(217 days)
Not Found
No
The description focuses on mechanical cleaning, rinsing, and thermal disinfection cycles controlled by validated software, with no mention of AI or ML technologies.
No.
This device is designed for the cleaning and disinfection of reusable surgical instruments, not for directly treating a disease or condition in a patient. Its function is to prepare instruments for sterilization, which is a step in the overall medical process but not a therapeutic act itself.
No
The device, RAS Racks, is described as being used for the cleaning, rinsing, drying, and intermediate-level disinfection of surgical instruments. Its function is to prepare instruments for sterilization, not to diagnose a medical condition or ailment.
No
The device description clearly states the RAS Racks are physical components designed to hold instruments within a washer/disinfector. The performance studies also focus on physical cleaning efficacy and thermal disinfection, not software performance related to image processing, AI, or data analysis. While software is mentioned as being validated, it controls the physical washer/disinfector system, not the medical device itself as a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cleaning, rinsing, drying, and intermediate level disinfection of reusable surgical instruments (da Vinci EndoWrist instruments and staplers). This is a process for preparing medical devices for subsequent use, not for diagnosing a condition or analyzing a biological sample.
- Device Description: The device is a rack designed to hold surgical instruments within a washer/disinfector. Its function is mechanical cleaning and thermal disinfection, not the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays for analysis
The device is clearly intended for the reprocessing of surgical instruments to ensure they are clean and disinfected before sterilization, which is a crucial step in preventing the spread of infection in a healthcare setting. This falls under the category of medical device reprocessing equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.
Product codes (comma separated list FDA assigned to the subject device)
NVE
Device Description
The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector. Twelve soiled da Vinci Endowrist X/Xi, S/Si, or Single-Site instruments and staplers, without prior manual cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053L Single-Chamber Washer/Disinfector, and the RAS Cycle is selected.
The RAS Cycle performs automated cleaning through a validated series of spraywashing, lumen flushing steps that use Prolystica Ultra Concentrate HP Enzymatic Cleaner alternately with Prolystica Ultra Concentrate HP Neutral Detergent in temperature-controlled solutions. When the series of automated prewash and washing stages are complete, a one-minute rinse occurs. Next the RAS Cycle completes a thermal rinse to achieve intermediate level disinfection of the load before drying it. Upon RAS Cycle completion, the devices are ready to be prepared and packed for steam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital/medical center SPD
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)
Simulated Use Testing: Endowrist instruments identified as master devices for their most challenging features were soiled and allowed to dry for at least one hour. They were processed in triplicate trials using the RAS Cycle to the end of the initial rinse (prior to thermal rinse), then examined visually and sampled for quantitation of two soil markers: protein
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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August 21, 2019
STERIS Corporation Marcia Benedict Senior Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K190081
Trade/Device Name: RAS-12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO® 7052HP/7053HP Single Chamber Washer/Disinfector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NVE Dated: July 19, 2019 Received: July 22, 2019
Dear Marcia Benedict:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number ( known)
K190081
Device Name
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO® 7052HP / 7053HP Single Chamber Washer-Disinfector
Indications for Use (Describe)
The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.
Type of Use (Select one or both, as applicable)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary For RAS 12 Rack, Ras 12 Long Rack and RAS Cycle in AMSCO® 7052HP / 7053HP Single Chamber Washer-Disinfectors
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Marcia L. Benedict Senior Director, Regulatory Affairs Tel: 440-392-7063 Fax: 440-357-9198
July 19, 2019 Submission Date:
Premarket Notification Number: K190081
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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Device Name 1.
| Trade Name: | RAS 12 Rack, RAS 12 Long Rack
RAS Cycle of AMSCO 7052HP Single Chamber
Washer/Disinfector and AMSCO 7053HP Single
Chamber Washer/Disinfector |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class: | Class II |
| Common/usual Name: | Endoscope cleaning accessory |
| Classification Name: | Endoscope washer, cleaner, automated |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | NVE |
2. Predicate Device
da Vinci SonicPro Cleaning System: K073112
Device Description 3.
The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector. Twelve soiled da Vinci Endowrist X/Xi, S/Si, or Single-Site instruments and staplers, without prior manual cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053L Single-Chamber Washer/Disinfector, and the RAS Cycle is selected.
The RAS Cycle performs automated cleaning through a validated series of spraywashing, lumen flushing steps that use Prolystica Ultra Concentrate HP Enzymatic Cleaner alternately with Prolystica Ultra Concentrate HP Neutral Detergent in temperature-controlled solutions. When the series of automated prewash and washing stages are complete, a one-minute rinse occurs. Next the RAS Cycle completes a thermal rinse to achieve intermediate level disinfection of the load before drying it. Upon RAS Cycle completion, the devices are ready to be prepared and packed for steam sterilization.
4. Indications for Use
The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.
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5. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Feature | Proposed Device K190081
RAS Racks and Cycles in
AMSCO® 7052HP/7053HP
Single-Chamber
Washer/Disinfectors | Predicate Device
da Vinci SonicPro
Cleaning System
(K073112) | Comparison |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use
Indications
for Use | The RAS Racks are used in the
RAS Cycles of the AMSCO
7052HP and 7053HP Single-
Chamber Washer/Disinfectors
for the effective cleaning,
rinsing, drying and
intermediate level disinfection
of reusable da Vinci
EndoWrist® X/Xi, S/Si, and
Single-Site instruments and
staplers. | The da Vinci SonicPro
Cleaning System is intended
for the automated cleaning
of reusable EndoWrist
Instruments and accessories
used with the da Vinci and
da Vinci S surgical systems.
