RP Brachytherapy Needles are intended to be used for the placement of radionuclide seeds, and/or gold markers and/or Brachytherapy spacer/sleeve accessories during Brachytherapy or IMRT procedures.

The RP Sleeve is intended to be used to facilitate the placement and containment of radioactive seeds and gold markers with or without spacers into the body during Brachytherapy or IMRT procedures.

The RP Spacer is intended to be used during Brachytherapy or IMRT procedures to facilitate the implant of radionuclide seeds or gold markers at predetermined intervals within the body tissue. Spacers are indicated for use in soft tissues or organ tissue, but not to be used during cardiovascular or neurological procedures.

RP Gold Markers are intended to provide localization information during Brachytherapy, IMRT, or other procedures involving radiation treatments.

Device Description

Riverpoint Medical Brachytherapy Needles and accessories are devices which are used together or independent of each other during Brachytherapy or other IMRT procedures. Intended uses and material information is included below.

Brachytherapy Needles are used to deliver a separately obtained radionuclide source and/or accessory into the patient at the desired location. Intended uses and material information is included below.

RP Sleeves are composed of an extruded polymer material with known biocompatibility which can be used with or without RP Spacers to facilitate the placement of radionuclide seeds into the patient during Brachytherapy or IMRT procedures.

Gold Markers consist of ≥99.99% which can be implanted in order to provide increased visibility at the location of implant. Markers are to be available in a variety of sizes and configurations as desired by customers.

All devices within this submission are provided sterile for one-time use or non-sterile for further processing, and are sterilized via Ethylene Oxide when applicable.

AI/ML Overview

This submission (K103449) is for various brachytherapy accessories (needles, sleeves, spacers, and gold markers), not a device that relies on performance criteria based on empirical study data like accuracy, sensitivity, or specificity. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through material properties, intended uses, and manufacturing processes. Therefore, the typical structure for describing acceptance criteria and study results related to performance metrics is not applicable here.

The document describes safety and effectiveness based on substantial equivalence to existing devices, adhering to special controls and guidance for brachytherapy sources.

Here's a breakdown of the relevant information from the provided text, framed in the context of substantial equivalence rather than performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable to substantial equivalence):

Acceptance Criteria Category	Description (as inferred from the document)	Reported Device "Performance" / Justification
Intended Use	Must be substantially equivalent to predicate devices.	The stated intended uses for the Brachytherapy Needles, RP Sleeve, RP Spacer, and Gold Markers align with the general uses of brachytherapy accessories.
Material Composition	Materials must be biocompatible and consistent with predicate devices.	RP Sleeves are composed of an "extruded polymer material with known biocompatibility." Gold Markers consist of "≥99.99% gold." (Implicitly, other components of needles, etc. are also consistent with predicates).
Sterilization	Must be sterilized via an appropriate and validated method.	"All devices within this submission are provided sterile for one-time use or non-sterile for further processing, and are sterilized via Ethylene Oxide when applicable."
Design/Functionality	Basic functional principles (e.g., placing seeds, providing localization) must be comparable to predicate devices.	The functional descriptions (e.g., "facilitate the placement of radionuclide seeds," "provide localization information") are consistent with the function of the predicate devices.
Absence of Radioactive Material	The devices do not contain radioactive material.	"Although the majority of the product classifications selected for the devices within this submission list radionuclide sources, none of the devices within this submission contain any amount of radioactive material." This distinguishes them from the radioactive sources themselves, which have separate regulatory considerations.
Regulatory Compliance	Adherence to relevant FDA guidance and regulations.	"FDA Guidance 'Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources' was followed (as applicable) during the preparation of this submission..."

