PRE-LOADED VISICOIL

K070305 · Radiomed Corporation · IYE · Mar 7, 2007 · Radiology

Device Facts

• Record ID: K070305
• Device Name: PRE-LOADED VISICOIL
• Applicant: Radiomed Corporation
• Product Code: IYE · Radiology
• Decision Date: Mar 7, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Pre-Loaded Visicoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Device Story

Pre-Loaded Visicoil is a sterile, single-use gold metallic coil marker; used to radiographically mark soft tissue for future therapeutic procedures. Device consists of gold coil (0.35mm to 1.2mm OD; 1cm to 6cm length) pre-loaded into 17, 18, or 19g delivery needle. Clinician inserts needle into target soft tissue to place marker. Marker provides radiographic visibility for subsequent therapeutic procedures. Sterilized via ethylene oxide. Device is a modification of the predicate Visicoil Marker, specifically adding pre-loading into the delivery needle and changing sterilization method from gamma irradiation to ethylene oxide.

Clinical Evidence

Bench testing only. Compliance with FDA QSR 21 CFR Part 820 Good Manufacturing Practices.

Technological Characteristics

Gold metallic coil; 0.35mm, 0.75mm, or 1.2mm OD; 1cm to 6cm length. Delivered via 17, 18, or 19g needle. Sterilization: Ethylene Oxide. Manufacturing complies with FDA QSR 21 CFR Part 820.

Indications for Use

Indicated for radiographic marking of soft tissue to facilitate future therapeutic procedures. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Visicoil™ Marker (K031206)
• 17, 18, 19g Needles manufactured by CP Medical (Class I exempt)

Submission Summary (Full Text)

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Ko70305

Special 510k Submission

RadioMed Corporation January 25, 2007

Section J

# 510k Summary

1. Sponsor Name

MAR 0 7 2007

Visicoil Marker

| sor Name | RadioMed Corporation |
|---------------------|-------------------------------------|
| | One Industrial Way |
| | Tyngsboro, Massachusetts 01879-1400 |
| Telephone: | [phone] voice |
| | [phone] fax |
| Contact Individual: | Gordon Roberts |

### 2. Device Name

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

# 3. Identification of Predicate or Legally Marketed Device The predicate devices for RadioMed™ Soft Tissue Marker are:

- 1. Visicoil™ Marker (K031206)
- 2. 17, 18, 19g Needles manufactured by CP Medical (Class I exempt)

### 4. Device Description

The Pre-Loaded Visicoil a sterile device, in the form of a gold coil loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm.

The Pre-Loaded Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method.

The Pre-Loaded Visicoil 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.

Depending on the coil size (0.35mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coil is supplied loaded and ready for use in the applicable needle.

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RadioMed Corporation January 25, 2007

Visicoil Marker Special 510k Submission

#### 5. Intended Use

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

The Pre-Loaded Visicoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

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

Predicate Device: Visicoil Marker

#### 510(k) Number: K 031206

The design of the predicate Visicoil Marker is identical to the Pre-Loaded Marker. It is a gold metallic coil, ranging from one centimeter to six centimeters in length for the 0.35mm and 0.75mm versions and one centimeter to three centimeter for the 1.2mm version. Note: The 1.2mm version is nominally sized at 1.1mm and is referenced as this size on the product label.

The changes to this product include:

- Pre-Loaded in the delivery needle
- 8 Sterilization method - Ethylene Oxide as opposed to Gamma Irradiation
- 7. Performance Testing

Summary of standards achieved:

FDA QSR 21 CFR Part 820 Good Manufacturing Practices

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Image /page/2/Picture/0 description: The image shows a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the seal, there is a stylized emblem consisting of three curved lines that resemble a human figure or a symbol representing health and human services.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Gordon Roberts Director, Quality Assurance and Regulatory Affairs RadioMed Corporation One Industrial Way TYNGSBORO MA 01879

MAR 07 2007

Re: K070305

Trade/Device Name: Pre-Loaded Visicoi]TM Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.1750 Regulatory Name: Computed tomography x-ray system Regulatory Class: II Product Code: IYE and JAK Dated: January 25, 2007 Received: February 5, 2007

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 (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a stylized font, with the word "Centennial" written below. Three stars are arranged beneath the word "Centennial". The logo is black and white and has a slightly distressed or vintage appearance.

Protecting and Promoting Public Health

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Page 2 -

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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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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# Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

070305

Pre-Loaded VisiCoil

Pre-Loaded VisiCoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Legmann

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 11/10 30 510(k) Number __