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.

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.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for medical devices (ASTRA TEE® Transesophageal Probe Reprocessor and ASTRA VR™ Endovaginal/Endorectal Probe Reprocessor). It outlines the device description, intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document primarily discusses the device's technical specifications and the testing conducted to ensure its safety and effectiveness in controlling high-level disinfection processes.

Unfortunately, the provided document does not contain the specific details required to answer all parts of your request about acceptance criteria met by a "device" in the context of an AI/human-in-the-loop study. The device in question here is an automated reprocessor for ultrasound probes, not an AI-powered diagnostic tool, and the performance criteria are related to disinfection efficacy, not diagnostic accuracy.

Therefore, I cannot populate most of the requested table and details, as they pertain to performance metrics and study designs common for AI-based diagnostic devices (e.g., sensitivity, specificity, reader performance studies, expert adjudication for ground truth).

However, I can extract the information relevant to the device's operational performance and the studies conducted to support its substantial equivalence.

Here's what can be extracted and what cannot be from the provided text:

What can be extracted:

Acceptance Criteria (Performance Attributes): The core performance attribute for this device is its ability to "control the HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terrae using Metricide OPA Plus, Cidex OPA, and Resert XL." This is the primary functional performance claim.
Study That Proves the Device Meets Acceptance Criteria:
- 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."
- Efficacy (Disinfection and Residual testing): "Pass as per simulated use (6log reduction of M. terrae), In-use Testing (complete kill) and residual testing (ISO10993-5 cytotoxic effect of <= 2)."
- Ground Truth Type for Efficacy: The efficacy is measured against a "6 log reduction of M. terrae" (a microbial standard) and "complete kill" for in-use testing. "Residual testing" uses "ISO10993-5 cytotoxic effect of <= 2." This indicates microbiological testing standards and biocompatibility standards are used as ground truth.
- Ground Truth for Functionality: The device controls time, temperature, and rinse cycles "as per HLD manufacturers' specifications." This implies that the ground truth for these parameters is the specified parameters from the high-level disinfectant manufacturers.

What cannot be extracted (and why, given the nature of the device):

Reported Device Performance (in the context of AI metrics): The document reports passing tests, but not specific percentages for sensitivity, specificity, or AUC, as these are not relevant metrics for a disinfection reprocessor.
Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective): The document mentions "Simulated use," "In-use testing," "Safety and EMC testing," "Residual testing," but does not provide specific sample sizes (e.g., number of probes, cycles, test samples) or the data provenance details (country, retrospective/prospective).
Number of experts used to establish ground truth and qualifications: This is irrelevant for a device that performs automated disinfection based on physical parameters and microbiological efficacy. There are no human experts "reading" or adjudicating the output for diagnostic purposes.
Adjudication method for the test set: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This device does not involve human readers interpreting images.
Standalone (algorithm only without human-in-the-loop performance) was done: The device itself is an automated system; its performance is "standalone" in the sense that it operates without continuous human interaction during the disinfection cycle. However, this is not in the context of an AI algorithm's diagnostic performance.
Sample size for the training set: Not applicable, as this is not an AI/machine learning model that undergoes a "training" phase. The device is a fixed-function electro-mechanical system.
How the ground truth for the training set was established: Not applicable.

Based on the available information, here is the breakdown:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Performance Attribute)	Reported Device Performance
Functional Performance: Control HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terrae using specified HLDs (Metricide OPA Plus, Cidex OPA, and Resert XL).	• The ASTRA system maintains time and temperature required for disinfection as per HLD manufacturers' specifications. • Efficacy: Passed simulated use (6 log reduction of M. terrae) and in-use testing (complete kill).
Safety and Electrical Safety:	• Passed Safety and EMC testing. • UL 61010 electrical safety: Pass as per METLabs testing. • Electromagnetic (EMC) compatibility: Pass as per METLabs testing.
Biocompatibility/Residuals: (Effectiveness of rinsing to remove harmful residues)	• Passed Residual testing: ISO10993-5 cytotoxic effect of <= 2.
Software and System Functionality:	• Passed Software Verification & Validation. • Passed Simulated Use Testing. • Passed In-Use Testing.
Cybersecurity:	• Passed Cybersecurity testing.

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the "Simulated use," "In-use testing," "Safety and EMC testing," or "Residual testing." It does not provide information on data provenance (e.g., country of origin, retrospective/prospective). These types of details are less common for an electro-mechanical device validation compared to a clinical study for a diagnostic AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The ground truth for this device's performance is based on established engineering, microbiological, and biocompatibility standards, not human expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human adjudication process involved in assessing the device's disinfection performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI diagnostic tool and does not involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is an automated system for high-level disinfection. Its performance metrics (time control, temperature control, log reduction of M. terrae, residual levels) are inherently "standalone" in function, as it performs its designated tasks without continuous human intervention. This is not in the context of an AI algorithm's diagnostic performance without human input.

