(62 days)
This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: medications, TPN nutritional solutions, and intravenous infusion of fluids are needed.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Peripherally Inserted Central Catheter (PICC). It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring the submission of new clinical studies with defined acceptance criteria for novel performance metrics unless specifically requested by the FDA or if the device introduces new technology or indications that raise new questions of safety and effectiveness.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Clyde N. Baker Regulatory Manager Footprint Medical, Incorporated 1203 Camden Street San Antonio, Texas 78215
DEC 1 7 2009
Re: K093252
Trade/Device Name: Peripherally Inserted Central Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 16, 2009 Received: November 20, 2009
Dear Mr. Baker:
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 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- Mr. Baker
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely,
Susan Reiner
Anthony D. Watson, B.S., M.S., M.B.A. 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 STATEMENT
510(K) NUMBER:
K- 093252
DEVICE NAME: FOOTPRINT MEDICAL, INC., PERIPHERALLY INSERTED CENTRAL CATHETER
INDICATIONS FOR USE:
This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: medications, TPN nutritional solutions, and intravenous infusion of fluids are needed.
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION
Ch. Ei. 9
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
PRESCRIPTION USE XX (per 21 CFR 801.109)
OR
Over The Counter Use
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”