(30 days)
Not Found
No
The summary describes a radiation therapy device and its components, including image registration for treatment planning. There is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is described as delivering a radiation dose for breast conserving treatment, which is a therapeutic intervention.
No
The device, GammaPod, is described as a teletherapy device for delivering radiation doses for breast treatment, not for diagnosing medical conditions. Its components and functions are geared towards therapeutic radiation delivery and treatment planning, not diagnostic imaging or analysis.
No
The device description explicitly lists multiple hardware components (irradiation unit, imager loader system, breast immobilization system) in addition to the treatment planning system software.
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 GammaPod is a "teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast". This describes a therapeutic device that delivers radiation to treat a condition within the body.
- Device Description: The description reinforces this by detailing a system that uses Cobalt-60 gamma-ray sources to deliver radiation to a patient's breast.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
Therefore, GammaPod is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
Product codes
IWB
Device Description
The GammaPod™ is a teletherapy device that uses rotating, multi-source Cobalt-60 gamma-ray emitting sources to noninvasively deliver a focal dose of radiation to a partial volume of a human breast of a patient in the prone position while sparing the surrounding normal tissues and structures.
The GammaPod system contains 4 main components:
- i. GammaPod irradiation unit. The GammaPod irradiation unit consists of a round "pod" containing a hemispherical source carrier that holds multiple Co® sources, a hemispherical dynamically changing collimator system (inside and concentric to the source carrier), a hemi-elliptical-sphere treatment space (inside the collimator) within which the breast is positioned for treatment and a treatment patient loader that lifts and rotates a patient positioned on a treatment couch from the standing to prone position above the round "pod". The couch contains a portal within which the breast immobilization cup is affixed. The irradiation unit is controlled by a computerized treatment control system.
- ii. Imager loader system. An imaging couch design and operation, which are similar to the treatment couch, are intended to make the imaging geometry identical to the treatment geometry. A patient is lifted and rotated from a standing position to prone position for imaging while wearing a breast immobilization device, which is affixed through a portal in the imaging couch.
- iii. Breast immobilization system. A vacuum-assisted breast cup is designed to reproducibly hold the breast in place and provide an accurate reference frame to match the tumor with the coordinate system of the irradiation unit. The cup consists of a rigid reusable outer cup with an imbedded stereotactic frame and a thin inner cup joined together by a silicone flange at the chest side. A mild negative pressure is applied between the inner and outer cups causing the skin of the breast to press against the inner cup, securing the breast in place.
- Treatment planning system. A treatment planning system is designed specifically iv. for planning breast radiotherapy using the GammaPod by:
- a) Placing the breast images within the stereotactic localization frame coordinate system through an image registration process;
- b) Optimizing a dynamic and deliverable trajectory of the focal spots of different sizes to realize the prescribed dose to the target volume while minimizing radiation exposure to the surrounding tissues and structures; and
- c) Ensuring accurate dose calculation of the optimized plan and providing dosimetric indices for review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
SUMMARY OF NONCLINICAL TESTS
A Hazard Analysis was conducted for the modified GammaPod according to ISO 14971 to determine necessary verification and validation testing. The were no changes to the mechanical components of the GammaPod and the control system software was not modified or impacted due to the change in source configuration.
Testing of the treatment planning system software was conducted to verify accuracy of treatment plans based on the 25-source configuration. Radiation tests including radiation safety measures and radiation dosimetric accuracy were conducted to demonstrate compliance with the requirements of the NRC and IEC 60601-2-11.
SUMMARY OF CLINICAL TESTS
No clinical testing was conducted for the current device modification.
CONCLUSIONS DRAWN FROM NONCLINICAL TESTS
The modified GammaPod has the same intended use, fundamental scientific technology and principles of operation as the unmodified predicate GammaPod. The modified GammaPod generates treatment plans of equivalent quality to those of the unmodified predicate. The measured radiation leakage profile of the modified GammaPod remains far below the recommended levels of IEC 60601-2-11 and NCRP Report #102.
Use of the modified GammaPod does not raise any new or different issues of safety or effectiveness when compared with the unmodified predicate GammaPod.
These tests have demonstrated that the modified GammaPod system has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use.
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
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 4, 2018
Xcision Medical Systems, LLC % Daniel R. Plonski, RAC Vice President, Regulatory Affairs & Quality Assurance 9176 Red Branch Road, Suite O COLUMBIA MD 21045
Re: K180571
Trade/Device Name: GammaPod™ - Model A Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 26, 2018 Received: March 5, 2018
Dear Mr. Plonski:
We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K180571 |
|---|---|
| Device Name | GammaPod - Model A |
| Indications for Use (Describe) | GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (7/17)
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EF |
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ﻳﻮﻧ
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510(k) Summary As Required by 21 CFR §807.92(c)
l. GENERAL INFORMATION
- February 23, 2018 Date Prepared:
- Xcision Medical Systems, LLC Manufacturer: 9176 Red Branch Road, Suite O Columbia, MD 21045
- Contact Person: Daniel R. Plonski, RAC Director, Requlatory Affairs and Quality Assurance 9176 Red Branch Road, Suite O Columbia, MD 21045 PHONE: (443) 681-7468 FAX: (443) 445-9201
ll. DEVICE NAME/CLASSIFICATION
| Trade Name: | GammaPod™ |
|---|---|
| Common Name: | Cobalt Teletherapy Device, Stereotactic Radiotherapy |
| System | |
| Classification Name: | Radionuclide Radiation Therapy System |
| Product Code: | IWB |
| Device Classification: | 21 CFR 892.5750, Class II |
lll. PREDICATE DEVICE IDENTIFICATION
Predicate Device: GammaPod (K172706)
IV. DEVICE DESCRIPTION
The GammaPod™ is a teletherapy device that uses rotating, multi-source Cobalt-60 gamma-ray emitting sources to noninvasively deliver a focal dose of radiation to a partial volume of a human breast of a patient in the prone position while sparing the surrounding normal tissues and structures.
