(27 days)
Not Found
Not Found
No
The summary describes a physical marker for breast tissue and contains no mention of software, image processing, or AI/ML terms.
No.
The device's stated intended use is to mark the location of a biopsy for radiographic purposes, not to treat or cure a disease or condition.
No
The device is described as a marker to radiographically mark the location of a biopsy procedure, not to diagnose a condition.
No
The 510(k) summary describes a physical device (Ultraclip II MR) intended to be attached to breast tissue, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Ultraclip II MR is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Ultraclip II MR Intended Use: The intended use of the Ultraclip II MR is to be attached to soft breast tissue during a biopsy procedure to radiographically mark the location. This is a device that is placed within the body to aid in imaging and localization, not a test performed on a sample taken from the body.
Therefore, the Ultraclip II MR falls under the category of a medical device used in vivo (within the body), not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Ultraclip II MR intended use is to attach to soft breast tissue at the time of an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Product codes
GDW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-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 Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three lines forming its body and wings. Above the eagle, the text "HUMAN SERVICES - USA" is arranged in a semi-circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2004
Ms. Melissa Lalomia RA/QA Manager INRAD, Inc. 4375 Donker Ct., S.E. Kentwood, Michigan 49512
Re: K041201
Trade/Device Name: Ultraclip® II MR Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: May 6, 2004 Received: May 7, 2004
Dear Ms. Lalomia:
We have reviewed your Section 510(k) premarket notification of intent to market the indication indication we nave reviewed your becaon 310(x) premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed prodicate devices marketed in interstate for use stated in the encrosure) to regars actment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the encentions and 1974, in the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allu Cosmelle Act (71ct) market the device, subject to the general controls provisions of the Act. The You may, ulerclove, market the device, basjon of the manual registration, listing of general controls provisions of the rice, 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 IT your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA Illay be subject to suen additional come in the 21, Parts 800 to 898. In addition, FDA may be found in the Outseenents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be auvised that FDA s issuation of a substitive with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that I DA has made a decerminations administered by other Federal agencies. You must of ally Federal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820), and 820), and if applicable, the electronic form in the quality systems (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 premarket notification. The FDA miding of basification 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 Patt 801), please If you desire specific advice for your as (301) 594-4659. Also, please note the regulation entitled, Colliation of Compilance at (Set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on your responsed its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincercly yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510K Number if Known:
Device Name:
Ultraclip® II MR
Indications for Use:
The Ultraclip II MR intended use is to attach to soft breast tissue at the THC Ottractip in Mr. an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
iriàm C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041201
Special 510K Notification
Inrad Inc. Ultraclip® II MR
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