(273 days)
The Accu-Source™ remote control 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.
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.
The provided document is a 510(k) summary for a medical device called Accu-Source™, a Remote Control High Dose Rate Afterloading Brachytherapy Device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a formal clinical study with performance metrics as one might see in a de novo or PMA submission.
Therefore, the document does not contain the acceptance criteria and study details as requested in the input prompt (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic device).
Instead, it focuses on demonstrating that the Accu-Source™ device is substantially equivalent to a legally marketed predicate device (Nucletron MicroSelectron HDR Version 2). This is done through a comparison of technical specifications, intended use, and general features.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as "acceptance criteria" in the context of a performance study. However, the implicit acceptance criteria for a 510(k) submission are that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness. This is demonstrated by showing similar specifications and performance characteristics to the predicate.
- Reported Device Performance: The document provides a comparison table of technical specifications between the Accu-Source™ and its predicate, the Nucletron MicroSelectron HDR Version 2. This table highlights features, intended use, and various physical and operational parameters. The "performance" here is described by these specifications, rather than quantitative metrics from a clinical study.
| FEATURE | Nucletron Micro-Selectron (Predicate) | Oncology Systems, Inc. ACCU-SOURCE™ (New Device) | Comparison |
|---|---|---|---|
| Intended Use | Remote Afterloading Brachytherapy for various treatments | Remote control high dose rate brachytherapy for various treatments of cancer and other lesions | Equivalent |
| Height | Variable | 101cm | Similar |
| Weight | 150 lbs | 180 lbs | Similar |
| Transportable | V2 only | Yes | Similar |
| Power Supply | 110 VAC | 110 VAC/220 VAC | Similar |
| Mobile | Yes | Yes | Equivalent |
| HDR | Yes | Yes | Equivalent |
| Number of Channels | 18 | 24 | Different |
| Shielding | Tungsten | Tungsten | Equivalent |
| Maximum Activity of Shielding | 10 Ci | 12 Ci | Different |
| Maximum Treatment Activity | 10 Ci | 12 Ci | Different |
| Maximum exposure rate at XX distance containing the maximum activity | At 10cm = >2mR/h | Inner vault: > 100mR/h at 20cm; Outer vault: >2mR/h at 10cm | Different |
| Dwell positions per channel | 48 | Up to 100 dwell points per channel not to exceed 1200 total | Different |
| Total Channels | 18 | 24 | Different |
| Contains radiation monitor | Optional | Yes, Included | Different |
| Device Control OS Software | Windows | Windows XP | Similar |
| Treatment Data maintained during power failure | Yes | Yes | Equivalent |
| Simulator (Dummy) Source | Yes | Yes | Equivalent |
| Verification of Channel Length by direct measurement | By direct measurements | Yes, By direct measurements | Equivalent |
| Source Positioning | Distal to proximal | Distal to proximal | Equivalent |
| Maximum Source Position error over treatment length (+/- .5mm) | 1mm | .5 mm | Different (Better) |
| Emergency container for the source included | Optional | Yes, Included | Different |
| Response to Emergency signal | Automatic Retraction of Source | Automatic Retraction of Source | Equivalent |
| Emergency manual | Yes | Yes | Equivalent |
| Source Isotope | Ir192 | Ir192 | Equivalent |
| Source Maximum Activity | 10 Ci | 12 Ci for Ir192 | Different |
| Source Maximum Treatment Activity | 10 Ci | 12 Ci for Ir192 | Different |
| Source 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 | Different |
| Source 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 | Different |
| Source extension length | 150cm | 160cm | Different |
| Operator Console with personal computer | Yes | Yes | Equivalent |
| Keyswitch Control | Yes | Yes | Equivalent |
| Operating Voltage | 110/220 VAC | 110/220 VAC | Equivalent |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable: The document does not describe a clinical performance study with a test set of data. It is a comparison of technical specifications against a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: No clinical performance study or ground truth establishment is described for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No clinical performance study or adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable: This device is a remote afterloading brachytherapy system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is a physical brachytherapy system, not solely an algorithm. Its performance is demonstrated through its physical and operational specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable: The concept of "ground truth" for a performance study is not relevant in this 510(k) submission, which focuses on substantial equivalence based on technical specifications and safety features.
