Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
Device Facts
| Record ID | K222734 |
|---|---|
| Device Name | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing |
| Applicant | Diversatek Healthcare |
| Product Code | OCX · Gastroenterology, Urology |
| Decision Date | Nov 8, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
The Diversatek Healthcare PureFlo™ Irrigation System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit. The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit. The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles. The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
Device Story
System comprises irrigation tubing, auxiliary water jet connectors, and water bottle tubing; provides sterile water irrigation during GI endoscopy. Tubing connects to sterile water bottles and endoscope auxiliary ports or air/water ports; utilizes irrigation pumps, electrosurgical units, or CO2 insufflators for fluid delivery. Operated by clinical staff in endoscopic settings. Foot pedal activation controls flow. Auxiliary connectors are single-patient use; tubing is multi-patient use (up to 24 hours). Provides visualization/cleaning benefits during procedures. No software or electronic processing involved.
Clinical Evidence
Bench testing only. No clinical data. Testing included device specification conformation, leakage, simulated use (irrigation and 24-hour), pinch clip, backflow, and tensile testing. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity) performed per ISO 10993-1.
Technological Characteristics
Materials: plastic tubing, injection-molded connectors, caps, one-way valves, pinch clips, and filters. Energy source: external irrigation pump, electrosurgical unit, or CO2 insufflator. Connectivity: mechanical interface to endoscope ports. Sterilization: EO gas (SAL 10^-6). Shelf life: 3 years.
Indications for Use
Indicated for patients undergoing gastrointestinal endoscopic procedures requiring irrigation fluids (e.g., sterile water) supplied via irrigation pump, electrosurgical unit, air source, or CO2 source.
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
- Torrent® Irrigation System (K140405)
- AquaShield® System (Water Bottle Cap System) (K101146)
- AquaShield® System CO2 (K191559)
Related Devices
- K103239 — IRRIGATION SYSTEM · United States Endoscopy Group, Inc. · Dec 30, 2010
- K193250 — Irrigation Tubing with CO2 or Air · Keymed (Medical and Industrial Equipment) , Ltd. · Apr 6, 2020
- K220395 — EndoGator Endoscopy Irrigation Tubing · STERIS Corporation · Mar 11, 2022
- K161482 — EndoChoice Water Bottle Cap Irrigation System · Endochoice, Inc. · Jun 27, 2016
- K140405 — TORRENT IRRIGATION SYSTEM · United States Endoscopy Group, Inc. · Mar 12, 2014
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 8, 2022
Diversatek Healthcare Alyssa Roelli Senior Regulatory Projects Manager 102 E. Keefe Ave. Milwaukee, WI 53212
Re: K222734
Trade/Device Name: Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX, FEQ Dated: September 7, 2022 Received: September 9, 2022
Dear Alyssa Roelli:
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
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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 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
#### 510(k) Number (if known)
K222734
#### Device Name
Diversatek Healthcare PureFlo™ Irrigation System / Water Bottle Tubing
#### Indications for Use (Describe)
The Diversatek Healthcare PureFlo™ System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
| Type of Use (Select one or both, as applicable) | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------|
| <table style="border:none"><tr><td>☑ Prescription Use (Part 21 CFR 801 Subpart D)</td><td>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
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Image /page/3/Picture/1 description: The image shows the logo for Diversatek Healthcare. The word "Diversatek" is in bold, black font on the top line. The word "Healthcare" is in a lighter, gray font on the bottom line.
