EndoVive™ Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.

The EndoVive™ Initial Placement Direct PEJ Kit is indicated for use for enteral nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.

The EndoVive™ Initial Placement PEG Safety Kit is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.

Device Description

The proposed EndoVive™ Initial Placement PEG Kit, the proposed EndoVive™ Initial Placement Direct PEJ Kit, and the EndoVive™ Initial Placement PEG Safety Kit are used during initial placement for direct feeding.

AI/ML Overview

This 510(k) premarket notification describes a special 510(k) for new material for domed PEG/PEJ devices. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, and comparative effectiveness studies is not applicable or not provided in the document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility (implied by "performance characteristics" and industry standards for implantable devices)	The proposed devices "were tested for biocompatibility." (Specific acceptance criteria, tests performed, and results are not detailed in this summary document.)
Substantial Equivalence (primary acceptance criteria for Special 510(k))	The proposed devices are "substantially equivalent to currently marketed devices, as they are identical with the exception of the proposed domed PEG/PEJ material." The proposed devices are also "substantially equivalent to currently marketed devices in terms of performance characteristics." (Specific characteristics and comparative data are not detailed in this summary document.)
Functionality (implied, as the new material should not negatively impact the intended use of the devices)	Intended uses remain the same as the predicate devices: enteral nutrition into the stomach (PEG kits) or jejunum (PEJ kit), and safety components to reduce sharps injury (PEG Safety Kit). The change in material for the domed PEG/PEJ is presented as not altering the fundamental function.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided summary. The document states that the devices "were tested for biocompatibility" and that they are "substantially equivalent ... in terms of performance characteristics," but it does not detail the size of the test sets for these evaluations.
Data Provenance: Not specified. Given the context of a 510(k) submission for new material, testing would typically be conducted by the manufacturer (Boston Scientific Corporation). It is likely prospective laboratory testing and/or material characterization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this is a device modification submission for material change, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set in the traditional sense. The "ground truth" here is adherence to material and performance specifications, likely evaluated internally by engineers and material scientists.

4. Adjudication method for the test set

Not applicable. This type of submission does not involve clinical trial data or expert adjudication for a test set.

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. This submission is for physical medical devices (PEG/PEJ kits) and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This submission is for physical medical devices and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for this special 510(k) primarily relates to material properties and biocompatibility standards. It would be based on:
- Material specifications: Conformance to established physical, chemical, and mechanical properties for the new domed PEG/PEJ material.
- Biocompatibility testing against recognized standards: Such as ISO 10993 (Biological evaluation of medical devices).
- Comparison to predicate device material: Demonstrating that the new material performs equivalently to, or better than, the material of the predicate devices for the relevant characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. There is no training set mentioned or implied.

Study Proving Device Meets Acceptance Criteria:

The document states: "The proposed devices are substantially equivalent to currently marketed devices in terms of performance characteristics and were tested for biocompatibility."

Type of Study: This indicates biocompatibility testing and performance characteristics evaluation. While the specific details of these studies are not provided in this summary, they would typically involve:
- In vitro and/or in vivo biocompatibility tests: Following standards like ISO 10993 to assess cytotoxicity, sensitization, irritation, systemic toxicity, and other biological effects of the new material.
- Physical and Mechanical Property Testing: Evaluating properties such as tensile strength, elongation, tear resistance, durometer hardness, and durability of the new domed material to ensure it meets the functional requirements of PEG/PEJ devices.
- Comparison to Predicate: The core of the "substantial equivalence" claim is that the results from the new material's testing demonstrate performance equivalent to or better than the predicate devices for critical parameters.
Evidence of Meeting Acceptance Criteria: The statement provided by Boston Scientific Corporation, and subsequently accepted by the FDA (as indicated by the clearance letter), is that these tests confirmed the substantial equivalence regarding performance characteristics and biocompatibility. The FDA's letter (K030855) confirms their agreement with this assessment, leading to marketing clearance.

