(119 days)
The Implant Sciences 125 Jodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. 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 125 lodine Seeds 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.
The Implant Sciences 125 Iodine Brachytherapy Seeds consist of a laser welded titanium capsule containing an aluminum clad copper rod that serves as both a substrate for the radioactive iodine source and as a radiopaque x-ray marker. The marker identifies the source location and orientation. The seeds are provided non-sterile and must be sterilized prior to use.
The provided document describes the safety and effectiveness of the Implant Sciences "I-plant" 125Iodine Brachytherapy Seeds (Model 3000) by demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance against those criteria through a new clinical study. The device is for brachytherapy treatment of localized tumors.
Here's an analysis based on the information provided, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices and Standards) | Reported Device Performance (Implant Sciences "I-plant" 125Iodine Brachytherapy Seeds) |
|---|---|---|
| Physical Dimensions | Same length and diameter as predicate devices | Consistent with predicate devices |
| Material Composition | Use of titanium capsule material common to predicate devices | Same titanium capsule material as predicate devices |
| Activity Levels | Range of apparent activity levels similar to predicate devices (0.1 to 5.0 mCi) | Similar to predicate devices |
| Safety Testing (ANSI/HPS N43.6 - 1997) | Performance requirements for temperature resistance | Consistent with test results for predicate devices |
| Performance requirements for external pressure resistance | Consistent with test results for predicate devices | |
| Performance requirements for impact resistance | Consistent with test results for predicate devices | |
| Performance requirements for vibration integrity | Consistent with test results for predicate devices | |
| Performance requirements for puncture resistance | Consistent with test results for predicate devices | |
| Radiation Profile | Profiles consistent with data generated from other Iodine-125 brachytherapy seeds with similar physical geometries | Consistent with data from other Iodine-125 brachytherapy seeds with similar physical geometries |
| Capsule Leak Testing | Adherence to ANSI standards | Carried out in accordance with ANSI standards, supporting equivalence |
| Sterilization Method | Provided non-sterile, requiring sterilization (autoclave or ethylene oxide) at the hospital | Provided non-sterile, requiring sterilization (autoclave or ethylene oxide) at the hospital |
| Absence of New Chemical/Biological Entities | Manufacturing and cleaning processes introduce no new chemical or biological entities to the device surface | Manufacturing and cleaning processes introduce no new chemical or biological entities to the device surface |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission relies on in vitro studies and comparison to predicate devices, not a clinical test set from human subjects to evaluate clinical efficacy or performance.
- Data Provenance: The studies mentioned are described as "in vitro studies" and involve tests against ANSI standards. They are not clinical studies from a specific country or collected retrospectively/prospectively from patients. The comparison is primarily against existing predicate device specifications and recognized industry standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. This submission does not describe a clinical study where expert ground truth was established for a test set. The "ground truth" here is compliance with established engineering and safety standards (ANSI N43.6-1997) and equivalence in characteristics to legally marketed predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring an adjudication method.
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 radioactive implant (brachytherapy seed), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on:
- Compliance with ANSI Standard N43.6-1997: For safety and performance parameters like temperature, pressure, impact, vibration, and puncture resistance, and capsule leak testing.
- Established characteristics of legally marketed predicate devices: For physical dimensions, material composition, activity range, and radiation profiles.
- Accepted manufacturing and sterilization practices: For ensuring the device does not introduce new chemical or biological entities and requires appropriate sterilization.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve a training set as it's not an AI/machine learning model. The "studies" mentioned are laboratory/engineering tests and comparisons.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, for the same reason as above.
In summary: The submission for the Implant Sciences "I-plant" 125Iodine Brachytherapy Seeds (Model 3000) is a 510(k) Pre-market Notification demonstrating substantial equivalence to existing legally marketed predicate devices. It relies on in vitro studies proving compliance with recognized safety and performance standards (ANSI N43.6-1997) and matching the characteristics of predicate devices, rather than a clinical trial with human subjects. Therefore, many of the requested elements pertaining to clinical studies, AI performance, expert review, and ground truth establishment from patient data are not relevant to this type of regulatory submission.
