(77 days)
Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
The proposed device is an extension to the Kendall Monoject PreFill™ ADVANCED™ Flush Syringe line is to include one or more PreFill syringe configurations equivalent to those already marketed by Tyco Healthcare with the syringe delivered to the customer in a package that will maintain the sterility of the syringe exterior surface.
The provided text is a 510(k) summary for a medical device: "Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery." This document describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.
However, the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria in the context of an algorithm or AI performance. The document is for a physical medical device (pre-filled syringes) and a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, primarily through nonclinical testing (like biocompatibility) and comparison of technological characteristics.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance (for an algorithm).
- Sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth used, or training set details.
The nonclinical testing mentioned in the document is:
Nonclinical Testing:
- Biocompatibility testing against ISO Standard 10993, Part 1 and FDA modified matrix (G95-1).
This testing is relevant to the safety and compatibility of the physical syringe and its contents with the human body, not to the performance of any AI or algorithmic component.
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510(k) Summary
In accordance with section 513(l) of the SMDA and as defined in 21 CFR Part 807, 3 final rule dated December 14, 1994, this summary is submitted by:
Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: February 08, 2006
APR 2 8 2006
Contact Person 1.
Bridget Gardner Manager, Regulatory Affairs (508) 261-6384
2. Name of Medical Device
Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Common or Usual Name: Chloride Flush Syringes for Sterile Delivery
3. Identification of Legally Marketed Device
The proposed Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is substantially equivalent in intended use, function and composition to the currently marketed Kendall Monoject PreFill™ ADVANCED "0.9% Sodium Chloride Flush Syringes K032438.
র্বা Device Description
The proposed device is an extension to the Kendall Monoject PreFill™ ADVANCED™ Flush Syringe line is to include one or more PreFill syringe configurations equivalent to those already marketed by Tyco Healthcare with the syringe delivered to the customer in a package that will maintain the sterility of the syringe exterior surface.
ട്. Device Intended Use
Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
6. Product Comparison
The proposed device has the same technological characteristics as the predicate devices. Each consists of Monoject® plastic syringes containing 0.9% Sodium Chloride.
7. Nonclinical Testing
Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1 and with the FDA modified matrix presented in memorandum G95-1.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Bridget Gardner Manager, Regulatory Affairs Tyco Healthcare Kendall 15 Hampshire Street Mansfield, Massachusetts 02048
APR 7 8 2006
Re: K060339
Trade/Device Name: Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: April 13, 2006 Received: April 14, 2006
Dear Ms. Gardner:
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. Gardner
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 (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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Suite Y. M. Marie Curie
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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Indications for Use
510(k) Number (if known): K060339
Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes Device Name: for Sterile Delivery
Indications for Use: Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Prescription Use v (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Shala P. Murphy, LS 4/27/04
- Very Good (excellent)
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).