(170 days)
No
The summary describes a mechanical device for preventing needle sticks and does not mention any computational or data-driven components indicative of AI/ML.
No
This device is an IV catheter used for administering fluids, drugs, and blood components, which are therapeutic actions, but the device itself is a delivery mechanism, not a therapeutic device delivering direct therapy through its technology, rather a critical tool for enabling therapy. Its primary benefit is the prevention of needle stick injuries.
No
The device is an IV catheter used for infusion, not for diagnosing conditions. Its primary function is to deliver fluids, drugs, or blood components into a patient.
No
The device description clearly describes a physical medical device (IV Catheter) with a passive needle stick prevention feature. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "venous or arterial access for the infusion of fluids, drugs, and/or blood components." This describes a device used for direct patient care and treatment, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces its use as a "passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components." Again, this is a device for accessing the circulatory system for therapeutic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the delivery of substances into the body.
N/A
Intended Use / Indications for Use
Passive anti-needle stick device for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.
Product codes
FOZ
Device Description
B. Braun Medical's Introcan Safety IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.
The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use for the Introcan® Safety™ IV Catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 2 8 2002
7.0 510(k) Summary
:
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500, ext. 2579
Contact: Amy S. Krall, RA Specialist |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Introcan ® Safety™ IV Catheter |
| COMMON OR USUAL NAME: | Safety Intravascular Catheter |
| DEVICE CLASSIFICATION: | Class II, 21 CFR 880.5200: Intravascular Catheter and
880.5440: Intravascular Administration Set |
| PREDICATE DEVICE: | B. Braun Medical Inc.
Introcan Safety IV Catheter, K982805.
Johnson and Johnson
JELCO™, JELCO-W™ and JELCO Plus I™, K990236
Becton Dickinson
INSYTE®, INSYTE-W® and INSYTE® AUTOGUARD II catheters, K971339 |
| DESCRIPTION: | B. Braun Medical's Introcan Safety IV Catheter is a passive
needle stick prevention device used for arterial and venous
access for the infusion of fluids, drugs and/or blood
components. 14 - 22 gauge catheters may be used with
power injectors for which the maximum pressure setting is
300 psi.
The Introcan Safety IV Catheter is available in 14 - 24
gauge sizes, and both winged and non-winged versions. |
| INTENDED USE: | Passive anti-needle stick device for venous or arterial
access for the infusion of fluids, drugs, and/or blood
components. 14 - 22 gauge catheters may be used with
power injectors for which the maximum pressure setting is
300 psi. |
| SUBSTANTIAL EQUIVALENCE: | The Introcan Safety IV Catheter is identical in materials
and design to B. Braun Medical's premarket notification,
Introcan Safety IV Catheter, K982805. The Introcan Safety |
| 000014 | |
1
IV Catheter is similar in indications for use to Johnson and Johnson Jelco™ catheters, K990236 and Becton Dickinson INSYTE® catheters, K971339. Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use
for the Introcan® Safety™ IV Catheter.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble an abstract human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2002
Ms. Amv S. Krall Regulatory Affairs Specialist B. Braun Medical, Incorporated 824 Twelfth Avenue Bethlehem, Pennsylvania 18018
Re: K020785
Trade/Device Name: Introcan SafetyTM IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: June 18, 2002 Received: June 19, 2002
Dear Ms. Krall:
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.
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.
3
Page 2 - Ms. Krall
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Timothy A. Ulatowski
Timo Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.0 Indications for Use Statement
-Page
| 510(k) Number (if known): | K020785 |
|---|---|
| --------------------------- | --------- |
Introcan® Safety™ IV Catheter Device Name:
Indications For Use:
Passive anti-needle stick devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Pactrice Cuenito
(Division Sign-Off)
ision of Anesthesiology, General Hospital, Infection Control, Dent
000007
510(k) Number: K020785