(108 days)
Not Found
No
The device description and performance studies focus on the physical components, materials, and functional performance (flow, pressure, sterilization) of tubing and cap sets for endoscopic procedures. There is no mention of data processing, algorithms, or learning capabilities.
No
The device provides sterile water and air for endoscopic procedures, but it does not directly treat or diagnose a disease or condition. It is an accessory to an endoscope.
No
Explanation: The device description states that the product "provide sterile water and air from a single source to an endoscope for endoscopic procedures" and "provide a conduit for water for endoscopic irrigation and lens cleaning as well as air for insufflation." These functions relate to preparing and assisting with endoscopic procedures, not to diagnosing a condition or disease.
No
The device description clearly outlines physical components made of medical-grade materials like plastics and brass, including tubing, caps, and connectors. The performance studies also focus on physical properties and functionality like flow testing, pressure testing, and tensile strength, indicating a hardware-based device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to provide sterile water and air to an endoscope for endoscopic procedures. This is a direct interaction with the patient's body during a medical procedure, not the examination of specimens derived from the human body.
- Device Description: The description details a system of tubing and caps that connect to a water source and an endoscope. This is a delivery system for fluids and air, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: The document 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 screening based on laboratory tests
- Using reagents or calibrators for testing
The device is clearly intended for use during an endoscopic procedure to facilitate visualization and manipulation within the body, which falls under the category of a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Erbe Tubing/Cap/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
Erbe's Tubing/Cap Sets are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The ERBEFLO CleverCap® devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air for insufflation; whereas, the ERBEFLO AeroRinse® devices provide a conduit for water for endoscopic lens cleaning as well as air for insufflation. There are four (4) and three (3) variants of Erbe's Tubing/Cap Sets for each group respectively (i.e., ERBEFLO CleverCap® and ERBEFLO AeroRinse®). All of the Sets respectively interface with a specified brand of scope (i.e., Pentax®, Olympus®, Fujifilm®, and Fujinon® Gastrointestinal Video Endoscopes). The Sets consist of tubing segment(s) 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, an irrigation tubing line (segment) of a Set (as applicable- only for the ERBEFLO CleverCap® Sets) interfaces with a designated peristaltic pump and via an ERBEFLO connector accessory attaches to the specified 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 endoscope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube in which the endoscope is used to pressurize the water bottle for functionality (air and water to the endoscope)]. Also, for the Pentax Set there is an additional air inlet tube that directs air from the endoscope's processor. For each Set, the irrigation tubing segment (as applicable) as well as the air/water tubing segment has a back flow check valve. The irrigation (as applicable) and air/water 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 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)
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 Sets.
2X Sterilization Functional Testing: Visual inspection, flow testing, back flow pressure testing, pressure decay testing, tensile strength testing, connection testing, and durability testing (including ensuring no leaks and connectability upon stressing Sets) confirmed that the Devices upon 2X sterilization met established performance specifications.
Packaging Inspection/Testing: Current pouching of the products maintained their integrity [Note: Inspection/Testing of the pouch (sterile barrier) was included in many of the previous ERBEFLO cleared 510(k)s including the predicate submissions. Visual packaging inspection as well as dye penetration, burst, and seal strength testing were used to evaluate, qualify the various size pouches]. For the new automated packaging system; inspection (visual for package integrity and barcode readability), dye penetration, bubble leak testing, burst testing, seal strength tensile testing) were performed on soft pouch trays upon 2X sterilization (as well as after handling/transit simulation), and upon aging. Inspection/Testing demonstrated the suitability of the new pouch trays for the Sets.
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.
0
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August 11, 2022
Erbe USA, Inc. Jeff Dill Senior Quality Engineer 2225 Northwest Parkway Marietta, GA 30067
Re: K221177
Trade/Device Name: Erbe's Tubing/Cap Sets Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: July 8, 2022 Received: July 11, 2022
Dear Jeff Dill:
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. 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
1
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-regulatory-information/postmarketing-safety-reportingcombination-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,
Shanil P. Haugen, Ph.D. 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) K221177
Device Name Erbe's Tubing/Cap Sets
Indications for Use (Describe)
The Erbe Tubing/Cap/Cap Sets provide sterile water and air from a single source 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
April 2022
| 510(k) SUMMARY | |
|---|---|
| Submitted By: | Erbe USA, Inc.
