(206 days)
FUID LAVAGE DEVICE THE COMBIPORT TO FLUSH FLUID INTO IS INTENDED DURING GASTRIC LAVAGE THE STOMACH PROCEDURES.
The CombiPort is a device intended to fluid into the stomach during gastric lavage procedure.
This document describes a 510(k) submission for the CombiPort Fluid Lavage Device. This is a medical device and not an AI/ML powered device. As such, the typical acceptance criteria and study data points requested (e.g., sample size for test set/training set, ground truth, MRMC studies, standalone performance) are not applicable in the usual sense for software or AI/ML.
The provided text focuses on demonstrating substantial equivalence to a predicate device and ensuring the device's safety and effectiveness through material testing and manufacturing quality control.
Here's an attempt to answer the questions based on the available information, noting where the requested information is not relevant or directly provided for a traditional AI/ML study:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (fluid lavage device), acceptance criteria are primarily related to material biocompatibility, functional performance (e.g., ability to flush fluid, connection integrity), and manufacturing quality. The document does not provide a quantitative table of specific performance metrics with target values.
| Acceptance Criteria Category | Reported Device Performance (Summary from Text) |
|---|---|
| Material Biocompatibility | "...materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product." |
| Functional Performance | Implied: The device is "intended to fluid into the stomach during gastric lavage procedure." The testing described below would confirm this. |
| Manufacturing Quality & Reliability | "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." |
| Substantial Equivalence | "The CombiPort Fluid Lavage Device is similar in intended use to the Easi-Lav cleared by Ballard Medical Products. There are no new issues of safety or effectiveness raised by The CombiPort Fluid Lavage Device." |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a physical medical device, not a software or AI/ML product evaluated on a "test set" of data. The "testing" refers to manufacturing quality control and material biocompatibility, which would involve samples of the device and its materials. The document does not specify general sample sizes for these tests, as these are typically defined by internal quality procedures.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic or predictive tools. For a fluid lavage device, the "ground truth" for its functional performance is based on engineering specifications and physical testing, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers or experts when establishing ground truth for AI/ML validation. This device undergoes physical and material testing, not human-read evaluation in this manner.
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. MRMC studies are specific to evaluating the clinical impact of AI/ML systems on human reader performance, particularly in diagnostic imaging. This device does not involve AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Specifications: The design parameters and functional requirements for the device (e.g., flow rate, material strength, connection integrity).
- Material Standards: Biocompatibility standards like ISO 10993.
- Quality Control Test Procedures: Established methods to verify that each manufactured unit meets specifications.
8. The Sample Size for the Training Set
Not applicable. There is no training set for a traditional medical device like this, as it's not an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an AI/ML model.
{0}------------------------------------------------
11 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
February 7, 1997
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem. PA 18018 (610)691-5400
OCT 2 7 1997
Contact: Mark S. Alsberge, Regulatory Affairs Manager
Product Name: CombiPort Fluid Lavage Device
Gastrointestinal Tube and Accessories Trade Name:
Classification name:
Hospital Class 1, 80KDH 21 CFR 880.5980
SUBSTANTIAL EQUIVALENCE1 TO:
| And States of Area Market | .with the production of the control of the production of the comments of theCarolina Career Station | www.sames.com and any and the same of the states |
|---|---|---|
| CORTIGIS |
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce The CombiPort Fluid Lavage Device. The CombiPort is a device intended to fluid into the stomach during gastric lavage procedure.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be market approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
{1}------------------------------------------------
Material:
The CombiPort Fluid Lavage Device is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.
15971259 2042
Substantial equivalence:
The CombiPort Fluid Lavage Device is similar in intended use to the Easi-Lav cleared by Ballard Medical Products. There are no new issues of safety or effectiveness raised by The CombiPort Fluid Lavage Device.
Safety And Effectiveness:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved. released, distributed and revised in accordance with document control GMP"s.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or fabric below the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1997
Mr. Mark S. Alsberge Director, Regulatory Affairs B. Braun Medical, Inc. 824 12th Avenue Bethlehem, Pennsylvania 18018-0027 Re: K971259 CombiPort Fluid Lavage Device Dated: July 29, 1997 Received: August 1, 1997 Regulatory Class: II 21 CFR§ 876.5980/Product Code: 78 KDH
Dear Mr. Alsberge:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent for the stated in the enclosure) to devices marketed in interstate commence prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally market 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known): _ K97 1259
Device Name:__________________________________________________________________________________________________________________________________________________________________ COMBIPORT FLUID LAVAGE DEVICE
Indications For Use:
FUID LAVAGE DEVICE THE COMBIPORT TO FLUSH FLUID INTO IS INTENDED DURING GASTRIC LAVAGE THE STOMACH PROCEDURES.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Satlung
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1971259 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
・・
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.