(60 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device facilitates irrigation during endoscopic procedures but does not directly treat a disease or condition. It is an accessory to an endoscope.
No
The device is an accessory (connector) for an irrigation system used during endoscopic procedures. Its purpose is to facilitate irrigation, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is manufactured with physical materials like plastics and silicone, and describes physical components like a luer lock connection and a check valve. It also details physical testing like leak and flow testing.
Based on the provided information, the Olympus® Scope Port Connector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to connect an irrigation line to an endoscope for irrigation during endoscopic procedures. This is a mechanical function for delivering fluid, not for performing tests on samples taken from the body.
- Device Description: The description focuses on the physical components and how it connects to other devices. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
The device is a component used in a medical procedure (endoscopy) to facilitate irrigation, which is a therapeutic or procedural function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Olympus® Scope Port Connector is intended to attach the irrigation line of an ERBEFLO 2, ERBEFLO CleverCap® and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
In general; the ERBEFLO® Olympus® Scope Port Connector will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, adhesive, etc. The device adjoins an irrigation line of an of an ERBEFLO 2, ERBEFLO CleverCap®, and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Scope to an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated Olympus ERBEFLO Tubing/Cap Set, check (backflow) valve, and housing (a scope specific connector for an Olympus 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 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 proposed Port Connector.
2X Sterilization Functional Testing
Visual inspection, connections testing, leak and flow testing, as well as back flow pressure testing demonstrated that the proposed device upon 2X sterilization met established performance specifications.
Packaging Evaluation
The evaluation demonstrated the adequacy and integrity of the packaging for the proposed product.
Sterilization Evaluation
The evaluation was performed using current recognized standards to demonstrate product sterility as well as the Connector meeting ethylene oxide residual requirements.
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 contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 6, 2018
Erbe USA, Inc. John Tartal Director of Quality and Regulatory Affairs 2225 Northwest Parkway Marietta, GA 30067
Re: K182444
Trade/Device Name: ERBEFLO® Olympus® Scope Port Connector Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCX Dated: September 6, 2018 Received: September 7, 2018
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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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,
Daniel G. Walter Jr -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
2
Indications for Use
510(k) Number (if known) K182444
Device Name ERBEFLO® Olympus® Scope Port Connector
Indications for Use (Describe)
The Olympus® Scope Port Connector is intended to attach the irrigation line of an ERBEFLO 2, ERBEFLO CleverCap® and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
September 2018
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: | September 6, 2018 |
| Common Name: | Endoscopic Irrigation Tubing System Accessory/Scope Port Connector |
| Trade/Proprietary Names: | ERBEFLO® Olympus® 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 Disposable Tubing System, 510(k) Number K103235 |
Device Description:
In general; the ERBEFLO® Olympus® Scope Port Connector will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, adhesive, etc. The device adjoins an irrigation line of an of an ERBEFLO 2, ERBEFLO CleverCap®, and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Scope to an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated Olympus ERBEFLO Tubing/Cap Set, check (backflow) valve, and housing (a scope specific connector for an Olympus Scope). The Port Connector is provided sterile, is single patient use and is disposable.
Intended Use:
The Olympus® Scope Port Connector is intended to attach the irrigation line of an ERBEFLO® 2, ERBEFLO CleverCap®, and ERBEFLO CleverCap® CO2 Tubing/Cap Set designated for an Olympus Scope to an Olympus® Gastrointestinal Video Endoscope for irrigation in endoscopic procedures.
Note: The ERBEFLO® Olympus® Scope Port Connector (i.e., the proposed device) is being compared to the Endoscopy Port Connector w/Valve for Olympus® Scopes (Part Number 20325-215) [i.e., the specific substantially equivalent accessory/predicate device] in 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 Olympus® Scope Port Connector has the same female connection and backflow valve as the predicate Port Connector (i.e., Endoscopy Port Connector w/Valve for Olympus® Scopes). The proposed Port Connector attaches to a designated ERBEFLO Tubing/Cap and Scope the same way (i.e., it screws on) as the predicate device. The proposed and the predicate devices will be/are 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, single use (i.e., use for a patient), and are disposable.
Differences
The proposed Olympus® Scope Port Connector has a specific intended use as a standalone accessory compared to the predicate device being a part of a Tubing System (Note: The predicate Port Connector's intended use would be the same as the proposed device if it had its own Notes On Use.). The proposed Port Connector's housing (scope specific connector) is exclusively made with one of three types of plastics and is bonded with a medical grade UV adhesive as compared to the predicate Connector which has metal and an o-ring as well as is solvent bonded. As compared to the predicate Port Connector, the proposed device's profile is less (i.e., slightly smaller in length as in weight due to the housing, scope specific connector, having a smaller shape). Evaluations and testing as described below demonstrated the safety and efficacy of the Port Connector.
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 proposed Port Connector.
2X Sterilization Functional Testing
Visual inspection, connections testing, leak and flow testing, as well as back flow pressure testing demonstrated that the proposed device upon 2X sterilization met established performance specifications.
Packaging Evaluation
The evaluation demonstrated the adequacy and integrity of the packaging for the proposed product. Sterilization Evaluation
The evaluation was performed using current recognized standards to demonstrate product sterility as well as the Connector meeting ethylene oxide residual requirements.
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
Conclusion:
The intended use of the predicate Endoscopy Port Connector w/Valve for Olympus® Scopes would be the same as proposed Olympus® Scope Port Connector if the predicate had its own Notes On Use. The proposed device has the same 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 Olympus® Scope Port Connector is safe and efficacious.