(29 days)
Not Found
No
The device description focuses on the physical components and their function in delivering fluids and gases. There is no mention of any computational processing, algorithms, or learning capabilities.
No.
The device facilitates endoscopic procedures by providing irrigation and insufflation, but it does not directly treat a disease or condition.
No
The device description indicates that it provides water, air, or CO2 to an endoscope for irrigation, lens cleaning, and insufflation during endoscopic procedures, which are therapeutic and facilitative functions, not diagnostic.
No
The device description clearly details physical components such as tubing, caps, connectors, and filters, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide sterile water and CO2 or air to an endoscope for endoscopic procedures. This is a functional role in assisting with a medical procedure, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components and how they facilitate the delivery of fluids and gases to the endoscope. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
- Reagents or calibrators used for in vitro testing
The device is clearly designed to support the endoscopic procedure itself by providing necessary resources (water, air, CO2) to the endoscope. This falls under the category of a medical device used during a procedure, not an IVD used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
Erbe's CO2 Tubing/Cap Sets provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.
Product codes
FEQ
Device Description
In general; Erbe's CO2 Tubing/Cap Sets will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, nitrile rubber, acrylic, nylon, ink, solvent, adhesive, etc. The ERBEFLO CleverCap® CO2 devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation; whereas, the ERBEFLO AeroRinse® CO2 devices provide a conduit for water for endoscopic lens cleaning as well as air or CO2 for insufflation. There are three (3) types of Erbe's CO2 Tubing/Cap Sets for each group (i.e., ERBEFLO CleverCap® CO2and ERBEFLO AeroRinse® CO-) which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olymous, and Fujinon Gastrointestinal video Endoscopes). There are two subsets of Sets for the Olympus scope in aech group; one that attaches to standard CO2 sources and the other which specifically attaches to an Olympus CO2 Unit Model UCR. 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 (as applicable- only for the ERBEFLO CleverCap® CO2 Sets) interfaces with a designated pump and via ERBEFLO 2 single use 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 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 CQ2 Source through the Set's CO2 segment.]. The third and final segment for both the Olympus and Fujinon Sets is for connecting to a CO2 Source for CO2 insufflation. For each Set, both the irrigation (as applicable) as well as the air/water tubing segments has a backflow valve. The CO2 segment of the Sets have a standard female luer connector for access a CO₂ Source or in the case of specified Olympus Sets there is a connector on the CO2 segment designed to accessing the Olympus CO3 Unit Model UCR. All of the CO2 segments have a hydrophobic air/gas filter which filters particulates from the CO, Source and keeps fluid from flowing into the CO2 Source. The irrigation (as applicable), air/water, and CO2 segments of the Sets have a clamp to close off the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's CO2 Tubing/Cap Sets 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)
The following evaluations and tests were performed to 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 products.
2X Sterilization Package Integrity and Functional Testing: Package integrity testing, visual inspection, flow testing, back flow pressure testing, pressure decay testing, tensile strength testing, durability testing (including ensuring no leaks and connectability upon stressing Sets), and clamp 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 as well as Sets meeting 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2016
Erbe USA, Inc. John Tartal Director of Quality and Regulatory Affairs 2225 Northwest Parkway Marietta. GA 30067
Re: K162152 Trade/Device Name: Erbe's CO2 Tubing/Cap Sets Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEO Dated: July 29, 2016 Received: August 2, 2016
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.
