The GUS ASTRA TEE™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transsophageal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.

The GUS ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and PCI Medical 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.

The GUS ASTRA TEE and GUS 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 GUS ASTRA TEE is an automated reprocessor which enables high-level disinfection and rinsing for transesophageal (TEE) ultrasound probes. The GUS 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.

AI/ML Overview

This appears to be a 510(k) premarket notification for a medical device, specifically automated reprocessors for ultrasound probes. The document focuses on demonstrating substantial equivalence to a predicate device ("TD-100 Transesophageal Probe Disinfector").

The information provided does not describe an AI/ML-based device, a comparative effectiveness study with human readers, or an algorithm-only standalone study. Therefore, sections pertaining to these aspects (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text.

The acceptance criteria relate to the physical and functional performance of the device, focusing on its ability to control the high-level disinfectant (HLD) process and user safety. The "study" mentioned refers to verification and validation testing to ensure the device meets these performance specifications and is substantially equivalent to the predicate.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Attribute	Reported Device Performance
Control of HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terrae at each site tested using FDA cleared Metricide OPA.	Device repeatedly maintains time and temperature required for disinfection. (This implies facilitating ≥6 Log reduction based on HLD specifications.)
Maintain time and temperature required for disinfection as per HLD specifications	Passed
Safety and EMC (Electromagnetic Compatibility) testing	Passed
Simulated use and residual testing	Passed (6 log reduction of M. terrae, residual testing ISO10993-5 cytotoxic effect of <= 2)
In-use testing	Passed (complete kill)
UL 61010 electrical safety	Passed as per METLabs testing
Electromagnetic (EMC) compatibility	Passed as per METLabs testing
Theory of Operation (Control time, temperature, and fluid levels to maintain optimal conditions for disinfection and rinsing as established by HLD manufacturers)	ASTRA TEE and ASTRA VR same as predicate (TD-100).
Disinfection time control (Timing Chip & Software)	Substantially equivalent to TD-100. Time control parameters are contingent to HLD Type and manufacturer specifications.
Disinfection temperature control (Temperature sensor & Software)	Substantially equivalent to TD-100. Temperature control parameters are contingent to HLD Type and manufacturer specifications.
HLD warming capability (Warmer pad)	Substantially equivalent to TD-100.
Liquid Level Control (HLD and rinse)	HLD Level control by sensor; Rinse level control by sensor. Substantially equivalent to TD-100 (which uses volume control for HLD and sensor for rinse).
Overflow Protection (Sensor & Software)	Same as predicate.
Probe Detection (Sensor/microswitch & Software)	Same as predicate.
HLD Vapor Control (Door, fan & filter)	Same as predicate.
User Interface (Text based interface, 4 button keypad, USB port)	Substantially equivalent to TD-100 (which uses 15 button keypad, Printer). ASTRA TEE and ASTRA VR utilize USB port and Barcode Scanner, unlike predicate's printer and manual keypad input.
HLD MRC (Minimum Recommended Concentration) Verification	Operator must verify MRC. Substantially equivalent to TD-100 (which requires operator to verify HLD expiration date, MRC not specified).
Compatible HLDs	Uses FDA cleared HLDs (Metricide OPA) per specifications. Substantially equivalent to TD-100 (which uses TD-100 specific FDA cleared HLD (TD-5)).
Disinfectant Usage	Approved for re-use per HLD specifications OPA up to 14 days or when MRC test fails. Substantially equivalent to TD-100 (which is single use). Usage contingent to HLD Type and manufacturer specifications.
Rinse water	Potable water filtered with FDA cleared 0.2µm bacteria retention filter. Substantially equivalent to TD-100 (which uses potable water). Usage contingent to HLD Type and manufacturer specifications.
Rinsing	Per HLD. Same as predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document
does not specify a "sample size" in the context of typical AI/ML testing (e.g., number of cases or images). The testing appears to be primarily laboratory-based and simulated use testing of the device itself.
Data provenance is not explicitly stated as country of origin, but the testing was conducted to U.S. and international standards (e.g., UL, ISO, EN, ANSI/AAMI/IEC) for medical devices. The nature of the testing suggests it is prospective in the sense of verifying device performance against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth in this context relates to the validated performance criteria of the disinfection process, not expert-labeled medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human reader interpretation or adjudication.

