(860 days)
Not Found
No
The description mentions a "computer controlled" system and "built-in sensors," but there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on disinfection efficacy and safety, not on algorithmic performance related to AI/ML.
No.
This device is designed to disinfect medical instruments (endoscopes), not for direct patient therapy or treatment of diseases.
No
This device is an automated system designed to wash and disinfect flexible endoscopes, not to diagnose medical conditions in patients.
No
The device is described as an "automated, computer controlled, electro-mechanical system" with physical components like processing chambers, sensors, and a water filtration system. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to wash and high-level disinfect flexible endoscopes used in the gastrointestinal and/or pulmonary tracts. This is a reprocessing function for medical devices, not a diagnostic test performed on biological samples.
- Device Description: The description details an automated system for cleaning and disinfecting endoscopes using detergents and disinfectants. It focuses on the physical process of reprocessing the endoscopes.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples, detecting diseases, or providing any diagnostic information about a patient.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device's purpose is to prepare medical instruments for reuse, which is a different category of medical device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FEB
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™.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal and/or pulmonary tracts
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)
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: Simulated use testing
Description: High-level disinfection validation of representative worst case endoscopes under worst case simulated use conditions
Acceptance Criteria: >=6 Log reduction of M.terrae at all inoculated sites
Pass / Fail: Pass
Performance Testing: In-use testing
Description: High-level disinfection validation of representative worst case endoscopes and valves under in-use conditions
Acceptance Criteria: =6 Log reduction of M.terrae
Pass / Fail: Pass
Performance Testing: Toxicological evaluation of residues and rinsing validation
Description: The safety of residual chemicals remaining on endoscopes after high level disinfection was evaluated. The testing was conducted in accordance with ISO 10993-5:2009
Acceptance Criteria: Reactivity grade of 2 or less
Pass / Fail: Pass
Performance Testing: Channel volume flushing
Description: Flushing validation testing of representative worst case endoscopes under worst case simulated use conditions
Acceptance Criteria: Satisfy endoscope manufacturer's manual flushing requirements
Pass / Fail: Pass
Performance Testing: Water filtration system validation
Description: Validation testing under worst case simulated use conditions
Acceptance Criteria: =99% efficient at removing particles >=250µm
Pass / Fail: Pass
Electrical safety testing was conducted. The system complies with the UL 60601-1:2003 standard for safety.
EMC testing was conducted. The system complies with the IEC 60601-1-2:2001 + A1:2004 standard for EMC.
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K173590
Device Name System 83 Plus™ Washer/Disinfector
Indications for Use (Describe)
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.
| 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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3
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
-
- 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
- 510(k) Submitter Custom Ultrasonics, Inc. 144 Railroad Drive lvyland, PA 18974 Phone: (215) 364-1477 Fax: (215) 364-7674
Date Prepared: March 20, 2020
-
- Device
Trade Name: Common Name: Classification Name: Requlatorv Class: Product Code: FEB
- Device
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
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™.
5. Indications for Use
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.
4
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 simultaneous | ||
| reprocessing of up to two flexible submersible | |||
| endoscopes that are used in the gastrointestinal | |||
| and/or pulmonary tracts. Flexible scopes that are | |||
| precleaned and then exposed to the washing / | |||
| disinfection cycle of the System 83 Plus™ may be | |||
| high-level disinfected when the disinfection cycle | |||
| corresponds to the labeled contact conditions for the | |||
| germicide as in the predicated. |
Note: The System 83 Plus™ device includes two
models.
The System 83 Plus™ 2 is a device with one
processing chamber that can process 1 to 2
flexible endoscopes at a time.
The System 83 Plus™ 9 is two 'System 83
Plus™ 2' units put together. It has two
processing chambers which can process 1 to 2
flexible endoscopes in each independently
operated processing chamber. | 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 pre-cleaned and manually cleaned,
and then exposed to the washing/disinfection cycle of the
System 83 Plus™, 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. | The underlined expression is modified;
however, the substantive content
remains the same. |
| Disinfectant | Various glutaraldehyde, OPA, and hydrogen
peroxide solutions | Ortho-Phthalaldehyde Solution high-level disinfectants
(OPA) with a nominal active ingredient composition of
0.55%, having a Minimum Recommended Concentration
(MRC) of 0.3% | Currently, the System 83 Plus is only
validated with Ortho-Phthalaldehyde
(OPA) Solution high-level disinfectants |
| Detergent | Tergal 800® detergent | Tergal 800® detergent | None |
| High Level
Disinfect Method | Exterior surfaces immersion in disinfectant solution
and channel interior flushing of disinfectant solution | Same as the predicate device | None |
| Ultrasonics
Detection | Audibly determine if ultrasonics are working by
listening for a distinct buzzing sound | Ultrasonic Abort - A feature in software version 1.0.15 that
indicates if the ultrasonics are not functioning during
reprocessing - The operator is alerted and the system
process is aborted. | Software Validation testing and risk
analysis was conducted to validate the
modification. As a result, this
modification does not affect the safety
and 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 of
representative worst case endoscopes
under worst case simulated use conditions | ≥6 Log reduction of M.terrae at
all inoculated sites | Pass |
| In-use testing | High-level disinfection validation of
representative worst case endoscopes and
valves under in-use conditions |