(86 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of a disposable tubing system for irrigation during endoscopic procedures. There is no mention of AI or ML in the intended use, device description, or performance evaluations.
No.
A therapeutic device is one that treats or alleviates a disease or condition. This device is a tubing system used to deliver sterile water for irrigation during endoscopic procedures, which is supportive rather than therapeutic.
No
The device is described as a "Disposable Tubing System" intended to deliver sterile water for irrigation during endoscopic procedures. Its function is to facilitate the procedure by providing a water source, not to diagnose a condition.
No
The device description explicitly states it is a "Disposable Tubing System" manufactured with physical materials like plastics and brass, and includes components such as tubing sets, connectors, and valves. This indicates a hardware-based medical device, not software-only.
Based on the provided information, the ERBEFLO® 2 Disposable Tubing System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide sterile water for irrigation during endoscopic procedures. This is a direct interaction with the patient's body (internal irrigation), not the examination of specimens in vitro (outside the body).
- Device Description: The description focuses on delivering fluid for irrigation, not on analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect markers, or provide any form of diagnostic information.
- Performance Studies: The performance studies focus on the physical and functional aspects of the tubing system (sterility, flow, pressure, durability, connections, usability), not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The ERBEFLO® 2 Disposable Tubing System does not fit this definition. It is a medical device used for a therapeutic/procedural purpose (irrigation).
N/A
Intended Use / Indications for Use
The ERBEFLO® 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The ERBEFLO® 2 Disposable Tubing System products are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The devices consist of tubing sets, port connectors, channel adapter, and back flow valve to deliver sterile water source through designated pumps and to/or through a scope channel of various endoscopes for irrigation in endoscopy procedures. Clinicians connect the associated products to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO® 2 Disposable Tubing System are provided sterile and are disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
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 ERBEFLO® 2 Disposable Tubing System.
2X Sterilization Functional Testing: Visual inspection, flow testing, back flow pressure testing, tensile strength testing, durability testing, and connections testing demonstrated that the devices upon 2X sterilization met established performance specifications.
ERBEFLO® 2 Endoscopy Port Connectors for Pentax® Scopes 2X Sterilization Functional Testing: Visual inspection and connections testing upon aging demonstrated that the devices upon 2X sterilization met established performance specifications.
Packaging Evaluation: The evaluation demonstrated the adequacy and integrity of the packaging for the products.
Sterilization Evaluation: The evaluation was performed using current recognized standards to demonstrate product sterility as well as that the products met ethylene oxide residual requirements.
Barrier Integrity and Simulated Use Testing: The testing showed that Erbe port connectors when used with an Erbe tubing set provides sufficient back flow protection and verified 24 hour multi-patient use.
Human Factors Engineering/Usability Engineering Testing: The evaluation testing demonstrated that Erbe's port connectors can be used as intended by following ERBEFLO® 2 Disposable Tubing System's Notes On Use.
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.
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Image /page/0/Picture/0 description: The image shows the logo for 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.
May 23, 2019
Erbe USA, Inc. John Tartal Director of Quality and Regulatory Affairs 2225 Northwest Parkway Marietta. GA 30067
Re: K190469
Trade/Device Name: ERBEFLO® 2 Disposable Tubing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: February 23, 2019 Received: February 26, 2019
Dear John Tartal:
We have reviewed vour 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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Shani Haugen, Ph.D. Acting 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
2
Indications for Use
510(k) Number (if known) K190469
Device Name ERBEFLO® 2 Disposable Tubing System
Indications for Use (Describe)
The ERBEFLO® 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential Use (CA STC 400 Solar Only) Please | On-Site Consumption (CA STC 400 |
|---|---|
| ------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------ |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Submitted By: | Erbe USA, Inc.