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
No, this type of study was not done. The device is an automated reprocessor, not an AI diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical reprocessor, not an algorithm. The device's "standalone" performance is assessed through its ability to independently control the disinfection process parameters.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from:

HLD (High-Level Disinfectant) manufacturer specifications: These define the required time and temperature for effective disinfection.
Industry standards: Such as ISO 10993-5 (cytotoxicity), UL 61010-1/CSA C22.2 No. 61010-1 (electrical safety), EN 61326-1 (EMC), ANSI/AAMI/IEC 62304 (Medical Device Software).
Microbiological performance standards: e.g., achieving ≥6 Log reduction of M. terrae.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.

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 consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending from its body. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.

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

May 30, 2017

PCI Medical, Inc. Mr. Kevin Mader Director of Quality and Regulatory 6 Winter Avenue Deep River, CT 06417

Re: K150504

Trade/Device Name: GUS ASTRA TEE™ Transesophageal Probe Reprocessor GUS ASTRA VRTM Endovaginal/Endorectal Probe Reprocessor Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: PSW Dated: October 16, 2015 Received: October 16, 2015

Dear Mr. Kevin Mader:

This letter corrects our substantially equivalent letter of November 16, 2015.

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.

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Page 2 - Mr. Kevin Mader

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 forth in the quality systems (QS) 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 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.

Tina
Kiang -S

Tina Kiang, Ph.D. 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) K150504

Device Name

GUS 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)

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) K | 50504

Device Name

GUS ASTRA VR™ Endovaginal/Endorectal Probe Reprocessor

Indications for Use (Describe)

The GUS ASTRA VRTM automated reprocessor facilitates high-level disinfortion and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

区 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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/4/Picture/0 description: The image shows a logo for PCI Medical. The logo consists of the letters "PCI" stacked on top of the word "MEDICAL". A plus sign is located above the letter "I" in "PCI". The text and symbol are in black and white.

510(k) SUMMARY

Submitter	PCI Medical, Inc.6 Winter AvenueDeep River, CT 06417
Contact Person	Kevin MaderDirector of Quality & Regulatoryk.mader@pcimedical.com(800) 862-3394 ext. 247(860) 526-3081 (fax)
Date Prepared	November 13th 2015
Trade Name(Common Name)
Regulation Name	Diagnostic Ultrasonic Transducer, 21 CFR 892.1570
Classification	Class II
Product Code	ITX
Predicate Device(s)	CS MEDICAL TD-100 Transesophageal Probe DisinfectorK051305

Intended Use

cilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.

ates high-level disinfection and rinsing of 1 or 2 endovaginal/endorectal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.

The intended use statements use similar language to the predicate TD-100 device (K051305). The differences in wording used does not raise new questions of safety or efficacy.

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Device Description

Model types

The GUS ASTRA family of products contai

Physical Characteristics

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

. ● . . Weight: 73 lbs. (33.1 kg) . . ●
. Weight: 73 lbs. (33.1 kg)

Materials

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:

◆ ● (PVC), Polyethylene, Polypropylene, EPDM, . Stainless Steel, Polycarbonate, Polyurethane, Polysulfone . ● Polycarbonate, ABS, Polypropylene. ● Sulfide resin, Acryl resin, Polycarbonate resin, stainless steel, silicone, silver, polyester. 6 Winter Avenue Deep River Connecticut, 06443 - Tel: (800) 862-3394 Fax: (860) 526-3081
www.pcimedical.com

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compliant electronics, PVC, Copper

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.

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 er 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

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 s MRC status at the next prompt. The user will

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

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Image /page/7/Picture/0 description: The image shows the logo for PCI Medical. The logo consists of the letters "PCI" in a bold, sans-serif font, with the word "MEDICAL" written in a smaller font below. A plus sign is located above the letter "i" in "PCI". The logo is black and white.

Performance Characteristics

The ASTRA Product Family of automated reprocessors utilizes the same technology and highlevel disinfection approach employed by the predicate device, the TD-100 cleared under K051305. It should be noted that TD-100 system is comprised of the instrument and proprietary TD-5 HLD. The TD-100 controls time, temperature, and rinse parameters using the TD-5 proprietary HLD to achieve a ≥6 Log reduction. The ASTRA controls time, temperature, and rinse parameters to facilitate a ≥6 Log reduction by the FDA approved HLD. As a result, this submission primarily focuses on the performance specification of the instrument and controls (time, temperature, and rinse) common to both devices.

