CFI ULTRASOUND PROBE DRAPE

{0}------------------------------------------------ **Sep 18 2009** ## 510(k) Summary 510(k) Owner Address Voice Number Fax Number Name of Contact Person Contour Fabricators, Inc. ("CFI") 14241 Fenton Road, Fenton, MI 48430 (810) 750-5300 . (810) 750-5310 John W. Schaefer, Regulatory Manager Establishment Registration Number 1825560 Contour Fabricators, Inc. is FDA registered as a medical device manufacturer, Device Trade or Proprietary Name Device Common or Usual Name Device Classification Name Classification Classification Panel Classification Product Code CFI Ultrasound Probe Drape Ultrasound Probe Drape System, Imaging, Pulsed Echo, Ultrasonic Class II under 21 CFR 892.1560 90 Radiology IYO #### Description of Devices Submitted for Premarket Notification: Contour Fabricators, Inc. Ultrasound Probe Drapes provide an efficient flexible covering to fit various specific ultrasound probes. These ultrasound probe drapes are constructed primarily of polyurethane film, a customary ultrasound probe drape material. Some drape designs additionally utilize an inner layer of polyethylene film to provide an extended cable cover. This extended cable cover has no patient contact and, at most, incidental user contact. Phone 810.750.5300 Fax 810.750.5310 CFI Medical Solutions 14241 Fenton Road Fenton, MI 48430 sales(a)cfimedical.com www.cfimedical.com {1}------------------------------------------------ Most product versions include a pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands that are customarily used to control extra "bulk" of drape material in the vicinity of the application procedure. Each Ultrasound Probe Drape is roll- or telescope-folded during its manufacturing to facilitate user application to the ultrasound probe. Each folded Ultrasound Probe Drape then is wrapped with a suitable piece of "CSR-wrap" (medical paper customarily used for this purpose). The wrapped, folded Ultrasound Probe Drape is then placed, along with the pre-sterilized foil packet of ultrasound coupling gel and the synthetic elastomer bands if provided, into a medical device pouch for terminal sterilization and distribution. When the Ultrasound Probe Drape is used as intended, ultrasound imaging is not impaired. Adequate coupling between the Drape and the probe normally is accomplished by applying an appropriate amount of ultrasound coupling gel to the ultrasound probe before application of the Drape. Once the Drape is fully applied, any excess Drape material covering the probe cable is gathered by means of elastic bands for neatness and convenience and to hold the Drane in place. The removal process for the Ultrasound Probe Drape is accomplished by removing the elastic bands, pulling off the Drape, disposing of those materials, and appropriately cleaning any remaining gel from the ultrasound probe, in a reverse method from the application. Evidence of compliance with ANSI/AAMI PB70, a Recognized Consensus Standard for barrier performance of Product Code KKX Surgical Drapes, and of independent-certifiedlaboratory determination of biocompatibility per Recognized Consensus Standard ISO 10993, is provided to demonstrate further equivalency to the predicate devices. #### Description of Predicate Devices The bundled Contour Fabricators, Inc. Ultrasound Probe Drape designs are based on, and are equivalent in dimensions, technology, materials, and intended use to selected ultrasound probe drapes that are manufactured by Civco Medical Instruments Company, Inc. and legally marketed per premarket notification K970513. A listing of specific equivalencies is provided in the Device Description section. Contour Fabricators, Inc. does not make equivalent models to all PHONE (810) 750-5300 Fax (810) 750-5310 {2}------------------------------------------------ models made by Civco, including Civco models made for certain applications that involve contact with broken skin, mucous membranes, and external blood paths. Therefore the scope of this premarket notification is less broad than that of the Civco 510(k) cited as the Predicate. #### Intended Use / Indications for Use: These ultrasound probe drape devices are intended for use by or as directed by a licensed medical practitioner during a medical ultrasound imaging procedure involving limited-duration unbroken-skin patient contact, to provide for maintenance of a sterile field (sterile covers only), to help protect the patient and healthcare worker from transfer of contaminants and biological risk agents (sterile and non-sterile covers), and to protect the ultrasound probe from contamination that could adversely affect its functionality or create downtime and require cleaning procedures (sterile and non-sterile covers). These single patient/procedure, disposable devices are furnished sterile, in most cases as an element of a kit-product that also includes a foil packet of ultrasound coupling gel, which always is pre-sterilized. #### Comparison of Submitted Devices to Substantially Equivalent, Legally Marketed Devices | Intended Use: | Both device groups provide a thin, conformal protective cover / drape system<br>for ultrasound transducer / probe usage in body-surface patient environments.