(95 days)
Not Found
No
The device description focuses on mechanical components (tubing, cap, valves, clamps) and fluid/air flow, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates the delivery of sterile water and air for endoscopic procedures, specifically for irrigation, air intubation, and lens cleaning, rather than directly treating a medical condition or restoring function.
No
The device description indicates its function is to provide sterile water and air to an endoscope for endoscopic procedures, specifically for irrigation, air intubation, and lens cleaning. This aids in the procedure but does not diagnose a condition.
No
The device description clearly outlines physical components (tubing segments, cap, backflow valve, clamp) and their interaction with other hardware (water source, pump, endoscope). There is no mention of software as the primary or sole component.
Based on the provided information, the ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets are not an In Vitro Diagnostic (IVD) device.
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 in vitro (outside the body).
- Device Description: The description details tubing and a cap that connect to a water source and an endoscope. This is a system for delivering fluids and air during an endoscopic procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis.
The device is clearly designed for use during an endoscopic procedure to facilitate visualization and irrigation, which falls under the category of surgical or procedural devices, not IVDs.
N/A
Intended Use / Indications for Use
The ERBEFLO CleverCap Hybrid Tubing/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.
Product codes
KOG, FAJ
Device Description
The ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes consist of two (2) 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, irrigation tubing of a Set interfaces with a designated pump and via ERBEFLO 2 connector accessories to a specified Olympus Scope for endoscopic lavage. The other segment, the air/water tubing, also coming from the same water bottle; connects to an air/water port of a specified Olympus® Scope for air intubation as well as lens cleaning (Note: The air/water tubing is a tube within a tube in which the endoscope's air/water processor pressures the bottle for water flow.). Both the irrigation as well as the air/water tubing segments have a backflow valve and a clamp to pinch off the tubing while not in use. Each Set is designed for use with designated irrigation pumps and have a air/water connector for specified Olympus® Scopes. The Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes 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)
Performance testing demonstrated improved flow rates as well as equivalent back flow pressure, internal pressure, and durability.
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
ERBE USA Incorporated
Traditional 510(k); ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes
| 510(k) SUMMARY | |
|---|---|
| MAR 2 2 2011 | |
| Submitted By: | ERBE USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 Tel: 770-955-4400 Fax: 770-955-2577 |
| Contact Person: | John Tartal QA/RA Manager |
| Date Prepared: | December 16, 2010 |
| Common Name: | Endoscopic Irrigation Tubing Set and Water Bottle Adaptor |
| Trade/Proprietary Name: | ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes |
| Classification Name: | Endoscopes And/or Accessories (21 CFR Part 876.1500) |
| Product Code: | KOG |
| Legally Marketed Predicate Device: | EndoGator® System, 510(k) Number K092429 and Endo SmartCap®, K093665 |
EndoGator and Endo SmartCap are registered trademarks of Byrne Medical. Inc.
Device Description:
The ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes consist of two (2) 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, irrigation tubing of a Set interfaces with a designated pump and via ERBEFLO 2 connector accessories to a specified Olympus Scope for endoscopic lavage. The other segment, the air/water tubing, also coming from the same water bottle; connects to an air/water port of a specified Olympus® Scope for air intubation as well as lens cleaning (Note: The air/water tubing is a tube within a tube in which the endoscope's air/water processor pressures the bottle for water flow.). Both the irrigation as well as the air/water tubing segments have a backflow valve and a clamp to pinch off the tubing while not in use. Each Set is designed for use with designated irrigation pumps and have a air/water connector for specified Olympus® Scopes. The Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes are provided sterile and are disposable.
1
ERBE USA Incorporated
Traditional 510(k): ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes
Olympus is a registered trademark of the Olympus Corporation
Intended Use:
The ERBEFLO CleverCap Hybrid Tubing/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.
Similarities and Differences of the Proposed Device to the Current Devices (Predicate Comparison/Substantial Equivalence):
Similarities
The ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes have the same basic intended use of both of the predicates combined. The proposed Sets have the same thread connections, cap, tubing segments, and back flow valve placement. The tubing of the Hybrid Sets also has comparable Durometer, Inner Diameters (I.D.s), and Outer Diameters (O.D.s) as the predicate devices. The proposed and predicate devices also both have the same locking clamp and tubing weight insert. The length of the air/water segment is the same with the Hybrid Sets as compared to the Endo SmartCap. The Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes have the same duration of use as the EndoGator System as well as Endo SmartCap (24 hour use). The proposed Sets and predicate devices use the same types of water bottles. pumps, endoscope connection accessories, and endoscope. Finally, the proposed and predicate devices are sterilized via Ethylene Oxide and disposable. Differences
The predicate devices (i.e., the EndoGator System and Endo SmartCap) can also be used with additional pumps and endoscopes as well as have capability of using CO2 instead of air for intubation. To address these differences, the ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes Notes On Use specifies designated pumps and Olympus® Scopes for use as well as only has instructions for use with the air/water processor of the Scopes. The types of materials used for the ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes are similar to the predicates (EndoGator System and Endo SmartCap) but specific materials are slightly different. Therefore. biocompatibility of the specific materials for the ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes was evaluated. See Section III, Product Data - Biocompatibility Study. The predicates are two separate products used to do the same function of the proposed device. The Hybrid Sets also use only one water source as compared to the predicates each having a respective water source. Additionally, the irrigation tubing of the ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes is a longer single PVC piece as compared to EndoGator Tubing being a shorter 3segment piece with a silicone portion interfacing with a pump head (Note: The segment of the proposed device also has a clamp and the predicate Tubing does not.). Also, the air/water tubing of the ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes has a back flow valve as compared
2
ERBE USA Incorporated
Traditional 510(k): ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes
to the predicate Endo SmartCap that does not have a valve. Nonetheless with the differences in the physical and dimensional aspects of the proposed Sets as compared to the combined predicate devices; performance testing demonstrated improved flow rates as well as equivalent back flow pressure, internal pressure, and durability. See Section III, Product Data - Performance Testing.
Conclusion:
The ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes intended use is a part of both of the predicate's indications in the previously cleared 510(k)s. The proposed Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes have the same principles of operation and technological characteristics as the predicate devices combined. The duration of use for the proposed and predicates is the same. As compared to the predicates, the proposed Sets are constructed with the same type of materials as well as have enhanced flow rates as well as comparable back flow pressure, internal pressure, and durability characteristics. In conclusion, all the differences were verified or validated. As a result, the ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes did not adversely affect safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. John Tartal QA/RA Manager ERBE USA, Inc. 2225 Northwest Parkway MARIETTA GA 30067.
MAR 2 2 2"11
Re: K103696
Trade/Device Name: ERBEFLOW CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: March 3, 2011 Received: March 4, 2011
Dear Mr. 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 of medical device-related
4
Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemmer, MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Ko35686
Device Name: ERBE USA, Inc.'s ERBEFLO CleverCap™ 2 Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes
Indications For Use:
The ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helentenn
Division Sign-Off
Division Sign-Off) Di sion of Reproductive, Gastro-R l, and Urological Devices 510(k) Number
Page 1 of 1
,