(263 days)
Not Found
No
The device description details a microprocessor-controlled system with fixed programs, sensors, and user inputs for automated disinfection and rinsing. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
This device is an automated reprocessor designed for high-level disinfection and rinsing of ultrasound probes, not for directly treating a medical condition or ailment.
No
Explanation: This device is an automated reprocessor designed for high-level disinfection and rinsing of ultrasound probes. Its function is to clean and disinfect medical equipment, not to diagnose medical conditions or analyze patient health data.
No
The device description clearly states it is "floor standing electromechanical lab equipment" and details hardware components like disinfection chambers, reservoirs, sensors (optical and door), and a microprocessor-controlled interface. While it has software control, it is fundamentally a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate high-level disinfection and rinsing of ultrasound probes. This is a process for cleaning and preparing medical devices for reuse, not for performing diagnostic tests on biological samples.
- Device Description: The device is described as "floor standing electromechanical lab equipment" that performs a disinfection process. It does not analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any features or functions related to analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic results.
- Predicate Device: The predicate device (CS MEDICAL TD-100 Transesophageal Probe Disinfector) is also a device for disinfecting medical equipment, not an IVD.
In summary, the GUS ASTRA TEE and GUS ASTRA VR are medical device reprocessors, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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 disinfortion and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.
Product codes (comma separated list FDA assigned to the subject device)
PSW, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transesophageal, endovaginal, endorectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Simulated use: 6log reduction of M. terrae
In-use Testing: complete kill
Residual testing: ISO10993-5 cytotoxic effect of
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K150504
Device Name
GUS ASTRA TEE™ Transesophageal Probe Reprocessor
Indications for Use (Describe)
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.
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."
3
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.
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
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 Avenue
Deep River, CT 06417 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kevin Mader
Director of Quality & Regulatory
k.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 Disinfector
K051305 |
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.
5
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 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
6
- ●
- .
- . .
.
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.
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.
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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.
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 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-100 | |||
| Transesophageal Probe | |||
| Disinfector System | CS Medical, Inc. | K051305 | Control the HLD temperature, |
| soak time, and rinse cycle to | |||
| achieve ≥6 Log reduction of M. | |||
| terrae using proprietary TD-5 | |||
| HLD |
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
8
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 to | |||
| facilitate ≥6 Log reduction of | |||
| M. terrae at each site tested | |||
| using FDA cleared Metricide | |||
| OPA. |
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 TEE | |||
| PCI medical | GUS ASTRA VR | |||
| PCI medical | TD-100 | |||
| CS Medical | ||||
| Regulatory | ||||
| 510(k) Number | K150504 | K150504 | K051305 | |
| Product Code | ITX | ITX | ITX | |
| Regulation | ||||
| Number | 21 CFR 892.1570 | 21 CFR 892.1570 | 21 CFR 892.1570 | |
| N/A | ||||
| ASTRA TEE and ASTRA VR same as | ||||
| predicate. | ||||
| ASTRA TEE and ASTRA VR same as | ||||
| predicate. | ||||
| Summary of Predicate Comparisons | ||||
| Characteristic | GUS ASTRA TEE | |||
| PCI medical | GUS ASTRA VR | |||
| PCI medical | TD-100 | |||
| CS Medical | ||||
| Regulation | ||||
| Name | Diagnostic | |||
| ultrasonic | ||||
| transducer | Diagnostic | |||
| ultrasonic | ||||
| transducer | Diagnostic | |||
| ultrasonic | ||||
