ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor

K163313 · CIVCO Medical Instruments Co., Inc. · ITX · Jun 9, 2017 · Radiology

Device Facts

• Record ID: K163313
• Device Name: ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
• Applicant: CIVCO Medical Instruments Co., Inc.
• Product Code: ITX · Radiology
• Decision Date: Jun 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The ASTRA TEE® automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants. The ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

Device Story

ASTRA TEE and ASTRA VR are floor-standing electromechanical reprocessors for enzymatically pre-cleaned ultrasound probes. Input: user-scanned HLD bottle barcode, probe ID, and MRC status via onboard barcode reader. Operation: microprocessor-controlled system monitors temperature, liquid levels, and soak time; uses warming pad to maintain HLD temperature; performs automated disinfection and rinse cycles. Output: disinfection status notification; reprocessing records accessible via USB. Used in clinical settings by healthcare staff. Benefits: automates disinfection process, ensures control of critical parameters, and provides tracking/recording of operational data to improve disinfection outcomes.

Clinical Evidence

Bench testing only. Performance validated via simulated use testing, in-use testing, and residual testing. Demonstrated ≥6 Log reduction of M. terrae using Cidex OPA, Resert XL, and Metricide OPA Plus. Passed electrical safety (UL 61010-1/CSA C22.2 No. 61010-1), EMC (EN 60601-1-2, EN 61326-1), and cytotoxicity (ISO 10993-5) testing.

Technological Characteristics

Floor-standing electromechanical units. Materials: Galvannealed steel, stainless steel, polycarbonate, ABS, PVC, polyethylene, polypropylene, EPDM, silicone. Sensing: optical sensors for HLD reservoir/probe ID, temperature sensors, microswitches. Energy: electrical. Connectivity: USB port for data retrieval. Software: microprocessor-controlled, rule-based. Sterilization: high-level liquid disinfection (HLD).

Indications for Use

Indicated for high-level disinfection and rinsing of transesophageal, endovaginal, and endorectal ultrasound probes.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• ASTRA TEE™ (Transesophageal Probe Reprocessor) (K150504)
• ASTRA VR™ (Endovaginal/Endorectal Probe Reprocessor) (K150504)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 9, 2017

CIVCO Medical Instruments Co., Inc. Mr. Kevin Mader Quality Assurance and Regulatory Affairs Manager 6 Winter Avenue Deep River, Connecticut 06417

Re: K163313

Trade/Device Name: ASTRA TEE® Transesophageal Probe Reprocessor and ASTRA VRTM Endovaginal/Endorectal Probe Reprocessor Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: ITX Dated: May 10, 2017 Received: May 11, 2017

Dear Kevin Mader:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K163313

Device Name

ASTRA TEE® Transesophageal Probe Reprocessor

Indications for Use (Describe)

The ASTRA TEE® automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

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."

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K163313

Device Name

ASTRA VR™ Endovaginal/Endorectal Probe Reprocessor

Indications for Use (Describe)

The ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

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."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, with the company name "CIVCO" in blue, sans-serif font to the right. Below "CIVCO" is the text "MEDICAL SOLUTIONS" in a smaller font, also in blue.

## K163313

# 510(k) SUMMARY

| Submitter | Civco Medical Instruments Co., Inc. d/b/a Civco Medical<br>Solutions<br>6 Winter Avenue<br>Deep River, CT 06417 |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration/Owner<br>Operator No.'s | 3010661106/1937223 |
| Contact Person | Kevin Mader<br>Manager of Quality & Regulatory<br>[e-mail]<br>[phone] (Phone)<br>[phone] (fax) |
| Date Prepared | June 1st 2017 |
| Trade Name(Common Name) | ASTRA TEE® (Transesophageal Probe Reprocessor)<br>ASTRA VR™ (Endovaginal/Endorectal Probe Reprocessor) |
| Regulation Name | Diagnostic Ultrasonic Transducer, 21 CFR 892.1570 |
| Classification | Class II |
| Product Code | ITX |
| Predicate Device(s) | ASTRA TEE™ (Transesophageal Probe Reprocessor)<br>ASTRA VR™ (Endovaginal/Endorectal Probe Reprocessor)<br>K150504 |

#### Intended Use

For the ASTRA TEE® -

The ASTRA TEE® automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

For the ASTRA VR™ -

The ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal/endorectal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

The intended use statements are the same to the predicate devices (K150504) with the following minor differences:

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the word "CIVCO" in large, bold letters. Below "CIVCO" are the words "MEDICAL SOLUTIONS" in smaller letters. The logo is in blue.