2225 Northwest Parkway
Marietta, GA 30067
Tel: 770-955-4400
Fax: 770-955-2577 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | John Tartal
Director of Quality and Regulatory Affairs |
| Date Prepared: | February 23, 2019 |
| Common Name: | Endoscopic Irrigation Tubing System |
| Trade/Proprietary Names: | ERBEFLO® 2 Disposable Tubing System |
| Classification Name: | Endoscopes and Accessories (21 CFR Part 876.1500) |
| Regulatory Class: | II |
| Product Code: | OCX |
| Legally Marketed
Predicate Device: | ERBEFLO® 2 Disposable Tubing System, 510(k) Number K103235 |
Device Description:
The ERBEFLO® 2 Disposable Tubing System products are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The devices consist of tubing sets, port connectors, channel adapter, and back flow valve to deliver sterile water source through designated pumps and to/or through a scope channel of various endoscopes for irrigation in endoscopy procedures. Clinicians connect the associated products to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO® 2 Disposable Tubing System are provided sterile and are disposable.
Intended Use:
The ERBEFLO® 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.
Similarities and Differences of the Proposed Device (Predicate Comparison/Substantial Equivalence):
Similarities
The ERBEFLO® 2 Disposable Tubing System products in this 510(k) are essentially the same (i.e., materials, construction, dimensionally, etc.) as the products in the previously cleared 510(k). The intended use, packaging, sterilization, use conditions, disposability, etc. are the same.
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February 2019
Differences
The ERBEFLO® 2 Disposable Tubing System Notes On Use's (i.e., the Labeling) Precautions and Warnings section is being updated to better inform users of potential hazards. Additionally, a back flow (check) valve is being added to the 24 hour use Endoscopy Port Connectors for Olympus® and Pentax® Scopes [Note: When Erbe scope accessories (i.e., connectors, channel adapter, and back flow valve) are used with Erbe tubing sets there will be two (2) back flow (check) valves. The redundant back flow protection features with Erbe products will provide an additional layer of protection to prevent back flow from occurring that could cause possible patient cross contamination and infection.]. These measures are being taken to warn against the use of Erbe products with other manufacturer's tubing products that are not specified in Erbe's Notes On Use (NOU), provide more clarity involving the importance of priming the scope channel and maintaining the water barrier in the scope channel, as well as mitigate risk if Connectors are used "off label" (i.e., use of non-Erbe tubing products not specified in Erbe's NOU). Fundamentally from a product design prospective, the single use Endoscopy Port Connector w/Valve for Olympus® Scopes submitted/cleared in the original 510(k) is also being packaged and labeled as the 24 hour use Endoscopy Port Connector for Olympus® Scopes and the single use Endoscopy Port Connector w/Valve for Pentax® Scopes submitted/cleared in the original 510(k) is also being packaged and labeled as the 24 hour use Endoscopy Port Connector for Pentax® Scopes (i.e., there is no product design change that hasn't already been reviewed/cleared. The changes are a designation/labeling change for both Connectors.).
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 ERBEFLO® 2 Disposable Tubing System.
2X Sterilization Functional Testing
Visual inspection, flow testing, back flow pressure testing, tensile strength testing, durability testing, and connections testing demonstrated that the devices upon 2X sterilization met established performance specifications.
ERBEFLO® 2 Endoscopy Port Connectors for Pentax® Scopes 2X Sterilization Functional Testing Visual inspection and connections testing upon aging demonstrated that the devices upon 2X sterilization met established performance specifications.
Packaqing Evaluation
The evaluation demonstrated the adequacy and integrity of the packaging for the products. Sterilization Evaluation
The evaluation was performed using current recognized standards to demonstrate product sterility as well as that the products met ethylene oxide residual requirements.
Barrier Integrity and Simulated Use Testing
The testing showed that Erbe port connectors when used with an Erbe tubing set provides sufficient back flow protection and verified 24 hour multi-patient use.
Human Factors Engineering/Usability Engineering Testing
The evaluation testing demonstrated that Erbe's port connectors can be used as intended by following ERBEFLO® 2 Disposable Tubing System's Notes On Use.
Applied Standards
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
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February 2019
Conclusion:
The ERBEFLO® 2 Disposable Tubing System is safe and efficacious.