Navina Classic System

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 11, 2017 Dentsply Sirona Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, PA 17401 Re: K170487 Trade/Device Name: Navina Classic System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: August 4, 2017 Received: August 7, 2017 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. 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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. Image /page/1/Picture/10 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be on a white background. The letters are clearly legible and well-spaced. Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K170487 Device Name Navina Classic System Indications for Use (Describe) The Navina Classic System is indicated for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management. The Navina Classic System is intended to promote evacuation of the colon and rectum by instilling water into the lower part of the colon through a rectal catheter which incorporates an inflatable balloon. 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. 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The text is in a simple, sans-serif font and is aligned to the right of the leaf-like shape. # 510(k) SUMMARY for Navina Classic System 1.0 Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 | Contact Person: | Karl Nittinger | |-------------------|-----------------------------------| | Telephone Number: | 717-849-4424 | | Fax Number: | 717-849-4343 | | Email: | karl.nittinger@dentsplysirona.com | Date Prepared: 31 August 2017 ## 2.0 Device Name: | • Proprietary Name: | Navina Classic System | |------------------------|----------------------------------------| | • Classification Name: | Gastrointestinal Tubes and Accessories | | • CFR Number: | 876.5980 | | • Device Class: | II | | • Product Code: | KNT | ## 3.0 Predicate Device: | Predicate Device Name | 510(k) | Company Name | |----------------------------------|---------|---------------| | Peristeen Anal Irrigation System | K140310 | Coloplast A/S | ## 4.0 Description of Device: The Navina Classic System is indicated for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management. The Navina Classic System is composed of a single use rectal catheter with an inflatable balloon, a water container, a control unit for manual control of instillation water flow and manual balloon inflation and deflation, and tubing with integral connectors for connection of the device components. The Navina Classic System is intended to promote evacuation of the contents of the colon and rectum by instilling water into the lower part of the colon through the rectal catheter which incorporates an inflatable balloon. {4}------------------------------------------------ #### 5.0 Indications for Use: The Navina Classic System is indicated for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management. The Navina Classic System is intended to promote evacuation of the contents of the colon and rectum by instilling water into the lower part of the colon through a rectal catheter which incorporates an inflatable balloon. #### 6.0 Substantial Equivalence: ## Technological Characteristics: For the purpose of substantial equivalence, the proposed Navina Classic System is compared to the predicate Peristeen Anal Irrigation System cleared under premarket notification K140310. Table 1a and b below summarizes the similarities and differences between the proposed Navina Classic System and the predicate Peristeen Anal Irrigation System (K140310). {5}------------------------------------------------ | Table 1a Similarities and Differences between the proposed and the predicate devices. | | | |---------------------------------------------------------------------------------------|--|--| |---------------------------------------------------------------------------------------|--|--| | Element | Proposed Device<br>Navina Classic System | Predicate Device<br>Peristeen Anal Irrigation System (K140430) | Difference between<br>Proposed device and<br>Predicate device | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For Use | The Navina Classic System is indicated for adults<br>who suffer from fecal incontinence, chronic<br>constipation, and/or time consuming bowel<br>management.<br>The Navina Classic System is intended to<br>promote evacuation of the contents of colon and<br>rectum by instilling water into the lower part of<br>the colon through a rectal catheter which<br>incorporates an inflatable balloon. | The Peristeen Anal Irrigation System is intended<br>to instill water into the colon through a rectal<br>catheter - which incorporates an inflatable balloon -<br>inserted into the rectum to promote evacuation of the<br>contents of the lower colon. The Peristeen Anal<br>Irrigation System is indicated for use by children (2-<br><12 years old), adolescent (12-<18 years old),<br>transitional adolescent (18-<21 years old) and adult<br>patients with neurogenic bowel dysfunction who<br>suffer from fecal incontinence, chronic constipation,<br>and/or time-consuming bowel management<br>procedures. | More narrow population for<br>proposed device. | | Prescription Device | Yes | Yes | None | | Target Population | Patients who suffer from fecal incontinence, chronic<br>constipation, and/or time consuming bowel<br>management. | Patients with neurogenic bowel dysfunction who<br>suffer from fecal incontinence, chronic constipation,<br>and/or time-consuming bowel management<br>procedures. | Proposed device does not<br>limit the target population to<br>patients with neurogenic<br>bowel dysfunction. Any<br>patient suffering from fecal<br>incontinence, chronic<br>constipation, and/or time<br>consuming bowel<br>management is included in<br>target population. | | Age Groups | Adults | Children (2-<12 years old), adolescent (12-<18 years<br>old), transitional adolescent (18-<21 years old) and<br>adult | More narrow age group for<br>proposed device. | | Anatomical Site | Rectum (and lower colon) | Rectum (and lower colon) | None | | Where Used | Health Care Facility and home use | Health Care Facility and home use | None | | Retention in Bowel<br>During Treatment | Rectal balloon catheter | Rectal balloon catheter | None | | Bowel Irrigation<br>Function | Irrigation fluid bag and pump (control unit) provided | Irrigation fluid bag and pump (control unit) provided | None | | Single Use | Catheter is for single use<br>Other parts are for repeated use | Catheter is for single use<br>Other parts are for repeated use | None | {6}------------------------------------------------ | Table 1a Similarities and Differences between the proposed and the predicate devices. | | | | |---------------------------------------------------------------------------------------|--|--|--| |---------------------------------------------------------------------------------------|--|--|--| | Element | Proposed Device<br>Navina Classic System | Predicate Device<br>Peristeen Anal Irrigation System (K140430) | Difference between<br>Proposed device and<br>Predicate device | |---------------------------------------------|------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------| | Rectal Catheter<br>Coating | Hydrophilic coating | Hydrophilic coating | None | | Fluid for Activation<br>of Catheter Coating | Water | Water | None | | Fluid for Irrigation | Lukewarm water (97-100 °F) | Lukewarm water (97-100 °F) | None | | Placement of<br>Catheter | Rectum -balloon inflated above sphincter | Rectum -balloon inflated above sphincter | None | | Balloon is Inflated<br>With | Air | Air | None | | Sterility | Provided non-sterile | Provided non-sterile | None | | Biocompatibility per<br>ISO10993 | Meets standard | Meets standard | None | #### Table 1b #### Similarities and differences regarding Contraindications and Precautions for Proposed and Predicate device (K140310) | Element | Proposed device<br><i>Navina Classic System</i> | Predicate device<br><i>Peristeen Anal Irrigation System</i><br>(K140130) | Difference between proposed and<br>predicate device | |------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contra<br>indications | You shall not use Navina Classic System if you have had one or more of the following: | Peristeen anal Irrigation must <b>not</b> be used in the following situations: | None | | | • Anal or colorectal stenosis | Known anal or colorectal stenosis | None | | | • Colorectal cancer | Colorectal cancer | None | | | • Active inflammatory bowel disease | Active inflammatory bowel disease | None | | | • Acute diverticulitis | Acute diverticulitis | None | | Element | Proposed device<br>Navina Classic System | Predicate device<br>Peristeen Anal Irrigation System<br>(K140130) | Difference between proposed and<br>predicate device | | | You are within three months of anal or colorectal surgery | Within three months of abdominal, anal or colorectal surgery | Abdominal surgery included for Predicate device. According to consensus expert review (Emmanuel et al 1) the absolute contraindication is "Within three months of rectal surgery". Contraindication for Proposed device is based on consensus expert review paper1. | | | You are within 4 weeks of previous endoscopic polypectomy | Within 4 weeks of endoscopic polypectomy | None | | | Ischhaemic colitis | Ischhaemic colitis | None | | | During spinal cord shock phase | During spinal cord shock phase | None | | | Complex diverticular disease | Complex diverticular disease | None | | | Navina Classic system shall not be used in patients who are pregnant. | In patients who are pregnant and have not used the system before.<br>*If the patient is pregnant and has never used anal irrigation before, they should not start the irrigation procedure during pregnancy. | None | | | As the list of contraindications may not be exhaustive, healthcare professionals will always consider individual user factors as well | Since the list is not exhaustive, the physician/health care professional should always consider individual patient factors as well | None | | Precautions | Always consult a health care professional specialized in TAI before using Navina Classic system | It is vital for your safety that you always consult a physician/health care professional specialized in Peristeen Anal irrigation before performing the irrigation procedure. | None | | | This product is NOT recommended for children. | Peristeen anal Irrigation is not recommended for children below two years of age | More narrow user group for Proposed device | | Element | Proposed device<br>Navina Classic System | Predicate device<br>Peristeen Anal Irrigation System<br>(K140130) | Difference between proposed and<br>predicate device | | Special caution must be shown if you<br>have had any of the following: | Special caution must be shown if you<br>have had any of the following: | Special caution must be shown if you<br>have had any of the following: | None | | • Painful anorectal conditions -any<br>condition which may cause pain<br>or bleeding, e.g. anal fissure, anal<br>fistula third or fourth grade of<br>hemorrhoids | • Painful anorectal conditions -any<br>condition which may cause pain<br>or bleeding, e.g. anal fissure, anal<br>fistula third or fourth grade of<br>hemorrhoids | Any anorectal condition, which may<br>cause pain or bleeding e.g. anal fissure,<br>anal fistula or third or fourth degree<br>haemorrhoids | None | | • Fecal impaction. If you are<br>heavily constipated an initial<br>clean out of your bowel must be<br>performed before starting up the<br>irrigation treatment | • Fecal impaction. If you are<br>heavily constipated an