(16 days)
Not Found
No
The summary describes a passive implantable marker and introducer needle, with no mention of any computational or analytical functions that would involve AI/ML.
No.
The device is described as a tissue marker used to mark the location of a biopsy procedure, not to treat a disease or condition.
No
The device is intended to mark a location in breast tissue so that it can be radiographically identified later. It does not diagnose or process medical images to make a diagnosis.
No
The device description explicitly states it is comprised of a disposable introducer needle and an implantable metal tissue marker with a polymer insert, indicating it is a physical medical device, not software-only.
Based on the provided information, this device 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 outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Function: The UltraClip II US Wing and Coil is an implantable marker designed to be placed inside the body (in vivo) during a breast biopsy procedure. Its purpose is to physically mark the location of the biopsy site for future radiographic identification.
- Lack of Diagnostic Testing: The device itself does not perform any diagnostic test on a sample. It is a physical marker.
Therefore, the function and intended use of this device clearly fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The UltraClip II US Wing and Coil are intended for use to mark a breast biopsy site.
The UltraClip II US Wing and Coil are intended for use 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
Device Description
The UltraClip II US Wing and Coil are sterile, single use devices comprised of a disposable introducer needle and an implantable metal tissue marker with a polymer insert composed of polyvinyl alcohol (PVA). The device is designed to attach the marker to soft breast tissue at the surgical site during an open surgical breast at biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographically
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)
The UltraClip II US Wing and Coil met all predetermined acceptance criteria of the design verification and validation testing performed under design controls, and is substantially equivalent to the predicate UltraClip II Wing and Coil.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
UltraClip II US Wing and Coil 510(k) Summary 21 CFR 807.92.
K090547 page 1/2
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based as follows:
1. Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|--------------------------------------------------------------------------------|
| Phone: | 480-379-2836 |
Fax: 480-449-2546
Contact: Cindy Moss
2. Subject Device Name:
| Device Trade Name: | UltraClip II US Wing and Co |
|---|---|
| Common or Usual Name: | Implantable Clip |
| Classification: | Class II |
| Classification Panel: | General & Plastic Surgery |
3. Predicate Device:
UltraClip II Wing and Coil, K063238, cleared January 30, 2007
4. Summary of Change:
A line extension to provide for the Wing and Clip markers with PVA,
5. Device Description:
The UltraClip II US Wing and Coil are sterile, single use devices comprised of a disposable introducer needle and an implantable metal tissue marker with a polymer insert composed of polyvinyl alcohol (PVA). The device is designed to attach the marker
Bard Peripheral Vascular, Inc.
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
Image /page/0/Picture/20 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and blocky, with a slight three-dimensional effect created by the outlines. The overall impression is a strong, simple logo or wordmark.
1
to soft breast tissue at the surgical site during an open surgical breast at biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
6. Intended Use of Device:
The UltraClip II US Wing and Coil are intended for use to mark a breast biopsy site.
7. Technological Comparison to Predicate Device:
The technological characteristics of the subject device are identical to those of the predicate device in terms of intended use, indications for use, target population, fundamental scientific technology, operating principle, method of sterilization, packaging configuration, sterility assurance level, and performance characteristics,
8. Conclusions:
The UltraClip II US Wing and Coil met all predetermined acceptance criteria of the design verification and validation testing performed under design controls, and is substantially equivalent to the predicate UltraClip II Wing and Coil.
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
Image /page/1/Picture/11 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font style is geometric and modern.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
MAR 1 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C.R. Bard, Inc. % Ms. Cindy Moss Associate Project Manager Regulatory Affairs 1625 W. 3rd Street Tempe, Arizona 85281
Re: K090547
Trade/Device Name: UltraClip II US Wing and Coil Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: February 27, 2009 Received: March 2, 2009
Dear Ms. Moss:
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. Cindy Moss
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 Compliance 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 Postmarket, 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 yours,
L.A. m.D. for.
Mark N. Mellekerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO90547 510(k) Number (if known):
Device Name: UltraClip II US Wing and Coil
Indications For Use:
The UltraClip II US Wing and Coil are intended for use 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 . X (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 Eva
Daniel Knoan for MKM March 16, 2009
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K090647