(54 days)
No
The summary describes a device that uses barcode scanning for verification, with no mention of AI or ML technologies.
No
The device is described as a verification system that prevents irradiation until the correct conical collimator is in place. It assists operators of radiation therapy devices but does not directly deliver therapy or treat a disease.
No
The device verifies the presence of a conical collimator required by a treatment plan, which is a safety mechanism to prevent incorrect irradiation, not to diagnose a patient's condition.
No
The device description explicitly states it provides verification for specific hardware devices (Varian High Energy Clinac and TrueBeam) and prevents treatment until a physical component (conical collimator) is scanned. This implies interaction with and control over hardware, not a standalone software function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Barcode Conical Collimator Verification device's function is to verify the presence of a specific piece of equipment (a conical collimator) on a radiation therapy machine. It does not analyze any biological samples from a patient.
- Intended Use: The intended use is to assist operators of radiation therapy devices by preventing irradiation until the correct collimator is in place. This is a safety and procedural check for the radiation therapy equipment itself, not a diagnostic test performed on a patient's sample.
Therefore, based on the provided information, the Barcode Conical Collimator Verification device falls under the category of a medical device used in the delivery of radiation therapy, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Barcode Conical Collimator Verification device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place.
Product codes
IYE
Device Description
The Barcode Conical Collimator Verification (BCCV) device provides verification of conical collimators for the Varian High Energy Clinac (K100890) and TrueBeam (K092871) devices. Conical collimators are used during stereotactic radiodurgery (SRS) treatments to deliver small diameter treatment beams. The BCCV will prevent treatment until the conical collimator, as required by the treatment plan, has been scanned.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operators of radiation therapy devices
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)
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
KID3394
Premarket Notification 510(k) Summary Barcode Conical Collimator Verification (BCCV)
JAN 1 2 2011
The following information is provided following the format of 21 CFR 807.92.
| Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way e-110
Palo Alto, CA 94304 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Vy Tran |
| | Phone: 650/424.5731 |
| | Fax: 650/842.5040 |
| | Date: 15 November 2010 |
| Proprietary Name: | Barcode Conical Collimator Verification (BCCV) |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: IYE |
| Common/Usual Name: | Barcode Conical Collimator Verification (BCCV) |
| Predicate Devices: | 4D Integrated Treatment Console with PAVS, K081036 |
| Device Description: | The Barcode Conical Collimator Verification (BCCV) device provides
verification of conical collimators for the Varian High Energy Clinac
(K100890) and TrueBeam (K092871) devices. Conical collimators are
used during stereotactic radiodurgery (SRS) treatments to deliver small
diameter treatment beams. The BCCV will prevent treatment until the
conical collimator, as required by the treatment plan, has been
scanned. |
| Statement of Indications for Use: | The Barcode Conical Collimator Verification device assists operators of
radiation therapy devices by preventing irradiation until the conical |
Technological Characteristics:
Refer to the Substantial Equivalence Comparison Chart in this dossier.
collimator required by the treatment plan is in place.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Vy Tran Official Correspondent Varian Medical Systems. Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
JAN 1 2 2011
Re: K103394
Trade/Device Name: Barcode Conical Collimator Verification (BCCV) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 17, 2010 Received: November 19, 2010
Dear Ms. Tran:
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 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
| Indications for Use Form | |
|---|---|
| -- | -------------------------- |
| 510(k) Number (if known): | K103394 | JAN 12 2011 | |
|---|---|---|---|
| Device Name: | Barcode Conical Collimator Verification (BCCV) | ||
| Indications for Use: | The Barcode Conical Collimator Verification device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place. |
| Prescription Use | ✓ (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| ------------------ | ----------------------------------------------------- | -------- | -------------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
| Division Sign-Off |
|---|
| Office of In Vitro Diagnostic Device |
0 Evaluation and Safety
ﺎﻧﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
510(k) K103394
Page 1 of 1
.