Summary

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K030855
1 of 2

Special 510(k) Premarket Notification New Material for Domed PEG/PEJ

Boston Scientific Corporation March 17, 2003

APR 1 7 2003

510(K) SUMMARY

SPONSOR:	Boston Scientific Corporation (BSC)Microvasive Endoscopy DivisionOne Boston Scientific PlaceNatick, MA 01760
CONTACT/SUBMITTER:	Paige SweeneySenior Regulatory Affairs Specialist
DATE OF SUBMISSION:	March 17, 2003
DEVICES:	EndoVive ™ Initial Placement PEG Kit EndoVive ™Initial Placement Direct PEJ KitEndoVive ™ Initial Placement PEG Safety Kit
TRADE NAME:	EndoVive ™ Initial Placement PEG Kit
COMMON NAME:	Gastrostomy Tube
CLASSIFICATION:	Tubes, Gastrointestinal & AccessoriesTube, Gastro-EnterostomyClassified Under 21 CFR Part 876, §5980.Classified as a Class II Device
TRADE NAME:	EndoVive ™ Initial Placement Direct PEJ Kit
COMMON NAME:	Jejunostomy Tube
CLASSIFICATION:	Tube, FeedingClassified Under 21 CFR Part 876, §5980.Classified as a Class II Device
TRADE NAME:	EndoVive ™ Initial Placement PEG Safety Kit
COMMON NAME:	Gastrostomy Tube
CLASSIFICATION:	Tubes, Gastrointestinal & AccessoriesTube, Gastro-EnterostomyClassified Under 21 CFR Part 876, §5980.Classified as a Class II Device
PREDICATE DEVICES:	EndoVive ™ Initial Placement PEG Kit(K014297)EndoVive ™ Initial Placement Direct PEJ Kit(K020120)EndoVive ™ Initial Placement PEG Safety Kit(K014297)
DEVICE DESCRIPTIONS:	The proposed EndoVive ™ Initial Placement PEGKit, the proposed EndoVive ™ Initial PlacementDirect PEJ Kit, and the EndoVive ™ Initial Placement

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K030855
2 of 2

ﻳﻨ

INTENDED USES:

COMPARISON OF

CHARACTERISTICS:

Boston Scientific Corporation March 17, 2003

PEG Safety Kit are used during initial placement for direct feeding.

EndoVive™ Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.

The proposed devices are substantially equivalent to currently marketed devices, as they are identical with the exception of the proposed domed PEG/PEJ material.

The proposed devices are substantially equivalent to PERFORMANCE DATA: currently marketed devices in terms of performance characteristics and were tested for biocompatibility.

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Image /page/2/Picture/12 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a human figure or a bird in flight, composed of several curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2003

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

Re: K030855

Trade/Device Name: EndoVive™ Initial Placement PEG Kit EndoVive™ Initial Placement Direct PEJ Kit EndoVive™ Initial Placement PEG Safety Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: March 17, 2003 Received: March 18, 2003

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

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Page 2 - Ms. Paige Sweeney

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.

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 component[s] 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, please contact the Office of Compliance at (301) 594- . 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 (301) 443-6597, or at its Internet address http://www.fda.gov/dsma/dsmamain.html.

Sincerely yours.

David A. Segner

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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KO 30855

Special 510(k) Premarket Notification New Material for Domed PEG/PEJ

Boston Scientific Corporation March 17, 2003

INDICATIONS FOR USE STATEMENTS

510(k) Number(if known)	To be determined	Page 1 of 1
Device Names	EndoVive™ Initial Placement PEG KitEndoVive™ Initial Placement Direct PEJ KitEndoVive™ Initial Placement PEG Safety Kit
Indications for Use	EndoVive™ Initial Placement PEG Kit is indicated for enteralnutrition directly into the stomach in both pediatric and adult patientswho are unable to consume nutrition by conventional means.
	The EndoVive™ Initial Placement Direct PEJ Kit is indicated fornutritional support and decompression directly into the jejunum whenfeeding via the upper gastrointestinal tract is contraindicated.
	The EndoVive™ Initial Placement PEG Safety Kit is indicated forproviding nutrition directly into the stomach in patients who areunable to consume nutrition by conventional means. The safetycomponents of the kit are designed to reduce the potential forinadvertent sharps injury to medical personnel during and after theprocedure.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

David R. Lehman

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number

000101

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.