(222 days)
The MammoSite RTS is an applicator intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
The MammoSite RTS is a radiation therapy system that includes the MammoSite RTS Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite RTS Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite is a catheter shaft with an inflatable balloon mounted on its distal end that positions the radiation source within the resected cavity for radiation delivery. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite. Any device specifications that have changed as a result of the modifications to the device presented in this 510(k) have been documented in Proxima's product specifications for the MammoSite RTS.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MammoSite Radiation Therapy System (RTS) (K032067).
Summary of Acceptance Criteria and Device Performance:
The provided document (K032067) is a 510(k) summary for the Ellipsoid MammoSite RTS. It focuses on demonstrating substantial equivalence to previously cleared predicate devices (MammoSite K011690 and K030558, and Nucletron afterloaders) rather than establishing specific, quantitative performance metrics as "acceptance criteria" in the traditional sense of a new technology proving efficacy.
The "acceptance criteria" for this 510(k) are implicitly:
- Equivalent intended use: The device should be intended to provide brachytherapy to surgical margins following lumpectomy for breast cancer.
- Similar technological characteristics: The device should function similarly to its predicates, utilizing the same principle of intracavitary radiation delivery.
- Equivalent safety and effectiveness: The device, despite any minor differences, should be demonstrated to be as safe and effective as the predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|
| Intended Use: To provide brachytherapy to the surgical margins following lumpectomy for breast cancer. | The MammoSite RTS (Ellipsoid version) has the same intended use as the predicate MammoSite devices. "The MammoSite RTS is an applicator intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer." |
| Technological Characteristics: Similar to predicate devices (catheter, inflatable balloon, use of 192Ir seed/ribbon, dosimetric properties). | "The MammoSite has the same intended use, similar technological characteristics, and similar materials/dimensions of the predicate MammoSite devices." It positions the radiation source within the resected cavity for radiation delivery and utilizes 192Ir seed or ribbon with similar dosimetric properties. "Any differences that exist between the ellipsoid MammoSite RTS and the predicate devices were discussed and shown that these differences do not affect safety or effectiveness." |
| Safety and Effectiveness: Demonstration that any differences from predicates do not affect safety or effectiveness, and that the device performs as intended in simulated and clinical conditions, delivering an equivalent radiation dose. | Pre-clinical Studies: In vitro laboratory studies demonstrated the ellipsoid MammoSite devices, accessories, and packaging performed as intended under simulated use and challenge conditions. Biocompatibility testing confirmed material compliance. Dosimetry was characterized and found similar to predicate devices. Animal studies illustrated device performance and successful delivery of a clinical dose of brachytherapy. Clinical Studies: "The multi-center phase II clinical study initially done to evaluate the safety and effectiveness of the MammoSite RTS supports the ellipsoid devices presented in this 510(k)." Brachytherapy was successfully delivered to patients. The study "demonstrated that the MammoSite RTS provides brachytherapy..." |
Detailed Study Information:
The 510(k) relies on a combination of preclinical studies for the ellipsoid device and leveraging clinical data from previous MammoSite RTS approvals (specifically K011690).
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Sample size used for the test set and the data provenance:
- Clinical Test Set: The document refers to "The multi-center phase II clinical study initially done to evaluate the safety and effectiveness of the MammoSite RTS supports the ellipsoid devices presented in this 510(k)." This implies the clinical data for the original MammoSite (K011690) is used to support the ellipsoid variant.
- Sample Size: Not explicitly stated for the clinical study directly within this 510(k) summary, but says "The clinical study included breast cancer patients who were undergoing tumor resection." It notes "A complete clinical summary including data analysis and individual patient data was provided to FDA in K011690." Without access to K011690, the exact number of patients isn't known from this document.
- Data Provenance: "multi-center phase II clinical study." The country of origin is not specified, but typically for US-based 510(k)s, such studies would include US sites. It was a prospective study.
- Pre-clinical Test Set (for Ellipsoid device):
- Sample Size: Not specified (e.g., number of devices tested in vitro, number of animals in animal studies).
- Data Provenance: In vitro laboratory studies and animal studies. Specific geographic origins are not provided but are generally internal lab testing or contract research. Retrospective for analysis, but the testing itself would be prospective.
- Clinical Test Set: The document refers to "The multi-center phase II clinical study initially done to evaluate the safety and effectiveness of the MammoSite RTS supports the ellipsoid devices presented in this 510(k)." This implies the clinical data for the original MammoSite (K011690) is used to support the ellipsoid variant.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the clinical study, "Assessment methods used to evaluate safety and effectiveness included radiological and clinical measures." This implies clinical experts (physicians, radiologists) were involved in assessing outcomes. However, the exact number and their qualifications are not specified in this document.
- For preclinical work, experts in dosimetry, biocompatibility, and possibly animal research would have been involved, but their numbers and qualifications are not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify any adjudication method for the clinical or preclinical studies. It generally states that "Brachytherapy was successfully delivered to the patients."
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This application is for a medical device (applicator system for brachytherapy), not an imaging or diagnostic AI device which would typically involve such studies. The focus is on the safe and effective delivery of radiation, not interpretation of images by multiple readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not relevant or performed. This device is a physical applicator system for radiation therapy,
not a software algorithm.
- No, a standalone algorithm performance study was not relevant or performed. This device is a physical applicator system for radiation therapy,
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Study: "radiological and clinical measures" were used to assess safety and effectiveness. This implies a combination of:
- Clinical Outcomes/Events: Success of brachytherapy delivery, adverse events, patient outcomes (implied, not fully detailed here).
- Radiological images: Used for assessment (e.g., assessing balloon inflation, catheter placement, dose distribution, though not explicitly labelled as 'ground truth' for an AI).
