Who is the manufacturer of EndoGator Endoscopy Irrigation Tubing?

STERIS Corporation filed the 510(k) submission for EndoGator Endoscopy Irrigation Tubing (K220395).

What is the FDA product code for EndoGator Endoscopy Irrigation Tubing?

FEQ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for EndoGator Endoscopy Irrigation Tubing?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like EndoGator Endoscopy Irrigation Tubing?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EndoGator Endoscopy Irrigation Tubing

K220395 · STERIS Corporation · FEQ · Mar 11, 2022 · Gastroenterology, Urology

Device Facts

Record ID	K220395
Device Name	EndoGator Endoscopy Irrigation Tubing
Applicant	STERIS Corporation
Product Code	FEQ · Gastroenterology, Urology
Decision Date	Mar 11, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The EndoGator Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

Device Story

EndoGator Endoscopy Irrigation Tubing provides sterile water irrigation during GI endoscopic procedures. System consists of bottle cap, tubing set, and connectors. Device connects to irrigation pump or cautery unit and disposable sterile water bottle. Tubing features distal backflow valve to prevent cross-contamination. Used in clinical settings by medical staff. Tubing sets are 24-hour use; accessories are single-use. Healthcare providers use irrigation to clear visualization during endoscopy, improving diagnostic or therapeutic outcomes.

Clinical Evidence

Bench testing only. Testing included tensile testing, flow rate verification, and structural integrity/durability testing when used with Torrent Irrigation Pump and gi4000 Electrosurgical Generator. All tests met design specifications.

Technological Characteristics

Materials: Acrylonitrile Butadiene (Buna-N), ABS, thermoplastic elastomer, isopropyl alcohol, nickel-plated brass, polycarbonate, polypropylene, PVC, silicone, UV cured glue. Peristaltic pump compatibility. Sterilization: Ethylene Oxide (SAL 10^-6). Form factor: Tubing set with distal backflow valve.

Indications for Use

Indicated for patients undergoing GI endoscopic procedures requiring irrigation via sterile water supply using an irrigation pump or cautery unit.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

EndoGator System (K092429)

