(221 days)
The Navina Systems are indicated for use for children (2 - < 12 years old), adolescents (12 - < 18 years old), and transitional adolescents (18 - < 21 vears old) neurogenic bowel dysfunction, congental disorders such as Hirschsprung disease or anorectal malformations, fecal incontinence or chronic constipation where therapies are not successful, as well as, for adults who suffer from fecal incontinence, chronic consuming bowel management. Use for pediative patients is to be performed under the supervision of a trained healthcare professional or adult caregiver. By instilling water up into the lower part of the colon, the Navina Systems promote evacuation of the contents of the colon and rectum.
The Navina Small Rectal Balloon catheter is limited to use for adolescent (12 - <18 years old) and transtional adolescent (18 - < 21 years old) patients and adults. The Navina Regular Rectal Balloon catheter is limited to use for adults. The Navina Cone catheter is limited to use for children (2 - < 12 years old), adolescent (12 - < 18 years old) and transitional adolescent (18 - < 21 years old) patients and adults.
The subject Navina Smart System is an electronically controlled, trans-anal irrigation system. The subject Navina Smart System consists of an electronic control unit, a water container and tubing set for water instillation, single-use, disposable rectal balloon catheters in two sizes (regular or small), and a disposable rectal cone catheter. The water container, tubing set and the regular (size) rectal balloon catheter utilized with the Navina Smart System are identical to the same components cleared under the original clearance of the predicate Navina Classic System in premarket notification, K170487.
With the Navina Smart control unit, the user controls water volume, irrigation speed, and rectal catheter balloon inflation. The Navina Smart system includes a mobile application in which users can save treatment data and rate their irrigation. The Navina Smart mobile application facilitates tracking of TAI treatment data (e.g., treatment duration, water volume used, rectal balloon size, etc.) but does not function in any way to control the function of the Navina Smart System itself.
The Navina Classic System is a manually operated trans-anal irrigation (TAI) system. The Navina Classic System, as subject of this "bundled" 510(k), consists of a manual control unit, a water container and tubing set for water instillation, single-use, disposable rectal balloon catheters in two sizes (regular or small), and a disposable rectal cone catheter. The water container, tubing set, and regular (size) rectal balloon catheter are identical to the same Navina Classic System components that were cleared under the system's original clearance in the predicate premarket notification, K170487.
This document describes the Dentsply Sirona Navina Smart System and Navina Classic System, trans-anal irrigation (TAI) systems. The submission is a 510(k) premarket notification (K190977) for the introduction of the Navina Smart System and modification of the Navina Classic System.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance values. Instead, it lists the types of performance tests conducted and states that "The results of the testing conducted in conformity with applicable standards support substantial equivalence." This implies that the devices met the performance requirements defined by these standards.
Here's an organized view of the performance testing categories:
| Acceptance Criteria Category (Implied by Test Type) | Reported Device Performance (Implicitly Met) |
|---|---|
| Control Unit Performance | |
| Control of air leakage | Met applicable standards |
| Complete deflation of balloon (air release) | Met applicable standards |
| Ability to instantly stop waterflow | Met applicable standards |
| Control of water flow rate | Met applicable standards |
| Control of water back flow | Met applicable standards |
| Setting of balloon size (Navina Smart System) | Met applicable standards |
| Small Rectal Catheter Performance | |
| Balloon burst volume | Met applicable standards |
| Flexibility | Met applicable standards |
| Even balloon inflation | Met applicable standards |
| Balloon burst diameter | Met applicable standards |
| Rectal catheter flow rate | Met applicable standards |
| Rectal catheter after catheter kink | Met applicable standards |
| Hydrophilic coating | Met applicable standards |
| Conical Rectal Catheter Performance | |
| Hydrophilic coating at insertion and withdrawal | Met applicable standards |
| Bonding strength between the catheter body and conical component | Met applicable standards |
| Software Verification & Validation | |
| Compliance with IEC 60601-1 (Basic safety and essential performance) | Met applicable standards |
| Compliance with IEC 60601-1-11 (Home healthcare environment) | Met applicable standards |
| Compliance with IEC 60601-1-2 (Electromagnetic disturbances) | Met applicable standards |
| Compliance with IEC 60601-1-6 (Usability) | Met applicable standards |
| Compliance with IEC 62304 (Software Life Cycle Processes) | Met applicable standards |
| Compliance with IEC 62133 (Secondary Cells and Batteries Saftey) | Met applicable standards |
| Compliance with IEC 62366-1 (Usability Engineering) | Met applicable standards |
| Biocompatibility | |
| Simulated use extraction (ISO 10993-12) | Supported substantial equivalence |
| Chemical characterization | Supported substantial equivalence |
| Toxicological analysis and assessment | Supported substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing and does not provide details on the sample sizes for these tests. It states that the testing was conducted to support substantial equivalence and addressed new components not part of the original clearance (K170487).
Regarding data provenance, the testing appears to be internal performance testing conducted by the manufacturer, Dentsply Sirona. The tests are for device components and software, not human subject data. Therefore, notions of "country of origin of the data" or "retrospective/prospective" studies are not directly applicable in the sense of clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance testing described is non-clinical, focusing on engineering and safety standards for the device itself. Therefore, the concept of "ground truth" as established by medical experts for a diagnostic or clinical outcome is not directly relevant here.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given that the performance testing is non-clinical and related to engineering standards, an adjudication method in the context of human interpretation or clinical endpoints would not typically be applicable. The tests likely have objective pass/fail criteria based on measured parameters and compliance with stated standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The Navina Smart System and Navina Classic System are trans-anal irrigation devices, not diagnostic AI systems that assist human readers in interpreting medical images or data. The Navina Smart system includes a mobile application for tracking data, but it does not function to control the device or provide AI assistance to human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Navina Smart System includes an "electronically controlled, trans-anal irrigation system" with a control unit that manages water volume, irrigation speed, and balloon inflation. It also has a mobile application for tracking treatment data.
