OPTISOURCE, MODEL 1032P

K040766 · International Brachytherapy S.A. · KXK · Jul 22, 2004 · Radiology

Device Facts

• Record ID: K040766
• Device Name: OPTISOURCE, MODEL 1032P
• Applicant: International Brachytherapy S.A.
• Product Code: KXK · Radiology
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OptiSource103 implants are indicated for interstitial implantation of select focalized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiSource103 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

Device Story

OptiSource103 is a permanent interstitial brachytherapy implant; 5.0 mm length x 0.88 mm diameter. Contains Palladium-103 (Pd-103) radioactive source within two solid polymeric cylinders; gold marker included for radiographic visibility; polymeric shell. Device implanted by physician into tumor tissue; provides localized radiation therapy. Used for focalized tumors (head, lung, neck, pancreas, prostate, unresectable) or residual disease. May be used as primary treatment or in combination with external beam radiation or chemotherapy. Benefits include targeted radiation delivery to tumor site while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Permanent interstitial implant; 5.0 mm x 0.88 mm dimensions. Materials: polymeric shell, Pd-103 radioactive source, gold marker. Energy source: Pd-103 radionuclide. Non-software device.

Indications for Use

Indicated for interstitial implantation in patients with focalized tumors of low to moderate radiosensitivity, including head, lung, neck, pancreas, prostate, and unresectable tumors, or residual disease post-excision. Used as primary treatment or concurrent/adjuvant to external beam radiation 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.

Submission Summary (Full Text)

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| IBt | 24 March 2004 | CONFIDENTIAL | Page 24 of 24 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------|
| Title: Premarket Notification: Traditional 510(k) – OptiSource ™ | | | |
| JUL 2 2 2004 | | 510(K) SUMMARY | |
| Applicant/Manufacturing Site: | | | |
| IBt s.a. | | | |
| Zone Industrielle C | | | |
| 7180 Seneffe - Belgium | | | |
| Tel: (+32) 64 / 520 811 | | | |
| Fax: (+32) 64 / 520 801 | | | |
| Establishment Registration Number: | | 9031509 (IBt s.a.) | |
| Contact Person IBt s.a.: | | Sylviane Berger, Management Representative<br>[e-mail] | |
| E-mail: | | | |
| Official Correspondent: | | | |
| IBt, Inc. | | | |
| 6000 Live Oak Parkway, Suite 107 | | | |
| Norcross, GA 30093 | | | |
| Tel: [phone] | | | |
| Fax: [phone] | | | |
| Establishment Registration Number: | 9035105 (IBt, Inc.) | | |
| Contact Person IBt, Inc.: | Ruth Feicht, President | | |
| E-mail: | [e-mail] | | |
| Device Information | | | |
| Trade Name: | OptiSource103 (OptiSource™ is a Trademark of IBt s.a.) | | |
| Model Number: | 1032P | | |
| Common Name of Device | Sealed Source; seed; interstitial implant | | |
| Construction: | OptiSource103 is a permanent interstitial implant 5.0 mm<br>long by 0.88 mm in diameter with a polymeric shell and<br>containing Pd-103 in two solid polymeric cylinders<br>separated by a gold marker to provide visibility. | | |
| Type of 510(k) Submission: | Traditional | | |
| Classification Information | | | |
| Classification: | Radionuclide Brachytherapy Source | | |
| Class of Device: | 21 CFR 892.5730, Class II | | |
| Product Code: | 90-KXK | | |
| Intended Use | | | |
| OptiSource103 implants are indicated for interstitial implantation of select focalized<br>tumors with low to moderate radiosensitivity. They are used either as primary<br>treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and<br>unresectable tumors, or for residual disease after excision of the primary tumor. | | | |
| OptiSource103 implants are indicated for use concurrent with or at the completion of<br>other treatment modalities, such as external beam radiation therapy or<br>chemotherapy. | | | |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wings and tail. The eagle is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 22 2004

Ms. Ruth Feicht President International Brachytherapy, Inc. 6000 Live Oak Parkway, Suite 107 NORCROSS GA 30093

Re: K040766

Trade/Device Name: OptiSource 103, Model 1032P Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: June 4, 2004 Received: June 8, 2004

Dear Ms. Feicht:

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 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.

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 fimited 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. Brydon

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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Page of

510(k) Number (if Known):

Device Name: OptiSource 103

Indications For Use:

OptiSource103 implants are indicated for interstitial implantation of select Optiource - "implants are includerste radiosensitivity. They are used either loodin.or treatment for turnors such as those of the head, lung, neck, as printaly .rostate, and unresectable turnors, or for residual disease after pancreas, prostate, and chrosoovas on so implants are indicated for use exeision of the primary tontent of other treatment modalities, such as external beam radiation therapy or chemotherapy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter-Use_

David A. Bergman

(Division Sign-Off) Division of Reproductive. Abdomina and Radiological Devices 510(k) Number .. __