Consolidated HC Steam Sterilizer

{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" 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. 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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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 | Sterilization<br>Temperature | Sterilization<br>Time | 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<br>Trays Maximum weight per<br>tray: 25lbs (11.3 kg) | | Gravity - IUSS | 270°F (132°C) | 3 minutes | 1 minutes | Single Unwrapped Tray<br>Maximum weight per tray: 25lbs<br>(11.3 kg) | | Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double Wrapped Instrument<br>Trays Maximum weight per<br>tray: 25lbs (11.3 kg) | | Pre-Vacuum -<br>IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Single Unwrapped Tray<br>Maximum weight per tray: 25lbs<br>(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<br>Trays Maximum weight per<br>tray: 25lbs (11.3 kg) | | Pre-Vacuum | 275°F (135°C) | 3 minutes | 30 minutes | Double Wrapped Instrument<br>Trays Maximum weight per<br>tray: 25lbs (11.3 kg) | | Pre-Vacuum | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack and Single<br>Unwrapped Tray Maximum<br>weight per tray: 25lbs (11.3 kg) | {3}------------------------------------------------ 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 Leak<br>Test | 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 | Sterilizer<br>Chamber Size | Double<br>Wrapped<br>Instrument<br>Trays1 | Fabric<br>Packs2 | Number of<br>Liquid<br>Containers3 | |---------|----------------------------|-------------------------------------------|------------------|----------------------------------------| | 26AV-HC | 26" X 26" X<br>39" | 9, maximum<br>weight 25lb<br>each | 12 | 70, 1 Liter<br>Volume Per<br>Container | | 26BV-HC | 26" X 26" X<br>49" | 12, maximum<br>weight 25lb<br>each | 16 | 90, 1 Liter<br>Volume Per<br>Container | | 3AV-HC | 20" X 20" X<br>38" | 3, maximum<br>weight 25lb<br>each | 9 | 28, 1 Liter<br>Volume Per<br>Container | 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. {4}------------------------------------------------ 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. 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}------------------------------------------------ ### 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 {6}------------------------------------------------ ## 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. {7}------------------------------------------------ # 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 | Sterilization<br>Temperature | Sterilization<br>Time | 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 Trays<br>Maximum weight per tray: 25lbs<br>(11.3 kg) | | Gravity - IUSS | 270°F (132°C) | 3 minutes | 1 minutes | Single Unwrapped Tray<br>Maximum weight per tray: 25lbs<br>(11.3 kg) | | Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double Wrapped Instrument Trays<br>Maximum weight per tray: 25lbs<br>(11.3 kg) | | Pre-Vacuum -<br>IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Single Unwrapped Tray Maximum<br>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 Instrument Trays<br>Maximum weight per tray: 25lbs<br>(11.3 kg) | | Pre-Vacuum | 275°F (135°C) | 3 minutes | 30 minutes | Double Wrapped Instrument Trays<br>Maximum weight per tray: 25lbs<br>(11.3 kg) | | Pre-Vacuum | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack and Single<br>Unwrapped Tray Maximum weight<br>per 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 {8}------------------------------------------------ #### Table 2: Load Size | Model | Sterilizer<br>Chamber Size | Double Wrapped<br>Instrument Trays1 | Fabric<br>Packs2 | Number of Liquid<br>Containers3 | |---------|----------------------------|-------------------------------------|------------------|----------------------------------------| | 26AV-HC | 26" X 26" X 39" | 9, maximum<br>weight 25lb each | 12 | 70, 1 Liter Volume Per<br>Container | | 26BV-HC | 26" X 26" X 49" | 12, maximum<br>weight 25lb each | 16 | 90, 1 Liter Volume Per<br>Container | | 3AV-HC | 20" X 20" X 38" | 3, maximum<br>weight 25lb each | 9 | 28, 1 Liter<br>Volume Per<br>Container | 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<br>(K183410) | Comparison | |---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------| | Intended Use | The sterilization of heat and<br>moisture-stable materials used in<br>healthcare facilities. | The sterilization of heat and<br>moisture-stable materials used in<br>healthcare facilities. | Same | | Critical Process<br>Parameters | Time, Chamber Temperature,<br>Pressure | Time, Chamber Temperature,<br>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 | | Chamber<br>Material | 316L Stainless Steel | 316L Stainless Steel | Same | | Nominal<br>Chamber Size | 26" X 26" X 39"<br>26" X 26" X 49"<br>20" X 20" X 38" | 26" X 26" X 39"<br>26" X 26" X 49" | Similar | | Door | 316L Stainless Steel<br>26" X 26" Power Vertical Sliding<br>20" X 20" Power Vertical Sliding | 304L Stainless Steel<br>26" X 26" Power Vertical Sliding | Similar | | Chamber<br>Pressure Rating | 45 psig, 300 °F | 45 psig, 300 °F | Same | | Door Seal | Air Activated Door Seal | Steam Activated Door Seal | Similar | | External<br>Process<br>Monitors | Electronic Control<br>Printer | Electronic Control<br>Printer | Same | {9}------------------------------------------------ | Internal Process<br>Monitors | RTD temperature sensor in chamber<br>drain<br>RTD temperature sensor in jacket<br>drain<br>RTD temperature sensor in waste<br>drain<br>Pressure transducer in chamber | RTD temperature sensor in chamber<br>drain<br>RTD temperature sensor in jacket<br>drain<br>RTD temperature sensor in heat<br>exchanger<br>Pressure 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,<br>Containers, Shelves, Loading<br>Equipment | Different | | Test Cycles | Warm Up, Leak Test, Bowie Dick Test | Warm Up, Leak Test, DART (Bowie<br>Dick) Test | Same | | Cycles | See Table 1 | 270°F, Prevac, 4 min, Full fabric pack<br>270°F, Prevac, 4 min, Full tray<br>270°F, Prevac, 4 min, one fabric pack<br>270°F, Prevac, 4 min, IUSS<br>275°F, Prevac, 4 min, Full fabric pack<br>250°F, Gravity, 30 min, Full tray | Similar | | Full Loads | 26AV: 9, 25 lb double wrapped trays<br>or 12 fabric packs<br>26BV: 12, 25 lb double wrapped trays<br>or 16 fabric packs<br>3AV: 3, 25 lb double wrapped trays or<br>6 fabric packs | 39″: 9, 25 lb double wrapped trays or<br>12 fabric packs<br>49″: 12, 25 lb double wrapped trays<br>or 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. {10}------------------------------------------------ # 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 Electrical<br>Safety | Meets requirements of UL 61010-1, 3rd Edition | Pass | | Sterilizer Electrical<br>Safety | Meets requirements of UL 61010-2-040 | Pass | | Electromagnetic<br>Compatibility | Meets requirements of IEC 61326-1:2020, FCC Part 15<br>subpart b, and Table 9 Per IEC 60601-1-2:2014 | Pass | | Pressure Vessel Safety | Meets requirements of Section VIII, ASME Boiler &<br>Pressure Vessel Code, 2019 | Pass | | Generator Safety | Meets requirements of Section I, ASME Boiler & Pressure<br>Vessel 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.