- Preclinical Studies:
- In vitro: Performance metrics against simulated use conditions.
- Biocompatibility: Standardized test results against established benchmarks.
- Dosimetry: Measurement of radiation dose distribution compared to expected or predicate values.
- Animal studies: Observation of device performance and successful radiation delivery in an animal model.
- Clinical Study: "radiological and clinical measures" were used to assess safety and effectiveness. This implies a combination of:
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The sample size for the training set:
- Not applicable. This device is a hardware system, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for the device would be its engineering design, manufacturing processes, and preclinical testing, not data-driven machine learning.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" in the context of AI/ML for this device. The "ground truth" for its design and verification would be engineering specifications, material properties, and established medical physics principles.
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FEB 1 0 2004
Section 3
510(k) Summary
| Generalinformation | The general information for the MammoSite RTS is included in the tablebelow: | |
|---|---|---|
| Submitters name and address: | Proxima Therapeutics, Inc.2555 Marconi Drive, Suite 220Alpharetta, Georgia 30005 | |
| Submitters phone and fax numbers: | Telephone: (770) 753-4848Fax: (770) 753-4937 | |
| Name of contact person: | Martine D. SchneiderManager, Regulatory Affairs & Quality Assurance | |
| Trade name: | MammoSite Radiation Therapy System (RTS) | |
| Common name: | Remote-controlled radionuclide applicator system | |
| Classification name: | System, applicator, radionuclide, remote-controlled (per 21 CFR 892.5700) | |
| Date summary was prepared: | July 2, 2002 | |
| Predicatedevices | The ellipsoid MammoSite RTS devices are substantially equivalent to thefollowing legally marketed medical devices in terms of its technicalspecification, intended use, and method of application: | |
| Name | Manufacturer | 510(k) Number |
| MammoSite RadiationTherapy System (RTS) | Proxima Therapeutics, Inc. | K011690 |
| MammoSite RTS -5-6 cm Spherical | Proxima Therapeutics, Inc. | K030558 |
| Afterloading Applicators | Nucletron Corp. | K853912, K983341 |
| Indications foruse | The MammoSite RTS is an applicator intended to provide brachytherapywhen the physician chooses to deliver intracavitary radiation to the surgical |
margins following lumpectomy for breast cancer.
Continued on next page
Proxima MammoSite® RTS 510(k) Application (K032067) - Ellipsolds
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Kø32ø67
510(k) Summary, Continued
| Device description | The MammoSite RTS is a radiation therapy system that includes the MammoSite RTS Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite RTS Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite is a catheter shaft with an inflatable balloon mounted on its distal end that positions the radiation source within the resected cavity for radiation delivery. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite. Any device specifications that have changed as a result of the modifications to the device presented in this 510(k) have been documented in Proxima's product specifications for the MammoSite RTS. |
|---|---|
| Technological characteristics | The MammoSite has the same intended use, similar technological characteristics, and similar materials/dimensions of the predicate MammoSite devices. The indication for use is the same as the predicate MammoSite RTS devices that are commercially available and is similar to other predicate devices. All MammoSite devices provide a means of delivering a radiation therapy in a tumor or tumor cavity. The MammoSite and brachytherapy applicators position the radioactive source for radiation therapy. The MammoSite and brachytherapy applicators utilize 192 Ir seed or ribbon as the radiation source with similar dosimetric properties.Any differences that exist between the ellipsoid MammoSite RTS and the predicate devices were discussed and shown that these differences do not affect safety or effectiveness. It was demonstrated that the ellipsoid MammoSite RTS is substantially equivalent to the predicate devices. |
| Continued on next page |
Continued on next page
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K/32667
510(k) Summary, Continued
Extensive pre-clinical studies were performed to support the ellipsoid devices Preclinical presented in this 510(k). Preclinical studies conducted included in vitro studies laboratory studies to demonstrate that the ellipsoid MammoSite devices, the accessories and packaging, performed as intended under simulated use and challenge conditions. Biocompatibility testing was performed to demonstrate that the materials meet the biocompatibility requirements. The dosimetry of the MammoSite was characterized and is similar to the predicate MammoSite devices. Animal studies illustrate the performance of the device, and demonstrate a clinical dose of brachytherapy can successfully be delivered. Based on these findings, it was concluded that the ellipsoid MammoSite RTS could deliver an equivalent radiation dose to current commercially available brachytherapy applicators. The multi-center phase II clinical study initially done to evaluate the safety Clinical studies and effectiveness of the MammoSite RTS supports the ellipsoid devices presented in this 510(k). The clinical study included breast cancer patients who were undergoing tumor resection. Assessment methods used to evaluate safety and effectiveness included radiological and clinical measures.
Brachytherapy was successfully delivered to the patients. A complete clinical summary including data analysis and individual patient data was provided to FDA in K011690. The clinical study demonstrated that the MammoSite RTS provides brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer,
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2004
Ms. Martine D. Schneider Manager, Regulatory Affairs & Quality Assurance Proxima Therapeutics, Inc. 2555 Marconi Drive, Suite 220 ALPHARETTA GA 30005-2066 Re: K032067 Trade/Device Name: Ellipsoid MammoSite® Radiation Therapy System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: November 10, 2003 Received: November 12, 2003
Dear Ms. Schneider:
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 such 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,
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This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Statement of Indications for Use
| 510(k) Number (if known) | K032067 |
|---|---|
| Device name | MammoSite Radiation Therapy System (RTS) |
| Indications for use | The MammoSite is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. |
Nancy C. Brogdon
Prescription Use
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Proxima MammoSite® RTS 510(k) Application (K032067) -- Ellipsolds
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.