Navina Smart System, Navina Classic System

K190977 · Dentsply Sirona · KNT · Nov 22, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190977
• Device Name: Navina Smart System, Navina Classic System
• Applicant: Dentsply Sirona
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

Navina Smart and Classic Systems are trans-anal irrigation (TAI) devices for bowel dysfunction management. Navina Smart is an electronically controlled system; Navina Classic is manually operated. Both systems use a water container, tubing, and rectal catheters (balloon or cone) to instill lukewarm water into the lower colon to promote evacuation. Navina Smart uses an electronic control unit with two pumps (one for balloon inflation, one for water instillation) to manage volume, speed, and inflation. It includes a mobile app for tracking treatment data (duration, volume, balloon size) and user ratings; the app does not control device function. Used in clinics or homes by patients or caregivers. Healthcare providers personalize settings. Benefits include improved bowel management for patients with neurogenic or chronic bowel conditions.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including control unit performance (flow, pressure, balloon inflation), catheter performance (burst volume, coating, bonding), software verification/validation, and biocompatibility analysis.

Technological Characteristics

Trans-anal irrigation system. Navina Smart: electronic control unit with two pumps; Navina Classic: manual pumps. Components: water container, tubing, hydrophilic-coated rectal catheters (balloon or cone). Energy: battery-powered (Smart). Connectivity: mobile app for data tracking. Standards: IEC 60601-1, 60601-1-11, 60601-1-2, 60601-1-6, 62304, 62133, 62366-1.

Indications for Use

Indicated for children (2-<12), adolescents (12-<18), transitional adolescents (18-<21), and adults with neurogenic bowel dysfunction, congenital disorders (e.g., Hirschsprung disease, anorectal malformations), fecal incontinence, or chronic constipation refractory to less invasive therapies. Pediatric use requires supervision by healthcare professional or adult caregiver.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Navina Classic System (K170487)
• Peristeen Anal Irrigation System (K140310)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | | | |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|--|
| <div> <span> <span style="font-size:16px">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | | | |

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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

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# 510(k) UMMARY

For K190977

Navina Smart System and Navina Classic System

- 1. 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 |

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.

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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.

- 5. 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).

