(88 days)
The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of balloon catheters, closed end catheters or angiographic catheters into the vasculature. AngioDynamics, Inc. Percutaneous Introducers are designed for use during interventional procedures and are not intended for critical care use.
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the AngioDynamics Percutaneous Introducer does not contain the detailed information necessary to answer your request in full.
Here's a breakdown of what can be extracted and what is missing, based on the input:
What can be extracted:
- Device Name: AngioDynamics, Inc. Percutaneous Introducer
- 510(k) Number: K040728
- Intended Use: "The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of balloon catheters, closed end catheters or angiographic catheters into the vasculature."
- Type of Study (Implied): A 510(k) clearance primarily relies on a demonstration of "substantial equivalence" to a legally marketed predicate device, rather than a clinical effects study. The letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This means the submission likely focused on design, materials, and performance characteristics (e.g., mechanical testing) to show it performs as safely and effectively as an existing device, rather than proving novel clinical benefit through a detailed clinical trial.
What is missing from the provided text:
The document is a clearance letter, not the actual 510(k) submission. Therefore, it does not include:
- Acceptance Criteria Table and Reported Device Performance: This would be found in the performance testing section of the 510(k) submission itself, detailing specific metrics (e.g., tensile strength, burst pressure, lubricity, insertion force, etc.) and the results that met pre-defined criteria. The clearance letter only confirms that the FDA reviewed the submission and found the device substantially equivalent.
- Sample Size Used for the Test Set and Data Provenance: This information would be specific to any non-clinical (e.g., benchtop, in vitro) or potentially limited clinical testing performed to support substantial equivalence. The letter does not specify this.
- Number of Experts Used to Establish Ground Truth and Qualifications: This is typically relevant for studies involving subjective assessments (e.g., imaging interpretation), which is not the primary focus of an introducer substantial equivalence claim.
- Adjudication method for the test set: Not applicable based on the available information.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Highly unlikely for an introducer device seeking 510(k) clearance, as these types of studies are typically for devices claiming improved diagnostic accuracy or clinical outcomes. The letter does not mention any such study.
- Standalone (Algorithm Only) Performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: For an introducer, "ground truth" would likely relate to objective physical and mechanical properties, not expert consensus on pathology or outcomes data in the way an AI diagnostic device would.
- Sample Size for the Training Set: Not applicable as this is a physical device, and there is no "training set" in the context of machine learning unless an AI component was involved, which is not indicated.
- How the Ground Truth for the Training Set was Established: Not applicable.
Conclusion:
The provided FDA clearance letter confirms that the AngioDynamics Percutaneous Introducer was found substantially equivalent to a predicate device based on a 510(k) submission (K040728). However, it does not contain the detailed technical data, study methodologies, or specific performance criteria and results that you are requesting. This information would be within the confidential 510(k) submission document itself, which is not publicly released in its entirety.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
JUN 1 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Teri Juckett Regulatory Affairs Specialist AngioDynamics, Inc. 603 Queensbury Avenue Oueensbury, NY 12804
K040728 Re:
Trade/Device Name: Percutaneous Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: March 18, 2004 Received: March 22, 2004
Dear Ms. 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.
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
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Page 2 - Ms. Teri Juckett
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR 1000-1050); var 11 - 150, st the Active Active Active 1000-1050, forth in the quality systems (QS) regulation (2 ~21 (2 %) =2 % =3 % =1 %) =1 % =1 % =1 % =1 % =1 % =1 % =1 % =1 % = product radiation control provisions (Sections 35 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leval This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA imalig of substantial equive 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
r the If you desire specific advice for your device of carded on all of the successforms on the contact the Office of Compliance at (301) 594-40 contact the Office of Compliance at (301) 594promotion and advertising of your device, please contact the office of Complia promotion and advertising of your devices promoting by reference to premarket
4639. Also, please note the regulation entitled, "Misbrangroomeral information on vour 4639. Also, please note the regulation entires, other general information on your notification" (21CFR Part 807.97) you hay be obtained from the Division of Small Manufacturers,
responsibilities under the Act may be obtained from the Comments of 2001 or (3 responsibilities under the Act may be out instruction in Britiston of Soll) 638-2041 or (301) 443-6597
International and Consumer Assistance at its toll-free min brokes broke imernational and Consumer Abolstant Processor of States of Smamain.html
Sincerely yours,
Dina R. Vochmer
QA Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040728
AngioDynamics, Inc. Percutaneous Introducer Device Name:
Indications For Use:
The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of The AngloDynamics inc. Ferodianous introductions into the vasculature.
balloon catheters, closed end catheters or angiographic catheters into the vasculature.
AngioDynamics, Inc. Percutaneous Introducers are designed for use during AngloDynamios, inc. I ordains and are not intended for critical care use.
Prescription Use ___ (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)
Duma R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_KU40728
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).