7. The type of ground truth used
The ground truth used for this device's performance validation includes:
* Microbiological standards: Achieving a "≥6 Log reduction of M. terrae" and "complete kill" in simulated and in-use testing for disinfection efficacy.
* Biocompatibility standards: ISO10993-5 for cytotoxic effect.
* Manufacturer specifications: Adherence to temperature, time, and rinse parameters defined by the High-Level Disinfectant (HLD) manufacturers.
* Safety and Electrical standards: UL 61010-1/CSA C22.2 No. 61010-1, EN 60601-1-2 / EN 61326-1 for electrical safety and electromagnetic compatibility.
* Quality System and Risk Management Standards: 21 CFR Part 820.30 Design Controls, ISO 14971, ANSI/AAMI/IEC 62304 for software, ANSI/AAMI HE75 for human factors.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning model.

9. How the ground truth for the training set was established
Not applicable.

Summary

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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Indications for Use

510(k) Number (if known) K163313

Device Name

ASTRA TEE® Transesophageal Probe Reprocessor

Indications for Use (Describe)

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."

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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.

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."

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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 MedicalSolutions6 Winter AvenueDeep River, CT 06417
EstablishmentRegistration/OwnerOperator No.'s	3010661106/1937223
Contact Person	Kevin MaderManager of Quality & Regulatorykevin.mader@civco.com(319) 248-7777 (Phone)(860) 526-3081 (fax)
Date Prepared	June 1st 2017
Trade Name(Common Name)	ASTRA TEE® (Transesophageal Probe Reprocessor)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)ASTRA VR™ (Endovaginal/Endorectal Probe Reprocessor)K150504

Intended Use

For the ASTRA TEE® -

For the ASTRA VR™ -

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

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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

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 ●

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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

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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™ (TransesophagealProbe Reprocessor)	Civco MedicalSolutions	K163313	Control the HLD temperature,soak time, and rinse cycle toachieve ≥6 Log reduction of M. terrae using Metricide OPAPlus, Cidex OPA, and Resert XL
ASTRA VR™(Endovaginal/EndorectalProbe Reprocessor)

6 Winter Avenue Deep River Connecticut, 06417 - Tel: (319) 248-7777 Fax: (860) 526-3081

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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™Ultrasound ProbeReprocessors	Civco MedicalSolutions	K150504	Control the HLD temperature,soak time, and rinse cycle tofacilitate ≥6 Log reduction ofM. terrae using Metricide OPAPlus

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.