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. For these types of devices (accessories for brachytherapy, where the focus is on material safety, sterilization, and mechanical function), the "test set" would typically refer to materials testing, biocompatibility studies, and sterilization validation, rather than a clinical performance study with patient data. The document does not detail specific studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided. "Ground truth" established by experts is relevant for diagnostic or AI-driven devices where accuracy against a gold standard is being assessed. For brachytherapy accessories, the "ground truth" relates more to material properties meeting specifications, sterility, and mechanical integrity, which are validated through engineering tests and accepted standards rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set:

This information is not applicable and not provided. Adjudication methods are used in scenarios where multiple readers interpret data (e.g., medical images) to resolve discrepancies for establishing ground truth, which is not the type of assessment described or implied for these devices.

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 and not provided. An MRMC study is relevant for diagnostic devices, particularly those involving AI, to assess the impact of the device on human reader performance. This submission is for brachytherapy accessories, not a diagnostic or AI-powered device.

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

This information is not applicable and not provided. "Standalone performance" refers to the performance of an algorithm without human intervention, again relevant for AI or automated diagnostic devices. This submission is for physical medical accessories.

7. The type of ground truth used:

The "ground truth" for this submission would primarily be established through material specifications, biocompatibility standards, mechanical testing results, and sterilization validation reports. The document does not explicitly detail these, but they are implied as the basis for demonstrating safety and effectiveness for such devices. The "safety and effectiveness" section broadly states that the devices "have been designed and manufactured to be substantially equivalent to the predicate devices listed in this submission for all aspects of safety and effectiveness," implying that the underlying evidence for this claim comes from technical and non-clinical testing.

8. The sample size for the training set:

This information is not applicable and not provided. "Training set" is relevant for machine learning or AI algorithms. This is a submission for physical medical devices.

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

This information is not applicable and not provided. (See point 8).

In summary, this 510(k) submission (K103449) is a premarket notification for brachytherapy accessories that relies on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria based on metrics like accuracy, sensitivity, or specificity. The "study" here refers to the compilation of evidence (e.g., material data, design specifications, manufacturing processes, sterilization validation) that demonstrates the new devices are as safe and effective as their legally marketed predecessors.

Summary

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510(k) Summary

K103449

FEB 2 5 2011

Submitter Information J

Submitter's Name:

Address:

Fax Number:

Contact Person:

825 NE 25th Ave. Portland, OR 97232

Riverpoint Medical

Phone Number: (503) 517-8001 or 866 445-4923

(503) 517-8002

Registration Number:

1. Introduction

This document describes the data and methods used to create the 2020 Census Demographic and Housing Characteristics File (DHC) Prototype Product 1. The DHC is a new product that will provide detailed demographic and housing characteristics for small geographic areas. The DHC Prototype Product 1 is a demonstration product that uses data from the 2020 Census, the American Community Survey (ACS), and administrative records to create estimates of demographic and housing characteristics for census blocks. This document provides an overview of the data sources, methods, and evaluation metrics used to create the DHC Prototype Product 1.

The DHC Prototype Product 1 is a valuable tool for understanding the potential of the DHC to provide detailed demographic and housing characteristics for small geographic areas. The DHC Prototype Product 1 can be used to inform the development of the final DHC product.

Douglas Rowley (503) 517-8001

November 12th, 2010

3006981798

Date of Preparation:

510(k) Type

Abbreviated

Device Names

Trade Names:

1. Brachytherapy Needles
1. RP Sleeve
1. RP Spacer
1. Gold Marker

Common Names:

Brachytherapy Needle Accessory to Sleeve Spacer Gold Marker

Classification Names:

Brachytherapy Needles, Sleeves, Spacers: System, applicator, radionuclide, manual and Source. Brachytherapy, radionuclide (or accessory to);

Gold Markers: Medical Charged Particle Radiation Therapy System

510(k) Summary - Brachytherapy Needles and Accessories

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Device Classification

FDA Class:

2 (all)

Product Classification:

1. Brachy Needles: 892.5730 Radionuclide Brachytherapy Source
1. Sleeves: 892.5730 Radionuclide Brachytherapy Source 3. Spacers:
892.5730 Radionuclide Brachytherapy Source 4. Gold Markers: 892.5050 Medical Charged Particle Radiation Therapy Sytem

