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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Dentsply Sirona Navina Classic System. It focuses on demonstrating substantial equivalence to a predicate device (Peristeen Anal Irrigation System), rather than detailing original clinical performance studies with specific statistical acceptance criteria for a novel AI/device.

Therefore, many of the requested details, such as those related to AI model acceptance criteria, ground truth establishment for test sets, MRMC studies, and standalone algorithm performance, are not applicable or not available in this document because the device itself is a mechanical medical device, not an AI/ML product.

However, I can extract information related to the performance testing that was conducted:

Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance testing against "requirements." While specific numerical acceptance criteria are not explicitly stated in a table format with corresponding reported values, the text indicates that the device met these requirements.

Note: The document states, "The performance of the Navina Classic System satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence." This implies that internal acceptance criteria were established and met for each test.

Test Category	Specific Performance Tests	Acceptance Criteria (Implicit)	Reported Device Performance
Control Unit	- Control of air leakage	Meets specified leakage limits.	Satisfactorily met requirements.
	- Complete deflation of balloon (air release)	Achieves complete balloon deflation.	Satisfactorily met requirements.
	- Control of maximum pump force	Stays within specified pump force range.	Satisfactorily met requirements.
	- Ability to instantly stop water flow	Stops water flow immediately upon control.	Satisfactorily met requirements.
	- Control of water flow rate	Maintains specified water flow rate.	Satisfactorily met requirements.
Rectal Catheter	- Hydrophilic coating at insertion and withdrawal	Maintains lubricity for smooth insertion/withdrawal.	Satisfactorily met requirements.
	- Flexibility	Meets specified flexibility standards.	Satisfactorily met requirements.
	- Even balloon inflation	Inflates uniformly without deformities.	Satisfactorily met requirements.
	- Balloon burst diameter	Bursts at or above specified diameter.	Satisfactorily met requirements.
	- Balloon burst volume	Bursts at or above specified volume.	Satisfactorily met requirements.
	- Rectal catheter flow rate	Achieves specified flow rate.	Satisfactorily met requirements.
	- Rectal catheter flow rate after catheter kink	Maintains acceptable flow rate after kinking.	Satisfactorily met requirements.
Water Container	- Proper air pressure	Maintains specified air pressure.	Satisfactorily met requirements.
	- Accuracy of the scale of the water container	Provides accurate volume measurement.	Satisfactorily met requirements.
Connectors	- Control of air leakage	Meets specified leakage limits.	Satisfactorily met requirements.
	- Tensile and torque resistance after simulated repeated use	Withstands specified tensile and torque forces after repeated use.	Satisfactorily met requirements.
Navina Classic System	- System backflow verification testing	Prevents backflow as specified.	Satisfactorily met requirements.
Biocompatibility (ISO 10993)	- Cytotoxicity (ISO10993-5:2009)	Non-cytotoxic.	Non-cytotoxic.
	- Irritation (ISO10993-10:2010)	Non-irritating.	Non-irritating.
	- Sensitization (ISO10993-10:2010)	Non-sensitizing.	Non-sensitizing.
	- Genotoxicity (ISO10993-3:2014)	Non-genotoxic.	Results demonstrate support for substantial equivalence.
Leachable Compounds	- Verification of leachables after simulated repeated use	Meets safety limits for leachable compounds.	Results support substantial equivalence.

Study Details

As the document is a 510(k) for a physical medical device, not an AI/ML product study, many of the requested fields are not applicable (N/A).

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly quantified in terms of "samples" in a clinical or data sense for bench testing. It refers to the physical units tested to verify performance. The document does not specify the number of units or iterations for each non-clinical test.
- Data Provenance: N/A for bench testing. These are laboratory tests conducted on the device components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. Ground truth in the context of AI/ML device performance (e.g., image annotation) is not relevant here. For a mechanical device, performance is evaluated against engineering specifications and industry standards. There is mention of "consensus expert review (Emmanuel et al)" for the contraindications and precautions, referencing a published paper by medical professionals, but this is for clinical context, not for establishing ground truth for a test set in the AI sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This concept applies to human review of data, typically in AI/ML performance studies.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a mechanical device, not an AI-assisted diagnostic tool. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance data, the "ground truth" or reference for acceptance is against pre-defined engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and relevant regulatory requirements.
The sample size for the training set:
- N/A. This device does not involve a "training set" in the machine learning context.
How the ground truth for the training set was established:
- N/A. This device does not involve machine learning or a training set.

Summary

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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.

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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.

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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

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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.

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)

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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.

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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).

