System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are precleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plu s™, may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact conditions of the high level disinfectant.

Note: The System 83 Plus™ device includes two models.

· The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time .

· The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible endoscopes at a time in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.

Device Description

The System 83 Plus™ is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes (per bay) utilizing a detergent and FDA cleared high-level disinfectant validated by CUI. The System 83 Plus™ device family includes two models. The System 83 Plus™ 2; a model with one processing chamber, which can process one to two flexible endoscopes at a time. The System 83 Plus™ 9: a model with two processing chambers which can asynchronously reprocess up to 2 endoscopes per bay (total of up to 4 endoscopes).

The System 83 Plus™ utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high level disinfected endoscope. The System 83 Plus™ is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer.

Built-in sensors detect fluid levels, fluid temperature, fluid flow, and the operating states of the components within System 83 Plus™.

AI/ML Overview

The provided text is a compilation of FDA documents related to the 510(k) premarket notification for the "System 83 Plus Washer/Disinfector." It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing performed to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Testing	Acceptance Criteria	Reported Device Performance
Simulated use testing (High-level disinfection)	≥6 Log reduction of M.terrae at all inoculated sites	Pass
In-use testing (High-level disinfection)	<1 CFU at all processed test sites	Pass
Alcohol and detergent line disinfection	≥6 Log reduction of M.terrae	Pass
Toxicological evaluation of residues and rinsing validation	Reactivity grade of 2 or less	Pass
Channel volume flushing	Satisfy endoscope manufacturer's manual flushing requirements	Pass
Water filtration system validation	<10 CFU per 100 mL	Pass
In-line Disc filter validation	≥99% efficient at removing particles ≥250µm	Pass
Electrical safety testing	UL 60601-1:2003 standard for safety	Complies
Electromagnetic compatibility testing (EMC)	IEC 60601-1-2:2001 + A1:2004 standard for EMC	Complies
Software verification and validation testing	Not explicitly numeric, but implies meeting FDA guidance for software in medical devices	Conducted and documentation provided as recommended by FDA guidance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific numerical sample sizes (e.g., number of endoscopes, number of runs) for each performance test. It uses terms like "representative worst case endoscopes" and "worst case simulated use conditions" for several tests.

Sample Size: Not explicitly stated as a number for individual tests.
Data Provenance: The document implies the tests were conducted by or on behalf of Custom Ultrasonics, Inc. (the submitter) as part of their 510(k) submission. There is no information about the country of origin of the data collectors or whether the studies were retrospective or prospective, though 510(k) testing is typically prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

The document does not provide any information about:

The number of experts used.
The qualifications of those experts.
How ground truth was established for the performance tests.

For this type of device (washer/disinfector), "ground truth" for disinfection performance would typically be established through microbiological assays (e.g., plating, colony counting) to determine bacterial reduction, rather than expert human interpretation in the sense of a medical image analysis.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given the nature of the testing (microbiological, chemical, engineering performance), adjudication by multiple human experts is unlikely to be relevant in the same way it would be for, say, a diagnostic AI device analyzing medical images. The acceptance criteria are objective and measurable (e.g., log reduction, CFU count).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human readers in interpreting medical images or data. The System 83 Plus Washer/Disinfector is an automated reprocessing device, not a diagnostic AI system involving human interpretation of complex medical cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The performance testing described ("Simulated use testing," "In-use testing," etc.) represents a "standalone" or "device-only" performance evaluation. The device itself performs the high-level disinfection process without human intervention during the active cycle. The tests evaluate the device's ability to meet the specified disinfection and other performance criteria independently.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on objective, quantitative measurements related to disinfection efficacy and device performance. Specifically:

Microbiological assays: For disinfection testing (simulated use, in-use, alcohol/detergent line), the ground truth is established by measuring the reduction of microbial load (e.g., M. terrae counts, CFU counts).
Chemical analysis: For toxicological evaluation of residues, ground truth is based on reactivity grades consistent with ISO standards.
Physical measurements/compliance: For channel volume flushing, water filtration, and disc filter efficiency, ground truth is based on meeting specified flow rates, filtration efficiency percentages, or industry standards.
Engineering standards compliance: For electrical safety and EMC, ground truth is compliance with recognized industry standards (UL 60601-1, IEC 60601-1-2).

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the System 83 Plus Washer/Disinfector is an electro-mechanical device with software logic, not an AI/machine learning device that requires a "training set" in the conventional sense (i.e., for learning from data to make predictions). The software verification and validation refer to traditional software development and testing, not AI model training.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI model, this question is not applicable. The device's "ground truth" is based on established engineering principles, microbiological science, and regulatory standards for medical device performance and safety.

