(101 days)
The TTP Jejunostomy Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.
The proposed TTP Jejunostomy Tube consists of a three-port device designed to be placed through a Boston Scientific gastrostomy tube to provide enteral access for decompression and delivery of nutrition and/or medication. The TTP Jejunostomy Tube is available in two tip configurations (pigtail and bent tip) and may be placed by either a pullwire (pull) or guidewire (push) technique. The proposed device is available within a kit which contains the following: a stiffening cannula, a guidewire, lubricating jelly, gauze, a double barbed fitting (attached to stiffening cannula), and a cable tie.
The provided document is a 510(k) summary for a medical device called the "TTP Jejunostomy Tube Kit." This type of submission is for demonstrating substantial equivalence to a predicate device, not for a novel device requiring extensive performance studies with acceptance criteria and ground truth validation in the way that an AI/ML medical device would.
Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for training/testing sets is not applicable to this document.
Here's why and what the document does state:
- Type of Device: The TTP Jejunostomy Tube Kit is a physical medical device (like a tube and associated accessories) for enteral access. It is not an AI/ML-driven diagnostic or prognostic tool.
- Purpose of Submission (510(k)): The 510(k) submission seeks to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This means it has the same intended use, technological characteristics, and safety/effectiveness profiles as devices already cleared by the FDA.
- Performance Data (Section 7): The document explicitly states: "As this is a request to clarify the indication the performance testing presented in K971906 was not repeated." This means that the current submission relied on the performance data of a previous version of the device (K971906) and other predicate devices, rather than conducting new performance studies for this specific submission. The clarification of indication itself did not necessitate new performance testing.
- Conclusion (Section 8): The conclusion reinforces that the device is substantially equivalent based on its identical technological characteristics to K971906 and its indication to K971906 and K042303.
In summary, there are no acceptance criteria, device performance tables, sample sizes for test/training sets, or details about expert consensus/ground truth determination as would be found for an AI/ML device study, because this submission pertains to a physical medical device seeking substantial equivalence based on prior device data.
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K072476 200 1012
SECTION 5 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: 508-683-4454 Fax: 508-683-5939
Contact: Virginia Carr Regulatory Affairs Specialist Date Prepared: August 31, 2007 DEC 1 4 2007
2. Device:
Trade Name: TTP Jejunostomy Tube Kit Common Name: Jejunostomy Tube Classification Name: Gastrointestinal Tubes and Accessories Regulation Number: 876.5980 Product Code: KNT Classification: Class II
3. Predicate Device(s):
- A Boston Scientific Corporation's TTP Jejunostomy Tube Kit, K971906
- A Wilson-Cook Medical's Nasal Jejunal Feeding Tube, Nasal Feeding Tube with Flaps, K042303
Both predicates are class II devices per 21 CFR 878.3610
4. Device Description:
The proposed TTP Jejunostomy Tube consists of a three-port device designed to be placed through a Boston Scientific gastrostomy tube to provide enteral access for decompression and delivery of nutrition and/or medication. The TTP Jejunostomy Tube is available in two tip configurations (pigtail and bent tip) and may be placed by either a pullwire (pull) or guidewire (push) technique. The proposed device is available within a kit which contains the following: a stiffening cannula, a guidewire, lubricating jelly, gauze, a double barbed fitting (attached to stiffening cannula), and a cable tie.
5. Intended Use:
The TTP Jejunostomy Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.
Premarket Notification, Through-The-PEG (TTP) Jejunostomy Tube Kit
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6. Technological Characteristics:
The proposed TTP Jejunostomy Tube Kit has the identical technological characteristics (materials, construction, manufacturing processes) as the currently marketed TTP Jejunostomy Tube Kit (K971906).
7. Performance Data:
As this is a request to clarify the indication the performance testing presented in K971906 was not repeated.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed TTP Jejunostomy Tube Kit is substantially equivalent to Boston Scientific Corporation's currently marketed TTP Jejunostomy Tube Kit (K971906) and, in terms of the proposed indication, to the Boston Scientific Corporation's TTP Jejunostomy Tube Kit (K971906) and Wilson-Cook Medical's Nasal Jejunal Feeding Tube and Nasal Feeding Tube with Flaps (K043203).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, and a pair of wings at the top.
Public Health Service
DEC 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer Kimball Regulatory Affairs Manager Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752-1234
Re: K072476
Trade/Device Name: Through the PEG (TTP) Jejunostomy Tube Kit Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: November 27, 2007 Received: November 28, 2007
Dear Ms. Kimball:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
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.
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Page 2 - Ms. Kimball
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 the labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'' (21 CFR Part 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh.dsmamain.html.
Sincerely yours,
Herbert Semmer for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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SECTION 4 INDICATIONS FOR USE STATEMENT
Indications for Use:
510(k) Number (if known): To Be Determined
Device Name: Through the PEG (TTP) Jejunostomy Tube Kit
Indications For Use:
The TTP Jejunostomy Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Premarket Notification, Through-The-PEG (TTP) Jejunostomy Tube Kit
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072476
000010
§ 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.