(133 days)
Not Found
No
The device description focuses on the physical properties and intended use of implanted markers for visualization in medical imaging, with no mention of AI or ML for image processing, analysis, or any other function.
No.
The device is used for marking anatomical locations for future medical procedures, not for treating any condition.
No
Explanation: The device is a marker used to identify the location of specific anatomy for future medical procedures, visualized by imaging devices. It does not perform a diagnostic function itself, but rather aids in the guidance of treatment after a diagnosis has likely been made.
No
The device description clearly states that the device is an implanted marker fabricated from physical materials (gold, titanium, PEEK, stainless steel). It is a physical object intended for implantation, not a software program.
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").
- Device Function: The Mixed Media Markers (MMM) are implanted into the body to mark the location of anatomy for future medical procedures. They are visualized using medical imaging devices.
- Intended Use: The intended use clearly states they are "intended to be implanted into the body."
The device is a medical device, specifically an implanted marker used for image-guided procedures, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical imaging devices (e.g., typical medical imaging devices)
Anatomical Site
body, specific anatomy, normal or diseased 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)
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.
Sufficient testing has been performed to show that the change in materials 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.
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
Image /page/0/Picture/0 description: The image shows the word "CORTEX" in all capital letters. The letters are black and bolded, and they are set against a background of gray dots. The word is centered in the image and takes up most of the space.
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.
1
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.
2
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
. . . . . . . . . . . .
3
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
4
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