While the control unit operates with programmed logic (an "algorithm"), the performance testing described (Control of air leakage, Complete deflation of balloon, Ability to instantly stop waterflow, Control of water flow rate, Control of water back flow, Setting of balloon size) represents a form of standalone testing for the functions controlled by the device's embedded software. This is not "algorithm only" in the sense of an AI model making a recommendation, but rather the functional performance of the electromechanical system. The mobile application facilitates tracking but does not function in any way to control the function of the Navina Smart System itself. So, the core function of water instillation and balloon inflation is a standalone device operation.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the non-clinical performance testing described, the "ground truth" would be the engineering specifications and applicable international standards (e.g., IEC 60601 series, IEC 62304, IEC 62133, IEC 62366-1, ISO 10993-12). The devices are tested against physical and functional requirements defined by these standards and the manufacturer's design specifications.
8. The Sample Size for the Training Set
This information is not provided as there is no mention of a "training set" in the context of machine learning or AI model development. The Navina Smart System and Navina Classic System are medical devices with electromechanical components and software, not AI algorithms that are trained on large datasets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for an AI model mentioned in the document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2019
Dentsply Sirona Karl Nittinger Director Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, PA 17401
Re: K190977
Trade/Device Name: Navina Smart System and Navina Classic System Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, FCE Dated: October 22, 2019 Received: October 23, 2019
Dear Karl Nittinger:
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
{1}------------------------------------------------
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 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,
For: Daniel Walter, Jr 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) K190977
Device Name
Navina Smart System and Navina Classic System
Indications for Use (Describe)
The Navina Systems are indicated for use for children (2 - < 12 years old), adolescents (12 - < 18 years old), and transitional adolescents (18 - < 21 vears old) neurogenic bowel dysfunction, congental disorders such as Hirschsprung disease or anorectal malformations, fecal incontinence or chronic constipation where therapies are not successful, as well as, for adults who suffer from fecal incontinence, chronic consuming bowel management. Use for pediative patients is to be performed under the supervision of a trained healthcare professional or adult caregiver. By instilling water up into the lower part of the colon, the Navina Systems promote evacuation of the contents of the colon and rectum.
The Navina Small Rectal Balloon catheter is limited to use for adolescent (12 - <18 years old) and transtional adolescent (18 - < 21 years old) patients and adults. The Navina Regular Rectal Balloon catheter is limited to use for adults. The Navina Cone catheter is limited to use for children (2 - < 12 years old), adolescent (12 - < 18 years old) and transitional adolescent (18 - < 21 years old) patients and adults.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| CONTINUE ON A SEPARATE PAGE IF NEEDED |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image shows the text "K190977" at the top, followed by "Page 1 of 18" highlighted in yellow. Below that is the Dentsply Sirona logo, with the Dentsply Sirona name in a sans-serif font. The logo is a stylized, abstract shape to the left of the company name.
510(k) UMMARY
For K190977
Navina Smart System and Navina Classic System
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
- Submitter Information:
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
Date Prepared: November 21, 2019
2. Device Name:
- Proprietary Name: Navina Smart System and Navina Classic System ●
- . Classification Name: 876.5980 (Gastrointestinal Tubes and Accessories) 876.5210 (Enema Kit) ● Device Class: II
- Primary Product Code: ● KNT [Tubes, Gastrointestinal (And Accessories)]
- Secondary Product Code: FCE [Enema Kit] ●
Predicate Devices: 3.
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Navina Classic System | K170487 | Dentsply Sirona |
| Peristeen Anal Irrigation System | K140310 | Coloplast A/S |
4. Description of Device:
The purpose of this bundled 510(k) premarket notification is for the introduction of the Navina Smart System and the modification of the existing Navina Classic System, previously cleared in premarket notification K170487. The Navina Smart System and Navina Classic System are trans-anal irrigation (TAI) systems intended to assist in the management of bowel dysfunction.
The subject Navina Smart System is an electronically controlled, trans-anal irrigation system. The subject Navina Smart System consists of an electronic control unit, a water container and tubing set for water instillation, single-use, disposable rectal balloon catheters in two sizes (regular or small), and a disposable rectal cone catheter. The water container, tubing set and the regular (size) rectal balloon catheter utilized with the Navina Smart System are identical to the same components cleared under the original clearance of the predicate Navina Classic System in premarket notification, K170487.
{4}------------------------------------------------
With the Navina Smart control unit, the user controls water volume, irrigation speed, and rectal catheter balloon inflation. The Navina Smart system includes a mobile application in which users can save treatment data and rate their irrigation. The Navina Smart mobile application facilitates tracking of TAI treatment data (e.g., treatment duration, water volume used, rectal balloon size, etc.) but does not function in any way to control the function of the Navina Smart System itself.
The Navina Classic System is a manually operated trans-anal irrigation (TAI) system. The Navina Classic System, as subject of this "bundled" 510(k), consists of a manual control unit, a water container and tubing set for water instillation, single-use, disposable rectal balloon catheters in two sizes (regular or small), and a disposable rectal cone catheter. The water container, tubing set, and regular (size) rectal balloon catheter are identical to the same Navina Classic System components that were cleared under the system's original clearance in the predicate premarket notification, K170487.
-
- Indications for Use:
Navina Smart System and Navina Classic System
The Navina Systems are indicated for use for children (2 - < 12 years old), adolescents (12 - < 18 years old), and transitional adolescents (18 - <21 years old) patients with neurogenic bowel dysfunction, congenital disorders such as Hirschsprung disease or anorectal malformations, fecal incontinence or chronic constipation where less invasive therapies are not successful, as well as, for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management. Use for pediatric patients is to be performed under the supervision of a trained healthcare professional or adult caregiver. By instilling water up into the lower part of the colon, the Navina Systems promote evacuation of the contents of the colon and rectum.