Product Codes:

1. Brachy Needles:	KXK
2. Sleeves:	KXK
3. Spacers:	KXK
4. Gold Markers:	IYE

Predicate Devices (applicable 510(k) number listed):

र मं RP Brachytherapy Needles: CP Medical, K071550 2. RP Sleeve: CP Medical, K034062 3. RP Spacer: CP Medical, K010621 4. Gold Marker: Cortex Manufacturing, K100267

Special Controls

FDA Guidance "Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources" was followed (as applicable) during the preparation of this submission due to the product classifications selected for these items.

Device Descriptions

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All devices within this submission are provided sterile for one-time use or non-sterile for further processing, and are sterilized via Ethylene Oxide when applicable.

Intended Uses

Brachytherapy Needles:

RP Brachytherapy Needles are intended to be used for the placement of radionuclide seeds, and/or gold markers and/or Brachytherapy spacer/sleeve accessories during Brachytherapy or IMRT procedures.

Sleeves:

The RP Sleeve is intended to be used to facilitate the placement and containment of radioactive seeds and gold markers with or without spacers into the body during Brachytherapy or IMRT procedures.

Spacers:

Gold Markers

RP Gold Markers are intended to provide localization information during Brachytherapy, IMRT, or other procedures involving radiation treatments.

Safety and Effectiveness

Riverpoint Medical Brachytherapy Needles and associated accessories have been designed and manufactured to be substantially equivalent to the predicate devices listed in this submission for all aspects of safety and effectiveness. Although the majority of the product classifications selected for the devices within this submission list radionuclide sources, none of the devices within this submission contain any amount of radioactive material.

510(k) Summary - Brachytherapy Needles and Accessories

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Image /page/3/Picture/0 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 overlapping wings, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Doug Rowley RA/QA Manager Riverpoint Medical 825 NE 25th Ave PORTLAND OR 97232

FEB 25 2011

Re: K103449

Trade/Device Name: Brachytherapy Needle, Brachytherapy Sleeve, Brachytherapy Spacer, and Gold Markers

Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 19, 2010 Received: November 23, 2010

Dear Mr. Rowley:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number:

K.103449

Device Name: Brachytherapy Needle

Unknown at this time

Trade Name: Brachytherapy Needle

Indications for Use:

RP Brachytherapy Needles are intended to be used for the placement of radionuclide seeds, and/or gold markers and/or Brachytherapy spacer/sleeve accessories during Brachytherapy or IMRT procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Postell

(Division Sign-Off)

Division of Radio Office of In Vi

510K K103449

Page 1 of 1

510(k) Indications for Use Statement - Brachytherapy Needles

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510(k) Number:	Unknown at this time K103449
----------------	------------------------------

Device Name: Brachytherapy Sleeve

Trade Name: RP Sleeve

Indications for Use:

The RP Sleeve is intended to be used to facilitate the placement and containment of radioactive seeds and gold markers with or without spacers into the body during Brachytherapy or IMRT procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Sastad
(Diving Sign Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103449

Page 1 of 1

510(k) Indications for Use Statement ~ Brachytherapy Sleeve

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510(k) Number:	Unknown at this time K1034449
----------------	-------------------------------

Device Name: Brachytherapy Spacer

Trade Name: RP Spacer

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Slatel

Office of In Vitro Diagnostic D

510K K103449

Page 1 of 1

510(k) Indications for Use Statement ~ Brachytherapy Spacer

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510(k) Number: Unknown at this time Device Name: Gold Markers

Gold Markers

Indications for Use:

Trade Name:

RP Gold Markers are intended to provide localization information during Brachytherapy, IMRT, or other procedures involving radiation treatments.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S Padal

(Division Sign-Off)

Office of In Vitro Diagnostic Device Evalu

510K K103449

Page 1 of 1

510(k) Indications for Use Statement - Brachytherapy Needles

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.