(120 days)
Not Found
No
The description focuses on integrating existing technologies (ultrasound, optical tracking, graphics workstations) and performing standard image processing and geometric calculations. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used for image-guidance and patient positioning in radiation therapy, not for delivering therapeutic treatment itself.
Yes
The device integrates medical diagnostic ultrasound systems and uses ultrasound to acquire image slices and generate 3D ultrasound volume data. It performs tasks such as segmenting anatomical structures, calculating their position and shape, and calculating displacement between structures. Although its primary purpose is patient positioning and tumor localization for radiation therapy, it clearly utilizes diagnostic imaging capabilities (ultrasound) to assess internal anatomy.
No
The device description explicitly states that the RESTITU system "integrates medical diagnostic ultrasound systems, position sensing optical tracking systems, graphics workstations and other parts used to link these components together," and that it "utilizes an ultrasound device, an optical camera tracking device and software platform." This indicates the device is a system comprising both hardware and software components, not software-only.
Based on the provided information, the RESTITU device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- RESTITU's Intended Use: The intended use of RESTITU is clearly stated as being for positioning internal anatomy for external beam radiation therapy/radiosurgery. It uses ultrasound imaging to visualize internal structures in vivo (within the living body) to ensure accurate radiation delivery.
- Device Description: The device description reinforces this by detailing its components (ultrasound system, optical tracking, software) and functions, all of which relate to image-guided patient positioning for radiation treatment. It does not mention the analysis of in vitro specimens.
Therefore, RESTITU falls under the category of a medical device used for image-guided therapy, specifically in the field of radiation oncology, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RESTITU 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 delivery of conformal radiation.
RESTITU™ can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.
Product codes
90 IYE, IWB, and KPQ
Device Description
The RESTITU system integrates medical diagnostic ultrasound systems, position sensing optical tracking systems, graphics workstations and other parts used to link these components together.
RESONANT's RESTITU is a 3D ultrasound-based image-guidance system that utilizes an ultrasound device, an optical camera tracking device and software platform to produce high quality data needed to perform accurate patient positioning and tumor localization.
RESTITU provides the capability to acquire high quality volumetric data before or after a treatment delivery fraction providing a strong set of data for treatment plan-delivery comparison studies. The RESTITU system can be integrated in any radiotherapy planning or treatment room for treatment verification. The RESTITU system resides in both the CT-Sim and LINAC rooms and can be fully integrated into a comprehensive data and image network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
internal anatomy that moves relative to external or bony landmarks. organs which are readily identifiable on ultrasound images.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiotherapy planning or treatment room
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)
K981424 NOMOS Corporation, BAT® Ultrasound Localization and Positioning System, K032100 Computerized Medical Systems, Inc., I-Beam, K030981 Varian Medical Systems, Inc., Eclipse, K923851 Phillips Medical Systems, Inc., ACQSIM Simulator/Localizer
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
KO41937
NOV 1 6 2004
510(k) Summary
| Date prepared: | July 16, 2004 |
|---|---|
| Submitter/Owner: | Resonant Medical Inc. |
| 460 Ste-Catherine West, Suite 805 | |
| Montreal, Quebec | |
| H3B 1A5 | |
| Contact person: | Sean M. Curry |
| 16787 Bernardo Center Drive, Suite A-1 | |
| San Diego, CA | |
| Phone number: | (858) 675-8200 |
| Fax number: | (858) 675-8201 |
| Proprietary name: | RESTITUTM |
| Common name: | Patient Positioning System, Ultrasound |
| Classification: | Class II, 892.5050, 5750, 5780, or 5840 |
| Substantial equivalence claimed to: |
-
- K981424 NOMOS Corporation, BAT® Ultrasound Localization and
Positioning System
- K981424 NOMOS Corporation, BAT® Ultrasound Localization and
-
- K032100 Computerized Medical Systems, Inc., I-Beam
-
- K030981 Varian Medical Systems, Inc., Eclipse
-
- K923851 Phillips Medical Systems, Inc., ACQSIM Simulator/Localizer
Description:
The RESTITU system integrates medical diagnostic ultrasound systems, position sensing optical tracking systems, graphics workstations and other parts used to link these components together.
RESONANT's RESTITU is a 3D ultrasound-based image-guidance system that utilizes an ultrasound device, an optical camera tracking device and software platform to produce high quality data needed to perform accurate patient positioning and tumor localization.
RESTITU provides the capability to acquire high quality volumetric data before or after a treatment delivery fraction providing a strong set of data for treatment plan-delivery comparison studies. The RESTITU system can be integrated in any radiotherapy planning or treatment room for treatment verification. The RESTITU system resides in both the CT-
1
Sim and LINAC rooms and can be fully integrated into a comprehensive data and image network.
Intended use:
RESTITU 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 delivery of conformal radiation.
In both the radiotherapy planning and treatment rooms, the RESTITU system is used to acquire 2D U/S image slices with the integrated ultrasound system, and to match each of these 2D slices with 3D position and orientation obtained from the optical tracking component. In addition, the system also accomplishes the following tasks:
-
- Enable users to segment anatomical structures from the 3D U/S volume data set;
-
- Calculate the position and shape of a segmented anatomical structure;
-
- Calculate the vector and magnitude of the displacement between two anatomical structures obtained from two 3D data sets acquired at different times;
-
- Enable users to contour anatomical structures from the 3-D ultrasound volume set or 2-D ultrasound image slices:
-
- Track position of treatment couch to verify patient position.
Summary of technological characteristics compared to Predicate Devices:
The RESTITU™ system has a ceiling mounted optical tracker for measuring position and orientation as opposed to an attached robotic mechanical sensing arm or camera that the predicate devices use. The RESTITM system is similar in design, construction, materials. intended use, and performance characteristics to the predicate device. No new issues of safety or effectiveness are introduced by using this device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
NOV 1 6 2004
Resonant Medical, Inc. % Mr. Sean M. Curry Chief Operating Officer , Certified Software Solutions 16787 Bernardo Center Drive, #A-1 SAN DIEGO CA 92128 -
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K041937
Trade/Device Name: Restitu™ Regulatory Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Number: 21 CFR 892.5840 Regulatory Name: Radiation therapy Simulation system Regulatory Class: II Product Code: 90 IYE, IWB, and KPQ Dated: October 22, 2004
Received: November 10, 2004
Dear Mr. Curry:
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 mclude 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 (Premarket Approval), 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.
3
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrb/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
4
510(k) Number (if known): · Ko4 /937
Device Name: RESTITUTM
Indications for Use:
RESTITU™ can be used for the positioning of 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)
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