The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Device Description

The BioLucent Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The BioLucent Applicator is provided sterile and is a single use device.

AI/ML Overview

The provided document is a 510(k) Special submission for a medical device (BioLucent Applicator), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with specific acceptance criteria related to disease detection or diagnosis.

Therefore, the document does not contain information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Here's why and what information is available:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of diagnostic effectiveness. For a device like the BioLucent Applicator (a remote controlled radionuclide applicator system), the "acceptance criteria" would primarily revolve around its mechanical integrity, biocompatibility, sterilization efficacy, and functional specifications that ensure it can safely and effectively deliver radiation as intended, consistent with its predicate devices.
Reported Device Performance: The document states:
- "Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."
- "The BioLucent Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics."
- This implies that the device's performance (e.g., functionality, safety features) met standards consistent with the predicate devices, but specific quantitative metrics are not provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This submission does not discuss a "test set" in the context of patient data or diagnostic performance. The "performance testing" mentioned would likely involve in vitro or engineering tests on device samples, not patient data. Therefore, this information is not applicable or available in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable, as there is no "test set" for diagnostic performance described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as there is no "test set" for diagnostic performance described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an applicator for radiation delivery, not a diagnostic imaging device involving human readers or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is a physical medical device for radiation delivery, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable, as there is no diagnostic or interpretive element described for this device's performance. The "ground truth" for the performance testing would likely be engineering specifications, material standards, and functional requirements for an applicator.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of available information related to performance and acceptance criteria from the document:

The BioLucent Applicator is a Class II device, specifically a "Remote Controlled Radionuclide Applicator System." This 510(k) submission is a "Special" submission, indicating minor changes to an already cleared device, allowing for reliance on substantial equivalence to predicate devices rather than new extensive clinical trials.

Acceptance Criteria (Implied): The device's "integrity, suitability and substantial equivalence" to predicate devices (BioLucent Applicator (K062830, K061241), Wright Vaginal Cuff Applicator (K980601), Comfort Catheters (K032372), Shielded Rectal Applicator Set (K033371)). This would involve ensuring the device mechanically performs as intended, is biocompatible, sterile, and safe for its intended use in delivering radiation during brachytherapy.
Study Proving Acceptance: "Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." No specific details of these tests (e.g., number of units tested, types of tests like tensile strength, leakage, dose distribution verification) are provided in this summary, as they are typically detailed in a separate section of the full 510(k) submission not included here.
Conclusion: Based on this performance testing, BioLucent, Inc. concluded that the device is "substantially equivalent to existing legally marketed devices" regarding its "intended use, principle of operation and overall technological characteristics." The FDA concurred with this determination, as indicated by the clearance letter.

Important Note: The FDA's clearance letter includes a specific warning required to be added to the device's labeling: "The safety and effectiveness of the BioLucent Applicator Kit for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established." This indicates a specific unmet acceptance criterion or an unproven extended indication, which the manufacturer must disclose. This is a crucial piece of information about limitations on the device's accepted use.

Summary

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APR 4 - 2007

BioLucent, Inc. 510(k) Submission- Special

BioLucent Applicator

510(k) Summary of Safety and Effectiveness

Device Name:	BioLucent Applicator
Device Model Number:	RTK-006RTK-008RTK-010
Classification Name:	Remote Controlled Radionuclide Applicator System(JAQ),21 CFR, 892.5700
Device Classification:	Class II
Predicate devices:	BioLucent Applicator (K062830, K061241)Wright Vaginal Cuff Applicator (K980601)Comfort Catheters (K032372)Shielded Rectal Applicator Set (K033371)
Manufacturer:	BioLucent, Inc.6 Journey, Suite 325Aliso Viejo, CA 92656
Establishment RegistrationNumber:	2032338
Official Contact:	Dave CampbellBioLucent, Inc.6 Journey, Suite 325Aliso Viejo, CA 92656Phone: (949) 349-1380 (x128

Intended Use:

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Device Description:

Technological Characteristics Summary

The BioLucent Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics.

Performance Data Summary

Performance testing was conducted on the BioLucent Applicator 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 BioLucent Applicator 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2007

Mr. Dave Campbell Director of Operations BioLucent, Inc. 6 Journey, Suite 325 ALISO VIEJO CA 92656

Re: K070659

Trade/Device Name: BioLucent Applicator Kit Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: March 6, 2007 Received: March 7, 2007

Dear Mr. Campbell:

This letter corrects our substantially equivalent letter of April 4, 2007.

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of the BioLucent Applicator Kit for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

The Warning must be presented within a black box, and the font should be bold and the same size as any surrounding text. The Warning should be the first item in your list of warnings.

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Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna-Bea Tillman. Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and adiological Health

Enclosure

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3. Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K (1) 70 65

Device Name:

BioLucent Applicator Kit

Indications for Use:

The BioLucent Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

(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
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number.

Regulation Number and Section

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.