(191 days)
Not Found
No
The 510(k) summary describes a purely mechanical device (catheter, trap door, adapter) for fluid instillation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies listed are standard tests for mechanical and biocompatibility properties, not algorithmic performance.
Yes
The device is used to instill fluids into the colon to promote evacuation and manage fecal incontinence, which directly addresses a health condition.
No
Explanation: The device is described as a "Chait Cecostomy Catheter" used to instill fluids and promote evacuation of bowel contents for managing fecal incontinence. Its function is therapeutic (instilling fluids, aiding evacuation), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly details physical components made of urethane and metal, including a catheter, trap door fitting, and access adapter. It also mentions accessories like a metal stiffener and wire guide. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Chait Cecostomy Catheter is a device inserted into the body (specifically, the cecum) to instill fluids for therapeutic purposes (promoting bowel evacuation). It does not perform tests on bodily samples.
- Intended Use: The intended use is to facilitate fluid instillation and aid in the management of fecal incontinence, not to diagnose or monitor a medical condition through testing of samples.
- Device Description: The description details a physical catheter and accessories for fluid delivery, not components for performing diagnostic tests.
Therefore, the Chait Cecostomy Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Chait Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The opening and is and maintained in a percutaneously prepared opening such as a cecostomy .
Product codes (comma separated list FDA assigned to the subject device)
78 KNT, 78 EXD
Device Description
The Chait Cecostomy Catheter is a "trap door", low profile catheter which facilitates antegrade colonic flushing. The device is supplied sterile and is intended for one time use. A tract must be established through the abdomen into the cecum prior to placement of the trap door catheter. Accessories used in conjunction with this device include, but are not limited to, a metal stiffener, a wire guide, a connecting tube, a syringe and saline solution.
The device consists of a cecostomy catheter with a trap door attachment and an access adapter. The 10.2 French catheter is made of urethane and is manufactured with five (total) pigtail curves. The distal end of the catheter includes three sideports which are evenly spaced inside the fifth curve. The endhole is 0.038 inches in diameter. The total length of the catheter is 20cm.
The trap door fitting is also made of urethane and lies flat against the abdomen wall. It incorporates a plastic plug which locks securely into place when the catheter is not being accessed.
The access adapter is a metal cannula. The distal end of the cannula is curved and can be attached to the trap door fitting as needed to fluids through the Chait Cecostomy Catheter and into the cecum. The proximal end of the cannula is designed with a large tapered fitting that will fit most taper tip syringes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cecum, colon
Indicated Patient Age Range
Not Found
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)
The Chait Cecostomy Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Clinical Trials
- Tensile Strength Tests
- Biocompatibility Tests
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a catheter which facilitates antegrade colonic flushing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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113
510(k) Premarket Notification Chait Cecostomy Catheter COOK INCORPORATED
Safety and Effectiveness Information
April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, In 47402 (812) 339-2235 July 17, 1998
| Device: | Trade Name: Chait Cecostomy Catheter |
|---|---|
| Proposed Classification Name: | Introduction, Drainage Catheter |
Predicate Devices:
The Chait Cecostomy Catheter is similar in terms of intended use, materials of construction, and technological characteristics to the predicate devices reviewed, the Ultrathane™ Biliary Drainage catheter with a COOK-Cope Type Loop and the Ultrathane™ Nephrostomy Catheter with a COOK-Cope Type Loop.
Device Description
The Chait Cecostomy Catheter is a "trap door", low profile catheter which facilitates antegrade colonic flushing. The device is supplied sterile and is intended for one time use. A tract must be established through the abdomen into the cecum prior to placement of the trap door catheter. Accessories used in conjunction with this device include, but are not limited to, a metal stiffener, a wire guide, a connecting tube, a syringe and saline solution.
The device consists of a cecostomy catheter with a trap door attachment and an access adapter. The 10.2 French catheter is made of urethane and is manufactured with five (total) pigtail curves. The distal end of the catheter includes three sideports which are evenly spaced inside the fifth curve. The endhole is 0.038 inches in diameter. The total length of the catheter is 20cm.
The trap door fitting is also made of urethane and lies flat against the abdomen wall. It incorporates a plastic plug which locks securely into place when the catheter is not being accessed.
The access adapter is a metal cannula. The distal end of the cannula is curved and can be
1
114
510(k) Premarket Notification Chait Cecostomy Catheter COOK INCORPORATED
attached to the trap door fitting as needed to fluids through the Chait Cecostomy Catheter and into the cecum. The proximal end of the cannula is designed with a large tapered fitting that will fit most taper tip syringes.
Substantial Equivalence
COOK INCORPORATED currently markets two devices, the Ultrathane™ Nephrostomy Catheter with a COOK-Cope Type Loop and the Ultrathane™ Biliary Drainage Catheter with a COOK-Cope Type Loop, which are believed to be substantially equivalent to the catheter, subject of this submission. The Ultrathane Biliary Drainage Catheter is indicated for antegrade biliary drainage. The Ultrathane™ Nephrostomy Catheter is indicated for external urine drainage from the renal pelvis. Both devices are manufactured in either Ultrathane™ or polyurethane. These devices are classified as modified Preamendment devices and were also reviewed as substantially equivalent under K851242.
The Ultrathane™ Biliary Drainage Catheter is manufactured with a single lumen polyurethane tubing measuring 8.5, 10.2, 12.0, and 14.0 Fr. in outside diameter in a nominal 40cm length. The Ultrathane™ Nephrostomy Catheter is manufactured with a single lumen polyurethane tubing measuring 8.5, 10.2, 12.0, and 14.0 Fr. in outside diameter in a nominal 25cm length. The Chait Cecostomy Catheter will be manufactured with a single lumen urethane tubing measuring 10.2 Fr. in outside diameter and 20cm in length.
Test Data
The Chait Cecostomy Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- જુન Clinical Trials
- જુન Tensile Strength Tests
- જીન Biocompatibility Tests
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a catheter which facilitates antegrade colonic flushing.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1999
COOK INCORPORATED c/o Ms. April Lavender, RAC Vice President Regulatory Affairs 925 South Curry Pike P.O Box 489 Bloomington, Indiana 47402
Re: K982500 Chait Cecostomy Catheter Set Dated: October 28, 1998 Received: October 29, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT 21 CFR 876.5895/Procode: 78 EXD
Dear Ms. Lavender:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear. Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
COOK INCORPORATED Response to Request for Additional Information K982500 Chait Cecostomy Catheter
510(k) Number (if known): K982500
Device Name:
Chait Cecostomy Catheter
Indications for Use:
The Chait Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The opening and is and maintained in a percutaneously prepared opening such as a cecostomy .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
| Prescription Use | |
|---|---|
| Use | |
| (Per 21 CFR 801.109) |
| OR | ||
|---|---|---|
| -- | ---- | -- |
| Over-the-Counter | |
|---|---|
| -- | ------------------ |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices |
| 510(k) Number | K982500/S001 |
|---|---|
| --------------- | -------------- |