Predicate Devices

Reference Devices

K/DEN number: K190081

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical cleaning and disinfection processes within a washer-disinfector, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No
The device is a rack used for cleaning, rinsing, and disinfecting surgical instruments, not for directly treating a patient's condition.

Diagnostic

No
The device is a rack used for cleaning and disinfecting surgical instruments, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (RAS Racks) and their interaction with a hardware washer/disinfector (AMSCO 7052HP or 7053HP). The submission is for a labeling update related to the use of these physical racks and cycles, not a standalone software product.

IVD (In Vitro Diagnostic)

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. This is a process for preparing instruments for subsequent sterilization, not for performing diagnostic tests on biological samples.
Device Description: The device is a rack used within a washer/disinfector. Its function is to hold and facilitate the cleaning and disinfection of instruments. It does not interact with biological samples for diagnostic purposes.
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 specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is clearly intended for the reprocessing of medical devices, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

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 7053HP 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

The purpose of this Special 510(k) is to update labeling based on a labeling revision being enacted by Intuitive Surgical to allow for automated cleaning and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers in the RAS Racks and RAS Cycles of the AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors. The RAS Racks and associated RAS Cycles were not altered in anyway.

Key Metrics

Not Found

Predicate Device(s)

K190081

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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April 3, 2020

STERIS Corporation Jennifer Nalepka Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K200577

Trade/Device Name: RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the 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: March 4, 2020 Received: March 5, 2020

Dear Jennifer Nalepka:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 (OS) 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 CAPT Elizabeth Claverie, M.S. Assistant Director 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 (if known)

K200577

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)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

| | 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:

Jennifer Nalepka Lead Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198 Email: jennifer_nalepka@steris.com

Submission Date: March 4, 2020

Premarket Notification Number: K200577

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

| 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

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector, K190081

3. 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 7053HP 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
RAS Racks and Cycles in
AMSCO® 7052HP/7053HP
Single-Chamber
Washer/Disinfectors
(K200577 ) | Predicate Device
RAS Racks and Cycles in
AMSCO® 7052HP/7053HP
Single-Chamber
Washer/Disinfectors
(K190081) | 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 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. | Identical |
| 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 level thermal
disinfection, and heated
drying, cannot be reduced
from the minimum default
parameters. | 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 level thermal
disinfection, and heated
drying, cannot be reduced
from the minimum default
parameters. | Identical |
| 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 | The Washer/Disinfector is a
stand-alone pass-through
design single-chamber unit | Identical |

Table 1. Technological Characteristics Comparison Table

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| | Proposed Device
RAS Racks and Cycles in
AMSCO® 7052HP/7053HP
Single-Chamber
Washer/Disinfectors
(K200577 ) | Predicate Device
RAS Racks and Cycles in
AMSCO® 7052HP/7053HP
Single-Chamber
Washer/Disinfectors
(K190081) | Comparison |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Feature | 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. | 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. | Identical |
| Instrument
preparation | Reusable EndoWrist® X/Xi,
S/Si, and Single-Site
instruments and staplers are
handled at point of use in the
OR, then transferred to the
Decontamination Area of the
sterile processing department
where they are prepared for
automated cleaning per the
manufacturer's IFU (da Vinci
Addendum for Automated
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. | Reusable EndoWrist® X/Xi,
S/Si, and Single-Site
instruments and staplers are
handled at point of use in the
OR, then transferred to the
Decontamination Area of the
sterile processing department
where they are prepared for
automated cleaning per the
manufacturer's IFU (da Vinci
Addendum for Automated
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. | |
| 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
heated
Wash phase 1 - initial 6-
minute stage @122°F
with Prolystica Ultra
Concentrate HP
Enzymatic Cleaner
followed by 6 minute | 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
heated
Wash phase 1 - initial 6-
minute stage @122°F
with Prolystica Ultra
Concentrate HP
Enzymatic Cleaner
followed by 6 minute | |
| Feature | Proposed Device
RAS Racks and Cycles in
AMSCO® 7052HP/7053HP
Single-Chamber
Washer/Disinfectors
(K200577) | Predicate Device
RAS Racks and Cycles in
AMSCO® 7052HP/7053HP
Single-Chamber
Washer/Disinfectors
(K190081) | Comparison |
| | 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 | 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 | |
| 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
• A₀ = 600 | Minimum critical cycle
parameters are provided by
default in the RAS Cycle:
• Temperature 194°F
(90°C)
• Time 1 minute
• A₀ = 600 | Identical |
| Drying | • Temperature (high =
setpoint 220°F)
• Default time 20 minutes
(adjustable from 2 to 30
minutes) | • Temperature (high =
setpoint 220°F)
• Default time 20 minutes
(adjustable from 2 to 30
minutes) | Identical |
| Record
keeping | Provides printout or
download capability from
USB port or using optional
printer | Provides printout or
download capability from
USB port or using optional
printer | Identical |
| Water
Quality |