Summary

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March 30, 2020

Custom Ultrasonics, Inc. Mario Infanti Quality Assurance Manager 144 Railroad Drive Ivyland, Pennsylvania 18974

Re: K173590

Trade/Device Name: System 83 Plus Washer/Disinfector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: December 17, 2019 Received: December 6, 2017

Dear Mario Infanti:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 medical devices and radiation-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,

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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Indications for Use

510(k) Number (if known) K173590

Device Name System 83 Plus™ Washer/Disinfector

Indications for Use (Describe)

Note: The System 83 Plus™ device includes two models.

· The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time .

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image features the logo of "Custom Ultrasonics Inc.". On the left side of the image is a blue circular logo with a "U" shape inside. To the right of the logo is the company name, "Custom Ultrasonics Inc.", written in blue.

Image /page/3/Picture/1 description: The image is a square divided into four smaller squares, each containing a different icon. The top left square has a blue background with a white icon representing waves. The top right square has a light blue background with a white icon that looks like sound waves emanating from a central point. The bottom left square has a green background with a white icon representing wind or air currents. The bottom right square has a blue background with a white icon that resembles a chemical structure or a molecule.

510(k) Summary K173590

1. 510(k) Submitter Custom Ultrasonics, Inc. 144 Railroad Drive lvyland, PA 18974 Phone: (215) 364-1477 Fax: (215) 364-7674
  Contact Person: Mario Infanti Quality Assurance Manager Phone: (215) 364-1477 Ext: 242 Email: mario.infanti@customultrasonics.com

Date Prepared: March 20, 2020

1. Device
  Trade Name: Common Name: Classification Name: Requlatorv Class: Product Code: FEB

System 83 Plus™ Washer/Disinfector Automated Endoscope Reprocessor Endoscope and accessories (21 CFR § 876.1500)

3. Predicate Device

Custom Ultrasonics, Inc., System 83 Plus™ Endoscope Washer/Disinfector, K122172

4. Device Description

Built-in sensors detect fluid levels, fluid temperature, fluid flow, and the operating states of the components within System 83 Plus™.

5. Indications for Use

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Image /page/4/Picture/0 description: The image shows a blue logo. The logo consists of a large, incomplete circle with a thick line forming the majority of its circumference. A smaller, rectangular shape is positioned to the right of the circle, partially overlapping it at the top. The overall design is simple and modern, using a single color to create a clean and recognizable symbol.

Image /page/4/Picture/2 description: The image is a square divided into four smaller squares, each containing a different icon. The top left square, colored in shades of blue, features a symbol representing water or waves. The top right square, in light blue, displays a symbol that could represent sound waves or communication signals. The bottom left square, colored in shades of green, contains a symbol that resembles wind or airflow. The bottom right square, in blue, features a symbol that looks like a power button or an on/off switch.

Flexible endoscopes that are pre-cleaned and manually cleaned, and then exposed to the washing/disinfection cvcle of the System 83 Plus™ , may be high level disinfection cycle corresponds to the System 83 Plus™ validated contact conditions of the high level disinfectant.

Note: The System 83 Plus™ device includes two models.

The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible . endoscopes at a time.
The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible . endoscopes at a time in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.

6. Summary of Technological Characteristics Compared to the Predicate Device

The System 83 Plus™ has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device, except for the following primary difference is the System 83 Plus device has been validated for use with ortho-Phthalaldehyde Solution high-level disinfectant (OPA) with a nominal active ingredient composition of 0.55%, having a Minimum Recommended Concentration (MRC) of 0.3%, minimum contact condition of 12 minutes at 20°C, and a re-use period not to exceed 14 days.

See Table 1: Technical Characteristics

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Image /page/5/Picture/0 description: The image shows a blue logo. The logo is a stylized letter 'C' with a smaller, rectangular shape attached to its lower right side. The color of the logo is a consistent shade of blue.

Image /page/5/Picture/2 description: The image is a square divided into four smaller squares. The top left square contains a blue background with white wavy lines, representing water. The top right square has a light blue background with white sound wave symbols. The bottom left square has a green background with white curved lines, representing wind. The bottom right square has a white background with a blue symbol that resembles a lowercase 'q' with a line extending from the bottom right.

