(182 days)
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.
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.
This looks like a 510k submission for a medical device called "Safety Introducer Needle". In this specific document, there is no discussion of acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on the administrative aspects of the 510(k) submission, confirming the device's classification, and its substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information from the given text.
Here's how I can tell the provided text doesn't contain the requested information:
- No mention of "acceptance criteria," "performance study," "test set," "sample size," "ground truth," or "experts." The document is primarily about regulatory approval.
- The "Description" section details the physical characteristics and safety mechanism, but not performance metrics.
- The "SUBSTANTIAL EQUIVALENCE" section compares the new device to existing ones based on indications for use, materials, and function, but not on quantitative performance outcomes from a study.
- The FDA letter confirms regulatory clearance, not a performance evaluation detailed in the submission.
To answer your request, I would need a document that describes the design verification and validation testing, which would typically include acceptance criteria and the results of studies conducted to demonstrate the device meets those criteria.
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7.0 510(k) Summary
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2375Contact: Amy K. Smith, RA Specialist |
|---|---|
| DEVICE NAME: | Safety Introducer Needle |
| COMMON OR USUALNAME: | Guidewire introducer needle |
| DEVICECLASSIFICATION: | Catheter Introducer, 21 CFR 870.1340, Product Code DYB |
| PREDICATE DEVICE: | Medamicus, Inc.Medamicus Guidewire Introducer Safety Needle, K011085B. Braun Medical Inc.Introcan® SafetyTM IV Catheter, K021094 |
| DESCRIPTION: | The Safety Introducer Needle consists of a standard needlewith an user-activated safety mechanism clip, clip pullerand needle hub. The Safety Introducer Needle ranges insize from 18 - 21 gauges and has needle lengths between1.5 - 2.75 inches. The needle can be made with anechogenic tip. An echogenic tip allows the tip of the needleto be located using Ultrasound techniques. The needlehubs are color coded to aid in recognition of needle gaugesize. The safety clip mechanism reduces the risk ofaccidental needlestick injuries by shielding the needle. Thesafety clip mechanism will activate once the puller is pulleddown the length of the needle. |
| INTENDED USE: | The Safety Introducer Needle is an anti-needlestick devicethat provides access to the vascular system for theintroduction of a guidewire. |
| SUBSTANTIALEQUIVALENCE: | The B. Braun Medical Inc. Safety Introducer Needle issimilar to the Medamicus Guidewire Introducer SafetyNeedle (K011085) in indications for use and other |
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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.
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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
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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
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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
§ 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).