(175 days)
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Not Found
No
The description focuses on mechanical accessories for patient positioning and collimation, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No.
The device is described as accessories for a Linear Accelerator, which is used for performing Stereotactic Radiosurgery or Radiotherapy. The accessories themselves do not directly perform the therapeutic action but facilitate it.
No
The device description indicates its use in performing Stereotactic Radiosurgery or Radiotherapy, which are treatment procedures, not diagnostic ones. The accessories are for patient positioning and treatment delivery, not for identifying a disease or condition.
No
The device description explicitly lists physical components such as a secondary collimation system, mounting components, and positioning components, indicating it is a hardware-based medical device.
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 Description: The SNT Linac Accessories are described as components used with a Linear Accelerator for Stereotactic Radiosurgery or Radiotherapy on cranial lesions. These are external treatment procedures performed directly on the patient's body, not on samples taken from the body.
- Intended Use: The intended use is to facilitate radiation treatment delivery, not to analyze biological samples for diagnostic purposes.
Therefore, the SNT Linac Accessories fall under the category of medical devices used for treatment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.
Product codes
90 IYE
Device Description
The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cranial lesions
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K971893". The characters are written in a cursive style, with some connections between the letters and numbers. The image is in black and white.
Summary of Safety and Effectiveness
SNT Linac Accessories
NOV 1 3 1997
Surgical Navigation Technologies I. Company: 530 Compton St. Broomfield, CO 80020 (303) 439-9709
- II. Product Name: SNT Linac Accessories
- III. The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.
- I V. The SNT Linac Accessories were shown to be substantially equivalent to other commercially available linear accelerator accessories.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1997
Roger N. White Group Director, Regulatory Affairs Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, CO 80020
Re:
K971893 SNT Linac Accessories Dated: August 15, 1997 Received: August 18, 1997 Regulatory class: II 21 CFR 892.5050 /Procode: 90 IYE
Dear Mr. White:
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 Cosmetic Act (Act). You may, therefore, 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 misbranion.
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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 Yui
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
Enclosure
2
Page _ l __ of_ l
510(k) Number (if known): ___ 9 71 89 3
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Ermit C. Simpson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Device 510(k) Number
Prescription Use " (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)