sterilizer | AMSCO 600 Steam Sterilizer(K183410) | Comparison |
|---|---|---|---|
| Intended Use | The sterilization of heat andmoisture-stable materials used inhealthcare facilities. | The sterilization of heat andmoisture-stable materials used inhealthcare facilities. | Same |
| Critical ProcessParameters | Time, Chamber Temperature,Pressure | Time, Chamber Temperature,Pressure | Same |
| Control | Programmable Logic Controller | Embedded Controller | Different |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Sterilant | Saturated Steam | Saturated Steam | Same |
| Utilities | Steam, Water, Electricity, Air | Steam, Water, Electricity, Air | Same |
| ChamberMaterial | 316L Stainless Steel | 316L Stainless Steel | Same |
| NominalChamber Size | 26" X 26" X 39"26" X 26" X 49"20" X 20" X 38" | 26" X 26" X 39"26" X 26" X 49" | Similar |
| Door | 316L Stainless Steel26" X 26" Power Vertical Sliding20" X 20" Power Vertical Sliding | 304L Stainless Steel26" X 26" Power Vertical Sliding | Similar |
| ChamberPressure Rating | 45 psig, 300 °F | 45 psig, 300 °F | Same |
| Door Seal | Air Activated Door Seal | Steam Activated Door Seal | Similar |
| ExternalProcessMonitors | Electronic ControlPrinter | Electronic ControlPrinter | Same |
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| Internal ProcessMonitors | RTD temperature sensor in chamberdrainRTD temperature sensor in jacketdrainRTD temperature sensor in wastedrainPressure transducer in chamber | RTD temperature sensor in chamberdrainRTD temperature sensor in jacketdrainRTD temperature sensor in heatexchangerPressure transducer in chamber | Same |
|---|---|---|---|
| Performance | Meets ANSI/AAMI ST8:2013 (R)2018 | Meets ANSI/AAMI ST8:2013 | Similar |
| Accessories | Shelves, Loading Equipment | BI, CI, Pouches, Trays, Wraps, Tape,Containers, Shelves, LoadingEquipment | Different |
| Test Cycles | Warm Up, Leak Test, Bowie Dick Test | Warm Up, Leak Test, DART (BowieDick) Test | Same |
| Cycles | See Table 1 | 270°F, Prevac, 4 min, Full fabric pack270°F, Prevac, 4 min, Full tray270°F, Prevac, 4 min, one fabric pack270°F, Prevac, 4 min, IUSS275°F, Prevac, 4 min, Full fabric pack250°F, Gravity, 30 min, Full tray | Similar |
| Full Loads | 26AV: 9, 25 lb double wrapped traysor 12 fabric packs26BV: 12, 25 lb double wrapped traysor 16 fabric packs3AV: 3, 25 lb double wrapped trays or6 fabric packs | 39″: 9, 25 lb double wrapped trays or12 fabric packs49″: 12, 25 lb double wrapped traysor 16 fabric packs | Similar |
The proposed device has the same intended use, instructions for use, and meets the same performance specification as the predicate device. The proposed device has similar technological characteristics as the predicate device. The proposed device offers more validated sterilization cycles than the predicate device. The proposed device offers an additional chamber size.
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Non-Clinical Tests
The Consolidated HC Steam Sterilizer non-clinical testing was performed according to the following standards, with passing results in all cases:
| Test | Acceptance Criteria | Result |
|---|---|---|
| Performance | Meets requirements of AAMI ST8: 2013/(R)2018 | Pass |
| General ElectricalSafety | Meets requirements of UL 61010-1, 3rd Edition | Pass |
| Sterilizer ElectricalSafety | Meets requirements of UL 61010-2-040 | Pass |
| ElectromagneticCompatibility | Meets requirements of IEC 61326-1:2020, FCC Part 15subpart b, and Table 9 Per IEC 60601-1-2:2014 | Pass |
| Pressure Vessel Safety | Meets requirements of Section VIII, ASME Boiler &Pressure Vessel Code, 2019 | Pass |
| Generator Safety | Meets requirements of Section I, ASME Boiler & PressureVessel Code, 2019 | Pass |
Table 4: Non-Clinical Test Results
The testing demonstrated that the subject devices, 3AV-HC, and 26BV-HC, met the acceptance criteria described in these standards.
Clinical Tests
No clinical testing was used in support of this submission.
Conclusion
The conclusions drawn from the nonclinical performance data demonstrate that the device, the Consolidated HC Steam Sterilizer, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K183410.
§ 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).