MICROSELECTRON PDR

{0}------------------------------------------------ 041933 AUG 1 8 2004 Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black circle with two white circles on opposite sides. The square has a thin black border. The word "Nucletron" is positioned to the right of the square. NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone +31 318 557133 +31 318 550485 Fax Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Special 510(k) section # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c) #### Submitter of 510(k): | Company name: | Nucletron Corporation | |----------------------|-----------------------------------------| | Registration number: | 1121753 | | Address: | 8671 Robert Fulton Drive | | | Columbia, MD 21046 | | Phone: | 410-312-4100 | | Fax: | 410-312-4197 | | Correspondent: | Lisa Dimmick | | | Director Assurance & Regulatory Affairs | #### Modified Device Name: | Trade/Proprietary Name: | MicroSelectron PDR | |-------------------------|--------------------------------------------------| | Common/Usual Name: | Afterloader | | Classification Name: | Remote controlled radionuclide applicator system | | Classification: | 21Cfr892.5700 Class II | | Product Code: | JAQ | #### Legally Marketed Device(s) Eegally Marketed Device(e) below: | Manufacturer | Device Device<br><br><br>A<br>.<br><br>and and the contract and the country of the count<br><br><br>.<br>.<br>.<br>Children Children Controller, Children, Children, Children, Children, Children, Children, Children, Children, Children, Children, Children, Children, Children, Children, Chil<br>1401<br><br>and and send and significant and the may | 4 # 510(k) # | 12 145 | |-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------| | <br>---------------------------------------------------------------------------------<br>Nucletron BV | MicroSelectron HDR | KOSZAAG | | {1}------------------------------------------------ #### Description: The microSelectron Afterloading System concerns a microSelectron -HDR (V2) with 18 The microSecuren Anonouang Of the microSelectron Afterloading System concerns a treatment chamiles. The operater vehich is similar as in the predicate device PC running dedicatou Troutinent plans are transferred from the radiotherapy treatment microseedformBrt (v2). Troatment Console Software by file transfer. Connection to a LAN is planning soltware to the Transfer of Treatment Plan Files. It is the same as in the predicate only for the parpose of I he Treatment Console Software Console Software from radiotherapy treatment planning software running on a separate computer. The radiotherapy treatment planning software is not part of this 510(k) submission. Applicators The Tadiotherapy « Cathere for microSelectron-HDR (V2) are also applicable for the aria Transfer Tubes as available for Information of the ended as a modality to the Nucletron microSelectron Afterloader system. The PC based Afterloader workstation is the current TCS workstation, but ported to from a rrie TO based Alteriouse woment of the PC based Afterloader workstation comes with functionality to support PDR procedures (i.e. Scheduling of treatments). The modifications to the previously cleared device K953946 are: - Addition of RCU and NSD previously cleared device K902533 . - Addition of Radiation Status Indicator . - Changes to TCS to enable the PDR workflow . - Addition of Smoothbase, part of previously cleared device K031158 . The software runs on a PC with a Windows XP platform. #### Intended use: The modified device has the same intended use as the legally marketed predicate device cited: The MicroSelectron PDR is intended to enable an operator to apply, by remote control, a r ric Millorolooron PB the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, radionablias obarbs into intra-operative) or to the surface of the body for radiation therapy. #### Summary of technological considerations: MicroSelectron PDR is substantially equivalent to the cleared predicate device, microSelectron HDR, 510(k)#: K953946. 5 July 2004 {2}------------------------------------------------ Name: Frits van Krieken Namor Title: Business Segment Manager Nucletron B.V. Nasional, The Netherlands Date {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's logo, which includes a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### AUG 1 8 2004 Ms. Lisa Dimmick Director Assurance & Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046 1 Re: K041933 Trade/Device Name: MicroSelectron HDR Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: July 16, 2004 Received: July 19 2004 Dear Ms. Dimmick: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your over in (d the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases of the enactment date of the Medical Device Amendments, or to conniner of the 11th) 2011/11/2017 11/2017 11/2017 11/2019 of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Oosmotion Free , market the device, subject to the general controls provisions of the Act. The I ou may) iterer or visions 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 rr your device to such additional controls. Existing major regulations affecting your device can may or subject to sateral 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 that I Dri has mado a deterministered by other Federal agencies. You nust comply or any I ocerar stareer and and ons, 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 our ); and mig (IT CFR Part 820); and if applicable, the electronic product quanty by sections (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 allow you to begin harketing four antial equivalence of your-device to a legally premarket notification. The PDA midning of succeantly of 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 dones on our of the following numbers, based on the regulation number at the top of the letter: | 8xx. Ixxx | (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 Additionally, for questions on the prement. Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Comphance at (301) 37 1 105 (21 Part 807.97) you may obtain. Other general by relevence to premarket notification (21 OF Act may be obtained from the Division of Small information on your responsionalities and its toll-free number (800) 638-2041 or Manufacturers, International and Oollsamer Passes http://www.fda.gov/cdrh/dsmaldsmamain.html. Sincerely yours, Nancy C. Brigdon 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 Device Name Indications for Use (041933 MicroSelectron PDR The MicroSelectron PDR is intended to enable an operator to apply, by remote The MicroSelectron FDR is intended to ony (including Interstitial, Intracavitary, control, a radionuclide source into the body (including Interstitial, Intracavitary, control, a radionucilde source into the boury (versionerative) or to the surface of the body for radiation therapy. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Tamiola Leggans (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number . Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_