# 510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
#### 1. Submission Sponsor and Contact
| Submitter's Name: | Diversatek Healthcare |
|---------------------------------|-----------------------------------------------------|
| Submitter's Address: | 102 E. Keefe Ave.<br>Milwaukee, WI 53212 |
| Establishment Registration No.: | 2183446 |
| Contact Person: | Alyssa Roelli<br>Senior Regulatory Projects Manager |
| Telephone: | 414-265-7620 x4814 |
| Fax | 414-265-7628 |
| Email: | aroelli@diversatek.com |
| Date Prepared: | August 10, 2022 |
### 2. Device Identification
| Trade Device Name: | Diversatek Healthcare PureFlo™ Irrigation System / Water Bottle Tubing |
|------------------------|------------------------------------------------------------------------|
| Common Device Name: | Irrigation System / Water Bottle Tubing |
| FDA Product Codes: | OCX, FEQ |
| FDA Device Names: | Endoscopic Irrigation / Suction System; Pump, Air, Non-Manual, For |
| | Endoscope |
| Classification Number: | 21 CFR 876.1500 |
| Classification Name: | Endoscope and accessories |
| Regulatory Class: | 2 |
# 3. Predicate Device Identification
In order to properly cover the entire product range of the application, multiple predicates have been selected.
# Primary Predicate Device
Predicate 510(k) No.: Predicate Trade Device Name: Predicate FDA Product Code: Predicate FDA Device Name: Predicate Classification Number: Predicate Classification Name: Predicate Regulatory Class:
K140405 Torrent® Irrigation System ОСХ Endoscopic Irrigation / Suction System 21 CFR 876.1500 Endoscope and Accessories 2
#### DiversatekHealthcare.com
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Page | 5.2
# Secondary Predicate Device
Predicate 510(k) No .: Predicate Trade Device Name: Predicate FDA Product Code: Predicate FDA Device Name: Predicate Classification Number: Predicate Classification Name: Predicate Requlatory Class:
K101146 AquaShield® System (Water Bottle Cap System) FEQ Pump, Air, Non-Manual, For Endoscope 21 CFR 876.1500 Endoscope and Accessories 2
# Secondary Predicate Device
Predicate 510(k) No .: Predicate Trade Device Name: Predicate FDA Product Code: Predicate FDA Device Name: Predicate Classification Number: Predicate Classification Name: Predicate Regulatory Class:
K191559 AquaShield® System CO2 FEQ Pump, Air, Non-Manual, For Endoscope 21 CFR 876.1500 Endoscope and Accessories 2
# 4. General Device Description
This submission includes the Diversatek Healthcare PureFlo™ Irrigation System and Water Bottle Tubing. All devices within this submission are provided sterile.
The Diversatek Healthcare PureFlo™ Irrigation System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The irrigation system consists of irrigation tubing and a single-use auxiliary water jet connector. The tubing is inserted into a water bottle and the cap is screwed on the water bottle. The roller pump tubing of the irrigation tubing is then positioned within one of the specified pumps. The tubing is then connected to the auxiliary water jet connector. The auxiliary water jet connector is then connected to the auxiliary water port of the endoscope. To activate the flow of water, the foot pedal of the pump is pressed. The tubing should be primed prior to insertion of the endoscope in the patient.
The auxiliary water jet connector is replaced after each patient. The irrigation tubing can be used for up to 24 hours on multiple patients.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the
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Image /page/5/Picture/1 description: The image shows the logo for Diversatek Healthcare. The word "Diversatek" is in bold, black font, with the "Healthcare" in a smaller, gray font underneath. The logo is simple and professional.
endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
With the pinch clip open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the Gl endoscope. The tubing is then primed prior to insertion of the endoscope in the patient.
The water bottle tubing can be used for up to 24 hours on multiple patients.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
The PureFlo™ Water Bottle Tubing CO2 is used with either air or CO2.
If using with air: With both blue and white pinch clips open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the GI endoscope. The white pinch clamp is then closed. The tubing is then primed prior to insertion of the endoscope in the patient.
If using with CO2: With both blue and white pinch clips open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the GI endoscope. The CO2 Connector / Luer Lock is then connected to the luer lock connection on the CO2 insufflator. The CO2 source and insufflator is then turned on. Then turn on the light source of the processor. The tubing is then primed prior to insertion of the endoscope in the patient.
The water bottle tubing CO2 can be used for up to 24 hours on multiple patients.
