CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.

Device Description

The CuRay Custom Seed Array is an integral assembly containing radionuclide source seeds, spacers, and markers which are custom loaded according to a prescribed treatment plan. The CuRay Custom Seed Array is provided sterile and is a single use device.

AI/ML Overview

This 510(k) submission for the CuRay™ Custom Seed Array focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a clinical study. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Demonstrate "substantial equivalence" to legally marketed predicate devices.	The FDA determined the device to be "substantially equivalent" to existing legally marketed devices.
Principles of Operation	Same principles of operation as predicate devices.	The device has the "same principles of operation" as predicate devices.
Technological Characteristics	Overall technological characteristics equivalent to predicate devices.	The device has "overall technological characteristics" equivalent to predicate devices.
Integrity	(Implicit) Device maintains its integrity.	"Performance testing was conducted on the CuRay Custom Seed Array to demonstrate the integrity..."
Suitability	(Implicit) Device is suitable for its intended use.	"...suitability and substantial equivalence of the device."
Sterility	Device must be sterile.	"The CuRay Custom Seed Array is provided sterile..."
Single Use	Device is for single use.	"...and is a single use device."

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. This submission is for a brachytherapy seed array, and the "performance data" refers to non-clinical, bench-top testing to demonstrate integrity and suitability (e.g., mechanical testing, sterility testing), not a clinical trial with a "test set" of patient data. The submission relies on demonstrating substantial equivalence to pre-existing predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. No ground truth established by experts for a patient test set in this type of submission.

4. Adjudication Method for the Test Set:

Not Applicable. No clinical test set requiring adjudication in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is not a software or imaging device that would typically involve a MRMC study for human reader improvement. The device is a physical medical implant.

6. Standalone Performance Study (Algorithm only):

Not Applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

Not Applicable/Implicit from Predicate Devices. The "ground truth" for this type of submission is essentially the established safety and effectiveness of the predicate devices it is being compared to, which have already gone through their own regulatory pathways (PMA or prior 510(k) clearances, or were pre-amendments devices). The current submission focuses on demonstrating that the new device is sufficiently similar to these legally marketed devices that it raises no new questions of safety or effectiveness.

8. Sample Size for the Training Set:

Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device submission.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As there is no training set, this is not applicable.

Summary

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FEB 2 8 2006

BioLucent. Inc. 510(k) Submission CuRay™ Custom Seed Array

K 053595

4. 510(k) Summary of Safety and Effectiveness

Device Name:	CuRay™ Custom Seed Array
Device Model Number:	CSA-xx
Classification Name:	Radionuclide Brachytherapy Source (KXK)21 CFR, 892.5730
Device Classification:	Class II
Predicate devices:	TheraLoad (K043596)SeedLink (K023073)Readi-Strand (K023179)RAPID-Strand (K030594)Nag Brachyflex Catheters (Cook, Inc.)
Manufacturer:	BioLucent, Inc.6 Journey, Suite 325Aliso Viejo, CA 92656
Establishment RegistrationNumber:	2032338
Official Contact:	Sheryl HigginsBioLucent, Inc.6 Journey, Suite 325Aliso Viejo, CA 92656Phone: (949) 349-1380 (x101)

Intended Use:

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Device Description:

Technological Characteristics Summary

The CuRay Custom Seed Array is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics.

Performance Data Summary

I erformance testing was conducted on the CuRay Custom Seed Array to demonstrate the integrity, suitability and substantial equivalence of the device.

Conclusion:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the CuRay Custom Seed Array is determined to be substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2006

Ms. Shervl W. Higgins Director of Engineering BioLucent, Inc. 6 Journey, Suite 325 ALISO VIEJO CA 92656

Re: K053595

Trade/Device Name: CuRay Custom Seed Array Regulation Number: 21 CFR §892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: December 21, 2005 Received: December 23, 2005

Dear Ms. Higgins:

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.

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 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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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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3. Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Kr 3 5 5 15

Device Name:

CuRay Custom Seed array

Indications for Use:

(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(Optional Format 1-2-96)
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	Nancy C Brogdon
	(Division Sign-Off)

Division of Reproductive, Abdominal, and
Radiological Devices

510(k) Number	K053595
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Confidential

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.