Table 1: Technical Characteristics

Features	Predicate Device: K122172	Subject Device: K173590	Comments on Difference
Intended Use	The System 83 Plus is designed for the simultaneousreprocessing of up to two flexible submersibleendoscopes that are used in the gastrointestinaland/or pulmonary tracts. Flexible scopes that areprecleaned and then exposed to the washing /disinfection cycle of the System 83 Plus™ may behigh-level disinfected when the disinfection cyclecorresponds to the labeled contact conditions for thegermicide as in the predicated.Note: The System 83 Plus™ device includes twomodels.The System 83 Plus™ 2 is a device with oneprocessing chamber that can process 1 to 2flexible endoscopes at a time.The System 83 Plus™ 9 is two 'System 83Plus™ 2' units put together. It has twoprocessing chambers which can process 1 to 2flexible endoscopes in each independentlyoperated processing chamber.	System 83 Plus™ Washer/Disinfector is designed for thesimultaneous high level disinfection of up to two flexiblesubmersible endoscopes that are used in thegastrointestinal and/or pulmonary tracts. Flexibleendoscopes that are pre-cleaned and manually cleaned,and then exposed to the washing/disinfection cycle of theSystem 83 Plus™, may be high level disinfected when thedisinfection cycle corresponds to the System 83 Plus™validated contact conditions of the high level disinfectant.Note: The System 83 Plus™ device includes two models.The System 83 Plus™ 2 has one processing chamberthat can process 1 to 2 flexible endoscopes at a time.The System 83 Plus™ 9 has two processing chambersthat can process 1 to 2 flexible endoscopes at a time ineach independently operated processing chamber for atotal of up to 4 endoscopes simultaneously.	The underlined expression is modified;however, the substantive contentremains the same.
Disinfectant	Various glutaraldehyde, OPA, and hydrogenperoxide solutions	Ortho-Phthalaldehyde Solution high-level disinfectants(OPA) with a nominal active ingredient composition of0.55%, having a Minimum Recommended Concentration(MRC) of 0.3%	Currently, the System 83 Plus is onlyvalidated with Ortho-Phthalaldehyde(OPA) Solution high-level disinfectants
Detergent	Tergal 800® detergent	Tergal 800® detergent	None
High LevelDisinfect Method	Exterior surfaces immersion in disinfectant solutionand channel interior flushing of disinfectant solution	Same as the predicate device	None
UltrasonicsDetection	Audibly determine if ultrasonics are working bylistening for a distinct buzzing sound	Ultrasonic Abort - A feature in software version 1.0.15 thatindicates if the ultrasonics are not functioning duringreprocessing - The operator is alerted and the systemprocess is aborted.	Software Validation testing and riskanalysis was conducted to validate themodification. As a result, thismodification does not affect the safetyand effectiveness of the subject device.

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Image /page/6/Picture/0 description: The image shows a blue logo. The logo is a circle with a square cut out of the bottom right quadrant. The square is the same color as the circle, and it is slightly smaller than the radius of the circle.

Image /page/6/Picture/2 description: The image is a square divided into four smaller squares. The top left square contains a symbol representing water, with three horizontal wavy lines in blue. The top right square contains a symbol representing sound, with three sets of curved lines emanating from a central point in light blue. The bottom left square contains a symbol representing wind, with curved lines in green. The bottom right square contains a symbol that looks like a white letter 'Q' with a small square inside.

Summary of Non-Clinical Testing 7.

Performance testing was conducted to satisfy the requirement for the System 83 Plus™ Washer/Disinfector , as outlined in the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (August 1993). This testing is summarized in the following Table.

Performance Testing	Description	Acceptance Criteria	Pass /Fail
Simulated use testing	High-level disinfection validation ofrepresentative worst case endoscopesunder worst case simulated use conditions	≥6 Log reduction of M.terrae atall inoculated sites	Pass
In-use testing	High-level disinfection validation ofrepresentative worst case endoscopes andvalves under in-use conditions	<1 CFU at all processed testsites	Pass
Alcohol and detergent linedisinfection	Disinfection of the alcohol and detergentinjection lines	≥6 Log reduction of M.terrae	Pass
Toxicological evaluation ofresidues and rinsingvalidation	The safety of residual chemicals remainingon endoscopes after high level disinfectionwas evaluated. The testing was conductedin accordance with ISO 10993-5:2009	Reactivity grade of 2 or less	Pass
Channel volume flushing	Flushing validation testing of representativeworst case endoscopes under worst casesimulated use conditions	Satisfy endoscopemanufacturer's manual flushingrequirements	Pass
Water filtration systemvalidation	Validation testing under worst casesimulated use conditions	<10 CFU per 100 mL	Pass
In-line Disc filter validation	Validation testing under worst casesimulated use conditions	≥99% efficient at removingparticles ≥250µm	Pass

Electrical safety testing:

Electrical safety testing was conducted. The system complies with the UL 60601-1:2003 standard for safety.

Electromagnetic compatibility testing:

EMC testing was conducted. The system complies with the IEC 60601-1-2:2001 + A1:2004 standard for EMC.

Software verification and validation testing:

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

8. Conclusion

Based on the intended use, technological characteristics, and performance data, the System 83 Plus Washer/Disinfector is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K122172).

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.