CONVATEC FECAL MANAGEMENT SYSTEM by CONVATEC, A BRISTOL-MYERS SQUIBB CO.

The provided text is a 510(k) Premarket Notification for the ConvaTec Fecal Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device and biocompatibility testing. The document does not contain information about acceptance criteria or a study proving performance against such criteria. Therefore, I cannot extract the requested information from the provided text.

Here's a breakdown of what is and is not in the document:

What is present:

Device Name: ConvaTec Fecal Management System
Applicant: ConvaTec
Intended Use/Indications: Fecal management for patients with little or no bowel control and for patients whose stool is semi-liquid or liquid.
Predicate Device: Indwelling Fecal Management System (K012113)
Classification: Gastrointestinal tube and accessories, 21 CFR 876.5980, Class II
Biocompatibility Testing: States that testing was done according to ISO 10993 Part I (FDA modified matrix) and concluded the device is non-sensitizing, non-cytotoxic, and non-irritating.
Regulatory Outcome: 510(k) clearance (substantial equivalence determination).

What is not present (and is required for your request):

Specific acceptance criteria for device performance.
Any study results (clinical or performance bench testing beyond biocompatibility) demonstrating the device meets performance criteria.
Sample sizes for test sets, data provenance, ground truth establishment for a performance study.
Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
Standalone algorithm performance or training set details.

A 510(k) submission, especially for a device demonstrating substantial equivalence, often does not include detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might. The "performance" in this context is often inferred from the predicate device and relevant bench testing (like biocompatibility and basic functional tests not detailed here).

Summary

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APR = 8 2004

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SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant:	ConvaTec, A Division of E.R. Squibb and Sons, L.L.C200 Headquarters Park Drive, Skillman, NJ 08558
Contact:	Nancy Regulski, Regulatory Affairs(908) 904-2721
Device:	ConvaTec Fecal Management System
SubstantiallyEquivalent Device	Indwelling Fecal Management System

The purpose of this 510(k) Premarket Notification is to request clearance to market The ConvaTec Fecal Management System. This product will be labeled as a prescription medic al device.

The ConvaTec Fecal Management System is indicated for the fecal management of patients with little or no bowel control and for patients whose stool is semi-liquid or liquid.

The ConvaTec Fecal Management System is substantially equivalent to Indwelling Fecal Management System, marketed by Bowel Management Systems, LLC, K012113. Both products are classified as Gastrointestinal tube and accessories, 21 CFR 876.5980 and are equivalent in design, components, materials, intended use, and indications for use.

The ConvaTec Fecal Management System has been subjected to biocompatibility testing utilizing the ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995). The results of this testing demonstrate that The ConvaTec Fecal Management System is considered to be non-sensitizing, non-cytotoxic, and non-irritating.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2004

Ms. Nancy Regulski Manager, Regulatory Affairs ConvaTec, A Division of E.R. Squibb and Sons, L.L.C. 200 Headquarters Park Drive SKILLMAN NJ 08558

Re: K032734

Trade/Device Name: ConvaTec Fecal Management System Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: January 21, 2004 Received: January 22, 2004

Dear Ms. Regulski:

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.

If your device is classified (scc above) into cither class II (Spccial 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. 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will allow you to begin mative of substantial equivalence of your device to a legally premarket notification. The PDA inding of sactiation 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), please If you desire specific advice for your dones and wing numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contract the Additionally, 101 questions on the promotes on the regulation entitled, "Misbranding Othice of Compliance at (301) 597-10597 1057.97) you may obtain. Other general by reference to premarket notification (21 SE Act may be obtained from the Division of Small information on your responsionities and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Solusantal of Sousantal vol. Eda.gov/cdrh/dsma/dsmamain.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

Page 2

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):- Not-Known

K032734

Device Name: ConvaTec Fecal Management System

Indications for Use:

For the fecal management of patients with little or no bowel control and for patients whose stool is semi-liquid or liquid

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription Use_X (Per 21CFR 801.109) OR

Over the Counter Use_ (Optimal Format 2-96)

Nancy Brogdon

(Division Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number

Regulation Number and Section

§ 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.