(182 days)
Not Found
No
The description focuses on a mechanical safety mechanism and mentions ultrasound compatibility, but there is no mention of AI or ML in the device description, intended use, or other sections.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device is an "anti-needlestick device" that provides "access to the vascular system for the introduction of a guidewire," which is a diagnostic or interventional step, not a treatment itself. Its primary function is safety (minimizing needlesticks), not therapy.
No
The device is described as an anti-needlestick device that provides access to the vascular system for the introduction of a guidewire. Its function is to facilitate the delivery of a guidewire, not to diagnose a condition. While it mentions the use of ultrasound techniques for locating the needle tip, this is an aid for placement, not a diagnostic application of the device itself.
No
The device description clearly outlines physical components like a needle, safety clip mechanism, clip puller, and needle hub, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access to the vascular system for the introduction of a guidewire. This is a direct medical intervention on a patient's body.
- Device Description: The device is a needle designed for physical insertion into the vascular system.
- Anatomical Site: The device is used on the vascular system, which is part of the human body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a medical device used for a procedural purpose (vascular access), not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Safety Introducer Needle is an anti-needlestick device that provides access to the vascular system for the introduction of a guidewire.
The Safety Introducer Needle incorporates an active safety clip mechanism designed to minimize inadvertent needlesticks when the needle is used to introduce a guidewire.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Safety Introducer Needle consists of a standard needle with an user-activated safety mechanism clip, clip puller and needle hub. The Safety Introducer Needle ranges in size from 18 - 21 gauges and has needle lengths between 1.5 - 2.75 inches. The needle can be made with an echogenic tip. An echogenic tip allows the tip of the needle to be located using Ultrasound techniques. The needle hubs are color coded to aid in recognition of needle gauge size. The safety clip mechanism reduces the risk of accidental needlestick injuries by shielding the needle. The safety clip mechanism will activate once the puller is pulled down the length of the needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
vascular system
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.
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
7.0 510(k) Summary
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500, ext. 2375
Contact: Amy K. Smith, RA Specialist |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Safety Introducer Needle |
| COMMON OR USUAL
NAME: | Guidewire introducer needle |
| DEVICE
CLASSIFICATION: | Catheter Introducer, 21 CFR 870.1340, Product Code DYB |
| PREDICATE DEVICE: | Medamicus, Inc.
Medamicus Guidewire Introducer Safety Needle, K011085
B. Braun Medical Inc.
Introcan® SafetyTM IV Catheter, K021094 |
| DESCRIPTION: | The Safety Introducer Needle consists of a standard needle
with an user-activated safety mechanism clip, clip puller
and needle hub. The Safety Introducer Needle ranges in
size from 18 - 21 gauges and has needle lengths between
1.5 - 2.75 inches. The needle can be made with an
echogenic tip. An echogenic tip allows the tip of the needle
to be located using Ultrasound techniques. The needle
hubs are color coded to aid in recognition of needle gauge
size. The safety clip mechanism reduces the risk of
accidental needlestick injuries by shielding the needle. The
safety clip mechanism will activate once the puller is pulled
down the length of the needle. |
| INTENDED USE: | The Safety Introducer Needle is an anti-needlestick device
that provides access to the vascular system for the
introduction of a guidewire. |
| SUBSTANTIAL
EQUIVALENCE: | The B. Braun Medical Inc. Safety Introducer Needle is
similar to the Medamicus Guidewire Introducer Safety
Needle (K011085) in indications for use and other |
1
application features such as needle size and guidewire sizes accepted. The Safety Introducer Needle is substantially equivalent to the Introcan Safety IV Catheter in materials and function of the safety clip mechanism.
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 2003
B. Braun Medical, Inc. c/o Ms. Amy K. Smith 901 Marcon Blvd. Allentown, PA 18109
Re: K030135 Safety Introducer Needle Regulation Number: 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 1, 2003 Received: May 5, 2002
Dear Ms. Smith:
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
3
Page 2 - Ms. Amy K. Smith
or any Federal statutes and regulations administered by other Federal agencies. 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 (OS) 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), please contact the Office of Compliance at (301) 594-4548. 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,
OleTM
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Correspondence to Mr. Shang Hwang Pending 510(k) K030135 05/01/03 Page 28 of 37
Indications for Use Statement
Page __________ of ___________________________________________________________________________________________________________________________________________________________
1030135 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Safety Introducer Needle Device Name:
Indications For Use:
The Safety Introducer Needle incorporates an active safety clip mechanism designed to minimize inadvertent needlesticks when the needle is used to introduce a guidewire.
(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)
ﺒﺔ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
OR
Over-The-Counter Use
Nogetu