(28 days)
Not Found
No
The description focuses on the mechanical function of tubing and accessories for irrigation, with no mention of AI or ML capabilities.
No
The device provides irrigation during GI endoscopic procedures; it does not treat a disease or condition.
No
The device is an irrigation tubing system used during GI endoscopic procedures to supply sterile water; it does not collect or analyze any physiological data to determine the presence or characteristics of a disease or condition.
No
The device description explicitly details physical components (tubing, accessories, back flow valve) and their function in delivering irrigation fluid, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide irrigation during GI endoscopic procedures. This is a procedural aid, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical components and their function in delivering irrigation fluid. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting markers, analyzing genetic material, or any other activity typically associated with in vitro diagnostics.
The device is a medical device used during a medical procedure (endoscopy) to facilitate that procedure. It does not provide diagnostic information about a patient's condition based on testing samples outside the body.
N/A
Intended Use / Indications for Use
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).
Product codes
FEQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI
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
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 |
Key Metrics
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
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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) |
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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).