| transducer | ASTRA TEE and ASTRA VR same as | |||
| predicate. | ||||
| Intended Use/ | ||||
| Indications for | ||||
| Use | The GUS ASTRA | |||
| reprocessor | ||||
| facilitates high-level | ||||
| disinfection and | ||||
| rinsing of 1 or 2 | ||||
| transesophageal | ||||
| ultrasound probes | ||||
| using FDA cleared | ||||
| and PCI Medical | ||||
| approved high-level | ||||
| liquid disinfectants. | 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. | The TD-100 | |||
| disinfector is | ||||
| designed to provide | ||||
| high-level | ||||
| disinfection of | ||||
| Transesophageal | ||||
| (TEE) ultrasound | ||||
| probes. The system | ||||
| uses the TD-5 | ||||
| disinfectant, which | ||||
| is designed to be | ||||
| used only with the | ||||
| TD-100. The | ||||
| disinfectant bottles | ||||
| cannot be reused in | ||||
| the system. | ||||
| TD-5 is intended for | ||||
| use as a single use | ||||
| high-level | ||||
| disinfectant to be | ||||
| used exclusively in | ||||
| the TD-100 for high | ||||
| level disinfection of | ||||
| TEE ultrasound | ||||
| probes. | ||||
| The TD-5 High Level | ||||
| Disinfectant and TD- | ||||
| 100 disinfector | ||||
| system is intended | ||||
| for use by qualified | ||||
| individuals trained | ||||
| in its use. | ASTRA TEE and ASTRA VR similar | |||
| to predicate: | ||||
| Both are intended for | ||||
| use with FDA cleared | ||||
| High-level Liquid | ||||
| Disinfectants (HLDs) to | ||||
| disinfect ultrasound | ||||
| probes and are to be | ||||
| used by trained | ||||
| personnel in non-sterile | ||||
| healthcare settings | ||||
| ASTRA TEE: | ||||
| The ASTRA TEE can | ||||
| reprocess up to 2 TEE | ||||
| probes; TD-100 does 1 | ||||
| TEE probe at a time | ||||
| The ASTRA TEE uses | ||||
| select FDA cleared | ||||
| HLDS; TD-100 uses | ||||
| proprietary HLD | ||||
| The ASTRA TEE re-uses | ||||
| HLD; TD-100 uses a | ||||
| single-use bottle | ||||
| ASTRA VR: | ||||
| The ASTRA VR con | ||||
| reprocess up to 2 | ||||
| endovaginal/endorectal | ||||
| ultrasound probes; TD- | ||||
| 100 does 1 TEE probe at | ||||
| a time | ||||
| The ASTRA VR uses | ||||
| select FDA cleared | ||||
| HLDs; TD-100 uses | ||||
| proprietary HLD | ||||
| The ASTRA VR re-uses | ||||
| HLD; TD-100 uses a | ||||
| single-use bottle | ||||
| Prescription | ||||
| Use | No | No | No | ASTRA TEE and ASTRA VR same as |
| predicate. | ||||
| Types of probes | Transesophageal | |||
| (TEE) probes | Endorectal, | |||
| endovaginal (VR) | ||||
| probes | Transesophageal | |||
| probes | (TD-100) | |||
| ASTRA VR | ||||
| equivalent to TD-100 as both | ||||
| reprocess non-lumened | ||||
| ultrasound probes of various | ||||
| geometries | ||||
| Summary of Predicate Comparisons | ||||
| Characteristic | GUS ASTRA TEE | |||
| PCI medical | GUS ASTRA VR | |||
| PCI medical | TD-100 | |||
| CS Medical | ||||
| Theory of | ||||
| Operation | • Control time, | |||
| temperature | ||||
| and fluid levels | ||||
| to maintain | ||||
| optimal | ||||
| conditions for | ||||
| disinfection | ||||
| and rinsing as | ||||
| established by | ||||
| HLD | ||||
| manufacturers | • Control time, | |||
| temperature | ||||
| and fluid levels | ||||
| to maintain | ||||
| optimal | ||||
| conditions for | ||||
| disinfection | ||||
| and rinsing as | ||||
| established by | ||||
| HLD | ||||
| manufacturers | • Control time, | |||
| temperature | ||||
| and fluid levels | ||||
| to maintain | ||||
| optimal | ||||
| conditions for | ||||
| disinfection | ||||
| and rinsing as | ||||
| established by | ||||
| HLD | ||||
| manufacturer | ASTRA TEE and ASTRA VR same as | |||
| predicate. | ||||
| Disinfection | ||||
| time control | • Timing Chip & | |||
| Software | • Timing Chip & | |||
| Software | • Electronics & | |||
| Software | ASTRA TEE and ASTRA VR | |||
| Substantially equivalent to TD- |
- Time control parameters are
contingent to HLD Type and
manufacturer specifications. |
| Disinfection
temperature
control | • Temperature
sensor &
Software | • Temperature
sensor &
Software | • Electronics &
Software | ASTRA TEE and ASTRA VR
Substantially equivalent to TD- - Temperature control
parameters are contingent to HLD
Type and manufacturer
specifications. |
| HLD warming
capability | • Yes (Warmer
pad) | • Yes (Warmer
pad) | • Yes (Unknown) | ASTRA TEE and ASTRA VR
Substantially equivalent to TD- -
|
| Liquid Level
Control
(HLD and rinse) | • Sensors
(upper/lower)
& Software | • Sensors
(upper/lower)
& Software | • Sensor (upper)
& Software
Fixed volume
single use
bottle (HLD) | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. HLD Level control
TEE and ASTRA VR use sensors to
detect when HLD level is met.
