(60 days)
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.
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 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.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance testing for the Diversatek Healthcare PureFlo™ Irrigation System / Water Bottle Tubing units. While explicit "acceptance criteria" are not listed with numerical thresholds, the document states: "All test results passed, demonstrating that the device is as safe, as effective, and performs as well as or better than the predicate device." This implies that the acceptance criteria were defined by achieving outcomes comparable to or superior to the predicate devices and demonstrating safety and effectiveness.
| Test Performed | Implied Acceptance Criteria (Based on "passed" statement) | Reported Device Performance |
|---|---|---|
| 1. Device Specification Conformation | Device specifications met | Passed |
| 2. Leakage Test | No detectable leaks | Passed |
| 3. Irrigation Tubing Simulated Use Test | Functioned as intended during simulated use | Passed |
| 4. Pinch Clip Test | Pinch clip operated correctly and maintained integrity | Passed |
| 5. Water Bottle Tubing Simulated Use Test | Functioned as intended during simulated use | Passed |
| 6. Backflow Test | No backflow observed | Passed |
| 7. 24-Hour Simulated Use Test | Maintained performance and integrity over 24 hours of simulated use | Passed |
| 8. Tensile Test | Components maintained strength and integrity under tensile forces | Passed |
| Sterilization (EO Gas) | Sterility Assurance Level (SAL) of 10⁻⁶ achieved and maintained for 3 years shelf life | Passed (validated EO cycle, aging validation passed) |
| Biocompatibility (Cytotoxicity) | No cytotoxic effects | Passed |
| Biocompatibility (Sensitization) | No sensitization reactions | Passed |
| Biocompatibility (Intracutaneous Reactivity) | No adverse intracutaneous reactions | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact number of units used for each non-clinical test. It states "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)."
- Data Provenance: The data is from non-clinical bench testing performed by Diversatek Healthcare. It is prospective in the sense that fresh, "to be marketed" devices were used for testing. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was conducted to meet U.S. regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the described study is a non-clinical bench testing study, not a clinical study involving human experts or ground truth in that sense. The "ground truth" for these tests would be the established engineering and biological specifications and performance standards.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reason as point 3. No human experts were involved in adjudicating outcomes for these bench tests. The results were likely assessed against predetermined engineering and biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical bench testing, not a clinical study comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this is not applicable. The device described (irrigation system/water bottle tubing) is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was based on established engineering specifications, performance standards, and biological safety criteria (e.g., ISO 10993-1 for biocompatibility). The claim is for "substantial equivalence" to predicate devices, inferring that the performance benchmarks of the predicate devices also serve as a form of reference.
8. The Sample Size for the Training Set:
This section is not applicable. The device is not an AI/machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
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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)
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) | ||
|---|---|---|
| ☑ 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) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDEDThis 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."
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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.Milwaukee, WI 53212 |
| Establishment Registration No.: | 2183446 |
| Contact Person: | Alyssa RoelliSenior 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 HealthcareIrrigation System | Steris (US Endoscopy)Irrigation System | Comparison |
|---|---|---|---|
| Trade Name | PureFlo™ Irrigation System | Torrent® Irrigation System | N/A |
| 510(k) Number | K222734 | K140405 | N/A |
| FDA ProductCode | OCX | OCX | Identical |
| FDA DeviceName | Endoscopic Irrigation /Suction System | Endoscopic Irrigation /Suction System | Identical |
| FDAClassificationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| FDAClassificationName | Endoscope and Accessories | Endoscope and Accessories | Identical |
| ManufacturingDesign /Materials | The irrigation system ismanufactured using plastictubing, plastic injectionmolded connectors andcaps, and one-way valves. | The irrigation system ismanufactured using plastictubing, plastic injectionmolded connectors and caps,and one-way valves. | Similar |
| PumpCompatibility | • Olympus• Medivators• Boston Scientific• ERBE | • Steris• Olympus• Medivators• ERBE | Similar |
| Intended UseIrrigation System | The Diversatek HealthcarePureFlo™ Irrigation System(tubing and accessories toaccommodate variousgastrointestinal endoscopesand irrigation pumps) isintended to provide irrigationvia irrigation fluids, such assterile water, duringgastrointestinal endoscopic | The Torrent® irrigationsystem (tubing andaccessories to accommodatevarious endoscopes andirrigation pumps) is intendedto provide irrigation viairrigation fluids, such assterile water, duringgastrointestinal endoscopicprocedures when used in | Similar |
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Healthcare
| Characteristic | Diversatek HealthcareIrrigation System | Steris (US Endoscopy)Irrigation System | Comparison |
|---|---|---|---|
