(90 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid delivery aspects of irrigation tubing, with no mention of AI/ML capabilities or data processing.
No
Therapeutic devices are generally defined as those used to treat or cure a disease or condition. This device is described as providing irrigation and air/CO2 during GI endoscopic procedures, which are diagnostic or procedural aid functions, not directly therapeutic.
No
Explanation: The ENDOGATOR™ Hybrid Irrigation Tubing is intended to provide irrigation and supply air/CO2 during GI endoscopic procedures. Its function is to deliver substances and facilitate procedures, not to identify or determine the nature of a disease or condition.
No
The device description clearly outlines physical components like tubing, caps, and valves, indicating it is a hardware device, not software-only.
Based on the provided information, the ENDOGATOR™ Hybrid Irrigation Tubing is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide irrigation and insufflation (air or CO2) during GI endoscopic procedures. This is a therapeutic or procedural support function, not a diagnostic one.
- Device Description: The device is a tubing set designed to deliver fluids and gases into the body during a procedure. It does not perform any tests on samples taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical and functional aspects of the tubing (flow rates, durability, biocompatibility), not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The ENDOGATOR™ Hybrid Irrigation Tubing does not fit this description.
N/A
Intended Use / Indications for Use
The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.
Product codes
OCX
Device Description
The ENDOGATOR™ HYBRID Irrigation Tubing device contains a threaded cap and tubeset designed to be attached to sterile water bottles. The proximal end of the irrigation tubing includes the threaded bottle cap for attachment to a sterile water bottle. The bottle cap has three tubes attached, one for receiving CO2 (and air in the case of Pentax SKU's), one coaxial tube which has an inner lens rinsing uptake tube surrounded by an air/CO2 delivery tube, and one for delivering water for irrigation which interfaces with an irrigation pump. The water delivery tubes, both irrigation as well as lens rinsing include backflow check valves.
Air/CO2 and Lens Rinse Line Description
The threaded cap uses a coaxial tube to partition water and air/CO2 which is connected to the endoscope-interfacing connector. Pressurized air or CO2 provided by the endoscope's processor/light source or a CO2 insufflator is fed into the endoscope (either directly or first through the device & bottle system via luer connection.) The Endogator Hybrid enables the air/CO2 to pressurize the bottle and flow through the endoscope to the air/water valve. The Endogator Hybrid serves as a passive element in the system, allowing the delivery of pressurized air/CO2 to endoscopes.
Irrigation Line Description
The irrigation tubing pump section is installed into peristaltic-roller-type irrigation pumps, which transfer water through means of applying force to the external surface of the tubeset via revolving rollers, actuated by a user-controlled foot pedal, causing water to be siphoned from the sterile water bottle and transferred downstream to the endoscope. The flow rate can be manipulated by user-interaction with the pump interface. The distal end of the irrigation tubing includes a backflow valve which allows water to travel only in one direction to mitigate cross-contamination. The irrigation check valve has a luer connection that enables the irrigation tubing to be connected to the ENDOGATOR™ auxiliary port or biopsy accessory adapters that interface with endoscopes (separate devices).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI
Indicated Patient Age Range
Pediatric to Adult
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)
Non-clinical testing was performed for Water Flow Rate, Insufflation Air & CO2 Flow, Backflow Test, Lens Rinsing Flow Rate, and Durability of glue bonded connections. All tests passed their respective requirements.