### 5. Intended Use
The Diversatek Healthcare PureFlo™ Irrigation System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
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Image /page/6/Picture/1 description: The image shows the logo for Diversatek Healthcare. The word "Diversatek" is in bold, black font, and the word "Healthcare" is in a lighter, gray font. The logo is simple and modern, and it is likely used on the company's website and marketing materials.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO)) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
# 6. Technological Characteristics
The following three tables include summaries of the Diversatek Healthcare technological characteristics as compared to the predicate devices manufactured by Steris (US Endoscopy).
For the Irrigation System, there is a separate Intended Use for the Auxiliary Water Jet Connector, which is a consumable accessory used within the Irrigation System. The Intended Use is the same as the predicate device manufactured by Steris (US Endoscopy) as listed in their IFU.
| Table 5.1 Diversatek Healthcare and the Predicate Steris (US Endoscopy) Irrigation System | |
|-------------------------------------------------------------------------------------------|--|
| Technological Characteristics | |
| Characteristic | Diversatek Healthcare<br>Irrigation System | Steris (US Endoscopy)<br>Irrigation System | Comparison |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | PureFlo™ Irrigation System | Torrent® Irrigation System | N/A |
| 510(k) Number | K222734 | K140405 | N/A |
| FDA Product<br>Code | OCX | OCX | Identical |
| FDA Device<br>Name | Endoscopic Irrigation /<br>Suction System | Endoscopic Irrigation /<br>Suction System | Identical |
| FDA<br>Classification<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| FDA<br>Classification<br>Name | Endoscope and Accessories | Endoscope and Accessories | Identical |
| Manufacturing<br>Design /<br>Materials | The irrigation system is<br>manufactured using plastic<br>tubing, plastic injection<br>molded connectors and<br>caps, and one-way valves. | The irrigation system is<br>manufactured using plastic<br>tubing, plastic injection<br>molded connectors and caps,<br>and one-way valves. | Similar |
| Pump<br>Compatibility | • Olympus<br>• Medivators<br>• Boston Scientific<br>• ERBE | • Steris<br>• Olympus<br>• Medivators<br>• ERBE | Similar |
| Intended Use<br>Irrigation System | The Diversatek Healthcare<br>PureFlo™ Irrigation System<br>(tubing and accessories to<br>accommodate various<br>gastrointestinal endoscopes<br>and irrigation pumps) is<br>intended to provide irrigation<br>via irrigation fluids, such as<br>sterile water, during<br>gastrointestinal endoscopic | The Torrent® irrigation<br>system (tubing and<br>accessories to accommodate<br>various endoscopes and<br>irrigation pumps) is intended<br>to provide irrigation via<br>irrigation fluids, such as<br>sterile water, during<br>gastrointestinal endoscopic<br>procedures when used in | Similar |
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**Healthcare**
| Characteristic | Diversatek Healthcare<br>Irrigation System | Steris (US Endoscopy)<br>Irrigation System | Comparison |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use<br>Auxiliary Water<br>Jet Connector | procedures when used in<br>conjunction with an irrigation<br>pump or electrosurgical unit.<br>The Diversatek Healthcare<br>PureFlo™ Auxiliary Water<br>Jet Connector is used in<br>conjunction with the<br>PureFlo™ Irrigation Tubing<br>and is intended to provide<br>irrigation via irrigation fluids<br>such as sterile water<br>supplied during<br>gastrointestinal endoscopic<br>procedures when used in<br>conjunction with an irrigation<br>pump or electrosurgical unit. | conjunction with an irrigation<br>pump or electrosurgical unit.<br>The Torrent® irrigation scope<br>connector is used in<br>conjunction with the Torrent®<br>irrigation tubing (tubing and<br>accessories to accommodate<br>various endoscopes and<br>irrigation pumps) and are<br>intended to provide irrigation<br>via irrigations fluids such as<br>sterile water supplied during<br>gastrointestinal endoscopic<br>procedures when used in<br>conjunction with an irrigation<br>pump (or electrosurgical unit). | Similar |
