PROSTEC 125I BRACHYTHERAPY SEEDS

K993280 · Prostec, LLC · KXK · Mar 14, 2000 · Radiology

Device Facts

• Record ID: K993280
• Device Name: PROSTEC 125I BRACHYTHERAPY SEEDS
• Applicant: Prostec, LLC
• Product Code: KXK · Radiology
• Decision Date: Mar 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Prostec 125I Brachytherapy Seed is a permanent interstitial implant for localized tumor therapy. Device consists of 125I isotope absorbed onto spherical polymeric (Dowex) substrate, sealed within welded titanium casing. Includes gold alloy radiographic marker for visualization. Delivered via 18-gauge or larger hypodermic needle, potentially using Mick applicator. Used by physicians in clinical settings for targeted radiation delivery. Titanium casing ensures containment of radioactive source. Benefit is localized radiation treatment of tumors.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of physical characterization, dimensional measurements, and comparison of anisotropy constants and dose rate constants against the predicate device. Compliance with ISO 2919-1980(e) and ISO/TR 4826-1979(E) for sealed radioactive sources and leak testing was demonstrated.

Technological Characteristics

Radioactive source: 125I; Substrate: Dowex polymeric beads; Casing: Titanium (ASTM F 67-95, ASTM F 1472-93); Marker: Gold alloy; Dimensions: 4.5 mm length, 0.8 mm diameter; Energy levels: 27.4, 31.4, 35.5 keV; Half-life: 59.4 days; Sealing: Laser weld; Delivery: 18-gauge needle; Sterilization: Delivered non-sterile.

Indications for Use

Indicated for permanent interstitial implantation in patients with selected localized tumors requiring nuclear radiation therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Amersham/Medi+Physics Model 6702 seeds (K915156)

Submission Summary (Full Text)

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MAR 1 4 2000

submitted by Prostec LLC 8200 NW 27 Street Miami. Fl 33122 Phone: [phone] Facsimile: [phone]

# 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.

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.

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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

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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-<br>tended for permanent interstitial<br>implantation in selected localized<br>tumors. The devices are implanted<br>as a source of nuclear radiation for<br>therapy. | 125I seeds are indicated for interstitial<br>treatment of tumors which have the<br>following characteristics: unresectable,<br>localized, and moderate radiosensitiv-<br>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<br>(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 placed<br>in a shipping carton | Glass vial in lead container placed in a<br>shipping carton |
| Length | 4.5 mm | 4.5 mm |
| Outside Diameter | 0.8 | 0.8 |
| Application Methods | Through an 18 gauge needle, needle<br>may be attached a Mick applicator<br>provided that the Prostec Cartridge<br>is used. | Through an 18 gauge needle, needle<br>may be attached to common applicators<br>such as the Mick, Henschke, or Scott |
| Apparent Activity Level | 0.1 to 5.0 mCi | 5.0 to 40 mCi |
| Point-source approxima-<br>tion anisotropy con-<br>stant $ϕan$ | 0.96 | 0.95 |
| Dose rate Constant<br>cGy/hr/U, 1999 NIST | 1.05 | 1.04 |
| Seed Strength Specifica-<br>tion | Apparent activity in mCi and air-<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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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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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)