(141 days)
The Flexi-Seal® PROTECT ™ Fecal Management System is an indwelling fecal management catheter intended for use to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is not intended for use on pediatric patients.
The new device is called Flexi-Seal® PROTECT™ Fecal Management System which is an upqrade to the predicate device K150350. Flexi-Seal® Signal™ Fecal Management System (also known as Flexi-Seal® Signal™ Fecal Management System with Odor Barrier), launched in October 2015. The new device uses the same design and components except
- (1) the change from the 1-dome fill indicator to a new 2-dome fill indicator to provide visual cue by using
- (a) a green color dome to indicate an optimal fill status of retention balloon which is similar to the existing fill indicator except the color, and
- (b) a red color dome to indicate the over inflation status of retention balloon,
- (2) adding a white cap that can close off the inflation port,
- (3) adding a dark blue color in the sample port, and
- (4) Privacy bag (one bag instead of 3).
The device is comprised of the following components (in a clamshell pack with label card, IFU and 5 date labels): see diagram
The provided document is a 510(k) premarket notification for a medical device called the Flexi-Seal® PROTECT™ Fecal Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Flexi-Seal® SIGNAL™ Fecal Management System) rather than presenting a study to prove acceptance criteria for a new, AI-powered device.
Therefore, the information required to answer your specific questions about acceptance criteria and a study proving device performance (especially in the context of AI, multi-reader multi-case studies, or standalone algorithm performance) is not present in the provided text.
The document discusses non-clinical testing for functional and structural parameters to demonstrate that modifications to the predicate device do not affect safety and effectiveness. These are not acceptance criteria for an AI algorithm's performance.
Here's an analysis based on the information that is available, highlighting the absence of the requested details:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table (pages 7 and 8) outlining similarities and differences between the subject device (Flexi-Seal® PROTECT™) and the predicate device (Flexi-Seal® SIGNAL™). This table details parameters and their values for both devices, mainly focusing on physical characteristics and some functional aspects.
This is NOT a table of acceptance criteria for an AI study. It describes product specifications and how the new device compares to the old one. For example:
| Parameter | Acceptance Criteria (from document, interpreted as "same as predicate") | Reported Device Performance (from document, interpreted as "new device value") |
|---|---|---|
| Fill indication for optimal inflation volume | Green dome inflated at 35 - 45 ml (Predicate was White dome inflated at 35-45ml) | Green dome inflated at 35 - 45 ml |
| Fill Indicator for overfilling status | Red dome inflated beyond 45 ml and above ("A new feature in the subject device") | Red dome inflated beyond 45 ml and above |
| Cap for inflation port | Removable silicone cap ("A new feature in the subject device") | Removable silicone cap with sufficient removal force and joint strength |
| Sampling port color | Dark blue color (Predicate was natural color) | Dark blue color |
| Collection bag configuration | One bag (Predicate was three bags) | One bag with gas filter |
| Collection bag - front panel color | White with a clear window (Predicate was Clear) | White with a clear window |
| Other parameters (e.g., Catheter tube material, tensile strength, balloon size) | Generally "Both devices are the same" as the predicate device (e.g., Silicone rubber, 245N, 56.82mm) | Match the predicate device's specifications |
The "Performance Testing - Bench" section (page 5-6) lists tests conducted (e.g., fill indicator testing, cap testing, sampling port testing, privacy bag testing, journey hazard testing) but does not provide specific numerical acceptance criteria or performance results within the provided text. It only states that "Based on non-clinical testing of the subject device for functional and structural parameters, the modifications in the subject device do not affect the safety and effectiveness of the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical testing" (bench testing) and does not involve patient data or clinical studies with test sets in the context of an AI device.
3. 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)
This information is not provided in the document. No expert review or ground truth establishment relevant to an AI model is mentioned, as this is not an AI device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. 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
This information is not provided in the document. No MRMC study is mentioned, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. No standalone algorithm performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. The "ground truth" for the non-clinical tests would be reference measurements or engineering specifications, not clinical outcomes or expert consensus for diagnoses.
8. The sample size for the training set
This information is not provided in the document. No training set is involved as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided in the document. No training set or associated ground truth establishment is mentioned.
