(125 days)
Not Found
No
The summary describes a mechanical device for gastrostomy tube placement and replacement, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is for placement and replacement of a feeding and/or decompression device, which are supportive functions, not directly therapeutic themselves, according to the provided information.
No
The device is described as a "Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube" used for initial percutaneous placement or replacement of a gastrostomy feeding and/or decompression device. Its function is to facilitate the placement of a feeding/decompression device, which is a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly states "Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube," which indicates a physical medical device kit containing hardware components (balloon dilation kit, gastrostomy tube). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure for placing a gastrostomy tube directly into the body (percutaneous placement) for feeding and decompression. This is a surgical/interventional procedure, not a test performed on samples outside the body.
- Device Description: The device is a kit for placing a gastrostomy tube, which is a medical device used for direct patient care.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to provide a means of feeding and/or decompression directly into the stomach, which is a therapeutic/supportive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The "intended use" is the same for the subject and predicate kit. The kit is intended to be used for non-surgical placement of a feeding device to instill nutritional fluids and/or medication directly into the stomach and/or to decompress the stomach.
For initial percutaneous placement of a gastrostomy feeding and/or decompression device into a stoma created by tissue dilation.
Also for percutaneous replacement of a gastrostomy feeding and/or decompression device info an established stoma site.
Product codes
KNT
Device Description
Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
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)
Not Found
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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FEB 1 3 208ard Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube Traditional 510(k)
Section 5
510(k) Summary
5.1 General Information
| Submitter Name: | Bard Access Systems, Inc. (BAS)
[wholly owned subsidiary of C.R. Bard, Inc.] |
|----------------------|---------------------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive
Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700 ext. 5484 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Susan Scott |
| Date of Preparation: | September 15, 2006 |
| Registration Number: | 1720496 BAS
2212754 C. R. Bard |
Subject Device Information 5.2
Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube Trade Name: Common/Usual Name: Percutaneous Gastrostomy Kit with Balloon Dilation Catheter Classification Name: 78 KNT - Gastrointestinal Tube & Accessories CFR Reference: 21 CFR §876.5980, Class II Classification Panel: Gastroenterology/Urology
5.3 Predicate Device Information
| Trade Name: | Bard® Gauderer™ Universal Percutaneous Endoscopic Gastrostomy |
|---|---|
| Common/Usual Name: | Percutaneous Endoscopic Gastrostomy Kit (PEG Kit) |
| Classification Name: | 78 KNT – Gastrointestinal Tube & Accessories |
| CFR Reference: | 21 CFR §876.5980, Class II |
| Classification Panel: | Gastroenterology/Urology |
| Premarket Notification: | K915841, clearance date 06/25/1993 |
5.4 Intended Use
The "intended use" is the same for the subject and predicate kit. The kit is intended to be used for non-surgical placement of a feeding device to instill nutritional fluids and/or medication directly into the stomach and/or to decompress the stomach.
રેં.રે Indications for Use
For initial percutaneous placement of a gastrostomy feeding and/or decompression device into a stoma created by tissue dilation.
Also for percutaneous replacement of a gastrostomy feeding and/or decompression device info an established stoma site.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "HUMAN SERVICES • USA" and "DEPARTMENT OF HEALTH" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Susan Scott Regulatory Affairs Specialist Bard Access Systems. Inc. 5425 W. Amelia Earhart Drive SALT LAKE CITY UT 84116
Re: K063118
Trade/Device Name: Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube Regulation Number: 21 CFR §876,5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 22, 2007 Received: January 29, 2007
Dear Ms. Scott:
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 (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.
Image /page/1/Picture/10 description: The image is a circular logo with the text "1906-2006 FDA Centennial" in the center. The letters "FDA" are large and bolded. There are three stars below the word "Centennial". The text "FDA Centennial" is in a cursive font. The logo is surrounded by a ring of text and stars.
Protecting and Promoting Public Health
2
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at 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 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
3
Section 4
Indications for Use Statement
510(k) Number (if known):
1063118
Device Name:
Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube
Indications for Use:
For initial percutaneous placement of a gastrostomy feeding and/or decompression device into a stoma created by tissue dilation.
Also for percutaneous replacement of a gastrostomy feeding and/or decompression device into an established stoma site.
Prescription Use V Over-The-Counter Use AND/OR (Part 21 CFR §801 Subpart D) (21 CFR §801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devic 10(k) Number