(158 days)
Not Found
Not Found
No
The summary describes a standard IV catheter with a check valve and does not mention any AI/ML components or functionalities.
No.
The device is an IV catheter used for administering drugs and fluids, not for treating a disease or condition itself.
No
This device is an IV catheter intended for administering drugs and fluids or withdrawing fluids, which are therapeutic and access functions, not diagnostic ones.
No
The device description clearly states it is a physical catheter with a check valve assembly, indicating it is a hardware device, not software-only.
Based on the provided information, the Aeroquip SafeStart™ IV Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "peripheral venous access" to "allow administration of drug and fluids into patients" and "withdrawal of fluids." This describes a device used in vivo (within the body) for therapeutic and diagnostic purposes related to accessing the circulatory system.
- Device Description: The description details a "peripheral vascular access catheter" with components like a catheter tube, check valve, and luer lock interface. This is consistent with a device used for accessing blood vessels.
- 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 samples like blood, urine, or tissue.
Therefore, the Aeroquip SafeStart™ IV Catheter is a medical device used for accessing the peripheral vascular system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aeroquip SafeStart™ IV Catheter is a sterile, non-pyrogenic, disposable peripheral vascular access catheter intended to provide peripheral venous access per CDC guidelines without the spillage of blood when accessing a vein or artery. It is intended to allow administration of drug and fluids into patients via a standard luer connection. The Aeroquip SafeStart™ IV Catheter permits for any type of intravenous fluid administration (continuous and intermittent) or withdrawal of fluids.
Product codes
FOZ
Device Description
The Aeroquip SafeStart™ IV Catheter device is a sterile, non-pyrogenic, disposable, peripheral vascular access catheter. The catheter check valve assembly consists of a catheter tube, a twoway internal check valve, a catheter body and a luer lock interface cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous
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): 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.
Not Found
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.
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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
AUG - | 1997
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is :_______________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
Aeroquip Medical Products 2323 Green Road Ann Arbor, MI 48105-1530 Contact Person: Ms. Christina L. Thomas, Medical Specialist
Date Summary Prepared: February 20, 1997
Name of the Device: 2.
Aeroquip SafeStart™ IV Catheter
Predicate Device Information: 3.
- Critikon PROTECTIV™ manufactured by Critikon Inc. 1)
- Low Profile Safsite Y-Site manufactured by B. Braun. 2)
4. Device Description:
The Aeroquip SafeStart™ IV Catheter device is a sterile, non-pyrogenic, disposable, peripheral vascular access catheter. The catheter check valve assembly consists of a catheter tube, a twoway internal check valve, a catheter body and a luer lock interface cap.
Intended Use: પતે
The Aeroquip SafeStart™ IV Catheter is a sterile, non-pyrogenic, disposable peripheral vascular access catheter intended to provide peripheral venous access per CDC guidelines without the spillage of blood when accessing a vein or artery. It is intended to allow administration of drug and fluids into patients via a standard luer connection.
The Aeroquip SafeStart™ IV Catheter permits for any type of intravenous fluid administration (continuous and intermittent) or withdrawal of fluids.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -- 1 1997
Ms. Susan Goldstein-Falk Official Correspondent Aeroquip Medical Products C/O MDI Consultants, Incorporated 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
Re : K970669 Trade Name: Aeroquip Safestart IV Catheter Requlatory Class: II Product Code: FOZ Dated: May 6, 1997 Received: May 8, 1997
Dear Ms. Goldstein-Falk:
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 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.
lf 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 requlations 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 Quality System Regulation (QS) for Medical
2
General requlation (21 CFR Part 820) and that, Devices: 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 action. In addition, FDA may publish further announcements in 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 requlations.
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 regulation (21 CFR Part 801 and additionally 809.10 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 notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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,
K.J. Lilienthal
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Aeroquip SafeStart™ IV Catheter
Device Mame:
Indications For Use:
The Aeroquip SafeStart™ IV Catheter is a sterile, non-The Aeroquip Sarestart" I v Cacleter access catheter
pyrogenic, disposable peripheral vascular access per CDC quidel intended to provide peripheral venous access per CDC guidelines
intended to provide peripheral venous accessing a vein or intended to provide partpanes of blood when accessing a vein or
hours without the spillage of blood when accessing of drugs and It is intended to allow administration of drugs and artery. into patients via a standard luer connection. fluids
permits for any type The Aeroquip SafeStart™ IV Catheter Seroquip Sarestart IV Cacheler and of . intermittent) or withdrawal of fluids.
(PLEASE:DO NOT WRITE SELOW TEDS LINE - CONTINUE ON ANOTHER. PAGE IS HERDED)
Concerence of CDRS, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
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Ore-The-Court Use
(Optics For at 1-2-96)