← Product Code [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA) · K970893 # ULTRASOUND TRANSDUCER DRAPE (K970893) _Protek Medical Products, Inc. · FYA · Oct 20, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K970893 ## Device Facts - **Applicant:** Protek Medical Products, Inc. - **Product Code:** [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA.md) - **Decision Date:** Oct 20, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it 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. ## Device Story Device is a sterile, single-use kit containing a polyurethane film cover/drape, conductivity gel, elastic bands, and plastic medical tape. The drape acts as a physical barrier between a non-sterile ultrasound transducer probe and the patient's internal or external body surfaces during surgical or diagnostic procedures. Used in hospitals and clinics by sonographers, physicians, and technicians. The drape is placed over the transducer and cord to maintain a sterile field and prevent microbial contamination of the surgical site. Benefits include infection control and protection of the transducer during procedures. ## Clinical Evidence Bench testing only. Evidence includes microbial challenge testing to verify barrier effectiveness against contamination and mechanical safety testing (tensile strength of 6250 PSI at break). Biocompatibility testing performed per ISO-10993 standards. No clinical data provided. ## Technological Characteristics Materials: Extruded polyurethane film (.001-.003" thickness). Components: Conductivity gel, elastic bands, plastic medical tape. Sterilization: Ethylene Oxide (ETO). Packaging: TYVEK chevron peel pouch. Manufacturing: Vertrod heat sealer. No electrical components. Biocompatibility: ISO-10993 compliant. ## Regulatory Identification Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded. ## Special Controls *Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. ## Predicate Devices - Civco Medical ([K844472](/device/K844472.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. : Oct. 17 1997 12:51PM P1 Document #9-926-0002 Rev. 4 FDA 510 (k) Notification-Polyurethane Surgical Drape Kit K970093 OCT 20 1997 6-1 PROTEK MEDICAL PRODUCTS INC. 211 E. MARKET SUITE 291 IOWA CITY IA 319-358-8080 FAX 319-339-8258 USA 52245-2166 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 POLYURETHANE 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 - POLYURETHANE 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 12:51PM P2 Document #9-926-0002 Rev. 4 FDA 510 (k) Notification-Polyurethane Surgical Drape Kit K970893 # SUMMARY 6-2 ## 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 | PROTEK Medical Products Inc. | Civco | Civco’s 510(k) | | --- | --- | --- | | 1-519-0223 | 610-001 | K844472 | | 1-519-0227 | 610-004 | K844472 | | 1-519-0229 | 610-005 | 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 and 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 12:52PM P3 Document #9-926-0002 Rev. 4 FDA 510 (k) Notification-Polyurethane Surgical Drape Kit K970893 # SUMMARY 6-3 ## 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 Polyurethane film, with a thickness of .001-.003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape. ## Intended use: A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it 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) 6-4 PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258 {3} FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. : Oct. 17 1997 12:52PM P4 Document #9-926-0002 Rev. 4 FDA 510 (k) Notification-Polyurethane Surgical Drape Kit K970893 # Appendix D in SUMMARY ## Substantially Equivalence Comparison Chart With Civco Medical K844472 | 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 | Polyurethane .001"-.003" | Polyurethane .001"-.003" | | Additional Kit Components | Conductivity Gel Elastic Bands Plastic Medical Tape | Conductivity Gel Elastic Bands | | Performance | Microbial Challenge | Microbial Challenge | | Sterility | ETO | ETO | | Biocompatibility | ISO-10993 | ISO-10993 | | Mechanical Safety | Tensile Strength 6250 PSI @ Break | Tensile Strength 6250 PSI @ Break | | 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. 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 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: K970893 Trade Name: Ultrasound Transducer Drape Kits, Polyurethane Regulatory Class: II Product Code: KKX Dated: June 30, 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, ![img-0.jpeg](img-0.jpeg) 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 #9-926-0002 Rev. 3 FDA 510 (k) Notification-Polyurethane Surgical Drapes K970893 510(k) Number K970893 # Statement # Indication For Use Device Name: Polyurethane 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. ![img-1.jpeg](img-1.jpeg) Rick L. Pruter, President/CEO PROTEK Medical Products Inc. 7-18-97 ![img-2.jpeg](img-2.jpeg) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number 970893 PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K970893](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K970893) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com