(87 days)
The Sterican hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.
The hypodermic needles are comprised of a metal tube that is sharpened at one end, and at the other end is bonded to a female connector (hub), which is designed to attach to a male connector, such as a syringe. The needles will be available in gauge sizes of 18 G through 27 G, and in lengths ranging from 1/2 inch to 4 3/4 inches.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for Sterican Needles, which is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, not a report on a study proving specific acceptance criteria for performance.
The document mentions:
- "Biocompatibility and functional testing have been performed to verify the safety and effectiveness of the Sterican needles."
- This testing was done to demonstrate "substantial equivalence" to the predicate device, not to meet specific performance criteria beyond that.
Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details. This information is typically found in design validation or verification reports, which are not included in this 510(k) summary.
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Ko 72247
510(k) Summary ട്.
SUBMITTER:
NOV 0 8 2007
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341
Contact: Christine Ford, Regulatory Affairs Specialist phone (610) 596-2367 fax (610) 266-4962
DEVICE NAME:
Sterican Needles
COMMON OR USUAL NAME:
DEVICE CLASSIFICATION:
PREDICATE DEVICE:
DESCRIPTION:
INTENDED USE:
SUBSTANTIAL EQUIVALENCE:
Hypodermic Single Lumen Needles
Hypodermic Single Lumen Needles Class II, CFR Title 21 § 880.5570
BD Precision Glide™ Needles (BD Single Lumen Needle, Syringe, and Blood Collection Set), K021475
The hypodermic needles are comprised of a metal tube that is sharpened at one end, and at the other end is bonded to a female connector (hub), which is designed to attach to a male connector, such as a syringe. The needles will be available in gauge sizes of 18 G through 27 G, and in lengths ranging from 1/2 inch to 4 3/4 inches.
The Sterican hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.
The Sterican hypodermic needles have the same intended use, operation, similar materials of construction, and are similar in design to the predicate device, the BD Precision Glide™ Needles, covered under K021475 (Single Lumen Needle, Syringe, and Blood Collection Set). Biocompatibility and functional testing have been performed to verify the safety and effectiveness of the Sterican needles. There are no differences between the predicate and proposed needles that raise new issues of safety and effectiveness.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 8 2007
Ms. Christine Ford Regulatory Affairs Specialist B. Braun Medical Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
Re: K072247
Trade/Device Name: Sterican Hypodermic Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 09, 2007 Received: August 13, 2007
Dear Ms. Ford:
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.
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Page 2 - Ms. Ford
Please be advised that I-DA'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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Neil R.L. Oyler
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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KC7341.
Indications for Use Statement 4.
of of Page 1
510(k) Number (if known):
Device Name:
Sterican Hypodermic Needles
Indications For Use:
The Sterican hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
W. on ortal Anthon
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ 长�72347
§ 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).