| Patient<br>Population | Patients undergoing an<br>endoscopic procedure | Patients undergoing an<br>endoscopic procedure | Identical |
| Patient Contact<br>Categorization | Indirect, Mucosal Membrane,<br>Limited Duration | Indirect, Mucosal Membrane,<br>Limited Duration | Identical |
| Sterilization<br>Method | EO Gas | EO Gas | Identical |
| Duration of<br>Usage | 24-Hour, Multi-Patient<br>(Irrigation Tubing)<br>Single Patient Use<br>(Auxiliary Water Jet<br>Connector) | 24-Hour, Multi-Patient<br>(Irrigation Tubing)<br>Single Patient Use<br>(Irrigation Scope Connector) | Identical |
| Shelf Life | 3 Years<br>(Irrigation Tubing)<br>3 Years<br>(Auxiliary Water Jet<br>Connector) | 1 Year<br>(Irrigation Tubing)<br>3 Years<br>(Irrigation Scope Connector) | Different |
#### Table 5.2 Diversatek Healthcare and the Predicate Steris (US Endoscopy) Water Bottle Tubing Technological Characteristics
| Characteristic | Diversatek Healthcare<br>Water Bottle Tubing | Steris (US Endoscopy)<br>Water Bottle Tubing | Comparison |
|---------------------------------|----------------------------------------------|----------------------------------------------|------------|
| Trade Name | PureFlo™ Water Bottle<br>Tubing | AquaShield® System | N/A |
| 510(k) Number | K222734 | K101146 | N/A |
| FDA Product<br>Code | FEQ | FEQ | Identical |
| FDA Device<br>Name | Pump, Air, Non-Manual, For<br>Endoscope | Pump, Air, Non-Manual, For<br>Endoscope | Identical |
| FDA<br>Classification<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
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| Characteristic | Diversatek Healthcare<br>Water Bottle Tubing | Steris (US Endoscopy)<br>Water Bottle Tubing | Comparison |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| FDA<br>Classification<br>Name | Endoscope and Accessories | Endoscope and Accessories | Identical |
| Manufacturing<br>Design /<br>Materials | The water bottle tubing is<br>manufactured using plastic<br>tubing, plastic injection<br>molded connectors, a plastic<br>cap and a plastic pinch clip. | The water bottle tubing is<br>manufactured using plastic<br>tubing, plastic injection<br>molded connectors, a plastic<br>cap and a plastic pinch clip. | Similar |
| Scope<br>Compatibility | Olympus | Olympus | Identical |
| Intended Use | The Diversatek Healthcare<br>PureFlo™ Water Bottle<br>Tubing is intended to be used<br>with an air source from an<br>endoscope with the purpose<br>of supplying sterile water to<br>the endoscope during<br>endoscopic procedures. It is<br>compatible with U.S.<br>commercially available sterile<br>water bottles. | The AquaShield® system is<br>intended to be used with an<br>air source from an endoscope<br>with the purpose of supplying<br>sterile water to the<br>endoscope during endoscopic<br>procedures. It is compatible<br>with U.S. commercially<br>available sterile water bottles. | Similar |
| Patient<br>Population | Patients undergoing an<br>endoscopic procedure | Patients undergoing an<br>endoscopic procedure | Identical |
| Patient Contact<br>Categorization | Indirect, Mucosal Membrane,<br>Limited Duration | Indirect, Mucosal Membrane,<br>Limited Duration | Identical |
| Sterilization<br>Method | EO Gas | EO Gas | Identical |
| Duration of<br>Usage | 24-Hour, Multi-Patient | 24-Hour, Multi-Patient | Identical |
| Shelf Life | Three Years | One Year | Different |
#### Table 5.3 Diversatek Healthcare and the Predicate Steris (US Endoscopy) Water Bottle Tubing CO2 Technological Characteristics
| Characteristic | Diversatek Healthcare<br>Water Bottle Tubing CO2 | Steris (US Endoscopy)<br>Water Bottle Tubing CO2 | Comparison |
|---------------------------------|--------------------------------------------------|--------------------------------------------------|------------|
| Trade Name | PureFlo™ Water Bottle<br>Tubing CO2 | AquaShield® System CO2 | N/A |
| 510(k) Number | K222734 | K191559 | N/A |
| FDA Product<br>Code | FEQ | FEQ | Identical |
| FDA Device<br>Name | Pump, Air, Non-Manual, For<br>Endoscope | Pump, Air, Non-Manual, For<br>Endoscope | Identical |
| FDA<br>Classification<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| FDA<br>Classification<br>Name | Endoscope and Accessories | Endoscope and Accessories | Identical |
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# Div!