The Navina Small Rectal Balloon catheter is limited to use for adolescent (12 - <18 years old) and transitional adolescent (18 - < 21 years old) patients and adults. The Navina Regular Rectal Balloon catheter is limited to use for adults. The Navina Cone catheter is limited to use for children (2 - < 12 years old), adolescent (12 - <18 years old) and transitional adolescent (18 - < 21 years old) patients and adults.
Substantial Equivalence: 6.
Technological Characteristics
The subjects of this Traditional 510(k) are the introduction of the Navina Smart System and modification of the Navina Classic System, originally cleared in the predicate premarket notification K170487. This Traditional 510(k) is submitted as a "bundled" submission due to the following principles:
- . The indications for use will be identical for the proposed Navina Smart System and the modified Navina Classic System.
- Components of the subject Navina Smart System: small rectal balloon catheter and . cone catheter, are proposed for inclusion in the modified Navina Classic System as subject to this premarket notification and the supporting data associated with these new components are the same and relate to both systems.
For the purpose of substantial equivalence, the proposed Navina Smart System and modified Navina Classic System are compared to the predicate Navina Classic System, as originally cleared under premarket notification K170487, and to the predicate Peristeen Anal Irrigation System, cleared under premarket notification K140310.
Table 1a and 1b summarize the similarities and differences between the proposed Navina Smart System and the originally cleared predicate Navina Classic System (K170487) and the predicate Peristeen Anal Irrigation System (K140310).
Table 2a and 2b summarize the similarities and differences between the modified Navina Classic System and the originally cleared predicate Navina Classic System (K170487) and the predicate Peristeen Anal Irrigation System(K140310).
{5}------------------------------------------------
K190977 Page 3 of 18
Table 1a: Similarities and Differences between the proposed Navina Smart System and the predicate devices: Navina Classic System and Peristeen Anal Irrigation System.
| Element | Proposed DeviceNavina Smart System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate DevicePeristeen Anal Irrigation System(K140310) | Differences betweenproposed device andpredicate devices |
|---|---|---|---|---|
| Indications For Use | The Navina Systems are indicated foruse for children (2 - <12 years old),adolescents (12 - <18 years old), andtransitional adolescents (18 - <21years old) patients with neurogenicbowel dysfunction, congenitaldisorders such as Hirschsprungdisease or anorectal malformations,fecal incontinence or chronicconstipation where less invasivetherapies are not successful, as wellas, for adults who suffer from fecalincontinence, chronic constipation,and/or time consuming bowelmanagement. Use for pediatricpatients is to be performed under thesupervision of a trained healthcareprofessional or adult caregiver. Byinstilling water up into the lower partof the colon, the Navina Systemspromote evacuation of the contents ofthe colon and rectum.The Navina Small Rectal Ballooncatheter is limited to use foradolescent (12 - <18 years old) andtransitional adolescent (18 - < 21years old) patients and adults. TheNavina Regular Rectal Ballooncatheter is limited to use for adults.The Navina Cone catheter is limited touse for children (2 - < 12 years old),adolescent (12 - <18 years old) andtransitional adolescent (18 - < 21years old) patients and adults. | Navina Classic system isindicated for adults who sufferfrom fecal incontinence,chronic constipation and/ortime consuming bowelmanagement.The Navina Classic system isintended to promote evacuationof the contents of the colon andrectum by instilling water intothe lower part of the colonthrough a rectal catheter whichincorporates an inflatableballoon. | The Peristeen Anal IrrigationSystem is intended to instill waterinto the colon through a rectalcatheter - which incorporates aninflatable balloon - inserted into therectum to promote evacuation ofthe contents of the lower colon. ThePeristeen Anal Irrigation System isindicated for use by children (2-<12years old), adolescent (12-<18years old), transitional adolescent(18-<21 years old) and adultpatients with neurogenic boweldysfunction who suffer from fecalincontinence, chronic constipation,and/or time-consuming bowelmanagement procedures | The proposed Navina SmartSystem has expandedindicated patient populationcompared to the primarypredicate device NavinaClassic System (K170487).The proposed Navina SmartSystem has the same indicatedpediatric patient populationsas the secondary predicatedevice: Peristeen AnalIrrigation System (K140310).However, the pediatricpopulations proposed in theindications for use for thesubject Navina Smart Systemare constrained in comparisonto those of the predicatePeristeen System(K140310) in order toclarify that use of thesubject Navina SmartSystem device in thesepediatric populations isproposed only in specificclinical circumstances andwhere less invasivetherapies are not successful andto identify specific indicateduses of propose catheters. |
| Element | Proposed DeviceNavina Smart System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate DevicePeristeen Anal Irrigation System(K140310) | Differences betweenproposed device andpredicate devices |
| Anatomical SiteWhere Used | Rectum (and lower colon)Health Care Facility and home use | Rectum (and lower colon)Health Care Facility and home use | Rectum (and lower colon)Health Care Facility and home use | None |
| Retention in BowelDuring Treatment | Rectal balloon catheterand cone catheter | Rectal balloon catheter | Rectal balloon catheter | The proposed Navina SmartSystem also includes anadditional cone catheter. |
| Bowel IrrigationFunction | Irrigation fluid container and pump(control unit) provided | Irrigation fluid container andpump (control unit) provided | Irrigation fluid bag and pump(control unit) provided | None |
| Single Use | Catheters are for single use. Otherparts are for repeated use | Catheter is for single useOther parts are for repeated use | Catheter is for single useOther parts are for repeated use | None |
| Rectal Catheter | Hydrophilic coating | Hydrophilic coating | Hydrophilic coating | None |
