Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869

K213545 · Steelco S.P.A. · FLE · Feb 2, 2023 · General Hospital

Device Facts

• Record ID: K213545
• Device Name: Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
• Applicant: Steelco S.P.A.
• Product Code: FLE · General Hospital
• Decision Date: Feb 2, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Indications for Use

The Steelco VS Series Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles, provided on the following page. At no time will there be patient contact with the subject device.

Device Story

Steelco VS Series Steam Sterilizers (models 262839, 262851, 262869) utilize saturated steam to sterilize heat-stable healthcare products. Operation involves air removal via gravity displacement or mechanical vacuum, followed by steam exposure at defined time/temperature parameters, and a drying phase. Used in sterile processing departments or surgical suites by technicians. Device features PLC-based control, dual independent temperature probes in chamber/jacket drains, and dual independent pressure transducers. Double-door models include interlocks to prevent simultaneous door opening and cross-contamination. Output includes process monitoring data via printer. Benefits include effective sterilization of surgical instruments and materials, ensuring patient safety by preventing infection transmission.

Clinical Evidence

Bench testing only. No clinical data. Performance validated against ANSI/AAMI ST8:2013, including biological performance, mechanical air removal, moisture retention, electrical safety (IEC/UL 61010-1/2-040), EMC (EN IEC 61326-1), and pressure vessel safety (ASME Boiler and Pressure Vessel Code).

Technological Characteristics

316 stainless steel chamber; steam-activated door seal; PLC-based control; dual independent temperature probes and pressure transducers; steam, water, electricity, and air utilities. Dimensions: 26x28x39", 26x28x51", 26x28x69". Complies with ANSI/AAMI ST8:2013, ASME Boiler and Pressure Vessel Code, and IEC/UL 61010 standards.

Indications for Use

Indicated for sterilization of heat and moisture-stable materials in healthcare facilities. Not for patient contact.

Regulatory Classification

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.

Predicate Devices

• AMSCO 600 Steam Sterilizer (K183410)

Submission Summary (Full Text)

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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

February 2, 2023

Steelco S.P.A. % Jonathan Wilder President H & W Technology, LLC 301 City Ave. Suite LL3 Bala Cynwyd, PA 19004

Re: K213545

Trade/Device Name: Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam sterilizer Regulatory Class: Class II Product Code: FLE Dated: December 16, 2022 Received: January 3, 2023

Dear Jonathan Wilder:

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray III -S

Clarence W. Murray, III, Ph.D Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K213545

Device Name

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869.

Indications for Use (Describe)

The Steelco VS Series Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles, provided on the following page.

At no time will there be patient contact with the subject device.

Please see page 2 for indications for use defining available, preprogrammed cycles.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div style="margin-right:5px;"> <span style="font-size: 20px;">☐</span></div>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><div style="margin-right:5px;"><span style="font-size: 20px;">☑</span></div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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### Form 3881 continued: Indications for Use K213545

| Cycles | Sterilization<br>temperature | Sterilization<br>time | Dry time | Maximum recommended load |
|-------------------|------------------------------|-----------------------|---------------|---------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30<br>minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg)<br>each. Refer to Load Table for recommended quantities. |
| Prevac | 275°F (135°C) | 3 minutes | 30<br>minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg)<br>each. Refer to Load Table for recommended quantities. |
| Prevac -<br>IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single unwrapped tray, nonporous items |
| Gravity | 250°F (121°C) | 30 minutes | 30<br>minutes | |
| Gravity | 270°F (132°C) | 15 minutes | 30<br>minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg)<br>each. Refer to Load Table for recommended quantities. |
| Gravity | 275°F (135°C) | 15 minutes | 30<br>minutes | Double wrapped instrument trays, maximum weight 25 lbs (11.3 kg)<br>each. Refer to Load Table for recommended quantities. |
| Gravity -<br>IUSS | 270°F (132°C) | 10 minutes | 1<br>minute | Immediate use - single unwrapped tray, nonporous items |
| Warm-up | 270°F (132°C) | N/A | N/A | N/A |
| Bowie<br>- Dick | 270°F (132°C) | 3.5 minutes | 5 minute | Bowie-Dick Test Pack, DART Test Pack |
| Leak test | N/A | N/A | N/A | N/A |

# Standard cycles pre-programmed at factory

The maximum loads and dimensions of the sterilizer for each of the sterilizer models are shown in the following table:

# Dimensions and Load Capacity

| Internal Chamber Dimensions | Overall dimensions | Number of trays/fabric packs for maximum load |
|-----------------------------|---------------------|-----------------------------------------------|
| 26 x 28 x 39" | 37.4 x 94.5 x 50.9" | 9/18 |
| 26 x 28 x 51" | 37.4 x 94.5 x 62.7" | 12/24 |
| 26 x 28 x 69" | 37.4 x 94.5 x 80.4" | 15/30 |

