RADIOMED SOFT TISSUE MARKER by RADIOMED CORP.

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.

AI/ML Overview

This document describes a 510(k) submission for the RadioMed™ Soft Tissue Marker, which is a medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics against acceptance criteria in a comprehensive study.

Based on the provided text, there is no specific acceptance criteria table or a study proving the device meets distinct performance criteria in terms of accuracy, sensitivity, specificity, etc. This is because 510(k) submissions for devices like markers often rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance testing mentioned is related to manufacturing standards and visibility, not a clinical effectiveness study with defined performance metrics.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

Missing Information (Not Applicable to this 510(k) submission):

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices and manufacturing quality, not a comparison against specific clinical performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of a clinical performance study as described in the prompt.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a physical marker, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Information that is present or can be inferred:

Overview of Evidence Presented:

The submission focuses on comparing the RadioMed™ Soft Tissue Marker to existing predicate devices (RadioMed™ Marker, Implanter/Adjustable/Anderson's Marker, Extracranial Marker) to demonstrate substantial equivalence. The key aspects of this comparison are:

Intended Use: The intended use and indications for use have not changed from the predicate device.
- Intended Use: "RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures."
Technological Characteristics: The fundamental scientific technology of the modified device has not changed.
- Material: The material (metallic gold) is identical to the Anderson Marker (K940121) and Extracranial Marker, and is widely used in other approved medical devices with a "safe history of use." This obviates the need for additional biocompatibility testing.
- Design: The design is identical to the predicate RadioMed™ Marker (K022326) except for the outside diameter (OD) and material (gold vs. unspecified material in K022326). The new marker ranges in OD between 0.75mm and 1.2mm.
Performance Testing (Non-Clinical):
- Summary of standards achieved:
  - FDA QSR 21 CFR Part 820 Good Manufacturing Practices
  - AAMI Standard 11134-1994 Recommended practice for Steam Autoclave
- Visibility Studies: "Visibility Studies (see section H - Performance Testing)" are mentioned, implying that the marker's visibility under radiographic imaging was assessed. However, no specific data, acceptance criteria, or experimental setup for these visibility studies are provided in this summary.

Conclusion from a 510(k) Perspective:

The FDA's letter (K031206) confirms that they have "determined the device is substantially equivalent...to legally marketed predicate devices." This determination is based on the information provided in the 510(k) submission, primarily focusing on the safety and effectiveness as demonstrated through comparison to predicates and adherence to manufacturing and sterilization standards, rather than direct clinical performance against novel acceptance criteria.

In summary, for this specific 510(k) submission, the "acceptance criteria" and "study" are intrinsically linked to demonstrating substantial equivalence through comparison with predicate devices and adherence to established manufacturing and safety standards, rather than a clinical trial proving specific performance metrics of an AI algorithm.

Summary

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MAY 21 2003

RadioMed Soft Tissue Marker Special 510k Submission

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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
Device Name

Proprietary Name:	RadioMed™ Soft Tissue Marker
Common/Usual Name:	RadioMed™ Soft Tissue Marker
Classification Name:	System X-Ray, Tomography, Computed

1. Identification of Predicate or Legally Marketed Device The predicate devices for RadioMed™ Soft Tissue Marker are:
- 1. The RadioMedTM Marker, K022326
- 1. The Implanter/Adjustable/Anderson's Marker, K940121
- 1. The Extracranial Marker (K number unknown)
1. 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 will be delivered using either a 17 gauge or 18 gauge needle and stylet.

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1. Intended Use
  The intended use and indications for use of the modified device, as described in its labeling has not changed.

RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

1. Comparison of Technological Characteristics
  The fundamental scientific technology of the modified device has not changed.

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

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RadioMed Soft Tissue Marker Special 510k Submission

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medical devices, no additional biocompatibility testing has been performed in support of this Premarket Notification.

1. Performance Testing
  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)

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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.

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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

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RadioMed Soft Tissue Marker Special 510k Submission

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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

ర్లు

Regulation Number and Section

§ 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.