(89 days)
The one.click needle is a sterile, single-packed, disposable hypodermic single lumen needle designed for use with a multidose pen injection device, the one.click auto-injector, for the subcutaneous injection of fluid drug products.
The one.click needle is a double-ended needle consisting of a tribeveled tip, hollow steel cannula, needle hub and needle shield. The one.click needle will be available as a 29 Gauge needle, with a patient-end needle length of 12 millimeters.
There is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The pages primarily contain a 510(k) summary and the FDA's clearance letter for the "one.click™ needle."
Therefore, I cannot provide the requested information in a table or answer the specific questions about the study, sample sizes, expert qualifications, or ground truth.
Input Summary:
The provided input describes a 510(k) summary for the "one.click™ needle" by B. Braun Medical Inc. and the FDA's clearance letter for this device. The summary details the device name, common name, classification, predicate device, description, intended use, and substantial equivalence to the predicate. The FDA letter confirms the device's substantial equivalence to a legally marketed predicate. However, neither document includes information about specific acceptance criteria or the details of a study proving the device meets those criteria.
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Image /page/0/Picture/0 description: The image shows the logo for B. Braun. The logo consists of the letter "B", a vertical line, and the word "BRAUN" in bold, sans-serif font. The logo is black and white.
FEB - 9 2004
7.0 510(k) Summary
| SUBMITTER: | B. Braun Medical Inc. 901 Marcon Boulevard Allentown PA 18109-9341 |
|---|---|
| Contact: Jennifer A. Kosoy, Senior Analyst, Regulatory Affairs (610) 266-0500 ext. 2516 | |
| DEVICE NAME: | one.click™ needle |
| COMMON OR USUAL NAME: | Pen needle |
| DEVICE CLASSIFICATION: | Class II, per Code of Federal Regulations, Title 21 § 880.5570 Hypodermic Single Lumen Needle |
| PREDICATE DEVICE: | Owen Mumford, Inc. Unifine® Pentip® (K973899) |
| DESCRIPTION: | The one.click needle is a double-ended needle consisting of a tribeveled tip, hollow steel cannula, needle hub and needle shield. The one.click needle will be available as a 29 Gauge needle, with a patient-end needle length of 12 millimeters. |
| INTENDED USE: | The one.click needle is a sterile, single-packed, disposable hypodermic single lumen needle designed for use with a multidose pen injection device, the one.click auto-injector, for the subcutaneous injection of fluid drug products. |
| SUBSTANTIAL EQUIVALENCE: | The proposed one.click needle has the same materials, method of construction, and is similar in design to the Unifine® Pentip®, currently manufactured by B. Braun for Owen Mumford Inc. under the Premarket Notification K973899 (Unifine Pentip). The one.click needle differs from the Unifine Pentip in range of needle lengths, needle diameter, and color of needle shield. The needle gauge and length of the one.click needle is within the sizes cleared in the Unifine Pentip 510(k). The one.click needle is similar to the Unifine Pentip in indications for use, as noted in product labeling. |
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Image /page/1/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 an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 2004
Ms. Jennifer A. Kosoy Senior Analyst, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allenstown, Pennsylvania 18109-9341
Re: K033575
Trade/Device Name: One.Click™ Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodernic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 12, 2003 Received: November 12, 2003
Dear Ms. Kosoy:
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 promarket 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 vour 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.
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Page 2 - Ms. Kosoy
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. 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Chiu Lin, Ph., D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BB
Indications for Use Statement 2.0
Page 1 1 of of of 1
510(k) Number (if known): / C 3.35 75
one.click™ needle Device Name:
Indications For Use:
The one.click needle is a sterile, single-packed, disposable hypodermic single lumen needle designed for use with a multidose pen injection device, the one.click auto-injector, for the subcutaneous injection of fluid drug products.
(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)
ાર
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
signature
ision Sign-Off on of Anesthesiology, General Hospital, Infection Control. Dental D
510(k) Number 4033575
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§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).