(88 days)
No
The summary does not mention AI, ML, deep learning, or any related concepts, and the device description focuses on image alignment and couch guidance based on user input and imported data.
No.
The device is used for patient positioning in radiation therapy, which is a treatment, but the device itself does not deliver the therapy or directly interact with the patient to cure, mitigate, treat, or prevent disease. It is an accessory to a therapeutic procedure.
No
The device is described as assisting in patient positioning for radiation therapy by locating internal anatomy using ultrasound, and guiding couch motion to achieve desired patient alignment with the treatment beam. This is a therapeutic and positioning function, not a diagnostic one.
No
The device description explicitly states that the BAT system "guides couch motion" and uses "perpendicular ultrasound images acquired at treatment time." This implies the system includes or interfaces with hardware components (ultrasound scanner, treatment couch control) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BAT device uses ultrasound imaging to locate and position internal anatomy for radiation therapy. It does not analyze biological samples from the patient.
- Intended Use: The intended use is for patient positioning during radiation therapy, not for diagnostic testing of biological samples.
The device is a medical device used in a clinical setting for treatment delivery, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
BAT is intended for use in external beam Radiation Therapy (RT)/Radiosurgery (RS) to locate internal anatomy that moves relative to external or bony landmarks, so as to position that anatomy correctly for the delivery of conformal radiation.
BAT can be used for the positioning of all patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.
Product codes
90 IYE
Device Description
BAT permits its user to align the isocenter crosshairs, structure contours or calculated dose (the latter 2 imported from a treatment planning system) with perpendicular ultrasound images acquired at treatment time. The BAT system then guides couch motion to achieve the desired patient alignment with the treatment beam. Additional ultrasound images can be taken to confirm proper positioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound images
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K945957, K930506, K930295, K955397
Reference Device(s)
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
Summary of Safety and Effectiveness ' V / y / 1 / 1 / 1 / 1
rith 513 (i) of the Rederal Food, Drug and Cosmetic Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
April 17, 1998
1. General Provisions
| Common/Usual Name | Patient Positioning System, Ultrasound |
|---|---|
| Proprietary Name | BAT TM Ultrasound Localization and Positioning System |
| Applicant Name and Address | NOMOS Corporation |
| 2591 Wexford Bayne Road | |
| Sewickley, PA 15143 |
2. Names of Predicate Devices'
| Product | Clearance Number | Clearance Date |
|---|---|---|
| Ausonics | ||
| OPUS 2 Realtime Ultrasound Scanner | K945957 | 4/15/96 |
| MMS TherpacPLUS 6.6 B3DTUI | ||
| (K930506) Treatment Planning System | K930506 | 8/29/94 |
| CP Bio-Medical Corp. | ||
| PatPos Compact Laser Positioning Device | K930295 | 5/21/93 |
| Mayfield/ACCISS Stereotactic Workstation | K955397 | 4/30/96 |
Classification 3.
1
This device is classified as a class II device according to 21 CFR 892 sections 5050, 5750, 5780, or 5840.
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).
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Performance Standards 4.
Performance standards for this type of device have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description 5.
BAT is intended for use in external beam Radiation Therapy (RT)/Radiosurgery (RS) to locate internal anatomy that moves relative to external or bony landmarks, so as to position that anatomy correctly for the delivery of conformal radiation.
BAT permits its user to align the isocenter crosshairs, structure contours or calculated dose (the latter 2 imported from a treatment planning system) with perpendicular ultrasound images acquired at treatment time. The BAT system then guides couch motion to achieve the desired patient alignment with the treatment beam. Additional ultrasound images can be taken to confirm proper positioning.
Biocompatibility 6.
All BAT components contacting the patient are 510(k) cleared (ultrasound probe: K945957; ultrasound gel: K802146 or equivalent). These components are made for diagnostic ultrasound using materials that have a long history of safe use for those applications. Their use in conjunction with BAT does not raise any new issues related to safety or effectiveness.
7. Summary of Substantial Equivalence
This device is similar in design, construction, materials, intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and the background is white. To the left of the text is a logo of the Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Marvin L. Sussman, Ph.D. Vice President, Product Assurance NOMOS Corporation 2591 Wexford Bayne Road Sewickley, PA 15143
Re:
K981424 BAT Positioning and Localization System Dated: April 17, 1998 Received: April 20, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Dr. Sussman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cometic 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 can be forms in the Code of Federal Remleriors, Title 21, Parts 800 to 895. A substantially equivalent determination assumes complience with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify was 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 submission does not affect any obligation you might have under sections 542 of the Act for derices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510%) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: BAT™ Ultrasound Localization and Positioning System
Indications for Use: BAT can be used for the positioning of all patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR Over-The Counter Use (Optional Format 1-2-96)
Elmer L. Segeer
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Device 510(k) Number