(78 days)
Not Found
Not Found
No
The summary describes a mechanical device for IV insertion with a needlestick protection feature. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is used for access to the vascular system for sampling blood, monitoring blood pressure, or administering fluids, and is not designed to treat a specific condition or disease itself.
No
This device is designed to gain access to the vascular system for purposes such as delivering fluids, monitoring blood pressure, or sampling blood. While blood sampling and blood pressure monitoring can be part of a diagnostic process, the device itself is an access tool and not performing the diagnostic analysis or interpretation.
No
The device description clearly outlines physical components like a catheter tube, catheter hub, housing, flash chamber, flash plug, stainless steel needle, and a needle safety mechanism. These are hardware components, 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 gain access to the vascular system for sampling blood, monitoring blood pressure, or administering fluids. This is a direct interaction with the patient's body for therapeutic or monitoring purposes.
- Device Description: The device is a catheter system designed for insertion into a vein or artery.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used outside the body to analyze samples (like blood, urine, tissue) to diagnose or monitor a condition. This device is used inside the body for direct patient care.
N/A
Intended Use / Indications for Use
The I.V. Catheter System is designed to gain access to and deliver a short term (
§ 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
K980493
510(k) - I.V. Catheter System
APR 28 1998
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for I.V. Catheter System
Johnson & Johnson Medical 2500 Arbrook Boulevard P.O. Box 90130 Arlington, Texas 76004-3130
Date: February 6, 1998
1. REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
2. CONTACT PERSON
Linda G. Hill (817) 784-4791
3. NAME OF MEDICAL DEVICE:
Catheter, Intravascular, Short Term Classification Name: Common/Usual Name: I.V. Catheter Proprietary Name: To be determined
4. DEVICE CLASSIFICATION:
The General Hospital Panel has classified Intravascular Catheters (21 CFR 880.5200) into Class II, Special Controls under section 513 of the Act.
5. STATEMENT OF SUBSTANTIAL EQUIVALENCE:
The I.V. Catheter System is substantially equivalent to JJM's existing CRITIKON* OCR I.V. Catheter and to Bio-Plexus' existing Punctur-Guard® Blood Collection Needle. See attached Comparison Matrix, Table 1.
6. INTENDED USE:
The I.V. Catheter System is designed to gain access to and deliver a short term (Specifications | | | |
| Multiple Gauge Sizes and Needle Lengths | Yes | Yes | Yes |
| EtO Sterilized | Yes | Yes | Yes |
| Other | | | |
| Sharps Injury Prevention Feature is an
Integral Part of Device | Yes | Not Applicable | Yes |
| Minimal User Training | Yes | Yes | Yes |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 28 1998
Ms. Linda G. Hill ·Sr. Manager, Regulatory Affairs Johnson & Johnson Medical 2500 Arbrook Boulevard Arlington, Texas 76004-3130
Re : K980493 I.V. Catheter System Trade Name: Requlatory Class: II Product Code: FOZ Dated: February 6, 1998 Received: February 9, 1998
Dear Ms. Hill:
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, Druq, 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.
If 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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
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Page 2 - Ms. Hill
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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,
Timothy A. Ulatowski
Directør Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
Applicant
Johnson & Johnson Medical P.O. Box 90130 Arlington, Texas 76004-3130, USA
510(k) Number
This is a new submission and FDA has not assigned a number at this time
Device Name
I.V. Catheter System
Indications for Use
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.
(Please do not write below this line-Continue on another page if needed) Concurrence of CDRH Office of Deyice Evaluation (ODE)
Palman (Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K980423
Prescription Use V OR Per 21 CFR 801.109 (Optional Format 1-2-96)_
Over-the-Counter
iV