- GUS was removed due to marketing reasons (i.e. the GUS trademark does not encompass probe reprocessors).
- -The ™ for ASTRA TEE was replaced with ® (update as per registrations as per USPTO)
- -'PCI Medical' was replaced with 'Civco Medical Solutions' (due to change in ownership of the company and products)

The differences in wording used does not change the intended use of the device and hence does not raise new questions of safety or efficacy.

#### Device Description

The ASTRA Product Family of automated reprocessors are floor standing electromechanical lab equipment that facilitate high-level liquid disinfection of ultrasound probes that have been enzymatically pre-cleaned.

### Model types

The ASTRA family of products contains two models 1) ASTRA TEE® for Transesophageal Probes and 2) ASTRA VR™ for Endovaginal/Endorectal probes.

### Physical Characteristics

The two models are floor standing units with the following physical characteristics:

#### ASTRA TEE®

- 12.0" (30.5 cm) Width:
- Depth: 14.0″ (35.6 cm)
- 65.0" (165.0 cm) Height:
- . Weight: 73 lbs. (33.1 kg)

#### ASTRA VR™

- Width: 12.0″ (30.5 cm)
- . Depth: 14.0″ (35.6 cm)
- Height: 53.0" (134.6 cm)
- Weight: 73 lbs. (33.1 kg)

## Materials

The ASTRA TEE® and ASTRA VR™ automated reprocessors are comprised of the same materials. Only the shape and length of the disinfection chamber and the probe cable restraining designs differ in order to properly accommodate the differences between TEE and VR ultrasound probes. Materials for various components include:

- Metal cabinetry and door Galvannealed steel ●

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, with the company name "CIVCO" in large, sans-serif font to the right. Below "CIVCO" are the words "MEDICAL SOLUTIONS" in a smaller font size.

- Adjustable feet Steel, polyethylene
- Plastic tubes and fittings Polyvinyl Chloride (PVC), Polyethylene, Polypropylene, EPDM, . Stainless Steel, Polycarbonate, Polyurethane, Polysulfone
- . Valves - EPR, Polyvinyl Chloride, Stainless Steel
- . Plastic disinfection tubes and chamber – Polycarbonate, ABS, Polypropylene.
- . Electromechanical sensors, switches, user interface - polyphernylene Sulfide resin, Acryl resin, Polycarbonate resin, stainless steel, silicone, silver, polyester.
- Plastic cover – Polycarbonate
- Diaphragm Pumps - Polypropylene, EPDM, Santoprene
- Electronics and wire harnesses – RoHS compliant electronics, PVC, Copper
- Metal fasteners – Stainless Steel
- Air Filter – Polyester, Silicone, Carbon
- Water filter - Polysulfone, Polypropylene, Silicone

Component selection was carefully performed to select materials that have appropriate electrical safety rating, fire safety rating, and to be compatible with select FDA cleared HLDs. No material changes were made from the predicate device.

#### Differences

Both reprocessors are derived from the same base unit (identical software, electronics, plumbing, valves, sensors, warming pad, cabinet, etc.) which is configurable to become either a ASTRA TEE® or ASTRA VR™ based on customer demand. To configure a base unit, TEE and VR specific components (e.g. disinfection chamber, chamber door, cable holder, etc.) are used to accommodate the differences between TEE and VR ultrasound probe geometries.

