(273 days)
No
The device description focuses on mechanical and electronic components for source positioning and control, with no mention of AI or ML terms or functionalities.
Yes
The device is intended for the treatment of cancer and other lesions using radiation, which directly delivers therapy to patients.
No
The device is used to treat cancer and other lesions by delivering radiation, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components such as an operator console, remote afterloading device, shielded storage safe, radioactive source, encoders, motors, electronic circuitry, battery, and uninterruptible power supply. This indicates it is a hardware system with integrated software, not a software-only device.
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 for diagnosis, monitoring, or screening.
- Device Function: The Accu-Source™ system is a therapeutic device. It delivers radiation directly to the patient's body to treat cancer and other lesions. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments." This is a description of a therapeutic procedure, not a diagnostic test.
Therefore, based on the provided information, the Accu-Source™ remote control high dose rate afterloading brachytherapy system is a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ACCU-SOURCE™ remote controlled high dose rate afterloading brachytherapy system is intended for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.
Product codes
JAQ
Device Description
The Accu-Source™ is a remote afterloading system for High Dose Rate Brachytherapy. The system is designed to deliver a predetermined dose of radiation to organs and tissue via a radioactive source.
The ACCU-SOURCE™ system includes an operator console and a remote afterloading device. The ACCU-SOURCE™ system has a tungsten shielded storage safe which houses a radioactive source when the system is not in use. There are encoders and motors used in conjunction with electronic circuitry that drive the source and keep track of its position. A battery is used for back-up power and an uninterruptible power supply is also integrated into the ACCU-SOURCE™ system to charge the battery backup subsystem.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
MAR 2 9 2006
510(k) Summary
Submitter: Oncology Systems, Inc.
Address: 206 N. Randolph Street, Suite 300 Champaign, IL 61820
Phone number: (217) 355-4460
Fax number: (217) 355-4470
Contact Person: Jennifer Williams
Date Prepared: May 27, 2005
Trade Name: Accu-Source™
Common Name: Remote Control High Dose Rate Afterloading Brachytherapy Device
Classification name: Remote Controlled Radionuclide System, 90 JAQ, Regulation 21 CFR క్ర892.5700.
Substantial Equivalence claimed to:
-
- Nucletron-Oldeft Corporation K953946 Microselectron-HDR Version 2
1
Kos1753
Description:
The Accu-Source™ is a remote afterloading system for High Dose Rate Brachytherapy. The system is designed to deliver a predetermined dose of radiation to organs and tissue via a radioactive source.
The ACCU-SOURCE™ system includes an operator console and a remote afterloading device. The ACCU-SOURCE™ system has a tungsten shielded storage safe which houses a radioactive source when the system is not in use. There are encoders and motors used in conjunction with electronic circuitry that drive the source and keep track of its position. A battery is used for back-up power and an uninterruptible power supply is also integrated into the ACCU-SOURCE™ system to charge the battery backup subsystem.
Intended Use:
The ACCU-SOURCE™ remote controlled high dose rate afterloading brachytherapy system is intended for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.
Technical Specifications:
Comparison Table Substantial Equivalent Device
The ACCU-SOURCE™ system is comparable to:
- Nucletron MicroSelectron HDR Version 2 .
| FEATURE
Device | Nucletron
Micro-Selectron | Oncology Systems, Inc.
ACCU-SOURCETM | |
|------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use | Remote
Afterloading
Brachytherapy unit
for interstitial,
intracavity,
intralumenal,
including bronchial,
intraoperative, and
surface applicator
treatments | The ACCU-SOURCE remote
control high dose rate
brachytherapy system is
intended for the treatment of
cancer and other lesions by
intracavity, interstitial,
intralumenal, intraoperative,
endobronchial and surface
applicator irradiation
treatments |
| | Base Area | | |
| | Height | Variable | 101cm |
| | Weight | 150 lbs | 180 lbs |
| | Transportable | V2 only | Yes |
| | Power Supply | 110 VAC | 110 VAC/220 VAC |
| | Mobile | Yes | Yes |
| | Nucletron
Micro-Selectron | Oncology Systems, Inc.
ACCU-SOURCE TM | |
| HDR | Yes | Yes | |
| Number of
Channels | 18 | 24 | |
| Shielding | Tungsten | Tungsten | |
| Maximum Activity of
Shielding | 10 Ci | 12 Ci | |
| Maximum
Treatment Activity | 10 Ci | 12 Ci | |
| Maximum exposure
rate a XX distance
containing the
maximum activity | At 10cm =
2mR/h | Inner vault: > 100mR/h at
20cm
Outer vault: >2mR/h at 10cm | |
| Dwell positions per
channel | 48 | Up to 100 dwell points per
channel not to exceed 1200
dwell points (Ex. 24 channels
w/ 50 dwell points each or 12
channels w/100 dwell points
each) | |
| Total Channels | 18 | 24 | |
| Contains radiation
monitor | Optional | Yes, Included | |
| Device Control OS
Software | Windows | Windows XP | |
| Treatment Data
maintained during
power failure | Yes | Yes | |
| Simulator (Dummy)
Source | Yes | Yes | |
| Verification of
Channel Length by
direct measurement | By direct
measurements | Yes
By direct measurements | |
| Source Positioning | Distal to proximal | Distal to proximal | |
| Maximum Source
Position error over
treatment length (+/-
.5mm) | 1mm | .5 mm | |
| Emergency
container for the
source included | Optional | Yes, Included | |
| Response to
Emergency signal | Automatic
Retraction of
Source | Automatic Retraction of
Source | |
| Emergency manual | Yes | Yes | |
| | | Nucletron
Micro-Selectron | Oncology Systems, Inc.
ACCU-SOURCE TM |
| Source | Isotope | Ir192 | Ir192 |
| | | | |
| | Maximum Activity | 10 Ci | 12 Ci for Ir192 |
| | | | |
| | Maximum
Treatment Activity | 10 Ci | 12 Ci for Ir192 |
| | | | |
| | Capsule
Dimensions | 4.5mm length by
.9mm width | 4.5mm length by .9mm width
for Ir192 and 6.9 mm length by
1.17 mm width for Yb169 |
| | | | |
| | Active dimensions | 3.6mm length by
.65mm width | 3.6mm length by .65mm width
for Ir192 and 5.4mm length by
.8mm width for Yb169 |
| | Source extension
length | 150cm | 160cm |
| Operator Console | Operating console
with personal
computer | Yes | Yes |
| | Keyswitch Control | Yes | Yes |
| | Operating Voltage | 110/220 VAC | 110/220 VAC |
2
【 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【
.
3
KOSI753
the state of the state of the states and
.
:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines, resembling a bird or a symbol representing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer Williams Official Correspondent Oncology Systems, Inc. 206 N. Randolph Street, Suite 300 CHAMPAIN IL 61820
Re: K051753
MAR 2 9 2006
Trade/Device Name: ACCU-SOURCE Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ
Dated: February 16, 2006 Received: February 21, 2006
Dear Ms. Williams:
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 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); 200d manufacturing practice requirements as set forth in the quality systems (05) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
5
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/cdrh/industrv/support/index.html
Sincerely yours.
T. Nancy C. Brigdon
Naney C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices ()fice of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Accu-Source™
Indications for Use:
The Accu-Source™ remote control high dose rate afterloading brachytherapy system is indicated for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K051753 |