The RadioMed"10 Source with activities from 0.1 to 5.0mCi per centimeter is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The Pd-103 sources may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

Device Description

The RadioMed™ source utilizes Pd-103 as the radionuclide for brachytherapy. The RadioMed The Source exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. The RadioMed™ Source is a naturally sealed source in the form of a wire.

The RadioMed The Source is packaged non-sterile, single use, and is intended to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave.

The RadioMed" Source will be manufactured. labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures.

The sources are delivered in the same manner as brachytherapy seeds currently on the market, i.e. a 17 or 18-gauge needle and stylet.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "RadioMed™ Source," a brachytherapy radionuclide source. It primarily focuses on demonstrating substantial equivalence to existing predicate devices. Consequently, the document does not detail specific acceptance criteria for performance metrics or present a study proving the device meets those criteria in the way one might expect for a diagnostic or AI-driven device.

Instead, the "Performance Testing" section outlines the standards achieved for different aspects of the device, implying that compliance with these standards serves as the "acceptance criteria" and the "study" is the demonstration of adherence to these standards.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for certain categories:

Acceptance Criteria and Device Performance Study for RadioMed™ Source

The RadioMed™ Source is a brachytherapy radionuclide source. Its "performance" is subdivided into four categories, and the device's acceptance is based on its compliance with established standards and specifications for these categories and general regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Category / Performance Aspect	Acceptance Criteria (Standard / Description)	Reported Device Performance
General Manufacturing & Quality	FDA QSR 21 CFR Part 820 Good Manufacturing Practices	Manufactured, labeled, and packaged under GMP controls. Device will be inspected to assure compliance to specifications. Devices will be tested in accordance with Standard Operating Procedures.
Biocompatibility	ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices	Achieved (Summary states "Summary of standards achieved: ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices")
Radioactive Source Classification	ANSI N43.6-1997: Classification of sealed radioactive sources	Achieved (Summary states "Summary of standards achieved: ANSI N43.6-1997: Classification of sealed radioactive sources")
Integrity & Test Specifications	ANSI N44.1-1973 Integrity and Test Specifications for selected Brachytherapy Sources	Achieved (Summary states "Summary of standards achieved: ANSI N44.1-1973 Integrity and Test Specifications for selected Brachytherapy Sources")
Leak Testing	ANSI N44.2-1973 Leak testing radioactive brachytherapy sources / ISO 9978: 1992(E) "Radiation protection - Sealed radioactive sources - Leakage test methods".	Achieved (Summary states "Summary of standards achieved: ANSI N44.2-1973 Leak testing radioactive brachytherapy sources" and "ISO 9978: 1992(E) "Radiation protection - Sealed radioactive sources - Leakage test methods".") The RadioMed™ Source is described as a naturally sealed source.
Sterilization (by end user)	AAMI Standard 11134-1994 Recommended practice for Steam Autoclave	Intended to be sterilized by the end user in accordance with a validated sterilization process (steam autoclave).
Radiation Energy	Energy emitted for 103Pd (20-23 keV x-rays)	The energy emitted for the RadioMed™ Source and the Theragenics 103Pd Seed is exactly the same: 20-23 keV x-rays.
Source Strength Measurement	Calibration and Calibration Accuracy	Performance is subdivided into this category, implying that established calibration and accuracy standards are met (details not provided in the text).
Dose Comparison	(Implicit comparison to predicate devices for therapeutic effect)	Performance is subdivided into this category, implying that dose characteristics are comparable to predicate devices (details not provided in the text).
Sealed Source Testing	(Implicit integrity and safety testing for sealed sources)	Performance is subdivided into this category, implying that all necessary tests for sealed sources are conducted (details not provided in the text). The device is described as a "naturally sealed source."

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

The document does not specify a "test set" in the context of a typical clinical trial or performance study for a diagnostic device. The performance testing appears to refer to engineering and quality assurance tests conducted on manufactured units.

No specific sample size for a "test set" is mentioned.
Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as the testing relates to manufacturing and product specifications rather than clinical data.

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

Not applicable. The ground truth for this device is based on objective measurements against engineering standards, physical properties of the radionuclide, and established regulatory benchmarks, rather than subjective expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective data (e.g., image interpretation). For this device, compliance is determined by objective measurements and adherence to technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a brachytherapy source, not a diagnostic imaging or AI-driven device intended to assist human readers. Therefore, an MRMC study is irrelevant to its evaluation.

