(195 days)
The EndoVive™ Low Profile Replacement Gastrostomy Tube is indicated in adult and pediatric populations for use in percutaneous placement of an Enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for decompression.
The EndoVive™ Low Profile Replacement GastrostomyTube is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using a silicone RTV. The shaft is filled with a radiopague barium RTV. In use, the balloon end of the catheter is inserted into an established stoma, the balloon inflated with 3 mL saline, and the bolster slide down to the skin to secure the device in place. There are two versions of the bolster, a straight version and a right angle
This document describes a 510(k) submission for the EndoVive™ Low Profile Replacement Gastrostomy Tube.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not list explicit numerical acceptance criteria for performance metrics (e.g., tensile strength, leak rate, burst pressure) or report specific quantitative device performance values against such criteria. Instead, the study's primary objective was to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance, safety, and effectiveness equivalent to predicate devices (K962375 and K014297). | Bench testing demonstrated no difference in performance, safety, or effectiveness between the EndoVive™ Low Profile Replacement Gastrostomy Tube and the specified predicate devices. |
| Materials equivalent to predicate devices. | Materials (primarily silicone) are described and compared to predicates. |
| Indications for Use equivalent to predicate devices. | Indications for Use are stated and shown to align with predicate devices. |
| Device description aligns with good manufacturing practices. | Device description is provided. |
| Labeling aligns with good manufacturing practices. | Labeling is mentioned as part of the submission package. |
2. Sample Size and Data Provenance:
The document refers to "bench test results" but does not specify any sample sizes for these tests. There is no information about the country of origin of the data, and the nature of "bench testing" inherently implies a prospective collection of data under controlled laboratory conditions, rather than retrospective data from patients.
3. Number of Experts and Qualifications for Ground Truth:
This submission does not involve human clinical data or expert-established ground truth in the way typically seen for diagnostic AI/ML devices. The "ground truth" here is established through engineering and material science principles, comparing the new device against existing, legally marketed predicate devices through bench testing. Therefore, there are no "experts" in the context of clinical evaluation of patient data, nor their qualifications, mentioned.
4. Adjudication Method for the Test Set:
Not applicable. As described above, there is no test set involving human interpretation or clinical outcomes that would require an adjudication method. Bench testing results are typically evaluated against engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not relevant to this medical device (a gastrostomy tube).
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This device is a physical medical device (gastrostomy tube), not an algorithm or software. Therefore, the concept of a "standalone algorithm performance" study is not relevant. The "standalone" performance could be interpreted as the device's intrinsic mechanical and material performance, which was assessed via bench testing.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance, in the context of demonstrating substantial equivalence, is based on:
- Engineering specifications and measurements: For properties like material composition, dimensions, and functional performance (e.g., balloon inflation, fluid flow through the tube, mechanical integrity).
- Comparison to predicate device performance: The critical "ground truth" is that the new device performs identically or acceptably similarly to the legally marketed predicate devices, as demonstrated through bench testing.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device and does not involve an algorithm that requires a "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an algorithm.
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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter Name: | Manufacturing and Research, Inc. |
|---|---|
| Submitter Address : | 4700 S. Overland Dr., Tucson, AZ 85714 |
| Contact Person: | Suzanne Dew |
| Phone Number: | 520-882-7794 x109 |
| Fax Number: | 520-882-6849 |
| Date Prepared: | November, 2008 |
| Device Trade Name: | EndoVive™ Low Profile Replacement GastrostomyTube |
| Device Common Name: | Tube, Gastro-enterostomy |
| Classification Name: | Tube, Gastro-enterostomy, product code KNT |
| Predicate device: | Microvasive Balloon Gastrostomy Tube Kit, K962375EndoVive™ Low Profile Button Replacement Gastrostomy Tube,K014297 |
| Reason for submission: | Not previously marketed in the USA |
Device Description and Materials:
The EndoVive™ Low Profile Replacement GastrostomyTube is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using a silicone RTV. The shaft is filled with a radiopague barium RTV. In use, the balloon end of the catheter is inserted into an established stoma, the balloon inflated with 3 mL saline, and the bolster slide down to the skin to secure the device in place. There are two versions of the bolster, a straight version and a right angle
Intended Use:
The EndoVive™ Low Profile Replacement Gastrostomy Tube is indicated in adult and pediations for use in percutaneous placement of an Enteral feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for decompression.
Substantial Equivalence/ Device - Technological Characteristics and Comparison to Predicate Device(s):
The EndoVive™ Low Profile Replacement Gastrostomy Tube is substantially equivalent to the Microvasive Balloon Gastrostomy Tube Kit, K962375 and EndoVive™ Low Profile Button Replacement Gastrostomy Tube, K014297
Among the information and data presented in the 510(k) submission to support the substantial equivalency of the EndoVive™ Low Profile Replacement Gastrostomy Tube to the specified predicate devices are: 1) device description, 2) indications for use, 3) bench test results, 4) materials, and 5) labeling. In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the EndoVive™ Low Profile Replacement Gastrostomy Tube and the specified predicate devices.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 25 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MRI Manufacturing and Research, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313
Re: K083685
Trade/Device Name: EndoVive Low Profile Replacement Gastrostomy Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: June 8, 2009 Received: June 10, 2009
Dear Mr. Job:
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/industry/support/index.html.
Sincerely yours.
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name: EndoVive™ Low Profile Replacement Gastrostomy Tube
Indications For Use:
The EndoVive™ Low Profile Replacement Gastrostomy Tube is indicated in adult and pediatric populations for use in percutaneous placement of an Enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for decompression.
Prescription Use × (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)
Tsai Mhong
(Division Sign-Off) (Division Sign-Off) ()
Division of Reproductive, Abdominal and Radiological Devices K083685 510(k) Number --
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§ 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.