(96 days)
Not Found
Not Found
No
The summary describes a physical marker for biopsy sites and contains no mention of AI, ML, image processing, or software analysis.
No
The device is used to mark the location of a biopsy procedure, which is a diagnostic rather than a therapeutic purpose.
No
The device is described as marking the location of a biopsy procedure, which is a therapeutic or procedural function, not a diagnostic one. It doesn't analyze or interpret data for the purpose of identifying a disease or condition.
No
The description clearly states the device is a physical clip (Ultraclip II WING and Ultraclip II COIL) intended to be attached to breast tissue, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the Ultraclip II WING and Ultraclip II COIL is to be attached to soft breast tissue during a biopsy procedure to mark the location. It is a device used in vivo (within the body) during a surgical procedure, not a test performed in vitro (outside the body) on a sample.
- The description focuses on a physical marker. The device is described as a clip intended to be attached to tissue for radiographic marking. This is a physical intervention, not a diagnostic test that analyzes biological samples.
Therefore, the Ultraclip II WING and Ultraclip II COIL falls under the category of a surgical or interventional device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the Ultraclip II WING and Ultraclip II COIL is to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Product codes
NEU, GDW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft breast tissue
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inrad, Inc. % Ms. Melissa Lalomia Manager, Regulatory Affairs and Ouality Assurance 4375 Donker Court S.E. Kentwood, Michigan 49512
JAN 3 0 2007
Re: K063238
Trade/Device Name: Ultraclip® II WING, Ultraclip® II COIL Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU, GDW Dated: December 20, 2006 Received: December 22, 2006
Dear Ms. Lalomia:
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 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.
1
Page 2 -- Ms. Melissa Lalomia
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 (240) 276-0115 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K063238
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510K Number if Known:
KO63238
Device Name:
Ultraclip® II WING Ultraclip® II COIL
Indications for Use:
The intended use of the Ultraclip II WING and Ultraclip II COIL is to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Prescription Use ✗
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Division of General, Restoral and Neurological Devices
V063238
510(k) Number
Special 510K Notification
Inrad Inc. Ultraclip® II WING Inrad Inc. Ultraclip® II COIL
CONFIDENTIAL
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