(84 days)
935411
Not Found
No
The device description and performance studies focus solely on the mechanical positioning of the breast for radiation therapy and do not mention any computational or data-driven components.
No
This device is described as a 'positioning device' and a 'linear accelerator couch-mounted platform' used to position the breast for radiation treatment, not to treat the condition itself.
No
The device is described as a 'positioning device' used during patient set-up for primary breast irradiation, and its function is to position the breast for treatment, not to diagnose a condition.
No
The device description clearly states it is a "linear accelerator couch-mounted platform," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "positioning device in patient set-up for primary breast irradiation." This describes a physical device used to position a patient for a medical treatment (radiation therapy).
- Device Description: The description reinforces this, describing it as a "linear accelerator couch-mounted platform" for positioning the breast.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological specimens or provide diagnostic information.
The information provided focuses on the physical function of the device for patient positioning during radiation therapy, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
To be used as a positioning device in patient set-up for primary breast irradiation.
The Prone Breast Positioning Board, model number 37-018 is to be used as a positioning device in patient set-up for primary breast irradiation.
Product codes
90 IYE
Device Description
The Prone Breast Positioning Board is a linear accelerator couch-mounted platform which enables the breast to hang in a comfortable, gravity-dependent fashion for treatment with opposed tangential photon beams. Women with large or pendulous breasts, in whom supine treatment would result in an unacceptable dose inhomogeneity, are targeted as the group who would benefit most from this device. Where dose to lung, heart or other normal tissue is also concerned, prone breast treatment offers advantages over supine treatment. The prone breast positioning device allows women to complete treatment expeditiously and minimize toxicity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast, lung, heart, chest wall
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)
Non-clinical Performance Data:
Two sample treatment plans (exhibits F and G) labeled "Jones, Pearl" are attached. The treatment plan marked with the 0.75, 0.75 scale is a prone treatment plan and supine on the same page for the same patient. The one with the 0.5, 0.5 scale is a conventional (parallel opposed) supine treatment plan. The sample treatment plans clearly show that in the supine treatment the dose to the chest wall is 90% of the max dose, whereas in the supine plan it is 110% of the max dose. Also the supine plan has hot spots near both beam entrance points of 123% of max dose, while the prone position provides a very uniform distribution with a uniform gradient through the breast. It is important to note that in breast conserving treatment, radiation therapy is treating the intact breast and a uniform, homogeneous dose distribution is desired if one is to achieve local control without complications such as skin reactions.
Clinical Study/Test Data:
Exhibit "H": The article from The Official Journal, entitled "Prone Position Breast Irradiation," by Thomas E. Merchant, D.O., and Beryl McCormick, M.D.
Exhibit "I": The article entitled "Dose to Lung in Primary Breast Irradiation"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Med-Tec, Breast Board, Mt, 510(k) #935411
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Premarket Notification [510(k)] Summary as required by section 807.92(c)
JUN - 6 1997
Date Summary was prepared:
March 4, 1997
Submitter's Name:
な Victoreen, Inc. 6000 Cochran Road Cleveland, Ohio 44139-3395
Contact Person:
Linda S. Nash Director of Regulatory Affairs and Quality Assurance 216-248-9300 Phone: Fax: 216-248-9301
Device Name:
Prone Breast Positioning Board, Model #37-018
Classification Name:
Medical Charged-Particle Radiation Therapy System
Predicate Device:
Med-Tec, Breast Board, Mt, 510(k) #935411
Device Description:
The Prone Breast Positioning Board is a linear accelerator couch-mounted platform which enables the breast to hang in a comfortable, gravity-dependent fashion for treatment with opposed tangential photon beams. Women with large or pendulous breasts, in whom supine treatment would result in an unacceptable dose inhomogeneity, are targeted as the
1
group who would benefit most from this device. Where dose to lung, heart or other normal tissue is also concerned, prone breast treatment offers advantages over supine treatment. The prone breast positioning device allows women to complete treatment expeditiously and minimize toxicity.
Intended Use:
To be used as a positioning device in patient set-up for primary breast irradiation.
Similarities to predicate device:
Both the Med-Tec Breast Board and the Prone Breast Positioning Board are used as positioning devices in patient set-up for primary breast irradiation.