In summary: The provided FDA 510(k) submission pertains to a conventional medical device (Fecal Management System) and its modifications. It details bench testing to show equivalence to a predicate device. None of the questions related to AI-specific acceptance criteria, study designs (test/training sets, experts, MRMC, standalone performance), or ground truth establishment for AI models are applicable or answerable using this document.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of interconnected profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2017
ConvaTec Karen Howes Regulatory Affairs Manager GDC, First Avenue, Deeside Industrial Park Deeside, Flintshire CH5 2NU United Kingdom
Re: K162906
Trade/Device Name: Flexi-Seal® PROTECT™ Fecal Management System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: February 2, 2017 Received: February 6, 2017
Dear Karen Howes:
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 (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 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,
Joyce M. Whang -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) Unknown K162906
Device Name
Flexi-Seal® PROTECT TM Fecal Management System
Indications for Use (Describe)
The Flexi-Seal® PROTECT ™ Fecal Management System is an indwelling fecal management catheter intended for use to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is not intended for use on pediatric patients.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 243-1741 EF
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Image /page/3/Picture/0 description: The image features the logo of ConvaTec, a global medical products and technologies company. The logo consists of two distinct elements: a circular icon on the left and the company name "ConvaTec" on the right. The circular icon is a blue circle with a white graphic inside, resembling a building with columns. The text "ConvaTec" is written in a bold, sans-serif font, also in blue, matching the color of the circular icon.
Section 5 510(k) Summary
Applicant: ConvaTec Limited.
Applicant Address: GDC, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU UK The Establishment Registration number is 1000317571
Contact: Karen Howes Regulatory Affairs Manager ConvaTec Ltd. GDC, First Avenue, Deeside industrial Park Deeside Flintshire, CH5 2NU UK Tel: +44(0) 1244832195
Date Prepared: 1 December 2016
Device Identification:
Trade Name: Flexi-Seal® PROTECT™ Fecal Management System Common Name: Fecal Management System
Regulation Number: 21 CFR §876.5980
Classification Panel: Gastroenterology and Urology
Classification Name: Gastrointestinal tube and accessories
Regulatory Class: II
Product Code: KNT
Predicate Devices: 510(K) number: K150350 Flexi-Seal® SIGNAL™ Fecal Management System
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Device Description
The new device is called Flexi-Seal® PROTECT™ Fecal Management System which is an upqrade to the predicate device K150350. Flexi-Seal® Signal™ Fecal Management System (also known as Flexi-Seal® Signal™ Fecal Management System with Odor Barrier), launched in October 2015. The new device uses the same design and components except
- (1) the change from the 1-dome fill indicator to a new 2-dome fill indicator to provide visual cue by using
- (a) a green color dome to indicate an optimal fill status of retention balloon which is similar to the existing fill indicator except the color, and
- (b) a red color dome to indicate the over inflation status of retention balloon,
- (2) adding a white cap that can close off the inflation port,
- (3) adding a dark blue color in the sample port, and
- (4) Privacy bag (one bag instead of 3).
The device is comprised of the following components (in a clamshell pack with label card, IFU and 5 date labels): see diagram
Image /page/4/Figure/9 description: The image shows a medical catheter with different parts labeled with numbers 1-11. The parts include the catheter irrigation and medication port, balloon inflation port, sampling port, catheter, position indicator line, low-pressure retention balloon, connector, hanging strap, luer-lock syringe, collection bag, and cinch clamp. The catheter is a long, flexible tube that is inserted into the body to drain fluids or deliver medications.
New device Flexi-Seal® PROTECT™ Fecal Management System
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Predicate device: Flexi-Seal® SIGNAL™ Fecal Management System
Image /page/5/Figure/1 description: This image shows a diagram of a catheter system with different parts labeled with numbers 1-11. The numbers correspond to the following parts: Catheter Irrigation and Medication Port, Balloon Inflation Port with Fill Indicator, Sampling Port, Catheter, Position Indicator Line, Low-Pressure Retention Balloon with Finger Pocket, Connector, Hanging Strap, Luer-lock Syringe, Collection Bag with Integrated Cap, and Cinch Clamp. The diagram shows the different parts of the catheter system and how they are connected.
