(206 days)
Not Found
Not Found
No
The summary describes a simple fluid delivery device for gastric lavage and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
A therapeutic device is one that treats a disease or condition. This device, a "FUID LAVAGE DEVICE THE COMBIPORT", is used to "FLUSH FLUID INTO IS INTENDED DURING GASTRIC LAVAGE THE STOMACH PROCEDURES." Gastric lavage is a procedure to clean out the stomach, often in cases of poisoning or overdose, which can be part of a treatment process but the device itself is an instrument for a procedure, not a therapy in itself that would alter a disease state. It facilitates a medical procedure rather than directly providing a therapeutic effect.
No
The device description states its purpose is to "flush fluid into the stomach during gastric lavage procedures," which is a treatment or intervention, not a diagnostic act.
No
The device description explicitly states it is a "device intended to fluid into the stomach during gastric lavage procedure," which implies a physical component for fluid delivery, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "flush fluid into the stomach during gastric lavage procedures." This is a procedure performed directly on a patient's body, not on a sample taken from the body.
- Device Description: The description reinforces the intended use of introducing fluid into the stomach.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural (introducing fluid), not diagnostic.
N/A
Intended Use / Indications for Use
FUID LAVAGE DEVICE THE COMBIPORT TO FLUSH FLUID INTO IS INTENDED DURING GASTRIC LAVAGE THE STOMACH PROCEDURES.
Product codes (comma separated list FDA assigned to the subject device)
KDH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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:
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And States of Area Market | .
with the production of the control of the production of the comments of the
Carolina Career Station | www.sames.com and any and the same of the states |
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| | | 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)