EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)

{0}------------------------------------------------ 3 Image /page/0/Picture/1 description: The image shows a logo with a geometric design on the left and text on the right. The geometric design consists of a square divided into four quadrants, with the upper-left quadrant filled with a solid black triangle and the other quadrants filled with dots. To the right of the geometric design, the text "EMM" is displayed in bold, followed by "Exact Medical Manufacturing, Inc." in a smaller font size. K101598 ### Sec. 6: 510(k) Summary - EMM Surgical Drape SMS w/PE Sides . . - ··· 510(k) Summary for Exact Medical Manufacturing Inc., EMM Surgical Drape – SMS w/PE Sides | Date Summary was Prepared | July 29, 2010 (rev.1) | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Submitter | David Nowicki, President<br>Exact Medical Manufacturing Inc.<br>4917 William Street, Suite C<br>Lancaster, NY 14086<br>dnowicki@exactmm.com<br>(p)716-681-0866, (f) 716-681-4110 | | Primary Contact for this 510(k) Submission | David Nowicki, President<br>Exact Medical Manufacturing Inc.<br>4917 William Street<br>Lancaster, NY 14086<br>dnowicki@exactmm.com<br>(p)716-681-0866, (f) 716-681-4110 | | Device Common Name | Surgical Drape | | Trade Name | EMM Surgical Drape SMS w/PE Sides, Model 13-005 | | Device Product Codes and<br>Classification Name | KKX, 21CFR878.4370, Surgical Drape and Drape accessories, Class II | | Predicate Device | Primeline (Primagard) Surgical drapes 510(k)021864 | | Device Description | Exact Medical Manufacturing Surgical Drapes Surgical Drape SMS w/PE Sides are sterile or<br>non-sterile single use devices made of natural or synthetic materials intended to be used as<br>a protective patient covering, such as to isolate a site of surgical incision from microbial and<br>other contamination.<br><br>Exact Medical Manufacturing Surgical Drapes SMS w/PE Sides are comprised of a single<br>layer of SMS (spunbond/meltblown/spunbond polypropylene), PE Layer, 3M Medical<br>Adhesive Tape. | | Intended Use | Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides are sterile or<br>non-sterile single use devices made of natural or synthetic materials intended to be used as<br>a protective patient covering, such as to isolate a site of surgical incision from microbial and<br>other contamination.<br><br>The Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides are also<br>sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further<br>packaging and ethylene oxide sterilization | | Technological Characteristics | Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides has the same<br>design, material and performance characteristics of the predicate device. Additional<br>summary and explanation of technological characteristics is included in the following<br>Addendum A | | Summary of Testing | Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides is<br>substantially equivalent and meets the same acceptance criteria as the predicate<br>device/gown in K021864. Non-clinical performance testing includes: Biocompatibility<br>(cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier<br>properties AAMI PB:70 Level 3, tensile, tear strength, flammability, linting and sterility. All<br>results of the testing met acceptance criteria. Additional summary and explanation of<br>non-clinical testing is included in the following Addendum B. | | Substantial Equivalence | The surgical drapes described in this 510(k) submission are substantially equivalent in all<br>specifications and performance compared to the predicate device indentified in K021864<br>except for minor variations in the widths and lengths. | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a square divided into four equal quadrants. The top left quadrant is filled with a solid black color. The remaining three quadrants are filled with a pattern of dots. The dots are arranged in rows and columns, creating a grid-like pattern. . ' . · : . ・ 、ご - ## xact Medical Manufacturing, Inc. # K/01598 ## Addendum A Summary and Explanation of Technological Characteristics: EMM SURGICAL DRAPE SMS w/PE Sides Predicate Device Comparison Table | Exact Medical Manufacturing - Surgical Drape<br>SMS w/PE Sides<br>Model # 13-005 | Substantially<br>Equivalent | Primeline (Primagard) Surgical Drapes<br>510(k)021864<br>PREDICATE DEVICE | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: Exact Medical Manufacturing<br>Surgical Drape SMS w/PE Sides are sterile or<br>non-sterile single use devices made of natural or<br>synthetic materials intended to be used as a<br>protective patient covering, such as to isolate a<br>site of surgical incision from microbial and other<br>contamination. | Substantially<br>Equivalent | devices made of natural or synthetic materials<br>intended to be used as a protective patient<br>covering, such as to isolate a site of surgical<br>incision from microbial and other contamination. | | Classification & Code: KKX, Surgical Drapes,<br>21CFR878.4370, Class II | Substantially<br>Equivalent | Classification & Code: KKX, Surgical Drapes.<br>21CFR878.4370, Class II | | Materials & Construction: SMS<br>(spunbond/meitblown/spunbond polypropylene),<br>Polyethylene, Absorbent Reinforcement, 3M<br>medical grade adhesive | Substantially<br>Equivalent | SMS, absorbent reinforcement, 3M medical grade<br>adhesive | | Barrier properties AATCC 42:2007, AATCC<br>127:2008: Liquid Barrier Performance and<br>Classification of Protective Apparel and Drapes<br>intended for Use in Health Care Facilities, AAMI<br>PB70:2003 /(R)2009, Level 3. Hydrostatic Head<br>=/> 50 cm | Substantially<br>Equivalent | Hydrostatic head = 30.5 cm | | Sterile (via EO Gas) ISO 11135-1:2007,<br>Sterilization of health care products - Ethylene<br>Oxide - Part 1 | Not Applicable | Non-sterile | | Non-Sterile | Substantially<br>Equivalent | Non-sterile | | Sterile Packaging: Chevron peel pouch (coated<br>paper (73gsm), PET12/PE40 film construction),<br>individual CSR internal wrap | Not Applicable | Not Applicable | | Biocompatibility: cytotoxicity, irritation and<br>sensitization - ISO 10993-5:1999, Cytotoxicity,<br>ISO 10993-10:2002, Skin Irritation, ISO 10993-<br>10:2002, Sensitization.<br>Cytotoxicity, Irritation, Sensitization tests<br>PASS | Substantially<br>Equivalent | Cytotoxicity, Irritation, Sensitization PASS | | Tear Strength - ASTM D5587-08 (no rev.)<br>Standard Test Method for Tearing Strength of<br>Fabrics by Trapezoid Procedure.<br>Tensile Strength for Md and Cd within general<br>industry tolerance +/- 20% | Substantially<br>Equivalent | Md=1.83 Ibs<br>Cd= 3.24 lbs | | Tensile Strength - ASTM D5034-09 (no rev.)<br>Standard Test Method for Breaking Strength and<br>Elongation of Textile Fabrics (Grab Test)<br>Tensile Strength for Md and Cd within general<br>industry tolerance +/- 20% | Substantially<br>Equivalent | Md=13.8 lbs<br>Cd=18.8 lbs | | Flammability - 16CFR1610:2010, Flammability of<br>Clothing Textiles<br>Class 1 - PASS | Substantially<br>Equivalent | Class 1 | | Lint and other Particles generated in the dry<br>state - ISO 9073-10:2003 | Not Applicable | No test | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol with three curved lines, resembling a human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the symbol. The logo is black and white. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Exact Medical Manufacturing, Incorporated C/O Mr. Robert O. Dean Compliance Systems International, LLC 1083 Delaware Avenue Buffalo, New York 14209 OCT 4 2010 Re: K101598 Trade/Device Name: Exact Medical Manufacturing Surgical Drape SMS w/PE Sides, Model 13-005 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape-and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 17, 2010 Received: September 24, 2010 Dear Mr. Dean: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {3}------------------------------------------------ Page 2- Mr. Dean 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 (reporting of medical 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, h for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Form Indications for Use: 510(k) Number (if known): K101598 Device Name: Exact Medical Manufacturing Surgical Drape SMS w/PE Sides, Model 13-005 Indications for Use: Exact Medical Manufacturing Surgical Drape SMS w/PE Sides are sterile or non-sterile single use devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The Exact Medical Manufacturing Surgical Drape SMS w/PE Sides are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) s Elizabeth F. Clarence-William (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital Division of Anesthesiology, General Devices Division of Anesthoolor of Infection Control, Devices 510(k) Number: K