(43 days)
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.
The Endo QuickConnect Scope Port Connectors will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, solvent, etc. The devices respectively adjoin an irrigation line of an ERBEFLO tubing/cap set to a designated gastrointestinal video endoscope. This line is a conduit for water to irrigate in endoscopic procedures. Each Port Connector has a standard female luer lock connection that attaches to an ERBEFLO tubing/cap set, backflow valve, and a scope specific connector (for an Olympus® or Pentax® Scope). The Port Connectors are provided sterile and are disposable.
The provided text describes the regulatory clearance of a medical device, the ERBEFLO® 2 Endo QuickConnect Scope Port Connectors, and outlines the testing conducted to demonstrate its safety and efficacy. However, it does not contain the level of detail requested for acceptance criteria and a structured study demonstrating performance against those criteria.
Specifically, it does not include:
- A table of acceptance criteria with specific performance metrics and reported values.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance, as these are typically relevant for AI/software devices. This device is a hardware accessory.
- Details on the training set or its ground truth establishment, again, not relevant for this type of hardware device.
Instead, the document focuses on comparative testing against a legally marketed predicate device (ERBEFLO® 2 Disposable Tubing System, K103235) to establish substantial equivalence for regulatory approval.
Here's a summary of the available information and an explanation of why many of your specific requests cannot be fully addressed from this document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes evaluations and testing without providing specific numeric acceptance criteria or detailed quantitative results in a table format. The reported performance is qualitative and comparative.
| Acceptance Criterion (Inferred from text) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility | "no biocompatibility issues with the materials used" |
| Flow Performance | "flow performance of the proposed products was comparable to the predicate devices" |
| Leakage | "no leaks" (during feasibility testing and proper connection) |
| Backflow Pressure Resistance | "withstood the same backflow pressure as the current Connectors" |
| Sterilization (2X) | "met established performance specifications" |
| Packaging Integrity | "adequacy and integrity of the packaging" |
| Sterility & Ethylene Oxide Residuals | "demonstrated product sterility as well as meeting acceptable ethylene oxide residual levels" |
| Proper Connection (for different endoscopes) | "no flow issues (including no leaks)" upon following proper connecting instructions for Olympus and Pentax scopes. |
| Safety and Efficacy | "did not adversely affect safety or effectiveness" (overall conclusion) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The "Performance Feasibility Testing" and "2X Sterilization Functional Testing" imply that a sample of the new connectors was tested, but the exact number isn't provided.
- Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective) for a hardware accessory. The testing was likely conducted in a controlled lab environment by the manufacturer (ERBE USA, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not relevant for the performance testing of a sterile scope port connector. The "ground truth" for this device's performance would be engineering specifications and established test protocols (e.g., measuring flow rate, pressure resistance, sterility).
4. Adjudication method for the test set:
- Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used for interpreting results from human observations or AI outputs in areas like radiology. The testing described here involves objective physical and biological measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this type of study was not done. MRMC studies are usually for evaluating diagnostic imaging software/AI's impact on human readers, which is not applicable to a physical medical device like a scope port connector.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a passive hardware accessory, not an algorithm or software. Its "performance" is inherent in its physical properties and function, not an algorithmic output.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on engineering specifications, material science standards (biocompatibility), and established test methodologies for fluid dynamics (flow, pressure, leaks), sterility, and packaging integrity. It's not based on expert consensus, pathology, or outcomes data in the usual clinical sense.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing are based on established engineering principles and prior device experience (predicate device).
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.
