ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
K132340 · Erbe USA, Inc. · FEQ · Dec 17, 2013 · Gastroenterology, Urology
Device Facts
Record ID
K132340
Device Name
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
Applicant
Erbe USA, Inc.
Product Code
FEQ · Gastroenterology, Urology
Decision Date
Dec 17, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
3rd-Party Reviewed
Indications for Use
The ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.
Device Story
Device consists of sterile, disposable Hybrid CO2 Tubing/Cap Sets and non-sterile, disposable CO2 Connector Tubes. Sets interface with specific endoscopes (Pentax, Olympus, Fujinon) and irrigation pumps. Cap attaches to sterile water bottle; irrigation tubing delivers water for lavage; air/water tubing delivers air/CO2 for insufflation and lens cleaning. CO2 Connector Tube includes hydrophobic air/gas filter to prevent fluid backflow into CO2 source. Used in clinical endoscopic settings by physicians. Provides conduit for irrigation and insufflation; enhances visualization and procedural utility. Benefits include sterile fluid delivery and controlled insufflation during endoscopy.
Clinical Evidence
Bench testing only. Evaluations included biocompatibility, flow rate performance, pressure testing, 24-hour durability, 2X sterilization functional testing, and packaging integrity. Results demonstrated performance comparable to or better than predicate devices.
Technological Characteristics
Medical grade materials including plastics, nickel-plated brass, nitrile rubber, acrylic, nylon, ink, solvent, and adhesive. Components include tubing segments, caps, luer connectors, and hydrophobic air/gas filters. Disposable, ethylene oxide sterilized. No software or electronic components.
Indications for Use
Indicated for providing sterile water and CO2 or air to an endoscope during endoscopic procedures.
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.
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K132340
page 1 of 4
ERBE USA. Inc. Traditional 510(k)/Third Party Review: ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube
DEC 17 2013
| 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: | John Tartal<br>QA/RA Director |
| Date Prepared: | May 22, 2013 |
| Common Name: | Endoscopic Irrigation and CO2 or Air Tubing/Cap Sets<br>and CO2 Connector Tube |
| Trade/Proprietary Name: | ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and<br>CO2 Connector Tube |
| Classification Name: | Endoscopes and Accessories (21 CFR Part 876.1500) |
| Product Code: | FEQ |
| Legally Marketed<br>Predicate Device: | Universal Irrigation Solution Hybrid™, 510(k) Number<br>K102855 and ERBEFLO CleverCap® Hybrid Tubina/Cap<br>Sets, 510(k) Number K103696 |
Device Description:
In general; the Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tubes will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, nickel plated brass, nitrile rubber, acrylic, nylon, ink. solvent, adhesive, etc. The devices provide as a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation.
There are three (3) types of ERBEFLO CleverCap Hybrid CO>Tubing/Cap Sets for which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olympus, and Fujinon) along with one (1) CO2 Connector Tube to attach to a CO2 source. The Sets consist of multiple tubing segments 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, irrigation tubing of a Set interfaces with a designated pump and via ERBEFLO 2 connector accessories to the specified endoscope for 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 scope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube within a
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#### ERBE USA. Inc. Traditional 510(k)/Third Party Review: ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube
tube in which the endoscope's processor or CO2 Source (if used) is used to pressurize the bottle for functionality (air and water to the endoscope). Also, for the Pentax Set there is an additional air inlet tube that directs air for endoscope functional use. Or if CO2 is used, pressurization (air and water function) occurs via a CO2 Source through a CO2 Connector Tube and a Pentax CO2 Adaptor (Pentax part #OF-G11).]. The third and final seqment for both the Olympus and Fujinon Sets is for connecting to the CO2 Connector Tube for CO2 insufflation. For each Set, both the irrigation as well as the air/water tubing segments have a backflow valve and a clamp to close the tubing while not in use. Additionally, each Set is designed for use with designated irrigation pumps and has an air/water connector(s) for its specified The Hybrid CO2Tubing/Cap Sets are provided sterile and are endoscope. disposable.
The CO₂ Connector Tube has a standard female luer connector for accessing a CO₂ Source. The other end of the Tube has a hydrophobic air/gas filter which filters particulates from the CO2 Source and keeps fluid from flowing into the CQ2 Source. The filtered end of the CO2 Connector Tube attaches to the CO2 segments of the Sets or in the case of the Pentax Set, the Pentax CO2 Adaptor that adjoins the Set to the Endoscope. The CO2 Connector Tube is provided non-sterile and is disposable.