Intended Use
The Flexi-Seal PROTECT FMS is an indwelling fecal management catheter intended for use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications. The device is not intended for use on pediatric patients.
Performance Testing - Bench
There are no differences in the intended use or performance of the subject and the predicate device. Non clinical testing has been conducted on the predicate and subject devices. The list of non-clinical testing for which the results are detailed in Sec. 18 includes:
-
- Fill indicator testing:
- a. Fill indication for optimal inflation volume of retention balloon
- b. Fill Indictor for overfilling status of retention balloon
- c. Fill Indicator joint strength to catheter
- d. Luer valve joint strength to Inflation Port
- e. Green ink adhesion
- Red ink adhesion f.
-
- Inflation port cap testing:
- a. Cap joint strength to the fill indicator
- b. Cap removal force
- c. Cap repeated removal 5 times
-
- Sampling port testing:
- a. Sampling port seal against air
- b. Sampling port seal against water
-
- Privacy bag testing:
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- a. Width of clear window at 10 25 mm
- b. Graduation at 500 ml is within ± 15%
- c. Graduation at 1000 ml is within ± 15%
- d. Pouch has 1 Liter capacity
- e. Ink Adhesion
-
- Journey hazard testing:
- a. Journey hazard testing
- b. Post-JHT Product Release Testing Visual, Color, and Cap
- c. Post-JHT Product Release Testing Fill indication for optimal inflation volume of retention balloon
- d. Post-JHT Product Release Testing Fill Indictor for overfilling status of retention balloon
Based on non-clinical testing of the subject device for functional and structural parameters, the modifications in the subject device do not affect the safety and effectiveness of the predicate device. Flexi-Seal® PROTECT™ Fecal Management System described in this submission is, in our opinion, substantially equivalent to the predicate device, Flexi-Seal® SIGNAL™ Fecal Management System per K150350.
Substantial Equivalence Conclusion
It has been demonstrated through comparison of design features and performance testing, that the proposed device and its predicate have been found to be substantially equivalent; see following pages.
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Substantial Equivalence Discussion
The following table compares the similarities and differences between the subject device: Flexi-Seal® PROTECT™ Fecal Management System and the predicate device: Flexi-Seal® SIGNAL™ Fecal Management System (ref; K150350) and outlines the product characteristics and specifications which form the basis of the substantial equivalence discussion.
The intended use, technological characteristics and principles of operation of the fecal management system remains the same as those of the predicate device.
| Subject Device | Predicate | Comparison | ||
|---|---|---|---|---|
| Parameter | Flexi-Seal® PROTECT™ Fecal ManagementSystem | Flexi-Seal® SIGNAL™ Fecal Management System(K150350) | Similarities | Differences |
| FDA Product Code | KNT | KNT | Both devices are the same | None |
| FDA ClassificationRegulation | 21 CFR 876.5980 | 21 CFR 876.5980 | Both devices are the same | None |
| Regulatory Class | Class II | Class II | Both devices are the same | None |
| Intended Use | To manage fecal incontinence through thecollection of liquid to semi-liquid stool and toprovide access to administer medications | To manage fecal incontinence through the collectionof liquid to semi-liquid stool and to provide access toadminister medications | Both devices are the same | None |
| Functionalconfiguration | Collapsible catheter with distal end securedin the rectum and proximal end connected toa collection bag | Collapsible catheter with distal end secured in therectum and proximal end connected to a collectionbag | Both devices are the same | None |
| Retention feature | Soft annular balloon | Soft annular balloon | Both devices are the same | None |
| Balloon material | Silicone rubber | Silicone rubber | Both devices are the same | None |
| Inflationmanagement | Sealed water filled balloon | Sealed water filled balloon | Both devices are the same | None |
