The Endovive™ Initial Placement Gastrostomy Kits (Guidewire & Pull) and the Securi-T™Initial Placement Gastrostomy Kits (Guidewire & Pull) are indicated for adult and pediatric populations to provide nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means.

The Endovive™ Low Profile Button Replacement Gastrostomy Tube is indicated in adult and pediatric populations to provide nutrition directly into the stomach through an existing stoma. They are indicated for use on patients who are unable to consume nutrition by conventional means.

Device Description

The Endovive™ Initial Placement Gastrostomy Kit and the Securi-T™ Initial Placement Gastrostomy Kits are used during initial placement for direct feeding, and the Endovive™ Low Profile Button Replacement Gastrostomy Tube is used for the replacement of direct feeding tubes used for direct feeding.

AI/ML Overview

The provided text is a 510(k) summary for medical devices (gastrostomy kits and tubes). It states that the proposed devices are identical to predicate devices, and therefore, no additional performance testing was performed.

Because of this, there is no information about specific acceptance criteria or a study proving that the devices meet them in the traditional sense of a performance evaluation against predefined metrics. The submission relies on establishing substantial equivalence to previously cleared devices.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.

Here's a breakdown of the available and unavailable information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not applicable/Not provided. The submission asserts substantial equivalence because "The proposed devices are identical to the predicate devices." No specific performance acceptance criteria or reported performance data for the new devices (as distinct from the predicates) are presented.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. No new performance testing was conducted, so there is no test set or related data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. As no new performance testing was conducted, there was no need for experts to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No new performance testing was conducted, so no adjudication method was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is a medical device (gastrostomy kit/tube), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. Since no performance study was conducted for the proposed devices, no ground truth was established within the scope of this submission. The "ground truth" for the clearance of these devices rests on their substantial equivalence to predicate devices, which were themselves cleared based on prior regulatory pathways.

8. The sample size for the training set

Not applicable/Not provided. There is no training set mentioned or implied as no new performance data or AI model development is being described.

9. How the ground truth for the training set was established

Not applicable/Not provided. As there is no training set, there is no ground truth establishment for it.

Summary of the 510(k) Approach:

The core of this 510(k) submission is the assertion of substantial equivalence to predicate devices. The manufacturer states:

"The proposed devices are identical to the predicate devices and therefore, no additional performance testing was performed."
"A thorough comparison of the descriptive characteristics between the proposed gastrostomy devices and the predicate devices show equivalence."

The FDA's letter (Page 3-4) confirms that they reviewed the submission and "determined the device is substantially equivalent... to legally marketed predicate devices." This means the acceptance criteria and proof of meeting them are implicitly tied to the previous clearances of the predicate devices based on their established safety and effectiveness.

Summary

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Koi4297 page lot 3

วันเ 9 2002

SECTION 14 510(K) SUMMARY

FOI RELEASABLE

Pursuant to §513(1)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

Date:	December 28, 2001
Common/Usual Names:	Tube, GastrointestinalTube, Gastro-Enterostomy
Trade/Proprietary Names:	- Endovive™ Initial PlacementGastrostomy Kit- Securi-T Initial PlacementGastrostomy Kit- Endovive™ Low Profile Button ReplacementGastrostomy Tube
Classification Name &Device Classification:	Class II
	Name	Number	21CFR Ref.
	Tubes,Gastroint. & Acc.	78 KNT	876.5980
	Tube,Gastro-Enterostomy	78 KGC	876.5980
Device Panel/Branch:	Gastroenterology-Urology (GU)Gastro-Renal (GRDB)
Owner/Operator:	Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760
Contact Person:	Paige SweeneyRegulatory Affairs Specialist

Proprietary and Confidential Information of Boston Scientific Corporation

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Description of Devices

Indications for Use

The Endovive™ Initial Placement Gastrostomy Kits (Guidewire & Pull) and the Securi-TTM Initial Placement Gastrostomy (Guidewire & Pull) are indicated to provide nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.

The Endovive™ Low Profile Button Replacement Gastrostomy Device is indicated to provide nutrition directly into the stomach through the stoma. It is indicated for use in adult and pediatric patients who are unable to consume nutrition by conventional means.

Descriptive and Technological Characteristics of Proposed and Predicate Devices

Boston Scientific Corporation believes that the Endovive™ Initial Placement Gastrostomy Kit, the Securi-T™ Initial Placement Gastrostomy Kit, and the Endovive™ Low Profile Button Replacement Gastrostomy Device, are substantially equivalent to the currently marketed Endovive™ Initial Placement Gastrostomy Kit, the Securi-T™ Initial Placement Gastrostomy Kit , and the Endovive™ Low Profile Button Replacement Gastrostomy Device, and the Endovive™ Low Profile Initial Placement Gastrostomy Kit. The major components of these devices are the internal bolster and the gastrostomy tube. A thorough comparison of the descriptive characteristics between the proposed gastrostomy devices and the predicate devices show equivalence.

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Performance Characteristics

The proposed devices are identical to the predicate devices and therefore, no additional performance testing was performed.

Conclusion

Boston Scientific Corporation has demonstrated that the Endovive™ Initial Placement Gastrostomy Kit, the Securi-TTM Initial Placement Gastrostomy Kit, and the Endovive™ Low Profile Button Replacement Gastrostomy Tube are substantially equivalent to the currently marketed Endovive™ Initial Placement Gastrostomy Kit, the Securi-T™ Initial Placement Gastrostomy Kit, the Endovive™ Low Profile Button Replacement Gastrostomy Tube, and the Endovive™ Low Profile Initial Placement Gastrostomy Kit.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three human profiles incorporated into its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2002 JUL

Ms. Paige Sweeney Regulatory Affairs Specialist Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537

Re: K014297

Trade/Device Name: Endovive™ Initial Placement Gastrostomy Kit Endovive™ Low Profile Button Replacement Gastrostomy Tube (Button™) Securi-TTM Initial Placement Gastrostomy Kit Regulation Number: 21 CFR 876.5980

Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: April 9, 2002 Received: April 10, 2002

Dear Ms. Sweeney:

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 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, 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.

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

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Page 2 - Ms. Paige Sweeney

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

In addition, we have determined that your device kit contains iodine swabs, lubricating jelly, antibiotic ointment, and 1% Xylocaine, which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 Part 807.97). Other general information on your responsibilities under the Act, may be obtained 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/dsma/dsmamain.html

Sincerely yours.

David C. Bergman

Nancy C. Brogdon Director Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO14644

SECTION 3 INDICATIONS FOR USE

510(k) Number:	To Be Determined
----------------	------------------

Endovive™ Initial Placement Gastrostomy Kit Device Names: -Endovive™ Low Profile Replacement Gastrostomy Tube -Securi-TTM Initial Placement Gastrostomy Kit -
Indications for Use: The Endovive™ Initial Placement Gastrostomy Kits (Guidewire & Pull) and the Securi-T™Initial Placement Gastrostomy Kits (Guidewire & Pull) are indicated for adult and pediatric populations to provide nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means.

The Endovive™ Low Profile Button Replacement Gastrostomy Tube is indicated in adult and pediatric populations to provide nutrition directly into the stomach through an existing stoma. They are indicated for use on patients who are unable to consume nutrition by conventional means.

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

Prescription Use		OR	Over-The-Counter Use
(Per 21CFR 801.1091)			(Optional Format 1-2-96)

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number

Proprietary and Confidential Information of Boston Scientific Corporation

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.