ULTRASOUND TRANSDUCER DRAPE

{0} FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. : Oct. 17 1997 09:38AM P1 Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit K970889 6-1  OCT 20 1997 October 17, 1997 Document Mail Center Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850 USA # SUMMARY ## PREMARKET NOTIFICATION 510 (k) ### FOR ### POLYETHYLENE ULTRASOUND TRANSDUCER ### SURGICAL DRAPE KIT | 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: ULTRASOUND TRANSDUCER DRAPE KIT - POLYETHYLENE COMMON NAME: TRANSDUCER COVER, PROBE COVER, SURGICAL DRAPE, INSTRUMENT COVER CLASSIFICATION NAME: SURGICAL DRAPE (per 21 CFR Section 878.4370) PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258 {1} FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. : Oct. 17 1997 09:39AM P2 Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit K970889 6-2 # SUMMARY ## COMMERCIALY PRODUCED PRODUCTS OF EQUIVALENCE: There are several products of equivalence legally marketed including the following: Amedic of Sweden, MicroTek of Mississippi, USA and Civco Medical from Iowa, USA. These devices are similar to the predicate devices in respect to the materials, packaging, distribution and intended use. ## Substantial Equivalence Comparison: The following is a cross reference of products that will be identical: | New Device | Predicate Device | Civco | Civco's 510(k) | | --- | --- | --- | --- | | PROTEK Medical Inc. | | | | | 1-519-0122 | | 610-013 | K844472 | | 1-519-0124 | | 610-015 | K844472 | | 1-519-0126 | | 610-209 | K844472 | *Other part numbers vary only on size and shape These new products have the same intended use as legally marketed devices. The same end users. The same material manufactures the same tests and processes as Civco's legally marketed devices under 510(k) K844472. PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258 {2} FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. : Oct. 17 1997 09:39AM P3 Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit K970889 6-3 # SUMMARY ## DEVICE DESCRIPTION: ### Narrative Description: A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe. ### Device Physical Specifications: Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyethylene film, with a thickness of .001 inches-.003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape. ## Intended use: A polyethylene cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses: 1. General Purpose: Ultrasound scanning. 2. Cord cover for an extended sterile field on ultrasound transducer cords. 3. Rectal and vaginal scanning. 4. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination. ## TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE: (SEE ATTACHED CHART - APPENDIX D) PROTEK Medical Products Inc. Contact: Rick L. Proter Phone (319)358-8080 Fax (319)339-8258 {3} Oct. 17 1997 09:39AM P4 FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. : Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit K970889 6-4 # Appendix D in SUMMARY ## Substantially Equivalence Comparison Chart With Civco Medical K844472 | Description | PROTEK Medical Products Inc. | Civco Medical | | --- | --- | --- | | Indications for use | Ultrasound transducer covers | Ultrasound transducer covers | | Target Population | Sonographers, Doctor's and Technicians | Sonographers, Doctor's and Technicians | | Design | Sizes & Shapes Varies | Sizes & Shapes Varies | | Materials | Polyethylene .001-.003inches | Polyethylene .001-.003inches | | Additional Kit Components | Conductivity Gel Elastic Bands Plastic Medical Tape | Conductivity Gel Elastic Bands | | Performance | ASTM - F1671-95 | ASTM - F1671-95 | | Sterility | ETO | ETO | | Biocompatibility | ISO-10993 | ISO-10993 | | Mechanical Safety | Tensile Strength 2400 - 3500 PSI | Tensile Strength 2400 - 3500 PSI | | 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 | Global Test Methods for Resistance to Penetration | Global Test Methods for Resistance to Penetration | | Electrical Safety | No Electrical Components | No Electrical Components | | Manufacturing Method | Vertrod Heat Sealer | Vertrod Heat Sealer | | Packaging | TYVEK "Chevron Peel Pouch" | TYVEK "Chevron Peel Pouch" | | Human Factor | No Known Adverse Effects | No Known Adverse Effects | PROTEK Medical Products Inc. Contact: Rick L. Proter 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 20856 Mr. Rick L. Pruter President/CEO PROTEK Medical Products Incorporated 221 E. Market Street, Suite 291 Iowa City, Iowa 52245 OCT 20 1997 Re: K970889 Trade Name: Ultrasound Transducer Drape Kits, Polyurethane Regulatory Class: II Product Code: KKX Dated: July 1, 1997 Received: July 23, 1997 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 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 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, labeling, and prohibitions against misbranding and adulteration. {5} Page 2 - Mr. Pruter If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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. In addition, we have determined that your device kit contains Ultra/Phonic Conductivity Gel which are subject to regulation as drug. Our substantially equivalent determination does not apply to the drug component[s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component[s]. For information on applicable Agency requirements for marketing this [these] drug[s], we suggest you contact: Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063 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 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the {6} Page 3 - Mr. Pruter 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 "dsmo@fdadr.cdrh.fda.gov". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {7} Document # 9-926-0001 Rev.2 FDA 510(k) Notification-Polyethylene Surgical Drape 4-3 # 510(k) Number K970889 ## Statement ### Indication For Use Device Name: Polyethylene Ultrasound Transducer Drape: *Kit* I, Rick L. Pruter, President/CEO of PROTEK Medical Products Inc., certify that the devices in this notification are used for: Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.  Rick L. Pruter, President/CEO PROTEK Medical Products Inc.   PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258