| Fluid for Activationof Catheter Coating | Water | Water | Water | None |
| Fluid for Irrigation | Lukewarm water (97-100 F) | Lukewarm water (97-100 F) | Lukewarm water (97-100 F) | None |
| Placement ofCatheter | Rectum -balloon inflated abovesphincter. Cone catheter withoutballoon placed in rectum | Rectum -balloon inflated abovesphincter | Rectum -balloon inflated abovesphincter | The proposed Navina SmartSystem includes also anadditional cone catheter. |
| Balloon is InflatedWith | Air | Air | Air | None |
| Element | Proposed Device | Primary Predicate Device | Secondary Predicate Device | Differences between |
| Navina Smart System | Navina Classic System | Peristeen Anal Irrigation System | proposed device and | |
| (K170487) | (K140310) | predicate devices | ||
| Control UnitDesign | Firmware controlled electroniccontrol unit containing two pumpsdependent on an energy source.One to inflate the balloon and oneto instill water | Two manual pumps: One toinflate the balloon and one toinstill water | One manual pump with a switchmode to inflate balloon and instillwater | The Navina Smart ControlUnit is an electro-mechanical designdependent on an energysource. Both predicates aredependent on manualpower. |
| Control UnitSettings | The settings are personalizedtogether with a health professional.The following can be set:1. The size of the inflatedballoon.2. The amount of instilledwater.3. The flow rate. | The size of the balloon, theamount of water and the flowrate is dependent on manualpumping. | The size of the balloon, the amountof water and the flow rate isdependent on manual pumping. | Balloon size control, maxfluid volume, and irrigationrate is software controlledaccording to presetparameters in the subjectNavina Smart System. |
| Instillation ofWater | Flow is generated by pressurizingthe water container with air | Flow is generated bypressurizing the water container | Flow is generated by pressurizingthe water container with air | None |
| Stop Water Flow | By releasing the button, the waterflow is stopped. | Manual valve on the controlunit. | Manual valve on the control unit. | Water flow is discontinuedby closing a manual valvein the predicate devices. Awater flow in the subjectNavina Classic System iselectro-mechanicallycontrolled and is activeonly for the duration thatthe flow button is pressed. |
| Security WaterContainer | Safety valve to ensure proper airpressure and water flow | Safety valve to ensure properair pressure and water flow | Safety valve to ensure proper airpressure and water flow | None |
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | None |
| Table 1b: Similarities and differences regarding Contraindications and Precautions for proposed Navina Smart System and the predicate devices: | ||||
| Navina Classic System and Peristeen Anal Irrigation System. | ||||
| Element | Proposed DeviceNavina Smart System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate devicePeristeen Anal Irrigation system(K140310) | Difference betweenproposed and predicatedevice |
| Contraindications | Do NOT use Navina Systemsif you have one or more of thefollowing:Known anal or colorectalstenosis | You shall not use Navina ClassicSystem if you have had one ormore of the following:Anal or colorectal stenosis | Peristeen anal Irrigation mustnot be used in the following situations:Known anal or colorectal stenosis | None |
| Colorectal cancer | Colorectal cancer | Colorectal cancer | None | |
| Active inflammatory boweldisease | Active inflammatory boweldisease | Active inflammatory bowel disease | None | |
| Acute diverticulitis | Acute diverticulitis | Acute diverticulitis | None | |
| You are within three monthsof anal or colorectal surgery | You are within three months ofanal or colorectal surgery | Within three months of abdominal,anal or colorectal surgery | None. | |
| You are within 4 weeks ofprevious endoscopicpolypectomy | You are within 4 weeks ofprevious endoscopic polypectomy | Within 4 weeks of endoscopicpolypectomy | None | |
| Ischemic colitis | Ischemic colitis | Ischemic colitis | None | |
| During Spinal cord Shockphase | During Spinal cord Shock phase | During Spinal cord Shock phase | None | |
| Complex diverticular disease | Complex diverticular disease | Complex diverticular disease | None | |
| Pregnant women | Navina Classic system shall notbe used in patients who arepregnant | In patients who are pregnant andhave not used the system before.*If the patient is pregnant and hasnever used anal irrigation before,they should not start the irrigationprocedure during pregnancy. | None | |
| Table 1b: Similarities and differences regarding Contraindications and Precautions for proposed Navina Smart System and the predicate devices: | ||||
| Navina Classic System and Peristeen Anal Irrigation System. | ||||
| Element | Proposed DeviceNavina Smart System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate devicePeristeen Anal Irrigation system(K140310) | Difference betweenproposed and predicatedevice |
| Contraindications | As the list may not beexhaustive, healthcareprofessionals will alwaysconsider individual userfactors as well. | As the list of contraindicationsmay not be exhaustive, healthcareprofessionals will always considerindividual user factors as well. | Since the list is not exhaustive, thephysician/health care professionalshould always consider individualpatient factors as well. | None |
| Precautions | This product is NOTrecommended for Childrenunder 2 years. | This product is NOTrecommended for children. | Peristeen anal Irrigation is notrecommended for children below twoyears of age. | Same as secondarypredicate Peristeen AnalIrrigation System(K140310). |
| Children shall beaccompanied by an adultcaregiver until the caregiverconsiders the child able toperform the procedure bythemselves. | Not applicable (Primary Predicatedevice was recommended forchildren) | Your first irrigation must besupervised by a health careprofessional. | Proposed device includesadditional precautioninformation for improvedunderstanding | |
| Always consult a health careprofessional specialized inTAI before using Navinasystems. | Always consult a health careprofessional specialized in TAIbefore using Navina Classicsystem. | Always consult a health careprofessional specialized in PeristeenAnal irrigation before you performthe procedure. | None | |
