(49 days)
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.
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.
The provided text describes the MicroMark™ II Tissue Marker, and the FDA's 510(k) clearance process. However, it does not include detailed study information, acceptance criteria, or performance data in the way requested. The document is a 510(k) summary that emphasizes substantial equivalence to a predicate device and mentions "bench testing" for MRI safety without providing specifics on the study design, sample sizes, or outcome metrics.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | MRI Safety: Device 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." |
| General functionality for marking biopsy sites (implied by indications for use) | No specific performance metrics are provided (e.g., marker retention rate, visibility, migration rate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "Bench testing."
- Data Provenance: Not specified, but generally, bench testing for device clearance would be conducted by the manufacturer (Ethicon Endo-Surgery, Inc.) in a controlled lab environment. This would be considered prospective for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "bench testing" described relates to MRI safety, not a clinical study requiring expert ground truth for interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The testing described is bench testing, not a clinical trial with independent review or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done? No. The document describes "Bench testing" for MRI safety, not a clinical comparative effectiveness study involving human readers.
- Effect Size of AI vs. without AI assistance: Not applicable, as this is not an AI-driven device and no MRMC study was conducted.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
- Was a standalone study done? Not applicable in the context of an algorithm. The device itself (the marker) is the product being evaluated for its standalone physical properties (MRI safety). The bench testing performed for MRI safety could be considered a form of standalone performance evaluation for the device's physical attributes, but it's not "algorithm only" as the device has no algorithm.
7. Type of Ground Truth Used
- Ground Truth Type: For the MRI safety testing, the "ground truth" would be established by scientific principles and validated measurement techniques for magnetic field interactions, movement, dislodgment, and heating in standardized phantom or test setups. This is based on objective physical measurements rather than expert consensus, pathology, or outcomes data in a clinical setting.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is a physical tissue marker, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
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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.
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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.
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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.
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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)
§ 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.