(32 days)
Not Found
Not Found
No
The description focuses on the mechanical features of the IV catheters and does not mention any computational or data-driven capabilities indicative of AI/ML.
No
These devices facilitate access to a vein or artery for administering solutions but do not inherently treat a condition themselves.
No
The provided text describes IV catheters, which are used for providing access to veins or arteries for infusion of solutions or potentially drawing blood, but not for diagnosis. Their function is access and delivery/withdrawal, not identification or determination of a medical condition.
No
The device description and intended use clearly describe physical IV catheters, which are hardware devices. There is no mention of software as the primary or sole component.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of these devices is to provide access to a vein or artery for infusing solutions or potentially for power injection. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic purposes (like injecting contrast for imaging), not for examining specimens in vitro (outside the body).
- Device Description: The description clearly states they are "Intravascular catheters," which are devices used within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVDs are typically used to test samples taken from the body to diagnose diseases, monitor conditions, or screen for health issues. These catheters are used to access the body for treatment or diagnostic procedures, not to perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
ACUVANCE PLUS Safety IV Catheter: A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a selfblunting needle system activated automatically as the catheter is threaded into the vessel. 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. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.
PROTECTIV PLUS Safety IV Catheter: The PROTECTIV PLUS I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
OPTIVA IV Catheter: The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
Intravascular catheters are single use devices which provide access to veins or arteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery
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)
Bench testing and biocompatibility data demonstrate that the new material is equivalent to the current material.
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.
ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter
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
§ 880.5200 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
ACUVANCE® PLUS Safety IV Catheter, PROTECTIV PLUS® Safety IV Catheter, OPTIVA® IV Catheter 510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
MAR 2 8 2003
Contact
Katie Fordyce Regulatory Affairs Associate II
Date Prepared:
February 21, 2003
Name of Device
Trade Name: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter Classification Name: Catheter, Intravascular (short-term)
Predicate Devices: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter
Device Description: Intravascular catheters are single use devices which provide access to veins or arteries.
Indications for Use:
ACUVANCE PLUS Safety IV Catheter: A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a selfblunting needle system activated automatically as the catheter is threaded into the vessel. 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. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.
PROTECTIV PLUS Safety IV Catheter: The PROTECTIV PLUS I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
1
OPTIVA IV Catheter: The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
Technological Characteristics: The catheter tube material has been modified for the IV Catheters. This new material is a different formulation of the material in the predicate devices. All other technological characteristics of the new device remain the same as those of the predicate device.
Performance Data: Bench testing and biocompatibility data demonstrate that the new material is equivalent to the current material.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Public Health Service
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Ms. Katie Fordyce Regulatory Affairs Associate II Ethicon Endo-Surgery, Incorporated 4545 Creek Road Cincinnati, Ohio 45242
Re: K030571
Trade/Device Name: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 21, 2003 Received: February 24, 2003
Dear Ms. Fordyce:
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.
3
Page 2 - Ms. Fordyce
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 (QS) 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 Bunner
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
4
510(k) Number (if known): K 030571
Device Name: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter
Indications for Use:
ACUVANCE PLUS Safety IV Catheter:
A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel. 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. 14 to 22 gauge catheters may be used with power injector up to 300 psi.
PROTECTIV PLUS Safety IV Catheter
The PROTECTIV PLUS Safety I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
OPTIVA IV Catheter:
The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
of CDRH, Office of Device Evaluation (ODE)
taltaux Vicente
(Optional Format 3-10-98)
(División Sign-On)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: