GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE

{0} K971115 JUN 13 1997 Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide 6-1  February 20, 1997 Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850 USA # SUMMARY ## PREMARKET NOTIFICATION 510 (k) ## FOR TRANSRCTAL NEEDLE GUIDE ## an ULTRASOUND TRANSDUCER ACCESSORY | SUBMITTER: | Rick L. Pruter | | --- | --- | | COMPANY: | PROTEK Medical Products Inc. | | ADDRESS: | 221 East Market Street | | CITY: | Iowa City | | STATE: | Iowa | | COUNTRY: | USA | | CONTACT: | Rick L. Pruter | | PHONE: | (319)358-8080 | | FAX: | (319)339-8258 | DATE SUMMARY PREPARED: January 21, 1997 Trade Name: Transrectal Needle/Biopsy Guide for Ultrasound Transducers Common Name: Needle Guide, Puncher guide, Biopsy guide, Needle Guide system Classification Name: Diagnostic Ultrasound Transducer Accessory 892.1570 ITX class 11 PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258 {1} Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide 6-2 # SUMMARY ## COMMERCIALLY PRODUCED PRODUCTS OF EQUIVALENCE: ### Substantial Equivalence Comparison: These new devices are the same as devices being legally marketed by several companies. The new devices design, manufacturing, labeling and its intended uses are the same as many existing devices currently being marketed by Civco Medical Instruments, and Amedic among others. The only deviation is in the size and shape. Owner of this new company is co-inventor of these products and was an officer at Civco, one of the companies we are claiming substantial equivalence. The following is a cross reference of products that will be identical: | New Device | PROTEK Medical Inc | Civco | Civco’s 510(k) | | --- | --- | --- | --- | | | 1-535-0001 Guide | 612-045 | K875128/A | | | 1-535-0002 Guide | 612-035 | K875128/A | *Other part numbers vary only in size and shape ### Commercially Produced Products of Equivalence: There are several products of equivalence legally marketed by companies including the following: - Civco Medical from Iowa, USA - Amedic of Sweden, - GE Medical Wis. USA, ### Other known companies that legally market this device: - ATL Bothell Washington - Siemens Medical Systems Isaque Washington - Diasonics San Jose Calif. - Toshiba Tustin, California among others ### Comparison: (see Comparison Chart Appendix D-1) These devices are similar to several predicate devices legally marketed in respect to the materials, packaging, distribution and intended use. There are several hundred different configurations that Civco and Amedic are currently legally marketing for the (OEM)original equipment manufacturers. The original equipment manufacturers also legally markets these devices. This notification compares our product with Civco,s and Amedic and GE Medical. These new products have the same intended use as legally marketed devices. The same end users. The same material manufactures and the same people that tested and processed Civco’s legally marketed devices. PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258 {2} Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide 6-3 # SUMMARY ## DEVICE DESCRIPTION: ### Narrative Description: A tube, a cannula that is an accessory that snaps or rests (depending on configuration) onto an ultrasound transducer (892.1570) A disposable, single use, sterile tube that helps direct a needle, biopsy or catheter to a target working in conjunction with an ultrasound transducer and system ### Device Physical Specifications: A stainless steel cannula or plastic tube with a small clip or bracket for locating and securing. Dimensions and designs vary and are specified with the original equipment manufacturer of ultrasound systems and transducers ### Intended use: 1. Used to assist doctors when performing a prostate biopsy 2. Used to guide a needle, biopsy or catheter into the prostate gland. 3. Used as an accessory in conjunction with an ultrasound transducer (892.1570) 4. Used to improve needle placement vs. guiding needle with the finger ## TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE: (SEE ATTACHED CHART - APPENDIX D) PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258 {3} Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide 6-4 # Appendix D in SUMMARY ## Substantially Equivalence Comparison Chart With Civco Medical 510(k) #K875128/A | Description | PROTEK Medical Products Inc. | Civco Medical | | --- | --- | --- | | Indications for use | Ultrasound transducer needle guide | Ultrasound transducer needle guide | | Target Population | Doctor’s | Doctor’s | | Designed by | OEM, Doctor, PROTEK | OEM, Doctor, Civco | | Design | Sizes & Shapes Varies | Sizes & Shapes Varies | | Materials | Stainless steel Medical grade plastic | Stainless steel Medical grade plastic | | Performance | Target fixtures Mil Std 105E | Target Fixtures Mil Std 105E | | Sterility | ETO | ETO | | Biocompatibility | ISO-10993 | ISO-10993 | | Mechanical Safety | end product tests | end products tests | | Chemical Safety | No Hazardous Components 29CFR 1910,1200 | No Hazardous Components 29CFR 1910,1200 | | Anatomical Sites | Where Ultrasound is Used | Where Ultrasound is Used | | Disposition | Disposable | Disposable | | Where Used | Hospitals & Clinics | Hospitals & Clinics | | Standards Met | Mil Std 105E on voluntary standards | Mil Std 105E on voluntary standards | | Electrical Safety | No Electrical Components | No Electrical Components | | Manufacturing Method | Injection molded clips and purchased surgical tube | Injection molded clips and purchased surgical tube | | Packaging | TYVEK “Chevron Peel Pouch” | TYVEK “Chevron Peel Pouch” | | Human Factor | No Known Adverse Effects | No Known Adverse Effects | *OEM definition: Original Equipment manufacturer of Ultrasound Transducer 892.1570 PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258 {4} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 13 1997 Rick L. Pruter President/CEO PROTEK Medical Products, Inc. 221 E. Market, Suite 291 Iowa City, IA 52245-2166 Re: K971115 1-535-0001 Transrectal Needle Guide for GE Medical and 1-535-0002 Transrectal Needle guide for Acuson, Inc. Dated: February 20, 1997 Received: February 27, 1997 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX Dear Mr. Pruter: 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 (for the indications for use stated in the enclosure) to 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. 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA 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, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours,  Enclosure {5} Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide 510(k) Number K971115 # Statement ## Indication For Use I, Rick L. Pruter, President/CEO of PROTEK Medical Products Inc., certify that the devices in this notification are used for: Needle Guides for Rectal Ultrasound Transducers used in prostate biopsies.  Rick L. Pruter, President/CEO PROTEK Medical Products Inc. 6-11-97 (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K971115 Prescription Use ☑ (Per 21 CFR 801.109) PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258