Predicate uses a pre-measured
HLD single use bottle
Rinse Water Level: ASTRA TEE and
ASTRA VR same as predicate. |
| Overflow
Protection | • Sensor
(overflow) &
Software | • Sensor
(overflow) &
Software | • Sensor
(overflow) &
Software | ASTRA TEE and ASTRA VR same as
predicate. |
| Probe
Detection | • Sensor
(microswitch)
& Software | • Sensor
(microswitch)
& Software | • Sensor
(microswitch)
& Software | ASTRA TEE and ASTRA VR same as
predicate. |
| HLD Vapor
Control | • Door, fan &
filter | • Door, fan &
filter | • Door, fan &
filter | ASTRA TEE and ASTRA VR same as
predicate. |
| User Interface | • Text based
interface
4 button
keypad
USB port | • Text based
interface
4 button
keypad
USB port | • Text based
interface
15 button
keypad
Printer | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. ASTRA TEE and ASTRA VR
utilize USB port to download data
while predicate uses printable
data. ASTRA TEE and ASTRA VR |
| Characteristic | GUS ASTRA TEE
PCI medical | GUS ASTRA VR
PCI medical | TD-100
CS Medical | |
| | Barcode
Scanner | Barcode
Scanner | | utilize Barcode Scanner to capture
input data while the predicate
device allows manual input
through keypad. |
| HLD MRC
Verification | Operator must
verify MRC | Operator must
verify MRC | Operator must
verify HLD
expiration date | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. |
| Material
Components | Diaphragm
Pump Solenoid valves Polyethylene
tubing Push Fit fittings Powder coated
sheet metal
cabinet with
ABS plastic
components | Diaphragm
Pump Solenoid valves Polyethylene
tubing Push Fit fittings Powder coated
sheet metal
cabinet with
ABS plastic
components | Diaphragm
Pump Solenoid valves Polyethylene
tubing Fittings ABS Plastic
cabinet | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. |
| Compatible
HLDS | Uses FDA
cleared HLDS
(Metricide
OPA) per
specifications | Uses FDA
cleared HLDS
(Metricide
OPA) per
specifications | Uses TD-100
specific FDA
cleared HLD
(TD-5) per
specifications | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. Temperature and time
control parameters are contingent
to HLD Type and manufacturer
specifications but operate under
the same principle. |
| Disinfectant
Usage | Approved for re-use
per HLD
specifications OPA up to 14
days Or when MRC
test fails | Approved for re-use
per HLD
specifications OPA up to 14
days Or when MRC
test fails | Approved for single
use per HLD
specifications Usage through
expiry date MRC test not
specified | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. Usage contingent to HLD
Type and manufacturer
specifications. Usage duration
controlled by system software for
the ASTRA TEE and ASTRA VR and
MRC verification by operator. TD-
100 usage controlled by single-use
bottle expiry date which is verified
by the operator. |
| Rinse water | Potable water
filtered with FDA
cleared 0.2µm
bacteria retention
filter | Potable water
filtered with FDA
cleared 0.2µm
bacteria retention
filter | Potable water. | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. Usage contingent to HLD
Type and manufacturer
specifications. |
| Rinsing | Per HLD | Per HLD | Per HLD | ASTRA TEE and ASTRA VR same as
predicate |
| Summary of Predicate Comparisons | | | | |
| Characteristic | GUS ASTRA TEE
PCI medical | GUS ASTRA VR
PCI medical | TD-100
CS Medical | |
| Base
Technology | Time and
temperature
management | Time and
temperature
management | Time and
temperature
management | ASTRA TEE and ASTRA VR same as
predicate. No new
questions/concerns of safety and
efficacy. |
| Liquid Level
Control | • HLD level
control by
sensor
• Rinse level
control by
sensor | • HLD level
control by
sensor
• Rinse level
control by
sensor | • HLD level
control by
volume
• Rinse level
control by
sensor | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. HLD Level control
TEE and ASTRA VR use sensors to
detect when HLD level is met.
Predicate uses a pre-measured
HLD single use bottle
Rinse Water Level: ASTRA TEE and
ASTRA VR same as predicate. No
new questions/concerns of safety
and efficacy. |
| User interface | • Barcode
scanner
accepts input
data | • Barcode
scanner
accepts input
data | • User inputs
data via keypad | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. No new questions/concerns
of safety and efficacy. |
| testing) | | | | |
| Control of
Critical
parameters | Device repeatedly
maintains time and
temperature
required for
disinfection | Device repeatedly
maintains time and
temperature
required for
disinfection | Device repeatedly
maintains time and
temperature
required for
disinfection | ASTRA TEE and ASTRA VR
Substantially equivalent to TD-
100. |
| 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