| Only use Navina Systems forits intended use, as describedin this instruction manual. | Only use Navina Systems for itsintended use, as described in thisinstruction manual. (listed underimportant safeguards) | Please read all of the instructionwarnings, contraindications andprecautions before performingPeristeen Anal Irrigation procedure | None(information for primarypredicate listed underimportant safeguards) | |
| Navina System is for a singleuser and should not be sharedwith other people. | Navina Classic is for a single userand should not be shared withother people. (listed underimportant safeguards) | Peristeen Anal Irrigation Systemmust only be used by the sameperson. Do not share with others | None(information for primarypredicate listed underimportant safeguards) | |
| The Navina catheters areavailable in two sizes | The Navina catheter is availablein one size(noted in IFU) | The Peristeen catheters are availablein two sizes(noted in IFU) | The proposed NavinaSmart System alsoincludes an additionalcone catheter. | |
| Table 1b: Similarities and differences regarding Contraindications and Precautions for proposed Navina Smart System and the predicate devices: Page 8 of 18 | ||||
| Navina Classic System and Peristeen Anal Irrigation System. | ||||
| Element | Proposed DeviceNavina Smart System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate devicePeristeen Anal Irrigation system(K140310) | Difference betweenproposed and predicatedevice |
| Precautions | The Navina catheter regular isfor adult only | The product is not recommendedfor Children | The regular catheter is intended foradults. | None |
| Special care must be taken ifyou have or have had any ofthe following: | Special caution must be taken ifyou have or have had any of thefollowing: | Special caution must be shown if youhave had any of the following: | None | |
| Painful anorectal conditions -any condition which maycause pain or bleeding, e.g.anal fissure, anal fistula, thirdor fourth grade ofhemorrhoids | Painful anorectal conditions -anycondition which may cause painor bleeding, e.g. anal fissure, analfistula third or fourth grade ofhemorrhoids | Any anorectal condition, which maycause pain or bleeding e.g. analfissure, anal fistula or third or fourthdegree hemorrhoids | None | |
| Fecal impaction. If you areheavily constipated an initialclean out of the bowel must beperformed before starting upthe irrigation treatment | Fecal impaction. If you areheavily constipated an initialclean out of your bowel must beperformed before starting up theirrigation treatment | Fecal impaction/heavy constipation.If you are heavily constipated(fecally impacted) an initial clean-outof your bowels is mandatory beforestarting up the Peristeen AnalIrrigation procedure | None | |
| Irradiation therapy in theabdominal or pelvic region | Irradiation therapy in theabdominal or pelvic region | Irradiation therapy in the abdominalor pelvic region | None | |
| Severe diverticulosis ordiverticular abscess | Severe diverticulosis ordiverticular abscess | Diverticular disease | Same as the primarypredicate Navina ClassicSystem (K170487). | |
| Previous anal or colorectalsurgery | Previous anal or colorectalsurgery | Previous anal or colorectal surgery | None | |
| Previous major pelvic surgery | Previous major pelvic surgery | Previous major pelvic surgery | None | |
| Severe autonomic dysreflexia | Severe autonomic dysreflexia | Severe autonomic dysreflexia | None | |
| Long term corticosteroidtherapy | Long term corticosteroid therapy | Long term corticosteroid therapy | None | |
| Increased risk of hemorrhageor using anticoagulant therapy(not including aspirin orclopidogrel) | Increased risk of hemorrhage orusing anticoagulant therapy (notincluding aspirin or clopidogrel) | Bleeding diathesis or anticoagulanttherapy (not including aspirin orclopidogrel) | None | |
| Table 1b: Similarities and differences regarding Contraindications and Precautions for proposed Navina Smart System and the predicate devices: | ||||
| Navina Classic System and Peristeen Anal Irrigation System. | ||||
| Element | Proposed DeviceNavina Smart System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate devicePeristeen Anal Irrigation system(K140310) | Difference betweenproposed and predicatedevice |
| Precautions | Changed stool pattern such assudden diarrhea. The cause ofdiarrhea must be identified. | Changed stool pattern such assudden diarrhea. The cause ofdiarrhea must be identified | Changed stool pattern such as suddendiarrhea of unknown origin. Thecause of diarrhea must be identified | None |
| Rectal medication since theeffect of such medication maybe changed by using analirrigation | Rectal medication since the effectof such medication may bechanged by using anal irrigation | Rectal medication since the effect ofsuch medication may be reduced bythe anal irrigation | None | |
| Active inflammatory bowel(contraindication) | Active inflammatory bowel(contraindication) | Inflammatory bowel disease (e.g.Crones disease or ulcerative colitis) | None | |
| Cancer in the abdominal orpelvic region | Cancer in the abdominal or pelvicregion | Cancer in the abdominal or pelvicregion | None | |
| Severe cognitive impairment(unless caregiver is availableto supervise/administer) | Severe cognitive impairment(unless caregiver is available tosupervise/administer) | Severe cognitive impairment (unlesscaregiver is available tosupervise/administer) | None | |
| Element | Modified DeviceNavina Classic System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate DevicePeristeen Anal IrrigationSystem(K140310) | Difference between themodified device and thepredicate devices |