<br>Both help to provide for maintenance of a sterile field (sterile covers only), to<br>help protect the patient and healthcare worker from transfer of contaminants<br>and biological risk agents (sterile and non-sterile covers), and to protect the<br>ultrasound probe from contamination that could adversely affect its<br>functionality or create downtime and require cleaning procedures (sterile and<br>non-sterile covers). Both are single patient/procedure, disposable devices,<br>furnished sterile or non-sterile, in most cases as an element of a kit-product<br>that also includes a foil packet of ultrasound coupling gel, which always is<br>pre-sterilized. | |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | one end and closed on the other end, with various dimensional configurations<br>as necessary to accommodate differences in ultrasound transducer / probe<br>geometries. Both are designed to be applied over the transducer / probe with<br>the open end of the ultrasound probe drape extending along the connecting<br>cable, and the closed end of the drape arranged against the working face of the | | | transducer / probe. | | Materials: | Both device groups are constructed primarily of polyurethane film, a<br>customary ultrasound probe drape material. Polyurethane film has been<br>effectively and safely used in ultrasound probe drapes for approximately<br>twenty years. Some designs of both device groups additionally utilize<br>polyethylene film, a customary material in medical-device drapes and covers,<br>other medical disposables, pharmaceutical packaging and food containers and<br>packaging. Polyethylene film has been effectively and safely used in medical-<br>device, pharmaceutical and food applications for approximately thirty-five<br>years. | | | Most product versions include a pre-sterilized foil packet of ultrasound<br>coupling gel and two sterile synthetic elastomer (non-latex) bands that are<br>customarily used to control extra "bulk" of drape material in the vicinity of<br>the application procedure.<br>These devices normally are colorless-transparent; which is the natural<br>(unpigmented) color of the polyurethane film and (if present) the polyethylene<br>film. Ancillary components such as elastic bands (which normally do not have<br>patient contact) may have other colors. | | Manufacturing: | CFI's device group is made using validated heat-seal fabrication processes,<br>with specification-compliance-controlling operations conducted in certified,<br>validated ISO 14644-1:1999(E) Class 8 cleanrooms. Sterile barrier packaging<br>(when applicable) is validated per ISO 11607. EtO sterilization (when<br>applicable) is conducted by an appropriately certified, audited sterilization | | | subcontractor utilizing processes validated per ISO 11135. All operations are<br>subject to the CFI quality management system. | | | The predicate device group is made using "impulse heat-seal cover<br>fabrication, packaging (in class 10,000 cleanroom), and EtO sterilization<br>(when applicable)". | | Safety: | Both device groups have been evaluated for potential adverse effects to the<br>healthcare worker and patient by means of biological testing by an<br>appropriately certified test laboratory. Representative post-sterilization<br>samples from CFI's device group were tested per Cytotoxicity Evaluation<br>(ISO 10993-5:1999) per Fluid Extract/L929 Mouse Fibroblast; Primary Skin<br>Irritation (ANSI/AAMI/ISO 10993-10:2002); Dermal Sensitization<br>Maximization (ISO 10993-10:2002 (0.9% NaCl Extract); and Dermal<br>Sensitization Maximization (ISO 10993-10:2002 (Cottonseed Oil Extract), for<br>safe use under conditions of limited contact (<24 hours) and surface contact<br>with unbroken skin, as appropriate for clinical applications of the CFI devices.<br>This testing was conducted in accordance with FDA Good Laboratory<br>Practice. Test results indicated best achievable scores for cytotoxicity,<br>irritation and sensitization per these standards, which exceeds the "Pass"<br>requirements for such testing.