(197 days)
Not Found
No
The device description and intended use are purely for a physical marker. There is no mention of any software, algorithms, or data processing that would suggest AI/ML.
No.
The device is used to mark soft tissue for future therapeutic procedures, not to provide therapy itself.
No
The device is indicated for marking soft tissue for future therapeutic procedures, not for identifying a disease, condition, or injury.
No
The device description explicitly states it is a "non-sterile, disposable device in the form of a rhodium coil," which is a physical hardware component.
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) for marking purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description of a rhodium coil used for marking soft tissue aligns with an in vivo medical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for use within the body to aid in future medical procedures, which is the domain of medical devices, not IVDs.
N/A
Intended Use / Indications for Use
RadioMed™ 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, IYE
Device Description
The RadioMed™ Marker is a non-sterile, disposable device in the form of a rhodium coil that is 0.35mm in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy, ultrasound, CT and x-ray.
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 OSR 21 CFR Part 820 Good Manufacturing Practices
ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices
AAMI Standard 11134-1994 Recommended Practice for Steam Autoclave
Visibility Testing (see section V)
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.
Not Found
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
K022326
Appendix S 510(k) Summary
JAN 3 1 2003
1. Sponsor Name
RadioMed Corporation One Industrial Way, Tyngsboro, Massachusetts 01879 Telephone: (978) 649 0300 (978) 649 0333 Fax: Contact Person: Gordon Roberts
-
- Device Name
Proprietary Name: Common/Usual Name: Classification Name:
- Device Name
RadioMed™ Marker RadioMed™ Marker Implantable Marker
4. Device Description
The RadioMed™ Marker is a non-sterile, disposable device in the form of a rhodium coil that is 0.35mm in diameter.
5. Intended Use
RadioMed Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
6. Comparison of Technological Characteristics
The design of each of the predicates and the RadioMed™ Marker is a metallic wire or coil that is visible as a marker under fluoroscopy or ultrasound. The material used in the RadioMed 110 Marker is rhodium, which is identical to the Genetra "M Source and passes biocompatibility testing per ISO 10993-1, and as shown in the animal and bench studies, is visible under fluoroscopy, ultrasound, CT and x-ray.
-
- Performance Testing
Summary of Standards Achieved:
- Performance Testing
FDA OSR 21 CFR Part 820 Good Manufacturing Practices ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices AAMI Standard 11134-1994 Recommended Practice for Steam Autoclave Visibility Testing (see section V)
1
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird, possibly an eagle, with three overlapping profiles, creating a sense of depth and movement.
JAN 3 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gordon Roberts Director, Quality Assurance & Regulatory Affairs RadioMed Corporation One Industrial Way TYNGSBORO MA 01879
- Re: K022326 Trade/Device Name: RadioMed™ Marker Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 JAK and IYE Dated: October 24, 2002 Received: November 4, 2002
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.
2
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
3
RadioMed Corporation July 16, 2002
RadioMed™ Marker Premarket Notification
510(k) Number (if known): K022326
Device Name: RadioMed Marker
Indications For Use: RadioMed™ Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ·
Nancy C. Houghton
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
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