| Indications For Use | The Navina Systems are indicatedfor use for children (2 - <12 yearsold), adolescents (12 - <18 yearsold), and transitional adolescents(18 - <21 years old) patients withneurogenic bowel dysfunction,congenital disorders such asHirschsprung disease or anorectalmalformations, fecal incontinenceor chronic constipation where lessinvasive therapies are notsuccessful, as well as, for adultswho suffer from fecal incontinence,chronic constipation, and/or timeconsuming bowel management.Use for pediatric patients is to beperformed under the supervision ofa trained healthcare professional oradult caregiver. By instilling waterup into the lower part of the colon,the Navina Systems promoteevacuation of the contents of thecolon and rectum.The Navina Small Rectal Ballooncatheter is limited to use foradolescent (12 - <18 years old)and transitional adolescent (18 - <21 years old) patients and adults.The Navina Regular RectalBalloon catheter is limited to usefor adults. The Navina Conecatheter is limited to use forchildren (2 - < 12 years old),adolescent (12 - <18 years old)and transitional adolescent (18 - <21 years old) patients and adults. | Navina Classic System isindicated for adults who sufferfrom fecal incontinence, chronicconstipation, and/or timeconsuming bowel management.The Navina Classic System isintended to promote evacuationof the contents of colon andrectum by instilling water intothe lower part of the colonthrough a rectal catheter whichincorporates an inflatableballoon. | The Peristeen Anal IrrigationSystem is intended to instillwater into the colon through arectal catheter - whichincorporates an inflatableballoon - inserted into the rectumto promote evacuation of thecontents of the lower colon. ThePeristeen Anal Irrigation Systemis indicated for use by children(2-<12 years old), adolescent(12-<18 years old), transitionaladolescent (18-<21 years old)and adult patients withneurogenic bowel dysfunctionwho suffer from fecalincontinence, chronicconstipation, and/or time-consuming bowel managementprocedures. | The proposed Navina SmartSystem has expanded indicatedpatient population compared tothe primary predicate deviceNavina Classic System(K170487). The proposed NavinaSmart System has the sameindicated pediatric patientpopulations as the secondarypredicate device: Peristeen AnalIrrigation System (K140310).However, the pediatricpopulations proposed in theindications for use for the subjectNavina Smart System areconstrained in comparison tothose of the predicate PeristeenSystem(K140310) in order to clarifythat use of the subject NavinaSmart System device in thesepediatric populations isproposed only in specificclinical circumstances andwhere less invasivetherapies are not successful andto identify specific indicateduses of propose catheters. |
| Element | Modified Device | Primary Predicate Device | Secondary Predicate Device | Difference between the |
| Navina Classic System | Navina Classic System(K170487) | Peristeen Anal IrrigationSystem(K140310) | modified device and thepredicate devices | |
| Anatomical Site | Rectum (and lower colon) | Rectum (and lower colon) | Rectum (and lower colon) | None |
| Where Used | Health Care Facility and home | Health Care Facility and home | Health Care Facility and home | None |
| Retention in BowelDuring Treatment | Rectal balloon catheter and conecatheter without an inflatableballoon. | Rectal balloon catheter | Rectal balloon catheter | The modified Navina ClassicSystem also includes anadditional cone catheter whichis also included for theproposed Navina SmartSystem. |
| Bowel IrrigationFunction | Irrigation fluid bag and pump(control unit) provided | Irrigation fluid bag and pump(control unit) provided | Irrigation fluid bag and pump(control unit) provided | None |
| Single Use | Catheter is for single use.Other parts are for repeated use. | Catheter is for single use.Other parts are for repeated use. | Catheter is for single use.Other parts are for repeated use. | None |
| Rectal CatheterCoating | Hydrophilic coating | Hydrophilic coating | Hydrophilic coating | None |
| Fluid for Activationof Catheter Coating | Water | Water | Water | None |
| Fluid for Irrigation | Lukewarm water (97-100 °F) | Lukewarm water (97-100 °F) | Lukewarm water (97-100 °F) | None |
| Placement ofCatheter | Rectum -balloon inflated abovesphincter. Cone without aballoon placed in the rectum. | Rectum -balloon inflated abovesphincter. | Rectum -balloon inflated abovesphincter. | The modified Navina ClassicSystem includes also anadditional cone catheter whichis also included for theproposed Navina SmartSystem. |
| Balloon is InflatedWith | Air | Air | Air | None |
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | None |
| Element | Modified DeviceNavina Classic System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate devicePeristeen Anal Irrigation system(K140310) | Difference between themodified device andthe predicate devices |
| Contraindications | Do NOT use NavinaSystems if you have oneor more of the following: | You shall not use Navina ClassicSystem if you have had one ormore of the following: | Peristeen anal Irrigation must notbe used in the following situations: | None |
| Known anal or colorectalstenosis | Anal or colorectal stenosis | Known anal or colorectal stenosis | None | |
| Colorectal cancer | Colorectal cancer | Colorectal cancer | None | |
| Active inflammatorybowel disease | Active inflammatory boweldisease | Active inflammatory bowel disease | None | |
| Acute diverticulitis | Acute diverticulitis | Acute diverticulitis | None | |
| You are within threemonths of anal orcolorectal surgery | You are within three months ofanal or colorectal surgery | Within three months of abdominal,anal or colorectal surgery | None | |
| You are within 4 weeksof previous endoscopicpolypectomy | You are within 4 weeks ofprevious endoscopic polypectomy | Within 4 weeks of endoscopicpolypectomy | None | |
| Ischemic colitis | Ischemic colitis | Ischemic colitis | None | |
| During Spinal cordShock phase | During Spinal cord Shock phase | During Spinal cord Shock phase | None | |
| Complex diverticulardisease | Complex diverticular disease | Complex diverticular disease | None | |
| Element | Modified DeviceNavina Classic System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate devicePeristeen Anal Irrigation system(K140310) | Difference between themodified device andthe predicate devices |
| Contraindications | Pregnant women | Navina Classic system shall notbe used in patients who arepregnant | In patients who are pregnant andhave not used the system before.*If the patient is pregnant and hasnever used anal irrigation before,they should not start the irrigationprocedure during pregnancy. | None |
| As the list may not beexhaustive, healthcareprofessionals will alwaysconsider individual userfactors as well | As the list of contraindicationsmay not be exhaustive, healthcareprofessionals will always considerindividual user factors as well | Since the list is not exhaustive, thephysician/health care professionalshould always consider individualpatient factors as well | None | |
| Precautions | This product is NOTrecommended forChildren under 2 years. | This product is NOTrecommended for children. | Peristeen anal Irrigation is notrecommended for children belowtwo years of age. | Same as secondary predicatePeristeen Anal Irrigation System(K140310). |