<br>The broader range of predicate devices, with device models that have<br>different clinical applications including invasive applications as indicated in<br>their broader Intended Use, were evaluated for safe use under "ISO 10993-<br>Part 1 Biological Evaluation of Medical Devices, FDA Blue Book<br>Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP)". Their<br>similar materials were found to be non-toxic, non-sensitizing, non-irritating,<br>non-hemolytic and non-pyrogenic. | | Effectiveness: | Both device groups have essentially equal physical and mechanical properties,<br>including material strength and elasticity that is adequate to allow use without<br>tearing or pinholing the Ultrasound Probe Drape during the drape's | Design: Both device groups are configured as tubular bags or loose "socks", open on PHONE (810) 750-5300 FAX (810) 750-5310 sales@contourfab.com www.contourfab.com {3}------------------------------------------------ {4}------------------------------------------------ , PHONE (810) 750-5300 FAX (810) 750-5310 . {5}------------------------------------------------ application to or removal from the probe / transducer, or during scanning per Intended Use. Ultrasound-related Product Codes ITX (the Predicate Device Group) and IYO (the Subject Device Group) do not specifically address effectiveness requirements for transducer / probe drapes. However, the functional requirements for these devices are related to those for Product Code KKX Surgical Drapes and MMP Protective Barrier Covers. ANSI/AAMI PB70:2003 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities" is a Recognized Consensus Standard for Product Codes KKX Surgical Drapes and MMP Protective Barrier Covers. The CFI device group's materials and heat-seals (the subject device group) were in-house-laboratory-evaluated per ANSI/AAMI PB70:2003 and determined to conform to Section 5.2.1.2 Level 1. This satisfies the 4.2.3.2 requirement that "the entire surgical drape shall have a barrier performance of at least Level 1." The predicate device group was laboratory tested under an unspecified "protocol adapted from that used to evaluate the barrier properties/resistance of surgeons glove materials to penetration by bloodborne pathogens using viral penetration as a test system." In both cases, the testing showed that the device groups were an effective barrier as required per their respective Intended Use. Contour Fabricators Inc. 14241 Fenton Road Fenton, MI 48430 PHONE (810) 750-5300 FAX (810) 750-5310 {6}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 SEP 1 8 2009 Mr. John W. Schaefer Regulatory Manager Contour Fabricators, Inc. 14241 Fenton Road FENTON MI 48430 Re: K090773 Trade/Device Name: Various Ultrasound Probe Drapes Regulation Number: 21 CFR 892.1560 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: IYO Dated: July 24, 2009 Received: August 12, 2009 #### Dear Mr. Schaefer: 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 application (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. 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); medical device reporting of medical {7}------------------------------------------------ Page 2 - device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Janine M. Morris Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number: K090773 Device Name: Various Ultrasound Probe Drapes Indications for Use: These ultrasound probe drape devices are intended for use by or as directed by a licensed medical practitioner during a medical ultrasound imaging procedure involving limited-duration unbroken-skin patient contact, to provide for maintenance of a sterile field (sterile covers only), to help protect the patient and healthcare worker from transfer of contaminants and biological risk agents (sterile and non-sterile covers), and to protect the ultrasound probe from contamination that could adversely affect its functionality or create downtime and require cleaning procedures (sterile and non-sterile covers). These single patient/procedure, disposable devices are furnished sterile, in most cases as an element of a kit-product that also includes a foil packet of ultrasound coupling gel, which always is pre-sterilized. Prescription Use -- YES AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use -- NO (Part 21 CFR 801 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) Hojue Karting (Division Sign-Off) (Division Sign-On) Division of Reproductive, Abdominal, Divisionogical Devices 9772 510(k) Number Contour Fabricators Inc. 14241 Fenton Road Fenton, MI 48430 Phone 810.750.5300 Fax 810.750.5310 sales(@contourfab.com www.contourfab.com 1 REVISED PAGE FOR SECTION "INDICATIONS FOR USE", TO BE SUBSTITUTED FOR EXISTING PAGE OF ORIGINAL SUBMISSION.