DRAPE, SURGICAL-LATEX

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 26 2004 Mr. Rick L. Pruter PROTEK Medical Products, Incorporated 221 East Market Street, Suite 291 Iowa City, Iowa 52245-2166 Re: K970891 Trade/Device Name: Latex Ultrasound Transducer Surgical Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 12, 1997 Received: July 23, 1997 Dear Mr. Pruter: This letter corrects our substantially equivalent letter of August 22, 1997 regarding the product code. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent [(for the indications for use stated in the enclosure)] 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) that do not require approval of a premarket approval (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1} Page 2 - Mr. Pruter 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, 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 quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours,  Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Document #9-926-0003 Rev. 1 FDA 510(k) Notification-Latex Surgical Drape 6-1 K970891 # PROTEK MEDICAL PRODUCTS INC. 211 E MARKET SUITE 291 IOWA CITY IS 319-358-8080 FAX 319-339-8258 USA 52245-2166 February 20, 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 ##### LATEX ###### ULTRASOUND TRANSDUCER SURGICAL DRAPE | 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-LATEX 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)359-8258 {3} Document #9-926-0003 Rev. 1 FDA 510(k) Notification-Latex Surgical Drape 6-2 # SUMMARY ## COMMERCIALLY 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, (details in body of this submission appendix). 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 | | | --- | --- | --- | --- | | PROTEK Medical Products Inc. | | Civco’s | Civco’s 510(k) | | 1-519-0350 | 5 X 30 | 610-043 | K895614 | | 1-519-0380 | 8 X 30 | 610-044 | K895614 | | 1-519-0399 | 10 X 30 | 610-046 | K895614 | | 1-519-0320 | 2 X 20 | 610-075 | K895614 | | 1-519-0326 | 2.6 X 20 | 610-213 | K895614 | | 1-519-0335 | 3.5 X 20 | 610-214 | K895614 | | 1-519-0336 | 3.5 X 20 | 610-010 | K895614 | *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 and the same people that tested and processed Civco’s legally marketed devices. Other 510(k) numbers that have the same intended use are K844472 and K943393 under Civco Medical, K882724 MicroTek Probe Drape and 3m #1071 Drape PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)359-8258 {4} Document #9-926-0003 Rev. 1 FDA 510(k) Notification-Latex Surgical Drape 6-3 # SUMMARY ## DEVICE DESCRIPTION: ### Narrative Description: A sterile bag to contain a non-sterile ultrasound transducer probe during a sterile procedure. A disposable, single use, sterile instrument cover/drape to protect the patients from cross contamination from bacteria’s of a non-sterile ultrasound transducer probe. A sterile barrier between patient and ultrasound transducer probe. ### Device Physical Specifications: Dip molded natural latex rubber Thickness-.001-.007 Sizes-Sizes range from 1.5cm X 10cm thru 8.0cm x 30cm ## Intended use: A cover/drape or sterile barrier placed on an ultrasound transducer 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. Intro-operative procedure that use non-sterile ultrasound transducers and require an extra sterile barrier. This would include invasive procedures where blood path indirect contact may occur. 3. Rectal and vaginal scanning. ## 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)359-8258 {5} Document #9-926-0003 Rev. 1 FDA 510(k) Notification-Latex Surgical Drape 6-4 # Appendix D in SUMMARY ## Substantially Equivalence Comparison Chart With Civco Medical | Description | PROTEK Medical Products Inc. | Civco Medical | | --- | --- | --- | | Comment | | | | 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 | LATEX.001-.007 | LATEX .001-.007 | | Vendors | Kent Latex, Ohio Killian Latex, Ohio | Kent Latex, Ohio Killian Latex, Ohio | | Performance | ASTM - ES - 22 | ASTM - ES - 22 | | 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 | | Manufacturing Method | Dipped Latex Vertrod Heat Scaler | | | Packaging | TYVEK “Chevron Peel Pouch” | TYVEK “Chevron Peel Pouch” | | Human Factor | Labels identify this product as Latex | Labels identify this product as Latex | PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)359-8258 {6} Document #9-926-0003 Rev. 2 FDA 510(k) Notification-Latex Surgical Drape 4-4 510(k) Number (if known) K970891 Device Name: Latex Ultrasound Transducer Drape Indication for Use: Latex Drapes for Ultrasound Transducers. A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE TO ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K970891 Prescription Use (Per 21 CFR 801.109) OR Over The Counter Use ☑ (Optional Format 1-2-96) PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)359-8258