initial<br>clean out of your bowel must be<br>performed before starting up the<br>irrigation treatment | Fecal impaction/heavy constipation. If<br>you are heavily constipated (fecally<br>impacted) an initial clean-out of your<br>bowels is mandatory before starting up<br>the Peristeen Anal Irrigation procedure | None | | • Irradiation therapy in the<br>abdominal or pelvic region | • Irradiation therapy in the<br>abdominal or pelvic region | Irradiation therapy in the abdominal or<br>pelvic region | None | | • Severe diverticulosis or<br>diverticular abscess | • Severe diverticulosis or<br>diverticular abscess | Diverticular disease | Precautions for Proposed device are<br>based on consensus expert review<br>paper¹. Consensus review state "Severe<br>diverticulosis or diverticular abscess"<br>as relative contraindication (Precaution) | | • Previous anal or colorectal<br>surgery | • Previous anal or colorectal<br>surgery | 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 corticosteroid therapy | • Long term corticosteroid therapy | Long term corticosteroid therapy | None | | • Increased risk of hemorrhage or<br>using anticoagulant therapy (not<br>including aspirin or clopidogrel) | • Increased risk of hemorrhage or<br>using anticoagulant therapy (not<br>including aspirin or clopidogrel) | Bleeding diathesis or anticoagulant<br>therapy (not including aspirin or<br>clopidogrel) | None | | • Changed stool pattern such as<br>sudden diarrhea of unknown<br>origin. The cause of diarrhea must<br>be identified | • Changed stool pattern such as<br>sudden diarrhea of unknown<br>origin. The cause of diarrhea must<br>be identified | Changed stool pattern such as sudden<br>diarrhea of unknown origin. The cause of<br>diarrhea must be identified | None | | Element | Proposed device<br>Navina Classic System | Predicate device<br>Peristeen Anal Irrigation System<br>(K140130) | Difference between proposed and<br>predicate device | | • | Rectal medication since the effect<br>of such medication may be<br>reduced by using anal irrigation | Rectal medication since the effect of such<br>medication may be reduced by the anal<br>irrigation | None | | | Active inflammatory bowel disease<br>(contraindication) | Inflammatory bowel disease (e.g. Crons<br>disease or ulcerative colitis) | Active inflammatory bowel is a<br>contraindication for Proposed device. | | | Cancer in the abdominal and pelvic<br>region | Cancer in the abdominal or pelvic region | None | | | Severe cognitive impairment (unless<br>caregiver is available to<br>supervise/administer) | Severe cognitive impairment (unless<br>caregiver is available to<br>supervise/administer) | None | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ 1 Emmanuel et al (A V Emmanuel, K Krogh, G Bazzochi, A.M Leroi, A Bremers, D Leder, D van Kuppevelt, G Mosiello, M Vogel, B Perrouin-Verbe, M Coggrave and P Christiensen (2013): "Consensus review of trans anal irrigation in adults". Spinal cord, 51, 732-738.) {10}------------------------------------------------ Non-Clinical Performance Data: The performance testing is divided into three parts; control unit, water container, rectal catheter, connectors, and system testing. Performance testing of the control unit included: - Control of air leakage - Complete deflation of balloon (air release) - Control of maximum pump force - Ability to instantly stop water flow - Control of water flow rate Performance testing of the rectal catheter included: - Hydrophilic coating at insertion and withdrawal - Flexibility - Even balloon inflation - Balloon burst diameter - Balloon burst volume - Rectal catheter flow rate - Rectal catheter flow rate after catheter kink Performance testing of the water container included: - Proper air pressure - Accuracy of the scale of the water container Performance testing of the connectors included: - Control of air leakage - Tensile and torque resistance after simulated repeated use. Performance testing of the Navina Classic System included: - System backflow verification testing The performance of the Navina Classic System satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence Biocompatibility has been assured by Cytotoxicity (ISO10993-5:2009), Irritation (ISO10993-10:2010), Sensitization (ISO10993-10:2010) and Genotoxicity (ISO10993-3:2014) analyses. The results of this testing demonstrates that the Navina Classic System is non-cytotoxic, non-irritating in support of substantial equivalence. Additional analysis has been included to verify the potential for leachable compounds to be present after simulated repeated use. The results of this testing support substantial equivalence. ## Clinical Performance Data: No data from human clinical studies have been included to support the substantial equivalence of the Navina Classic System. {11}------------------------------------------------ # Conclusion Regarding Substantial Equivalence: The Navina Classic System is a device for Anal Irrigation. By instilling water up into the lower part of the colon, through a rectal catheter, which incorporates an inflatable balloon, the peristaltic muscles in the bowel can be triggered and start to evacuate the colon and rectum. The proposed Navina Classic System has the same intended use, incorporates the same fundamental technology, and has similar indications for use as does the predicate Peristeen Anal Irrigation System cleared under premarket K140310. The proposed device has a more narrowly defined indicated patient population when compared to the indicated use of the predicate device. Test data to verify the specified performance requirements of the subject device has been included. The results of this testing combined with the design, biocompatibility, and intended use comparison to the predicate device support the substantial equivalence of the Navina Classic System.