(27 days)
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 proposed EndoVive™ Initial Placement Direct PEJ Kit is used during initial placement for direct feeding.
This is a 510(k) summary for the EndoVive™ Initial Placement Direct PEJ Kit, a device for enteral nutritional support. The document indicates that the device is substantially equivalent to a previously marketed device (K020120) with the exception of a modified kit component. This essentially means it is an update or slight modification to an existing device, rather than a completely new one.
Given this context, the submission focuses on demonstrating substantial equivalence rather than fulfilling novel acceptance criteria with a new, extensive study. The performance data section explicitly states: "The proposed device is substantially equivalent to currently marketed device in terms of performance characteristics tested and biocompatibility." This implies that the 'acceptance criteria' are met by showing it performs as well as the predicate device.
Therefore, for this specific device and submission type, the questions about acceptance criteria and study details are addressed by referring to the substantial equivalence claim, rather than a de novo clinical trial with specific performance metrics.
Here's how to interpret the provided information in the context of your questions:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The proposed device must be substantially equivalent to currently marketed predicate devices. | The proposed device is substantially equivalent to currently marketed devices, as they are identical with the exception of a modified kit component. The proposed device is substantially equivalent to currently marketed device in terms of performance characteristics tested and biocompatibility. |
| The device must meet performance characteristics (e.g., integrity, functionality, safety). | Performance characteristics were tested and found to be equivalent to the predicate device. Biocompatibility was also confirmed to be equivalent. |
Study Details (as infered from a Substantial Equivalence submission)
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate clinical study with a "test set" and human subjects was likely not conducted for this specific 510(k). The substantial equivalence claim is based on the previously cleared predicate device and engineering/performance testing on the modified component.
- Data Provenance: The 'data' primarily comes from performance characteristics testing of the modified component and biocompatibility assessments, and comparison to the predicate device's established performance. This would typically be internal laboratory testing by the manufacturer. Specific country of origin is not detailed, but the manufacturer (Boston Scientific Corporation) is US-based. These would be retrospective in the sense that they rely on the established performance of the predicate and new internal validation on the modified component, rather than a prospective clinical trial.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of a substantial equivalence submission for a device like this. There isn't a "ground truth" to be established by panels of experts in the way there would be for an AI diagnostic device evaluating images, for example. The evaluation is primarily focused on engineering performance, material properties, and comparison to a predicate device.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical trials involving subjective interpretations (e.g., radiology reads) to establish a consensus ground truth. This submission is about the physical and functional equivalence of a medical device component.
-
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 device is a physical medical instrument (a Jejunostomy Tube Kit), not an AI diagnostic tool or software. MRMC studies are used for evaluating diagnostic imaging systems or AI assistance tools.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" here relies on established engineering standards, biocompatibility testing results (e.g., ISO standards), and the proven safety and effectiveness profile of the predicate device (EndoVive™ Initial Placement Direct PEJ Kit, K020120). This is essentially a regulatory compliance and engineering performance ground truth.
-
The sample size for the training set:
- Not applicable. There is no AI model being trained for this device.
-
How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary of Approach:
The K022648 submission for the EndoVive™ Initial Placement Direct PEJ Kit is a substantial equivalence filing. This means the primary "study" is a comparison to a legally marketed predicate device (K020120). The manufacturer is demonstrating that the new device is "identical with the exception of a modified kit component" and that its "performance characteristics tested and biocompatibility" are equivalent to the predicate. Therefore, specific clinical trials, expert panels for ground truth, or AI-specific studies are not part of this type of submission. The 'acceptance criteria' are primarily related to proving this substantial equivalence through engineering, material, and performance testing.
{0}------------------------------------------------
Section 10 510(K) SUMMARY
| SPONSOR: | Boston Scientific Corporation (BSC)Microvasive Endoscopy DivisionOne Boston Scientific PlaceNatick, MA 01760 |
|---|---|
| CONTACT/SUBMITTER: | Paige SweeneyRegulatory Affairs Specialist |
| DATE OF SUBMISSION: | August 8, 2002 |
| DEVICE: | EndoVive ™ Initial Placement Direct PEJ Kit |
| 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. |
| PREDICATE DEVICE: | EndoVive ™ Initial Placement Direct PEJ Kit(K020120) |
| DEVICE DESCRIPTION: | The proposed EndoVive ™ Initial Placement Direct PEJKit is used during initial placement for directfeeding. |
| INTENDED USE: | The EndoVive ™ Initial Placement Direct PEJ Kit isindicated for use for enteral nutritional support anddecompression directly into the jejunum when feedingvia the upper gastrointestinal tract is contraindicated. |
| COMPARISON OFCHARACTERISTICS: | The proposed device is substantially equivalent tocurrently marketed devices, as they are identical with theexception of a modified kit component. |
| PERFORMANCE DATA: | The proposed device is substantially equivalent tocurrently marketed device in terms of performancecharacteristics tested and biocompatibility. |
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 2002
Ms. Paige Sweeney Regulatory Affairs Specialist Boston Scientific Corporation Microvasive Endoscopy One Boston Scientific Place NATICK MA 01760-1537
Re: K022648
Trade/Device Name: EndoVive™ Initial Placement Direct PEJ Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: August 8, 2002 Received: August 9, 2002
Dear Ms. Sweeney:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 vour 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 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
{2}------------------------------------------------
Page 2 - Ms. Paige Sweeney
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 component[s]. For information on applicable Agency requirements for marketing this [these] drug[s], 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,
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}------------------------------------------------
Indications for Use Statement
| 510(k) Number (if known) | K022648 |
|---|---|
| Device Name | EndoVive™ Initial Placement Direct PEJ Kit |
| Indications for Use | 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. |
Page 1 of 1## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) /
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Nancy Crozdon
(Division Sign Off) Division of Reproductive, Abdom and HadioIngical Devices 510(k) Number
§ 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.