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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 –ASTRA TEE®PCI medical	Predicate –ASTRA VR™PCI medical	ASTRA TEE®Civco Medical	ASTRA VR™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 ultrasonictransducer	Diagnostic ultrasonictransducer	Same as predicate	Same as predicate
Intended Use/Indications for Use(differences in boldfont)	The GUS ASTRA TEE™automated reprocessorfacilitates high-leveldisinfection and rinsingof 1 or 2transesophagealultrasound probesusing FDA cleared andPCI Medical approvedhigh-level liquiddisinfectants.	The GUS ASTRA VR™automated reprocessorfacilitates high-leveldisinfection and rinsingof 1 or 2 endovaginaland/or endorectalultrasound probesusing FDA cleared andPCI Medical approvedhigh-level liquiddisinfectants.	The ASTRA TEE®automated reprocessorfacilitates high-leveldisinfection and rinsingof 1 or 2transesophagealultrasound probesusing FDA cleared andCivco MedicalSolutions approvedhigh-level liquiddisinfectants.	The ASTRA VR™automatedreprocessor facilitateshigh-level disinfectionand rinsing of 1 or 2endovaginal and/orendorectal ultrasoundprobes using FDAcleared and CivcoMedical Solutionsapproved high-levelliquid disinfectants.
Prescription Use	No	No	Same as predicate	Same as predicate
Types of probes	Transesophageal (TEE)probes	Endorectal,endovaginal (VR)probes	Same as predicate	Same as predicate
Technology and Materials
Theory of Operation	• Control time,temperature andfluid levels tomaintain optimalconditions fordisinfection andrinsing asestablished byHLDmanufacturers	• Control time,temperature andfluid levels tomaintain optimalconditions fordisinfection andrinsing asestablished byHLDmanufacturers	Same as predicate	Same as predicate
Disinfection timecontrol	• Timing Chip &Software	• Timing Chip &Software	Same as predicate	Same as predicate
Disinfectiontemperature control	• Temperaturesensor & Software	• Temperaturesensor & Software	Same as predicate	Same as predicate
HLD warmingcapability	• Yes (Warmer pad)	• Yes (Warmer pad)	Same as predicate	Same as predicate
Liquid Level Control(HLD and rinse)	• Sensors(upper/lower) &Software	• Sensors(upper/lower) &Software	Same as predicate	Same as predicate
Overflow Protection	• Sensor (overflow)& Software	• Sensor (overflow)& Software	Same as predicate	Same as predicate
Summary of Predicate Comparisons (affected items/changes are in BOLD font)
Characteristic	Predicate -ASTRA TEE®PCI medical	Predicate -ASTRA VR™PCI medical	ASTRA TEE®Civco Medical	ASTRA VR™Civco Medical
	(microswitch) &Software	(microswitch) &Software
HLD Vapor Control	●Door, fan & filter	●Door, fan & filter	Same as predicate	Same as predicate
User Interface	●Text basedinterface●4 button keypad●USB port●Barcode Scanner	●Text basedinterface●4 button keypad●USB port●Barcode Scanner	Same as predicate	Same as predicate
HLD MRCVerification	●Operator mustverify MRC	●Operator mustverify MRC	Same as predicate	Same as predicate
MaterialComponents	●Diaphragm Pump●Solenoid valves●Polyethylenetubing●Push Fit fittings●Powder coatedsheet metalcabinet with ABSplasticcomponents	●Diaphragm Pump●Solenoid valves●Polyethylenetubing●Push Fit fittings●Powder coatedsheet metalcabinet with ABSplasticcomponents	Same as predicate	Same as predicate
Compatible HLDs(differences in boldfont)	●Uses FDA clearedHLDs (MetricideOPA) permanufacturer'sspecifications	●Uses FDA clearedHLDs (MetricideOPA) permanufacturer'sspecifications	Uses FDA clearedHLD (MetricideOPA, Cidex OPAand Resert XL) permanufacturer'sspecifications	Uses FDA clearedHLD (MetricideOPA, Cidex OPAand Resert XL)permanufacturer'sspecifications
Disinfectant Usage(differences in boldfont)	Approved for re-useper HLDManufacturer'sspecifications●OPA up to 14 days●Or when MRC testfails	Approved for re-useper HLDManufacturer'sspecifications●OPA up to 14 days●Or when MRC testfails	Same as predicate withthe addition of "ResertXL up to 21 days"Cidex OPA usagespecifications areidentical to MetricideOPA	Same as predicate withthe addition of "ResertXL up to 21 days"Cidex OPA usagespecifications areidentical to MetricideOPA
Rinse water	Potable water filteredwith FDA cleared0.2µm bacteriaretention filter	Potable water filteredwith FDA cleared0.2µm bacteriaretention filter	Same as predicate	Same as predicate
Rinsing	Per HLDManufacturer'sspecifications	Per HLDManufacturer'sspecifications	Same as predicate	Same as predicate
Summary of Predicate Comparisons (affected items/changes are in BOLD font)
Characteristic	Predicate -ASTRA TEE®PCI medical	Predicate -ASTRA VR™PCI medical	ASTRA TEE®Civco Medical	ASTRA VR™Civco Medical
Do Technical differences raise new questions of safety & efficacy to that of the predicate device?
Base Technology	Time and temperaturemanagement	Time and temperaturemanagement	Same as predicate	Same as predicate
Liquid Level Control	• HLD level controlby sensor• Rinse level controlby sensor	• HLD level controlby sensor• Rinse level controlby sensor	Same as predicate	Same as predicate
User interface	• Barcode scanneraccepts input data	• Barcode scanneraccepts input data	Same as predicate	Same as predicate
Device characteristics that ensure comparable safety & efficacy to the predicate device (non-clinicaltesting)
Control of Criticalparameters	Device repeatedlymaintains time andtemperature requiredfor disinfection	Device repeatedlymaintains time andtemperature requiredfor disinfection	Same as predicate	Same as predicate
Efficacy (Disinfectionand Residual testing)	Pass as per simulateduse (6log reduction ofM. terrae ), In-useTesting (complete kill)and residual testing(ISO10993-5 cytotoxiceffect of <= 2)	Pass as per simulateduse (6log reduction ofM. terrae ), In-useTesting (complete kill)and residual testing(ISO10993-5 cytotoxiceffect of <= 2)	Same as predicate	Same as predicate
UL 61010 electricalsafety	Pass as per METLabstesting	Pass as per METLabstesting	Same as predicate	Same as predicate
Electromagnetic(EMC) compatibility	Pass as per METLabstesting	Pass as per METLabstesting	Same as predicate	Same as predicate

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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.

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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

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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.

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.