| | Healthcare | |
|--|------------|--|
| | | |
| Characteristic | Diversatek Healthcare<br>Water Bottle Tubing CO2 | Steris (US Endoscopy)<br>Water Bottle Tubing CO2 | Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturing<br>Design /<br>Materials | The water bottle tubing CO2 is<br>manufactured using plastic<br>tubing, plastic injection<br>molded connectors, a plastic<br>cap, a filter housed in a<br>molded plastic part, and<br>plastic pinch clips. | The water bottle tubing CO2 is<br>manufactured using plastic<br>tubing, plastic injection<br>molded connectors, a plastic<br>cap, a filter housed in a<br>molded plastic part, and<br>plastic pinch clips. | Similar |
| Scope<br>Compatibility | Olympus | Olympus | Identical |
| Intended Use | The Diversatek Healthcare<br>PureFlo™ Water Bottle<br>Tubing CO2 is intended to be<br>used with an air or carbon<br>dioxide (CO2) source with the<br>purpose of supplying sterile<br>water to the endoscope<br>during endoscopic<br>procedures. It is compatible<br>with U.S. commercially<br>available sterile water bottles. | The AquaShield® system<br>CO2 is intended to be used<br>with an air or carbon dioxide<br>(CO2) source with the<br>purpose of supplying sterile<br>water to the endoscope<br>during endoscopic<br>procedures. It is compatible<br>with U.S. commercially<br>available sterile water bottles. | Similar |
| Patient<br>Population | Patients undergoing an<br>endoscopic procedure | Patients undergoing an<br>endoscopic procedure | Identical |
| Patient Contact<br>Categorization | Indirect, Mucosal Membrane,<br>Limited Duration | Indirect, Mucosal Membrane,<br>Limited Duration | Identical |
| Sterilization<br>Method | EO Gas | EO Gas | Identical |
| Duration of<br>Usage | 24-Hour, Multi-Patient | 24-Hour, Multi-Patient | Identical |
| Shelf Life | Three Years | One Year | Different |
# 7. Non-Clinical Performance Testing
Diversatek Healthcare performed bench testing to support substantial equivalence. The following testing was performed on Diversatek Healthcare samples from final, finished devices that were subjected to all manufacturing processes for the "to be marketed" device (including sterilization, environmental conditioning, and transportation). All test results passed, demonstrating that the device is as safe, as effective, and performs as well as or better than the predicate device.
- 1. Device Specification Conformation
- 2. Leakage Test
- 3. Irrigation Tubing Simulated Use Test
- 4. Pinch Clip Test
- 5. Water Bottle Tubing Simulated Use Test
- 6. Backflow Test
- 7. 24-Hour Simulated Use Test
- 8. Tensile Test
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# 8. Sterilization / Shelf Life
All the devices within this submission are sold in a sterile package with a three year shelf life. The devices have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10°. An aging validation was performed on the final, finished devices within this submission to confirm product sterility throughout the life of the product. The devices passed all pre-established acceptance criteria of the validation.
### 9. Biocompatibility
Biocompatibility testing was performed on the sterile, final, finished devices per FDA Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The testing included Cytotoxicity, Sensitization, and Intracutaneous Reactivity. The devices are categorized as surface devices with mucosal membrane contact for a limited duration (≤24 hours). All devices passed pre-established acceptance criteria for the testing.
### 10. Conclusion
Based on the intended use, technological characteristics and overall performance of the devices in bench testing, Diversatek Healthcare believes the proposed Irrigation System and Water Bottle Tubing and the predicate devices are substantially equivalent.
Through risk assessment and bench testing, Diversatek Healthcare has concluded the Irrigation System and Water Bottle Tubing does not raise any new issues of safety and effectiveness and performs as well as the legally marketed predicate devices.
