ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183

{0}------------------------------------------------ DEC 1 1 2002 48 ## 4. 510(k) Summary | Product Submitted by: | Arthronet Medical, Inc.<br>8 Hammond, Suite 108<br>Irvine, CA 92618<br>Phone (760) 436-3766<br>FAX (760) 632-0276 | |-----------------------|-----------------------------------------------------------------------------------------------------------------------| | Manufactured by: | Arthronet GmbH & Co. KG.<br>(formerly Imtec Medizintechnik)<br>Geilenbacher Straße 31<br>D-51399 Burscheid<br>Germany | ### Introduction The Arthronet BLACKLINE Arthroscopic Blades are manufactured by Arthronet GmbH & Co. KG (formerly Imtec Medinzentechnik). The Blades are limited-use arthroscopic blade components (intended to be used three times, or until they are damaged/dull - whichever occurs first). This product consists of either two or three components. The three-component product has an outer blade assembly, an inner blade, and an inner blade hub adapter. The two component product has an outer blade assembly and an inner blade assembly. The blade sets consist of six hub assembly configurations, and has both straight and curved blade configurations. Each configuration, except for the Arthronet 123 series, is designed to fit a specific FDA Cleared Arthroscopic Shaver System. {1}------------------------------------------------ ## BLACKLINE Blade System | Arthronet<br>Blackline Shaver<br>Blade Series: | Hub Adapter Fits the<br>following Shaver System: | Materials Used: | Equivalent to: | |------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | 123 | Arthronet (pending review<br>and FDA clearance) | 304 grade Stainless Steel<br>and anodized aluminum<br>for hub | Smith & Nephew Dyonics, Inc. Limited<br>Reuse Arthroscopic Blades (K955914);<br>Arthronet, Inc. Series 145/155 Blades<br>(K003203) | | 133 | Linvatec, Friatec, Arthrex<br>Shaver Systems | 304 grade Stainless Steel<br>and anodized aluminum<br>for hub | Smith & Nephew Dyonics, Inc. Limited<br>Reuse Arthroscopic Blades (K955914);<br>Arthronet, Inc. Series 145/155 Blades<br>(K003203) | | 153 | Dynonics EP 1 | 304 grade Stainless Steel<br>and anodized aluminum<br>for hub | Smith & Nephew Dyonics, Inc. Limited<br>Reuse Arthroscopic Blades (K955914);<br>Arthronet, Inc. Series 145/155 Blades<br>(K003203) | | 163 | Aesculap | 304 grade Stainless Steel<br>and anodized aluminum<br>for hub | Smith & Nephew Dyonics, Inc. Limited<br>Reuse Arthroscopic Blades (K955914):<br>Arthronet, Inc. Series 145/155 Blades<br>(K003203) | | 173 | Stryker | 304 grade Stainless Steel<br>and anodized aluminum<br>for hub | Smith & Nephew Dyonics, Inc. Limited<br>Reuse Arthroscopic Blades (K955914);<br>Arthronet, Inc. Series 145/155 Blades<br>(K003203) | | 183 | Storz | 304 grade Stainless Steel<br>and anodized aluminum<br>for hub | Smith & Nephew Dyonics, Inc. Limited<br>Reuse Arthroscopic Blades (K955914);<br>Arthronet, Inc. Series 145/155 Blades<br>(K003203) | Arthronet BLACKLINE Arthroscopic Blades are all made from 304 Stainless Steel and the adapter hubs are made from hardened anodized aluminum and stainless steel. These materials are essentially equivalent to those of predicate devices. Configurations and sizes are typical of predicate devices and indicated in catalog labeling. Arthronet BLACKLINE Arthroscopic Blade assemblies consist of 2 piece and 3 piece blade assemblies, depending upon the shaver system they are used with. The 3 Piece blade consists of a single outer blade/hub assembly within which a two-piece inner blade and hub assembly can be inserted. The inner blade assembly snaps into place within the inner blade hub adapter. The resulting inner blade assembly, in turn, snaps into place within the outer blade assembly. The 2 Piece blade consists of a single blade/hub outer and a single inner blade/hub that are joined together in the identical fashion as the 3 Piece. The distal cutting orifices of the inner and outer blade assemblies align precisely to allow for rotary cutting as the inner blade rotates within the fixed outer blade. These assemblies are designed to facilitate cleaning and autoclave sterilization. Autoclave sterilization parameters are equivalent to predicate products noted and directions for use, cleaning and sterilization are contained in product labeling. {2}------------------------------------------------ The Arthronet BLACKLINE Arthroscopic Blade configurations utilize materials similar to the predicate devices noted in the previous table. All predicate devices noted in this section have the same intended use. The Arthronet BLACKLINE Arthroscopic Blades have been sold worldwide by Arthronet GmbH & Co. KG and their previous company for eight years and meet international product safety requirements. Submitted product intended for sale in the USA will also bear the CE mark and registration number of the Arthronet GmbH & Co. KG Notified Body and will also meet FDA product labeling requirements. Blades are identified with etched labeling noting the manufacturer and the country of manufacture. The Arthronet BLACKLINE Arthroscopic Blades are essentially equivalent to the Arthronet Limited Use Arthroscopic Blades (such as the series 145/155 Blades, K003203) and the Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695) and the Smith & Nephew Dyonics Limited Use Arthroscopic Blades (K955914). Materials used are essentially equivalent and conform to many other surgical instruments. Arthronet BLACKLINE Arthroscopic Blades are provided in a Non-Sterile condition. Recommended disassembly, cleaning, reassembly and sterilization instructions