(170 days)
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.
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.
This document is a 510(k) summary for the Introcan® Safety™ IV Catheter and does not contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/CAD/imaging device.
The provided text describes a medical device (an IV catheter) and its regulatory clearance process, focusing on substantial equivalence to predicate devices rather than a performance study with defined acceptance criteria and statistical analysis to demonstrate novel efficacy.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available in this document.
Here's an attempt to answer the questions based on the provided text, highlighting what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document focuses on regulatory clearance based on substantial equivalence for a medical device (intravenous catheter), not an AI/CAD/imaging device with specific performance metrics like sensitivity, specificity, or F1-score.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document states "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." However, it does not specify the sample size, data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As this is a physical medical device (IV catheter), the concept of "ground truth" and "experts" for establishing it in the context of an AI/CAD/imaging device's performance study does not directly apply here. The "functional testing" mentioned would typically involve engineering and biocompatibility tests, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for studies involving human interpretation or consensus, which is not described for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. An MRMC study is relevant for AI/CAD systems that assist human readers (e.g., radiologists). This document describes an IV catheter, which is a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This document describes an IV catheter, which is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided. For physical devices like an IV catheter, "ground truth" would relate to meeting engineering specifications, biocompatibility, and functional requirements (e.g., flow rate, pressure resistance, needle stick prevention efficacy). The document refers to "functional testing" but does not detail the specific ground truth metrics or how they were established.
8. The sample size for the training set
This information is not applicable/provided. A "training set" is relevant for AI/machine learning models. This document describes a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, this concept applies to AI/ML model development, not the regulatory submission for a physical IV catheter.
{0}------------------------------------------------
AUG 2 8 2002
7.0 510(k) Summary
:
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2579Contact: 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 and880.5440: Intravascular Administration Set |
| PREDICATE DEVICE: | B. Braun Medical Inc.Introcan Safety IV Catheter, K982805.Johnson and JohnsonJELCO™, JELCO-W™ and JELCO Plus I™, K990236Becton DickinsonINSYTE®, INSYTE-W® and INSYTE® AUTOGUARD II catheters, K971339 |
| DESCRIPTION: | B. Braun Medical's Introcan Safety IV Catheter is a passiveneedle stick prevention device used for arterial and venousaccess for the infusion of fluids, drugs and/or bloodcomponents. 14 - 22 gauge catheters may be used withpower injectors for which the maximum pressure setting is300 psi.The Introcan Safety IV Catheter is available in 14 - 24gauge sizes, and both winged and non-winged versions. |
| INTENDED USE: | Passive anti-needle stick device for venous or arterialaccess for the infusion of fluids, drugs, and/or bloodcomponents. 14 - 22 gauge catheters may be used withpower injectors for which the maximum pressure setting is300 psi. |
| SUBSTANTIAL EQUIVALENCE: | The Introcan Safety IV Catheter is identical in materialsand 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
§ 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).