FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Ascendia. The logo consists of a stylized letter "A" on the left and the word "ASCENDIA" in bold, sans-serif font on the right. The letter "A" is formed by two intersecting curves, creating a dynamic and modern design. AUG 1 5 2005 - 510(k) Summary KO50320 12 January 2005 # General Information | Submitter's name: | Ascendia MedTech AB | |---------------------------------------|------------------------------------------------------------------------------------------------------| | Address: | Finlandsgatan 18, SE-164 74 Kista, Sweden | | Telephone No: | +45 8 444 54 00 | | Contact Person: | Anders Weiland | | Establishment Registration<br>Number: | 8032029 | | Device Trade Name: | FreeeScan® Ultrasound Transducer Cover | | Device Common Name: | Ultrasound Transducer Cover/Sheath/Drape | | Device Classification Name: | Diagnostic Ultrasonic Transducer | | Classification: | Class II (under 21 CFR 892.1570) | | Classification Panel: | Radiology | | Classification Procode: | ITX | | Performance Standards: | No applicable standards have been issued<br>under Section 514 of the Food, Drug and<br>Cosmetic Act. | ### Subcontractors Contracted Sterilizer: Paper-Pak Sweden AB Jarnvagsgatan 34 311 22 Aneby Sweden Phone No. +46 380-475 00 Manufacturer: Nolato Medevo AB 260 93Torekov Sweden Phone No. +46 431-44 22 90 Contact Name: Rickard Thorsen Contact Name: Henrik Rosengren ASCENDIA MEDTECH AB · FINLANDSGATAN 18 · SE164 74 · KISTA · SWEDEN PHONE:+46-8-444 5400 ・ FAX: +46-8-623 0972 EMAIL: info@ascendia.se · WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SE556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA. {1}------------------------------------------------ - 2 - 28 January 2005 Repackager: TotalLoqistik Box 143 311 22 Falkenberg Sweden Phone No. +46 34-62 94 30 Contact Name: Jan Lindman ## Device Description The FreeeScan® Ultrasound Transducer Cover provides a thin, conformal covering to fit various ultrasound transducer geometries. The device is manufactured as a one-piece design that provides a covering to prevent the transmission of pathogens, as the ultrasound transducer is reused from one patient to another. The cover material is Chloroprene (synthetic rubber), which is similar to the non-latex material used in medical examination gloves or surgical gloves. Type I natural latex allergy does not occur in response to Chloroprene since the synthetic rubber does not contain the natural protein allergen which is present in latex. Various sizes and shapes of covers are offered in order to fit different transducer geometries. The following product models are currently included (other shapes are likely to be added): - . FreeeScan® 1 - W:3.4 cm, L:45-244 cm (Drawing 5500-000002-1B) - FreeeScan® 4 W:10 cm, L:45-244 cm (Drawing 5500-000003-1B) . - FreeeScan® 6 W:9.5/11.5 cm, L:45-244 cm (Drawing 5500-000004-1B) . - . FreeeScan® 8 - W:7.5 cm, L:45-244 cm (Drawing 5500-000005-1B) - FreeeScan® 77 Ø:2.6 cm, L:30 cm (Drawing 5500-000016-1A) . - FreeeScan® 84 Ø:3 cm, L:30 cm (Drawing 5500-000015-1A) . All of these versions are composed of the same materials, they are made using the same processes and procedures, in the same facilities and on the same equipment. > ASCENDIA MEDTECH AB · FINLANDSGATAN 18 · SE164 74 · KISTA · SWEDEN PHONE : + 46-8-444 5400 · FAX: + 46-8-623 0972 EMAIL: info@ascendia.se · WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SE556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA. {2}------------------------------------------------ - 3 - ## Intended Use of the Device The FreeeScan® Ultrasound Transducer Covers are protective covers applied to ultrasound transducers. These covers are designed to provide a sterile barrier between the non-sterile TXD's (and instrument guide adapters in some cases) and the patient/healthcare worker. The covers are intended for use during both sterile and non-sterile procedures using sector, linear, intravaginal and rectal transducers. The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive. The transducer covers are supplied sterile or non-sterile and intended for single-use. Covers are packed in sterile or non-sterile "convenience" kits form for single patient/procedure, disposable use. Covers kits are supplied with needle guide devices, coupling gel packet, elastic bands, and tape. ## Predicate Device Ascendia MedTech AB believes that the FreeeScan® Ultrasound Transducer Cover is substantially equivalent to the CIVCO Medical's ultrasound transducer cover, NeoFlex™ Ultrasound Transducer Cover. | Predicate Device | 510(k)<br>Reference | Manufacturer | |-----------------------------------------|---------------------|---------------------------------------| | NeoFlex™ Ultrasound Transducer<br>Cover | K991236 | CIVCO Medical, Inc<br>Kolona, IA, USA | ASCENDIA MEDTECH AB · FINLANDSGATAN 18 · SE164 74 · KISTA · SWEDEN PHONE:+46-8-444 5400 ■ FAX: +46-8-623 0972 EMAIL: info@ascendia.se · WEBSITE: www.ascendia.se and www.amedic.se VAT NO. 5E556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: