MERIDIAN CRANIAL PERFORATOR

{0}------------------------------------------------ K121253 Image /page/0/Picture/1 description: The image shows the word "adeor" in a simple, sans-serif font. To the left of the word is a cluster of black dots, arranged in a pattern that resembles a stylized star or burst. The dots vary in size, with some being larger and more prominent than others. # 510(k) Summarv # JUL 1 7 2012 | Submitter: | adeor Medical Technologies GmbH<br>Kirchpaltz 1<br>82049 Pullach<br>Germany | |----------------------|-----------------------------------------------------------------------------| | Contact Person: | Fabio von Zeppelin<br>General Manager | | | Phone: +49 (0)89-744 42 398<br>Fax: +49 (0)89-744 24 809 | | Preparation Date: | April 16th, 2012 | | Trade Name: | Meridian™ Cranial Perforator | | Common Name: | Cranial Perforator | | Classification Name: | Neurological surgical devices | ### Device Description: The Meridian™ Cranial Perforator is a sterile packed, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery, driven by powered sources having a standardized and commonly used Hudson fitting clutch. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. Both versions are available for burr-hole diameters of Ø6. Ø7 and Ø11 mm. The Meridian™ Cranial Perforator per CFR. Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr-holes through the skull of a patient. An integrated clutch mechanism prevents plunging of the perforator tip into the underlying dura and parenchyma tissue. The device is a Class II (USA) device and classified IIa in Europe (EEC). The Meridian™ Cranial Perforator is a device similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra-Cut models DGR-II and Codman Disposable Perforators etc ... ) The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains a sequence of characters that appear to be handwritten. The sequence starts with the letters 'klala' followed by the numbers '253'. The characters are written in a simple, clear style, with consistent line thickness. Image /page/1/Picture/1 description: The image shows the logo for Adeor. The logo consists of a cluster of black dots in the upper left corner, arranged in a pattern that resembles a constellation or a network. To the right of the dots is the word "adeor" in lowercase, sans-serif font. The overall design is simple and modern. #### Intended Use: The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery #### Indications for Use: The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm. #### Predicate Devices: | K933894, K071931 | 2 | Disposable Perforators | 2 | Codman & Shurtleff, Inc. | |------------------|---|-----------------------------------------|---|--------------------------| | K833266 | 3 | Automatic Cranial Drill<br>(Perforator) | 3 | Acra Cut, Inc. | #### Substantial Equivalence: The Meridian™ Cranial Perforator is substantially equivalent to the currently marketed Acra-Cut DGR-II and Codman 26-1221 based on the device's similarity to the predicate devices in indications, principle of operations, materials and design. The predicate and subject devices are marketed in the European Union as substantially equivalent. #### Technological Characteristics Comparison: | | Acra-Cut Inc. | Codman | Adeor | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Parameters: | DGR-II | 26-1221 | Meridian | | Class | II | II | II | | Indications for Use: | The Acra-Cut DGR-I is<br>designed to<br>automatically release<br>and stop upon<br>penetration of bone that<br>is at least 3 mm thick.<br>The DGR-II perforator is<br>for use on thin skull/skull<br>areas such as pediatric,<br>temporal and<br>suboccipital areas. They<br>are designed to<br>automatically release<br>and stop upon<br>penetration of bone as<br>thin as 1 mm. | The Codman Disposable<br>Perforator is for use in<br>perforating the cranium.<br>When properly used, it is<br>designed to<br>automatically disengage<br>once perforation is<br>accomplished and when<br>pressure is removed<br>from the drill point. | The Meridian™<br>Perforator is a, single-use<br>surgical device for<br>cranium perforation. The<br>device automatically<br>releases and stops<br>perforating at cranial<br>bone thickness of at<br>least 3 mm.<br>The Meridian™ pediatric<br>perforators automatically<br>release and stop<br>perforating at cranial<br>bone thickness of at<br>least 1.5 mm. | | Dimensions and design: | similar | similar | similar | | Materials | Plastic/ stainless steel | Plastic/stainless steel | Plastic/stainless steel | | Fitting | Hudson | Hudson | Hudson | | Principle of operation | similar | similar | similar | | Cutting Performance | similar | similar | similar | 05_510(k)_Summary rev. 01.doc Page 2 of 4 {2}------------------------------------------------ K121253 Image /page/2/Picture/1 description: The image shows the logo for Adeor. The logo consists of a cluster of dots in the upper left corner, arranged in a pattern that resembles a stylized star or burst. To the right of the dots is the word "adeor" in lowercase letters. The font is simple and sans-serif, and the overall design is clean and modern. | Burr hole diameters Ø | Ø 5/8,7/11,11/14 mm | Ø 6/9, 7/11, 11/14 mm | Ø 6/9, 7/11, 11/14 mm | |-----------------------|---------------------|-----------------------|-----------------------| | Release mechanism | automatic | automatic | automatic | | Rotation speed | 800 RPM | Not-known | 800-1200 RPM | | Cutting performance | similar | similar | similar | | Single-use supply | Gamma sterile | Gamma sterile | Gamma sterile | The technological characteristics of the subject device are based on the same cranial perforator technology as the predicate devices. Substantial equivalence of the Meridian™ Adeor cranial perforator is based upon the comparison to predicate device's characteristics. #### Performance Standards: Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act. #### Performance testing: Substantial equivalence of the Meridian™ Adeor cranial perforator is based upon the comparison to predicate device's technical characteristics, indications, principle of operations, materials, design, and sterile supply as a single-use medical device. #### Performance Bench Testing: Samples of each model were used to drill holes in wood and animal bone to verify its mechanical functionality similar to predicate devices. The release mechanism worked reliable on both materials and stopped cutting as soon as the thin remaining pad of material became elastic. On animal cadavers (pig head and calf shoulder) the release mechanism worked reliable and a clear bone pad has been formed which can easily be removed from the bur-hole. All tests have been performed satisfactory with the following positive remarks: The release mechanism worked reliable on several bur-holes. There was no friction observed between the rotating cutting parts. There has been no skidding of the subject device on the animal cadaver bone. A firm axial rotation and no wobbling of the subject device have been observed. A plain and even surface of the perforated bone and on the bone flap was observed. (See "Performance Bench testing protocol" for details in Chapter 18) #### Sterilzation Process Validation: The sterilization process is based on international Standards ISO 11137-1:2006, ISO 11137-2:2006 and ISO 11137-3:2006 which are recognized by FDA, as well. The sterilization dose of 25 kGy has been validated according to ISO 11137-1:2006, ISO 11137-2:2006 (see Validation Report: Radiation Sterilization for product family "Perforators" n. PR/7-5-0-331). Latest revalidation has been performed 05-24-2012. The sterilization process according to standards ISO 11137-1:2006, ISO 11137-2:2006 and ISO 11137-3:2006 has been validated (see Validation Report: Radiation Sterilization "HiCut & Perforators" n. V 7-5-0-235 R). {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a handwritten string of characters. The string appears to be a combination of a letter and numbers. The string reads 'k121253'. Image /page/3/Picture/1 description: The image shows the word "adeor" in lowercase letters. To the left of the word is a cluster of black dots that are arranged in a circular pattern. The dots vary in size, with the largest dots in the center and the smallest dots on the periphery. The Test Report no. 100239-10 (see annex) investigation indicates that any microbial contamination of the device (average bioburden of three independent lots < 2 cfu/sample) was inactive by the irradiation of 4.8 kGy (according to prEN ISO 111137-2) Therefore, the Gamma irradiation method ensures effective conditions (sterility assurance level (SAL) < 10 6) for the sterilization of the product by application of a minimum dose of 25 kGy. #### Final Sterilization Process Assessment: It can be confirmed that the requirements of the standards ISO 11137-1:2006. ISO 11137-2:2006 and ISO 11137-3:2006 and the validation protocol V 7-5-0-235 P with regard to the validation of the sterilization procedure for the product group "Perforators" are met. It could be shown that the documented procedure of a routine sterilization with >25 kGy ensures a SAL < 10°. #### Conclusion: Substantial equivalence of the Meridian ™ Adeor cranial perforator in comparison to predicate device's the currently marketed Acra Cut DGR-I/II and Codman 26-1221 is demonstrated with regard to the similarity of device characteristics, described functionality. for the same indications of use, and sterile supply as a single-use medical device. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the symbol. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Adeor Medical Technologies GmbH c/o Mr. Fabio von Zeppelin General Manager Kirchplatz 1 Pullach Germany 82049 JUL 1 7 2012 Re: K121253 Trade/Device Name: Meridian™ Cranial Perforator Regulation Number: 21 CFR 882.4305 Regulation Name: Powered Compound Cranial Drills, Burrs, Trephines, and their Accessories Regulatory Class: Class II Product Code: HBF Dated: April 19, 2012 Received: April 27, 2012 Dear Mr. Zeppelin: 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. {5}------------------------------------------------ Page 2 - Mr. Fabio von Zeppelin 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Qula. Thum, MD f Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known): KI21253 Device Name: Meridian™ Cranial Perforator Indications for Use: The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm. | Pediatric: for bone thickness of at least 1.5 mm: | For bone thickness of at least 3.0 mm: | |---------------------------------------------------|----------------------------------------| | PER 6-9-SP | PER 6-9-S | | PER 7-11-SP | PER 7-11-S | | PER 11-14-SP | PER 11-14-S | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) (Divisi Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Prescription Use. 0-010000011000 510(k) Number K121253 (Per 21 CFR 801.109) 04_Indications_for_Use_Statement.doc