Related Devices

K230773 — Endoscopy Irrigation Tubing · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Nov 21, 2023
K231418 — ENDOGATOR Hybrid Irrigation Tubing · Medivators · Aug 14, 2023
K181457 — EndoStream(TM) · Partnership Medical Limited · Jul 11, 2019
K223171 — AquaPulse® Irrigation Tubing · Ga Health Company Limited · Nov 10, 2022
K092429 — ENDOGATOR · Byrne Medical, Inc. · Nov 19, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 11, 2022 STERIS Corporation Carroll Martin Regulatory Affairs Director 5960 Heislev Road Mentor, OH 44060 Re: K220395 Trade/Device Name: Endogator Endoscopy Irrigation Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FEQ Dated: February 11, 2022 Received: February 11, 2022 Dear Carroll Martin: 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 medical devices and radiation-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) K220395 Device Name EndoGator Endoscopy Irrigation Tubing Indications for Use (Describe) The EndoGator Endoscopy Irrigation Tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit). 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the STERIS logo with a wavy line design underneath. The text "K220395 Page 1 of 5" is located in the upper right corner of the image. The STERIS logo is large and bold, making it the focal point of the image. # 510(k) Summary for the ENDOGATOR Endoscopy Irrigation Tubing STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Contact: Carroll Martin Regulatory Affairs Director Tel: 440-358-6259 Email: Carroll_Martin@steris.com February 11, 2022 Submission Date: STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ #### 1. Device Name | Trade Name: | ENDOGATOR Endoscopy Irrigation Tubing | |--------------------|---------------------------------------| | Device Class: | Class II | | Regulation Name: | Endoscope and Accessories | | Common/usual Name: | Irrigation Tubing | | Regulation Number: | 21 CFR 876.1500 | | Product Code: | FEQ | #### 2. Predicate Device EndoGator System, K092429 #### 3. Device Description The ENDOGATOR Endoscopy Irrigation Tubing is composed of the following: 1) EndoGator™ Irrigation Tubing, and 2) EndoGator™ Irrigation Accessories The ENDOGATOR Endoscopy Irrigation Tubing is indicated for irrigation during endoscopic procedures by using it in coniunction with an irrigation pump or cauterv units, irrigation accessory, endoscope and disposable sterile water bottle. All tubing sets contain a back flow valve at the distal tip that allows irrigation water to travel in one direction, and therefore the risk of cross contamination is significantly reduced. The irrigation tubing sets are for twenty-four hour use and are to be discarded daily. The accessories are single-use devices and are to be discarded between patients. Tubing sets do not come into direct contact with patient tissue. #### 4. Indications for Use The ENDOGATOR Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit). #### Technological Characteristics Comparison Table 5. A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1. {5}------------------------------------------------ | Features | Endogator System Predicate Device K092429 | Modified Device | Comparison | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The EndoGatorTM system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit). | The EndoGator Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit). | Identical | | Construction | The EndoGator TM System consists of a bottle cap, tubing set and connector | The EndoGator Endoscopy Irrigation Tubing consists of a bottle cap, tubing set and connector | Identical | | Sterile/Non- sterile | Sterile | Sterile | Identical | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical | | Sterilization Assurance Level | 10-6 | 10-6 | Identical | | Accessories | • Single Use Auxiliary Water Jet Connector for Olympus® Endoscopes • Single Use Auxiliary Water Jet Connector for Pentax® Endoscopes • Endogator Channel Adapter • Endogator Backflow Valve • Endogator Y-Connector • Endogator Pump Cartridge • Endogator Extension Tubing • SpyGlass Tube Set | • Single Use Auxiliary Water Jet Connector for Olympus® Endoscopes • Single Use Auxiliary Water Jet Connector for Pentax® Endoscopes • Endogator Channel Adaptor • Endogator Backflow Valve | Similar All of the applicable listed accessories for the modified device are identical to the predicate. | | Usage | Single Use: • Single Use Auxiliary Water Jet Connector for Olympus Endoscopes • Single Use Auxiliary Water Jet Connector for Pentax Endoscopes • Endogator Backflow Valve • Endogator Channel Adaptor • Endogator Y-Connector • SpyGlass Tube Set 24 Hour/Multi-patient Use • Endogator Extension Tubing | Single Use: • Single Use Auxiliary Water Jet Connector for Olympus® Endoscopes • Single Use Auxiliary Water Jet Connector for Pentax® Endoscopes • Endogator Backflow Valve • Endogator Channel Adaptor 24 Hour/Multi-patient Use • Endogator for Endostat II, Olympus OFP or Endo Stratus | Identical The usage of the applicable accessories with modified device is identical as the usage for the accessories from the predicate device. Identical The usage of the irrigation tubing | | Features | Endogator System Predicate Device K092429 for Olympus Endoscopes | Modified Device | Comparison | | | • Auxiliary Water jet Connector for Pentax Endoscopes | Pumps • Endogator for EGP-100, Olympus OFP, Torrent Irrigation Pumps and the gi4000 Electrosurgical Generator (irrigation pump component) | for the modified device is identical to the usage for the predicate device. | | | • Endogator for Pentax/Meditron Pumps | | | | | • Endogator for Pentax/Meditron Pumps with Fujinon Endoscope Connectors | | | | | • Endogator for Endostat II/III Unit or Olympus OFP Unit | | | | | • Endogator for EGP-100 Irrigation Unit | | | | | • Endogator for EGP-100 Irrigation Units with Fujinon Endoscope Connectors | | | | | Reusable: • Endogator Pump Cartridge | Reusable: • None | Similar There are no reusable accessories being used with the modified device. | | Materials | Acrylonitrile Butadiene (Buna-N) Acrylonitrile Butadiene Styrene (ABS) Cyclohexanone High Impact Polystyrene (HIPS) Isopropyl Alcohol Nickel-plated Brass Polycarbonate Polypropylene Polyvinyl Chloride (PVC) Silicone UV cured Glue | Acrylonitrile Butadiene (Buna-N) Acrylonitrile Butadiene Styrene (ABS) Thermoplastic elastomer Isopropyl Alcohol Nickel-plated Brass Polycarbonate Polypropylene Polyvinyl Chloride (PVC) Silicone UV cured Glue | Similar Cyclohexane and high impact polystyrene were used in components for part numbers that have been discontinued. The acrylonitrile butadiene (Buna- N) in the o-ring of the check valve for the irrigation tubing was replaced by thermoplastic elastomer (Buna-N still exists in other components of the device). Thermoplastic elastomer is a well- known material in the medical device industry. Identical | | Target Population | Patients undergoing an endoscopic procedure | Patients undergoing an endoscopic procedure | Identical | | Features | Endogator System Predicate Device K092429 | Modified Device | Comparison | | Used/Delivered | | | | | Method of Application | Manual | Manual | Identical | | Compatible Endoscopes | Olympus, Pentax, Fujinon | Olympus, Pentax, Fujinon | Identical | | Compatible Irrigation Pumps | Pentax, Meditron, Endostat II, Endostat III, Olympus OFP | Endostat II, EGP-100, Olympus OFP, Endo Stratus, Torrent Irrigation Pump, gi4000 Electrosurgical Generator (irrigation pump component) | Similar. All compatible pumps are peristaltic pumps. | Table 1. Technological Characteristics Comparison Table {6}------------------------------------------------ {7}------------------------------------------------ K220395 Page 5 of 5 #### Summary of Non-Clinical Performance Testing 6. The following testing was conducted to verify the changes: | Test | Purpose | Acceptance Criteria | Results | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Tensile Testing | Ensure the modification to the change in connection method between the pump tubing and irrigation tubing sections meet specifications. | Tensile values are to meet design specifications | Pass | | Flow Rate Testing | Verify that flowrate was not impacted when using the irrigation tubing with the Torrent Irrigation pump and the gi4000 Electrical Surgical Generator. | Flowrate values are to meet design specifications | Pass | | Durability Testing | Verify that the irrigation tubing structural integrity was not impacted when used with the Torrent Irrigation pump and the gi4000 Electrical Surgical Generator | Device structural integrity must not be compromised when used with the Torrent Irrigation Pump and the gi4000 Electrosurgical Generator | Pass | #### 7. Conclusion Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K092429).