#### Device Operational Overview

The ASTRA Product Family of automated reprocessors are designed to control the temperature of the high-level liquid disinfectant (HLD), the disinfection time and the rinse cycles used to disinfect ultrasound probes in accordance with HLD manufactures' instructions. The system automatically loads the appropriate preset parameters based on the barcode of the scanned HLD bottle. After the probes are enzymatically pre-cleaned per hospital protocol, reprocessing in the ASTRA is initiated through the use of a simple user interface. The operator presses Enter to start the cycle and uses the onboard barcode reader to scan and load 1 or 2 probes and to scan their ID. The operator then enters the HLD's MRC status at the next prompt. The user will be notified of the probe's disinfection status upon completion of the disinfection cycle. The ASTRA systems use select FDA cleared high-level liquid disinfectant to safely and effectively disinfect medical devices. By automating the disinfection process through validated software and hardware, the ASTRA Product Family of automated reprocessors help users improve their

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for CIVCO Medical Solutions. The logo features a blue globe-like graphic on the left, followed by the company name in blue, with "CIVCO" in larger letters and "MEDICAL SOLUTIONS" in smaller letters below. The logo has a clean and professional design.

disinfection outcomes by controlling and tracking the critical process parameters and recording the key operational data.

The ASTRA TEE® and ASTRA VR™ are automated reprocessors which are identical with the exception of the disinfection chamber configuration necessary to compensate for two different types of ultrasound probes. The ASTRA TEE® is an automated reprocessor which enables highlevel disinfection and rinsing for transesophageal (TEE) ultrasound probes. The ASTRA VR™ is an automated reprocessor which enables high-level disinfection and rinsing for endovaginal and/or endorectal ultrasound probes.

Both ASTRA systems utilize predefined programs based upon the high-level liquid disinfectant (HLD) used during the disinfection and potable water rinsing cycles. The system controls the HLD temperature and cycle times which are fixed, no user configuration is available. The device will perform the defined automated disinfection and rinsing cycles based upon the HLD specifications. The microprocessor controlled interface monitors temperature and liquid levels of the HLD in the disinfection chamber and the reservoir. Optical sensors are used for HLD reservoir presence and probe identification. Additional user inputs include unique probe identification (for disinfection records) and the results entry of the Minimum Recommended Concentration (MRC) test using test strips and minimum concentration levels as defined by the HLD manufacturer. A sensor located on the disinfection chamber door is used to initiate the cycle after the user has input the required information. User retrievable data/information regarding reprocessing is accessible through a USB port.

#### Performance Characteristics

The ASTRA Product Family of automated reprocessors utilizes the same technology and highlevel disinfection approach employed by the predicate devices, cleared under K150504. Only the software has been re-activated to recognize the additional HLDs (Cidex OPA and Resert XL) originally targeted as part of K150504 for approval as part of this current Traditional 510k submission. The ASTRA controls time, temperature, and rinse parameters used to facilitate a ≥6 Log reduction by the select FDA approved HLDs. As a result, this submission primarily focuses on the performance specification of the instrument and controls (time, temperature, and rinse) common to both devices as it relates to the select HLDs.

The ASTRA systems control the HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terrae on enzymatically cleaned probes.

| Device Name | Manufacturer | 510(k) | Performance Attribute |
|------------------------------------------------------------|----------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTRA TEE™ (Transesophageal<br>Probe Reprocessor) | Civco Medical<br>Solutions | K163313 | Control the HLD temperature,<br>soak time, and rinse cycle to<br>achieve ≥6 Log reduction of <i>M. terrae</i> using Metricide OPA<br>Plus, Cidex OPA, and Resert XL |
| ASTRA VR™<br>(Endovaginal/Endorectal<br>Probe Reprocessor) | | | |

6 Winter Avenue Deep River Connecticut, 06417 - Tel: [phone] Fax: [phone]

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for CIVCO Medical Solutions. The logo features a blue globe-like design on the left, followed by the company name in blue, bold letters. Below the company name, the words "MEDICAL SOLUTIONS" are written in smaller, thinner letters.