The ASTRA system and the TD-100 both 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
TD-100Transesophageal ProbeDisinfector System	CS Medical, Inc.	K051305	Control the HLD temperature,soak time, and rinse cycle toachieve ≥6 Log reduction of M.terrae using proprietary TD-5HLD

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). The intended use and function of the automated reprocessors are the same and they are substantially equivalent to the TD-100 probe disinfector in design and function. The ASTRA

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series of automated reprocessors control the HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terroe on enzymatically cleaned probes at each site tested, thus achieving equivalent performance to the TD-100 instrument.

Device Name	Manufacturer	510(k)	Performance Attribute
Probe Reprocessors	PCI Medical, Inc.	K150504	Control the HLD temperature,soak time, and rinse cycle tofacilitate ≥6 Log reduction ofM. terrae at each site testedusing FDA cleared MetricideOPA.

Clinical/Non-Clinical Performance Testing Summary

. The ASTRA system maintains time and temperature required for disinfection as per HLD
. The ASTRA system passes Safety and EMC testing
The ASTRA system passes simulated use and residual testing ●
. The ASTRA system passes In-use testing

Technology Comparison to Predicate Devices

The ASTRA Product Family of automated reprocessors utilizes the same technology employed by the predicate device, the TD-100 cleared under K051305. The ASTRA system and the TD-100 both control the HLD temperature, soak time, and rinse cycle for the safe and effective disinfection of ultrasound probes.

Summary of Predicate Comparisons
Characteristic	GUS ASTRA TEEPCI medical	GUS ASTRA VRPCI medical	TD-100CS Medical
Regulatory
510(k) Number	K150504	K150504	K051305
Product Code	ITX	ITX	ITX
RegulationNumber	21 CFR 892.1570	21 CFR 892.1570	21 CFR 892.1570
			N/AASTRA TEE and ASTRA VR same aspredicate.
			ASTRA TEE and ASTRA VR same aspredicate.
		Summary of Predicate Comparisons
Characteristic	GUS ASTRA TEEPCI medical	GUS ASTRA VRPCI medical	TD-100CS Medical
RegulationName	Diagnosticultrasonictransducer	Diagnosticultrasonictransducer	Diagnosticultrasonictransducer	ASTRA TEE and ASTRA VR same aspredicate.
Intended Use/Indications forUse	The GUS ASTRAreprocessorfacilitates high-leveldisinfection andrinsing of 1 or 2transesophagealultrasound probesusing FDA clearedand PCI Medicalapproved high-levelliquid disinfectants.	automatedreprocessorfacilitates high-leveldisinfection andrinsing of 1 or 2endovaginal and/orendorectalultrasound probesusing FDA clearedand PCI Medicalapproved high-levelliquid disinfectants.	The TD-100disinfector isdesigned to providehigh-leveldisinfection ofTransesophageal(TEE) ultrasoundprobes. The systemuses the TD-5disinfectant, whichis designed to beused only with theTD-100. Thedisinfectant bottlescannot be reused inthe system.TD-5 is intended foruse as a single usehigh-leveldisinfectant to beused exclusively inthe TD-100 for highlevel disinfection ofTEE ultrasoundprobes.The TD-5 High LevelDisinfectant and TD-100 disinfectorsystem is intendedfor use by qualifiedindividuals trainedin its use.	ASTRA TEE and ASTRA VR similarto predicate:Both are intended foruse with FDA clearedHigh-level LiquidDisinfectants (HLDs) todisinfect ultrasoundprobes and are to beused by trainedpersonnel in non-sterilehealthcare settingsASTRA TEE:The ASTRA TEE canreprocess up to 2 TEEprobes; TD-100 does 1TEE probe at a timeThe ASTRA TEE usesselect FDA clearedHLDS; TD-100 usesproprietary HLDThe ASTRA TEE re-usesHLD; TD-100 uses asingle-use bottleASTRA VR:The ASTRA VR conreprocess up to 2endovaginal/endorectalultrasound probes; TD-100 does 1 TEE probe ata timeThe ASTRA VR usesselect FDA clearedHLDs; TD-100 usesproprietary HLDThe ASTRA VR re-usesHLD; TD-100 uses asingle-use bottle
PrescriptionUse	No	No	No	ASTRA TEE and ASTRA VR same aspredicate.
Types of probes	Transesophageal(TEE) probes	Endorectal,endovaginal (VR)probes	Transesophagealprobes	(TD-100)ASTRA VRequivalent to TD-100 as bothreprocess non-lumenedultrasound probes of variousgeometries
	Summary of Predicate Comparisons
Characteristic	GUS ASTRA TEEPCI medical	GUS ASTRA VRPCI medical	TD-100CS Medical

