(88 days)
Not Found
Not Found
No
The summary describes a standard intravascular catheter and makes no mention of AI or ML technology.
No.
The device is described as an intravascular catheter used for sampling blood or administering solutions. While it facilitates medical procedures, it does not directly treat a disease or condition itself, which is the primary characteristic of a therapeutic device. It is an access device.
No
The device description indicates it is used for sampling blood or administering solutions, not for diagnosis. It's an access device, not a diagnostic tool.
No
The device description clearly describes a physical intravascular catheter, which is a hardware component, not 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 sample blood or administer fluids intravenously. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic sampling purposes, not for testing samples in vitro (outside the body).
- Device Description: The device is an intravascular catheter designed for insertion into veins. This is a medical device used in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples, perform tests on biological specimens, or provide information about a patient's health status based on in vitro analysis.
IVD devices are typically used to examine specimens such as blood, urine, or tissue outside the body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on accessing the vascular system within the body.
N/A
Intended Use / Indications for Use
To sample blood or administer drug solutions, blood products, and other fluids intravenously. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
Product codes
FOZ
Device Description
The subject catheter is a short term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large veins such as the baslic or cephalic veins
Indicated Patient Age Range
any patient population
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)
The Becton Dickinson Infusion Therapy Systems Inc. FIRST MIDCATH™ brand catheters.
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
K 772254
SUMMARY OF SAFETY AND EFFICACY
-
A. The submitter's name, address, telephone number, contact person, and date of preparation.
Submitted by Becton Dickinson Infusion Therapy Systems Inc., 9450 South State Street, Sandy, UT 84070. Contact: C. J. Welle. Telephone: 801-565-2535. Prepared: June 11, 1997. -
B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.
Name: Intravascular Catheter Brand: FIRST MIDCATH™ Common Name: Midline Catheter Classification Name: Intravascular Catheter (80 FOZ) -
C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:
Predicate Device: The Becton Dickinson Infusion Therapy Systems Inc. FIRST MIDCATH™ brand catheters. -
D. A description of the device that is the subject of the Premarket Notification submission.
The subject catheter is a short term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter. -
E. Statement of intended use of the device.
The intended use is to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously. -
F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above.
The proposed catheter differs from the FIRST MIDCATH™ brand catheter in that the stylet and labeling have been modified.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three curved lines that suggest the shape of a bird in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP / 2 1997
Mr. Charles Welle Manager, Requlatory Affairs Becton Dickinson Infusion Therapy Systems 9450 South State Street Sandy, Utah 84070
K972254 Re: Trade Name: First MIDCATH™ Catheter Requlatory Class: II Product Code: FOZ Dated: June 11, 1997 Received: June 16, 1997
Dear Mr. Welle:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions However, you are responsible to determine that the of Act. medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510 (k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 (Premarket Approval) it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the
2
Page 2 - Mr. Welle
requlation (21 CFR Part 820) and that, through periodic (QS) inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
In addition, we have determined that your device kit contains Iodophor swabsticks, alcohol swabsticks, and skin protectant swabsticks which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063
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 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 requlation (21 CFR Part 801 and additionally 809 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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
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Page 3 - Mr. Welle
notification" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the fear responsible 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,
Patricex Cucurite ffor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
June 11, 1996
INDICATIONS FOR USE
510(k) Number: K 9 7 225 4
Device Name: _FIRST MIDCATH™ Catheter
Indications for Use: To sample blood or administer drug solutions, blood products, and other fluids intravenously. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
Patricia Crescentz
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 697225
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X (Per 21 CFR 801.109)
OR
Over-The -Counter Use: _______________________________________________________________________________________________________________________________________________________