GENETRA

K013660 · Radiomed Corporation · KXK · Dec 5, 2001 · Radiology

Device Facts

• Record ID: K013660
• Device Name: GENETRA
• Applicant: Radiomed Corporation
• Product Code: KXK · Radiology
• Decision Date: Dec 5, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GENETRA™ 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 tumors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. GENETRA 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

GENETRA™ is a brachytherapy radionuclide source consisting of a coiled rhodium wire containing Palladium-103 (Pd-103). The rhodium matrix provides radiopacity. The device is a naturally sealed source delivered via a 19-gauge needle and stylet to the tumor site. It emits 20-23 keV x-rays for therapeutic radiation. The device is supplied non-sterile and requires steam autoclave sterilization by the end user. It is intended for clinical use by physicians for the treatment of localized tumors. The device provides localized radiation therapy, potentially reducing tumor size or treating residual disease.

Clinical Evidence

Bench testing only. Performance evaluated via radiation energy verification, source strength calibration, dose comparison, and sealed source integrity testing. Compliance with standards including ANSI N43.6-1997, ANSI N44.1-1973, ANSI N44.2-1973, ISO 9978:1992, and ISO 10993-1:1992.

Technological Characteristics

Sealed brachytherapy source; rhodium wire matrix; Palladium-103 radionuclide; 20-23 keV x-ray emission; 19-gauge delivery needle/stylet; glass barrel/stainless steel cartridge packaging; steam autoclave sterilization; compliant with ANSI N43.6, ANSI N44.1, ANSI N44.2, ISO 9978, and ISO 10993-1.

Indications for Use

Indicated for patients with localized tumors of the head, neck, lung, pancreas, prostate, or other accessible sites requiring temporary or permanent interstitial implantation or surface application of radiation. Used as primary treatment or for residual disease post-excision; may be used with external beam therapy, hyperthermia, or chemotherapy.

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

• RadioMed™ Source (K001070)

Submission Summary (Full Text)

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KDI 3660

GENETRA ™

Special 510(K) Submission

RadioMed Corporation November 2, 2001

DEC 0 5 2001

#### Section F

#### 510k Summary

1. Sponsor Name

RadioMed Corporation One Industrial Way Tyngsboro, Massachusetts 01879-1400

Telephone: [phone] voice [phone] fax

Contact Individual: Gordon Roberts

- 2. Device Name

| Proprietary Name: | GENETRA™ |
|----------------------|-----------------------------------|
| Common/Usual Name: | Brachytherapy Radionuclide Source |
| Classification Name: | Brachytherapy Radionuclide |

- 3. Identification of Predicate or Legally Marketed Device The predicate device for GENETRA™ is the RadioMed™ Source K001070.
- 4. Device Description

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

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

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

The sources are delivered using a 19 gauge needle and stylet. Currently marketed Brachytherapy seeds are delivered using a 17 or 18 gauge needle and stylet.

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### 5. Intended Use

- The intended use and indications for use of the modified device as described in its labeling have not changed.
GENETRA™ 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 tumors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent turnors. GENETRA 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 fundamental scientific technology of the modified device has not changed.

RadioMed™ Source Predicate Device:

K001070 510(k) Number:

The design of the predicate RadioMed 104 Source is identical to GENETRA™ . This is a sealed source in the form of a wire from which to deliver a therapeutic dosage of radioactive energy.

The energy emitted for GENETRA™ and the RadioMed™ Source is identical: 20-23 keV x-rays.

The materials that make up the components of the predicate RadioMed™ Source and GENETRA™ are identical. The packaging has been modified to utilize a glass barrel with the original stainless steel cartridge. GENETRA™ uses rhodium as did the RadioMed™ Source.

The radionuclide for GENETRA™ is Palladium - 103, which is the same as the radionuclide used for the predicate RadioMed™ Source.

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

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## 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 GENETRA™ 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare. The symbol consists of a staff with two snakes coiled around it, and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 0 5 2001

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

Re: K013660

Trade/Device Name: GENETRA™ Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: November 2, 2001

Received: November 6, 2001

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 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:

| 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" (21 CFR Part 807.97). 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. Snogdon

Nancv 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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K013660

RadioMed Corporation November 2, 2001

GENETRA Special 510(K) Submission

Section E

## Indications For Use

indications For USE
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Prescription Use

Nancy Broglon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013660