DReal

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of a bird. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002 March 24, 2016 Carevature Medical, Ltd. Ms. Orly Maor Company Consultant 42nd Tvuot Haarets Street Tel Aviv, Israel 6954648 Re: K153519 Trade/Device Name: DReal™ Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE Dated: February 9, 2016 Received: February 11, 2016 Dear Ms. Orly Maor: This letter corrects our substantially equivalent letter of March 16, 2016. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, Carlos L. Pena -S/Δ Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K153519 Device Name DReal™M Indications for Use (Describe) The Carevature DReal™ is intended to be used with high-speed compatible electric and pneumatic motors. When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for neurosurgical and spinal applications. Specific applications include laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts < 1 cm3. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |--------------------------------------------------------------------------------------| | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Traditional Premarket Notification Submission – 510(k) Summary DReal™ 510(k) Number K153519 ### I. SUBMITTER Carevature Medical Ltd. 42 Tvuot Haarets St. Tel Aviv, Israel 6954648 Tel: +972-8-6757073 Fax: +972-8-6757073 #### Contact Person Orly Maor Company consultant ra@carevature.com Tel: +972-9-7453607 Fax: +972-8-6757073 42nd Tvuot Haarets St. Tel Aviv, Israel 6954648 Date Prepared: February 26, 2016 ### II. DEVICE Name of Device: DReal™ Common or Usual Name: DReal™ Classification Name: drills, burrs, trephines & accessories (simple, powered) CFR: 21 CFR §882.4310 Regulatory Class: II Product Code: HBE ### III. PREDICATE DEVICE The predicate device is the Stryker Corporation Stryker MIS Attachments and Cutting Accessories cleared under K143540 (product code HBE, Regulation No. 21 CFR \$882.4310). ### IV. DEVICE DESCRIPTION The DReal™ is a handheld bone-removal device based on a rotating cutter, with a protective shield (hood) partially covering the cutter; following its indications for use, it is designed to cut bone < 1 cm3. The DReal™ comprises a handpiece with a plastic grip ("handle") and a central shaft that curves at its distal end ("tip"). The curved tip is equipped with an active, drill-like {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "carevature MEDICAL". The word "carevature" is in a sans-serif font, with the "c" in a darker shade of blue than the rest of the word. Below "carevature" is the word "MEDICAL" in a smaller, sans-serif font. There are two curved lines above and below the word "carevature", both in shades of blue. cutter that is protected by an extension of the central shaft as a protective shield. The DReal™ has two models, with different angles of curvature at the distal end: Short 45° and Long 75°. Located in the proximal end of the handle, is the motor adaptor (the motor is not part of the supplied product). The DReal™ principles of operation are the same as any other bone cutting tool, as well as the predicate device; it uses electrical or pneumatic power to rotate a cutting element that is approximated to the bone requiring cutting. The DReal™ has an irrigation port on its handle that connects to irrigation source. Irrigation should be running at all times while the DReal™ is active. In case of irrigation malfunction, irrigation can be added externally as with any high-speed, rotating power device, including the predicate. The DReal™ can be powered by an electric or pneumatic motors using a 'micro' adaptor as per ISO 3964; however, it can rotate only clockwise (right-hand, or Forward). The following motor system (Class II, Product Code HBE) was validated for use with the DRealTM. - Stryker Consolidated Operating Room Equipment (CORE) -K112593 ● ## V. INDICATIONS FOR USE The Carevature DReal™ is intended to be used with high-speed compatible electric and pneumatic motors. When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for neurosurgical and applications. Specific applications include laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts < 1cm . ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE A substantial equivalence table, which summarizes the similarities and differences between the DReal™ and the predicate device, is provided below. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for "carevature MEDICAL". The word "carevature" is in a sans-serif font, with the word "MEDICAL" in a smaller font size below it. There are two curved lines above and below the text, creating a circular shape around the logo. The logo is in a light blue color. | | Carevature Medical DReal™ | Stryker MIS Attachments<br>and Cutting Accessories | SE<br>JUSTIFICATION | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K153519 | K143540 | — | | Manufacturer | Carevature Medical Ltd. | Stryker Corporation | — | | Product Code | HBE | HBE, ERL | Same | | CFR | §882.4310 | §882.4310, §874.4240 | Same | | Intended Use | The Carevature DReal™ is<br>intended to be used with high-<br>speed compatible electric and<br>pneumatic motors | The MIS Attachments and<br>Cutting Accessories are<br>intended to be used with the<br>Stryker<br>Consolidated Operating Room<br>Equipment (CORE Console<br>and electric and pneumatic<br>motors | Same-<br>Substantially<br>equivalent | | | When used with these motors,<br>it is intended to cut bone by<br>drilling, reaming, decorticating,<br>shaping, dissecting, shaving<br>and smoothing for<br>neurosurgical and spinal<br>applications. | When used with these motors,<br>the MIS Attachments and<br>Cutting Accessories are<br>intended to cut bone in the<br>following manner: drilling,<br>reaming, decorticating,<br>shaping, dissecting, shaving,<br>and smoothing for the<br>following medical applications:<br>Neuro; Spine; Ear, Nose, and<br>Throat<br>(ENT)/Otorhinolaryngology;<br>and Endoscopic applications. | Different<br>The DReal™ has<br>limited<br>indications than<br>the Stryker MIS<br>attachments. The<br>specific<br>indications are a<br>subset of already<br>cleared<br>indications for<br>the predicate<br>device. | | | Specific applications include<br>laminectomy/laminotomy and<br>craniotomy/craniectomy/ skull<br>base cuts < 1cm3. | Specific applications include<br>Craniotomy/Craniectomy,<br>Laminotomy/Laminectomy,<br>Minimally Invasive Surgery<br>(MIS) Spine, Expanded<br>Endonasal Approach<br>(EEA)/Anterior Skull Base/<br>Endoscopic/Transnasal/Transph<br>enoidal, and Orthopedic Spine.<br>These devices are also usable in<br>the preparation for the<br>placement of screws, metal,<br>wires, pins, and other fixation<br>devices. | | | | Carevature Medical DReal™ | Stryker MIS Attachments<br>and Cutting Accessories | SE<br>JUSTIFICATION | | Patient<br>Population | General<br>Prescription medical device | General<br>Prescription medical device | Same | | Function | • The subject Carevature<br>DReal™ models act as an<br>interface between the high speed<br>motors and the cutting<br>accessories<br>• Carevature DReal™ models<br>are intended as a location for the<br>user to hold and grip the device<br>system | • The predicate Stryker MIS<br>Attachments act as an interface<br>between the high speed motors<br>and the cutting accessories<br>• The predicate MIS<br>attachments are intended as a<br>location for the user to hold<br>and grip the device system.<br>MIS Attachments and Cutting<br>Accessories are intended to cut<br>bone and used in the preparation<br>for the placement of screws,<br>metal, wires, pins, and other<br>fixation devices | Same | | Contraindications | None known | None known | Same | | Type of operation | Open surgical procedures | Open surgical procedures | Same | | Conditions for<br>Use | DReal™– Single Use | Attachments – Reusable<br>Cutting accessories – Single use | Same<br>Carevature<br>DReal™ devices<br>are unified<br>attachments and<br>cutting<br>accessories<br>therefore, a single<br>use | | Sterilization | DReal™– supplied sterile,<br>gamma irradiated | Attachments– sterilized by the<br>user<br>Cutting accessories – supplied<br>sterile, gamma irradiated | Similar<br>Carevature<br>DReal™ devices<br>are unified<br>attachments and<br>cutting<br>accessories<br>therefore,<br>sterilized by the<br>manufacturer | | | Carevature Medical DReal™ | Stryker MIS Attachments<br>and Cutting Accessories | SE<br>JUSTIFICATION | | Main Materials | Commonly used medical grade<br>metals and plastics:<br>The handle is made of<br>Steralloy, a USP-6 plastic<br>material The central shaft is made<br>of medical grade stainless<br>steel The cutter is made of<br>medical grade stainless<br>steel | Commonly used medical grade<br>metals and plastics | Same<br>Both the subject<br>and the predicate<br>are comprised of<br>similar materials.<br><br>Different<br>The DReal™ has<br>no color strip;<br>instead, the<br>various models<br>are designated on<br>the single-use<br>outer and inner-<br>packaging. | | Packaging<br>Configuration | Carevature DReal™ products -<br>double sterile sealed pouches<br>and corresponding cardboard<br>box. | Attachments - Retention insert in<br>a rigid carton<br><br>MIS Cutting Accessories –<br>sealed chevron style pouch<br>sterile barrier system | Similar<br>Carevature<br>DReal™ models<br>are unified<br>attachments and<br>cutting accessories<br>therefore, packed<br>in sterile sealed<br>way | | Available Style | Curved, Angled (45° and 75°),<br>partially-hooded burr | Straight, Curved, Angled | Similar<br>The curve and<br>angle