(49 days)
MicroMark™ Clip
Not Found
No
The description focuses on the mechanical components and materials of the tissue marker and its use with existing imaging modalities and biopsy probes. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device's stated indication for use is to radiographically mark the location of a biopsy procedure, not to treat a disease or condition.
No.
The device is used to mark the location of a biopsy procedure, not to diagnose a condition. It is a tissue marker that is implanted to enable radiographic identification of a surgical site.
No
The device description clearly states it is comprised of a stainless steel marker (clip) and a disposable introducer and applier, which are physical components, not software.
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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The MicroMark™ II Tissue Marker is a physical device implanted into the body to mark a location for future reference (radiographically). It does not analyze biological samples or provide diagnostic information based on the analysis of those samples.
- Intended Use: The intended use is to "radiographically mark the location of the biopsy procedure," not to diagnose or provide information about a disease or condition based on in vitro analysis.
The device is a surgical accessory used in conjunction with biopsy procedures and imaging, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The MicroMark™ II Tissue Marker is indicated 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 MicroMark II Tissue Marker is a sterile, single patient use device comprised of a small stainless steel marker (clip) and a disposable introducer and applier. The introducer consists of a flexible tube, a distal ramp, and a lateral port. The applier consists of a flexible shaft, a deployment mechanism and a handle. The marker is located at the distal end of the applier.
The MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery MAMMOTOME® Probes which function as standard rigid coaxial introducer needles post biopsy.
The Tissue Marker is used with imaging guidance (stereotactic and ultrasound). The stainless steel marker is Magnetic Resonance (MR) safe at 3.0 Tesla field strength or less. The marker, when present in a patient undergoing an MRI procedure at 3.0 Tesla or less, will not create an additional hazard or risk with respect to magnetic field-related interactions, movement / dislodgment, or heating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
imaging guidance (stereotactic and ultrasound)
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
Bench testing was performed to demonstrate that the device will perform as intended in MRI procedures utilizing 3.0 Tesla or less.
Key Metrics
Not Found
Predicate Device(s)
MicroMark™ Clip
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
DEC 0 3 2001 MicroMark™ II Tissue Marker 510(k) Summary of Safety and Effectiveness Information
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242
Contact
Georgia C. Abernathy, MBA. RAC Senior Regulatory Affairs Associate Telephone: (513) 337-3179 Fax: (513) 337-3773 Email: gabernat@eesus.jnj.com
Date Prepared
October 12, 2001
Device Name
Trade Name: MicroMark™ II Tissue Marker Classification Name: Implantable Staple
Predicate Device
MicroMark™ Clip
Device Description
The MicroMark II Tissue Marker is a sterile, single patient use device comprised of a small stainless steel marker (clip) and a disposable introducer and applier. The introducer consists of a flexible tube, a distal ramp, and a lateral port. The applier consists of a flexible shaft, a deployment mechanism and a handle. The marker is located at the distal end of the applier.
The MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery MAMMOTOME® Probes which function as standard rigid coaxial introducer needles post biopsy.
The Tissue Marker is used with imaging guidance (stereotactic and ultrasound). The stainless steel marker is Magnetic Resonance (MR) safe at 3.0 Tesla field strength or less. The marker, when present in a patient undergoing an MRI procedure at 3.0 Tesla or less, will not create an additional hazard or risk with respect to magnetic field-related interactions, movement / dislodgment, or heating.
1
Indications for Use
The MicroMark II Tissue Marker is indicated 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.
Technological Characteristics
No design changes have been made to the MicroMark II Tissue Marker. The specification and labeling-modified marker is identical and possesses the same technological characteristics as the currently marketed marker.
Performance Data
Bench testing was performed to demonstrate that the device will perform as intended in MRI procedures utilizing 3.0 Tesla or less.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The central image resembles a bird in flight, composed of three curved lines that suggest movement and progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Georgia C. Abernathy, MBA, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839
DEC 0 3 2001
Re: K013413
Trade/Device Name: MicroMark™ II Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: October 12, 2001 Received: October 15, 2001
Dear Ms. Abernathy:
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.
3
Page 2 - Ms. Georgia C. Abernathy, MBA, RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, us
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
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Enclosure
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Indications for Use Statement
| 510 (k) Number (if known): | K013413 |
|---|---|
| ---------------------------- | --------- |
Device Name:
MicroMark™ II Tissue Marker
Indications for Use:
The MicroMark™ II Tissue Marker is indicated for use to attach to soft breast tissue The Microivials Tissue Marker 16 indical breast biopsy or a percutaneous breast at the surgical site darms an open barger starget of the biopsy procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)