(140 days)
Not Found
No
The description focuses on standard steam sterilization technology controlled by a PLC system, with no mention of AI or ML capabilities.
None
No
This device is a steam sterilizer, used for sterilizing medical products, not for treating patients.
No
This device is a steam sterilizer (autoclave) used to sterilize medical products and instruments. It does not perform any diagnostic functions.
No
The device description clearly states it is a steam sterilizer (autoclave), which is a physical hardware device used for sterilization. While it has a PLC-based control system (software component), the core device is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for sterilizing heat and moisture-stable materials used in healthcare facilities using saturated steam. This is a sterilization process for medical devices and supplies, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a steam sterilizer (autoclave) used to sterilize medical products. This aligns with sterilization equipment, not diagnostic equipment.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis
- Reagents, calibrators, or controls used in diagnostic testing
The device's function is to render medical items sterile, which is a crucial step in preventing the spread of infection in healthcare settings. This is a process applied to medical devices themselves, not a diagnostic test performed on a patient or their samples.
N/A
Intended Use / 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 for all models of the HC Series steam sterilizers are provided below.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider / Ambulatory Surgery Centers (ASCs), Clinics, and Hospitals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed according to the following standards, with passing results in all cases:
- 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)
The testing demonstrated that the subject devices, 3AV-HC, and 26BV-HC, met the acceptance criteria described in these standards.
No clinical testing was used in support of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" 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
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
Temperature | Sterilization
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 Maximum weight per
tray: 25lbs (11.3 kg) |
| Gravity - IUSS | 270°F (132°C) | 3 minutes | 1 minutes | Single Unwrapped Tray
Maximum weight per tray: 25lbs
(11.3 kg) |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double Wrapped Instrument
Trays Maximum weight per
tray: 25lbs (11.3 kg) |
| Pre-Vacuum -
IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Single Unwrapped Tray
Maximum 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 Maximum weight per
tray: 25lbs (11.3 kg) |
| Pre-Vacuum | 275°F (135°C) | 3 minutes | 30 minutes | Double Wrapped Instrument
Trays Maximum weight per
tray: 25lbs (11.3 kg) |
| Pre-Vacuum | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack and Single
Unwrapped Tray Maximum
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 | ||||
| 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
Chamber Size | Double
Wrapped
Instrument
Trays1 | Fabric
Packs2 | Number of
Liquid
Containers3 |
|---------|----------------------------|-------------------------------------------|------------------|----------------------------------------|
| 26AV-HC | 26" X 26" X
39" | 9, maximum
weight 25lb
each | 12 | 70, 1 Liter
Volume Per
Container |
| 26BV-HC | 26" X 26" X
49" | 12, maximum
weight 25lb
each | 16 | 90, 1 Liter
Volume Per
Container |
| 3AV-HC | 20" X 20" X
38" | 3, maximum
weight 25lb
each | 9 | 28, 1 Liter
Volume Per
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)
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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
Temperature | Sterilization
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
Maximum weight per tray: 25lbs
(11.3 kg) |
| Gravity - IUSS | 270°F (132°C) | 3 minutes | 1 minutes | Single Unwrapped Tray
Maximum weight per tray: 25lbs
(11.3 kg) |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double Wrapped Instrument Trays
Maximum weight per tray: 25lbs
(11.3 kg) |
| Pre-Vacuum -
IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Single Unwrapped Tray Maximum
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
Maximum weight per tray: 25lbs
(11.3 kg) |
| Pre-Vacuum | 275°F (135°C) | 3 minutes | 30 minutes | Double Wrapped Instrument Trays
Maximum weight per tray: 25lbs
(11.3 kg) |
| Pre-Vacuum | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack and Single
Unwrapped Tray Maximum weight
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
Chamber Size | Double Wrapped
Instrument Trays1 | Fabric
Packs2 | Number of Liquid
Containers3 |
|---------|----------------------------|-------------------------------------|------------------|----------------------------------------|
| 26AV-HC | 26" X 26" X 39" | 9, maximum
weight 25lb each | 12 | 70, 1 Liter Volume Per
Container |
| 26BV-HC | 26" X 26" X 49" | 12, maximum
weight 25lb each | 16 | 90, 1 Liter Volume Per
Container |
| 3AV-HC | 20" X 20" X 38" | 3, maximum
weight 25lb each | 9 | 28, 1 Liter
Volume Per
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
(K183410) | Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------|
| Intended Use | The sterilization of heat and
moisture-stable materials used in
healthcare facilities. | The sterilization of heat and
moisture-stable materials used in
healthcare facilities. | Same |
| Critical Process
Parameters | 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 |
| Chamber
Material | 316L Stainless Steel | 316L Stainless Steel | Same |
| Nominal
Chamber 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 Steel
26" X 26" Power Vertical Sliding
20" X 20" Power Vertical Sliding | 304L Stainless Steel
26" X 26" Power Vertical Sliding | Similar |
| Chamber
Pressure Rating | 45 psig, 300 °F | 45 psig, 300 °F | Same |
| Door Seal | Air Activated Door Seal | Steam Activated Door Seal | Similar |
| External
Process
Monitors | Electronic Control
Printer | Electronic Control
Printer | Same |
9
| Internal Process
Monitors | RTD temperature sensor in chamber
drain
RTD temperature sensor in jacket
drain
RTD temperature sensor in waste
drain
Pressure transducer in chamber | RTD temperature sensor in chamber
drain
RTD temperature sensor in jacket
drain
RTD temperature sensor in heat
exchanger
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,
Containers, Shelves, Loading
Equipment | Different |
| Test Cycles | Warm Up, Leak Test, Bowie Dick Test | Warm Up, Leak Test, DART (Bowie
Dick) Test | Same |
| Cycles | See Table 1 | 270°F, Prevac, 4 min, Full fabric pack
270°F, Prevac, 4 min, Full tray
270°F, Prevac, 4 min, one fabric pack
270°F, Prevac, 4 min, IUSS
275°F, Prevac, 4 min, Full fabric pack
250°F, Gravity, 30 min, Full tray | Similar |
| Full Loads | 26AV: 9, 25 lb double wrapped trays
or 12 fabric packs
26BV: 12, 25 lb double wrapped trays
or 16 fabric packs
3AV: 3, 25 lb double wrapped trays or
6 fabric packs | 39″: 9, 25 lb double wrapped trays or
12 fabric packs
49″: 12, 25 lb double wrapped trays
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 | ||
| 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 |
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.