{0}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS
General Company Information
| Name: | Implant Sciences Corporation |
|---|---|
| Address: | 107 Audubon Road, #5Wakefield, MA 01880-1246 |
| Telephone: | (781) 246 - 0700 |
| Fax: | (781) 246 - 1167 |
| General Device Information |
| Product Name: | Implant Sciences "I-plant" 125Iodine Brachytherapy Seeds (Model 3000) |
|---|---|
| Classification: | Brachytherapy Radionuclide Source, 21 CFR 892.5730 - Class II |
Predicate Devices
North American Scientific, Inc. (NASI) loGold™ I-125 Brachytherapy Source (Model MED3631-A) [510(k) K9722711
Medi-Physics. Inc. (Amersham) |-125 Seeds (No. 6711) |510(k) K9142811
International Isotopes, Inc. Imagyn 125 lodine Brachytherapy Seed [510(k) K982421]
Theragenics Corp. (Nuclear Medicine, Inc.) TheraSeed® Palladium 103 Implants (Model 100) [510(k) K852542 and K874787]
Description
The Implant Sciences 125 Iodine Brachytherapy Seeds consist of a laser welded titanium capsule containing an aluminum clad copper rod that serves as both a substrate for the radioactive iodine source and as a radiopaque x-ray marker. The marker identifies the source location and orientation. The seeds are provided non-sterile and must be sterilized prior to use.
Intended Use
The Implant Sciences 125 lodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual
{1}------------------------------------------------
disease after excision of primary or recurrent tumors. The 125 lodine Seeds 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.
Technological Characteristics Versus Predicate Devices
The Implant Sciences 125 lodine Brachytherapy Seeds use the same titanium capsule material and are the same physical dimensions (length and diameter) as the predicate devices. The range of apparent activity levels is similar to that of the predicate devices. The results of safety testing in accordance with the ANSI Standard for Sealed Radioactive Sources (ANSI/HPS N43.6 - 1997) are consistent with the test results for the predicate devices.
Substantial Equivalence
This 510(k) Notice supports the position that the Implant Sciences 145 lodine Brachytherapy Seeds are substantially equivalent in design and function to the North American Scientific, Inc. (NASI) loGold™ |-125 Brachytherapv Source (Model MED3631-A) [510(k) K972271], the Medi-Physics, Inc. (Amersham) I-125 Seeds (No. 6711) [510(k) K914281], the International Isotopes, Inc. Imagyn 125 Iodine Brachytherapy Seed [510(k) K982421] and the Theragenics Corp. TheraSeed® Palladium 103 Implants (Model 100) [510/k) K852542 which are brachytherapy radionuclides that have previously been cleared for marketing under the Premarket Notification regulations. Each of these devices has been placed in the same classification category (21 CFR 892.5730) as the ISC Brachytherapy Seeds; and each is appropriate for the same clinical application.
The 510(k) Notice contains summaries of both in vitro studies which were conducted to evaluate the safety, and appropriateness of the ISC Brachytherapy Seeds. Data are presented which demonstrate that the ISC Brachytherapy Seeds satisfy performance requirements for temperature resistance, external pressure resistance, impact resistance, vibration integrity, and puncture resistance as specified by ANSI Standard N43.6-1997. These test results confirm that the ISC 125 lodine Brachytherapy Seeds meet the requirements for radioactive sources in its class and are equivalent to other currently marketed radionuclide brachytherapy sources. The 510(k) Notice also describes further standardized studies which describe the radiation profile of the sources. These profiles are consistent with the data generated from other lodine-125 brachytherapy seeds with similar physical geometries. In addition, capsule leak testing was carried out in accordance with ANSI standards. The results of these studies again support the equivalence of the Implant Sciences device to the predicate devices.
Both the ISC device and the predicate devices are provided non-sterile and must be sterilized by autoclave or ethylene oxide at the hospital prior to use. The manufacturing and cleaning processes for the seeds introduce no new chemical or biological entities to the surface of the device.
{2}------------------------------------------------
Implant Sciences believes that the information provided establishes that similar legally marketed and pre-enactment devices have been used historically for the same types of clinical applications as the Implant Sciences 185 lodine Brachytherapy Seeds. The materials from which the Implant Sciences device is fabricated have an established history of use in medical applications, and the specific materials used by Implant Sciences have been thoroughly tested in accordance with applicable guidelines.
{3}------------------------------------------------
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
MAY 20 1999
Howard Schrayer Implant Sciences Corporation 107 Audobon Road, No. 5 Wakefield, Massachusetts 01880-1246 Re:
K990193 125 Iodine Brachytherapy Seeds (Model 3000) Dated: April 13, 1999 Received: April 14, 1999 Regulatory Class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Mr. Schrayer:
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 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 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 notification"(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 Setit
APT 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
Image /page/3/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a bird or a series of flowing lines, possibly representing the organization's mission related to health and well-being.
{4}------------------------------------------------
510(k) Number (if known):
Device Name: Implant Sciences 125 Iodine Brachytherapy Seeds - (Model 3000)
Indications For Use:
The Implant Sciences 125 Jodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. 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 125 lodine Seeds 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Kyaniya 510(k) Number
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.