RADIOMED MARKER

K022326 · Radiomed Corporation · JAK · Jan 31, 2003 · Radiology

Device Facts

• Record ID: K022326
• Device Name: RADIOMED MARKER
• Applicant: Radiomed Corporation
• Product Code: JAK · Radiology
• Decision Date: Jan 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

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

Device Story

RadioMed Marker is a non-sterile, disposable rhodium coil (0.35mm diameter) used as an implantable marker. It is placed in soft tissue to serve as a radiographic reference point. The device is visible under fluoroscopy, ultrasound, CT, and x-ray imaging. It assists clinicians in localizing specific tissue sites for subsequent therapeutic interventions. The device is intended for prescription use.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and animal studies confirming visibility under fluoroscopy, ultrasound, CT, and x-ray, as well as biocompatibility testing per ISO 10993-1.

Technological Characteristics

Rhodium coil, 0.35mm diameter. Non-sterile, disposable. Visible under fluoroscopy, ultrasound, CT, and x-ray. Biocompatibility per ISO 10993-1. Manufacturing per 21 CFR Part 820. Sterilization via steam autoclave per AAMI 11134-1994.

Indications for Use

Indicated for radiographic marking of soft tissue in patients requiring future therapeutic procedures.

Regulatory Classification

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.

Predicate Devices

• United States Surgical Auto Suture Site Marker Staple (K983400)
• Senorx Gel Mark 1M Biopsy Site Marker (K000060)
• Genetra™ Source (K013660)

Submission Summary (Full Text)

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# K022326

## Appendix S 510(k) Summary

JAN 3 1 2003

### 1. Sponsor Name

RadioMed Corporation One Industrial Way, Tyngsboro, Massachusetts 01879 Telephone: [phone] [phone] Fax: Contact Person: Gordon Roberts

- 2. Device Name
Proprietary Name: Common/Usual Name: Classification Name:

RadioMed™ Marker RadioMed™ Marker Implantable Marker

- 3. Identification of Predicate of Legally Marketed Device The predicate devices for the RadioMed™ Marker are: United States Surgical Auto Suture Site Marker Staple, K983400 Senorx Gel Mark 1M Biopsy Site Marker, K000060 Genetra™ Source, K013660
### 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.

- 7. Performance Testing
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)

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 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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