| Intended UseAuxiliary WaterJet Connector | procedures when used inconjunction with an irrigationpump or electrosurgical unit.The Diversatek HealthcarePureFlo™ Auxiliary WaterJet Connector is used inconjunction with thePureFlo™ Irrigation Tubingand is intended to provideirrigation via irrigation fluidssuch as sterile watersupplied duringgastrointestinal endoscopicprocedures when used inconjunction with an irrigationpump or electrosurgical unit. | conjunction with an irrigationpump or electrosurgical unit.The Torrent® irrigation scopeconnector is used inconjunction with the Torrent®irrigation tubing (tubing andaccessories to accommodatevarious endoscopes andirrigation pumps) and areintended to provide irrigationvia irrigations fluids such assterile water supplied duringgastrointestinal endoscopicprocedures when used inconjunction with an irrigationpump (or electrosurgical unit). | Similar |
| PatientPopulation | Patients undergoing anendoscopic procedure | Patients undergoing anendoscopic procedure | Identical |
| Patient ContactCategorization | Indirect, Mucosal Membrane,Limited Duration | Indirect, Mucosal Membrane,Limited Duration | Identical |
| SterilizationMethod | EO Gas | EO Gas | Identical |
| Duration ofUsage | 24-Hour, Multi-Patient(Irrigation Tubing)Single Patient Use(Auxiliary Water JetConnector) | 24-Hour, Multi-Patient(Irrigation Tubing)Single Patient Use(Irrigation Scope Connector) | Identical |
| Shelf Life | 3 Years(Irrigation Tubing)3 Years(Auxiliary Water JetConnector) | 1 Year(Irrigation Tubing)3 Years(Irrigation Scope Connector) | Different |
Table 5.2 Diversatek Healthcare and the Predicate Steris (US Endoscopy) Water Bottle Tubing Technological Characteristics
| Characteristic | Diversatek HealthcareWater Bottle Tubing | Steris (US Endoscopy)Water Bottle Tubing | Comparison |
|---|---|---|---|
| Trade Name | PureFlo™ Water BottleTubing | AquaShield® System | N/A |
| 510(k) Number | K222734 | K101146 | N/A |
| FDA ProductCode | FEQ | FEQ | Identical |
| FDA DeviceName | Pump, Air, Non-Manual, ForEndoscope | Pump, Air, Non-Manual, ForEndoscope | Identical |
| FDAClassificationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
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| Characteristic | Diversatek HealthcareWater Bottle Tubing | Steris (US Endoscopy)Water Bottle Tubing | Comparison |
|---|---|---|---|
| FDAClassificationName | Endoscope and Accessories | Endoscope and Accessories | Identical |
| ManufacturingDesign /Materials | The water bottle tubing ismanufactured using plastictubing, plastic injectionmolded connectors, a plasticcap and a plastic pinch clip. | The water bottle tubing ismanufactured using plastictubing, plastic injectionmolded connectors, a plasticcap and a plastic pinch clip. | Similar |
| ScopeCompatibility | Olympus | Olympus | Identical |
| Intended Use | The Diversatek HealthcarePureFlo™ Water BottleTubing is intended to be usedwith an air source from anendoscope with the purposeof supplying sterile water tothe endoscope duringendoscopic procedures. It iscompatible with U.S.commercially available sterilewater bottles. | The AquaShield® system isintended to be used with anair source from an endoscopewith the purpose of supplyingsterile water to theendoscope during endoscopicprocedures. It is compatiblewith U.S. commerciallyavailable sterile water bottles. | Similar |
| PatientPopulation | Patients undergoing anendoscopic procedure | Patients undergoing anendoscopic procedure | Identical |
| Patient ContactCategorization | Indirect, Mucosal Membrane,Limited Duration | Indirect, Mucosal Membrane,Limited Duration | Identical |
| SterilizationMethod | EO Gas | EO Gas | Identical |
| Duration ofUsage | 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 HealthcareWater Bottle Tubing CO2 | Steris (US Endoscopy)Water Bottle Tubing CO2 | Comparison |
|---|---|---|---|
| Trade Name | PureFlo™ Water BottleTubing CO2 | AquaShield® System CO2 | N/A |
| 510(k) Number | K222734 | K191559 | N/A |
| FDA ProductCode | FEQ | FEQ | Identical |
| FDA DeviceName | Pump, Air, Non-Manual, ForEndoscope | Pump, Air, Non-Manual, ForEndoscope | Identical |
| FDAClassificationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| FDAClassificationName | Endoscope and Accessories | Endoscope and Accessories | Identical |
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Div!
| Healthcare | ||
|---|---|---|
| Characteristic | Diversatek HealthcareWater Bottle Tubing CO2 | Steris (US Endoscopy)Water Bottle Tubing CO2 | Comparison |
|---|---|---|---|
| ManufacturingDesign /Materials | The water bottle tubing CO2 ismanufactured using plastictubing, plastic injectionmolded connectors, a plasticcap, a filter housed in amolded plastic part, andplastic pinch clips. | The water bottle tubing CO2 ismanufactured using plastictubing, plastic injectionmolded connectors, a plasticcap, a filter housed in amolded plastic part, andplastic pinch clips. | Similar |
| ScopeCompatibility | Olympus | Olympus | Identical |
| Intended Use | The Diversatek HealthcarePureFlo™ Water BottleTubing CO2 is intended to beused with an air or carbondioxide (CO2) source with thepurpose of supplying sterilewater to the endoscopeduring endoscopicprocedures. It is compatiblewith U.S. commerciallyavailable sterile water bottles. | The AquaShield® systemCO2 is intended to be usedwith an air or carbon dioxide(CO2) source with thepurpose of supplying sterilewater to the endoscopeduring endoscopicprocedures. It is compatiblewith U.S. commerciallyavailable sterile water bottles. | Similar |
| PatientPopulation | Patients undergoing anendoscopic procedure | Patients undergoing anendoscopic procedure | Identical |
| Patient ContactCategorization | Indirect, Mucosal Membrane,Limited Duration | Indirect, Mucosal Membrane,Limited Duration | Identical |
| SterilizationMethod | EO Gas | EO Gas | Identical |
| Duration ofUsage | 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.
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- Device Specification Conformation
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- Leakage Test
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- Irrigation Tubing Simulated Use Test
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- Pinch Clip Test
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- Water Bottle Tubing Simulated Use Test
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- Backflow Test
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- 24-Hour Simulated Use Test
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- 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.
§ 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.