#### Performance Specifications

The ASTRA Product Family of automated reprocessors share common hardware and software with minor differences necessary to accommodate the different ultrasound probes (TEE and VR) and different HLDs. The intended use and function of the automated reprocessors are the same and they are substantially equivalent to the predicate in design and function. The ASTRA series of automated reprocessors control the HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terrae on enzymatically cleaned probes, thus achieving equivalent performance to the ASTRA systems cleared under K150504.

| Device Name | Manufacturer | 510(k) | Performance Attribute |
|----------------------------------------------------------|----------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------|
| ASTRA TEE®/ASTRA VR™<br>Ultrasound Probe<br>Reprocessors | Civco Medical<br>Solutions | K150504 | Control the HLD temperature,<br>soak time, and rinse cycle to<br>facilitate ≥6 Log reduction of<br>M. terrae using Metricide OPA<br>Plus |

#### Clinical/Non-Clinical Performance Testing Summary

- The ASTRA system maintains time and temperature required for disinfection as per HLD manufacturers' specifications.
- The ASTRA system passed Safety and EMC testing
- The ASTRA system passed Simulated use and Residual testing
- The ASTRA system passed In-use testing

#### Technology Comparison to Predicate Devices

The ASTRA Product Family of automated reprocessors utilizes the same technology employed by the predicate device, ASTRA TEE® and ASTRA VR™ cleared under K150504. The ASTRA systems control the HLD temperature, soak time, and rinse cycle for the safe and effective disinfection of ultrasound probes.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, with the company name "CIVCO" in large, bold letters to the right. Below "CIVCO" are the words "MEDICAL SOLUTIONS" in smaller letters. The logo is in blue and white.

