(38 days)
Not Found
No
The description focuses on a physical device (catheter and accessories) for delivering radiation, with no mention of software, algorithms, or data processing that would typically involve AI/ML. The performance studies described are preclinical and clinical evaluations of the physical device's function and dosimetry, not algorithmic performance.
Yes
The device is used to deliver brachytherapy for breast cancer, which is a therapeutic intervention.
No
Explanation: This device is a radiation therapy system used for delivering brachytherapy to surgical margins after lumpectomy for breast cancer. It is not used to diagnose a medical condition.
No
The device description explicitly states it is a "radiation therapy system that includes the MammoSite Catheter Tray and the MammoSite HDR Afterloader Accessories Tray," detailing physical components like a catheter, balloon, and accessories for connecting to an afterloader. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide brachytherapy (a type of radiation therapy) directly to the surgical margins following lumpectomy for breast cancer. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a catheter system designed to deliver radiation sources in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health information. This device is a therapeutic device used to deliver treatment directly to the patient's body.
N/A
Intended Use / Indications for Use
The MammoSite RTS is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
Product codes (comma separated list FDA assigned to the subject device)
90 JAQ
Device Description
The MammoSite is a radiation therapy system that includes the MammoSite Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite 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.
Mentions image processing
Not Found
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
Physician
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)
Extensive pre-clinical studies were performed to support the MammoSite. Preclinical studies conducted included in vitro laboratory studies to demonstrate that the MammoSite device, 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. Previously conducted animal studies (included in the cleared K011690) illustrate the performance of the device, and demonstrate a clinical dose of brachytherapy could successfully be delivered. Based on these findings, it was concluded that the modified MammoSite delivers an equivalent radiation dose compared to the predicate MammoSite devices. Clinical studies: The multi-center phase clinical study initially done to evaluate the safety and effectiveness of the MammoSite supports the modified MammoSite. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
041929
The general information for the modified MammoSite is included in the table General information below:
| Submitters name and address: | Proxima Therapeutics, Inc.
2555 Marconi Drive, Suite 220
Alpharetta, Georgia 30005 |
|-----------------------------------|------------------------------------------------------------------------------------------|
| Submitters phone and fax numbers: | Telephone: (770) 753-4848
Fax: (770) 753-4937 |
| Name of contact person: | Deborah J. Moore
VP, RA, CA, & QA |
| 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 16, 2004 |
The modified MammoSite device is substantially equivalent to the following Predicate devices cleared MammoSite devices:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| MammoSite Radiation | ||
| Therapy System (RTS) - | ||
| 4-5 cm Spherical | Proxima Therapeutics, Inc. | K011690 |
| MammoSite RTS - | ||
| 5-6 cm Spherical | Proxima Therapeutics, Inc. | K030558 |
Indications for The MammoSite is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following use lumpectomy for breast cancer.
Continued on next page
1
510(k) Summary, Continued
| Device
description | The MammoSite is a radiation therapy system that includes the MammoSite
Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The
MammoSite 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. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | The modified MammoSite has the same intended use, same technological
characteristics, and similar materials/dimensions of the predicate
MammoSite. The indication for use is the same as the predicate MammoSite.
All MammoSite devices provide a means of delivering a radiation therapy in
a tumor or tumor cavity. The MammoSite positions the radioactive source for
radiation therapy and utilizes a $^{192}Ir$ seed or ribbon as the radiation source
with similar dosimetric properties. |
| | Any differences that exist between the modified MammoSite and the
predicate MammoSite devices were discussed and shown they do not affect
the safety or effectiveness of the MammoSite device. It was demonstrated
that the modified MammoSite is substantially equivalent to the predicate
MammoSite. |
Continued on next page
2
1141929 510(k) Summary, Continued
Extensive pre-clinical studies were performed to support the MammoSite. Preclinical Preclinical studies conducted included in vitro laboratory studies to studies demonstrate that the MammoSite device, 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. Previously conducted animal studies (included in the cleared K011690) illustrate the performance of the device, and demonstrate a clinical dose of brachytherapy could successfully be delivered. Based on these findings, it was concluded that the modified MammoSite delivers an equivalent radiation dose compared to the predicate MammoSite devices. Clinical studies The multi-center phase clinical study initially done to evaluate the safety and effectiveness of the MammoSite supports the modified MammoSite. 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.
3
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2004
Ms. Martine D. Schneider Manager, Worldwide Regulatory Affairs & Compliance Proxima Therapeutics, Inc. 2555 Marconi Drive, Suite 220 ALPHARETTA GA 30005-2066 Re: K041929
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: July 16, 2004 Received: July 27, 2004
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 for associated in the 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 may or our 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ought in."
Premarket notification. The FDA finding of substantial equivalence of your device to a legally premaired predication. The 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 If you desire specifice at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (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 Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Othphares as (snotification" (21CFR Part 807.97) you may obtain. Other general by recented to promative sunder the Act may be obtained from the Division of Small miormation on your responsible and Consumer Assistance at its toll-free number (800) 638-2041 or Manataorarers, 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
5
Statement of Indications for Use
| 510(k) Number (if known) | K041929 |
|---|---|
| Device name | MammoSite Radiation Therapy System (RTS) |
| Indications for use | The MammoSite RTS is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. |
David A. Lynn
Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 6 510();) Number
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |