(72 days)
Medline disposable sterile syringes are intended for use to inject fluids into, or withdraw fluids from, the body.
Medline disposable sterile insulin syringes are intended for subcutaneous injection of insulin.
Not Found
This document is primarily a 510(k) clearance letter from the FDA for Medline Piston Syringes and Medline Insulin Syringes. It states that the devices are substantially equivalent to legally marketed predicate devices.
Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or a summary of safety and effectiveness data.
The FDA 510(k) clearance process reviews evidence of substantial equivalence to an existing predicate device, which can involve performance testing, but the specifics of how the device meets particular acceptance criteria are generally detailed in the submission itself, not in the clearance letter.
Therefore, I cannot provide the requested information based on this document. The document confirms the FDA's decision but does not describe the underlying study details.
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Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three curved lines representing the staff and two wavy lines representing the snakes. The text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 19 2006
Ms. Lara Simmons Corporate Director, Regulatory Affairs Medline Industries, Incorporated (One Medline Place Mundelein, Illinois 60060
Re: K061275
Trade/Device Name: Medline Piston Syringes, Medline Insulin Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 2, 2006 Received: May 8, 2006
Dear Ms. Simmons:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have revent of one a young determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in moreations for use stated in the enotes and on the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to devroed martic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Connects, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 If your device is classified (See above) in a controls. Existing major regulations affecting (FMA), it may be subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the South no announcements concerning your device in the Federal Register.
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Page 2 -- Ms. Simmons
lease 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 mean that + D7 mas may statutes and regulations administered by other Federal agencies. on mo Act of any Pouchall the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice aller houng (21 ce read on the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet 1011 aroduct 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) Fins fotor Hilfication. 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), nlease 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 maj Volum Street gallery, 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/industry/support/index.html.
Sincerely yours,
Chiu-Ling, Ph.D.
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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Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string appears to be an alphanumeric code or identifier. The characters are 'K061275', with some of the characters slightly distorted or stylized due to the handwriting.
Indications For Use
510(k) Number (if known):___K061275
Device Name: Medline Piston Syringes
Medline disposable sterile syringes are intended for use to inject fluids into, or withdraw fluids from, the body.
X Prescription Use (Per 21 CFR 801 Subpart C) (Part 21 CFR 901 Subpart D) AND/OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Del For Now 7/18/2006 Page 1 of 1
vion Sign-Off)
ivision of Anesthesiology, General Hospital,
hieuen Control, Dental Devices
track) Number: K 061275
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Indications For Use
510(k) Number (if known): ___K061275
Device Name: Medline Insulin Syringes
Medline disposable sterile insulin syringes are intended for subcutaneous injection of insulin.
Prescription Use (Per 21 CFR 801 Subpart C) (Part 21 CFR 901 Subpart D) AND/OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
n of Anesthesiology, General Hospital, n Control, Dental Devices
Number. K401213
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§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).