ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM

{0}------------------------------------------------ # K033164 ## 510(k) Summary As Required by 21 section 807.92 ( c ) Dr Len's Medical Products LLC 1-Submitter Name: 555 Andorra Glen Ct. Suite #7. Lafayette Hill, PA 19444 2-Address: - (484) 530- 0557 3-Phone: (484) 530- 0559 4-Fax: Marc Swartz 5-Contact Person: 6-Date summary prepared: August 30th, 2004 by Jay Mansour, Mansour Consulting LLC 7-Device Trade or Proprietary Name: ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM 8-Device Common or usual name: Dressing #### 9-Device Classification Name: Dressing 10-Substantial Equivalency is claimed against the following device: - Ferris Polymem Sterile Wound Dressing with Collagen from Ferris Manufacturing . Corporation, 510k #K002129 - Contreet Foam Adhesive/Non-Adhesive from Coloplast Corporation, 510k #K . 022416 #### 11-Description of the Device: The patented Abrams Multi-Density Polyurethane Foam Wound Dressing System is a single-patient use sterile medical device that contains silver based anti-microbial agent, effective as antibacterial barrier in the dressing. The dressing is available in different configurations: - 4x4" and 4x8" sizes with adhesive backing, sterile. . - 4x4" and 4x8" sizes without adhesive backing, sterile. . - 4x11" size without adhesive backing, sterile, attached to 11x38" cotton bandage. . #### 12-Intended use of the device: (refer to FDA form attached) The patented Abrams Multi-Density Polyurethane Foam Wound Dressing System is indicated for use for the treatment of pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, trauma wounds (abrasions, lacerations, second degree burns) and draining wounds. #### 13-Safety and Effectiveness of the device: This device is safe and effective as the predicate device cited above. The main submission includes a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes above a wavy line. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP = 7 2004 Dr. Len's Medical Products, LLC c/o Mr. Jay Mansour Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022 Re: K033164 KU33164 Trade/Device Name: Abrams Multi-Density Polyurethane Foam Wound Dressing System Regulatory Class: Unclassified Product Code: FRO Dated: August 3, 2004 Received: August 9, 2004 Dear Mr. Mansour: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocurities 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 commerce proc to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM allu Cosmetic Act (110c) that to hevice, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a007 of als. Existing major regulations affecting your device can may or subject to back arealers, Title 21, Parts 800 to 898. In addition, FDA may be fourther announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease be actived that I germination that your device complies with other requirements of the Act that I Dr Axal statutes and regulations administered by other Federal agencies. You must or any 1 ederal statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT at 6077, lucomig (21 OFR regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byetems (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Mr. Jay Mansour This letter will allow you to begin marketing your device as described in your Section 510(k) rms sotet 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, iriam C. Provost Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K033164 Device Name: Abrams Multi-Density Polyurethane Foam Wound Dressing system Indications For Use: This device is indicated for use for the treatment of pressure ulcers, venous ulcers, diabetic This devilo is indicated for est, surgical wounds, trauma wounds (abrasions, lacerations, second degree burns) and draining wounds. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 510(k) Number_________________________________________________________________________________________________________________________________________________________________