Peristeen Anal Irrigation System

K140310 · Coloplast A/S · KNT · Sep 3, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K140310
• Device Name: Peristeen Anal Irrigation System
• Applicant: Coloplast A/S
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Sep 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 years -< 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

Device Story

Peristeen Anal Irrigation System facilitates colon/bowel evacuation for patients with neurogenic bowel dysfunction. System comprises single-use irrigation catheter with inflatable balloon for retention and water instillation; multi-use components for irrigation control. Device used by patients or caregivers in home or clinical settings. Procedure involves inserting catheter into rectum, inflating balloon to secure position, and instilling water to promote lower colon evacuation. Output is mechanical evacuation of bowel contents. Benefits include improved bowel management and symptom relief for incontinence and constipation. Device is identical to previously cleared predicate; no design, material, or manufacturing changes.

Clinical Evidence

No clinical testing was performed, referenced, or relied upon for this 510(k) submission. The device is identical to the predicate.

Technological Characteristics

Class II gastrointestinal tube and accessories. System includes single-use rectal catheter with inflatable balloon and multi-use irrigation components. Mechanical operation; no energy source or software. Non-sterile catheter.

Indications for Use

Indicated for children (2 to <12 years), adolescents (12 to <18 years), transitional adolescents (18 to <21 years), and adults with neurogenic bowel dysfunction suffering from fecal incontinence, chronic constipation, or time-consuming bowel management.

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

• Peristeen™ Anal Irrigation System (K112860)

Reference Devices

• Peristeen Anal Irrigation System (K083770)
• Peristeen Anal Irrigation System (K103254)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, 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 3, 2015

Coloplast A/S % Brian Schmidt Regulatory Affairs Manager Coloplast Corp. 1601 West River Road North Minneapolis, MN 55411

Re: K140310

> Trade/Device Name: Peristeen™ Anal Irrigation System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT. FCE Dated: July 23, 2015 Received: July 27, 2015

Dear Brian Schmidt.

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.

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.

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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 (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 at its toll-free number [phone] or [phone] 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for 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) K140310

Device Name Peristeen™ Anal Irrigation System

#### Indications for Use (Describe)

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 years -< 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

Type of Use (Select one or both, as applicable)

| <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 1. 510(K) SUMMARY OR 510(K) SUMMARY STATEMENT

| 510(k) Summary | | | |
|-------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------|--|
| 510(K) Owner's Name: | | Coloplast A/S | |
| Address: | | Holtedam 1<br>3050 Humlebaek, Denmark<br>Establishment Registration: 9610694<br>Owner/Operator: 8010144 | |
| Name of Contact Person: | | Brian Schmidt<br>Regulatory Affairs Manager | |
| Address/Contact: | | 1601 West River Road<br>Minneapolis, MN 55411 | |
| Phone/Fax/Email: | Office:<br>Mobile:<br>Fax:<br>email: | [phone]<br>[phone]<br>[phone]<br>[e-mail] | |
| Date Prepared: | | February 4, 2014 | |
| Trade Name: | | Peristeen™ Anal Irrigation System | |
| Common Name: | | Rectal Catheter and accessories and<br>Enema kit | |
| Classification Name: | | 876.5980 Gastrointestinal tube & accessories<br>Class II and<br>876.5210 Enema kit<br>Class I (Exempt) | |
| Product Code: | | KNT and FCE | |

### Legally Marketed Devices To Which Your Firm Is Claiming Equivalence:

The Peristeen™ Anal Irrigation System is substantially equivalent in performance, indications, design and materials to the Peristeen™ Anal Irrigation System cleared on June 8, 2012 under premarket notification 510(k) number K112860.

### Indications for Use

The Peristeen™ Anal Irrigation (PAI) 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 PAI System is indicated for use by Children (2 years - < 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - < 21

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years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

# Device Description

The Peristeen™ Anal Irrigation (PAI) System is a Class II device intended for intermittent use that facilitates emptying of the colon/bowel in patients with neurogenic bowel dysfunction. The PAI system consists of a single-use irrigation catheter that incorporates an inflatable balloon to keep the catheter in place during the procedure and retain the water that flows into the colon. The rectal catheter is non-sterile, intended for single-use, and packaged and labeled accordingly. The other components may be used multiple times; usage guidelines are detailed in the labeling. All System components are also provided separately in various accessory packages.

No changes have been made to the device design, materials, components, technological characteristics or manufacturing processes of the subject device compared to the predicate.

# PAI System Performance Testing Summary

No change is being made to the predicate device. The subject device is identical to the previously clear device, Peristeen Anal Irrigation System (K083770, K103254, and K112860). The only change being effected is release of an updated IFU. As such, testing for Performance, Shelf Life and Biocompatibility was not deemed necessary to support substantial equivalence.

# Substantial Equivalence Conclusion

No clinical testing was performed, referenced, or relied on in the 510(k) for a determination of substantial equivalence. Based upon the device comparisons, the PAI System is substantially equivalent in performance, indications, design, and materials to the Coloplast Peristeen™ Anal Irrigation (PAI) system cleared on June 8, 2012 under premarket notification 510(k) number K112860.