8. The sample size for the training set:
- Not Applicable: No machine learning or algorithm development with a training set is described.
9. How the ground truth for the training set was established:
- Not Applicable: No machine learning or algorithm development with a training set is described.
In summary: The provided 510(k) summary for the Accu-Source™ device establishes substantial equivalence by comparing its technical specifications and intended use to a predicate device, rather than through a detailed clinical or diagnostic performance study that would typically involve acceptance criteria, test/training sets, expert ground truth, or MRMC studies.
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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
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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 .
| FEATUREDevice | NucletronMicro-Selectron | Oncology Systems, Inc.ACCU-SOURCETM | |
|---|---|---|---|
| Intended Use | RemoteAfterloadingBrachytherapy unitfor interstitial,intracavity,intralumenal,including bronchial,intraoperative, andsurface applicatortreatments | The ACCU-SOURCE remotecontrol high dose ratebrachytherapy system isintended for the treatment ofcancer and other lesions byintracavity, interstitial,intralumenal, intraoperative,endobronchial and surfaceapplicator irradiationtreatments | |
| 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 | |
| NucletronMicro-Selectron | Oncology Systems, Inc.ACCU-SOURCE TM | ||
| HDR | Yes | Yes | |
| Number ofChannels | 18 | 24 | |
| Shielding | Tungsten | Tungsten | |
| Maximum Activity ofShielding | 10 Ci | 12 Ci | |
| MaximumTreatment Activity | 10 Ci | 12 Ci | |
| Maximum exposurerate a XX distancecontaining themaximum activity | At 10cm =>2mR/h | Inner vault: > 100mR/h at20cmOuter vault: >2mR/h at 10cm | |
| Dwell positions perchannel | 48 | Up to 100 dwell points perchannel not to exceed 1200dwell points (Ex. 24 channelsw/ 50 dwell points each or 12channels w/100 dwell pointseach) | |
| Total Channels | 18 | 24 | |
| Contains radiationmonitor | Optional | Yes, Included | |
| Device Control OSSoftware | Windows | Windows XP | |
| Treatment Datamaintained duringpower failure | Yes | Yes | |
| Simulator (Dummy)Source | Yes | Yes | |
| Verification ofChannel Length bydirect measurement | By directmeasurements | YesBy direct measurements | |
| Source Positioning | Distal to proximal | Distal to proximal | |
| Maximum SourcePosition error overtreatment length (+/-.5mm) | 1mm | .5 mm | |
| Emergencycontainer for thesource included | Optional | Yes, Included | |
| Response toEmergency signal | AutomaticRetraction ofSource | Automatic Retraction ofSource | |
| Emergency manual | Yes | Yes | |
| NucletronMicro-Selectron | Oncology Systems, Inc.ACCU-SOURCE TM | ||
| Source | Isotope | Ir192 | Ir192 |
| Maximum Activity | 10 Ci | 12 Ci for Ir192 | |
| MaximumTreatment Activity | 10 Ci | 12 Ci for Ir192 | |
| CapsuleDimensions | 4.5mm length by.9mm width | 4.5mm length by .9mm widthfor Ir192 and 6.9 mm length by1.17 mm width for Yb169 | |
| Active dimensions | 3.6mm length by.65mm width | 3.6mm length by .65mm widthfor Ir192 and 5.4mm length by.8mm width for Yb169 | |
| Source extensionlength | 150cm | 160cm | |
| Operator Console | Operating consolewith personalcomputer | Yes | Yes |
| Keyswitch Control | Yes | Yes | |
| Operating Voltage | 110/220 VAC | 110/220 VAC |
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KOSI753
the state of the state of the states and
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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.
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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
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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 |
§ 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.