125I Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.

Device Description

The 125I Brachytherapy Seeds consist of 125I absorbed onto the surface of a spherical polymeric substrate sealed in a welded titanium casing. A typical Brachytherapy Seed is shown below. For higher activity levels the number of beads with absorbed 1431 may be increased from 2 to 4.

Typically, the 1351 Brachytherapy Seeds are placed within or in close to the turnor to be treated utilizing guidance. The devices are delivered using an 18 gauge or greater diameter hypodermic needle.

AI/ML Overview

The provided text describes the Prostec 125I Brachytherapy Seed and its substantial equivalence to a predicate device, rather than a study with detailed acceptance criteria and performance metrics in the typical sense of a clinical trial or algorithm validation. This submission is for a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device.

However, I can extract the "acceptance criteria" as implied by the comparison to the predicate device and the reported "device performance" as stated in the document.

Here's an interpretation based on the provided text, recognizing that this is a technical equivalence comparison, not a performance study in the context of diagnostic algorithms or clinical outcomes:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Prostec 125I Brachytherapy Seeds)
Intended Use: For permanent interstitial implantation in selected localized tumors, as a source of nuclear radiation for therapy.	Matches predicate intended use.
Material-Capsule: Titanium	Titanium
Material-Radioisotope: 125I	125I
Material-Substrate: Dowex®	Dowex®
Physical Dimensions - Length: 4.5 mm	4.5 mm
Physical Dimensions - Outside Diameter: 0.8 mm	0.8 mm
Key Radiological Characteristics - Half-life: 59.4 days	59.4 days
Key Radiological Characteristics - Principal Energy Levels (keV): 27.4, 31.4, and 35.5	27.4, 31.4, and 35.5
Key Radiological Characteristics - Point-source approximation anisotropy constant (φan): 0.95 (predicate)	0.96 (Prostec) - considered equivalent
Key Radiological Characteristics - Dose rate Constant (cGy/hr/U, 1999 NIST): 1.04 (predicate)	1.05 (Prostec) - considered equivalent
Key Radiological Characteristics - Residual Activity: < 0.2 µCi after 2 years	< 0.2 µCi after 2 years
Manufacturing - Capsule Sealing Method: Weld	Laser Weld - considered equivalent
Manufacturing - Delivered Non-sterile: Yes	Yes
Manufacturing - Packaging: Glass vial in lead container placed in a shipping carton	Glass vial in lead container placed in a shipping carton
Application Methods: Through an 18 gauge needle, attachable to common applicators	Through an 18 gauge needle, attachable to common applicators including Mick applicator with Prostec Cartridge. - considered equivalent
Quality Standards: Compliance with ISO 2919-1980(e), ISO/TR 4826-1979(E)	Complies with these standards.
Biocompatibility Standards: Meets ASTM F 1472 -- 93, ASTM F 67 95	Meets these standards.
Radiographic Marker: Presence of a radiographic marker.	Gold Alloy (Predicate had none, but this is an enhancement not a deviation from safety/effectiveness).

Note: The activity level differs (0.1 to 5.0 mCi for Prostec vs. 5.0 to 40 mCi for predicate). This is presented as a characteristic difference, not an 'acceptance criterion' that Prostec failed, likely because the range still falls within therapeutic use and possibly reflects different clinical needs or manufacturing capabilities. The key is that the type of seed and its fundamental physical and radioactive properties are equivalent.

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

This is not a traditional "test set" study. The evaluation is based on comparison of physical characteristics, dimensional measurements, and anisotropy of the Prostec device against the predicate device specifications and recognized standards.

Sample Size: Not explicitly stated in terms of a "test set" of devices for statistical analysis. It implies that these characteristics were measured on the Prostec device and compared to the established specifications of the predicate device.
Data Provenance: The data comes from the manufacturer (Prostec LLC) performing measurements and comparisons to established specifications of the predicate device and international/national standards. This is not a retrospective or prospective patient data study.

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

Not applicable. The "ground truth" here is the technical specifications of the predicate device and recognized industry standards (ISO, ASTM). The submission itself implies internal expertise at Prostec LLC and the FDA's regulatory team as evaluators, but not experts establishing ground truth for a clinical dataset.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication by clinicians for a diagnosis or outcome. The comparison is against established technical benchmarks.

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 is a medical device for brachytherapy (a physical treatment), not a diagnostic algorithm or AI-assisted system. No human readers or AI were involved in this type of substantial equivalence comparison.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for demonstrating substantial equivalence relied on:

Predicate device specifications: The known and legally marketed characteristics of the Amersham/Medi+Physics Model 6702 seeds.
Recognized consensus standards: ISO 2919-1980(e), ISO/TR 4826-1979(E), ASTM F 1472 -- 93, ASTM F 67 95.
Published scientific literature: Referencing Hilaris, Holt, and St. Germain regarding the use of 125I radioactive seeds for interstitial implant.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable. There is no training set for a machine learning model. The foundational "truth" for the device's design and manufacturing comes from established physics, materials science, and medical needs as embodied in existing successful predicate devices and industry standards.