Biocompatibility testing was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (
§ 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 14, 2023
Medivators Disha Kabrawala Senior Regulatory Affairs Specialist 14605 28th Avenue North Minneapolis, Minnesota 55447
Re: K231418
Trade/Device Name: ENDOGATOR™ Hybrid Irrigation Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX Dated: May 11, 2023 Received: May 16, 2023
Dear Disha Kabrawala:
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
1
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 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 (OS) 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 -S
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) K231418
Device Name ENDOGATOR™ Hybrid Irrigation Tubing
Indications for Use (Describe)
The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water 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) |
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510(k) Summary For ENDOGATOR™ Hybrid Irrigation Tubing
Medivators Inc 14605 28th Ave N, Minneapolis, MN 55447 Fax No: 844-348-5637
- Contact Person: Disha Kabrawala Senior Regulatory Affairs Specialist Phone: 732-319-7766 Email: disha kabrawala@steris.com
May 11, 2023 Summary Date:
4
CANTEL MEDICAL TRADITIONAL PREMARKET NOTIFICATION [510(k)] ENDOGATOR™ Hybrid Irrigation Tubing
1. Device Name
| Trade Name: | ENDOGATOR™ Hybrid Irrigation Tubing |
|---|---|
| Device Class: | II |
| Common/usual Name: | ENDOGATOR™ Hybrid Irrigation Tubing |
| Classification Name: | Endoscope and Accessories |
| Classification Number: | 876.1500 |
| Product Code: | OCX (endoscopic irrigation/suction system) |
2. Predicate Devices
The Universal Irrigation Solution Hybrid, K102855
3. Description of Devices
The ENDOGATOR™ HYBRID Irrigation Tubing device contains a threaded cap and tubeset designed to be attached to sterile water bottles. The proximal end of the irrigation tubing includes the threaded bottle cap for attachment to a sterile water bottle. The bottle cap has three tubes attached, one for receiving CO2 (and air in the case of Pentax SKU's), one coaxial tube which has an inner lens rinsing uptake tube surrounded by an air/CO2 delivery tube, and one for delivering water for irrigation which interfaces with an irrigation pump. The water delivery tubes, both irrigation as well as lens rinsing include backflow check valves.
Air/CO2 and Lens Rinse Line Description
The threaded cap uses a coaxial tube to partition water and air/CO2 which is connected to the endoscope-interfacing connector. Pressurized air or CO2 provided by the endoscope's processor/light source or a CO2 insufflator is fed into the endoscope (either directly or first through the device & bottle system via luer connection.) The Endogator Hybrid enables the air/CO2 to pressurize the bottle and flow through the endoscope to the air/water valve. The Endogator Hybrid serves as a passive element in the system, allowing the delivery of pressurized air/CO2 to endoscopes.
Irrigation Line Description
The irrigation tubing pump section is installed into peristaltic-roller-type irrigation pumps, which transfer water through means of applying force to the external surface of the tubeset via revolving rollers, actuated by a user-controlled foot pedal, causing water to be siphoned from the sterile water bottle and transferred
5
CANTEL MEDICAL TRADITIONAL PREMARKET NOTIFICATION [510(k)] ENDOGATOR™ Hybrid Irrigation Tubing
downstream to the endoscope. The flow rate can be manipulated by userinteraction with the pump interface. The distal end of the irrigation tubing includes a backflow valve which allows water to travel only in one direction to mitigate cross-contamination. The irrigation check valve has a luer connection that enables the irrigation tubing to be connected to the ENDOGATOR™ auxiliary port or biopsy accessory adapters that interface with endoscopes (separate devices).
4. Intended Use / Indications for Use
The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.
ડ. Comparison of Technological Characteristics with the Predicate Device
A comparison of technical characteristics between the proposed and predicate devices is included in Table 1.
