Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

K193325 · Prosys International, Ltd. · KNT · Mar 13, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K193325
• Device Name: Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
• Applicant: Prosys International, Ltd.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Mar 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Avantgarde Faecal Management System is intended for faecal management by the collection of semi-liquid or liquid faecal matter in bedridden adults.

Device Story

Avantgarde Faecal Management System is an invasive device for managing faecal matter in bedridden adults. It consists of a silicone catheter tube with an inflation cuff, irrigation port, 1,500ml collection bag, mounting plate, and 45ml syringe. The catheter is inserted into the rectum; the balloon is inflated to retain the device. Liquid or semi-liquid stool is diverted through the tube into the collection bag. The system includes a pressure release valve on the inflation port to prevent over-inflation. The device is used in clinical settings by healthcare providers to manage incontinence, reduce skin breakdown, and improve patient hygiene.

Clinical Evidence

Bench testing only. Testing included accelerated aging (ASTM F1980), seal strength (ASTM F88), leak detection (ASTM F1929), shipping performance (ASTM D4169), and urine collection bag requirements (ISO 8669-2). Biocompatibility testing was performed per ISO 10993, confirming the device is non-toxic.

Technological Characteristics

Silicone catheter with Parylene coating; 1,500ml collection bag; inflation cuff with pressure release valve; irrigation port (Luer). Non-sterile, single-use. 5-year shelf life. Standards: ASTM F1980, F88, F1929, D4169; ISO 8669-2, ISO 10993.

Indications for Use

Indicated for faecal management via collection of semi-liquid or liquid faecal matter in bedridden adults.

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

• Flexi-Seal Signal (K150350)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized depiction of a human figure. To the right of it is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

March 13, 2020

ProSys International Ltd Graham Steer R&D Director Suite 303, Highland House 165 The Broadway SW19 1NE Wimbledon, Loudon UNITED KINDOM

Re: K193325

Trade/Device Name: Avantgarde Faecal Management Systems Avantgarde Faecal Management System Replacement Pouches Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: February 13, 2020 Received: February 19, 2020

Dear Graham Steer:

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

{1}------------------------------------------------

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

Shani P. Haugen, PhD Acting 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K193325

Device Name

Avantgarde Faecal Management System Avantgarde Faecal Management System Replacement Pouches

Indications for Use (Describe)

The Avantgarde Faecal Management System (FMS) is intended for faecal management by the collection of semi liquid or liquid faecal matter in bedridden adults.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

*[e-mail]*

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for Pro Sys International Limited. The words "Pro" and "International Limited" are in blue, while "Sys" is in white. The logo is simple and professional, and it is likely used by a company that provides professional services.

K193325 Page 1 of 3

# 510(k) SUMMARY

In accordance with 21 CFR 807.92 and the Safe Medical Devices Act 1990, the following information is provided for the Avantgarde Faecal Management System 510(k) Premarket Notification. This submission was prepared in accordance with the FDA Guidance Document "Format for Traditional & Abbreviated 510(k)s'

| Subject Device(s): | Avantgarde Faecal Management System<br>Avantgarde Faecal Management System Replacement Pouches |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 1st December 2019 |
| Applicant: | ProSys International Ltd<br>Suite 303, Highland House,<br>165 The Broadway<br>Wimbledon<br>London<br>SW19 1NE<br>United Kingdom |
| Contact: | Mr Graham Steer<br>R&D Director<br>ProSys International Ltd<br>Tel: + 44 (0) 208 944 7585<br>Fax: + 44 (0) 208 944 5434<br>Email: [e-mail] |
| Device Trade Name: | Avantgarde Faecal Management System |
| Classification Name: | Gastrointestinal tube and accessories |
| Product Code: | KNT |
| Regulation: | CFR 876-5980 |
| Device Class: | Class II |

# PREDICATE DEVICES:

Legally marketed Medical Devices to which Substantial Equivalence is claimed:

| Trade Name: | Flexi-Seal Signal |
|--------------------------------------|-----------------------------------------|
| Manufacturer: | ConvaTec Inc |
| 510(k) Substantial Equivalence: | K150350 - See FDA Approval in Section 3 |
| Determined Substantially Equivalent: | 21st July 2015 |

{4}------------------------------------------------

### DEVICE DESCRIPTION

The Avantgarde Faecal Management System (catheter) is an invasive medical device to be used inside the body. It consists of a silicone catheter tube with inflation cuff and irrigation port, a 1,500ml collection bag, mounting plate with an attachment strap and 45ml syringe. This tray of devices, is supplied as a Convenience Kit. In addition, other related medical devices to enable the Avantgarde work effectively, include the Avantgarde Faecal Management System Replacement Pouches which are to be supplied on a bundle basis.

This non-sterile device is for single use only.

The FMS catheter tube is constructed of a silicone material. The balloon once inflated retains the device in the rectum. The liquid or semi-liquid stool is diverted into the drainage tube, which provides a route for the liquid or semi-liquid faecal matter to pass into the collection bag.

Along the tube are two lumens with individual access ports. One port to inflate and deflate the balloon and the other to add water to flush and irrigate the catheter tube.

Its shelf life is 5 years from the date of production.

#### INTENDED USE

The Avantgarde Faecal Management System is intended for faecal management by the collection of semi-liquid or liquid faecal matter in bedridden adults.

## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The following table which forms part of this 510(k) submission contains a very brief summary of the technological characteristics of Avantgarde Faecal Management System compared to the predicate device. This table is supported by additional information in section 30 (Substantial Equivalence Discussion) and the Executive Summary section 28.

| Function | Avantgarde Faecal<br>Management System | ConvaTec Flexi Seal Signal<br>FMS | Similarities |
|------------------------------------|--------------------------------------------------|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Faecal Management | Faecal Management | Both devices are the same |
| Animal Derived<br>Material Content | None | None | Both devices are the same |
| Sterility | Non Sterile | Non Sterile | Both devices are the same |
| Medical Device Class | Class II | Class II | Both devices are the same |
| Inflation Port | Pressure Release Valve | Luer | Avantgarde is provided with a pressure<br>release valve to ensure the balloon/cuff<br>can not physically be over inflated. |
| Irrigation Port | Luer | Luer | Both devices are the same |
| Collection Bag | 1,500ml Silicone Disposable<br>Bags | 1,000ml Disposable<br>Collection Bags | Avantgarde has a larger collection<br>capacity but they are basically similar |
| Catheter Tube Length | 1,700mm | 1,550mm – 1,670mm | Avantgarde is slightly longer but they are<br>basically similar |
| Device Material | Constructed of Silicone with<br>Parylene coating | Silicone Rubber | Avantgarde has an enhanced waste<br>fecal flow rate but they are basically<br>the same |

{5}------------------------------------------------

# SUMMARY OF PERFORMANCE (NON CLINICAL TESTING) DATA

Non clinical testing of the subject device for functional and structural characteristics has been performed. In the testing, the device was found to be substantially equivalent to the predicate device. Typical testing included F1980 Standards guide for accelerated aging of sterile medical device package; F 88 Standard test method for seal strength of flexible barrier materials; F1929 Standard test method for detecting seal leaks in porous medical packaging by dye penetration; ASTM D 4169 Standard practice for performance testing of shipping containers and systems; W-ZK-08-65 Final Inspection criteria for faecal management system: ISO8669-2 Urine collection bags-part 2: Requirements and test methods.

In addition Avantgarde Faecal Management Systems had been tested against ISO 10993 by Soochow University and it confirms that Avantgarde is non-toxic.

In conclusion, the subject device (Avantgarde) has been shown to be as safe and effective and substantially equivalent to the predicate devices.

## END