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 (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 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,
For Division
Douglas Silverstein -S 2016.08.31 12:09:18 -04'00'
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) K162152
Device Name Erbe's CO2 Tubing/Cap Sets
Indications for Use (Describe)
Erbe's CO2 Tubing/Cap Sets provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
July 2016
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: | July 29, 2016 |
| Common Name: | Endoscopic CO₂ Tubing/Cap Sets |
| Trade/Proprietary Names: | Erbe's CO₂ Tubing/Cap Sets (i.e., ERBEFLO CleverCap* Hybrid CO₂
Tubing/Cap Sets and ERBEFLO AeroRinse® CO₂ and Water Tubing/Cap Sets) |
| Classification Name: | Endoscopes and Accessories (21 CFR Part 876.1500) |
| Product Code: | FEQ |
| Legally Marketed
Predicate Device: | ERBEFLO CleverCap* Hybrid CO₂ Tubing/Cap Sets and Connector Tube,
510(k) Number K132340 |
Device Description:
In general; Erbe's CO2 Tubing/Cap Sets will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, nitrile rubber, acrylic, nylon, ink, solvent, adhesive, etc. The ERBEFLO CleverCap® CO2 devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation; whereas, the ERBEFLO AeroRinse® CO2 devices provide a conduit for water for endoscopic lens cleaning as well as air or CO2 for insufflation. There are three (3) types of Erbe's CO2 Tubing/Cap Sets for each group (i.e., ERBEFLO CleverCap® CO2and ERBEFLO AeroRinse® CO-) which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olymous, and Fujinon Gastrointestinal video Endoscopes). There are two subsets of Sets for the Olympus scope in aech group; one that attaches to standard CO2 sources and the other which specifically attaches to an Olympus CO2 Unit Model UCR. 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 (as applicable- only for the ERBEFLO CleverCap® CO2 Sets) interfaces with a designated pump and via ERBEFLO 2 single use 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 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 CQ2 Source through the Set's CO2 segment.]. The third and final segment for both the Olympus and
4
Fujinon Sets is for connecting to a CO2 Source for CO2 insufflation. For each Set, both the irrigation (as applicable) as well as the air/water tubing segments has a backflow valve. The CO2 segment of the Sets have a standard female luer connector for access a CO₂ Source or in the case of specified Olympus Sets there is a connector on the CO2 segment designed to accessing the Olympus CO3 Unit Model UCR. All of the CO2 segments have a hydrophobic air/gas filter which filters particulates from the CO, Source and keeps fluid from flowing into the CO2 Source. The irrigation (as applicable), air/water, and CO2 segments of the Sets have a clamp to close off the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's CO2 Tubing/Cap Sets are provided sterile and are disposable.
Intended Use:
Erbe's CO2 Tubing/Cap Sets provide sterile water and CO2 or air (if CO3 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
Erbe's CO2 Tubing/Cap Sets have the same intended use as the predicate device (i.e., the ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Sets and Connector Tube). The proposed Sets have the same materials and basic design as the predicate devices. The modified 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 (as applicable), endoscope connection accessories, endoscopes, and CO2 sources. Finally, the proposed and predicate devices are sterilized via Ethylene Oxide and disposable.
Differences
Modified Sets (i.e., the ERBEFLO AeroRinse® CO-) were created to eliminate the irrigation line/segment. Also, the CO2 segment on the Sets was modified to have the Sets directly connect to a CO2 Source (i.e., "A CO2 Connector Tube" was included as part of the Sets). Included in the CO3 segment modification was replacing the actuvator valve with a connector and clamp. Additionally, Olympus Sets were created to directly connect to the Olympus CQ2 Unit Model UCR. Finally, for standardization purposes the packaging configuration was changed to have 10 Sets per shelf box. Evaluations and testing as described below demonstrated the safety and efficacy of the Sets.
Evaluations and Testing:
The following evaluations and tests were performed to 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 products.
2X Sterilization Package Integrity and Functional Testing
Package integrity testing, visual inspection, flow testing, back flow pressure testing, pressure decay testing, tensile strength testing, durability testing (including ensuring no leaks and connectability upon stressing Sets), and clamp 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.
5
Sterilization Evaluation
The evaluation was performed using current recognized standards to demonstrate product sterility as well as Sets 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:
Erbe's CO2 Tubing/Cap Sets intended use is the same as the Hybrid CO2Tubing/Cap Sets and CO2 Connector Tube. The proposed Sets 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 predicate, the proposed Sets are constructed with the same type of materials and as applicable have the same performance characteristics. In conclusion, Erbe's CO2 Tubing/Cap Sets did not adversely affect safety or effectiveness.