(90 days)
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.
The subject catheter is a long term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to the central venous system. It is inserted into the vascular system through a spittable introducer catheter.
The provided text describes a 510(k) premarket notification for a medical device, the FIRST PICC™ Catheter with Dual Lumens. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics in the way an AI/ML device submission would.
Therefore, the information required in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present for this specific device in the provided text, as it describes a traditional medical device submission (Preamendments device) and not an AI/ML powered device.
The submission confirms that the device is a "long term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to the central venous system." The key change from the predicate device is a modification to the "stylet and labeling." The FDA's letter states that the device is substantially equivalent to a predicate device and may be marketed.
In summary, none of the requested information regarding acceptance criteria, study details, or performance metrics in a structured way (as expected for an AI/ML device) can be extracted from this document.
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X972263
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 PICC™ Common Name: PICC Catheter with Dual Lumens Classification Name: Percutaneous 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 PICC™ brand catheters. -
D. A description of the device that is the subject of the Premarket Notification submission.
The subject catheter is a long term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to the central venous system. 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 PICC™ brand catheter in that the stylet and labeling have been modified.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 5 1997
Mr. Charles Welle Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems 9450 South State Street Sandy, Utah 84070
Re : K972263 First PICC™ Catheter with Dual Lumens Trade Name: Requlatory Class: II Product Code: FOZ Dated: June 11, 1997 Received: June 17, 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 of Act. However, you are responsible to determine that the 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 qeneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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
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Page 2 - Mr. Welle
Quality System Regulation for Medical Devices: General gaarlog by (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 may partil 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 diagnostic 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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notification" (21 CFR 807.97). Other general information on notification - (x) - (x) may be obtained from the Division of Small Manufacturers Assistance at its toll free birler (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Quarer
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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June 11, 1996
INDICATIONS FOR USE
510(k) Number: K 9722 63
Device Name: _FIRST PICCTM Catheter with Dual Lumens
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 Caccenito
(Division Sign-Off) K972263.
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X (Per 21 CFR 801.109)
OR
Over-The -Counter Use: ______________________________________________________________________________________________________________________________________________________
§ 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).