(17 days)
No
The summary describes a radioactive implant device for brachytherapy and does not mention any AI or ML components or functionalities.
Yes
The device is used for the treatment of malignant disease, which is a therapeutic purpose.
No
Explanation: The device is used for treating malignant diseases by delivering radiation, not for diagnosing them. The "Intended Use" section clearly states "for the treatment of malignant disease".
No
The device description clearly states that the device consists of physical components (brachytherapy seeds, bioabsorbable spacers, strands, and needles) that are implanted into the body. This is a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of malignant disease using radiation therapy. IVDs are used for the diagnosis or monitoring of diseases or conditions by examining samples from the human body.
- Device Description: The device is an implantable radioactive source designed to deliver radiation directly to a tumor. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Proxcelan™ (Cesium-131) Implant Device is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Proxcelan™ (Cesium-131) Implant Devices 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 primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment for residual disease after excision of primary tumors.
Product codes
KXK
Device Description
The Proxcelan (Cesium-131) Implant Devices are single use, prescription devices consisting of IsoRay Model CS-1 Brachytherapy Seeds that are combined with bioabsorbable spacers and preloaded into bioabsorbable hollow strands or 18 gauge brachytherapy needles for implant. The Implant Devices are designed to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. These Implant Devices are described as follows:
PL-1 Cs-131 Preloaded Strands: Proxcelan PL-1 Cs-131 Strands consist of a series of Cesium-131 Brachytherapy Seeds and bioabsorbable spacers held in place within a hollow bioabsorbable sleeve (strand). The seeds and spacers 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.
PL-2 - Cs131 Preloaded Strands in 18 Gauge Needles: The PL-2 -Cs-131 Preloaded Strands in 18 Gauge Needles consist of a hollow strand containing Cesium131 Brachytherapy Seeds and spacers as described above that are preloaded into 18 gauge brachytherapy seeding needles. As with PL-1 above, the seeds and spacers 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.
PL-3 - Cs131 Preloaded 18 Gauge Needles: The PL-3 - Cs-131 Preloaded 18 Gauge Needles consist of a standard 18 gauge brachytherapy needle to which seeds and spacers 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. (These seeds and spacers are not contained in a strand as described for PL-1 and PL-2 above.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface, body cavity or tissue (for treatment of malignant disease, e.g., head and neck, brain, breast, lung, prostate, eye)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 a stylized atom symbol on the left, followed by the company name in bold, sans-serif font. Below "IsoRay" is the word "MEDICAL" in a smaller font size.
Section C: 510(k) Summary Required by 21 CFR § 807.92 3.0
AUG 2 8 2009
- 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
- Fredric Swindler 3.4 Contact Person: fswindler@isoray.com
- 3.5 Date of preparation of this Summary: 08/07/09
- Device Name, Regulatory and Classification Information: 3.6
- Trade Name: Proxcelan™ (Cesium-131) Implant Devices: 3.6.1
- PL-1 Cs-131 Preloaded Strands ●
- PL-2 Cs-131 Preloaded Strands in 18 Gauge Needles ●
- PL-3 - Cs-131 Preloaded 18 Gauge Needles
- 3.6.2 Common Name: Preloaded Brachytherapy Seeds
- Trade Name: Proxcelan™ (Cesium-131) Implant Devices: 3.6.1
- 3.7 Classification Name: Radionuclide Brachytherapy Source (Per 21CFR 8892.5730)
- 3.8 Marketed device to which equivalence is claimed: The Proxcelan (Cesium-131) Implant Devices 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 are single 3.9 use, prescription devices consisting of IsoRay Model CS-1 Brachytherapy Seeds that are combined with bioabsorbable spacers and preloaded into bioabsorbable hollow strands or 18 gauge brachytherapy needles for implant. The Implant Devices are designed to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. These Implant Devices are described as follows:
- PL-1 Cs-131 Preloaded Strands: Proxcelan PL-1 Cs-131 Strands 3.9.1 consist of a series of Cesium-131 Brachytherapy Seeds and bioabsorbable spacers held in place within a hollow bioabsorbable sleeve (strand). The seeds and spacers 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.
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Image /page/1/Picture/0 description: The image shows the logo for IsoRay Medical. The logo consists of an atom-like symbol on the left, followed by the words "IsoRay" in large, bold letters. Below "IsoRay" is the word "MEDICAL" in smaller letters. The logo is black and white.
K092458
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- 3.9.2 PL-2 - Cs131 Preloaded Strands in 18 Gauge Needles: The PL-2 -Cs-131 Preloaded Strands in 18 Gauge Needles consist of a hollow strand containing Cesium131 Brachytherapy Seeds and spacers as described above that are preloaded into 18 gauge brachytherapy seeding needles. As with PL-1 above, the seeds and spacers 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.
- 3.9.3 PL-3 - Cs131 Preloaded 18 Gauge Needles: The PL-3 - Cs-131 Preloaded 18 Gauge Needles consist of a standard 18 gauge brachytherapy needle to which seeds and spacers 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. (These seeds and spacers are not contained in a strand as described for PL-1 and PL-2 above.)
- 3.10 Statement of intended use compared to the currently marketed predicate device: Proxcelan (Cesium-131) Implant Devices 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).
- 3.11 Statement of Technological Characteristics: The technical characteristics consist of cesium-131 brachytherapy seeds with bioabsorbable spaces that are preloaded into 18 gauge brachytherapy needles and/or 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 differences between the currently marketed Proxcelan (Cesium-131) Implant Devices and the proposed modification are a change in the formulation of the copolvmer.
- 3.12 Safety and Effectiveness: To ensure that the devices are safe and effective, all finished products are tested and must meet all requires release specifications before distribution. The testing required for release includes, but is not limited to leak testing, testing for external contamination, apparent activity, sterility, and 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 is detailed in the Device Master Record.
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Image /page/2/Picture/0 description: The image shows a logo with three thick, curved lines stacked on top of each other, resembling a stylized bird in flight. To the left of the lines, there is a partial circular shape with text arranged along its curve. The text is small and difficult to read, but it appears to be part of the logo's official branding.
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
AUG 2 8 2009
Mr. Frederic G. Swindler Vice President, Regulatory Affairs and Quality Assurance IsoRay Medical, Inc. 350 Hills Street, Suite 106 RICHLAND WA 99354-5411
Re: K092458
Trade/Device Name: Proxcelan™ (Cesium-131) Implant Devices, Multiple Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: August 7, 2009 Received: August 11, 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 (reporting of medical
3
device-related adverse events) (21 CFR 803); 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.
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/CDRHOffices/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: K092485 K092458
Device Name: Proxcelan (Cesium-131) Implant Devices, Multiple
Indications for Use:
Proxcelan™ (Cesium-131) Implant Devices 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 primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment for residual disease after excision of primary tumors.
| Prescription Use | X |
|---|---|
| (Per 21 CFR § 801.109) |
OR
Over-The-Counter Use
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number