(52 days)
The Photon Radiosurgery System (PRS) is indicated for radiation therapy treatments.
The PRS Spherical Applicators are indicated for use with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or turnor bed during intracavity or intraoperative radiotherapy treatments.
The Photoelectron Corporation Photon Radiosurgery System (PRS) is a miniature, high-dose rate, low energy X-ray source that emits X-ray radiation from the tip of a 3 mm diameter probe. The original PRS Model was cleared for marketing in the 510(k) K964947. The PRS was subsequently modified and cleared for marketing in 510(k) K980526 (PRS400). The PRS was cleared by these 510(k)s for the irradiation of intracranial tumors.
Since the currently cleared PRS400 is restricted to treatment of intracranial tumors, Photoelectron Corporation is also proposing in this 510(k) to modify the PRS indications for use to permit use of the PRS to irradiate tumors other than at intracranial locations.
This 510(k) is also being submitted to add the use of PRS Spherical Applicators to the PRS System. The Spherical Applicators will permit the PRS to be used for intracavitary or intraoperative radiation therapy. In addition, two accessories for use with the Spherical Applicators are also being added to the PRS: the Radiation Shields, which protect surrounding tissue and/or organs from radiation, and the PRS Interface Adapters, which provide a means for connecting the PRS X-ray Source (XRS), and the Spherical Applicators to various commercially available surgical support systems for non-stereotactic applications.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Photon Radiosurgery System (PRS):
Overall Assessment:
The provided document (K992577) is a 510(k) premarket notification for the Photoelectron Corporation's Photon Radiosurgery System (PRS). This document seeks to expand the indications for use of an already cleared device and introduce new accessories. A 510(k) typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data or detailed performance acceptance criteria in the same way a PMA (Premarket Approval) might.
As such, the document does not describe traditional clinical acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. Instead, it focuses on dosimetry data to demonstrate the performance of the new applicators and substantial equivalence to existing radiation therapy devices.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly tied to the dosimetry data demonstrating the performance of the Spherical Applicators. There are no explicit, quantifiable acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for a diagnostic outcome, as this is a therapeutic device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Uniformity of dose delivered to tumor margins by Spherical Applicators | "Photoelectron submitted dosimetry data on the Spherical Applicators that demonstrates the uniformity of dose delivered to tumor margins." (Excerpt, Section 7.0 Testing) |
Note: The document provides no specific numerical values or detailed results of the dosimetry data beyond this statement.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense of a patient test set for an AI/ML diagnostic. The "test set" here refers to the physical characterization of the device through dosimetry. The document does not specify how many tests or measurements were conducted for the dosimetry data.
- Data Provenance: Not applicable. This is not patient-derived data but rather engineering and physics characterization of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for dosimetry measurements is derived from physical measurement techniques, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication needed for physical dosimetry measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a radiation therapy system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device itself is a standalone therapeutic system. The "performance" being evaluated is its ability to deliver radiation, not an algorithm's diagnostic output. The dosimetry data is a measure of the device's standalone performance in terms of radiation delivery characteristics.
7. The Type of Ground Truth Used
The ground truth used for the evaluation mentioned (dosimetry) is based on physical measurements and scientific principles related to radiation dose distribution. This is a form of objective, empirical data to characterize the device's output.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system trained on a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is not an AI/ML system.
{0}------------------------------------------------
SEP 2 3 1999
Photoelectron Corporation's Photon Radiosurgery System (PRS)
-
- SPONSOR
Photoelectron Corporation 5 Forbes Road, Suite 2 Lexington, MA 02421-7305
- SPONSOR
| Contact Person: | Paul A. PelletierDirector of Regulatory Affairs and Quality Assurance |
|---|---|
| Telephone: | 781-861-2069 |
July 30, 1999 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | Photon Radiosurgery System (PRS) |
|---|---|
| Common/Usual Name: | Miniature X-ray source with control and calibrationsystems and accessories |
| Classification Name: | X-ray Radiation Therapy System and Accessories |
3. PREDICATE DEVICES
The PRS and PRS Spherical Applicators are substantially equivalent to the following devices:
- Nucletron-Oldelft microSelectron-HDR brachytherapy device (K953946) .
- Varian VariSource Remote Afterloader for High Dose Brachytherapy (K945383) .
- Intraop Medical MOBETRON System (K981112) .
6. DEVICE DESCRIPTION
The Photoelectron Corporation Photon Radiosurgery System (PRS) is a miniature, high-dose rate, low energy X-ray source that emits X-ray radiation from the tip of a 3 mm diameter probe. The original PRS Model was cleared for marketing in the 510(k) K964947. The PRS was subsequently modified and
{1}------------------------------------------------
cleared for marketing in 510(k) K980526 (PRS400). The PRS was cleared by these 510(k)s for the irradiation of intracranial tumors.
Since the currently cleared PRS400 is restricted to treatment of intracranial tumors, Photoelectron Corporation is also proposing in this 510(k) to modify the PRS indications for use to permit use of the PRS to irradiate tumors other than at intracranial locations.
This 510(k) is also being submitted to add the use of PRS Spherical Applicators to the PRS System. The Spherical Applicators will permit the PRS to be used for intracavitary or intraoperative radiation therapy. In addition, two accessories for use with the Spherical Applicators are also being added to the PRS: the Radiation Shields, which protect surrounding tissue and/or organs from radiation, and the PRS Interface Adapters, which provide a means for connecting the PRS X-ray Source (XRS), and the Spherical Applicators to various commercially available surgical support systems for non-stereotactic applications.
7. INTENDED USE
The Indications for Use for the PRS400 will be revised to read as follows:
"The Photon Radiosurgery System is intended to be used for radiation therapy treatment".
The proposed Indications for Use for the Spherical Applicators are:
"The PRS Spherical Applicators are intended to be used with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments".
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed PRS intended use is substantially equivalent to commercially available brachytherapy and LINAC devices. All of the devices are intended to deliver a high radiation dose to tumors with low to minimal dose to healthy tissue. In addition, all of the devices have been used for treatment of tumors in a wide variety of anatomical locations, such as brain and breast tumors. All
{2}------------------------------------------------
systems provide a variety of applicators to facilitate radiation treatment in the various anatomical locations.
7.0 TESTING
Photoelectron submitted dosimetry data on the Spherical Applicators that demonstrates the uniformity of dose delivered to tumor margins.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1999
Mr. Paul A. Pelletier Director of Regulatory and Quality Assurance Photoelectron Corporation 5 Forbes Road, Suite 2 Lexington, MA 02421-7305 Re:
K992577 Photelectron Radiosurgery System (PRS) Dated: July 30, 1999 Received: August 2, 1999 Product Code: 90 JAD Regulatory Class: II (two) 21 CFR 892.5900
Dear Mr. Pelletier:
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 redassified 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 reguirements 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 (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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
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
{4}------------------------------------------------
510(k) Number (if known):
Device Name: Photon Radiosurgery System (PRS)
Indications For Use:
The Photon Radiosurgery System (PRS) is indicated for radiation therapy treatments.
The PRS Spherical Applicators are indicated for use with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or turnor bed during intracavity or intraoperative radiotherapy treatments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segmen
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 299257 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.