Differences to predicate device:
The Med-Tec Breast Board is for supine positioning in treatment of the breast. The Prone Breast Positioning Board is for prone positioning in treatment of the breast. Listed below are the clinical and dosimetric advantages to prone breast positioning. (Please reference the attached article form The Official Journal, entitled "Prone Position Breast Irradiation," by Thomas E. Merchant, D.O., and Beryl McCormick, M.D.)
Clinical advantages:
- Women with large or pendulous breast may be treated with ease: 1.
-facilitates breast conserving therapy for large breasted women
-improves reproducibility of treatment for large breasted women
-
- The lung and heart may be avoided through this positioning technique:
-important for women with pre-existing cardiac and pulmonary conditions
- The lung and heart may be avoided through this positioning technique:
-reduces the chance of long-term effects on heart and lungs
-
- Significantly reduces skin reaction through improved does homogeneity:
-treatment breaks are less likely due to improved skin tolerance
- Significantly reduces skin reaction through improved does homogeneity:
2
-allows treatment to be given in a continuos course-oncologically superior -may facilitate simultaneous administration of chemotherapy in some women
-may allow patients with connective tissue disorder to receive treatment
- Prone positioning simplifies breast boosts by making photon treatment possible: 4.
- -avoids the need for electron capability when treating breast patients 11:48:00 -skin-sparing boost treatment (photons) decreases skin reactions
Dosimetric advantages:
-
The amount of internal scatter is markedly reduced: 1.
-the volume of chest wall irradiated can be reduced by this technique -
Radiation scatter to the contralateral (opposite) breast can be minimized: 2.
-the opposite breast can be moved away from the field edge -
Beam attenuators (wedges) are not required to improve homogeneity: 3.
-the number of accelerator monitor units required for treatment is less
-internal scatter and scatter to the opposite breast are further minimized
Non-clinical Performance Data:
Two sample treatment plans (exhibits F and G) labeled "Jones, Pearl" are attached. The treatment plan marked with the 0.75, 0.75 scale is a prone treatment plan and supine on the same page for the same patient. The one with the 0.5, 0.5 scale is a conventional (parallel opposed) supine treatment plan. The sample treatment plans clearly show that in the supine treatment the dose to the chest wall is 90% of the max dose, whereas in the supine plan it is 110% of the max dose. Also the supine plan has hot spots near both beam entrance points of 123% of max dose, while the prone position provides a very uniform distribution with a uniform gradient through the breast. It is important to note that in
3
3
breast conserving treatment, radiation therapy is treating the intact breast and a uniform, homogeneous dose distribution is desired if one is to achieve local control without complications such as skin reactions.
Cinical Study/Test Data:
| Please reference: | |
|---|---|
| Exhibit "H" | The article from The Official Journal, entitled "Prone |
| Position Breast Irradiation," by Thomas E. Merchant, | |
| D.O., and Beryl McCormick, M.D. | |
| Exhibit "I" | The article entitled "Dose to Lung in Primary Breast |
| Irradiation" |
Safety and Effectiveness Conclusion:
The conclusions drawn from the enclosed medical physics test data (see sample treatment plan/180 dose distributions in "F" and "G" Exhibits), and the supportive clinical articles (Exhibits "H" and "I") demonstrate that the Prone Breast Board (Model 37-018) presents no new issues relating to safety and effectiveness and is substantially equivalent to the legally marketed predicate device listed on page one of this document.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 3200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Linda S. Nash Director of Regulatory Affairs and Quality Assurance · Victoreen, Inc. 6000 Cochran Road Cleveland, OH 44139-3395
Re: K971382 Prone Breast Positioning Board, Model #37-018 Dated: March 4, 1997 Received: April 14, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Nash:
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We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Foderal 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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.gov/cdrh/dsmamain.html"
Sincerely yours,
William Y
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number:
Prone Breast Positioning Board, model number 37-018 Device Name:
Indications for Use:
The Prone Breast Positioning Board, model number 37-018 is to be used as a positioning device in patient set-up for primary breast irradiation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices and Radiological Devi 510(k) Number J
Prescription Use V
Over-The-Counter Use