OPTISOURCE, MODEL 1032P

• K Number: K040766
• Device Name: OPTISOURCE, MODEL 1032P
• Manufacturer: INTERNATIONAL BRACHYTHERAPY S.A.
• Date Cleared: 2004-07-22 ( 119 days)
• Product Code: KXK
• Regulation Number: 892.5730
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: K082159

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 Description

OptiSource103 is a permanent interstitial implant 5.0 mm long by 0.88 mm in diameter with a polymeric shell and containing Pd-103 in two solid polymeric cylinders separated by a gold marker to provide visibility.

AI/ML Overview

This document is a 510(k) premarket notification for the OptiSource™ device, a radionuclide brachytherapy source. As such, it is a submission for regulatory clearance and does not contain the results of a study designed to demonstrate performance against specific acceptance criteria for diagnostic or AI-driven medical devices.

The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, providing general device information, and receiving FDA clearance to market.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, study details, sample sizes, ground truth establishment, or clinical effectiveness studies in the format you provided. This type of information is typically found in clinical trial reports, peer-reviewed publications, or more detailed technical documentation, which are not present in this regulatory submission.

Here's what can be inferred from the provided text, but it falls short of the detailed study information requested:

• Device Type: The device is a "Radionuclide Brachytherapy Source" for interstitial implantation. It is not an AI-driven or diagnostic device that would typically have acceptance criteria related to accuracy, sensitivity, specificity, etc., in the way you've outlined. Its performance is related to its physical characteristics, radiation output, and safety.
• Regulatory Context: This is a 510(k) submission, which aims to demonstrate that a device is "substantially equivalent" to an existing legally marketed device. This process generally does not involve new clinical efficacy studies unless substantial equivalence cannot be established through other means (e.g., performance testing against recognized standards, comparison to predicate device specifications).
• 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."

In summary, the provided document does not contain the information needed to fill out your requested table and study details as it pertains to a regulatory clearance for a physical medical device (brachytherapy source) rather than a performance study for an AI or diagnostic device.

Summary

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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 [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 mmlong by 0.88 mm in diameter with a polymeric shell andcontaining Pd-103 in two solid polymeric cylindersseparated 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 focalizedtumors with low to moderate radiosensitivity. They are used either as primarytreatment for tumors such as those of the head, lung, neck, pancreas, prostate, andunresectable tumors, or for residual disease after excision of the primary tumor.
OptiSource103 implants are indicated for use concurrent with or at the completion ofother treatment modalities, such as external beam radiation therapy orchemotherapy.

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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.

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

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 .. __

Regulation Number and Section

§ 892.5730 Radionuclide brachytherapy source.

(a)
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.(b)
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.