| Summary of Predicate Comparisons (affected items/changes are in BOLD font) | | | | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate –<br>ASTRA TEE®<br>PCI medical | Predicate –<br>ASTRA VR™<br>PCI medical | ASTRA TEE®<br>Civco Medical | ASTRA VR™<br>Civco Medical |
| Regulatory | | | | |
| 510(k) Number | K150504 | K150504 | K163313 | K163313 |
| Product Code | ITX | ITX | Same as predicate | Same as predicate |
| Regulation Number | 21 CFR 892.1570 | 21 CFR 892.1570 | Same as predicate | Same as predicate |
| Regulation Name | Diagnostic ultrasonic<br>transducer | Diagnostic ultrasonic<br>transducer | Same as predicate | Same as predicate |
| Intended Use/<br>Indications for Use<br>(differences in <b>bold</b><br>font) | The GUS ASTRA TEE™<br>automated reprocessor<br>facilitates high-level<br>disinfection and rinsing<br>of 1 or 2<br>transesophageal<br>ultrasound probes<br>using FDA cleared and<br>PCI Medical approved<br>high-level liquid<br>disinfectants. | The GUS ASTRA VR™<br>automated reprocessor<br>facilitates high-level<br>disinfection and rinsing<br>of 1 or 2 endovaginal<br>and/or endorectal<br>ultrasound probes<br>using FDA cleared and<br>PCI Medical approved<br>high-level liquid<br>disinfectants. | The ASTRA TEE®<br>automated reprocessor<br>facilitates high-level<br>disinfection and rinsing<br>of 1 or 2<br>transesophageal<br>ultrasound probes<br>using FDA cleared and<br>Civco Medical<br>Solutions approved<br>high-level liquid<br>disinfectants. | The ASTRA VR™<br>automated<br>reprocessor facilitates<br>high-level disinfection<br>and rinsing of 1 or 2<br>endovaginal and/or<br>endorectal ultrasound<br>probes using FDA<br>cleared and Civco<br>Medical Solutions<br>approved high-level<br>liquid disinfectants. |
| Prescription Use | No | No | Same as predicate | Same as predicate |
| Types of probes | Transesophageal (TEE)<br>probes | Endorectal,<br>endovaginal (VR)<br>probes | Same as predicate | Same as predicate |
| Technology and Materials | | | | |
| Theory of Operation | • Control time,<br>temperature and<br>fluid levels to<br>maintain optimal<br>conditions for<br>disinfection and<br>rinsing as<br>established by<br>HLD<br>manufacturers | • Control time,<br>temperature and<br>fluid levels to<br>maintain optimal<br>conditions for<br>disinfection and<br>rinsing as<br>established by<br>HLD<br>manufacturers | Same as predicate | Same as predicate |
| Disinfection time<br>control | • Timing Chip &<br>Software | • Timing Chip &<br>Software | Same as predicate | Same as predicate |
| Disinfection<br>temperature control | • Temperature<br>sensor & Software | • Temperature<br>sensor & Software | Same as predicate | Same as predicate |
| HLD warming<br>capability | • Yes (Warmer pad) | • Yes (Warmer pad) | Same as predicate | Same as predicate |
| Liquid Level Control<br>(HLD and rinse) | • Sensors<br>(upper/lower) &<br>Software | • Sensors<br>(upper/lower) &<br>Software | Same as predicate | Same as predicate |
| Overflow Protection | • Sensor (overflow)<br>& Software | • Sensor (overflow)<br>& Software | Same as predicate | Same as predicate |
| Summary of Predicate Comparisons (affected items/changes are in BOLD font) | | | | |
| Characteristic | Predicate -<br>ASTRA TEE®<br>PCI medical | Predicate -<br>ASTRA VR™<br>PCI medical | ASTRA TEE®<br>Civco Medical | ASTRA VR™<br>Civco Medical |
| | (microswitch) &<br>Software | (microswitch) &<br>Software | | |
| HLD Vapor Control | ●<br>Door, fan & filter | ●<br>Door, fan & filter | Same as predicate | Same as predicate |
| User Interface | ●<br>Text based<br>interface<br>●<br>4 button keypad<br>●<br>USB port<br>●<br>Barcode Scanner | ●<br>Text based<br>interface<br>●<br>4 button keypad<br>●<br>USB port<br>●<br>Barcode Scanner | Same as predicate | Same as predicate |
| HLD MRC<br>Verification | ●<br>Operator must<br>verify MRC | ●<br>Operator must<br>verify MRC | Same as predicate | Same as predicate |
| Material<br>Components | ●<br>Diaphragm Pump<br>●<br>Solenoid valves<br>●<br>Polyethylene<br>tubing<br>●<br>Push Fit fittings<br>●<br>Powder coated<br>sheet metal<br>cabinet with ABS<br>plastic<br>components | ●<br>Diaphragm Pump<br>●<br>Solenoid valves<br>●<br>Polyethylene<br>tubing<br>●<br>Push Fit fittings<br>●<br>Powder coated<br>sheet metal<br>cabinet with ABS<br>plastic<br>components | Same as predicate | Same as predicate |
| Compatible HLDs<br>(differences in bold<br>font) | ●<br>Uses FDA cleared<br>HLDs (Metricide<br>OPA) per<br>manufacturer's<br>specifications | ●<br>Uses FDA cleared<br>HLDs (Metricide<br>OPA) per<br>manufacturer's<br>specifications | Uses FDA cleared<br>HLD (Metricide<br>OPA, Cidex OPA<br>and Resert XL) per<br>manufacturer's<br>specifications | Uses FDA cleared<br>HLD (Metricide<br>OPA, Cidex OPA<br>and Resert XL)<br>per<br>manufacturer's<br>specifications |
| Disinfectant Usage<br>(differences in bold<br>font) | Approved for re-use<br>per HLD<br>Manufacturer's<br>specifications<br>●<br>OPA up to 14 days<br>●<br>Or when MRC test<br>fails | Approved for re-use<br>per HLD<br>Manufacturer's<br>specifications<br>●<br>OPA up to 14 days<br>●<br>Or when MRC test<br>fails | Same as predicate with<br>the addition of "Resert<br>XL up to 21 days"<br>Cidex OPA usage<br>specifications are<br>identical to Metricide<br>OPA | Same as predicate with<br>the addition of "Resert<br>XL up to 21 days"<br>Cidex OPA usage<br>specifications are<br>identical to Metricide<br>OPA |
| Rinse water | Potable water filtered<br>with FDA cleared<br>0.2µm bacteria<br>retention filter | Potable water filtered<br>with FDA cleared<br>0.2µm bacteria<br>retention filter | Same as predicate | Same as predicate |
| Rinsing | Per HLD<br>Manufacturer's<br>specifications | Per HLD<br>Manufacturer's<br>specifications | Same as predicate | Same as predicate |
| Summary of Predicate Comparisons (affected items/changes are in BOLD font) | | | | |
| Characteristic | Predicate -<br>ASTRA TEE®<br>PCI medical | Predicate -<br>ASTRA VR™<br>PCI medical | ASTRA TEE®<br>Civco Medical | ASTRA VR™<br>Civco Medical |
| Do Technical differences raise new questions of safety & efficacy to that of the predicate device? | | | | |
| Base Technology | Time and temperature<br>management | Time and temperature<br>management | Same as predicate | Same as predicate |
| Liquid Level Control | • HLD level control<br>by sensor<br>• Rinse level control<br>by sensor | • HLD level control<br>by sensor<br>• Rinse level control<br>by sensor | Same as predicate | Same as predicate |
| User interface | • Barcode scanner<br>accepts input data | • Barcode scanner<br>accepts input data | Same as predicate | Same as predicate |
| Device characteristics that ensure comparable safety & efficacy to the predicate device (non-clinical<br>testing) | | | | |
| Control of Critical<br>parameters | Device repeatedly<br>maintains time and<br>temperature required<br>for disinfection | Device repeatedly<br>maintains time and<br>temperature required<br>for disinfection | Same as predicate | Same as predicate |
| Efficacy (Disinfection<br>and Residual testing) | Pass as per simulated<br>use (6log reduction of<br><i>M. terrae</i> ), In-use<br>Testing (complete kill)<br>and residual testing<br>(ISO10993-5 cytotoxic<br>effect of <= 2) | Pass as per simulated<br>use (6log reduction of<br><i>M. terrae</i> ), In-use<br>Testing (complete kill)<br>and residual testing<br>(ISO10993-5 cytotoxic<br>effect of <= 2) | Same as predicate | Same as predicate |
| UL 61010 electrical<br>safety | Pass as per METLabs<br>testing | Pass as per METLabs<br>testing | Same as predicate | Same as predicate |
| Electromagnetic<br>(EMC) compatibility | Pass as per METLabs<br>testing | Pass as per METLabs<br>testing | Same as predicate | Same as predicate |

