(65 days)
Not Found
No
The document describes a physical brachytherapy seed and its performance characteristics, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is indicated for temporary or permanent implantation or application to treat localized tumors, which is a therapeutic purpose.
No
The device description and intended use clearly state that the I-Plant Model 3500 is a brachytherapy seed used for treating localized tumors by delivering radiation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the device consists of a physical titanium capsule containing a radioactive source and other physical components. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors." This describes a therapeutic device used within the body to treat disease.
- Device Description: The description details a radioactive seed designed for implantation. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples in vitro (outside the body), or provide information about a patient's health status based on laboratory tests.
- Performance Studies: The performance studies focus on the physical integrity and radiation profile of the seeds, which are relevant to their function as a therapeutic radiation source. They do not describe studies related to diagnostic accuracy or performance in analyzing biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Implant Sciences I-Plant Model 3500 (135)odine Brachytherapy Seed)-Sterile with individual activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized turnors. They can be used either as primary treatment, such as for prostate cancer or for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors. I-Plant Model 3500 Brachytherapy 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, breast and other accessible tumors are commonly treated.
Product codes (comma separated list FDA assigned to the subject device)
90 KXK
Device Description
The Implant Sciences 125 lodine (Model 3500) Brachytherapy Seeds consist of a laser welded titanium capsule containing a silica capillary tube that serves as a substrate for the radioactive iodine source. The tube is positioned around a silver radiopaque x-ray marker that identifies the source location and orientation. The seeds are provided non-sterile and must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, neck, lung, pancreas, prostate, breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 510(k) Notice contains summaries of in vitro studies which were conducted to evaluate the safety, and appropriateness of the ISC Model 3500 Brachytherapy Seeds. Data are presented which demonstrate that the Model 3500 seeds salisfy 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 (Model 3500) 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 also support the equivalence of the ISC Model 3500 device to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
General Company Information
DEC 0 4 2002
| Name: | Implant Sciences Corporation |
|---|---|
| ------- | ------------------------------ |
MAR 2 1 2000
107 Audubon Road, #5 Address: Wakefield, MA 01880-1246
(781) 246 - 0700 Telephone: (781) 246 - 1167 Fax:
General Device Information
| Product Name: | Implant Sciences "I-plant" 125 Iodine Brachytherapy Seeds (Model 3500) |
|---|---|
| Classification: | Brachytherapy Radionuclide Source, 21 CFR 892.5730 - Class II |
Predicate Devices
Implant Sciences, Inc. I-Plant™ I-125 Brachytherapy Seeds (Model 3000) 1510(k) K990193]
Medi-Physics, Inc. (Amersham) 1-125 Seeds (No. 6711) [510(k) K9142811
Description
The Implant Sciences 125 lodine (Model 3500) Brachytherapy Seeds consist of a laser welded titanium capsule containing a silica capillary tube that serves as a substrate for the radioactive iodine source. The tube is positioned around a silver radiopaque x-ray marker that 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 Iodine (Model 3500) 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 145 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.
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$\qquad K_{0}23242$
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Technological Characteristics Versus Predicate Devices
The Implant Sciences 135 Jodine 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 125 lodine (Model 3500) Brachytherapy Seeds are substantially equivalent in design and function to the Implant Sciences (Model 3000) 125 lodine Brachytherapy Seed [510(k) K990193] and the Medi-Physics, Inc. (Amersham) I-125 Seeds (No. 6711) [510(k) K914281], which are brachytherapy radionuclides that have previously been cleared for marketing under the Premarket Notification regulations. These devices have been placed in the same classification category (21 CFR 892,5730) as the ISC Model 3500 seeds; and each is indicated for the same clinical application.
The 510(k) Notice contains summaries of in vitro studies which were conducted to evaluate the safety, and appropriateness of the ISC Model 3500 Brachytherapy Seeds. Data are presented which demonstrate that the Model 3500 seeds salisfy 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 (Model 3500) 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 also support the equivalence of the ISC Model 3500 device to the predicate devices.
Both the Model 3500 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.
Implant Sciences believes that the information provided establishes that similar predicate devices have been used historically for the same types of clinical applications as the Implant Sciences 155 lodine (Model 3500) 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right. The profiles are connected and appear to be emerging from a single form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John J. Munro III Vice President, Brachytherapy Products Implant Sciences Corporation 107 Audubon Road, #5 WAKEFIELD MA 01880-1246
Re: K023242
Trade/Device Name: I-Plant Model 3500 (125 Iodine Brachytherapy Seeds)-Sterile Regulation Number: 21 CFR 892.5730 . Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: November 5. 2002 Received: November 6, 2002
Dear Mr. Munro:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.
Sincerely yours,
Henry C. Snoddon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
Device Name: Implant Sciences Corp. I-Plant Model 3500 (123 odine Brachytherapy Seed)-Sterile
Indications for Use:
Implant Sciences I-Plant Model 3500 (135)odine Brachytherapy Seed)-Sterile with individual activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized turnors. They can be used either as primary treatment, such as for prostate cancer or for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors. I-Plant Model 3500 Brachytherapy 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, breast 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)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K023742 |