(23 days)
Not Found
No
The device description focuses on the physical components and radioactive properties of the brachytherapy seeds and strands. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The treatment plan is prepared by a physician or medical physicist, not generated or assisted by AI/ML.
Yes
The device is indicated for the treatment of malignant disease, which is a therapeutic purpose.
No.
The device is a treatment device, containing radioactive seeds for brachytherapy. It is used to treat malignant diseases by delivering radiation, not to diagnose them.
No
The device description clearly states it consists of physical components (brachytherapy seeds, braided sleeve, mesh, needle) designed for implantation, which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The description clearly states that the Proxcelan™ (Gesium-131) Implant Devices are designed to be "preloaded into into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease." This is an in vivo (within the body) application, not an in vitro (outside the body) application.
- Intended Use: The intended use is for the "treatment of malignant disease" through brachytherapy (internal radiation therapy). This is a therapeutic intervention, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a therapeutic medical device, specifically a brachytherapy source, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ProxcelanTM (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands, containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity applications for tumors with known radiosensitivity. These devices may be used as a rimary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment modalites, after excision of primory tumore after excision of primary tumors.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
The Proxcelan (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands are single use, prescription devices, will consisting of IsoRay Model CS-1 Brachytherapy Seeds that are preloaded into into a body series of the Implant Devices are designed to be preloaded into into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. The PL-5 – Cs-131 Preloaded Braided Braided Strands consist of a series of Proxcelan (Cesium-131) Brachytherapy Seeds held in place within a bioabsorbable braided sleeve (or strand). The seeds are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on a treatment plan prepared by the physician or medical physicist for an individual patient. If required by the treatment plan, the braided strands containing the brachytherapy seeds may be woven into a bioabsorbable mesh supplied as a kit component for implant. A (non-patient contact) needle may also be provided either attached or unattached to the braided strand to attach it to the mesh.
The technical characteristics consist of cesium-131 brachytherapy seeds that are preloaded into braided bioabsorbable sleeves (strands). All materials used in the construction of the Proxcelan (Cesium-131) Implant Devices are biocompatible and currently used in similar marketed devices that are in wide clinical application. The difference between the currently marketed Proxcelan (Cesium-131) Implant Devices and the proposed modification is the addition of a preloaded flexible braided stand instead of the current rigid hollow tubular strand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface or into a body cavity or tissue (for treatment of malignant disease in e.g. head and neck, brain, breast, lung, prostate, eye, etc.)
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)
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo for IsoRay Medical. The logo features an atom symbol to the left of the company name. The word "MEDICAL" is written in smaller letters below "IsoRay".
1092136
AUG 0 7 2009
3.0 Section C: 510(k) Summary Required by 21 CFR § 807.92
- 3.1 Submitter: IsoRay Medical, Inc.
- 3.2 Address: 350 Hills Street, Suite 106 Richland, WA 99354-5411
- 3.3 Telephone and Fax Numbers: 509-375-1202 (Fax) 509-375-3473
- 3.4 Contact Person: Fredric Swindler fswindler@isoray.com
- Date of preparation of this Summary: 07/10/09 3.5
- Device Name, Regulatory and Classification Information: 3.6
- Trade Name: Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 --3.6.1 Cs-131 Preloaded Braided Strands
- 3.6.2 Common Name: Preloaded Brachytherapy Seeds
- Classification Name: Radionuclide Brachytherapy Source (Per 21CFR 3.7 8892.5730)
- Marketed device to which equivalence is claimed: The Proxcelan (Cesium-3.8 131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands that are the subject of this submission are substantially equivalent to the IsoRay Proxcelan™ (Cesium-131) Implant Devices as described in 510(k) No. K062384 (SE 11/09/2006).
- Product Description: The Proxcelan (Cesium-131) Implant Devices, Model PL-5 3.9 – Cs-131 Preloaded Braided Strands are single use, prescription devices, will consisting of IsoRay Model CS-1 Brachytherapy Seeds that are preloaded into into a body series of the Implant Devices are designed to be preloaded into into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. The PL-5 – Cs-131 Preloaded Braided Braided Strands consist of a series of Proxcelan (Cesium-131) Brachytherapy Seeds held in place within a bioabsorbable braided sleeve (or strand). The seeds are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on a treatment plan prepared by the physician or medical physicist for an individual patient. If required by the treatment plan, the braided strands containing the brachytherapy seeds may be woven into a bioabsorbable mesh supplied as a kit component for implant. A (non-patient contact) needle may also be provided either attached or unattached to the braided strand to attach it to the mesh.
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Image /page/1/Picture/0 description: The image shows the logo for IsoRay Medical. The logo features a stylized atom symbol on the left, followed by the text "IsoRay" in a bold, sans-serif font. Below "IsoRay" is the word "MEDICAL" in a smaller, sans-serif font. The overall design is simple and professional.
- Statement of intended use compared to the currently marketed predicate 3.10 device: Proxcelan (Cesium-131) Implant Devices, Model PL-5 - Cs-131 Preloaded Braided Strands are single use prescription devices that are 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. This is identical to the legally marketed predicate devices, the IsoRay Proxcelan (Cesium-131) Implant Devices as described in 510(k) No. K062384 (SE 11/09/2006).
- Statement of Technological Characteristics: The technical characteristics 3.11 consist of cesium-131 brachytherapy seeds that are preloaded into braided bioabsorbable sleeves (strands). All materials used in the construction of the Proxcelan (Cesium-131) Implant Devices are biocompatible and currently used in similar marketed devices that are in wide clinical application. The difference between the currently marketed Proxcelan (Cesium-131) Implant Devices and the proposed modification is the addition of a preloaded flexible braided stand instead of the current rigid hollow tubular strand.
- Safety and Effectiveness: To ensure that the devices are safe and effective, all 3.12 finished products are tested and must meet all required release specifications before distribution. The testing required for release specifications
tech to the county of the testing required for release includes, but is not limited to leak testing for external contamination, apparent activity, but is not himmed labeling. The required testing is defined by written and approved procedures that conform to the product design specifications. The testing for Proxcelan (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands is detailed in the Device Master Record.
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Image /page/2/Picture/0 description: The image shows a partial logo of the Department of Health and Human Services. The logo features a stylized human figure with outstretched arms, and the text "DEPA" is visible to the right of the figure. The image is black and white and appears to be a close-up of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration · 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Fredric G. Swindler Vice President Regulatory Affairs and Quality Assurance IsoRay Medical, Inc. 350 Hills St., Suite 106 RICHLAND WA 99354-5411
AUG 0 7 2009
Re: K092136
Trade/Device Name: Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 - Cs-131 Preloaded Braided Strands Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: July 10, 2009 Received: July 15, 2009
Dear Mr. Swindler:
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); medical device reporting of medical
3
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.0 Section B
Indications for Use
510(k) Number:
f092136
Device Name: Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands
Indications for Use:
Proxcelan™ (Gesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands, containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity applications for tumors with known radiosensitivity. These devices may be used as a rimary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment modalites,
after excision of primory tumore after excision of primary tumors.
Prescription Use × (Per 21 CFR § 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Leun
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 10(k) Number
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