K221177 · Erbe USA, Inc. · OCX · Aug 11, 2022 · Gastroenterology, Urology
Device Facts
Record ID
K221177
Device Name
Erbe's Tubing/Cap Sets
Applicant
Erbe USA, Inc.
Product Code
OCX · Gastroenterology, Urology
Decision Date
Aug 11, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The Erbe Tubing/Cap Sets provide sterile water and air from a single source to an endoscopic procedures.
Device Story
Erbe's Tubing/Cap Sets are sterile, disposable accessories for gastrointestinal video endoscopes (Pentax, Olympus, Fujifilm, Fujinon). The system consists of tubing segments and a cap that creates an airtight seal on a sterile water bottle. The device functions by using the endoscope to pressurize the water bottle, enabling air insufflation and water delivery for lens cleaning and irrigation. Certain variants (ERBEFLO CleverCap) interface with a peristaltic pump for irrigation. Components include backflow check valves and clamps to control flow. Used in clinical settings by medical professionals during endoscopic procedures. The device facilitates clear visualization and insufflation, aiding the physician in performing diagnostic or therapeutic endoscopy.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including biocompatibility evaluation, 2X sterilization functional testing (visual inspection, flow, backflow pressure, pressure decay, tensile strength, connection, and durability), and packaging integrity testing (dye penetration, burst, bubble leak, and seal strength).
Technological Characteristics
Materials: medical-grade plastics, brass, adhesives. Components: tubing segments, caps, backflow check valves, clamps, air/water connectors. Principle: pneumatic/fluidic conduit for air insufflation and water irrigation. Connectivity: mechanical interface to endoscope ports and peristaltic pumps. Sterilization: ethylene oxide. Standards: ISO 14971, ISO 10993-1, ISO 594-1/2, ISO 15223-1, ISO 11607-1/2, ISO 11135-1, ISO 10993-7.
Indications for Use
Indicated for use during endoscopic procedures to provide sterile water and air from a single source to an endoscope for patients undergoing gastrointestinal video endoscopy.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes (K103696)
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August 11, 2022
Erbe USA, Inc. Jeff Dill Senior Quality Engineer 2225 Northwest Parkway Marietta, GA 30067
Re: K221177
Trade/Device Name: Erbe's Tubing/Cap Sets Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: July 8, 2022 Received: July 11, 2022
# Dear Jeff Dill:
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 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,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K221177
Device Name Erbe's Tubing/Cap Sets
Indications for Use (Describe)
The Erbe Tubing/Cap/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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#### April 2022
| | 510(k) SUMMARY |
|--|----------------|
| | |
| Submitted By: | Erbe USA, Inc.<br>2225 Northwest Parkway<br>Marietta, GA 30067<br>Tel: 770-955-4400<br>Fax: 770-955-2577 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jeff Dill<br>Senior Quality Engineer |
| Date Prepared: | April 21, 2022 |
| Common Name: | Endoscopic Tubing/Cap Sets |
| Trade/Proprietary Names: | Erbe's Tubing/Cap Sets (i.e., ERBEFLO CleverCap® Hybrid Tubing/Cap Sets<br>and ERBEFLO AeroRinse® Air and Water Tubing/Cap Sets) |
| Classification Name: | Endoscopes and Accessories (21 CFR Part 876.1500) |
| Regulatory Class: | II |
| Product Code: | OCX |
| Legally Marketed<br>Predicate Devices: | ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and<br>180 Series Scopes, 510(k) Number K103696 and Erbe's CO2 Tubing/Cap<br>Sets. 510(k) Number K162152 |
#### Device Description:
Erbe's Tubing/Cap Sets are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The ERBEFLO CleverCap® devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air for insufflation; whereas, the ERBEFLO AeroRinse® devices provide a conduit for water for endoscopic lens cleaning as well as air for insufflation. There are four (4) and three (3) variants of Erbe's Tubing/Cap Sets for each group respectively (i.e., ERBEFLO CleverCap® and ERBEFLO AeroRinse®). All of the Sets respectively interface with a specified brand of scope (i.e., Pentax®, Olympus®, Fujifilm®, and Fujinon® Gastrointestinal Video Endoscopes). The Sets consist of tubing segment(s) and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, an irrigation tubing line (segment) of a Set (as applicable- only for the ERBEFLO CleverCap® Sets) interfaces with a designated peristaltic pump and via an ERBEFLO connector accessory attaches to the specified endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified endoscope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube in which the endoscope is used to pressurize the water bottle for functionality (air and water to the endoscope)]. Also, for the Pentax Set there is an additional air inlet tube that directs air from the endoscope's processor. For each Set, the irrigation tubing segment (as applicable) as well as the air/water tubing segment has a back flow check valve. The irrigation (as applicable) and air/water segments of the Sets have a clamp to close off
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the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's Tubing/Cap Sets are provided sterile and are disposable.