The Cleaning System when
used in accordance with its
labeling provides an
automated cleaning method
as part of the re-processing
sequence for the EndoWrist
Instruments and Accessories. | The intended
use is the same;
details
provided differ.
The proposed
device
specifically
names claimed
da Vinci
EndoWrist
device models.
The proposed
device achieves
cleaning
without
preliminary
manual
cleaning, while
the predicate
device requires
EndoWrist
manual
cleaning. |
| Operating
Principles
/
Technology | The RAS Racks and RAS
Cycle of the 7052HP/7053HP
SC w/d provide the necessary
combination of cleaning
agents in hot water with
temperature and water
pressure control during timed
sequences to achieve effective
cleaning of complex lumened
da Vinci instruments and
staplers. Validated parameters
of the RAS cycle, which
includes prewash, cleaning
stages, rinsing, intermediate | The Cleaning System
provides a microprocessor
controlled unit with the
ability to clean internal and
external surfaces of lumened
robotic surgical instruments
such as the da Vinci
EndoWrist instruments.
Cleaning follows manual
cleaning steps and is
accomplished through use of
hot water, user-selected
detergent, flow, ultrasonic
energy, and rinsing | Similar;
however
The predicate
includes use of
ultrasonic
energy
The proposed
device includes
thermal
disinfection
and drying,
without
sonication |
| Feature | Proposed Device K190081
RAS Racks and Cycles in
AMSCO® 7052HP/7053HP
Single-Chamber
Washer/Disinfectors | Predicate Device
da Vinci SonicPro
Cleaning System
(K073112) | Comparison |
| | level thermal disinfection, and
heated drying, cannot be
reduced from the minimum
default parameters. | mechanism. | |
| Where
Used | Hospital/medical center SPD | Hospital/medical center SPD | Identical |
| Design | The Washer/Disinfector is a
stand-alone pass-through
design single-chamber unit
with integrated software. The
RAS Racks position and
provide flow to loaded da
Vinci items throughout the
RAS Cycle while spray arms
assure all surfaces are cleaned
with validated chemistries,
rinsed, thermal disinfected,
and dried. | The Cleaning System is a
stand-alone unit mounted on
a movable frame with
integrated hardware and
software. Provides
temperature controlled
spray, ultrasonic cleaning,
and flushing with user-
selected chemistries.
Includes pumps, filter,
chamber/tank, basket, flush
tubes, printer connection. | Similar |
| Instrument
preparation | Reusable EndoWrist X/Xi,
S/Si, and Single-Site
instruments and staplers are
handled at point of use in the
OR per the manufacturer's
IFU (da Vinci Instrument
Reprocessing Manual). When
received in the SPD within one
hour they are flushed with
water and installed in the
appropriate RAS Rack
according to the detailed
instructions provided in its
Operator Manual. | Thoroughly clean the outside
of the entire instrument or
accessory using running
water with a clean, soft,
nylon bristled brush. Repeat
scrubbing as needed. See
Reprocessing Instructions
PN 550875. Thoroughly
rinse. Place in SonicPro
instrument basket. Attach
the slip luer end of flush
tubes to main flush port of
each instrument and to
quick-connect fittings in
tank. | Different
instrument prep
required, as
reflected in
intended use
statements. |
| Critical
Parameters
for
Cleaning | Minimum critical cycle
parameters are provided by
default in the RAS Cycle:
Dosing of validated
concentrated chemistries at
specified volume of 0.74
oz. (22 mL)Series of washing stages:
2-minute Prewash, not | The critical process
parameters are:
Instrument Cycle (5mm or 8
mm): 30 - 45 °C (86 - 113°F)User-selected pH neutral
cleaning agent @ 0.5
oz/gal - 3.0 oz/gal | Each system
has established
critical
parameters to
achieve
validated
outcomes. The
cycles differ. |
| Feature | Proposed Device K190081
RAS Racks and Cycles in
AMSCO® 7052HP/7053HP
Single-Chamber
Washer/Disinfectors | Predicate Device
da Vinci SonicPro
Cleaning System
(K073112) | Comparison |
| | heated
Wash phase 1 - initial 6-
minute stage @122°F
with Prolystica Ultra
Concentrate HP
Enzymatic Cleaner
followed by 6-minute
stage @150°F with
Prolystica Ultra
Concentrate HP Detergent
2-minute rinse, not heated
Wash phases 3 and 4,
each - initial 6-minute
stage @122°F with
Prolystica Ultra
Concentrate HP
Enzymatic Cleaner
followed by 6-minute
stage @150°F with
Prolystica Ultra
Concentrate HP Detergent
1-minute rinse, not heated
• Pump provides continuous
circulation through lumens
and spray arms at pressure
above 45 psi | • 135 W/gal ultrasonic
power density
• 30 psi minimum flushing
pressure
Accessory Cycle:
• 25 - 45 °C (77 - 113°F)
• User-selected pH neutral
cleaning agent @ 0.5
oz/gal - 3.0 oz/gal
• 135 W/gal ultrasonic
power density
• 30 psi minimum flushing
pressure | |
| Critical
Parameters
for
Thermal
Disinfection | Minimum critical cycle
parameters are provided by
default in the RAS Cycle:
• Temperature 194°F (90°C)
• Time 1 minute
• $A_0$ = 600 | No disinfection cycle | Capabilities
differ |
| Drying | • Temperature (high =
setpoint 220°F)
• Default time 20 minutes
(adjustable from 2 to 30
minutes) | No drying capability | Capabilities
differ |
| Record
keeping | Provides printout or download
capability from USB port or
using optional printer | Connection to separate
thermal printer | Capabilities
differ |
| Water
Quality |