(206 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid control aspects, with no mention of AI/ML terms or data processing capabilities.
Yes
The device is intended to treat medical conditions (fecal incontinence, chronic constipation, and/or time consuming bowel management) by promoting evacuation of the colon and rectum, which is a therapeutic action.
No
Explanation: The device is intended to treat fecal incontinence and chronic constipation by promoting evacuation of the colon and rectum, not to diagnose these conditions.
No
The device description explicitly lists physical components such as a rectal catheter, water container, control unit, and tubing, indicating it is a hardware-based medical device.
Based on the provided information, the Navina Classic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Navina Classic System Function: The Navina Classic System is a device used to physically irrigate the colon and rectum by instilling water. It is a therapeutic device aimed at promoting bowel evacuation, not analyzing biological samples.
- Intended Use: The intended use clearly states it's for managing fecal incontinence and chronic constipation by promoting evacuation, not for diagnostic purposes.
- Device Description: The description details the components involved in the physical process of irrigation, not the analysis of biological samples.
- Performance Studies: The performance studies focus on the mechanical and physical performance of the device components and system (water flow, balloon inflation, material properties), not on the accuracy or reliability of analyzing biological samples.
Therefore, the Navina Classic System falls under the category of a therapeutic or management device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 colon and rectum by instilling water into the lower part of the colon through a rectal catheter which incorporates an inflatable balloon.
Product codes (comma separated list FDA assigned to the subject device)
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectum (and lower colon)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Health Care Facility and home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
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)
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3
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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.
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
Navina Classic System | Predicate Device
Peristeen Anal Irrigation System (K140430) | Difference between
Proposed device and
Predicate device |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 colon and
rectum by instilling water into the lower part of
the colon through a rectal catheter which
incorporates an inflatable balloon. | The Peristeen Anal Irrigation System is intended
to instill water into the colon through a rectal
catheter - which incorporates an inflatable balloon -
inserted into the rectum to promote evacuation of the
contents of the lower colon. The Peristeen Anal
Irrigation System is indicated for use by children (2-
Navina Classic System | Predicate device
Peristeen Anal Irrigation System
(K140130) | Difference between proposed and
predicate device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contra
indications | 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 device
Navina Classic System | Predicate device
Peristeen Anal Irrigation System
(K140130) | Difference between proposed and
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.
*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
Navina Classic System | Predicate device
Peristeen Anal Irrigation System
(K140130) | Difference between proposed and
predicate device |
| Special caution must be shown if you
have had any of the following: | Special caution must be shown if you
have had any of the following: | Special caution must be shown if you
have had any of the following: | None |
| • Painful anorectal conditions -any
condition which may cause pain
or bleeding, e.g. anal fissure, anal
fistula third or fourth grade of
hemorrhoids | • Painful anorectal conditions -any
condition which may cause pain
or bleeding, e.g. anal fissure, anal
fistula third or fourth grade of
hemorrhoids | Any anorectal condition, which may
cause pain or bleeding e.g. anal fissure,
anal fistula or third or fourth degree
haemorrhoids | None |
| • Fecal impaction. If you are
heavily constipated an initial
clean out of your bowel must be
performed before starting up the
irrigation treatment | • Fecal impaction. If you are
heavily constipated an initial
clean out of your bowel must be
performed before starting up the
irrigation treatment | Fecal impaction/heavy constipation. If
you are heavily constipated (fecally
impacted) an initial clean-out of your
bowels is mandatory before starting up
the Peristeen Anal Irrigation procedure | None |
| • Irradiation therapy in the
abdominal or pelvic region | • Irradiation therapy in the
abdominal or pelvic region | Irradiation therapy in the abdominal or
pelvic region | None |
| • Severe diverticulosis or
diverticular abscess | • Severe diverticulosis or
diverticular abscess | Diverticular disease | Precautions for Proposed device are
based on consensus expert review
paper¹. Consensus review state "Severe
diverticulosis or diverticular abscess"
as relative contraindication (Precaution) |
| • Previous anal or colorectal
surgery | • Previous anal or colorectal
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
using anticoagulant therapy (not
including aspirin or clopidogrel) | • Increased risk of hemorrhage or
using anticoagulant therapy (not
including aspirin or clopidogrel) | Bleeding diathesis or anticoagulant
therapy (not including aspirin or
clopidogrel) | None |
| • Changed stool pattern such as
sudden diarrhea of unknown
origin. The cause of diarrhea must
be identified | • Changed stool pattern such as
sudden diarrhea of unknown
origin. The cause of diarrhea must
be identified | Changed stool pattern such as sudden
diarrhea of unknown origin. The cause of
diarrhea must be identified | None |
| Element | Proposed device
Navina Classic System | Predicate device
Peristeen Anal Irrigation System
(K140130) | Difference between proposed and
predicate device |
| • | Rectal medication since the effect
of such medication may be
reduced by using anal irrigation | Rectal medication since the effect of such
medication may be reduced by the anal
irrigation | None |
| | Active inflammatory bowel disease
(contraindication) | Inflammatory bowel disease (e.g. Crons
disease or ulcerative colitis) | Active inflammatory bowel is a
contraindication for Proposed device. |
| | Cancer in the abdominal and pelvic
region | Cancer in the abdominal or pelvic region | None |
| | Severe cognitive impairment (unless
caregiver is available to
supervise/administer) | Severe cognitive impairment (unless
caregiver is available to
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.)
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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.
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.