Theory ofOperation	• Control time,temperatureand fluid levelsto maintainoptimalconditions fordisinfectionand rinsing asestablished byHLDmanufacturers	• Control time,temperatureand fluid levelsto maintainoptimalconditions fordisinfectionand rinsing asestablished byHLDmanufacturers	• Control time,temperatureand fluid levelsto maintainoptimalconditions fordisinfectionand rinsing asestablished byHLDmanufacturer	ASTRA TEE and ASTRA VR same aspredicate.
Disinfectiontime control	• Timing Chip &Software	• Timing Chip &Software	• Electronics &Software	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100. Time control parameters arecontingent to HLD Type andmanufacturer specifications.
Disinfectiontemperaturecontrol	• Temperaturesensor &Software	• Temperaturesensor &Software	• Electronics &Software	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100. Temperature controlparameters are contingent to HLDType and manufacturerspecifications.
HLD warmingcapability	• Yes (Warmerpad)	• Yes (Warmerpad)	• Yes (Unknown)	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100.
Liquid LevelControl(HLD and rinse)	• Sensors(upper/lower)& Software	• Sensors(upper/lower)& Software	• Sensor (upper)& SoftwareFixed volumesingle usebottle (HLD)	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100. HLD Level controlTEE and ASTRA VR use sensors todetect when HLD level is met.Predicate uses a pre-measuredHLD single use bottleRinse Water Level: ASTRA TEE andASTRA VR same as predicate.
OverflowProtection	• Sensor(overflow) &Software	• Sensor(overflow) &Software	• Sensor(overflow) &Software	ASTRA TEE and ASTRA VR same aspredicate.
ProbeDetection	• Sensor(microswitch)& Software	• Sensor(microswitch)& Software	• Sensor(microswitch)& Software	ASTRA TEE and ASTRA VR same aspredicate.
HLD VaporControl	• Door, fan &filter	• Door, fan &filter	• Door, fan &filter	ASTRA TEE and ASTRA VR same aspredicate.
User Interface	• Text basedinterface4 buttonkeypadUSB port	• Text basedinterface4 buttonkeypadUSB port	• Text basedinterface15 buttonkeypadPrinter	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100. ASTRA TEE and ASTRA VRutilize USB port to download datawhile predicate uses printabledata. ASTRA TEE and ASTRA VR
Characteristic	GUS ASTRA TEEPCI medical	GUS ASTRA VRPCI medical	TD-100CS Medical
	BarcodeScanner	BarcodeScanner		utilize Barcode Scanner to captureinput data while the predicatedevice allows manual inputthrough keypad.
HLD MRCVerification	Operator mustverify MRC	Operator mustverify MRC	Operator mustverify HLDexpiration date	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100.
MaterialComponents	DiaphragmPump Solenoid valves Polyethylenetubing Push Fit fittings Powder coatedsheet metalcabinet withABS plasticcomponents	DiaphragmPump Solenoid valves Polyethylenetubing Push Fit fittings Powder coatedsheet metalcabinet withABS plasticcomponents	DiaphragmPump Solenoid valves Polyethylenetubing Fittings ABS Plasticcabinet	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100.
CompatibleHLDS	Uses FDAcleared HLDS(MetricideOPA) perspecifications	Uses FDAcleared HLDS(MetricideOPA) perspecifications	Uses TD-100specific FDAcleared HLD(TD-5) perspecifications	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100. Temperature and timecontrol parameters are contingentto HLD Type and manufacturerspecifications but operate underthe same principle.
DisinfectantUsage	Approved for re-useper HLDspecifications OPA up to 14days Or when MRCtest fails	Approved for re-useper HLDspecifications OPA up to 14days Or when MRCtest fails	Approved for singleuse per HLDspecifications Usage throughexpiry date MRC test notspecified	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100. Usage contingent to HLDType and manufacturerspecifications. Usage durationcontrolled by system software forthe ASTRA TEE and ASTRA VR andMRC verification by operator. TD-100 usage controlled by single-usebottle expiry date which is verifiedby the operator.
