(74 days)
MicroMark Clip
Not Found
No
The device description and intended use focus on a mechanical tissue marker and its delivery system, with no mention of AI/ML for image analysis, diagnosis, or any other function. The use of imaging guidance is standard for this type of procedure and does not imply AI/ML processing.
No.
The device is a tissue marker used to mark the location of a biopsy procedure, not to treat a medical condition.
No
Explanation: The device is a tissue marker used to mark the location of a biopsy procedure. It does not perform any diagnostic function such as identifying, confirming, or measuring a disease or condition.
No
The device description clearly outlines physical components (stainless steel marker, introducer, applier, flexible tube, distal ramp, lateral port, flexible shaft, deployment mechanism, handle) and is used in conjunction with a physical probe. This indicates it is a hardware 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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The 8 Gauge MicroMark II Tissue Marker is a physical device used to mark a location within the body (soft breast tissue) for radiographic identification. It is a surgical accessory used during biopsy procedures.
- No Sample Analysis: The device itself does not analyze any biological samples or provide diagnostic information based on the analysis of those samples. Its function is purely mechanical and locational.
Therefore, the device's intended use and description clearly indicate it is a surgical marking device, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The 8 Gauge 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 8 Gauge 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 8 Gauge MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery, Inc. Mammotome® Hand-Held 8 Gauge Probe, which functions as a standard rigid coaxial Introducer.
The Tissue Marker is used with imaging guidance (stereotactic and ultrasound).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to demonstrate that the device will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Summary of Safety and Effectiveness Information
1020276
| 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) 337-1444 |
| | Email: | gabernat@eesus.jnj.com |
| Date Prepared | January 25, 2002 | |
| Device Name | Trade Name: 8 Gauge MicroMark™ II Tissue Marker
Classification Name: Implantable Staple | |
| Predicate Device | MicroMark Clip | |
Device Description
The 8 Gauge 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 8 Gauge MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery, Inc. Mammotome® Hand-Held 8 Gauge Probe, which functions as a standard rigid coaxial Introducer.
The Tissue Marker is used with imaging guidance (stereotactic and ultrasound).
Indications for Use
The 8 Gauge 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
Design changes made to the 8 Gauge MicroMark II Tissue Marker are an increase in the diameter of the Introducer. There are no changes to the implantable stainless steel marker (clip); it is identical to the marketed device.
Performance Data
Bench testing was performed to demonstrate that the device will perform as intended.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
APR 1 2 2002
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
Re: K020276
Trade/Device Name: 8 Gauge MicroMark™II Tissue Marker Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: NEU Dated: January 25, 2002 Received: January 28, 2002
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 mav 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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,
Miriam C. Provost
for 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
3
Indications for Use Statement
K020276 510 (k) Number (if known):
Device Name:
8 Gauge MicroMark™ II Tissue Marker
Indications for Use:
The 8 Gauge 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of OM
(Division Sign-Off) Division of General, Restorative and Neurological Devices
(Optional Format 3-10-98)
510(k) Number K020276