In conclusion: The provided document is a regulatory approval letter and 510(k) summary for a physical medical device. It successfully demonstrates "substantial equivalence" to a predicate device through various engineering and material tests. However, the nature of this device (a connector, not an AI, diagnostic, or therapeutic system) means that many of the detailed questions regarding acceptance criteria, ground truth, and study methodologies (especially those related to AI/software performance) are not directly applicable or documented in the format you've requested. The regulatory submission focused on proving that the new device is as safe and effective as the existing, legally marketed device through direct comparison of features and performance characteristics.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
ERBE USA, Inc. John Tartal Director of Quality and Regulatory Affairs 2225 Northwest Parkway Marietta, GA 30067
Re: K143186 Trade/Device Name: ERBEFLO® 2 Endo QuickConnect Scope Port Connectors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCX Dated: December 3, 2014 Received: December 5, 2014
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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
K143186 510(k) Number (if known):
Device Name: ERBEFLO® 2 Endo QuickConnect Scope Port Connectors
Indications For 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
| Submitted By: | ERBE USA, Inc.2225 Northwest ParkwayMarietta, GA 30067Tel: 770-955-4400Fax: 770-955-2577 |
|---|---|
| Contact Person: | John TartalDirector of Quality and Regulatory Affairs |
| Date Prepared: | October 31, 2014 |
| Trade/Proprietary Name: | ERBEFLO® 2 QuickConnect Scope Port Connectors |
| Common Name: | Endoscopic Irrigation Tubing System Accessory/ScopePort Connector |
| Classification Name and Code: | Endoscopes and Accessories (21 CFR Part 876.1500) |
| Product Code: | OCX |
| Legally MarketedPredicate Device: | ERBEFLO® 2 Disposable Tubing System, 510(k)Number K103235 |
Device Description:
The Endo QuickConnect Scope Port Connectors will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, solvent, etc. The devices respectively adjoin an irrigation line of an ERBEFLO tubing/cap set to a designated gastrointestinal video endoscope. This line is a conduit for water to irrigate in endoscopic procedures. Each Port Connector has a standard female luer lock connection that attaches to an ERBEFLO tubing/cap set, backflow valve, and a scope specific connector (for an Olympus® or Pentax® Scope). The Port Connectors are provided sterile and are 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 Endo QuickConnect Scope Port Connectors are additional accessories/single use connectors for the ERBEFLO® 2 Disposable Tubing System.
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Similarities and Differences of the Proposed Device to the Current Device (Predicate Comparison/Substantial Equivalence):
Similarities
The Endo QuickConnect Scope Port Connectors will be a part of the ERBEFLO 2 Disposable Tubing System (i.e., they have the same intended use). The proposed Connectors have the same female connection and backflow valve as the predicate Connectors. Also, the same solvent for bonding is used for the proposed and predicate devices. The proposed and the predicate will be packaged in the same pouch, box, and carton and labeled in the same manner. Finally, the proposed and predicate devices are sterilized via Ethylene Oxide and are disposable.
Differences
The Endo QuickConnect Scope Port Connectors as compared to our current standard Connector's (predicate devices) hub is a softer/more pliable plastic with no o-ring or metal. The material for the hub of the Endo QuickConnect Scope Port Connectors is the same material used for hubs of other ERBEFLO products and has shown to be biocompatible and very durable. The proposed Connectors are slightly lighter and wider but shorter as compared to the predicate Connectors. No issues were found with the slight profile difference with either Connector. Finally, the scope connection of the proposed and predicate devices is slightly different. The proposed Olympus QuickConnector attaches to the Olympus Scope by pushing onto the port of the Scope as compared to our current Connector being screwed on. For the Pentax QuickConnector it is also pushed on like the current Connector but requires the removal of the Scope's port gasket. To ensure proper connection, these attachment differences are clearly defined in the Notes On Use and associated QuickStart Guides. Upon following proper connecting instructions, there were no flow issues (including no leaks). None of these differences impacted the safety or efficacy of the Endo QuickConnect Scope Port Connectors.
Evaluations and Testing:
The following evaluations and tests were performed on the Endo QuickConnect Scope Port Connectors 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 proposed products.
Performance Feasibility Testing
The feasibility testing showed that the flow performance of the proposed products was comparable to the predicate devices with no leaks. Additionally, the Endo QuickConnect Scope Port Connectors withstood the same backflow pressure as the current Connectors.
2X Sterilization Functional Testing
The testing demonstrated that the proposed products upon 2X sterilization met established performance specifications.
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ERBE USA Incorporated Special 510(k) for ERBEFLO® 2 Endo QuickConnect Scope Port Connectors
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 and demonstrated product sterility as well as meeting acceptable ethylene oxide residual levels prior to distribution.
Conclusion:
The intended use is the same for the Endo QuickConnect Scope Port Connectors as the current Connectors. The proposed devices have the same principles of operation and technological characteristics as the predicate devices. As compared to the predicates, the proposed Connectors are constructed with the same type of materials as well as have the same performance characteristics. In conclusion, the ERBEFLO 2 Endo QuickConnect Scope Port Connectors did not adversely affect safety or effectiveness.
§ 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.