(14 days)
The ANGIODYNAMICS, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, parenteral nutrition, and blood sampling.
Not Found
I apologize, but this document is a 510(k) clearance letter from the FDA to AngioDynamics, Inc. for their Morpheus PICC and Procedure Kit.
It is a regulatory document granting market clearance and does not contain any information about a clinical study, acceptance criteria, or device performance metrics as they relate to a study's results.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning its safety and effectiveness are considered to be at the same level as devices already on the market, but it does not detail the specific performance metrics or studies used to demonstrate this equivalence, other than the general statement of "special 510(k) device modification" which implies some changes were made and reviewed.
{0}------------------------------------------------
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
Ms. Teri Juckett Regulatory Affairs Manager Angiodnamics, Incorporated 603 Queensbury Avenue Queensbury, New York 12804
Re: K040446
K040440
Trade/Device Name: AngioDynamics, Incorporated Morpheus PICC and Procedure Kit Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: February 18, 2004 Received: February 20, 2004
Dear Ms. Juckett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becareermined the device is substantially cquivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in multions for use nated in in May 28, 1976, the enactment date of the Medical Device interstate commerce proves 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 approval application (1 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 (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 NH), it thay be babyest is the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 - Ms. Juckett
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 27 - 115dailed of that your device complies with other requirements mean that ITA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statutes and regurements, including, but not limited to: registration You mast comply with an the Heces rog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 867), labeling (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality bjolenis (Sections 53) -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) This letter will anow you to begin mailering your substantial equivalence of your device to a prematically marketed predication for your device and the 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), If you desire specific advice to: Join de at (301) 594-4618. Also, please note the regulation in 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 may outain other general micrimational and Consumer Assistance at its toll-free Drisber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrf./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
{2}------------------------------------------------
Confidential
INDICATIONS FOR USE
510(k) Application: Special 510(k) Device modification
.
AngioDynamics, Inc. Morpheus™ PICC and Procedurc: Kit Device Name:
Indications for Use:
The ANGIODYNAMICS, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long The ANGIODY NAMICS, Inc. Morpheds - FICO and Procession and blood sampling.
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-the-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | ||
| (Division Sign-Off)Division of Anesthasinhay Constal Hocaital |
Infection Control, Dental Devices
510(k) Number: K040446
§ 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.”