KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS

{0}------------------------------------------------ 'JAN 3 0 2004 ## K033796 ### Section 2 ## 510(k) SUMMARY of Safety and Effectiveness (as required by Section 807.92) | Applicant: | Heinz Kurz GmbH Medizintechnik<br>Tübinger Str. 3<br>D-72144 Dusslingen<br>Germany<br>Tel. 011-49-7072-91790<br>Fax 011-49-7072-917979<br>E-mail: info@kurzmed.de | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Angelika Scherp<br>Business Support International<br>Amstel 320-1<br>1017AP Amsterdam<br>The Netherlands<br>Tel. 011-31-20-428-9591<br>Fax 011-31-20-428-9429<br>E-mail: bsi@xs4all.nl | | Proprietary Name: | KURZ Silicone Strips | | Common Name: | Silicone Strips | | Classification Name: | Elastomer, Silicone Block | | Substantial<br>Equivalence: | KURZ Silicone Strips are substantially equivalent in<br>function, performance and material to Silicone Elastomer Sheeting<br>marketed by Specialty Surgical Products, Inc., K974653. | | Device Description:<br>General | KURZ Silicone Strips are manufactured from a medical grade<br>silicone elastomer cut to size specifically for use within the external<br>ear canal following ear surgery. The pliable, soft consistency of the<br>silicone strips adapts itself to the shape of the auricular canal<br>without further shaping by the physician, which saves valuable<br>time in the operating room.<br><br>KURZ Silicone Strips are intended for single use and are provided<br>sterile. They require no further processing. They will be supplied<br>transparent, white or transparent with blue stripes. Application, use<br>and technical characteristics of the three presentations are<br>identical. Choice of one or the other is entirely a matter of personal<br>preference of the operating surgeon. Some surgeons prefer the<br>transparent silicone strip, since the healing process can be<br>checked without removing the dressing. Others prefer the white<br>silicone strip, since they find it easier to see and handle. The<br>transparent strips imprinted with blue stripes combine both | {1}------------------------------------------------ #### K033796 | | advantages. The healing process can be observed through the<br>transparent parts of the silicone, while the blue stripes make the<br>silicone strips easily visible. | | | | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--| | Dimensions | 0.12 x 45 x 6 mm (thickness, length, width) | | | | | Colors | 1. Transparent<br>2. White<br>3. Transparent with blue stripes | | | | | Packaging | Each package contains ten sterile (10) pouches with three<br>strips/pouch | | | | | Intended Use: | KURZ Silicone Strips are placed over the tympanic membrane<br>after surgical procedures in the middle ear to reduce the risk of<br>adhesion to the surgical packing and to aid in the prevention of<br>canal granulation and polyp formation. Using conventional otologic<br>pliers and tweezers, the three sterile strips contained in one pouch<br>are placed one over the other covering the tympanic membrane in<br>a star-shaped pattern, with the atraumatic, rounded end toward the<br>anterior meatal flap. The center of the strip is inserted to overly the<br>tympanic membrane. | | | | | | Once the wound has healed, the silicone strips are removed from<br>the auricular canal by the physician, should they not be expelled<br>with the tamponage or upon disintegration of the gelatinous<br>tamponage. This usually takes place after 10-21 days. | | | | | Predicate Device: | KURZ Silicone Strips are substantially equivalent in material,<br>function and performance to Silicone Elastomer Sheeting marketed<br>by Specialty Surgical Products, Inc. However, they are precut and<br>rarely need additional shaping. | | | | | Sterilization: | KURZ Silicone Strips are sterilized by low-temperature gas plasma<br>to avoid the degrading effects of steam or the residues of ethylene<br>oxide. The sterility assurance level (SAL) for the KURZ Silicone<br>Strips will be 10-6. | | | | | Biocompatibility: | The silicone elastomer, coloring agents and packaging material<br>were tested for biocompatibility in conformance with international<br>and FDA-recognized standards, including the FDA "Blue Book<br>Memorandum" based on ISO 10993 Part 1 "Biological Evaluation<br>of Medical Devices". KURZ Silicone Strips present no safety<br>risks or hazards and are safe and effective for the indicated use. | | | | | Information Bearing on Safety and Effectiveness | [807.92(b))3)]<br>There are no additional characteristics known that should<br>adversely affect the safety and effectiveness of KURZ Silicone<br>Strips. The results of design validation raise no issues of<br>safety and effectiveness. | | | | {2}------------------------------------------------ #### K033796 ## SE COMPARISON TABLE | | KURZ | SPECIALTY<br>SURGICAL<br>PRODUCTS<br>K974653 | AESTHETIC &<br>RECONSTRUCTIVE<br>TECHNOLOGIES<br>K022223 | SE | |---------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------|-----| | Material | Silicone sheeting | Silicone sheeting | Silicone sheeting | YES | | Sterility | Sterile | Not labeled | Sterile | YES | | Indications for Use | Temporary protective<br>sheathing for<br>the external ear<br>canal | Temporary protective<br>sheathing for<br>the external ear<br>canal | Temporary protective<br>sheathing for the external<br>ear canal | YES | | Measurements | 0.12 x 45 x 6 mm | Cut to size by user | Cut to size by user | YES | | Reusable | No | No | No | YES | | Coloring Agents | 1% Titanium<br>Dioxide NuSil<br>MED3-4502<br>(USP Grade)<br>Silicone Coating /<br>Marking Ink<br>NuSil R1008-7 | Not labeled | Not labeled | | | Biocompatible | Yes | Yes | Yes | YES | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked vertically. JAN 3 0 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Heinz Kurz GmbH Medizintechnik c/o Angelika Scherp Business Support International Amstel 320-1 1017 AP Amsterdam The Netherlands Re: K033796 Trade/Device Name: KURZ Silicone Strips Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: December 3, 2003 Received: December 5, 2003 Dear Ms. Scherp: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use suned in also encreated of the Medical Device Amendments, or to devices that proble to thay 20, 1978, and cordance 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 therefore, mainer the 00 1.000 include requirements for annual registration, listing of devices, good ecanofacturing 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 n your device to such additional controls. Existing major regulations affecting your device can be may be subject to sain adata 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 1 tease of advisod that 127 rination that your device complies with other requirements of the Act or that Federal statutes and regulations administered by other Federal agencies. You must comply with ally t oderal blankted une registration of limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. {4}------------------------------------------------ Page 2 - Angelika Scherp 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. 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, A helyl Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Traditional 510(k) ENT Devices Branch HFZ-460 510(k) Number K033 796 Device Name Silicone Strips # INDICATIONS FOR USE KURZ Silicone Strips are designed to temporarily cover the tympanic AORE Officent after surgical procedures in the middle ear. Signature (Division Sign-Off) Division o onthalmic Ear, Nose and ithroat Devis 510(k) Number K033796 (Please Do NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per CFR 801 109) OR Over-The-Counter Use (Optional Formal 1-2-96) A - 1