(82 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 and blood sampling.
Not Found
This document is not a study report but rather an FDA 510(k) clearance letter for the AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance criteria through a detailed clinical or technical study as described in the prompt. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics will not be found in this type of document.
Here's what can be extracted from the provided text, and where information is inherently missing:
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A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not describe specific performance acceptance criteria or report on device performance based on a study against such criteria. The FDA clearance is based on substantial equivalence to a predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not mention any specific test set, sample size, or data provenance from a device performance study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This document does not describe a study involving expert truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This document does not describe a study involving adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a medical device (PICC and Procedure Kit), not an AI diagnostic medical device. No MRMC study is mentioned or relevant here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth is mentioned as this is a device clearance based on substantial equivalence.
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The sample size for the training set
- Not Applicable. No training set for an algorithm is mentioned as this is a medical device and not an AI/machine learning product.
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How the ground truth for the training set was established
- Not Applicable. No training set information is available or relevant.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for the AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit. This type of clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
The clearance letter does not contain information about specific performance acceptance criteria or a study designed to prove the device meets such criteria in the way requested for an AI/diagnostic device. Instead, the basis for clearance is the demonstration of substantial equivalence, which typically involves comparing the new device's technological characteristics, materials, and intended use to an existing predicate device, often through bench testing and sometimes limited clinical data, but not typically a formal study with detailed acceptance criteria and ground truth as outlined in the prompt.
The "Indications for Use" section (Page 3) states: "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 and blood sampling." These are the clinical statements of what the device is intended for, not performance criteria.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.
Public Health Service
APR 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Teri Juckett Regulatory Affairs Manager AngioDynamics, Incorporated 603 Queensbury Avenue Queensbury, New York 12804
Re: K030415
Trade/Device Name: AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: March 24, 2003 Received: March 26, 2003
Dear Mr. Juckett:
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 -Mr. Juckett
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 (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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Susan Runroe
Susan Runner, DDS, MA Interim 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) Application: New Application
AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit Device Name:
Indications for Use:
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 and blood sampling.
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use ✓
Over-the-Counter Use
(Per 21 CFR 801.109)
Patricia Crescenti
n of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K030715
§ 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.”