(35 days)
No
The device description and intended use focus on a physical marker (gold coil) for radiographic marking. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used to mark soft tissue for future therapeutic procedures, but it does not perform a therapeutic function itself.
No
The device is a soft tissue marker used for future therapeutic procedures, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "gold coil" and is delivered using a "needle and stylet," indicating it is a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiographically mark soft tissue for future therapeutic procedures." This describes a device used in vivo (within the body) to aid in a medical procedure, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description of a "gold coil" delivered via a needle further supports its use as an implantable marker within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the RadioMed™ Soft Tissue Marker is a medical device used for marking tissue within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The RadioMed™ Soft Tissue Marker is a non-sterile device, in the form of a gold coil that ranges in OD between 0.75mm and 1.2mm.
The RadioMed™ Soft Tissue Marker is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is achieved by exposure to steam autoclave.
The RadioMed™ Soft Tissue Marker will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.
The RadioMed™ Soft Tissue Marker will be delivered using either a 17 gauge or 18 gauge needle and stylet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft 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)
Summary of standards achieved:
FDA QSR 21 CFR Part 820 Good Manufacturing Practices AAMI Standard 11134-1994 Recommended practice for Steam Autoclave Visibility Studies (see section H - Performance Testing)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K970278, K010026, P980001/S07, K011740
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
MAY 21 2003
RadioMed Soft Tissue Marker Special 510k Submission
K∅3/2∅6
Section J
510k Summary
-
Sponsor Name RadioMed Corporation One Industrial Way Tyngsboro, Massachusetts 01879-1400 (978) 649-0300 voice Telephone: (978) 649-0333 fax Contact Individual: Gordon Roberts
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Device Name
| Proprietary Name: | RadioMed™ Soft Tissue Marker |
|---|---|
| Common/Usual Name: | RadioMed™ Soft Tissue Marker |
| Classification Name: | System X-Ray, Tomography, Computed |
-
- Identification of Predicate or Legally Marketed Device The predicate devices for RadioMed™ Soft Tissue Marker are:
-
- Device Description
The RadioMed™ Soft Tissue Marker is a non-sterile device, in the form of a gold coil that ranges in OD between 0.75mm and 1.2mm.
The RadioMed™ Soft Tissue Marker is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is achieved by exposure to steam autoclave.
The RadioMed™ Soft Tissue Marker will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.
The RadioMed™ Soft Tissue Marker will be delivered using either a 17 gauge or 18 gauge needle and stylet.
1
K$\phi$3/2$\phi$6
-
- Intended Use
The intended use and indications for use of the modified device, as described in its labeling has not changed.
- Intended Use
RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
-
- Comparison of Technological Characteristics
The fundamental scientific technology of the modified device has not changed.
- Comparison of Technological Characteristics
Predicate Device: RadioMed™ Marker
510(k) Number: K022326
The design of the predicate RadioMed Marker is identical to the RadioMed Soft Tissue Marker except for the outside diameter dimension and material from which it is manufactured.
It is a metallic coil, ranging from one centimeter to six centimeters in length.
Predicate Device: Anderson Marker
510(k) Number: K940121
Predicate Device: Extracranial Marker
510(k) Number: Not Known
The material of the predicate Anderson Marker (K940121) and the Extracranial Marker is metallic gold, which is identical to the material used in the manufacture of the RadioMed™ Soft Tissue Marker.
In addition to the predicates referenced in this document, metallic gold is widely used in a number of other applications including dental restorative materials, surgical devices (ref. Microvasive Gold Probe; K970278), and other implants such as (Embogold Microsphere K010026, Boston Scientific, NiRoyale Elite Premounted Stent System (P980001/S07) and (Meddev contour design gold eyelid implant K011740).
Because the patient-contacting material used in the proposed RadioMed™ Soft Tissue Marker is known to have a safe history of use in currently marketed
2
RadioMed Soft Tissue Marker Special 510k Submission
Kb312ø6
medical devices, no additional biocompatibility testing has been performed in support of this Premarket Notification.
-
- Performance Testing
Summary of standards achieved:
- Performance Testing
FDA QSR 21 CFR Part 820 Good Manufacturing Practices AAMI Standard 11134-1994 Recommended practice for Steam Autoclave Visibility Studies (see section H - Performance Testing)
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 21 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gordon Roberts Director, Quality Assurance and Regulatory Affairs RadioMed Corporation One Industrial Way TYNGSBORO MA 01879
Re: K031206
Trade/Device Name: RadioMed™ Soft Tissue Marker Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: April 15, 2003 Received: April 16, 2003
Dear Mr. Roberts:
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 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.
4
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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) you may obtain. 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
RadioMed Soft Tissue Marker Special 510k Submission
K$\phi$312$\mu$6
Section E
Indications For Use
RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Prescription Use
Nancy C Brogdon
.
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