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.

Device Description

The ERBEFLO™ 2 Disposable Tubing System consists of tubing sets, port connectors, channel adapter, and backflow valve to deliver sterile water from a water source through designated pumps and to/or through a scope channel of various endoscopes. Clinicians connect the associated Product(s)/Component(s) to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO™ 2 Disposable Tubing System is provided sterile and is disposable.

AI/ML Overview

The provided text describes a 510(k) submission for the ERBEFLO™ 2 Disposable Tubing System. While it mentions that performance testing was conducted, it does not provide specific acceptance criteria or detailed results of those tests. Instead, it broadly states that "performance testing involving flow rates, back flow pressure, internal pressure, and durability testing was performed" and that the device had "comparable dimensional, flow, back flow pressure, internal pressure, and durability characteristics" to the predicate device.

Therefore, I cannot fully complete the requested table and answer all questions due to the lack of detailed information in the provided document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Expected Performance)	Reported Device Performance
Flow Rates: (Specific values not provided)	Performance testing was performed. Conclusion: "comparable ... flow ... characteristics" to the predicate (EndoGator® System). The document does not specify the numerical flow rates achieved or the acceptance thresholds.
Back Flow Pressure: (Specific values not provided)	Performance testing was performed. Conclusion: "comparable ... back flow pressure ... characteristics" to the predicate. The document does not specify the numerical back flow pressure achieved or the acceptance thresholds.
Internal Pressure: (Specific values not provided)	Performance testing was performed. Conclusion: "comparable ... internal pressure ... characteristics" to the predicate. The document does not specify the numerical internal pressure achieved or the acceptance thresholds.
Durability: (Specific criteria not provided, e.g., number of cycles, resistance to damage)	Performance testing was performed. Conclusion: "comparable ... durability characteristics" to the predicate. The document does not specify the durability test results or the acceptance thresholds.
Biocompatibility: (Compliance with ISO 10993 or equivalent)	"Biocompatibility of the specific materials for the Products/Components of the ERBEFLO™ 2 Disposable Tubing System was evaluated." The document does not provide the specific acceptance criteria or results.
Sterility: (Sterile via Ethylene Oxide)	"Provided sterile" and "sterilized via Ethylene Oxide." No specific test results or acceptance criteria are provided in terms of sterility assurance levels (e.g., SAL).
Dimensional Characteristics: (Specific dimensions not provided)	"The physical aspects and overall length of the proposed System were comparable to the predicate System." The document does not provide specific dimensional criteria or measurements.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document only states that "performance testing" was performed.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). This was an internal test performed 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

This question is not applicable. The device is a disposable tubing system, and its performance (flow rates, pressure, durability) would typically be evaluated through objective engineering and laboratory tests, not by human expert assessment of images or clinical outcomes that require a "ground truth" to be established by experts.

4. Adjudication method for the test set

This question is not applicable, as it relates to expert review for subjective assessments, which is not relevant for this type of device's performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The ERBEFLO™ 2 Disposable Tubing System is a medical device for fluid delivery, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used

This question is not entirely applicable in the same way as for AI/diagnostic devices. For engineering performance tests like flow rates, pressure, and durability, the "ground truth" is typically the measured physical properties against predefined engineering specifications and regulatory standards. The document implies comparison to the predicate device's characteristics as a benchmark.

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as above.

Summary

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K 1032 35
pg 1 of r

ERBE USA Incorporated Traditional 510(k): ERBEFLO™ 2 Disposable Tubing System

DEC 2 3 2010

510(k) SUMMARY

Submitted By:

ERBE USA. Inc. 2225 Northwest Parkway Marietta, GA 30067 Tel: 770-955-4400 Fax: 770-955-2577

John Tartal Contact Person: QA/RA Manager

October 29, 2010 Date Prepared:

Endoscopic Irrigation Tubing System Common Name:

Trade/Proprietary Name: ERBEFLO™ 2 Disposable Tubing System

Endoscopes And/or Accessories (21 CFR Part 876.1500) Classification Name:

KOG Product Code:

Legally Marketed EndoGator® System, 510(k) Number K924102 Predicate Device:

EndoGator is a registered trademark of Byrne Medical, Inc.

Device Description:

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.

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K 10 3235
pg 2 of 2

ERBE USA Incorporated Traditional 510(k): ERBEFLO™ 2 Disposable Tubing System

Similarities and Differences of the Proposed Device to the Current Devices (Predicate Comparison/Substantial Equivalence):

Similarities

The ERBEFLO™ 2 Disposable Tubing System has the same basic intended use as the predicate. The Systems have the same thread connections, vented cap, tubing segments, and back flow valve placements. The tubing of each System also has the same Inner Diameter (ID), Outer Diameter (OD), and Durometer. They also both have the same locking collars, pump head tubing segment length, and tubing weight insert. Also, the accessories are the same. Products/Components of each System have the same durations of use. Both Systems use the same types of water bottles, pumps, and endoscopes. Both of the components/products of each System are sterilized via Ethylene Oxide and are disposable.

Difference

The predicate device (i.e., the EndoGator® System) can also be used with pumps having a cartridge as well as pumps with a pump head. To address this issue, the ERBEFLO™ 2 Disposable Tubing System Notes On Use specifies designated pumps. The types of materials used for the ERBEFLO™ 2 Disposable Tubing System are similar to the predicate (EndoGator® System) but specific materials are slightly different. Therefore, biocompatibility of the specific materials for the Products/Components of the ERBEFLO™ 2 Disposable Tubing System was evaluated. See Section III, Product Data - Biocompatibility Study. The physical aspects and overall length of the proposed System were comparable to the predicate System but not identical. Therefore performance testing involving flow rates, back flow pressure, internal pressure, and durability testing was performed on the ERBEFLO™ 2 Disposable Tubing System. See Section III, Product Data -Performance Testing.

Conclusion:

The ERBEFLO™ 2 Disposable Tubing System's intended use is a part of the predicate's indications in the previously cleared 510(k). The ERBEFLO™ 2 Disposable Tubing System has the same principles of operation and technological characteristics as the predicate device. The duration of use for both Systems is the same. As compared to the predicate, the proposed System is constructed with the same type of materials as well as comparable dimensional, flow, back flow pressure, internal pressure, and durability characteristics. In conclusion, all the changes were verified or validated. As a result, the ERBEFLO™ 2 Disposable Tubing System did not adversely affect safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. John Tartal Quality Assurance/Regulatory Affairs Manager ERBE USA. Inc. Surgical Systems 2225 Northwest Parkway MARIETTA GA 30067 DEC 2 3 2010

Re: K103235

Trade/Device Name: ERBEFLO" 2 Disposable Tubing System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: October 29, 2010 Received: November 2, 2010

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

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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/uccr1118001, prifise 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 regultion (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 no mber (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Stucher Lemur 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

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DEC 2 3 2010

Indications for Use

510(k) Number (if known): // // 0 32 3 5

Device Name: ERBE USA, Inc.'s ERBEFLO™ 2 Disposable Tubing System

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.

X Prescription Use (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)

Heels Leun

The , 21:0

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Regulation Number and Section

§ 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.