(34 days)
Not Found
No
The description focuses on hardware components (dosimeters, reader) and basic data storage/reporting, with no mention of AI/ML terms or functionalities like image processing, complex data analysis, or learning algorithms.
No.
The device measures a patient's dose during radiotherapy application, rather than directly treating or diagnosing a condition.
No
The device measures a patient's radiation dose during radiotherapy, which is a treatment process. It does not identify a disease, condition, or state of health.
No
The device description explicitly lists hardware components such as disposable dosimeters, a hand-held reader, and a calibration test strip, in addition to the reader download software.
Based on the provided information, the OneDose Patient Dosimetry System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "measure a patient's dose during radiotherapy application." This involves measuring a physical parameter (radiation dose) directly on or within the patient's body.
- Device Description: The device components and their function (measuring radiation dose using a MOSFET placed on the patient) are consistent with in vivo measurement, not in vitro testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests outside of the body.
IVDs are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The OneDose system does not fit this definition. It is a device for measuring a physical quantity (radiation dose) applied to the patient.
N/A
Intended Use / Indications for Use
The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy application.
The One Pattent Dosimeter System is intended to measure a patient's dose during radiotherapy applications. This intended use thas not changed as a result of the modifications.
Product codes
IYE
Device Description
The OneDose Patient Dosimetry System consists of the following components and accessories: (1) disposable, single use, pre-calibrated radiation dosiments, (2) a hand held, battery powered reader, (3) a reader calibration test strip and (4) reader download software. The dosimeters use a MOSFET, metal oxide semiconductor field effect transistor as a sensing mechanism. The dosimeters are inserted into the Reader and zeroed, then positioned onto a patient. The dosimeters are small and have no wires. They have a medical grade adhesive and liner on the back. The liner is removed and the adhesive side of the dosimeter is adhered to the patient. Following radiotherapy, the dosimeters are removed from the patient, re-inserted into the Reader, and the patient's dose is read and reported by the Reader. The patient's records are stored on the dosimeter for future reference and in the Reader's memory.
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)
Furthermore, verification and validation testing provided information sufficient to determine that the modifications did not have an effect on safety or effectiveness and demonstrated that the device met pre-determined acceptance criteria based on performance specifications. The testing demonstrated that the modified device is substantially equivalent to the predicate device and performs as well as the predicate device.
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
§ 892.5050 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
AUG - 4 2008 081855
Attachment 5 - 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h).
Submitter:
Sicel Technologies, Inc. 3800 Gateway Centre Blvd. Suite 308 Morrisville, NC 27560
Contact: Suzanne Schwaller, Regulatory Affairs Associate Phone: (919) 465-2236 ext. 363 Fax: (919) 465-0153
Prepared: June 27, 2008
| Common or Usual
| Name: | Radiation Dosimeter |
|---|---|
| Proprietary Name: | OneDose Patient Dosimetry System |
| Classification Name: | Accelerator, Linear, Medical |
| Manufactured By: | Sicel Technologies, Inc. |
| 3800 Gateway Centre Blvd. | |
| Suite 308 | |
| Morrisville, NC 27560 | |
| Phone: (919) 465-2236 | |
| Fax: (919) 465-0153 |
Predicate Device(s):
Sicel Technologies, Inc. K040687 OneDose Patient Dosimetry System
Device Description:
The OneDose Patient Dosimetry System consists of the following components and accessories: (1) disposable, single use, pre-calibrated radiation dosiments, (2) a hand held, battery powered reader, (3) a reader calibration test strip and
1
(4) reader download software. The dosimeters use a MOSFET, metal oxide semiconductor field effect transistor as a sensing mechanism. The dosimeters are inserted into the Reader and zeroed, then positioned onto a patient. The dosimeters are small and have no wires. They have a medical grade adhesive and liner on the back. The liner is removed and the adhesive side of the dosimeter is adhered to the patient. Following radiotherapy, the dosimeters are removed from the patient, re-inserted into the Reader, and the patient's dose is read and reported by the Reader. The patient's records are stored on the dosimeter for future reference and in the Reader's memory.
Intended Use:
The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy application.
Comparison with Predicate Device:
The intended use of this OneDose Patient Dosimetry System is identical to the predicate device, the OneDose Patient Dosimetry System as cleared in K040687.
The technological features of the OneDose Patient Dosimetry System are the same as the predicate including the use of MOSFET technology, the calibration method, the dose range for a single dose, the energy types measured, and the method of adhesion to the skin. The principle of operation is the same as the predicate. The primary difference between the predicate device and the modified device is the change in the accuracy specification, the addition of a dosimeter version with an integrated build-up cap, and the addition of a download software option which allows programming of the reader and creating of predefined reports. There are multiple material changes including minor changes to the dosimeter encapsulant, circuit board components and passivation laver and an addition of a grommet edging to the keypad connector. Minor changes dimensions were also implemented. Details of the substantial equivalence comparison are provided.
Furthermore, verification and validation testing provided information sufficient to determine that the modifications did not have an effect on safety or effectiveness and demonstrated that the device met pre-determined acceptance criteria based on performance specifications. The testing demonstrated that the modified device is substantially equivalent to the predicate device and performs as well as the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Suzanne M. Schwaller Regulatory Affairs Associate Sicel Technologies, Inc. 3800 Gateway Centre Blyd., Suite 308 MORRISVILLE NC 27560
AUG - 4 2008
Re: K081859
Trade/Device Name: OneDose Patient Dosimetry System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 30, 2008 Received: July 1, 2008
Dear Ms. Schwaller:
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 (PMA), 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.
3
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 associa product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.
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 legally marketed predicate device results in a classification for your device of your device to resur 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 Center for Devices and Radiological Health's (CDRH's) Office of Comminations) problem 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, release contact CDRH Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may reportain 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) 633-241 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html U
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 6 - Intended Use Statement
510(k) Number (if known): K022859
Device Name: OneDose Patient Dosimetry System
Intended Use:
The One Pattent Dosimeter System is intended to measure a patient's dose during
radiotherapy applications. This intended use thas not changed as a result of the modifications.
(Please do not white below this line - continue on another page if ne
Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use (Per 21 C.F.R. 801.109
The Counter Us
(Optional Format
Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Nümber
chnologies, Inc. One Dose Patient Dosimetry System Special 510(k) Jun 2001: