ONEDOSE PATIENT DOSIMETRY SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Sicel Technologies, Inc. The logo is in black and white and features the company name in a simple, sans-serif font. Above the company name is the date JUN 2 5 2004. 3800 Gateway Centre Boulevard • Suite 308 • Morrisville, NC 27560 • (919) 465-2236 • FAX (919) 465-0153 Ky4pi687 ## SUMMARY OF SAFETY AND EFFECTIVENESS This 510(k) summary of safety and effectiveness information is submitted in ro(is) outhinary the requirements of 21 CFR Part 807.87 (h). Submitter: Sicel Technologies, Inc. 3800 Gateway Centre Blvd. Suite 308 Morrisville, NC 27560 Contact: Tammy B. Carrea, Director Regulatory Affairs Phone: (919) 465-2236 ext. 225 Fax: (919) 465-0153 Prepared: March 15, 2004 Patient Radiation Dosimeter Common or Usual Name: OneDose Patient Dosimetry System Proprietary Name: Accelerator, Linear, Medical Classification Name: Sicel Technologies, Inc. Manufactured By: 3800 Gateway Centre Blvd. Suite 308 Morrisville, NC 27560 Phone: (919) 465-2236 Fax: (919) 465-0153 {1}------------------------------------------------ Predicate Device(s): Predicate Device(s): Thomson Nielsen K010472 and K032725 TN-RD-50 and Autosense Wireless Dosimetry System Sun Nuclear K021463 and K011332 rf-IVD and rf-IVD PC version Device Description: The OneDose Patient Dosimetry System consists of the following components and accessories: (1) disposable, single use, pre-calibrated radiation dosimeters, and accounts ( ( ) a reader, and (3) a reader calibration test strip. (2) a hand hold, bakery powers, metal oxide semiconductor field effect transistor as a sensing mechanism. The dosimeters are inserted into the Reader and as a sonoing mochanie a patient. The dosimeters are small and have no wires. They have a medical grade adhesive and liner on the back. The liner is veroo. They have 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 into the records are stored on the dosimeter for future reference and in the Reader's memory. Indication for Use: The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy applications. Comparison with Predicate Device: The OneDose and the Thomson Nielsen Patient Dose Verification System (K010472, K032725) and the Sun Nuclear RF-IVD System (K011332 and K021463) have the same intended use and similar indications, principles of operation and similar technological characteristics. Both devices are intended for patient dosimetry. The Sun Nuclear device and OneDose are battery powered. The Thomson Nielsen device and the OneDose use a MOSFET as the sensing mechanism. The only technological differences between the OneDose and its predicates are: (1) the OneDose is not wired to a patient; (2) the OneDose is precalibrated; and (3) the OneDose is a disposable, single use device. These differences do not present any new issues of safety or effectiveness because the OneDose is safer for the patient since there are no cables wired to the patient and the OneDose is more convenient for the user since it is pre {2}------------------------------------------------ calibrated and disposable. Kp40687 The OneDose, while pre-calibrated, is calibrated for thermal fluctuations in a The OneDoo, while pro callerater, is also provided by the methou similar to the outh Ractors built in. The OneDose is calibrated at the manufacturer with conceenship laction ball many on Nielsen for evaluating ractiation lactory using the same mothou are is calibrated under controlled conditions at the factory and the Thomson Nielsen device must be calibrated by the user. The the factory and the Thorneon Melescribed in sufficient detail within the 510(k) to lactory callbration procedureed to assure calibration and the data contained with demonstrate the mothers section demonstrates that calibrated devices perform within the stated performance specifications of the labeling. The OneDose is a single use dosimeter and the used device may be archived or The Onoboos to a omgio continuous re-use of dosimeters like with other dosimetry thrown away volous on. 510(k) demonstrates that the adhesive used with the Systems: Data whillif it adhering to skin is a safe, medical grade material found to be non-toxic, a non-sensitizer, and a non-irritant. Thus, the OneDose is substantially equivalent to the Thomson Nielsen Patient Dose Verification System (K010472, K032725) and the Sun Nuclear RF-IVD System (K011332 and K021463). {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUN 2 5 2004 Ms. Tammy B. Carrea Director, Regulatory Affairs Sicel Technologies, Inc. 3800 Gateway Centre Boulevard Suite 308 MORRISVILLE NC 27560 Re: K040687 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: 90 IYE Dated: June 1, 2004 Received: June 2, 2004 Dear Ms. Carrea: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beceived the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stared in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to may 2011 devices that have occh resulte approval of a premarket approval application (PMA). and Cosmetic Hot (710-) that 50 hevice, subject to the general controls provisions of the Act. The I ou may, therefore, mains 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 If your device is classinod (social controls . Existing major regulations affecting your device can may be subject to sater additions, 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 that I Dr. has made a determination and ministered by other Federal agencies. You must comply or any I catal statures and regalantians, but not limited to: registration and listing (21 CFR Part with an the 21 CFR Part 801); good manufacturing practice requirements as set forth in the 807), labornig (DF CFR Part 820); and if applicable, the electronic product quality of control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceling your antial equivalence of your device to a legally premaired predicated . The PDA misms of backed that the spermits 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 If you desire specific advice for your of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Auditionally, for questions on the promote the regulation entitled, "Misbranding Other of Comphanoo at (201) 97 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 by reletence to premarked nonmounton (21 cle Act may be obtained from the Division of Small Information on your responsionities and closed its toll-free number (800) 638-2041 or Manufacturers, International and Colress http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Bugden Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Indications for Use Statement 510(k) Number (if known): K844687 Device Name: OneDose Patient Dosimetry System Indications for Use: The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy applications. (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 C.F.R. 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) David Ch. Lyson (Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number __