## Intended Use:
The ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.
Similarities and Differences of the Proposed Device to the Current Device (Predicate Comparison/Substantial Equivalence):
## Similarities
The ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Sets have the same intended use as the Universal Irrigation Solution Hybrid™ Sets and a similar intended use to the ERBEFLO CleverCap Hybrid Tubing/Cap Sets. The proposed Sets have the same thread connections, cap, tubing seqments, and valve placements in comparison to one or both of the predicates. The tubing of the Hybrid CO2 Sets has the same or comparable durometer, Inner Diameters (I.D.s), Outer Diameters (O.D.s), and lengths as the predicate devices. The proposed and predicate devices both have the same locking clamp. Also, the Hybrid Tubing/Cap Sets have the same duration of use as the predicate devices (24 hour use). The proposed Sets and predicate devices use the same types of water bottles, pumps, endoscope connection accessories, endoscopes, and CO2 sources. Finally, the proposed and predicate devices are sterilized via Ethylene Oxide and disposable.
The ERBEFLO CleverCap CO2 Connector Tube compared to Universal Irrigation Solution Hybrid™ CO2 Source Tubing in that both are manufactured with similar materials, are provided non sterile, have the same luer fittings and a hydrophobic
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K132340 pg. 3 of 4
## ERBE USA. Inc. Traditional 510(k)/Third Party Review: ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube
air/gas filter, and are used in the same manner for the same duration. Differences
For the Sets, there is one difference not covered by either predicate. The ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set will have a luer actuated valve on the CO2 access tube as compared to the predicate device which has a backflow valve. Evaluations and testing as described below demonstrated the safety and efficacy of this Set.
The ERBEFLO CleverCap CO2 Connector Tube is different than the Universal Irrigation Solution Hybrid ™ CO2 Source Tubing in that it is one piece (i.e., it is not in seaments), it is shorter in length, and its filter is not as prominent (i.e., a smaller footbrint). None of these differences impacted the safety or efficacy of the ERBEFLO CleverCap CO2 Connector Tube.
#### Evaluations and Testing:
The following evaluations and tests were performed on the ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube to demonstrate the 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 proposed products.
Performance Feasibility Testing
The feasibility testing showed that the flow performance of the proposed products was as good or better than the predicate devices.
Flow Rate Testing
Flow rates for irrigation and lens cleaning were found to be comparable to or better than the predicate devices and/or commercially available products. Pressure Testing
The pressure testing demonstrated that the proposed devices would withstand maximum internal pressures that could be encountered during normal use.
Durability Testing
The products were tested and proved durable for 24 hour use.
2X Sterilization Functional Testing
The testing demonstrated that the proposed products upon 2X sterilization met established performance specifications.
Packaging Evaluation
The evaluation demonstrated the adequacy and integrity of the packaging for the proposed products.
Sterilization Evaluation
The evaluation was performed using current recognized standards to demonstrate product sterility.
Conclusion:
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## ERBE USA, Inc. Traditional 510(k)/Third Party Review: ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube
The ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube's intended use is the same, although written differently, as the Universal Irrigation Solution Hybrid™ predicate. Also, the proposed device's intended use is similar to the ERBEFLO CleverCap Hybrid Tubing/Cap Sets with exception of the CO2 access/use addition. The proposed Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube have the same principles of operation and technological characteristics as the predicate devices. The duration of use for the proposed and predicates is the same. As compared to the predicates, the proposed Sets are constructed with the same type of materials as well as have comparable performance characteristics. In conclusion, the ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube did not adversely affect safety or effectiveness.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2013
ERBE USA, Inc. % Mark Job Responsible Third Party Regulatory Technology Services, LLC 1394 25d Street NW Buffalo, MN 55313
K132340 Re:
Trade/Device Name: ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and Accessories Regulatory Class: Class II Product Code: FEQ Dated: November 27, 2013 Received: December 2, 2013
Dear Mark Job: .
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. 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 may of subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mark Job
, .. . . . . . . . .
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known): __K132340
Device Name: ERBE USA, Inc.'s ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube
Indications For Use:
The ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S 2013.12.17 16:18:08 -05'00'
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