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

Not applicable. The RadioMed™ Source is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the RadioMed™ Source's performance and safety is:

Engineering Specifications: Compliance with design blueprints and material properties.
Physical Standards: Adherence to established physical properties of the radionuclide (Pd-103 energy emission).
Regulatory Standards: Compliance with national and international standards for medical devices, manufacturing (GMP, QSR), radiation safety (ANSI, ISO), and biocompatibility (ISO).
Predicate Device Equivalence: The comparison to legally marketed predicate devices serves as a "ground truth" for demonstrating substantial equivalence in function and safety.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

Not applicable, as there is no training set.

Summary

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RadioMed Corporation March 31, 2000

OCT 2 4 2000

K001070

Lone

RadioMed™ Source Premarket Notification

RadioMed Corporation 9 Linnell Circle Billerica. MA 01821-3902

510k Summary

Sponsor Name

RadioMed Corporation 9 Linnell Circle Billerica, Massachusetts 01821-3902

Telephone:

(978) 663-7400 voice (978) 663-7771 fax

Contact Individual: John Schwamb

1. Device Name
  Proprietary Name: Common/Usual Name: Classification Name:

RadioMed™ Source Brachytherapy Radionuclide Source Brachytherapy Radionuclide

1. Identification of Predicate or Legally Marketed Device
  The predicate devices for the RadioMed™ Source are: Theragenics Pd-103 Seed K874787 Medi-Physics Rapid Strand TM K940632 Ir-192 Wires from Amersham International - Preammendments device

4. Device Description

The RadioMed" Source will be manufactured. labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to

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RadioMed Corporation March 31, 2000

RadioMed™ Source
Premarket Notification

10081620
Page 2 of 3

7 Performance Testing

Summary of standards achieved:

FDA QSR 21 CFR Part 820 Good Manufacturing Practices ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices ANSI N43.6-1997: Classification of sealed radioactive sources ANSI N44.1-1973 Integrity and Test Specifications for selected Brachytherapy Sources ANSI N44.2-1973 Leak testing radioactive brachytherapy sources ISO 9978: 1992(E) "Radiation protection - Sealed radioactive sources - Leakage test methods".

AAMI Standard 11134-1994 Recommended practice for Steam Autoclave

The "performance" of the RadioMed™ source is subdivided into four categories

1. Radiation Energy
1. Source Strength Measurement: Calibration and Calibration Accuracy
1. Dose Comparison
1. Sealed Source Testing

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specifications. The devices will be tested in accordance with Standard Operating Procedures.

The sources are delivered in the same manner as brachytherapy seeds currently on the market, i.e. a 17 or 18-gauge needle and stylet.

5. Intended Use

The RadioMed" Source with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. The RadioMed M Source may be used concurrently with or following treatment with other interventions. such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

1. Comparison of Technological Characteristics
  The design of each of the predicates and the RadioMed™ Source is a sealed source from which to deliver a therapeutic dosage of radioactive energy. The predicate devices use a sealed source in a "can" configuration, often referred to as a seed. The RadioMed™ Source is a sealed source in the form of a wire. The RadioMed source, like Ir-192 wires, is linear. In contrast, the Theragenics Seed and the I-125 Seeds that are inside of the Rapid Strand 10 are designed to emulate point sources.

The energy emitted for the RadioMed™ Source and the Theragenics 103Pd Seed is exactly the same: 20-23 keV x-rays.

The materials that make up the components of the predicates and the RadioMed The Source are both similar and different. The shells for the predicate devices and the RadioMed "" Source are different. Both predicate seeds use titanium. The RadioMed Source uses rhodium. The radionuclide for the predicate Theragenics 103Pd seed is Palladium - 103 which is the same as the RadioMedith Source. The marker in each of the predicate devices is lead, while that in the RadioMed Source is rhodium.

The delivery of the predicates and the RadioMed" Source is through a 17 or 18-gauge needle and stylet.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2000

John Schwamb Quality Manager RadioMed Corporation 9 Linnell Circle Billerica, MA 01821

Re:

K001070 RadioMed™ Source Dated: August 4, 2000 Received: August 7, 2000 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK

Dear Mr. Schwamb:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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. 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 (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 895. A substantialion assumes compliance with the Current Good Mannfacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

The text in the image is:

Baniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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RadioMed Corporation March 31, 2000

RadioMed™ Source Premarket Notification

510(k) Number (if known): K001070

Device Name:

RadioMed™ Source

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)

Over-The-Counter Use

Simil Ch. Segura

(Division Sign Off) Division of Reproductive, Abdominal, ENT. 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.