RAPID Strand™ Rx is a device specifically made in accordance with a medical specialist's written prescription, specified dose and design characteristics. It is intended to be use only for an individual named patient and 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.

RAPID Strand ™ Rx is indicated for permanent interstitial implantation of selected localized tumors, which are low to moderate radio sensitivity. They may be used either as primary tunnors, which are low to moderate racterestable tumors) or for treatment of residual disease after excision of the primary tumor.

RAPID Strand™ Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

Device Description

RAPID Strand™ Rx is consists of absorbable seeding spacers and radionuclide brachytherapy sources spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method. The apparent activity of the seed ranges from 0.191 to 1.01 mCi that correspond air kerma strength value of 0.243 to 1.285 µGym2/h per seed. RAPID Strand™ RX is sterilized and ready to be use when shipped. RAPID Strand™ Rx should not be re-sterilized.

AI/ML Overview

The provided text is a 510(k) summary for the RAPID Strand™ Rx, a radionuclide brachytherapy source. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study or multi-reader multi-case (MRMC) study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present in this type of regulatory submission.

Here's an breakdown of the information that can be extracted and a clear indication of what is not available based on the provided text:

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

This information is not provided in the 510(k) summary. The document focuses on demonstrating equivalence to a predicate device, not on meeting predefined acceptance criteria for novel performance.

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

This information is not provided. The submission states "Non-clinical test data that includes design validation, process validation, bench test results and sterilization validation have been provided in the Section-H." However, it does not specify sample sizes or data provenance for a clinical test set because a clinical study of this nature appears not to have been conducted for this submission. The "test set" here refers to non-clinical bench testing.

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)

This information is not applicable/provided. There is no mention of a clinical test set requiring expert ground truth establishment. The evaluation is against a predicate device based on technological characteristics and non-clinical data.

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

This information is not applicable/provided. No clinical test set requiring an adjudication method is 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

This information is not applicable/provided. The device is a radionuclide brachytherapy source, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.

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

This information is not applicable/provided. This device is a physical medical implant, not an algorithm.

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

This information is not provided in the context of a clinical study. The device's "ground truth" for its safety and effectiveness is largely based on its technological characteristics being equivalent to a predicate device that has already been deemed safe and effective. Non-clinical testing would have relied on established engineering and materials standards.

8. The sample size for the training set

This information is not applicable/provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

This information is not applicable/provided for the reasons stated in point 8.

Summary of available information regarding the device and its assessment from the provided text:

Device: RAPID Strand™ Rx, a radionuclide brachytherapy source.
Purpose of Submission: To demonstrate substantial equivalence to a legally marketed predicate device (RAPID Strand™) under 510(k) K030594 and K940632.
Basis for Equivalence:
- Comparison of similar and different technological characteristics presented in "Section-F".
- All components of the subject device have been previously cleared through the 510(k) process.
- Changes made to the design and manufacturing processes do not raise questions about safety and efficacy, supported by "Non-clinical Test Data" (design validation, process validation, bench test results, sterilization validation) provided in "Section-H".
- The labeling has been revised for clarity, and these changes are non-significant.
Conclusion of FDA: The FDA determined the device to be substantially equivalent to legally marketed predicate devices.

In essence, this 510(k) submission is a "predicate device" pathway, meaning the manufacturer is asserting their device is so similar to an already approved device that it doesn't require new clinical efficacy and safety studies based on novel acceptance criteria. The "study" mentioned is the comparison to the predicate and the non-clinical bench testing, which is implicitly accepted if it demonstrates the equivalence and safety of the changes.

Summary

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NOV 3 0 2006

K063177

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following 510(k) Summary of Safety and Effectiveness is prepared and provided in accordance with the requirements of 21 CFR 807.92 as amended under the Safe Medical Devices Act of 1990 (SMDA).

Submitter's Information

Submitter Name:	Subhash Patel, RACConsultant
Sponsor Name:Address:	Oncura Inc.401 Plymouth RoadPlymouth Meeting, PA 19462
Contact Name:Phone Number:E-mail:	Subhash Patel, RAC(732) 821-7021spatelraqpro@yahoo.com

Summary Prepared Date:

Subject Device Information

Trade Name:	RAPID Strand™ Rx
Common Name:	Radionuclide Brachytherapy Source
Class:	II
Classification:	21 CFR 892.5730
Product Code:	90-KXK

Predicate Devices

Legally marketed device to which equivalence is claimed.

October 5, 2006

Trade Name:	RAPID Strand™
Model:	7000
Common Name:	Radionuclide Brachytherapy Source
Class:	II
Classification:	21 CFR 892.5730
Product Code:	90-KXK
Cleared in 510(k):	K030594 and K940632
Owner/Holder:	Medi-Physics, Inc., Arlington Heights, IL

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Description of Device

Intended Use

Indications for Use

RAPID Strand ™ is indicated for permanent interstitial implantation of selected localized turnors which are low to moderate radiosensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor.

RAPID Strand™ may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

Technological Characteristics

Section-F of this submission contains comparison of Similar and different characteristics compared to the predicate device (RAPID Strand™). All components used in the subject device have been previously cleared through 510(k) process. The differences shown in the table do not raise any issue about safety or efficacy of the subject device for its intended use. The labeling has been revised for clarity of device use and changes are non-significant. Please refer to Section-G for the Draft Copy of the proposed labeling. Please refer to the Section-C through Section-G for details.

Non-clinical Test Data

Non-clinical test data that includes design validation, process validation, bench test results and sterilization validation have been provided in the Section-H. Based on the results, one can conclude that changes made to the design and manufacturing processes do not raise any question about the safety and efficacy of the subject device for its intended use.

Conclusion:

Upon reviewing the safety and effectiveness information provided in this submission and comparing the design, intended use, indications for use, method of use and other technological characteristics, it can be concluded that the subject RAPID Strand™ Rx is substantially equivalent to the predicate RAPID Strand™ which was cleared under 510(k) # K030594 and K940632.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

NOV 3 0 2006

ONCURA, Inc. % Mr. Subhash Patel RA Consultant 43 Palmetto Way NORTH BRUNSWICK NJ 08902

Re: K063177

Trade/Device Name: RAPID StrandTM Rx Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: October 19, 2006 Received: October 23, 2006

Dear Mr. Patel:

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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

Protecting and Promoting Public Health

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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.

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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 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/cdrfv/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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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Indications for Use Form

510(k) Number (if known): K063177

Device Name:

RAPID Strand™ Rx

Indications For Use:

RAPID Strand™ Rx may be indicated for use concurrent with or at the completion 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 (Per 21 CFR 801.109) OR

Over-The-Counter Use

Nancy C Brogdon

(Division Sign-Off) Division of Reproductive, Ab 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.