| Children shall beaccompanied by an adultcaregiver until thecaregiver considers thechild able to perform theprocedure by themselves. | Not applicable (Primary predicatedevice was not recommended forchildren) | Your first irrigation must besupervised by a health careprofessional. | Proposed device includesadditional precaution informationfor improved understanding | |
| Always consult a healthcare professionalspecialized in TAI beforeusing Navina Systems | Always consult a health careprofessional specialized in TAIbefore using Navina Classicsystem | Always consult a health careprofessional specialized inPeristeen Anal irrigation before youperform the procedure. | None | |
| Only use Navina Systemsfor its intended use, asdescribed in thisinstruction manual. | Only use Navina Systems for itsintended use, as described in thisinstruction manual. (listed underimportant safeguards) | Please read all of the instructionwarnings, contraindications andprecautions before performingPeristeen Anal Irrigation procedure | None(information for primarypredicate listed under importantsafeguards) | |
| Navina Systems is for asingle user and shouldnot be shared with otherpeople. | Navina Classic is for a single userand should not be shared withother people. (listed underimportant safeguards) | Peristeen Anal Irrigation Systemmust only be used by the sameperson. Do not share with others | None(information for primarypredicate listed under importantsafeguards) | |
| Element | Modified DeviceNavina Classic System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate devicePeristeen Anal Irrigation system(K140310) | Difference between themodified device andthe predicate devices |
| Precautions | The Navina catheters areavailable in two sizes | The Navina catheter is availablein one size(noted in IFU) | The Peristeen catheters areavailable in two sizes(noted in IFU) | Proposed device includesadditional precaution informationfor improved understanding |
| The Navina catheterregular is for adult only | The product is not recommendedfor Children | The regular catheter is intended foradults. | Proposed device includesadditional precaution informationfor improved understanding | |
| Special care must beshown if you have orhave had any of thefollowing: | Special care must be taken if youhave or have had any of thefollowing: | Special caution must be shown ifyou have had any of the following: | None | |
| Painful anorectalconditions -any conditionwhich may cause pain orbleeding, e.g. analfissure, anal fistula thirdor fourth grade ofhemorrhoids | Painful anorectal conditions -anycondition which may cause painor bleeding, e.g. anal fissure, analfistula third or fourth grade ofhemorrhoids | Any anorectal condition, whichmay cause pain or bleeding e.g.anal fissure, anal fistula or third orfourth degree hemorrhoids | None | |
| Fecal impaction. If youare heavily constipatedan initial clean out ofyour bowel must beperformed before startingup the irrigationtreatment | Fecal impaction. If you areheavily constipated an initialclean out of your bowel must beperformed before starting up theirrigation treatment | Fecal impaction/heavy constipation.If you are heavily constipated(fecally impacted) an initial clean-out of your bowels is mandatorybefore starting up the PeristeenAnal Irrigation procedure | None | |
| Irradiation therapy in theabdominal or pelvicregion | Irradiation therapy in theabdominal or pelvic region | Irradiation therapy in the abdominalor pelvic region | None | |
| Severe diverticulosis ordiverticular abscess | Severe diverticulosis ordiverticular abscess | Diverticular disease | Same as primary predicateNavina Classic System(K170487) which is alsoincluded for the proposed NavinaSmart System. | |
| Previous anal orcolorectal surgery | Previous anal or colorectalsurgery | Previous anal or colorectal surgery | None | |
| Element | Modified DeviceNavina Classic System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate devicePeristeen Anal Irrigation system(K140310) | Difference between themodified device andthe predicate devices |
| Precautions | Previous major pelvicsurgery | Previous major pelvic surgery | Previous major pelvic surgery | None |
| Severe autonomicdysreflexia | Severe autonomic dysreflexia | Severe autonomic dysreflexia | None | |
| Long term corticosteroidtherapy | Long term corticosteroid therapy | Long term corticosteroid therapy | None | |
| Increased risk ofhemorrhage or usinganticoagulant therapy(not including aspirin orclopidogrel) | Increased risk of hemorrhage orusing anticoagulant therapy (notincluding aspirin or clopidogrel) | Bleeding diathesis or anticoagulanttherapy (not including aspirin orclopidogrel) | None | |
| Changed stool patternsuch as sudden diarrhea.The cause of diarrheamust be identified. | Changed stool pattern such assudden diarrhea. The cause ofdiarrhea must be identified | Changed stool pattern such assudden diarrhea of unknown origin.The cause of diarrhea must beidentified | None | |
| Rectal medication sincethe effect of suchmedication may bechanged by using analirrigation | Rectal medication since the effectof the medication may be changedby using anal irrigation | Rectal medication since the effectof such medication may be reducedby the anal irrigation | None | |
| Active inflammatorybowel (contraindication) | Active inflammatory bowel(contraindication) | Inflammatory bowel disease (e.g.Crones disease or ulcerative colitis) | None | |
| Cancer in the abdominalor pelvic region | Cancer in the abdominal or pelvicregion | Cancer in the abdominal or pelvicregion | None | |
| Element | Modified DeviceNavina Classic System | Primary Predicate DeviceNavina Classic System(K170487) | Secondary Predicate devicePeristeen Anal Irrigation system(K140310) | Difference between themodified device andthe predicate devices |
| Severe cognitiveimpairment (unlesscaregiver is available tosupervise/administer) | Severe cognitive impairment(unless caregiver is available tosupervise/administer) | Severe cognitive impairment(unless caregiver is available tosupervise/administer) | None |
{6}------------------------------------------------
Table 1a: Similarities and Differences between the proposed Navina Smart System and the predicate devices: Navina Classic System and Peristeen Anal Irrigation System.