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### 510(k) Summary for Steelco VS Steam Sterilizers K213545

SUBMITTER: Steelco S.P.A. Via Balegante. 27 31039 Riese Pio X (TV), Italy Phone [phone] Fax [phone]

CONTACT PERSON: Jonathan A. Wilder US Agent Tel: [phone] Fax [phone] E-mail: [e-mail]

DATE PREPARED: January 31, 2023

TRADE NAME: Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869

COMMON NAME: Steam Sterilizer

DEVICE CLASSIFICATION: Class II

DEVICE Steam Sterilizer

PANEL: General Hospital

CLASSIFICATION NAMES: Steam Sterilizer, 21 CFR 880.6880, classification code FLE

PREDICATE DEVICES: AMSCO 600 Steam Sterilizer K183410

DEVICE DESCRIPTION: The Steelco VS Series Steam Sterilizers use saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.

The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.

The sterilizers are generally operated by technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite to allow for Immediate Use Steam Sterilization (IUSS) for instances where an instrument is needed immediately for a procedure (e.g. after an instrument has been dropped and there is no replacement readily available). Standard practices for use of sterilizers in health care facilities are provided by various organizations (e.g. ANSI/AAMI ST79).

#### INTENDED USE/INDICATIONS FOR USE:

At no time will there be patient contact. The Steelco VS Series Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles, shown in the table below:

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| Cycles | Sterilization<br>temperature | Sterilization<br>time | Dry time | Maximum recommended load |
|-------------------|------------------------------|-----------------------|------------|----------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | weight 25 lbs (11.3 kg) each. Refer to Load Table<br>for recommended quantities. |
| Prevac -<br>IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single unwrapped tray,<br>nonporous items |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays, maximum |
| Gravity | 270°F (132°C) | 15 minutes | 30 minutes | weight 25 lbs (11.3 kg) each. Refer to Load Table<br>for recommended quantities. |
| Gravity | 275°F (135°C) | 15 minutes | 30 minutes | for recommended quantities. |
| Gravity -<br>IUSS | 270°F (132°C) | 10 minutes | 1 minute | Immediate use - single unwrapped tray,<br>nonporous items |
| Warm-up | 270°F (132°C) | N/A | N/A | N/A |
| Bowie-<br>Dick | 270°F (132°C) | 3.5 minutes | 5 minute | Bowie-Dick Test Pack, DART Test Pack |
| Leak test | N/A | N/A | N/A | N/A |

Standard cycles pre-programmed at factory

The maximum loads and dimensions of the sterilizer for each of the sterilizer models are shown in the following table:

## Dimensions and Load Capacity

| Internal Chamber Dimensions | Overall dimensions | | | Number of trays/fabric packs for maximum load |
|-----------------------------|--------------------|--------|-------|-----------------------------------------------|
| | Width | Height | Depth | |
| 26 x 28 x 39" | 37.4" | 94.5" | 50.9" | 9/18 |
| 26 x 28 x 51" | 37.4" | 94.5" | 62.7" | 12/24 |
| 26 x 28 x 69" | 37.4" | 94.5" | 80.4" | 15/30 |

Sterilizers are available in single-door (suffix of /1 to the model number) or double-door (suffix of /2 to the model number) configurations with double-door models interlocked to not permit both doors to be open at the same time, and to not allow release of improperly sterilized items to the sterile side of the machine.

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The environment of use will be a healthcare facility's sterile processing department, or wherever else in the facility sterilizers are used.

The Steelco VS Series Sterilizers are compared to the predicate device in the following table.