| Feature | Proposed
ENDOGATOR Hybrid
Irrigation tubing | Predicate (K102855)
The Universal Irrigation
Solution Hybrid | Comparison |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ENDOGATOR™ Hybrid
Irrigation Tubing (tubing and
accessories to accommodate
various endoscopes and
irrigation pumps) is intended to
provide irrigation via sterile
water and to supply air (via an
air pump) or CO2 (via a CO2
supply) along with sterile water
during GI endoscopic
procedures when used in
conjunction with an irrigation
pump or cautery unit. | The Universal Irrigation
Hybrid™ solution (tubing and
accessories to accommodate
various endoscopes and
irrigation pumps) is intended
to provide irrigation via sterile
water and to supply air (via an
air pump) or CO2 (via a CO2
supply) along with sterile
water during GI endoscopic
procedures when used in
conjunction with an irrigation
pump or cautery unit. | Identical |
| Sterile | Sterile | Sterile | Identical |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterilization
Assurance
Level | 10-6 | 10-6 | Identical |
| Feature | Proposed
ENDOGATOR Hybrid
Irrigation tubing | Predicate (K102855)
The Universal Irrigation
Solution Hybrid | Comparison |
| Intended Use | 24hr/ Multi-patient use | 24hr/ Multi-patient use | Identical |
| Reprocessing | None; Daily disposal | None; Daily disposal | Identical |
| Compatible
Endoscope(s) | Olympus® 140/160/180/190
series GI endoscopes
PENTAX™ GI Endoscopes,
FUJI 500 series GI Endoscopes
FUJI 700 series GI Endoscopes | Olympus®
140/160/180/240/260 series GI
endoscopes | Different
Additional
part
numbers
implemente
d to for
Pentax, Fuji
endoscopes |
| Patient
Contact | No direct contact | No direct contact | Identical |
| Target
Patient
Population | Male/Female, Pediatric to
Adult
- Patients population
undergoing GI endoscopic
procedure | Male/Female, Pediatric to
Adult - Patients population
undergoing GI endoscopic
procedure | Identical |
| Materials | Nitrile Butadiene (Buna-N)
acrylonitrile-butadiene-styrene
Acrylonitrile Butadiene Styrene
(ABS)
BLACK PEARL C
Thermoplastic Elastomer
Polycarbonate
Non-Phthalate Polyvinyl
Chloride (PVC)
Polypropylene
Buna-N Nitrile
Nickel-Plated Brass
Silicone
Mabs Terflux
UV cured Glue | Nitrile Butadiene (Buna-N)
acrylonitrile-butadiene-styrene
Acrylonitrile Butadiene Styrene
(ABS)
BLACK PEARL C
Thermoplastic Elastomer
Polycarbonate
Phthalate Polyvinyl Chloride
(PVC)
Polypropylene
Buna-N Nitrile
Nickel-Plated Brass
Silicone
Mabs Terflux | Similar
Use of non-
phthalate
polyvinyl
Chloride
material for
tubing |
| Usage | Single Use | Single Use | Identical |
| Feature | Proposed
ENDOGATOR Hybrid
Irrigation tubing | Predicate (K102855)
The Universal Irrigation
Solution Hybrid | Comparison |
| Construction | Threaded Cap,
Irrigation Tube set,
Coaxial Tube,
Backflow Check Valve | Threaded Cap,
Irrigation Tube set,
Coaxial Tube | Different
Backflow
check valve
is added to
prevent the
flow in
reverse
direction.
The
successful
results of
testing
prove that
device is
safe and
effective |
| Energy Used
/ Delivered | None | None | Identical |
Table 1: Physical Description and Technological Properties vs the Predicate Device
6
CANTEL MEDICAL TRADITIONAL PREMARKET NOTIFICATION [510(k)] Page 4 of 6
ENDOC ATORIN Uybrid Friisotion Tubing ENDOGATOR™ Hybrid Irrigation Tubing
7
CANTEL MEDICAL TRADITIONAL PREMARKET NOTIFICATION [510(k)] ENDOGATOR™ Hybrid Irrigation Tubing
6. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
| Testing | Requirements | Results |
|---|---|---|
| Water Flow Rate | Lensing Flow Rate must be no lower | |
| than 10% of Predicate after calling for | ||
| water for 20 seconds | Pass | |
| Insufflation Air & CO2 Flow | Air & CO2 Flow Rate must be no | |
| lower than 10% of the predicate | Pass | |
| Backflow Test | The backflow valve must withstand at | |
| least 10 PSI | Pass | |
| Lens Rinsing Flow Rate | Lensing Flow Rate must be no lower | |
| than 10% of predicate after calling for | ||
| water for 20 seconds | Pass | |
| Durability of glue bonded | ||
| connections | The bonded connections must meet or | |
| exceed 10 lbs of axial pull force and | ||
| must maintain strength and durability | ||
| requirements after being subjected to | ||
| 2X EtO sterilization. | Pass |
Table 2: Non-clinical testing
8
Biocompatibility testing
Biocompatibility of the ENDOGATOR Hybrid™ Irrigation Tubing was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface -Mucosal Membrane" with a contact duration of "Limited (