Rinse water	Potable waterfiltered with FDAcleared 0.2µmbacteria retentionfilter	Potable waterfiltered with FDAcleared 0.2µmbacteria retentionfilter	Potable water.	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100. Usage contingent to HLDType and manufacturerspecifications.
Rinsing	Per HLD	Per HLD	Per HLD	ASTRA TEE and ASTRA VR same aspredicate
Summary of Predicate Comparisons
Characteristic	GUS ASTRA TEEPCI medical	GUS ASTRA VRPCI medical	TD-100CS Medical
BaseTechnology	Time andtemperaturemanagement	Time andtemperaturemanagement	Time andtemperaturemanagement	ASTRA TEE and ASTRA VR same aspredicate. No newquestions/concerns of safety andefficacy.
Liquid LevelControl	• HLD levelcontrol bysensor• Rinse levelcontrol bysensor	• HLD levelcontrol bysensor• Rinse levelcontrol bysensor	• HLD levelcontrol byvolume• Rinse levelcontrol bysensor	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100. HLD Level controlTEE and ASTRA VR use sensors todetect when HLD level is met.Predicate uses a pre-measuredHLD single use bottleRinse Water Level: ASTRA TEE andASTRA VR same as predicate. Nonew questions/concerns of safetyand efficacy.
User interface	• Barcodescanneraccepts inputdata	• Barcodescanneraccepts inputdata	• User inputsdata via keypad	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100. No new questions/concernsof safety and efficacy.
testing)
Control ofCriticalparameters	Device repeatedlymaintains time andtemperaturerequired fordisinfection	Device repeatedlymaintains time andtemperaturerequired fordisinfection	Device repeatedlymaintains time andtemperaturerequired fordisinfection	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100.
Efficacy(Disinfectionand Residualtesting)	Pass as persimulated use (6logreduction of M.terrae), In-useTesting (completekill) and residualtesting (ISO10993-5cytotoxic effect of<= 2)	Pass as persimulated use (6logreduction of M.terrae), In-useTesting (completekill) and residualtesting (ISO10993-5cytotoxic effect of<= 2)	Pass as persimulated use (6logreduction of M.terrae) and residualtesting	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100.
UL 61010electrical safety	Pass as per METLabstesting	Pass as per METLabstesting	UL approved	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100.
Electromagnetic(EMC)compatibility	Pass as per METLabstesting	Pass as per METLabstesting	UL approved	ASTRA TEE and ASTRA VRSubstantially equivalent to TD-100.

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6 Winter Avenue Deep River Connecticut, 06443 - Tel: (800) 862-3394 Fax: (860) 526-3081

www.pcimedical.com

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Image /page/10/Picture/0 description: The image shows the logo for PCI Medical. The logo consists of the letters "PCI" stacked on top of the word "MEDICAL". A plus sign is located to the upper right of the letter "i".

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Image /page/12/Picture/0 description: The image shows the logo for PCI Medical. The logo has the letters "PCI" stacked on top of the word "MEDICAL". To the right of the letters is a plus sign.

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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 assuranc

Management System to demonstrate substantial equivalence to the predicate device and to confirm safety and efficacy:

21 CFR Part 820.30 Design Controls .
●
. ISO 10993-5 Tests for in vitro cytotoxicity
Part 1-2: General Requirements for Safety . and essential performance - collateral standard: electromagnetic compatibility requirements and tests
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 measur
- General requirements
ANSI/AAMI/IEC 62304 Medical Device Soft ●
.
System, Software, and Hardware Verification & Validation �

Conclusion

Transesophageal Probe Disinfector. Based on the nonclinical tests performed the subject device performs as safely and as effectively as the legally marketed predicate devices, CS Medical TD-100 Transesophageal probe disinfector (K051305).

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.