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a blue globe-like graphic on the left, followed by the text "CIVCO" in blue, with the words "MEDICAL SOLUTIONS" in smaller blue letters underneath. The globe graphic is made up of curved lines that form a grid-like pattern.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a blue globe-like graphic on the left, followed by the text "CIVCO" in blue, bold letters. Below "CIVCO" is the text "MEDICAL SOLUTIONS" in a smaller, less bold font, also in blue. The logo appears to be for a medical company.

#### Summary of Functional and Safety Testing

Verification and validation was performed for the ASTRA Product Family of automated reprocessors in accordance with following design control regulations, risk management standards, and established quality assurance processes within Civco Medical Solutions' Quality Management System to demonstrate substantial equivalence to the predicate device and to confirm safety and efficacy:

- 21 CFR Part 820.30 Design Controls
- ISO 14971 Medical devices Application of risk management to medical devices ●
- ISO 10993-5 Tests for in vitro cytotoxicity
- EN 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a blue globe-like icon on the left, with curved lines representing the earth's surface. To the right of the icon, the word "CIVCO" is written in blue, with the words "MEDICAL SOLUTIONS" written in smaller letters below it.

- UL 61010-1/CSA C22.2 No. 61010-1 Standard for safety electrical equipment for . measurement, control and laboratory use; Part 1: general requirements
- . EN 61326-1 Electrical equipment for measurement, control and laboratory use – EMC requirements — Part 1: General requirements
- ANSI/AAMI/IEC 62304 Medical Device Software – Software life cycle processes
- ANSI/AAMI HE75 Human factors engineering Design of medical devices ●
- Software Verification & Validation, Simulated Use Testing, and In-Use Testing
- HLD Stress/Re-use testing as per EPA guidelines
- Material Compatibility Testing
- Management of Cybersecurity in Medical Devices - Cybersecurity testing

#### Conclusion

Based on the nonclinical tests performed, the subject device is as sffective and performs as well as or better than the predicate device.