(261 days)
Procon 2 is a single use catheter with an inflatable balloon cuff intended to act as a barrier to the passage of fecal matter through the rectum.
Procon2 is for an individual with fecal incontinence that has impaired quality of life, is sufficiently motivated psychologically to participate in their own treatment, and having good manual dexterity is an ideal candidate. He or she is either not a surgical candidate or has not responded to conservative treatment.
A single use rectal silicone catheter with a water filled cuff acting as a barrier to the unintended passage of feces through the rectum.
The provided text describes the Procon2 device, a rectal catheter for fecal incontinence, and its equivalence to a predicate device (Procon). However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a detailed study proving performance. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical trial with acceptance criteria.
Here's what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text.
- Reported Device Performance: The text refers to "Patient acceptance trials of the Predicate Device" that "determined the efficacy of the Predicate Device as a 'mechanical barrier' to the impending passage of feces." It further quotes a medical text stating, "The mechanical barrier component, however, cannot be underestimated even when patients voluntarily turned off the alarm, with the catheter still in position, very few experienced episodes of focal accidents or major leakage." This refers to the predicate device, Procon, not Procon2 directly. The document claims Procon2 is substantially equivalent due to similar technological characteristics and intended use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for either the predicate device's trials or any new trials for Procon2.
- Data Provenance: The trials for the predicate device were "conducted at the Cleveland Clinic Florida." This indicates the data is from the United States and was likely prospective as they were "patient acceptance trials," but the timeline isn't specified in detail for Procon2.
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)
- Number of Experts & Qualifications: Not specified. The trials for the predicate device were under the "direction of the Chairman, Dept. of Colorectal Surgery, S.D. Wexner M.D., F.A.C.S., F.R.C.S., F.R.C.S.Ed., F.A.S.C.R.S., F.A.C.G." This indicates a highly qualified expert in colorectal surgery, but it doesn't state how many experts were involved in establishing "ground truth" or assessing patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not applicable. This device is a physical medical device (rectal catheter), not an AI diagnostic tool that involves human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical device, and its performance is assessed by its function as a mechanical barrier. The predicate device had an alarm, but Procon2 does not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the predicate device, the "efficacy... as a 'mechanical barrier' to the impending passage of feces" was "determined" through "patient acceptance trials." This strongly suggests patient-reported outcomes data and direct observation/assessment of fecal leakage events as the ground truth.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The manufacturer is relying on the predicate device's clinical performance and a demonstration of substantial equivalence through comparable technological characteristics.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary of Device and Evidence Presented:
- Device: Procon2, a single-use rectal silicone catheter with a water-filled cuff, intended as a barrier to fecal matter for patients with significant fecal incontinence who are not surgical candidates or have not responded to other treatments.
- Study Proving Performance: The document refers to "Patient acceptance trials of the Predicate Device" (Procon) conducted at the Cleveland Clinic Florida under the direction of Dr. S.D. Wexner. These trials determined the predicate device's efficacy as a "mechanical barrier" and are cited in a medical text.
- Key Finding (from Predicate Device): "very few experienced episodes of focal accidents or major leakage" when the catheter (predicate device) was in position.
- Procon2's Claim: Substantial equivalence to the predicate device based on similar intended use and technological characteristics, despite changes like silicone material (vs. latex), water cuff (vs. air), and absence of an electronic alarm. The submission argues that the mechanical barrier function, demonstrated for the predicate, is the key component.
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Image /page/0/Picture/0 description: The image shows the word "Procon" in a stylized font. The "2" is large and overlaps the "o" in "Procon". There is a small circle with a dot in the upper right corner of the image.
INCONTINENT CONTROL DEVICES, INC. 2727 Bens Branch Drive, Suite 1402, Kingwood, Texas 77339
MAY 2 7 2005
Ref: K042431
510(k) Summary
prepared: 09/30/04
Submitted by: Nyle Elliott Incontinent Control Devices, Inc. 2727 Bens Branch Drive, Ste, 1302 Kingwood, Texas 77339 Phone: 281-360-4638 Fax: 281-360-4638 nyc1939@carthlink.net Contact person: Nyle Elliott
Trade name of device: Procon2 Common name: Rectal Plug Classification: Gastrointestinal Tube & Accessories #876.5980
Incontinent Control Devices, Inc. is claiming equivalence of Procon2 to Procon. a class II Mcdical Device. K8642218 issued 01/12/1987
Description of Procon2: A single use rectal silicone catheter with a water filled cuff acting as a barrier to the unintended passage of feces through the rectum.
