(28 days)
Not Found
No
The device description and performance studies focus on the physical components, sterilization, and functional performance of a disposable tubing system connector, with no mention of AI or ML.
No
The device is a disposable tubing system and port connector used to provide sterile water for irrigation during endoscopic procedures; it does not directly treat or diagnose a disease or condition.
No
The device is a disposable tubing system and connector intended to provide a sterile water source for irrigation during endoscopic procedures. It facilitates the procedure but does not diagnose any conditions in the patient.
No
The device description clearly outlines physical components made of materials like plastics and silicone, and the performance studies focus on sterilization, connections, leak, and flow testing, all indicative of a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 for a procedural purpose, not for analyzing a sample taken from the body to diagnose a condition.
- Device Description: The device is a tubing system and connector designed to deliver fluid to an endoscope. It does not perform any analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on biological specimens.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
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
OCX
Device Description
In general; the ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector will be manufactured with materials or agents that can be used in the medical device industry such as plastics, silicone, solvent, etc. The device adjoins an irrigation line of an of an ERBEFLO Tubing/Cap Set designated for a Pentax Scope to a Pentax Gastrointestinal Video Endoscope with a forward water jet channel for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated ERBEFLO Tubing/Cap Set for Pentax Scopes, back flow (check) valve, and housing (a scope specific connector for a Pentax Scope). The Port Connector is provided sterile, is single patient use, and is 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)
The following evaluations and tests 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 proposed Port Connector.
2X Sterilization Functional Testing
Visual inspection, connections testing, as well as leak and flow testing demonstrated that the proposed device upon 2X sterilization met established performance specifications.
Sterilization Evaluation
The evaluation was performed using current recognized standards and demonstrates product sterility as well as the Connector meets ethylene oxide residual requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains 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.
June 27, 2019
ERBE USA, Inc. John Tartal Director of Quality and Regulatory Affairs 2225 Northwest Parkway Marietta, GA 30067
K191438 Re:
Trade/Device Name: ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCX Dated: May 29, 2019 Received: May 30, 2019
Dear John Tartal:
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.
1
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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,
for
Shanil P. 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) K191438
Device Name
ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
May 2019
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: | May 29, 2019 |
| Common Name: | Endoscopic Irrigation Tubing System Accessory/Scope Port Connector |
| Trade/Proprietary Name: | ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector |
| Classification Name: | Endoscopes and accessories (21 CFR Part 876.1500) |
| Regulatory Class: | II |
| Product Code: | OCX |
| Legally Marketed
Predicate Device: | ERBEFLO® 2 Endo QuickConnect Scope Port Connectors, 510(k) Number
K143186 |
Device Description:
In general; the ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector will be manufactured with materials or agents that can be used in the medical device industry such as plastics, silicone, solvent, etc. The device adjoins an irrigation line of an of an ERBEFLO Tubing/Cap Set designated for a Pentax Scope to a Pentax Gastrointestinal Video Endoscope with a forward water jet channel for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated ERBEFLO Tubing/Cap Set for Pentax Scopes, back flow (check) valve, and housing (a scope specific connector for a Pentax Scope). The Port Connector is provided sterile, is single patient use, and is disposable.
Intended Use:
The ERBEFLO 2 Disposable Tubing System is intended to provide sterile water from a water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.
Note: The ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector is an accessory/single use connector for the ERBEFLO® 2 Disposable Tubing System.
4
Similarities and Differences of the Proposed Device to the Current Device (Predicate Comparison/Substantial Equivalence):
Similarities
The proposed ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector is dimensionally the same from an exterior point of view as the current Connector with the same backflow valve, packaged the same, sterilized the same via Ethylene Oxide, single use (i.e., use for a patient), and is disposable like the predicate device.
Differences
The proposed ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector is different than the predicate in that its Port Connector housing is manufactured with a different plastic resin. Additionally since the last submission, there were some minor internal changes in which the core depth was increased along with a slight increase to the ring seal. Evaluations and testing as described below demonstrated the safety and efficacy of the Port Connector.
Evaluations and Testing:
The following evaluations and tests demonstrate safety and efficacy.
Bioloqical 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 Port Connector.
2X Sterilization Functional Testing
Visual inspection, connections testing, as well as leak and flow testing demonstrated that the proposed device upon 2X sterilization met established performance specifications.
Sterilization Evaluation
The evaluation was performed using current recognized standards and demonstrates product sterility as well as the Connector meets ethylene oxide residual requirements.
Applied Standards (or as applicable adoption of previous work regarding a standard) 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:
The proposed device has the same intended use (i.e., single patient use), principles of operation, and technological characteristics as the predicate device. As compared to the proposed Connector is constructed with the same type of materials as well as has the same performance characteristics. In conclusion, the ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector is safe and efficacious.