K1STA. {3}------------------------------------------------ # Substantial Equivalent Summary Ascendia MedTech AB believes that the FreeeScan® Ultrasound Transducer Cover is substantially equivalent in safety and effectivness to the CIVCO Medical NeoFlex™ Ultrasound Transducer Cover. The following comparison table shows this substantial equivalence: | Parameter | FreeeScan® Ultrasound<br>Transducer Cover | NeoFlex™ Ultrasound<br>Transducer Cover | |----------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use/Indications<br>for Use | Same | Provides a thin,<br>conformal protective<br>cover system for<br>diagnostic ultrasound<br>transducer usage in<br>body surface,<br>endocavity, and intra-<br>operative patient<br>environments; helps to<br>prevent transfer of<br>micro organisms, body<br>fluids, and particulate<br>material to the patient<br>and healthcare worker<br>during reuse of the<br>transducer, and helps<br>to maintain the sterile<br>field where applicable;<br>disposable device - for<br>single patient/procedure<br>use.<br><br>Is non-latex therefore<br>beneficial when treating<br>a patient with known<br>type I hypersensitivity,<br>or for the healthcare<br>worker who has<br>become type I<br>sensitised. | | Design | The FreeeScan® Ultrasound<br>Transducer Cover is folded.<br>In other respects the same. | One-piece, closed end,<br>rolled (condom style)<br>with various<br>dimensional<br>configurations<br>necessary to<br>accommodate<br>differences in<br>ultrasound transducer<br>geometries. | ASCENDIA MEDTECH AB • FINLANDSGATAN 18 • SE164 74 • KISTA • SWEDEN PHONE: + 46-8-444 5400 · FAX: + 46-8-623 0972 EMAIL: info@ascendia.se • WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SE556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA. {4}------------------------------------------------ – 5 – : . 28 January 2005 | Parameter | FreeeScan® Ultrasound<br>Transducer Cover | NeoFlex™ Ultrasound<br>Transducer Cover | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Same | Polychloroprene,<br>synthetic rubber<br>Materials used in<br>compounding meet the<br>recommended safe<br>levels as specified in<br>the US Food and Drugs<br>Administration CFR,<br>Title 21, Section<br>177.2600 and<br>182.5991.<br>USP Absorbable<br>Dusting Powder<br>Synthetic rubber does<br>not contain the natural<br>protein allergen<br>residuals present in<br>latex. | | Manufacturing | Packaged in class 100 000<br>clean room, otherwise the<br>same. | Dip-molding/rubber<br>vulcanisation<br>Packaged in class 10<br>000 clean room per<br>Federal Std 209e.<br>Packaging system per<br>ANSI/AAMI/ISO 11607 | | Quality System | Same | FDA/QSR cGMP<br>21CFR Part 820.<br>ISO 9001/ISO<br>13485/EN 46001 | | Sterility | Same | Sterilization (when<br>applicable) by<br>100%EtO method;<br>Validated<br>ANSI/AAMI/ISO 11135<br>SAL 106 | | Parameter | FreeeScan® Ultrasound<br>Transducer Cover | NeoFlex™ Ultrasound<br>Transducer Cover | | Contact<br>category | Same | Surface devices, intact<br>skin/mucosal<br>membranes/breached<br>surfaces; limited<br>contact duration (<24<br>hours)<br><br>External communicating<br>devices, tissue<br>communicating; limited<br>contact duration (<24<br>hours) | | Safety | Biocompatibility tests for<br>cytoxicity, irritation,<br>sensitisation, and ethylene<br>oxide sterilization residuals<br>have demonstrated the<br>FreeeScan® chloroprene<br>material/cover device is:<br>Severely cytotoxic<br>Non-sensitizing<br>Non-irritating<br>Testing is in accordance with<br>- ISO 10993-Part 1 Biological<br>Evaluation of Medical<br>Devices, FDA Blue Book<br>Memorandum #G95-1, and<br>FDA-Good Laboratory<br>Practices (GLP).<br>Type I natural latex allergy<br>does not occur in response to<br>chloroprene synthetic rubber. | Biocompatibility tests<br>for acute systemic<br>toxicity, irritation,<br>sensitisation,<br>hemolysis, material<br>mediated pyrogen, and<br>ethylene oxide<br>sterilization residuals<br>have demonstrated the<br>NeoFlex™<br>polychloroprene<br>material/cover device<br>is:<br>Non-toxic<br>Non-sensitizing<br>Non-irritating<br>Non-hemolytic<br>Non-pyrogenic<br>Testing is in<br>accordance with - ISO<br>10993-Part 1 Biological<br>Evaluation of Medical<br>Devices, FDA Blue<br>Book Memorandum<br>#G95-1, and FDA-Good<br>Laboratory Practices<br>(GLP)<br>Type I natural latex<br>allergy does not occur<br>in response to<br>polychloroprene | | Parameter | FreeeScan® Ultrasound<br>Transducer Cover | NeoFlex™ Ultrasound<br>Transducer Cover | | Effectiveness | The FreeeScan® Ultrasound<br>Transducer Cover has a<br>nominal thickness of 0.2 mm.<br>The FreeeScan® Ultrasound<br>Transducer Cover provides<br>an effective barrier to<br>prevention of microbial<br>migration.<br>In other respects the same. | Testing for NeoFlex™<br>polychloroprene covers<br>has shown that the<br>material is adequate for<br>the intended use:<br>Strength and elastic<br>characteristics are<br>effectively similar to that<br>of latex and allows use<br>without tearing or pin<br>holing the cover - a)<br>during application and<br>removal of cover from<br>transducer, b) during<br>scanning under<br>intended uses, and c)<br>attaching/removing a<br>disposable needle<br>guide to the transducer<br>bracket over the cover.