(133 days)
The Mixed Media Markers (MMM) are intended to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The MMM can be visualized using medical imaging devices; the MMM provides a reference from which the treatment can be guided. MMM's not intended for use with ultrasonography.
These implanted markers are used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.
The markers are fabricated of biocompatible materials. Specifically, gold (99.99%), medical grade titanium or PEEK Optima (polymer) with a medical grade stainless steel core.
They are available in varying lengths and have a diameter of 1.0 MM (+/- 0.2 MM)
They are intended for single use and are permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.
This document is a 510(k) summary for the Mixed Media Marker (MMM) and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as one might find for a novel device. Therefore, much of the requested information regarding a formal study with acceptance criteria is not present in this document.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define quantitative acceptance criteria for image-based performance, nor does it present a tabular comparison of such criteria against measured performance. Instead, it relies on a qualitative statement of equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visibility in typical medical imaging devices (X-ray, CT, MRI, etc.) | "These markers have been imaged using the typical medical imaging devices and they are visible in all of the modalities required." |
| No adverse effect on safety or effectiveness due to material change. | "Sufficient testing has been performed to show that the change in materials did not adversely affect the safety or effectiveness of the new device." |
| Imaging characteristics similar to predicate devices. | "The new markers image in the same fashion as the predicate devices thus met the rules governing substantial equivalence." |
| Not intended for use with ultrasonography. | "MMM's not intended for use with ultrasonography." (This is a limitation, not a performance criterion, but is mentioned in relation to imaging.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. No details on the sample size of markers tested, the type of data (e.g., in vivo, ex vivo, phantom studies), or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. No ground truth establishment process by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no MRMC study mentioned, nor is there any AI component to this device. This document describes an implanted physical marker, not an AI-driven medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical marker; there is no algorithm or software component described that would have a standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. The document mainly focuses on demonstrating substantial equivalence through material changes and qualitative statements about visibility. There's no mention of a formal "ground truth" used for performance evaluation beyond general imaging visibility.
8. The sample size for the training set
This information is not applicable/provided. This device is a physical implanted marker and does not involve a "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as point 8.
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JAN 1 2 2011
510(k) Summary for Mixed Media Marker
| Preparation date: | January 04, 2011 |
|---|---|
| Manufacturer: | Cortex Manufacturing Inc.421 South Davies Rd.Lake Stevens WA 98258 |
Contact: Andrew Jones Phone: (425) 334-2277
| Trade Name: | Mixed Media Marker |
|---|---|
| Product Code: | NEU |
| Common Name: | Implanted Marker |
| Classification: | 878.4300 |
| Class: | II |
SE Devices:
| (K071614) | Trade name: Implanted Fiducial | CIVCO Medical Solutions |
|---|---|---|
| (K100267) | Trade name: FlexiMarc | Cortex Manufacturing Inc. |
Device Description:
These implanted markers are used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.
The markers are fabricated of biocompatible materials. Specifically, gold (99.99%), medical grade titanium or PEEK Optima (polymer) with a medical grade stainless steel core.
They are available in varying lengths and have a diameter of 1.0 MM (+/- 0.2 MM)
They are intended for single use and are permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.
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K102506 Page 2/2
Intended Use Statement with Additional Use Data
The Mixed Media Markers (MMM) are intended to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The MMM can be visualized using medical imaging devices: the MMM provides a reference from which the treatment can be guided. MMM's not intended for use with ultrasonography.
Technological Characteristics
These new markers vary only in material. The predicate devices are made of all gold or a combination of gold and other absorbable materials while the new markers are fabricated of gold and titanium or PEEK-Optima polymer and medical grade stainless steel. Sufficient testing has been performed to show that the change in materials did not adversely affect the safety or effectiveness of the new device.
Performance Comparison (Image Based)
These markers have been imaged using the typical medical imaging devices and they are visible in all of the modalities required.
Conclusion
The change in material composition did not adversely affect the safety or effectiveness of the new device. The new markers image in the same fashion as the predicate devices thus met the rules governing substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an eagle or bird-like figure with flowing lines, positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Cortex Manufacturing, Inc. % Mr. Andrew Jones 421 South Davies Road Lake Stevens, Washington 98258
JAN 1 2 201
Re: K102506
Trade/Device Name: Mixed Media Marker (MMM) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: December 14, 2010 Received: December 14, 2010
:
Dear Mr. Jones:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
. . . . . . . . . . . .
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Page 2 - Mr. Andrew Jones
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
AK. J. 15. M.
fa.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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JAN 1 2 2011
Indications for Use
510(k) Number: K102506
Device Name: Mixed Media Marker (MMM)
Indications For Use:
The Mixed Media Markers (MMM) are intended to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The MMM can be visualized using medical imaging devices; the MMM provides a reference from which the treatment can be guided. MMM's not intended for use with ultrasonography.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone be MXM
(Division Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102506
§ 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.