(102 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a faecal management system, with no mention of AI or ML capabilities.
No
The device is for managing faecal matter by collecting it from bedridden adults and does not treat or cure a disease or condition.
No
The device is described as a Faecal Management System (FMS) intended for the collection of faecal matter, which is a treatment or management function, not a diagnostic one.
No
The device description explicitly details physical components such as a silicone catheter tube, inflation cuff, irrigation port, collection bag, mounting plate, strap, and syringe. It also describes the physical mechanism of the device (balloon inflation, drainage tube). There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "faecal management by the collection of semi liquid or liquid faecal matter in bedridden adults." This describes a physical collection and management system for bodily waste.
- Device Description: The description details a physical catheter, collection bag, and related components designed to be inserted into the body to collect faecal matter.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples, detect substances, or provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for in vitro examination of specimens derived from the human body.
The Avantgarde Faecal Management System is a medical device used for patient care and management, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Avantgarde Faecal Management System (FMS) is intended for faecal management by the collection of semi liquid or liquid faecal matter in bedridden adults.
Product codes
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectum
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
Avantgarde Faecal Management System Replacement Pouches |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 1st December 2019 |
| Applicant: | ProSys International Ltd
Suite 303, Highland House,
165 The Broadway
Wimbledon
London
SW19 1NE
United Kingdom |
| Contact: | Mr Graham Steer
R&D Director
ProSys International Ltd
Tel: + 44 (0) 208 944 7585
Fax: + 44 (0) 208 944 5434
Email: gsteer@prosysinternational.co.uk |
| 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 |
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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
Management System | ConvaTec Flexi Seal Signal
FMS | Similarities |
|------------------------------------|--------------------------------------------------|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Faecal Management | Faecal Management | Both devices are the same |
| Animal Derived
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
release valve to ensure the balloon/cuff
can not physically be over inflated. |
| Irrigation Port | Luer | Luer | Both devices are the same |
| Collection Bag | 1,500ml Silicone Disposable
Bags | 1,000ml Disposable
Collection Bags | Avantgarde has a larger collection
capacity but they are basically similar |
| Catheter Tube Length | 1,700mm | 1,550mm – 1,670mm | Avantgarde is slightly longer but they are
basically similar |
| Device Material | Constructed of Silicone with
Parylene coating | Silicone Rubber | Avantgarde has an enhanced waste
fecal flow rate but they are basically
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.