(218 days)
Not Found
No
The summary describes a physical medical device (catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a catheter used for administration, sampling, and monitoring within the venous system, not for treating a disease or disorder itself.
No
Explanation: The device is a catheter used for administration of substances, blood sampling, and monitoring, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components of a catheter, including radiopaque material, a flexible tip, hub junction, suture wings, extension tubing, and luer taper hubs. This indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a catheter inserted into the venous system for various therapeutic and monitoring purposes (administering substances, blood sampling, pressure monitoring). This is an in vivo (within the body) device.
The intended use and device description do not involve any testing of specimens outside the body.
N/A
Intended Use / Indications for Use
The Pediatric Central Venous Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs, for blood sampling, and for central venous pressure monitoring.
Product codes
FOZ
Device Description
The Pediatric Central Venous Catheter consists of radiopaque catheter with a flexible soft tapered tip, hub junction, moveable suture wings, extension tubing with removable slide clamps and proximal rigid luer taper hubs. The catheter will be available in sizes ranging from 4 F to 5.5 F, with a double or triple lumen, and useable lengths of 3-1/8" to 8".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system
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)
K971085, The Premarket Notification [510(k) number] for this device is not known
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
8.0 510(k) Summary
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500, ext. 2280
Contact: Patricia D. Wilson, Regulatory Affairs Specialist | MAY 0 6 2003 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| DEVICE NAME: | Pediatric Central Venous Catheter Kit | |
| COMMON OR USUAL
NAME: | Central Venous Catheter | |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR § 880.5200: Intravascular Catheter | |
| PREDICATE DEVICE: | B. Braun Medical Inc. Soft Tip Multi-Lumen Central Venous
Catheter (K971085)
Arrow Pediatric Central Venous Catheterization Kit (The
Premarket Notification [510(k) number] for this device is
not known] | |
| DESCRIPTION: | The Pediatric Central Venous Catheter consists of radiopaque
catheter with a flexible soft tapered tip, hub junction, moveable
suture wings, extension tubing with removable slide clamps and
proximal rigid luer taper hubs. The catheter will be available in
sizes ranging from 4 F to 5.5 F, with a double or triple lumen, and
useable lengths of 3-1/8" to 8". | |
| INTENDED USE: | The Pediatric Central Venous Catheter is a device that is inserted
into the venous system for the administration of blood products,
parenteral nutrition, I.V. fluids or drugs, for blood sampling, and
for central venous pressure monitoring. | |
| SUBSTANTIAL
EQUIVALENCE: | The Pediatric Central Venous Catheter is similar in design, method
of construction, and materials as the Soft Tip Multi-Lumen Central
Venous Catheter that was previously cleared under the B. Braun
Premarket Notification K971085. The indications for the Pediatric
Central Venous Catheter are similar to the indications for the
Arrow Pediatric Multi-Lumen Central Venous Catheterization Kit,
as noted in product labeling. | |
B. Braun Medical Inc.
510(k) Premarket Notification
Pediatric CVC Kit
000019
.
.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and three human profiles are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 0 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia D. Wilson Regulatory Affairs Specialist B. Braun Medical Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K023253
Trade/Device Name: Pediatric Central Venous Catheter Kit Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 16, 2003 Received: April 17, 2003
Dear Ms. Wilson:
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 such 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.
2
Page 2 - Ms. Wilson
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 systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0 Indications for Use Statement
1 -Page of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| 510(k) Number (if known): | K0232253 |
|---|---|
| --------------------------- | ---------- |
Device Name:
Pediatric Central Venous Catheter Kit
Indications For Use:
The Pediatric Central Venous Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs, for blood sampling, and for central venous pressure monitoring.
(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 _________________________________________________________________________________________________________________________________________________________
Patrizio Cuccenite
(Division of Anesthesiology, General Hospital, Infection Control, Dental D
B. Braun Medical Inc. 510(k) Premarket Notification Pediatric CVC Kit
510(k) Number:
000005