<br>Nominal thickness of<br>.0065"<br>Does not impair<br>ultrasound imaging<br>NeoFlex™<br>polychloroprene<br>transducer cover<br>provides an effective<br>barrier to prevention of<br>microbial migration -<br>tested under protocol<br>adapted from that used<br>to evaluate the barrier<br>properties/resistance of<br>surgical gloves and<br>endoscope sheaths to<br>penetration by blood<br>borne pathogens using<br>viral penetration as a<br>test system.<br>Polychloroprene<br>(neoprene) material is<br>used for medical<br>examination/surgical<br>gloves. | ASCENDIA MEDTECH AB • FINLANDSGATAN 18 • SE164 74 • KISTA • SWEDEN PHONE : + 46 - 8 - 4 4 5 4 0 - F A X : + 4 6 - 8 - 6 2 3 0 9 7 2 EMAIL: info@ascendia.se · WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SESS6236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA. {5}------------------------------------------------ -6- . . . . . . ASCENDIA MEDTECH AB • FINLANDSGATAN 18 • SE164 74 • KISTA • SWEDEN PHONE:+46-8-444 5400 ◆ FAX: +46-8-623 0972 EMAIL: info@ascendia.se · WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SE556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA. {6}------------------------------------------------ : : ASCENDIA MEDTECH AB • FINLANDSGATAN 18 • SE164 74 • KISTA • SWEDEN PHONE:+46-8-444 5400 • FAX: +46-8-623 0972 EMAIL: info@ascendia.se · WEBSITE: www.ascendia.se and www.amedic.se E MITE: THIO@ ENCHROW . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA. {7}------------------------------------------------ 28 January 2005 1. Sales of the same # Conclusion Ascendia MedTech AB believes that this premarket notification submission for FreeeScan® Ultrasound Transducer Cover has demonstrated Substantial Equivalence as defined and in accordance with the Federal Food, Drug and Cosmetic act and various guidance documents issued by the Center for Device and Radiological Health. > ASCE NDIA MEDTECH AB • FINLANDSGATAN 18 • SE 164 74 • KISTA • SWEDEN PHONE:+46-8-444 5400 ● FAX: +46-8-623 0972 EMAIL: info@ascendia.se • WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SE556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA. {8}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/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 extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white. AUG 1 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ascendia MedTech AB % Ms. Jane B. Campbell President J & D Campbell Associates, Inc. 485 LaRoe Road CHESTER NY 10918 Re: K050320 Trade/Device Name: FreeeScan® Ultrasound Transducer Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: August 2, 2005 Received: August 3, 2005 Dear Ms. Campbell: 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). You may, therefore, market the device, subject to the general controls provisions of the 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 legally 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, and 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. {9}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be devilsed that I Dri breasures of the complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other federal agencies. You must or any I oderal bakated and sequirements, including, but not limited to: registration (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice 007); nounig (21 est forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet ronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin 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 the labeling derive to processe contact the Office of Compliance at (240) 276-0100. Also, please note the regulation, produce conding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may 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/industry/support/index.html. Sincerely yours, David R. Ingram Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "ASCENDIA" in bold, sans-serif font. To the left of the word is a stylized graphic that resembles an infinity symbol or a sideways figure-eight. The graphic is also in bold and appears to be a single, continuous line. The overall impression is of a logo or brand mark. Document Title 510(k) Application FreeeScan Chloroprene Cover Re Docu ent Nun 9000-000054 01 #### Statement of Indications for Use 1 Device name: FreeeScan® Ultrasound Transducer Cover ## 1.1 Indications for Use The FreeeScan® Ultrasound Transducer Covers are protective covers applied to The I recobran o Cransducers. These covers are designed to provide a sterile barrier between the non-sterile transducer (and instrument guide adapters in some cases) and the patienthealthcare worker. The covers are intended for use during both sterile and nonsterile procedures using sector, linear, intravaginal and rectal transducers. The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive. The transducer covers are supplied sterile or non-sterile and intended for single-use. Prescription use i David R. Legron (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _