(44 days)
No
The summary provides no information suggesting the use of AI/ML. It describes a fiber for endovascular coagulation, a procedure that typically does not involve AI/ML. The predicate and reference devices are also laser systems, further indicating a non-AI/ML technology.
Yes.
The device is indicated for "endovascular coagulation," "treatment of varicose veins and varicosities," and "treatment of incompetence and reflux of superficial veins," all of which describe therapeutic actions.
No
Explanation: The device is indicated for endovascular coagulation for treatment of superficial vein reflux and varicose veins, which are therapeutic applications, not diagnostic.
No
The 510(k) summary describes a "Fiber," which is a physical component used in endovascular procedures. This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed within the patient's body (endovascular coagulation of veins). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: While the description is "Not Found," the intended use clearly points to a therapeutic device, not a diagnostic one.
- Anatomical Site: The anatomical sites mentioned are within the patient's body, consistent with a therapeutic procedure.
The device is a fiber used in a laser system for treating vein issues, which is a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The AngioDynamics, Inc. NeverTouch II Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of variose veins and varicosties associated with superficial reflux of the great saphenous vein, and for the treatment of incomprence and reflux of superficial veins of the lower extremity.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
great saphenous vein, superficial veins of the lower extremity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
"Special 510(k): Device Modification" AngioDynamics, Inc. NeverTouch II 400μm Fiber and VenaCure Procedure Kit
Confidential
General Information:
ANGIODYNAMICS, Inc. intends to introduce the following device into commercial distribution:
| a) | Trade Name: | AngioDynamics, Inc. NeverTouch II 400µm Fiber
and VenaCure Procedure Kit | | | |
|----|-------------------------------------------------|--------------------------------------------------------------------------------------------------|--|------------|--|
| b) | Legally Marketed Device: | AngioDynamics, Inc. NeverTouch 600µm Fiber
and VenaCure Procedure Kit | | | |
| | 510(k) Number: | K071959 | | | |
| b) | Common Name: | Greater Saphenous Vein Procedure Kit | | | |
| c) | Classification Name: | Laser Instrument, Surgical Powered | | JAN 23 200 | |
| d) | Established Registration Number: | 1319211 | | | |
| e) | Manufacturing Site Address: | ANGIODYNAMICS, Inc.
603 Queensbury Avenue
Queensbury, New York
12804 | | | |
| f) | Sterilization Site Address: | Sterigenics / IBA / Griffith Microscience
27 Park Rd.
Glens Falls, NY 12801 | | | |
| g) | Sterilizer Establishment
Registration Number | 13196189 | | | |
| h) | Classification: | Accessories to Laser Instrument, Surgical
Instruments
Product Code: GEX
21 CFR 878.4810 | | | |
i) Device Equivalence:
:
This product is substantially equivalent to the following device:
-
AngioDynamics, Inc. NeverTouch 600μm Fiber VenaCure Procedure Kit, . K071959
: -
CoolTouch Laser System, K040921 .
Page 3 of 23
.
1
This device does not present additional risks to patients or different considerations regarding safety and effectiveness than those presented by the predicate devices.
- Performance Standards: None Established j)
ANGIODYNAMICS® Contact Information: k)
Teri Juckett, Regulatory Affairs Manager Name:
603 Queensbury Avenue Address: Queensbury, New York 12804
Phone: (518) 798-1215 extension 1142
Fax: (518) 798-3625
- I) Payment Identification Number MD6033627-956733
Page 4 of 23
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
JAN 23 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AngioDynamics, Inc. % Ms. Teri Juckett Regulatory Affairs Manager 603 Queensbury Avenue Queensbury, New York 12804
Re: K073464
Trade/Device Name: AngioDynamics, Inc. NeverTouch II 400pm Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 28, 2007 Received: December 31, 2007
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
3
Page 2 - Ms. Teri Juckett
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 Center for Devices and Radiological Health's (CDRH's) Office of Comrtial ce at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlet Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K073464 Pg 1 of 1
INDICATIONS FOR USE
510(k) Application: Special 510(k): Device Modification
Device Name: AngioDynamics, Inc. NeverTouch II 400um Fiber
Indications for Use:
The AngioDynamics, Inc. NeverTouch II Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of variose veins and varicosties associated with superficial reflux of the great saphenous vein, and for the treatment of incomprence and reflux of superficial veins of the lower extremity.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Pevice Evalual
Office of Device Evaluation (ODE)
Mark A. Millan
(Division Sign-Off Division of General, Restorative, and Neurological Dev
510(k) Number
AngioDynamics NeverTouch II 400µm Fiber and VenaCure Procedure Kit, 510(k) Design History File 525
:
.
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