2225 Northwest Parkway
Marietta, GA 30067
Tel: 770-955-4400
Fax: 770-955-2577 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jeff Dill
Senior Quality Engineer |
| Date Prepared: | April 21, 2022 |
| Common Name: | Endoscopic Tubing/Cap Sets |
| Trade/Proprietary Names: | Erbe's Tubing/Cap Sets (i.e., ERBEFLO CleverCap® Hybrid Tubing/Cap Sets
and ERBEFLO AeroRinse® Air and Water Tubing/Cap Sets) |
| Classification Name: | Endoscopes and Accessories (21 CFR Part 876.1500) |
| Regulatory Class: | II |
| Product Code: | OCX |
| Legally Marketed
Predicate Devices: | ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and
180 Series Scopes, 510(k) Number K103696 and Erbe's CO2 Tubing/Cap
Sets. 510(k) Number K162152 |
Device Description:
Erbe's Tubing/Cap Sets are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The ERBEFLO CleverCap® devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air for insufflation; whereas, the ERBEFLO AeroRinse® devices provide a conduit for water for endoscopic lens cleaning as well as air for insufflation. There are four (4) and three (3) variants of Erbe's Tubing/Cap Sets for each group respectively (i.e., ERBEFLO CleverCap® and ERBEFLO AeroRinse®). All of the Sets respectively interface with a specified brand of scope (i.e., Pentax®, Olympus®, Fujifilm®, and Fujinon® Gastrointestinal Video Endoscopes). The Sets consist of tubing segment(s) 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, an irrigation tubing line (segment) of a Set (as applicable- only for the ERBEFLO CleverCap® Sets) interfaces with a designated peristaltic pump and via an ERBEFLO connector accessory attaches to the specified 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 endoscope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube in which the endoscope is used to pressurize the water bottle for functionality (air and water to the endoscope)]. Also, for the Pentax Set there is an additional air inlet tube that directs air from the endoscope's processor. For each Set, the irrigation tubing segment (as applicable) as well as the air/water tubing segment has a back flow check valve. The irrigation (as applicable) and air/water segments of the Sets have a clamp to close off
4
the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's Tubing/Cap Sets are provided sterile and are disposable.
Intended Use:
The Erbe Tubing/Cap Sets provide sterile water and air from a single source to an endoscopic procedures.
Similarities and Differences of the Proposed Device to the Current Device (Predicate Comparison/Substantial Equivalence):
Similarities
Erbe's Tubing/Cap Sets in this 510(k) are essentially the same (i.e., materials, construction, dimensionally, etc.) as the Sets in the previously cleared 510(k)s. The intended use is the same as the primary predicate (ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes). The additional Sets in the submission are essentially the same as the second predicate (Erbe's CO2 Tubing/Cap Sets) but without the CO2 tubing line (segment)/feature. The Sets have the same intended use, sterilization, use conditions, disposability, etc.
Differences
There are primarily two (2) differences as follows:
-
- The main difference involves the addition of a more automated packaging system for pouching and labeling the Sets (i.e., currently packaging Sets in a pouch and proposed packaging Sets in a soft pouch tray). Package integrity with the new system was verified as described below.
-
- Minor change of creating a Hybrid Tubing/Cap Set for the new Fujifilm Scopes (700 Series Endoscope). The air/water scope connector is slightly different than the Set for the Fujinon Scope so that it fits (attaches/detaches) to the new Scope Series. Inspection/Testing demonstrated that the Set met specifications as described below.
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 Sets.
2X Sterilization Functional Testing
Visual inspection, flow testing, back flow pressure testing, pressure decay testing, tensile strength testing, connection testing, and durability testing (including ensuring no leaks and connectability upon stressing Sets) confirmed that the Devices upon 2X sterilization met established performance specifications.
Packaging Inspection/Testing
Current pouching of the products maintained their integrity [Note: Inspection/Testing of the pouch (sterile barrier) was included in many of the previous ERBEFLO cleared 510(k)s including the predicate submissions. Visual packaging inspection as well as dye penetration, burst, and seal strength testing were used to evaluate, qualify the various size pouches]. For the new automated packaging system; inspection (visual for package integrity and barcode readability), dye penetration, bubble leak testing, burst testing, seal strength tensile testing) were performed on soft pouch trays upon 2X sterilization (as well as after handling/transit simulation), and upon aging. Inspection/Testing demonstrated the suitability of the new pouch trays for the Sets.
5
Sterilization Evaluation
The evaluation was performed using the current recognized standard to demonstrate product sterility as well as that the products met ethylene oxide residual requirements.
Applied Standards
ISO 14971, 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 Tubing/Cap Sets intended use is the same as the ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes. The proposed Sets have the same principles of operation and technological characteristics as the predicate devices. The duration of use for the proposed and predicate Sets is the same. As compared to the predicates, the proposed Sets are constructed with the same type of materials and as applicable have the same performance characteristics. Additionally, the packaging (pouches or soft pouch trays) of the products have been found to maintain their sterile barrier. In conclusion, Erbe's Tubing/Cap Sets are safe and efficacious.