RADIOMED SOURCE

K001070 · Radiomed Corp. · KXK · Oct 24, 2000 · Radiology

Device Facts

• Record ID: K001070
• Device Name: RADIOMED SOURCE
• Applicant: Radiomed Corp.
• Product Code: KXK · Radiology
• Decision Date: Oct 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RadioMed™ Source with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. The RadioMed M Source may be used concurrently with or following treatment with other interventions. such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

Device Story

RadioMed™ Source is a brachytherapy device utilizing Palladium-103 (Pd-103) as a radionuclide. The device consists of a coiled rhodium wire, which serves as both the matrix and a radiopaque marker. It is a sealed source designed for interstitial implantation or surface application. The device is delivered to the tumor site using a 17 or 18-gauge needle and stylet, similar to existing brachytherapy seeds. It is intended for use by clinicians to treat localized tumors, either as primary therapy or for residual disease, and may be used in conjunction with external beam therapy, hyperthermia, or chemotherapy. The device is supplied non-sterile and requires steam autoclave sterilization by the end user prior to clinical application. By delivering therapeutic radioactive energy directly to the tumor site, the device aims to destroy malignant tissue while sparing surrounding healthy structures.

Clinical Evidence

Bench testing only. Performance was validated through compliance with ANSI N43.6-1997 (sealed source classification), ANSI N44.1-1973 (integrity/test specifications), ANSI N44.2-1973 (leak testing), and ISO 9978:1992 (leakage test methods). Sterilization validation was performed per AAMI 11134-1994 for steam autoclave. No clinical trial data was provided.

Technological Characteristics

Sealed radioactive source; radionuclide: Pd-103; form factor: coiled rhodium wire; radiopacity: provided by rhodium matrix; energy: 20-23 keV x-rays; delivery: 17 or 18-gauge needle and stylet; sterilization: steam autoclave; standards: ISO 10993-1, ANSI N43.6-1997, ANSI N44.1-1973, ANSI N44.2-1973, ISO 9978, AAMI 11134-1994.

Indications for Use

Indicated for temporary or permanent interstitial implantation or surface application to treat localized tumors (e.g., head, neck, lung, pancreas, prostate) in patients requiring primary treatment or treatment for residual/recurrent disease.

Regulatory Classification

Identification

A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

Special Controls

*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Theragenics Pd-103 Seed (K874787)
• Medi-Physics Rapid Strand™ (K940632)
• Ir-192 Wires from Amersham International (Preammendments device)

Submission Summary (Full Text)

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RadioMed Corporation March 31, 2000

# OCT 2 4 2000

K001070

Lone

RadioMed™ Source Premarket Notification

RadioMed Corporation 9 Linnell Circle Billerica. MA 01821-3902

### 510k Summary

1. Sponsor Name

RadioMed Corporation 9 Linnell Circle Billerica, Massachusetts 01821-3902

Telephone:

[phone] voice [phone] fax

Contact Individual: John Schwamb

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

RadioMed™ Source Brachytherapy Radionuclide Source Brachytherapy Radionuclide

- 3. Identification of Predicate or Legally Marketed Device
The predicate devices for the RadioMed™ Source are: Theragenics Pd-103 Seed K874787 Medi-Physics Rapid Strand TM K940632 Ir-192 Wires from Amersham International - Preammendments device

## 4. Device Description

The RadioMed™ source utilizes Pd-103 as the radionuclide for brachytherapy. The RadioMed The Source exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. The RadioMed™ Source is a naturally sealed source in the form of a wire.

The RadioMed The Source is packaged non-sterile, single use, and is intended to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave.

The RadioMed" Source will be manufactured. labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to

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RadioMed Corporation March 31, 2000

RadioMed™ Source
Premarket Notification

10081620
Page 2 of 3

#### 7 Performance Testing

Summary of standards achieved:

FDA QSR 21 CFR Part 820 Good Manufacturing Practices ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices ANSI N43.6-1997: Classification of sealed radioactive sources ANSI N44.1-1973 Integrity and Test Specifications for selected Brachytherapy Sources ANSI N44.2-1973 Leak testing radioactive brachytherapy sources ISO 9978: 1992(E) "Radiation protection - Sealed radioactive sources - Leakage test methods".

AAMI Standard 11134-1994 Recommended practice for Steam Autoclave

The "performance" of the RadioMed™ source is subdivided into four categories

- 1. Radiation Energy
- 2. Source Strength Measurement: Calibration and Calibration Accuracy
- 3. Dose Comparison
- 4. Sealed Source Testing

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specifications. The devices will be tested in accordance with Standard Operating Procedures.

The sources are delivered in the same manner as brachytherapy seeds currently on the market, i.e. a 17 or 18-gauge needle and stylet.

### 5. Intended Use

The RadioMed" Source with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. The RadioMed M Source may be used concurrently with or following treatment with other interventions. such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

- 6. Comparison of Technological Characteristics
The design of each of the predicates and the RadioMed™ Source is a sealed source from which to deliver a therapeutic dosage of radioactive energy. The predicate devices use a sealed source in a "can" configuration, often referred to as a seed. The RadioMed™ Source is a sealed source in the form of a wire. The RadioMed source, like Ir-192 wires, is linear. In contrast, the Theragenics Seed and the I-125 Seeds that are inside of the Rapid Strand 10 are designed to emulate point sources.

The energy emitted for the RadioMed™ Source and the Theragenics 103Pd Seed is exactly the same: 20-23 keV x-rays.

The materials that make up the components of the predicates and the RadioMed The Source are both similar and different. The shells for the predicate devices and the RadioMed "" Source are different. Both predicate seeds use titanium. The RadioMed Source uses rhodium. The radionuclide for the predicate Theragenics 103Pd seed is Palladium - 103 which is the same as the RadioMedith Source. The marker in each of the predicate devices is lead, while that in the RadioMed Source is rhodium.

The delivery of the predicates and the RadioMed" Source is through a 17 or 18-gauge needle and stylet.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2000

John Schwamb Quality Manager RadioMed Corporation 9 Linnell Circle Billerica, MA 01821

Re:

K001070 RadioMed™ Source Dated: August 4, 2000 Received: August 7, 2000 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK

Dear Mr. Schwamb:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). 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 (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 895. A substantialion assumes compliance with the Current Good Mannfacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

The text in the image is:

Baniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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RadioMed Corporation March 31, 2000

RadioMed™ Source Premarket Notification

510(k) Number (if known): K001070

Device Name:

RadioMed™ Source

Indications For Use:

The RadioMed"10 Source with activities from 0.1 to 5.0mCi per centimeter is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The Pd-103 sources may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

(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

Simil Ch. Segura

(Division Sign Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 510(k) Number