(178 days)
K861479, UNKNOWN
Not Found
No
The summary describes a physical catheter for fluid infusion and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development or validation.
Yes
The device is described as being "designed to be inserted into the perioreral dendes system for the infusion of southous into the central varies system," which directly describes a therapeutic action (infusion of substances).
No
The device is designed for infusion of solutions into the central venous system, which indicates a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a "Midclavicular Catheter," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "INFOSION OF SOUTHOUS INTO THE CENTRAL varies system." This describes a device used in vivo (within the body) for delivering substances.
- Device Description: The description identifies it as a "Midclavicular Catheter," which is a type of medical device used for accessing the central venous system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing blood, urine, tissue, or other samples.
Therefore, this device falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"THE DEDICE IS DESIGNED TO DE INSELTED INTO THE PERIORERAL DENDES SYSTEM FOR THE INFOSION OF SOUTHOUS INTO THE CENTRAL varies system."
Product codes (comma separated list FDA assigned to the subject device)
"80FOZ"
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 a Midclavicular Catheter."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
"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."
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.
"K861479, UNKNOWN"
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
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
971999
May 28, 1997 Nov. 24, 1997
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
Mark S. Alsberge, Director, Regulatory Affairs Contact:
Product Name: Midclavicular Catheter
Trade Name: Cavafix
Classification name:
Cardiovascular Class II, 80FOZ 21 CFR 880.5200
SUBSTANTIAL EQUIVALENCE1 TO:
| 510(k) number | Name | Applicant |
|---|---|---|
| K861479 | Cavafix | B. Braun Medical Inc. |
| UNKNOWN | SoloPICC | SoloPak |
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 a Midclavicular Catheter.
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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 marketed without premarket 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 Midclavicular Catheter is composed of materials that have been tested in accordance with and the ISO Standard 10993 for this category. The materials have been determined to be suitable for the intended use of this product.
Substantial equivalence:
The Peripherally Inserted Central Catheter is similar in materials, form, and intended use to the Cavafix cleared by B. Braun Medical Inc. and the SoloPICC manufactured for SoloPak. There are no new issues of safety or effectiveness raised by Midclavicular Catheter.
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1997
Mr. Mark S. Alsberge Director, Regulatory Affairs B. Braun Medical, Incorporated 824 Twelfth Avenue P.O. Box 4027 18018-0027 Bethlehem, Pennsylvania
Re : K971999 Accuguide® Midclavicular Catheter Trade Name: Unclassified Requlatory Class: Product Code: LJS Dated: September 11, 1997 Received: September 12, 1997
Dear Mr. Alsberge:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ್ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
3
Page 2 - Mr. Alsberge
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Product Radiation Control provisions, or other Federal laws or regulations.
regulations.
This letter will allow you to begin marketing your device as legal This letter will allow you to begin market notification.
described in your 510(k) premarket notification of a love This letter will arton for your device of your device to a least your your server your your your your your your your your your your your your your your your your your your yo described in your 350(t) pearlance of your device to a 109004)
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If you desire specific advice for your device office of If you desire specific advice for your device on our car in regulation (2) CFR Part 801 and additionally 6000
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Compliance at (301) 594-4639. Also, Alaso, po Compliance at (301) Sol advance and device, prease concerners the office of Compliance at (301) Starter of Concerner Company Co
the regulation entitled, "Misbranding by references of the regulation
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obtained from the Division of Small Manufacturers at and one of the Manner of Santas Collection of Children obtained from the between (800) 638%2041 of (301) 445-6991 111.
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its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Director
Division of Dental, Infection Control
Division of Demital Devices vision of Dencarious Devices
and General Hospital Devices and General nobfiral Evaluation
Office of Device Evaluation Office for Devices and enter 101 bellee - Radiological Health -- -
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Enclosure
4
510(k) Number (if known): Kall 1 1999
Device Name: MID LAWICHLAR CATHERER
Indications For Use:
0 1
THE DEDICE IS DESIGNED TO DE INSELTED INTO THE PERIORERAL DENDES SYSTEM FOR THE INFOSION OF SOUTHOUS INTO THE CENTRAL varies system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Caccavale
Division Sign-Off Division of Dental, and General He 510(k) Number
Prescription Use V (Per 21 CFR 801.109)
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OR
Over-The-Counter Use
(Optional Format 1-2-96)
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