(207 days)
Not Found
Not Found
No
The 510(k) summary describes a standard intravascular catheter and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device provides access to a vein or artery for infusion, which is a diagnostic or supportive purpose, not a direct therapeutic intervention.
No
The device, an intravascular catheter, is primarily used for providing access to veins or arteries for infusion purposes, not for diagnosing medical conditions.
No
The device description clearly states it is an "Intravascular catheter," which is a physical, hardware medical device. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an intravascular catheter. Its function is to provide access to a vein or artery for purposes like infusing solutions or potentially drawing blood (though the primary focus is infusion). This is a direct interaction with the body's circulatory system, not a test performed on a sample outside the body.
- Intended Use: The intended use is to provide access to a vein or artery for therapy, not to diagnose or monitor a condition based on a sample.
The information provided about the device's use with power injectors and its performance studies further reinforces that it's a medical device used for direct patient care, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Johnson & Johnson Medical Intravascular Catheters are designed for single use. A properly placed I. V. catheter provides access to a viein 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. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 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 data demonstrates that the 16 to 24 gauge JJM catheters are appropriate for use with power injectors rated for a maximum of 300 psi.
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.
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
AUG 20 1999
510(k) Summary
| Date | August 16, 1999 |
|---|---|
| Contact | Linda G. Hill |
| Sr. Project Manager, Regulatory Affairs | |
| Johnson & Johnson Medical, Division of Ethicon, Inc. | |
| 2500 East Arbrook Boulevard | |
| Arlington, TX 76014-3631 | |
| Telephone: (817)262-4791 | |
| Telefax: (817)262-5369 | |
| Trade Names | JELCO*, JELCO*-W and JELCO* PLUS Intravascular (I.V.) CathetersCATHLON* I.V. CathetersOPTIVA* I.V. CathetersPROTECTIV*, PROTECTIV*-W, PROTECTIV* PLUS and PROTECTIV* PLUS-W I.V. Catheter Safety Systems |
| Common Name | Intravascular Catheter |
| Classification | Intravascular Catheters have been classified by the General Hospital and |
| Personal Use Devices as Class II under 21 CFR Part 880.5200. The product | |
| code assigned to these devices is FOZ. | |
| Device Description | Intravascular catheters are single use devices which provide access to veins or |
| arteries. | |
| Continued on next page |
*Trademark
INSYTE, AUTOGUARD and VIALON are trademarks of Becton-Dickinson, Inc.
v- l
1
510(k) Summary, Continued
| Indications | The intravascular catheters and safety systems are designed for single use. A properly placed intravascular 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. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi. |
|---|---|
| Contra-indications | The devices are not designed, sold or intended for use except as indicated. |
| Predicate Devices | The intravascular catheters with the proposed additional indication for use (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. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi) are substantially equivalent to the currently-marketed catheters: JELCO*, JELCO*-W, and JELCO* PLUS, I.V. CathetersCATHLON* I.V. CathetersOPTIVA* I.V. CathetersPROTECTIV*, PROTECTIV*-W, PROTECTIV* PLUS, and PROTECTIV* PLUS-W I.V. Catheter Safety SystemsBecton-Dickinson INSYTE®, INSYTE®-w AND INSYTE® AUTOGUARD TM I.V. CATHETERS |
Continued on next page
*Trademark
INSYTE, AUTOGUARI) and VIAI.ON are trademarks of Becton-Dickinson, Inc.
v-2
2
510(k) Summary, Continued
| Technological
Characteristics
Comparison | The Johnson & Johnson Medical (JJM) catheters have the same technological
characteristics as the predicate devices. The catheters with the proposed
additional indication for use are identical to the currently-marketed catheters.
No changes (materials, specifications, manufacturing and sterilization
processes) have been made to the currently-marketed catheters. The catheters
differ from the currently-marketed JJM catheters only in the instructions for
use which now include use of the 16 to 24 gauge catheters with power
injectors for which the maximum rated pressure is 300 psi. The use with
power injectors claim is the same as the Becton-Dickinson catheters claim for
use with power injectors. |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Data | Bench data demonstrates that the 16 to 24 gauge JJM catheters are appropriate
for use with power injectors rated for a maximum of 300 psi. |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR
Part 807, and based upon the information provided in this premarket
notification, Johnson & Johnson Medical, Division of Ethicon, Inc.,
concludes that the modified devices are safe, effective and substantially
equivalent to the predicate devices. |
| Other
Information | Johnson & Johnson Medical will update and include in this summary any
other information deemed reasonable necessary by the FDA. |
*Trademark
INSYTE, AUTOGUARD and VIALON are trademarks of Becton-Dickinson, Inc.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and body.
ﻬﺎ
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1999
Ms. Linda G. Hill Sr. Project Manager, regulatory Affairs Johnson & Johnson Medical, Division Of Ethicon, Incorporated 2500 East Arbrook Boulevard 76014-3631 Arlington Texas
K990236 Re : Modification Of Jelco*, Jelco*-W And Jelco* Plus Trade Name: I.V. Catheters Requlatory Class: II Product Code: FOZ Dated: July 01, 1999 Received: July 02, 1999
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 bommerce 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.
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Hill
This letter will allow you to begin marketing your device as This lected will arrow you co bogin manifaction. The Frankinding described in your from premation nevice to a legally marketed of substantial equivalence on foassification for your device and predicate actice rebaries to proceed to the market. thus, permics your acvice for your device on our labeling if you desire specific advice for your for your for in for institro regulation (21 crk Fare over and auther office of Compliance at diagnostic devices), prease concact circums on the promotion and in (301) 594-4692. Addictionally, Ese contact the Office of Also, please note the regulation Compliance at (301) 594-4639. Compilance at (3017-594-1059) Rise, Frience to premarket notification' (21 spranding by referenation on your responsibilities CFR 807.97). Crk 807.977. Other general division of Small under the Act may be Obcarned Iron Inter (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours;
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
Indications for Use
1290236 510(k) Number:
Device Name: JELCO*, CATHLON* AND OPTIVA* I.V. Catheters and PROTECTIV* I.V. Catheter Safety Systems
Indications for Use:
Johnson & Johnson Medical Intravascular Catheters are designed for single use. A properly placed I. V. catheter provides access to a viein 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. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.) ==============================================================================================================================================================================
Concurence of CDRH, Office of Device Evaluation (ODE)
Prescription Use A (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
*Trademark
Patricia Crescenti
İV