Summary

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MAR 1 4 2000

submitted by Prostec LLC 8200 NW 27 Street Miami. Fl 33122 Phone: (305) 716-7000 Facsimile: (305) 716-7020

Identification of Device

Classification Name:	Radionuclide brachytherapy source
Common/Usual Name:	125I Radioactive Seeds
Proprietary Name:	Prostec 125I Brachytherapy Seed
Classification:	Class II, classification number is 90KXK

Identification of a Legally Marketed Predicate Device

The Prostec LLC 1251 Brachytherapy Seeds are substantially equivalent to the Amersham/Medi+Physics Model 6702 seeds, which are legally manufactured and distributed pursuant to 510(k) K915156.

Device Description

The 1251 Brachytherapy Seeds consist of 1251 absorbed onto the surface of a spherical polymeric substrate sealed in a welded titanium casing. A typical Brachytherapy Seed is shown below. For higher activity levels the number of beads with absorbed 1431 may be increased from 2 to 4.

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Image /page/1/Figure/2 description: The image shows a diagram of a typical 125I Brachytherapy Seed. The diagram includes labels for different parts of the seed, such as the "Plug", "Seed Half (2 Places)", "Hot Bead (125I)", and "Cold Bead". The diagram also includes measurements, such as "4.5 mm" and "0.8 mm", and labels for "Gold Alloy Radiographic Marker".

Intended Use

1251 Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized turnors. The devices are implanted as a source of nuclear radiation for therapy.

Summary of Technological Characteristics

The table below compares the technological characteristics of the 1231 Brachytherapy Seeds to the predicate device.

Feature	125I Brachytherapy Seeds	Predicate Device
Manufacturer	Prostec LLC	Amersham/Medi+Physics
510(k) Number	To be determined	K915156
Delivered Non-sterile	Yes	Yes
Intended use	125I Brachytherapy Seeds are in-tended for permanent interstitialimplantation in selected localizedtumors. The devices are implantedas a source of nuclear radiation fortherapy.	125I seeds are indicated for interstitialtreatment of tumors which have thefollowing characteristics: unresectable,localized, and moderate radiosensitiv-ity.

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Feature	125I Brachytherapy Seeds	Predicate Device
Capsule	Titanium	Titanium
Capsule Sealing Method	Laser Weld	Weld
Radioisotope	125I	125I
Half-life	59.4 days	59.4 days
Principal Energy Levels(keV	27.4, 31.4, and 35.5	27.4, 31.4, and 35.5
125I Substrate	Dowex®	Dowex®
Radiographic Marker	Gold Alloy	None
Packaging	Glass vial in lead container placedin a shipping carton	Glass vial in lead container placed in ashipping carton
Length	4.5 mm	4.5 mm
Outside Diameter	0.8	0.8
Application Methods	Through an 18 gauge needle, needlemay be attached a Mick applicatorprovided that the Prostec Cartridgeis used.	Through an 18 gauge needle, needlemay be attached to common applicatorssuch as the Mick, Henschke, or Scott
Apparent Activity Level	0.1 to 5.0 mCi	5.0 to 40 mCi
Point-source approxima-tion anisotropy con-stant $ϕan$	0.96	0.95
Dose rate ConstantcGy/hr/U, 1999 NIST	1.05	1.04
Seed Strength Specifica-tion	Apparent activity in mCi and air-kerma	Apparent activity in mCi and air-kerma
Residual Activity	< 0.2 µCi after 2 years	< 0.2 µCi after 2 years

Summary of Performance Data

The 1351 Brachytherapy Seeds comply with the following standards, practices, and guidances:

ISO 2919-1980(e), Sealed radioactive sources -- Classification, International Or-. ganization for Standardization, First Edition (1980)
ISO/TR 4826-1979(E), Technical Report 4826: Sealed radioactive sources -. Leak test methods, pg 2 , International Organization for Standardization (1979)

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The tissue contact materials of the 1251 Brachytherapy Seeds meet the requirements of the following recognized consensus standards.

ASTM F 1472 -- 93, Standard Specification for Wrought Ti-6Al-4V Alloy for . Surgical Implant Applications.
ASTM F 67 95, Standard Specification for Unalloyed Titanium for Surgical Im-. plant Applications.

The anisotropy of the 12-1 Brachytherapy Seeds and the Amersham/Medit+Physics 1-125 were compared and found to be equivalent. The 1257 Brachytherapy Seeds are substantially equivalent to the Amersham/Medi+Physics Model 6702 seeds, which are legally manufactured and distributed pursuant to 510(k) K915156. This has been demonstrated by comparison of physical characteristics, dimensional measurements, and anisotropy.

Brachytherapy is an old and well-established medical treatment. 1251 is a wellcharacterized radioactive source for brachytherapy treatment. The use of 1231 is has been documented by B. C. Hilaris, D. J. Holt and J. St. Germain in FDA Report 76-8022.1

Since the 1231 Brachytherapy Seeds meet the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The 1231 Brachytherapy Seeds will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

1 Hilaris BC, Holt DJ, St. Germain J: Use of Iodine 123 Radioactive Seeds for Interstitial Implant

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2000

Al Weisenborn Prostec LLC 19526 East Lake Drive Miami, FL 33015

Re:

K993280

Prostec 125 I Brachytherapy Seeds Dated: January 6, 2000 Received: January 7, 2000 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK

Dear Mr. Weisenborn:

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 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. 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 notfication"(21 CFR 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,
Dan Setiz

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1_of_1_

510(k) Number (if known):

K93280

Device Name 1251 Brachytherapy Seeds

Indications for Use:

125I Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized The devices are implanted as a source of tumors. nuclear radiation for therapy.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993280

Prescription Use √
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.