(89 days)
The MammoSite is 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.
The provided text describes the MammoSite Radiation Therapy System (RTS) and its substantial equivalence to a predicate device, rather than a study proving a device meets specific acceptance criteria with quantifiable metrics. The document details preclinical and clinical studies conducted to support the modifications to the device and its safety/effectiveness. However, it does not present a table of acceptance criteria with corresponding performance metrics in a format that lends itself to a direct comparison as requested.
Based on the information provided, here's a breakdown of the requested elements:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as quantifiable performance metrics with specific thresholds. Instead, it relies on demonstrating equivalence to a predicate device and successful delivery of brachytherapy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Preclinical: | |
| Performance as intended under simulated use and challenge conditions | Demonstrated through in vitro laboratory studies. |
| Biocompatibility requirements met | Demonstrated through biocompatibility testing. |
| Dosimetry characterized | The dosimetry of the MammoSite was characterized. |
| Equivalent radiation dose to commercially available brachytherapy applicators | Animal studies illustrated the performance of the device and demonstrated that a clinical dose of brachytherapy could be successfully delivered. It was concluded that the MammoSite RTS could deliver an equivalent radiation dose. |
| Clinical: | |
| Safety and effectiveness | Evaluated through a multi-center phase II clinical study, which assessed safety and effectiveness using radiological and clinical measures. Brachytherapy was successfully delivered to patients. The 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. The clinical study supported the changes to the device presented in the 510(k). A complete clinical summary including data analysis and individual patient data was provided to FDA. |
| Substantial equivalence to predicate device | The document repeatedly states that the device is "substantially equivalent to the predicate device" in terms of "intended use, similar technological characteristics, and similar materials/dimensions". Any differences were discussed and shown not to affect safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only mentions a "multi-center phase II clinical study." It does not specify the number of patients included in this clinical study (the "test set").
- Data Provenance: The document does not specify the country of origin of the data. It mentions a "multi-center" study, implying data from multiple locations, but no specific countries. The clinical study was prospective, as it involved "breast cancer patients who were undergoing tumor resection" and where "brachytherapy was successfully delivered to the patients."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document refers to "radiological and clinical measures" for assessment in the clinical study. It does not provide information on:
- The number of experts involved in establishing ground truth.
- The specific qualifications of those experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. The device is a physical radiation therapy system, not an AI-powered diagnostic tool for human readers.
- Effect Size of AI Improvement: Not applicable, as this is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The MammoSite RTS is a physical medical device (a catheter and accessories) used to deliver brachytherapy, not a standalone algorithm. Its performance is always in conjunction with medical professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The clinical study assessed "safety and effectiveness" using "radiological and clinical measures." The successful delivery of brachytherapy and "a complete clinical summary including data analysis and individual patient data" formed the basis of the conclusions. This suggests that ground truth was established through a combination of:
- Clinical observation and assessment by physicians.
- Radiological evaluation (imaging data indicating proper placement and successful delivery).
- Patient outcomes data relating to the safety and successful delivery of the therapy.
8. The sample size for the training set
This information is not applicable in the context of this device and study description. The MammoSite RTS is a physical device, and its development and evaluation did not involve a "training set" in the sense of machine learning algorithms. The preclinical and clinical studies were for validation of the device's performance, not for training an algorithm.
9. How the ground truth for the training set was established
Not applicable. As mentioned above, there was no "training set" in the machine learning sense for this device.
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MAY 21 2003
Section 3
K∅3∅558
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: | February 19, 2003 | ||
| Predicatedevices | The additional MammoSite RTS size (variable 5-6 cm) is substantiallyequivalent to the following legally marketed medical devices in terms of itstechnical specification, intended use, and method of application: | ||
| Name | Manufacturer | 510(k) Number | |
| MammoSite RadiationTherapy System (RTS) | Proxima Therapeutics, Inc. | K011690 |
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K∅3∅558
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 device. The indication for use is identical to the predicate MammoSite RTS that is commercially available and is similar to the other predicate devices. Both 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 MammoSite RTS and the predicate device were discussed and it has been shown that these differences do not affect safety or effectiveness. It was demonstrated that the MammoSite RTS is substantially equivalent to the predicate device. |
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510(k) Summary, Continued
K$\phi$3$\phi$558
| Preclinical studies | Extensive pre-clinical studies were performed to support the modifications to the device presented in this 510(k). Preclinical studies conducted included in vitro laboratory studies to demonstrate that the MammoSite catheter, its 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. 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 MammoSite RTS could deliver an equivalent radiation dose to current commercially available brachytherapy applicators. |
|---|---|
| Clinical studies | The multi-center phase II clinical study initially done to evaluate the safety and effectiveness of the MammoSite RTS supports the changes to the device 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. 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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 2003
Ms. Martine D. Schneider Manager, Regulatory Affairs and Quality Assurance Proxima Therapeutics, Inc. 2555 Marconi Drive, Suite 220 ALPHARETTA GA 30005-2066 Re: K030558
Trade/Device Name: MammoSite Radiation Therapy System (RTS) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: February 19, 2003 Received: February 21, 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 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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131558
Statement of Indications for Use
| 510(k) Number(if known) | |
|---|---|
| Device name | MammoSite Radiation Therapy System (RTS) |
| Indications foruse | The MammoSite is intended to provide brachytherapy when the physicianchooses to deliver intracavitary radiation to the surgical margins followinglumpectomy for breast cancer. |
Prescription Use
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abd and Radiological Device 510(k) Number .
Proxima MammoSite® RTS 510(k) Application
§ 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.