Intended use for Procon2: ProCon2 is a single use catheter with an inflatable balloon cuff intended to act as a barrier to the passage of fecal matter through the recturn. The device is intended for patients with significant fecal incontinence who are either not surgical candidates or have not responded to prior conservative and surgical treatment. The device is intended for selfinsertion after a thorough demonstration of its use.
Purposes and functions of Procon2: 1. To provide a rectal barrier to the discharge of fecal matter. 2. To help prevent the spread of infectious diseases, and 3. To restore a better quality of life for the users.
Technological characteristics of Predicate device: ( Device number K8642218 issued 01/12/1987) A single use rectal balloon cuff, 16Fr Latex, Foley Catheler with a photo-sensor alarm, and an air-filled cuff acting as a barrier to the unintended passage of feces.
Technological characteristics of Procon2: A single use rectal balloon cuff, 18Fr. Silicone, Foley catheter (without a conventional electronic alarm) acting as a barrier to the unintended passage of feces.
Procon2
Ref: K042431
510(k) Summary
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Technological characteristics of Procon2 compared to a legally marketed devic are cluiming equivalence:
Predicate Device: Uses software Procon2: No software required
Predicate Device: Has low current circuitry using electrical conduit to a distal infrared sensor. Procun2: I las no clectrical circuitry or sensor tio.
Predicate Device: Utilizes infrared photo-transducer to detect presence of fecal matter. Procob 2: Uses rectal tactile response or predetermined lime to remind user when to evacualc.
Predicate Device: Uses a balloon cuff filled with 25cc of air Procon2: Uses a balloon cuff filled with 25cc of water.
And States of Article Career States
Predicate Device: Provides a balloon barrier, sensor and alan Procon2: Provides a balloon barrier only,
Predicate Device: Catheter material is Latcx Procon2: Catheter material is Silicone,
Summary of Clinical Performance Data:
Ref: K042431
Procon2 -
Patient acceptance trials of the Predicate Device conducted at the Cleveland Clinic Florida, under the direction of the Chairman, Dept. of Colorcetal Surgery, S.D. Wexner M.D., F.A.C.S., F.R.C.S., F.R.C.S.Ed., F.A.S.C.R.S., F.A.C.G., determined the efficacy of the Predicate Device as a "mechanical barrier" to the impending passage of feces.
The medical text, Diamosis and Treatment of Fecal Incontinence (2000) Giovanni Romano, P. a. Lehur. E. Weiss (eds), ISBN: 192864919X. Publisher: Idelson-Gnocchi Ltd. Publishing provides a summary of Dr. Wexner's findings:
"The ProCon Incontinence Device: A new Ontion for the Treatment of Symptoms of Fecal Incontinence" by Dr. Paolo Giamundo, S.D. Wexner states the following:
"The mechanical barrier component, however, cannot be underestimated even when patients voluntarily turned off the alarm, with the catheter still in position, very few experienced episodes of focal accidents or major Icakage."
510(k) Summary
. And of the may
な気持ちのです。 アメリカ
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Image /page/2/Picture/12 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN" written around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The logo appears to be a government or organizational seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Mr. Nyle Elliot Director of Product R & D Incontinent Control Devices, Inc. 2727 Bens Branch Drive, Suite 1302 KINGWOOD TX 77339
Re: K042431
Trade/Device Name: Procon 2 Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: April 12, 2005 Received: April 13, 2004
Dear Mr. Elliot:
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 do increative appeal controls provisions of the Act. The general controls provisions of the Act include reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 I DA nas made a addressions administered by other Federal agencies. You must comply with all the I odors starse are are as a so Act 3 requirements, morating practice requirements as set forth in the quality systems (QS) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
1948) 1 This letter will anow your to begin marketing of substantial equivalence of your device to a legally premarket notification. The FDA Inding of substantial vice of Survice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring ong the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation cunned, "Thisonation on your responsibilities under the Act from the 180 807.97). You may obtain other general mionnal and Consumer Assistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumers/demarks/dema Drvision of Small Manufacturers, International and Octoberty/www.fda.gov/cdrl/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K04243 I
Procon 2 Devicc Name:
Indications for Use:
Procon 2 is a single use catheter with an inflatable balloon cuff intended to act as a barrier to the passage of fecal matter through the rectum.
Procon2 is for an individual with fecal incontinence that has impaired quality of life, is sufficiently motivated psychologically to participate in their own treatment, and having good manual dexterity is an ideal candidate. He or she is either not a surgical candidate or has not responded to conservative treatment.
Prescription Use
(Part 21 CFR 801 Subpart D)
118 - 11 - 11
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PH:EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Liveluation (ODE
510(k) Number
Daniel G. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
http://www.fda_gov/cdrh/ode/INDICA なっていましたときたくなるだ
§ 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.