| Feature | Steelco VS Series<br>Steam Sterilizers (K213545) | AMSCO 600 Steam<br>Sterilizer<br>(predicate device K183410) | Comparison |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Steelco VS Series Steam<br>Sterilizers are designed for<br>sterilization of heat and moisture-stable materials used in<br>healthcare facilities | The AMSCO 600<br>Steam Sterilizer is designed for<br>sterilization of heat and moisture-stable materials used in<br>healthcare facilities. | Same |
| Critical<br>Process<br>Parameters | Time, Chamber Temperature,<br>Pressure | Time, Chamber Temperature,<br>Pressure | Same |
| Control | PLC | Embedded controller | Similar |
| SAL | 10-6 | 10-6 | Same |
| Sterilant | Saturated steam | Saturated steam | Same |
| Utilities | Steam, water, electricity,<br>air | Steam, water, electricity,<br>air | Same |
| Chamber<br>material | 316 stainless steel | 316L stainless steel | Similar |
| Nominal<br>chamber size | 26" x 28" x 39"<br>26" x 28" x 51"<br>26" x 28" x 69" | 26" x 26" x 39"<br>26" x 26" x 49"<br>26" x 26" x 61" | Similar |
| Feature | Steelco VS Series Steam Sterilizers<br>(K213545) | AMSCO 600 Steam<br>Sterilizer<br>(predicate device K183410) | Comparison |
| Door | 316 Stainless Steel<br>28" x 26" Power vertical sliding | 304L Stainless Steel 26" x 26"<br>Power vertical sliding | Similar |
| Chamber<br>pressure<br>rating | 44 PSIG/291°F | 45 PSIG, 300°F | Similar |
| Door seal | Steam activated door seal | Steam activated door seal | Same |
| External<br>process<br>monitors | Independent process control and<br>monitors Printer | Electronic Control Printer | Similar |
| Internal<br>process<br>monitors | Temperature<br>-Dual independent temperature<br>probes in chamber drain<br>-Temperature probe in jacket<br>drain<br>-Temperature probe in cooling<br>water reservoir tank Pressure<br>-Dual independent pressure<br>transducers in chamber<br>-Pressure transducer<br>in on-board boiler (if this option<br>chosen) | Temperature<br>-Dual element RTD located in<br>chamber drain<br>- RTD located in the jacket drain<br>- RTD located in heat<br>exchanger Pressure<br>-Pressure transducer in chamber | Similar |
| Performance | Meets ANSI/AAMI ST8:2013 | Meets ANSI/AAMI ST8:2013 | Same |
| Accessories | Shelves, loading equipment | BI, CI, Pouches, Trays, Wraps,<br>Tape,<br>Containers, Shelves, Loading<br>Equipment | Similar |
| Test Cycles | Warm Up, Leak Test, Bowie Dick<br>Test | Warm Up, Leak Test, DART<br>(Bowie Dick) Test | Same |
| Cycles | Prevac 270°F (132°C)/4 minutes,<br>fabric packs Prevac 275°F<br>(135°C)/3 minutes, | 270F, Prevac, 4' Full fabric pack<br>270F, Prevac, 4' Full tray<br>270F, Prevac, 4' one fabric pack | Similar |
| Feature | Steelco VS Series Steam Sterilizers<br>(K213545) | AMSCO 600 Steam<br>Sterilizer<br>(predicate device K183410) | Comparison |
| | double-wrapped instrument trays<br>Prevac - IUSS 270°F (132°C)/4<br>minutes, single unwrapped tray,<br>nonporous items Gravity 250°F<br>(121°C)/30 minutes, double-wrapped<br>instrument trays Gravity 270°F<br>(132°C) 15 minutes, double-wrapped<br>instrument trays Gravity 275°F<br>(135°C)/10 minutes, double-wrapped<br>instrument trays Gravity - IUSS<br>270°F (132°C)/10 minutes, single<br>unwrapped tray, nonporous items | 270F, Prevac, 4' IUSS<br>275F, Prevac, 3' Full fabric<br>250F, Gravity, 30' Full tray | |
| Full loads | • 39": 9, 25-lb double wrapped<br>trays or 18, fabric packs<br>• 51": 12, 25-lb<br>double wrapped trays or 24, fabric<br>packs<br>• 69": 15, 25-lb<br>double wrapped trays or 30, fabric<br>packs | • 39": 9, 25-lb<br>double wrapped trays or 12,<br>fabric packs<br>• 51": 12, 25-lb<br>double wrapped trays or 16,<br>fabric packs<br>• 63": 15, 25-lb<br>double wrapped trays or 20,<br>fabric<br>packs | Similar |

## Technological Characteristics Comparison Table

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The proposed device has the same or similar indications for use as the predicate with similar technological characteristics. The subject devices slightly differ in design, indications, and features from the predicate devices.

## SUMMARY OF NON-CLINICAL TESTS:

The Steelco VS Steam Sterilizer non-clinical test was performed according to the standards in the following table. The testing demonstrated that the subject device met the acceptance criteria of these standards.