4
The GammaPod system contains 4 main components:
- i. GammaPod irradiation unit. The GammaPod irradiation unit consists of a round "pod" containing a hemispherical source carrier that holds multiple Co® sources, a hemispherical dynamically changing collimator system (inside and concentric to the source carrier), a hemi-elliptical-sphere treatment space (inside the collimator) within which the breast is positioned for treatment and a treatment patient loader that lifts and rotates a patient positioned on a treatment couch from the standing to prone position above the round "pod". The couch contains a portal within which the breast immobilization cup is affixed. The irradiation unit is controlled by a computerized treatment control system.
- ii. Imager loader system. An imaging couch design and operation, which are similar to the treatment couch, are intended to make the imaging geometry identical to the treatment geometry. A patient is lifted and rotated from a standing position to prone position for imaging while wearing a breast immobilization device, which is affixed through a portal in the imaging couch.
- iii. Breast immobilization system. A vacuum-assisted breast cup is designed to reproducibly hold the breast in place and provide an accurate reference frame to match the tumor with the coordinate system of the irradiation unit. The cup consists of a rigid reusable outer cup with an imbedded stereotactic frame and a thin inner cup joined together by a silicone flange at the chest side. A mild negative pressure is applied between the inner and outer cups causing the skin of the breast to press against the inner cup, securing the breast in place.
- Treatment planning system. A treatment planning system is designed specifically iv. for planning breast radiotherapy using the GammaPod by:
- a) Placing the breast images within the stereotactic localization frame coordinate system through an image registration process;
- b) Optimizing a dynamic and deliverable trajectory of the focal spots of different sizes to realize the prescribed dose to the target volume while minimizing radiation exposure to the surrounding tissues and structures; and
- c) Ensuring accurate dose calculation of the optimized plan and providing dosimetric indices for review.
V. INTENDED USE
GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO THE PREDICATE DEVICE
As compared with the pre-modified predicate device, the modified GammaPod has the same intended use, uses the same radioisotope, applies the same operating principle, has the same technical characteristics, and meets the same performance specifications. Both the predicate GammaPod and the modified GammaPod meet the same sets of requlations and standards.
Prior to modification, the GammaPod was configured with 36 Cobalt 60 sources. The modified device is configured with 25 Cobalt 60 sources. This modification was made following dosimetric evaluation which indicated that an optimized distribution of 25 sources could deliver a nearly identical target volume dose while significantly reducing incidental radiation to the heart.
The modified source configuration includes changes to the Irradiation Unit and inputs to the Treatment Planning System software. The modification does not require any changes or have any impact on the Treatment Control System software, the Imager Loader or Breast Immobilization systems.
VII. STANDARDS APPLIED
- . IEC 60601-1: 2012 (ed. 3.1): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: 2014 (ed. 4.0): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-4: 2000 (ed. 1.1): Medical electrical equipment - General requirements for safety - Collateral Standard: Programmable electrical medical systems
- . IEC 60601-2-11: 2013 (ed. 3.0): Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
- IEC 60731: 2016 (ed. 3.1): Consolidated Version Medical electrical equipment -● Dosimeters with ionization chambers as used in radiotherapy
- IEC 61217: 2011 (ed. 2.0): Radiotherapy equipment Coordinates, movements, . and scales
- . IEC 62083: 2009 (ed. 2.0): Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
- . IEC 62274: 2005 (First edition): Medical electrical equipment - Safety of radiotherapy record and verify systems
- IEC 62304: 2006: Medical device software Software life cycle processes .
6
- IEC 62366: 2016 (ed. 1.0): Medical devices -Part 1: Application of usability . engineering to medical devices
- . ISO 10993-1: 2009 (ed. 4.0): Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- . ISO 14971: 2007 (Second edition): Medical Devices - Application of Risk Management and Medical Devices
VIII. SUMMARY OF NONCLINICAL TESTS
A Hazard Analysis was conducted for the modified GammaPod according to ISO 14971 to determine necessary verification and validation testing. The were no changes to the mechanical components of the GammaPod and the control system software was not modified or impacted due to the change in source configuration.
Testing of the treatment planning system software was conducted to verify accuracy of treatment plans based on the 25-source configuration. Radiation tests including radiation safety measures and radiation dosimetric accuracy were conducted to demonstrate compliance with the requirements of the NRC and IEC 60601-2-11.
SUMMARY OF CLINICAL TESTS IX.
No clinical testing was conducted for the current device modification.
X. CONCLUSIONS DRAWN FROM NONCLINICAL TESTS
The modified GammaPod has the same intended use, fundamental scientific technology and principles of operation as the unmodified predicate GammaPod. The modified GammaPod generates treatment plans of equivalent quality to those of the unmodified predicate. The measured radiation leakage profile of the modified GammaPod remains far below the recommended levels of IEC 60601-2-11 and NCRP Report #102.
Use of the modified GammaPod does not raise any new or different issues of safety or effectiveness when compared with the unmodified predicate GammaPod.
These tests have demonstrated that the modified GammaPod system has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use.