#### Intended Use:
The Erbe Tubing/Cap Sets provide sterile water and air from a single source to an endoscopic procedures.
## Similarities and Differences of the Proposed Device to the Current Device (Predicate Comparison/Substantial Equivalence):
## Similarities
Erbe's Tubing/Cap Sets in this 510(k) are essentially the same (i.e., materials, construction, dimensionally, etc.) as the Sets in the previously cleared 510(k)s. The intended use is the same as the primary predicate (ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes). The additional Sets in the submission are essentially the same as the second predicate (Erbe's CO2 Tubing/Cap Sets) but without the CO2 tubing line (segment)/feature. The Sets have the same intended use, sterilization, use conditions, disposability, etc.
## Differences
There are primarily two (2) differences as follows:
- 1. The main difference involves the addition of a more automated packaging system for pouching and labeling the Sets (i.e., currently packaging Sets in a pouch and proposed packaging Sets in a soft pouch tray). Package integrity with the new system was verified as described below.
- 2. Minor change of creating a Hybrid Tubing/Cap Set for the new Fujifilm Scopes (700 Series Endoscope). The air/water scope connector is slightly different than the Set for the Fujinon Scope so that it fits (attaches/detaches) to the new Scope Series. Inspection/Testing demonstrated that the Set met specifications as described below.
## Evaluations and Testing:
The following evaluations and tests were performed to demonstrate safety and efficacy.
## Biological Evaluation
The evaluation was performed per the current recognized standard and demonstrated that there were no biocompatibility issues with the materials used for the Sets.
## 2X Sterilization Functional Testing
Visual inspection, flow testing, back flow pressure testing, pressure decay testing, tensile strength testing, connection testing, and durability testing (including ensuring no leaks and connectability upon stressing Sets) confirmed that the Devices upon 2X sterilization met established performance specifications.
## Packaging Inspection/Testing
Current pouching of the products maintained their integrity [Note: Inspection/Testing of the pouch (sterile barrier) was included in many of the previous ERBEFLO cleared 510(k)s including the predicate submissions. Visual packaging inspection as well as dye penetration, burst, and seal strength testing were used to evaluate, qualify the various size pouches]. For the new automated packaging system; inspection (visual for package integrity and barcode readability), dye penetration, bubble leak testing, burst testing, seal strength tensile testing) were performed on soft pouch trays upon 2X sterilization (as well as after handling/transit simulation), and upon aging. Inspection/Testing demonstrated the suitability of the new pouch trays for the Sets.
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#### Sterilization Evaluation
The evaluation was performed using the current recognized standard to demonstrate product sterility as well as that the products met ethylene oxide residual requirements.
#### Applied Standards
ISO 14971, AAMI / ANSI / ISO 10993-1, ISO 594-1, ISO 594-2, AAMI / ANSI / ISO 15223-1, AAMI / ANSI / ISO 11607-1, AAMI / ANSI / ISO 11607-2, AAMI / ANSI / ISO 11135(-1), AAMI / ANSI / ISO 10993-7
#### Conclusion:
Erbe's Tubing/Cap Sets intended use is the same as the ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes. The proposed Sets have the same principles of operation and technological characteristics as the predicate devices. The duration of use for the proposed and predicate Sets is the same. As compared to the predicates, the proposed Sets are constructed with the same type of materials and as applicable have the same performance characteristics. Additionally, the packaging (pouches or soft pouch trays) of the products have been found to maintain their sterile barrier. In conclusion, Erbe's Tubing/Cap Sets are safe and efficacious.
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Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
