The 2-Port TTP Jejunostomy Tube consists of a two-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 2-Port TTP Jejunostomy Tube is available with a pigtail tip and in two lengths, 80cm and 105cm. It may be placed by either a pullwire (pull) or guidewire (push) The proposed device is available within a kit which contains the following: a technique. stiffening cannula with female luer fitting, a guidewire, lubricating jelly, gauze, a female-to-female luer adapter, port caps, and a retention ring.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Summary of Device Performance Study

The provided text details a 510(k) submission for the 2-Port Through-The-PEG (TTP) Jejunostomy Tube Kit (referred to as EndoVive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit in the FDA letter). The submission aims to demonstrate substantial equivalence to a predicate device, the 3-Port Through-The-PEG (TTP) Jejunostomy Tube Kit (K072476).

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Specifications for all components, subassemblies, and/or full devices met.	"In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests."
Device is substantially equivalent to the predicate device (K072476).	"Boston Scientific Corporation has demonstrated that the proposed 2-Port Through-The-PFG (TTP) Jejunostomy Tube Kit is substantially equivalent to Boston Scientific Corporation's currently marketed 3-Port Through-The-PEG (TTP) Jejunostomy Tube Kit (K072476)."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified in the provided text. The text only mentions "in-vitro testing."
Data Provenance: Not specified. It's likely the in-vitro testing was conducted internally by Boston Scientific Corporation, but no country of origin or whether it was retrospective/prospective is mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Not applicable. The study involved in-vitro testing against required specifications, not human expert evaluations of a test set with ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As this was in-vitro testing, there was no adjudication method involving human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. The study focused on in-vitro performance and substantial equivalence to a predicate device, not on comparing human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

This is not applicable as the device is a medical tube kit, not an algorithm or AI system. The "performance" refers to the physical and functional attributes of the device.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance was the "required specifications" for its components, subassemblies, and full devices established through in-vitro testing. It's based on engineering and design specifications rather than expert consensus, pathology, or outcomes data in a clinical setting.

8. Sample Size for the Training Set:

Not applicable. As this is not an AI/ML device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this type of medical device.

Summary

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DEC 0 3 2008

SECTION 5 510(k) SUMMARY

510(k) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4454 Fax: 508-683-5939

Contact: Marybeth Gamber Regulatory Affairs Manager Date Prepared: June 18, 2008

2. Device:

Trade Name: 2-Port Through-The-PEG (TTP) Jejunostomy Tube Kit Classification Name: Tube, Gastrointestinal (and Accessories) Regulation Number: 876.5980 Product Code: KNT Classification: Class II

3. Predicate Device:

K072476 Through-The-PEG (TTP) Jejunostomy Tube Kit Manufactured by Boston Scientific, Inc.

4. Device Description:

5. Intended Use:

The 2-Port TTP Jejunostomy Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.

6. Technological Characteristics:

The proposed 2-Port TTP Jejunostomy Tube Kit is similar in design, materials, and manufacturing processes to the predicate 3-Port TTP Jejunostomy Tube Kit (K072476).

7. Performance Data:

In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

Premarket Notification, 2-Port Through-The-PEG Jejunostomy Tube Kit

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8. Conclusion:

. .

.....

Boston Scientific Corporation has demonstrated that the proposed 2-Port Through-The-PFG (TTP) Jejunostomy Tube Kit is substantially equivalent to Boston Scientific Corporation's currently marketed 3-Port Through-The-PEG (TTP) Jejunostomy Tube Kit (K072476).

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Premarket Notification, 2-Port Through-The-PEG Jejunostomy Tube Kit

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a person embracing or supporting another, rendered in a simple, abstract design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marybeth Gamber Manager. Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way Endoscopy Division, M11 MARLBOROUGH MA 01752

Re: K081739

Trade/Device Name: EndoVive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT

DEC 0 3 2008

Dated: November 25, 2008 Received: November 26, 2008

Dear Ms. Gamber:

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. 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. Gamber

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,

Helen Remer
Joyce M. Whang, Ph.D.

Acting 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

510(k) Number (if known):

Device Name:

Indications for Use:

K081739

EndoVive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-Tube) Kit

The EndoVive Two-Port Through The PEG (TTP) Jejunal Feeding Tube (J-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)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jom M. Whm
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 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.