are identified and included in product labeling. These products are intended to be steam pressure autoclaved at cycle parameters equal to or exceeding 132°C and 2bar pressure for 5 minutes. Cautionary warnings alert the user to thoroughly clean the units prior to sterilization and to remove all debris during the cleaning process. Cleaning and sterilization criteria are recommendations only and are based upon simulated use testing on file with the manufacturer. Labeling clearly indicate that hospitals should use their own validated cleaning and sterilization processes for these types of products. Arthronet BLACKLINE Arthroscopic Blades are limited use devices. Blades are clearly labeled for use a maximum of three (3) uses. The blade assemblies can be discarded after three uses. Product usage and cautions related to potential damage to the blade assemblies as a result of handling or cleaning are clearly defined in product labeling. All product usage is based upon design data developed during product design, simulated use verification testing, and is also based upon seven years of clinical product experience in the worldwide market. {3}------------------------------------------------ A complete risk analysis has been performed for these products and has been filed with the products' 510(k) submission. There were no identifiable risks associated with the use of this device that can be alleviated by product redesign. {4}------------------------------------------------ ronet Medical, Inc. The following table demonstrates the substantial equivalence of the Arthroscopic Blades to the following to | Company: | Device: | Blade<br>Material | Hub Adapter<br>Material | Provided<br>Sterile? | Recommended<br>Sterilization: | Intended Use: | Reusable? | Design: | 510(k) | |------------------------------------------------|----------------------------------------------------------|-----------------------------------------|----------------------------------------------------------------------|---------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------|---------| | Arthronet<br>GmbH &<br>CO. KG | Limited Use<br>Arthroscopic<br>Blades and Hub<br>Adapter | Surgical<br>Grade<br>Stainless<br>Steel | Surgical Grade<br>anodized aluminum | NO | Steam<br>Autoclave | Joint Surgery<br>(used with<br>Arthronet,<br>Dyonics EP1,<br>Aesculap, Strkyer,<br>Storz, Linvatec,<br>Friatec and<br>Arthrex external<br>Shaver systems) | Blades are<br>Limited Use<br>(3 times). | Inner and<br>outer tube<br>with distal<br>cutting | Pending | | Arthronet, Inc. | Limited Use<br>Arthroscopic<br>Blades and Hub<br>Adapter | Surgical<br>Grade<br>Stainless<br>Steel | Surgical Grade<br>Stainless Steel | NO | Steam<br>Autoclave | Joint Surgery<br>(used with Dyonics<br>PS 3500/EP1,<br>Linvatec, Concept<br>and Arthrex<br>external Shaver<br>systems) | Blades are<br>Limited Use<br>(3 times);<br>Hubs are<br>reusable. | Inner and<br>outer tube<br>with distal<br>cutting | K003203 | | Smith &<br>Nephew<br>Dyonics, Inc. | Limited Use<br>Arthroscopic<br>Blades | Surgical<br>Grade<br>Stainless<br>Steel | Surgical Grade<br>Stainless Steel | NO | Steam<br>Autoclave | Joint Surgery<br>(used with Dyonics<br>PS 3500 Shaver<br>system, or<br>equivalent) | Limited Use | Inner and<br>outer tube<br>with distal<br>cutting | K955914 | | Smith &<br>Nephew<br>Dyonics, Inc. | Disposable<br>Arthroscopic<br>Blades | Surgical<br>Grade<br>Stainless<br>Steel | Surgical Grade<br>Stainless Steel and<br>Non-Autoclavable<br>Plastic | Yes<br>ETO<br>sterilized by<br>Manufacturer | Not<br>intended to<br>be<br>resterilized | Joint Surgery | Single Use | Inner and<br>outer tube<br>with distal<br>cutting | K953695 | | Micro-Aire<br>Surgical<br>Instruments,<br>Inc. | Arthroscopic<br>Surgical Blades<br>(several<br>models) | Surgical<br>Grade<br>Stainless<br>Steel | Surgical Grade<br>Stainless Steel and<br>aluminum | NO | Steam<br>Autoclave | Joint Surgery | Limited Use | Inner and<br>outer tube<br>with distal<br>cutting | K901735 | allerialia de article ochile adal o cuente a problemos. Production note note of onlined o por more o por more o por more o por more o por more o por maimente de bara maimane {5}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/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 top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three figures. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Arthronet Medical, Inc. Carolina Schaber 8 Hammond, Suite 108 Irvine, California 92618 Re: K023777 Trade/Device Name: Arthronet Blackline Arthroscopic Blades Regulation Number: 888.1100 Regulation Name: Arthroscope accessories Regulatory Class: Class II Product Code: HRX Dated: November 5, 2002 Received: November 12, 2002 Dear Ms. Schaber: 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 such 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); good manufacturing practice requirements as set forth in {6}------------------------------------------------ Page 2 – Ms. Carolina Schaber 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. 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) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Special 510(k) Submission Arthronet Medical, Inc Limited-Use Arthronet BLACKLINE Arthroscopic Blade Assemblies #### 3. Indications for Use The Arthronet BLACKLINE Arthroscopic Blades are indicated for minimally invasive joint surgeries, including but not limited to synovectomie, subacromial decompression, chondroplastic and ACL reconstruction. Miriam C. Provoost Jivision Sign-Off) Division of General, Restorative and Neurological Devices 210(k) Number K023777