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| Test | Purpose of the<br>Test | Acceptance Criteria | Result | Conclusion |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Performance | To ensure that the<br>performance,<br>labeling, and<br>safety<br>requirements<br>specified in AAMI<br>ST8:2013 (ST8)<br>are met. | Labeling complies<br>with section 4.1 of<br>ST8. | Compliance is documented<br>in the labeling, user manual,<br>service manual, and<br>inventory of user interface<br>screens and the ST8<br>Compliance Test Protocols<br>for the individual models. | Pass |
| | | Sterilizer design,<br>construction,<br>components, and<br>accessories comply<br>with section 4.2 of<br>ST8. | Compliance is documented<br>in the Machine Hardware<br>Design Specification, risk<br>analysis, FMEA section 3,<br>mechanical aspects, ETL<br>construction data file, ETL<br>report IEC 61010-1 and<br>61010-2-040 compliance<br>data report, ETL<br>corrigendum, and the ST8<br>Compliance Test Protocols<br>for the individual models. | Pass |
| | | Sterilizer safety<br>complies with<br>section 4.3 of ST8. | Compliance is documented<br>in the Machine Hardware<br>Design Specification, risk<br>analysis, FMEA section 3,<br>mechanical aspects, ETL<br>construction data file, ETL<br>report IEC 61010-1 and<br>61010-2-040 compliance<br>data report, and ETL<br>corrigendum, and the ST8<br>Compliance Test Protocols<br>for the individual models. | Pass |
| | | Process monitoring<br>and control devices<br>comply with section<br>4.4 of ST8. | Compliance is documented<br>in the Design Specification<br>Control and User Interface<br>Hardware, ETL construction<br>data file, ETL report IEC<br>61010-1 and 61010-2-040<br>compliance data report, ETL<br>corrigendum, and the ST8<br>Compliance Test Protocols<br>for the individual models. | Pass |
| | | Biological<br>performance of<br>sterilizers complies<br>with section 4.5 of<br>ST8. | Compliance is documented<br>in the ST8 Compliance Test<br>Protocols for the individual<br>machines. | Pass |
| | | Mechanical air<br>removal complies<br>with section 4.6 of<br>ST8. | Compliance is documented<br>in the ST8 Compliance Test<br>Protocols for the individual<br>machines. | Pass |
| | | Moisture retention<br>complies with<br>section 4.7 of ST8. | Compliance is documented<br>in the ST8 Compliance Test<br>Protocols for the individual<br>machines. | Pass |
| Test | Purpose of the | Acceptance Criteria | Result | Conclusion |
| General<br>Electrical<br>Safety | Test<br>To ensure<br>electrical safety in<br>the construction<br>and design of the<br>sterilizers | Compliance with the<br>appropriate<br>provisions of<br>IEC/UL 61010-1 and<br>61010-2-040 | Compliance is documented<br>in the ETL construction data<br>file, ETL report IEC 61010-<br>1 and 61010-2-040<br>compliance data report, and<br>ETL corrigendum. | Pass |
| Sterilizer<br>Electrical<br>Safety | To ensure<br>electrical safety in<br>the construction<br>and design of the<br>sterilizers | Compliance with the<br>appropriate<br>provisions of<br>IEC/UL 61010-1 and<br>61010-2-040 | Compliance is documented<br>in the ETL construction data<br>file, ETL report IEC 61010-<br>1 and 61010-2-040<br>compliance data report, and<br>ETL corrigendum. | Pass |
| EMC testing | To ensure that the<br>machine does not<br>interfere with the<br>operation of<br>nearby machinery<br>nor is interfered<br>with by external<br>EMC issues. | Compliance with the<br>appropriate<br>provisions of EN<br>IEC 61326 part 1. | Compliance is documented<br>in the EN IEC 61326 pt. 1<br>compliance report. | Pass |
| Software<br>validation | To ensure that the<br>software executes<br>its designed<br>functions and, if it<br>fails, takes the<br>machine to a safe<br>state. | Compliance with<br>software validation<br>provisions of ISO<br>62304 | Compliance is documented<br>in the Software<br>Requirements Specification<br>Functional Specification<br>Control and User Interface<br>System, Risk Analysis,<br>FMEA section 5 for control<br>systems, and software<br>validation | Pass |
| Pressure<br>Vessel<br>Safety | To ensure that the<br>pressure vessels<br>are designed and<br>built in a safe<br>manner. | Compliance with the<br>safety requirements<br>of ASME Boiler and<br>Pressure Vessel<br>Code, Section VIII<br>(Division 1) for the<br>chamber and jacket<br>and Section 1 for the<br>boiler (if furnished) | Meets requirements of<br>ASME Boiler and Pressure<br>Vessel Code, Section VIII<br>(Division 1) for the chamber<br>and jacket and Section 1 for<br>the boiler (if furnished). See<br>rating plate, section 6.2 of<br>the ST8 Compliance Test<br>Protocols for the individual<br>machines | Pass |

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## CONCLUSIONS:

The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K183410, Class II (21 CFR 880.6860), product code FLE.