| Retention balloon | Water/saline (45ml) | Water/saline (45ml) | Both devices are the same | None |
| inflation material | same | |||
| Retention ballooninflated diameter | 56.82mm | 56.82mm | Both devices are thesame | None |
| Retention ballooninflated height | 25.96mm | 25.96mm | Both devices are thesame | None |
| Catheter tubematerial | Silicone rubber plus 3% zeolite, by weight | Silicone rubber plus 3% zeolite, by weight | Both devices are thesame | None |
| Catheter tubesurface roughness | <15µm | <15µm | Both devices are thesame | None |
| Fill indication foroptimal inflationvolume ofretention balloon | Green dome inflated at 35 - 45 ml | White dome inflated at 35 - 45 ml | Except color, bothdevices provided thesame visual indicationfor optimal ballooninflation volume. Thedimension of the fillindicator is similar. | Color |
| Fill Indictor foroverfilling status ofretention balloon | Red dome inflated beyond 45 ml and above | None | A new feature in thesubject device using asimilar fill indicatordesign | A new feature in thesubject device |
| Cap for inflationport | A removable silicone cap to close off theinflation port with sufficient removal forceand joint strength | None | A new feature in thesubject device todifferentiate theinflation port from theirrigation port | A new feature in thesubject device |
| Catheter tubehardness | Shore A 38.5 - 51 | Shore A 38.5 - 51 | Both devices are thesame | None |
| Catheter tube wallthickness | 0.40 - 0.65mm | 0.40 - 0.65mm | Both devices are thesame | None |
| Catheter tubetensile strength | 245N | 245N | Both devices are thesame | None |
| Balloon-to-tubebonding strength | 25.4N | 25.4N | Both devices are thesame | None |
| Catheter tubelength | 1,550mm - 1,670mm | 1,550mm - 1,670mm | Both devices are thesame | None |
| Length ofsphincter section | >10cm | >10cm | Both devices are thesame | None |
| Drain channel | Large main drain tube | Large main drain tube | Both devices are thesame | None |
| Inflation andirrigation portconnections | Luer | Luer | Both devices are thesame | None |
| Inflation lumendiameter | Two lumens at 1.45 mm | Two lumens at 1.45 mm | Both devices are thesame | None |
| Inflation lines | 2 | 2 | Both devices are thesame | None |
| Irrigation lines | 1 | 1 | Both devices are thesame | None |
| Irrigation lumensize | 8mm x 1.6mm (collapsible) | 8mm x 1.6mm (collapsible) | Both devices are thesame | None |
| Sampling port | Closable snap seal for catheter syringeaccess - dark blue color | Closable snap seal for catheter syringe access -natural color | Except color, bothdevices provided thesame seal againstwater and air. | Color |
| Waste lumendiameter collapsed | 10mm | 10mm | Both devices are thesame | None |
| Collection bagconfiguration | Disposable with gas filter | Disposable with gas filter | Both devices use thesame filter, flange,and film panels in thecollection bag. | One bag in the subjectdevice vs. three bags inthe predicate device |
| Collection bag size | 1 litre disposable | 1 litre disposable | Both devices are thesame | None |
| Collection bagmaterial | Ethyl vinyl acetate | Ethyl vinyl acetate | Both devices are thesame | None |
| Collection bag -front panel color | White with a clear window | Clear | Except color in thefront panel, both bagsperform the same | Color |
| Method of bedconnection | Hanging strap on bag connector | Hanging strap on bag connector | Both devices are thesame | None |
| Accessorycomponents | Syringe and cinch clamp | Syringe and cinch clamp | Both devices are thesame | None |
| Flow stopmechanism | External cinch clamp | External cinch clamp | Both devices are thesame | None |
| Sterility status(how provided) | Non-sterile | Non-sterile | Both devices are thesame | None |
| Packaging | Thermoformed plastic clamshell PETG(POLYETHYLENE TEREPHTHALATEGLYCOL-MODIFIED) or APET(AMORPHOUS POLYETHYLENETEREPHTHALATE), both sides coated with2% silicone. | Thermoformed plastic clamshell PETG(POLYETHYLENE TEREPHTHALATE GLYCOL-MODIFIED) or APET (AMORPHOUSPOLYETHYLENE TEREPHTHALATE), both sidescoated with 2% silicone. | Both devices use thesame packagingmaterial | None |
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§ 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.