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Table 1a Similarities and Differences between the proposed and the predicate devices.
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Element	Proposed DeviceNavina Classic System	Predicate DevicePeristeen Anal Irrigation System (K140430)	Difference betweenProposed device andPredicate device
Indications For Use	The Navina Classic System is indicated for adultswho suffer from fecal incontinence, chronicconstipation, and/or time consuming bowelmanagement.The Navina Classic System is intended topromote evacuation of the contents of colon andrectum by instilling water into the lower part ofthe colon through a rectal catheter whichincorporates an inflatable balloon.	The Peristeen Anal Irrigation System is intendedto instill water into the colon through a rectalcatheter - which incorporates an inflatable balloon -inserted into the rectum to promote evacuation of thecontents of the lower colon. The Peristeen AnalIrrigation System is indicated for use by children (2-<12 years old), adolescent (12-<18 years old),transitional adolescent (18-<21 years old) and adultpatients with neurogenic bowel dysfunction whosuffer from fecal incontinence, chronic constipation,and/or time-consuming bowel managementprocedures.	More narrow population forproposed device.
Prescription Device	Yes	Yes	None
Target Population	Patients who suffer from fecal incontinence, chronicconstipation, and/or time consuming bowelmanagement.	Patients with neurogenic bowel dysfunction whosuffer from fecal incontinence, chronic constipation,and/or time-consuming bowel managementprocedures.	Proposed device does notlimit the target population topatients with neurogenicbowel dysfunction. Anypatient suffering from fecalincontinence, chronicconstipation, and/or timeconsuming bowelmanagement is included intarget population.
Age Groups	Adults	Children (2-<12 years old), adolescent (12-<18 yearsold), transitional adolescent (18-<21 years old) andadult	More narrow age group forproposed 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 BowelDuring Treatment	Rectal balloon catheter	Rectal balloon catheter	None
Bowel IrrigationFunction	Irrigation fluid bag and pump (control unit) provided	Irrigation fluid bag and pump (control unit) provided	None
Single Use	Catheter is for single useOther parts are for repeated use	Catheter is for single useOther parts are for repeated use	None

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Table 1a Similarities and Differences between the proposed and the predicate devices.
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Element	Proposed DeviceNavina Classic System	Predicate DevicePeristeen Anal Irrigation System (K140430)	Difference betweenProposed device andPredicate device
Rectal CatheterCoating	Hydrophilic coating	Hydrophilic coating	None
Fluid for Activationof Catheter Coating	Water	Water	None
Fluid for Irrigation	Lukewarm water (97-100 °F)	Lukewarm water (97-100 °F)	None
Placement ofCatheter	Rectum -balloon inflated above sphincter	Rectum -balloon inflated above sphincter	None
Balloon is InflatedWith	Air	Air	None
Sterility	Provided non-sterile	Provided non-sterile	None
Biocompatibility perISO10993	Meets standard	Meets standard	None

Table 1b

Similarities and differences regarding Contraindications and Precautions for Proposed and Predicate device (K140310)

Element	Proposed deviceNavina Classic System	Predicate devicePeristeen Anal Irrigation System(K140130)	Difference between proposed andpredicate device
Contraindications	You shall not use Navina Classic System if you have had one or more of the following:	Peristeen anal Irrigation must not 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 deviceNavina Classic System	Predicate devicePeristeen Anal Irrigation System(K140130)	Difference between proposed andpredicate 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.*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 deviceNavina Classic System	Predicate devicePeristeen Anal Irrigation System(K140130)	Difference between proposed andpredicate device
Special caution must be shown if youhave had any of the following:	Special caution must be shown if youhave had any of the following:	Special caution must be shown if youhave had any of the following:	None
• Painful anorectal conditions -anycondition which may cause painor bleeding, e.g. anal fissure, analfistula third or 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. anal fissure,anal fistula or third or fourth degreehaemorrhoids	None
• Fecal impaction. If you areheavily constipated an initialclean out of your bowel must beperformed before starting up theirrigation treatment	• Fecal impaction. If you areheavily constipated an initialclean out of your bowel must beperformed before starting up theirrigation treatment	Fecal impaction/heavy constipation. Ifyou are heavily constipated (fecallyimpacted) an initial clean-out of yourbowels is mandatory before starting upthe Peristeen Anal Irrigation procedure	None
• Irradiation therapy in theabdominal or pelvic region	• Irradiation therapy in theabdominal or pelvic region	Irradiation therapy in the abdominal orpelvic region	None
• Severe diverticulosis ordiverticular abscess	• Severe diverticulosis ordiverticular abscess	Diverticular disease	Precautions for Proposed device arebased on consensus expert reviewpaper¹. Consensus review state "Severediverticulosis or diverticular abscess"as relative contraindication (Precaution)
• 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 corticosteroid therapy	• Long term corticosteroid therapy	Long term corticosteroid therapy	None
• Increased risk of hemorrhage orusing anticoagulant therapy (notincluding aspirin or clopidogrel)	• Increased risk of hemorrhage orusing anticoagulant therapy (notincluding aspirin or clopidogrel)	Bleeding diathesis or anticoagulanttherapy (not including aspirin orclopidogrel)	None
• Changed stool pattern such assudden diarrhea of unknownorigin. The cause of diarrhea mustbe identified	• Changed stool pattern such assudden diarrhea of unknownorigin. The cause of diarrhea mustbe identified	Changed stool pattern such as suddendiarrhea of unknown origin. The cause ofdiarrhea must be identified	None
Element	Proposed deviceNavina Classic System	Predicate devicePeristeen Anal Irrigation System(K140130)	Difference between proposed andpredicate device
•	Rectal medication since the effectof such medication may bereduced by using anal irrigation	Rectal medication since the effect of suchmedication may be reduced by the analirrigation	None
	Active inflammatory bowel disease(contraindication)	Inflammatory bowel disease (e.g. Cronsdisease or ulcerative colitis)	Active inflammatory bowel is acontraindication for Proposed device.
	Cancer in the abdominal and pelvicregion	Cancer in the abdominal or pelvic region	None
	Severe cognitive impairment (unlesscaregiver is available tosupervise/administer)	Severe cognitive impairment (unlesscaregiver is available tosupervise/administer)	None

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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.)

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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.

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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.

Regulation Number and Section

§ 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.