{7}------------------------------------------------
Table 1a: Similarities and Differences between the proposed Navina Smart System and the predicate devices: Navina Classic System and Peristeen Anal Irrigation System.
{8}------------------------------------------------
{9}------------------------------------------------
K190977
Page 7 of 18
{10}------------------------------------------------
K190977
Page 8 of 18
{11}------------------------------------------------
K190977
Page 9 of 18
{12}------------------------------------------------
Table 2a: Similarites and Differences between the modified Navina Classic System and the predicate devices-Navina Classic System and Peristeen Anal Irrigation System
{13}------------------------------------------------
Table 2a: Similarites and Differences between the modified Navina Classic System and the predicate devices-Navina Classic System and Peristeen Anal Irrigation System
{14}------------------------------------------------
K190977 Page 12 of 18
Table 26. Similarities and differences regarding Contraindications for modified Navina Classic System and predicate devices, Navina Classic System and Peristeen Anal Irrigation System.
{15}------------------------------------------------
Table 26. Similarities and differences regarding Contraindications for modified Navina Classic System and predicate devices, Navina Classic System and Peristeen Anal Irrigation System.
{16}------------------------------------------------
Table 26. Similarities and differences regardinations and Precautions for modified Navina Classic System and predicate devices, Navina Classic System and Peristeen Anal Irrigation System.
{17}------------------------------------------------
K190977 Page 15 of 18
Table 26. Similarities and differences regarding Contraindications for modified Navina Classic System and predicate devices, Navina Classic System and Peristeen Anal Irrigation System.
{18}------------------------------------------------
K190977 Page 16 of 18
Table 26. Similarities and differences regarding Contraindications for modified Navina Classic System and predicate devices, Navina Classic System and Peristeen Anal Irrigation System.
{19}------------------------------------------------
7. Non-Clinical PerformanceData:
The performance testing of the Navina Classic System and Navina Smart System which has been conducted to support substantial equivalence is divided into two parts; control unit and rectal catheters. The Navina Classic System and the Navina Smart System utilize the same range of accessories (i.e. water container, rectal catheters, and tubing). Only test data related to new components (rectal catheter Small, rectal catheter Cone, and Navina Smart control unit) which were not the subject of the original clearance of the Navina Classic System under K170487 have been included in this submission to support substantial equivalence.
Performance for the control units include:
- Control of air leakage
- Complete deflation of balloon (air release)
- Ability to instantly stop waterflow
- Control of water flow rate
- Control of water back flow
- Setting of balloon size (Navina Smart System)
Performance for the small rectal catheter:
- Balloon burst volume
- Flexibility
- Even balloon inflation
- Balloon burst diameter
- Rectal catheter flow rate
- Rectal catheter after catheter kink
- Hydrophilic coating
Performance for the conical rectal catheter:
- Hydrophilic coating at insertion and withdrawal
- Bonding strength between the catheter body and conical component.
Software verification and validation, as well as, electrical safety and electromagnetic compatibility testing for compliance with applicable standards and to validate the Navina Smart System against its design requirements has been included in support of substantial equivalence, including:
- -Testing according to IEC 60601-1, Medical electrical equipment - part 1 : general requirements for basic safety and essential performance.
- Testing according to IEC 60601-1-11, Medical electrical equipment part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- Testing according to IEC 60601-1-2, Medical electrical equipment part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances --requirements and tests.
- Testing according to IEC 60601-1-6, Medical electrical equipment part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
- Testing according to IEC 62304, Medical Device Software Software Life Cycle । Processes.
- Testing according to IEC 62133, Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes- Safety Requirements for Portable Sealed Secondary Cells, and for Batteries made from them, for use in portable applications.
{20}------------------------------------------------
-
Testing according to IEC 62366-1, Medical Devices Part 1: Application of Usability Engineering to MedicalDevices.
The results of the testing conducted in conformity with applicable standards support substantial equivalence. -
- Biocompatibility
Although there are no new patient contacting materials introduced as subject to this premarket notification, simulated use extraction according to ISO 10993-12, (Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials) chemical characterization, and toxicological analysis and assessment are included relating to the differences in indications for use between the subject and predicate devices.
- Biocompatibility
The results of these analyses support substantial equivalence.
9. Clinical PerformanceData:
No data from human clinical studies have been included to support substantial equivalence.
Conclusion Regarding Substantial Equivalence: 10.
The proposed Navina Smart System has the same intended use and has similar indications for use as the predicate Navina Classic System as cleared under K170487 and the predicate Peristeen Anal Irrigation System cleared under K140310. Certain technological characteristics relating to the control mechanism of the Navina Smart System are different when compared to the predicate Navina Classic System (K170487) and Peristeen (K140310). Performance data are included to address these differences. The results of this testing, combined with the design, biocompatibility, and intended use comparison to the predicate devices support the substantial equivalence of the Navina SmartSystem.
The modified Navina Classic System has the same intended use, incorporates the same fundamental technology, but has expanded indications for use as the predicate Navina Classic System as cleared under K170487. The expanded indications for use with respect to intended patient populations are similar to the predicate device cleared under K140310. Test data to verify the specified performance of the subject device has been included. The results of this testing combined with the design, biocompatibility, and intended use comparison to the predicate devices support the substantial equivalence of the modified Navina Classic System.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.