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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 Device<br>Navina Smart System | Primary Predicate Device<br>Navina Classic System<br>(K170487) | Secondary Predicate Device<br>Peristeen Anal Irrigation System<br>(K140310) | Differences between<br>proposed device and<br>predicate devices |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | The Navina Systems are indicated for<br>use for children (2 - <12 years old),<br>adolescents (12 - <18 years old), and<br>transitional adolescents (18 - <21<br>years old) patients with neurogenic<br>bowel dysfunction, congenital<br>disorders such as Hirschsprung<br>disease or anorectal malformations,<br>fecal incontinence or chronic<br>constipation where less invasive<br>therapies are not successful, as well<br>as, for adults who suffer from fecal<br>incontinence, chronic constipation,<br>and/or time consuming bowel<br>management. Use for pediatric<br>patients is to be performed under the<br>supervision of a trained healthcare<br>professional or adult caregiver. By<br>instilling water up into the lower part<br>of the colon, the Navina Systems<br>promote evacuation of the contents of<br>the colon and rectum.<br>The Navina Small Rectal Balloon<br>catheter is limited to use for<br>adolescent (12 - <18 years old) and<br>transitional adolescent (18 - < 21<br>years old) patients and adults. The<br>Navina Regular Rectal Balloon<br>catheter is limited to use for adults.<br>The Navina Cone catheter is limited to<br>use for children (2 - < 12 years old),<br>adolescent (12 - <18 years old) and<br>transitional adolescent (18 - < 21<br>years old) patients and adults. | Navina Classic system is<br>indicated for adults who suffer<br>from fecal incontinence,<br>chronic constipation and/or<br>time consuming bowel<br>management.<br>The Navina Classic system is<br>intended to promote evacuation<br>of the contents of the colon and<br>rectum by instilling water into<br>the lower part of the colon<br>through a rectal catheter which<br>incorporates an inflatable<br>balloon. | The Peristeen Anal Irrigation<br>System is intended to instill water<br>into the colon through a rectal<br>catheter - which incorporates an<br>inflatable balloon - inserted into the<br>rectum to promote evacuation of<br>the contents of the lower colon. The<br>Peristeen Anal Irrigation System is<br>indicated for use by children (2-<12<br>years old), adolescent (12-<18<br>years old), transitional adolescent<br>(18-<21 years old) and adult<br>patients with neurogenic bowel<br>dysfunction who suffer from fecal<br>incontinence, chronic constipation,<br>and/or time-consuming bowel<br>management procedures | The proposed Navina Smart<br>System has expanded<br>indicated patient population<br>compared to the primary<br>predicate device Navina<br>Classic System (K170487).<br>The proposed Navina Smart<br>System has the same indicated<br>pediatric patient populations<br>as the secondary predicate<br>device: Peristeen Anal<br>Irrigation System (K140310).<br>However, the pediatric<br>populations proposed in the<br>indications for use for the<br>subject Navina Smart System<br>are constrained in comparison<br>to those of the predicate<br>Peristeen System<br>(K140310) in order to<br>clarify that use of the<br>subject Navina Smart<br>System device in these<br>pediatric populations is<br>proposed only in specific<br>clinical circumstances and<br>where less invasive<br>therapies are not successful and<br>to identify specific indicated<br>uses of propose catheters. |
| Element | Proposed Device<br>Navina Smart System | Primary Predicate Device<br>Navina Classic System<br>(K170487) | Secondary Predicate Device<br>Peristeen Anal Irrigation System<br>(K140310) | Differences between<br>proposed device and<br>predicate devices |
| Anatomical Site<br>Where Used | Rectum (and lower colon)<br>Health Care Facility and home use | Rectum (and lower colon)<br>Health Care Facility and home use | Rectum (and lower colon)<br>Health Care Facility and home use | None |
| Retention in Bowel<br>During Treatment | Rectal balloon catheter<br>and cone catheter | Rectal balloon catheter | Rectal balloon catheter | The proposed Navina Smart<br>System also includes an<br>additional cone catheter. |
| Bowel Irrigation<br>Function | Irrigation fluid container and pump<br>(control unit) provided | Irrigation fluid container and<br>pump (control unit) provided | Irrigation fluid bag and pump<br>(control unit) provided | None |
| Single Use | Catheters are for single use. Other<br>parts are for repeated 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 |
| Rectal Catheter | Hydrophilic coating | Hydrophilic coating | Hydrophilic coating | None |
| Fluid for Activation<br>of 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 of<br>Catheter | Rectum -balloon inflated above<br>sphincter. Cone catheter without<br>balloon placed in rectum | Rectum -balloon inflated above<br>sphincter | Rectum -balloon inflated above<br>sphincter | The proposed Navina Smart<br>System includes also an<br>additional cone catheter. |
| Balloon is Inflated<br>With | 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 Unit<br>Design | Firmware controlled electronic<br>control unit containing two pumps<br>dependent on an energy source.<br>One to inflate the balloon and one<br>to instill water | Two manual pumps: One to<br>inflate the balloon and one to<br>instill water | One manual pump with a switch<br>mode to inflate balloon and instill<br>water | The Navina Smart Control<br>Unit is an electro-<br>mechanical design<br>dependent on an energy<br>source. Both predicates are<br>dependent on manual<br>power. |
| Control Unit<br>Settings | The settings are personalized<br>together with a health professional.<br>The following can be set:<br>1. The size of the inflated<br>balloon.<br>2. The amount of instilled<br>water.<br>3. The flow rate. | The size of the balloon, the<br>amount of water and the flow<br>rate is dependent on manual<br>pumping. | The size of the balloon, the amount<br>of water and the flow rate is<br>dependent on manual pumping. | Balloon size control, max<br>fluid volume, and irrigation<br>rate is software controlled<br>according to preset<br>parameters in the subject<br>Navina Smart System. |
| Instillation of<br>Water | Flow is generated by pressurizing<br>the water container with air | Flow is generated by<br>pressurizing the water container | Flow is generated by pressurizing<br>the water container with air | None |
| Stop Water Flow | By releasing the button, the water<br>flow is stopped. | Manual valve on the control<br>unit. | Manual valve on the control unit.…