MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT

{0}------------------------------------------------ K983/24 # Attachment 4 ## 510(k) Summary ## Premarket Notification [510(k)]: ## TBNA Cytology Procedural Kit | 1. | Submitter: | Mill-Rose Laboratories, Inc. | |----|------------|----------------------------------------------------------| | | | 7310 Corporate Blvd. | | | | Mentor, OH 44060 | | | | (440) 255-7995 | | | Contact: | Alan C. Poje, Director of Regulatory Affairs and Quality | This summary was prepared on August 24, 1998. - Proprietary Name: Mill-Rose Laboratories Transbronchial Needle Aspiration 2. (TBNA) Cytology Procedural Kit Common Name: none Classification Name: none #### Statement of Equivalence 3. All the components of the kit are either legally marketed preamendments devices, exempt from premarket notification, or have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is to be intended. The following chart lists the components, their 510(k) status, and classification. | Components | 510(k) Status | Classification | |---------------------------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------| | "MRL transbronchial<br>aspiration needle (TBAN)<br>of choice" | K914181 | 21 C.F.R. § 874.4680<br>Bronchoscope (flexible or<br>rigid) and accessories,<br>Class II | | MW-100 lockable syringe<br>(20cc) | K852607 | 21 C.F.R. § 880.5860<br>Piston syringe, Class II | | 95% EtOH fixative (50cc) | Exempt from premarket<br>notification | 21 C.F.R. § 864.4010<br>General purpose reagent,<br>Class I | {1}------------------------------------------------ | Components | 510(k) Status | Classification | |-------------------------------------|---------------------------------------|--------------------------------------------------------------------| | Cytolyt preservative (30cc<br>vial) | Exempt from premarket<br>notification | 21 C.F.R. § 864.4010<br>General purpose reagent,<br>Class I | | NaCI irrigation solution<br>(110cc) | Exempt from premarket<br>notification | 21 C.F.R. § 864.4010<br>General purpose reagent,<br>Class I | | Microscope slides (1" x 3") | Exempt from premarket<br>notification | 21 C.F.R. § 864.3010<br>Tissue processing<br>equipment,<br>Class I | ### Device Description 4. The Transbronchial Needle Aspiration Cytology Procedural Kit contains items for obtaining and handling of cytologic specimens in the context of a transbronchial aspirating needle procedure. ### 5. Intended Use The Transbronchial Needle Aspiration Cytology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic examination. ### 6. Technological Characteristics The technological characteristics of the kit components do not vary from those of the components when used individually and not in the context of the kit. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 3 0 1998 Alan C. Poje Director of Regulatory Affairs and Quality Mill-Rose Laboratories, Inc. 7310 Corporate Blvd. Mentor, OH 44060 Re: K983124 Mill-Rose Laboratories Transbronchial Needle Aspiration (TBNA) Cytology Procedural Kit Regulatory class: II/21 CFR 874.4680 Product Code: 77 EOQ Dated: September 4, 1998 Received: September 8, 1998 Dear Mr. Poje: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (DDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, ar other Federal Laws or Regulations. {3}------------------------------------------------ Page 2 - Alan C. Poje This letter will allow you to begin marketing your device as described in your S10(k) prematice notification This letter will allow you to begin maketing your device to slots predicated predicated motivation The FDA finding of substantial equits your device to proceed to the market. The FDA finding of substantial equivalence of your device to proceded to the market. The FDA finding of substantial equivalence of your device to processor to treasure and classification for your device on the labeling regulation (2) CFR Part 801 and additionally If you desire specific advice for your device on the labeling regulation of Compli If you desire specific advice on the labeling regulation (21 ℃ 1 × 1 × 1 (100 × 809.10 for in vitro diagnosic devices), please contact the Office of Compliance of Conficultur If you desire specific devices), please contact the Office of Complance at (30) 7 >> Poster of 809.10 for in yitte diagnosio and advertising of your device, please of anneles Additionally, for questions on the promotion and advertising of your device the the the counted to the the counter the comments of the comments of the comments of the comment Additionalig. Of Question on the regilation intitled. "Nisranding of versions in Actives une Active Act Compliance at (301) 594–639. Also, please note information on your res Complance at (501) 734 1697.97). Other general information on your responsibility on the more and the more and the more and the more and the more of the manner (800) 638-204 premainted from the Division of Small Manufacturers Assistance at is too and the more of the main.html". or (301) 443-6597, or at its internet address "http://www.fda.gov/cdr Sincerely yours, Thos. L. Seysson \$\mu\$ Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Health Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # Attachment 2 Indications for Use Statement Premarket Notification [510(k)]: TBNA Cytology Procedural Kit Indications for Use: The Transbronchial Needle Aspiration Cytology Procedural Kit is intended to retrieve The Transbronchlar Needle Aspiration Oyclogy Prossal in and handle specimens and to prepare them for proper cytopathic examination. 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) Amit h. Sengar Division Sign-Off ion Sign-Off ivision of Reproductive, Abdominal, ENT and Radiological 510(k) Number