← Product Code [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX) · K981069 # ULTRA-COVER PU-TRANSDUCER COVER (K981069) _International Medical Products B.V. · ITX · Sep 23, 1998 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K981069 ## Device Facts - **Applicant:** International Medical Products B.V. - **Product Code:** [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX.md) - **Decision Date:** Sep 23, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1570 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** 3rd-Party Reviewed ## Intended Use Protective cover placed over diagnostic ultrasound transducer/ probe/scanhead instruments. The cover allows use of the transducer in scanning procedures for body surface, endocavity, and intra-operative diagnostic ultra-sound, while helping to prevent transfer of microorganisms, body-fluids, and material to the patient and healthcare worker during reuse of the transducer. Ultra-Cover® PU-transducer covers are furnished sterile; single use patient/procedure, disposable. The intended use and indications for use place Ultra-Cover® PU-transducer covers in device body contact categories as follows: - a) surface devices, intact skin/mucosal membranes/ breached surfaces, limited contact duration . (< 24 hours) - b) external communicating devices, blood path indirect/tissue communicating, limited contact duration (<24 hours). ## Device Story Ultra-Cover PU-transducer covers are thin, conformal polyurethane thermoplastic film sheaths designed to fit various ultrasound transducer geometries. The device acts as a physical barrier to prevent the transmission of pathogens, body fluids, and particulate material between patients and healthcare workers during diagnostic ultrasound procedures. The cover is applied by the clinician by placing transmission gel on the transducer face or inside the cover, then inserting the transducer into the closed end of the cover. It is intended for single-patient, disposable use in body surface, endocavity, and intraoperative environments. The device maintains the sterile field where applicable and does not impair ultrasound imaging. Biocompatibility testing confirms the material is non-toxic, non-sensitizing, and non-irritating for limited contact duration. ## Clinical Evidence Bench testing only. Biocompatibility testing was conducted in accordance with ISO 10993, including evaluations for cytotoxicity, acute systemic toxicity, irritation, and sensitization. Results demonstrated the materials are non-toxic, non-sensitizing, and non-irritating. Mechanical testing confirmed adequate strength and elasticity to prevent tearing or pinholing during application, removal, and scanning. ## Technological Characteristics Materials: Polyurethane thermoplastic film and aqueous polyurethane suspension. Form factor: Conformal, one-piece, open-ended sheath in various sizes/shapes. Sterilization: Gamma irradiation. Biocompatibility: Tested per ISO 10993 for limited contact duration (<24 hours) with skin, mucosal membranes, and breached surfaces. ## Regulatory Identification A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container. ## Predicate Devices - Civco Medical Instruments Poly Ultrasound Transducer Cover ([K970513](/device/K970513.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "SEP 23 1998". The text is written in a simple, handwritten font. The letters and numbers are all clearly legible. The date is likely a stamp or handwritten note on a document. K981069 # International Medical #### Poly-urethane Ultrasound Transducer Cover 510 (k) SUMMARY Date Summary Prepared: 2 october 1997 Submitter's Name: Address Telephone No: Contact Person: International Medical Products BV Gerritsenweg 5, 7202 BP, Zutphen, Holland (+31)(0575)596500 fax: (+31)(0575)519639 H.G te Winkel, Product-Manager Establishment Registration Number: Device Trade/ Proprietary Name: Device Common/ Usual Name: Device Classification Name: Ultra-Cover® PU-transducer cover Ultrasound Transducer Cover/ Sheath/Drape Ultrasonic Diagnostic Transducer Accessories Classification: Classification Panel: Classification Procode: Class II under 21 CFR 892.1570 90 Radiology ITX Description of Predicate device(s): The Ultra-Cover ® PU transducer cover is equivalent to Civco Medical Instruments legally marketed Poly Ultrasound Transducer Cover, 510(k) reference number K970513 8030461 {1}------------------------------------------------ # International Medical i m Description of Subiect Device Submitted for Premarket Notification: Ultra-Cover® PUtransducer covers provides an efficient, conformal covering to fit various & specific ultrasound transducer geometries. The cover helps prevent the transmission of pathogens from one patient to another. Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required transmission gel onto the transducer face or into open end of cover, inserting ultrasound transducer into closed end of cover. The removal process is a reverse method from the application. Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Covers are packaged in both sterile and non-sterile procedure kit form for single patient/procedure, disposable use. Product categories/models include: General Purpose Ultra-Cover® PU-transducer covers (sterile and non sterile) Intraoperative Ultra-Cover® PU-kits (sterile) Intended use/ Indications for use: Protective cover placed over diagnostic ultrasound transducer/ probe/scanhead instruments.The cover allows use of the transducer in scanning procedures for body surface, endocavity, and intra-operative diagnostic ultra-sound, while helping to prevent transfer of microorganisms, body-fluids, and material to the patient and healthcare worker during reuse of the transducer. Ultra-Cover® PU-transducer covers are furnished sterile; single use patient/procedure, disposable. The intended use and indications for use place Ultra-Cover® PU-transducer covers in device body contact categories as follows: - a) surface devices, intact skin/mucosal membranes/ breached surfaces, limited contact duration . (< 24 hours) - b) external communicating devices, blood path indirect/tissue communicating, limited contact duration (<24 hours). {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a black and white graphic of a stylized letter 'm'. The letter is formed by thick, bold lines, creating a blocky and geometric appearance. The negative space within the letter is white, providing contrast against the black lines. ### Comparison of Device to Substantially, Equivalent, Legally Marketed Device(s): - Intended Use : Both the Civco device and International Medical device is a thin, conformal protective cover system for ultrasound transducer usage in body surface, endocavity, and intraoperative patient environments helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer, and help maintain the sterile field where applicable; a disposable device for single use only. - : a one-piece, open on one end, closed on other end with various dimensional configu-Design rations necessary to accommodate differences in ultrasound transducer geometries. Covers are externally applied to ultrasound transducer. - Material : The Civco device is made of poly-urethane and poly-ethylene. The International Medical device is made of poly-urethane thermoplastic film and aqueous polyurethane suspension. Manufacturing : manufacturing IMP device processes: - impulse heat-seal fabrication -dipping techniques. Manufacturing Civco device process : - impulse heat-seal fabrication : packaging : cleanroom class 10.000 : sterilization IMP device: Gamma irradiation sterilization Civco device: Ethyleen Oxide Manufacturing Facilities: - Medistad Holland Nijverheidsweg 1 1670 AB Medemblik - International Medical Products BV Lichtenvoorde Dieselstraat 9 7131 PC Lichtenvoorde - Sterilization Facility : - Gammaster Morsestraat 3 6716 AH Ede - Safety : materials have been biologically evaluated using biocompatibility tests for cytotoxicity acute systematic toxicity, irritation and sensizitation. Testing is in accordance with ISO 10993 Biological Evaluation of Medical Devices, executed by NamSa USA and Wickham Laboratories GB. Ultra-Cover ® PU-transducer covers have been evaluated for safe use under device categories of limited contact duration and body contact for surface devices (skin/ mucosal membranes/breached surfaces) and body contact for external communicating devices (blood path indirect/tissue communication). Testing has demonstrated subject materials/devices to be non-toxic, non-sensitizing, and non-irritating. - material strength and elasticity is adequate to allow use without tearing or pinholing Effictiveness : the cover during application and removal of cover from transducer and during scanning under intended uses. Page 3 of 3 {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 3 1999 Carole Stamp Program Manager International Medical Products, B.V. c/o TUV Product Service Inc. 1775 Old Highway 8 New Brighton, MN 55112 Re: K981069 Ultra-Cover/ Pu-Transducer Cover Dated: September 14, 1998 Received: September 15, 1998 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX Dear Ms. Stamp: 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 III (Premarket Aproval), 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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 S10(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) 594-4613. 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/cdrl/dsmaldsmamain.html". Sincerely yours, Kilian Yi Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure t {4}------------------------------------------------ GEZ. DOOR INTERNATIONAL MEDICAL : 17 3-98 ; 11:05 ; 1. M. P. BV- 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Indications For Use: Protective cover placed over diagnostic ultrasoundtransducer/probe/scanhead instruments. The cover allows use of the transducer in scanning procedures for body surface, endocavity, and intra-operative diagnostic ultra-sound, while helping to prevent transfer of microorganisms, body-fluids, and material to the patient and healthcare worker during reuse of the transducer. Ultra-Cover PU-transducer covers are furnished sterile & non-sterile; single use patient/procedure, disposable The intended use and indications for use place Ultra-Cover PU-transducer covers in device body contact categories as follows: - a) surface devices, intact skin/mucosal membranes/ breached surfaces, limited contact duration. (24 hours) - external communicating devices, blood path indirect/ tissue communicating, limited contact duration (424 hours) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ### Concurrence of CDRH, Office of Device Evaluation (ODE) David C. Bergman (Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number K981169 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K981069](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K981069) **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. 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