of the tip<br>are intended to<br>improve its access<br>and visibility<br><br>Different<br>• The DReal™<br>possesses a<br>sharper<br>angulation near<br>the distal end<br>• The DReal™<br>possesses a<br>partially-hooded<br>burr to provide<br>protection for<br>surrounding<br>tissue | | | Carevature Medical DRealTM | Stryker MIS Attachments<br>and Cutting Accessories | SE<br>JUSTIFICATION | | Driving motor | The Carevature DRealTM<br>models were validated to be<br>used with the Stryker<br>Consolidated Operating Room<br>Equipment (CORE Console<br>and electric motors) | The MIS Attachments and<br>Cutting Accessories are<br>intended to be used with the<br>Stryker Consolidated Operating<br>Room Equipment (CORE<br>Console and electric or<br>pneumatic motors) | Same | | Head Style<br>Offering | Match Head | Round, Diamond, Match Head | Similar | | Diameter/Head<br>Size | 2.5 mm | 1.5 mm - 5.0 mm | Similar | | Length | Shaft length 11cm | Two lengths 13 and 16 cm | Similar | | Motor power<br>supply | Electric and Pneumatic | Electric and Pneumatic | Same | | Speed | 10,000-40,000 rpm | 5,000-75,000 rpm | Similar | | Pneumatic<br>Pressure<br>Recommendation | 120 psi (pounds per square inch) | 120 psi (pounds per square inch) | Same | | Source of<br>Activation | Footswitch | Handswitch and Footswitch | Similar | | Performance | 1. Shelf life testing<br>2. Temperature Testing<br>3. Slippage testing<br>4. Simulated distribution testing<br>transportation validation<br>(Chatter testing)<br>5. Simulated use testing<br>6. Fatigue test<br>7. Motor compatibility<br>8. Excessive vibrations | 1. Shelf life testing<br>2. Temperature Testing<br>3. Slippage testing<br>4. Chatter testing<br>5. Whip testing | Same<br>Whip test was<br>deemed<br>unnecessary due<br>to the product<br>design. Whipping<br>effect is<br>inherently limited<br>to an acceptable<br>value. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for "carevature MEDICAL". The word "carevature" is in a larger, bold font, and the word "MEDICAL" is in a smaller font below it. There are two curved lines above and below the text, creating a circular effect. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Carevature Medical. The logo consists of the word "carevature" in a sans-serif font, with the word "MEDICAL" in a smaller font below it. There are two curved lines above and below the word "carevature", which are blue. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for "carevature MEDICAL". The word "carevature" is in a sans-serif font, with the word "MEDICAL" in a smaller font below it. There are two curved lines above and below the word "carevature", which are blue in color. The logo is simple and modern. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for "carevature MEDICAL". The word "carevature" is in a sans-serif font, with the word "MEDICAL" in smaller letters below it. There are two curved lines above and below the word "carevature", which are blue in color. The logo is simple and modern. ## VII. PERFORMANCE DATA The following performance data was provided in support of the substantial equivalence determination: ## Biocompatibility testing An evaluation of biocompatibility was performed in compliance with ISO 10993-1. The biocompatibility tests are listed in the table below: | Test | Results | Conclusions | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | GLP Cytotoxicity per<br>ISO 10993-5 | Less than grade 2 (mild reactivity) | Non-cytotoxic | | ISO- intracutaneous in<br>Rabbits (irritation) per<br>ISO 10993-10 | The difference between each test article<br>extract overall mean score and<br>corresponding control was 0.0 and 0.1<br>for test articles extract | Not irritant | | Sensitization per ISO<br>10993-10 | The test article showed no evidence of<br>causing delayed dermal contact in the<br>guinea pig | Not considered a<br>sensitizer | | Systemic toxicity per<br>ISO 10993-11 | No mortality or evidence of systemic<br>toxicity from the extracts injected into<br>mice | Nontoxic | | Systemic toxicity USP<br>pyrogen Study per ISO<br>10993-11 | The total rise of rabbit temperatures<br>was within acceptable USP limits | Nonpyrogenic | | LAL test per NAMSA<br>LAL SOP | Less than 0.06 EU/ml | Acceptable | All tests were successfully completed. ## Sterilization, Packaging and Shelf Life Testing Sterilization validation testing was performed to demonstrate compliance with ISO 11137-1. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests, including packaging integrity and simulated use (performance), were performed after simulated distribution testing (transportation validation) and successfully completed. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for "carevature MEDICAL". The word "carevature" is in a sans-serif font, with the word "MEDICAL" in smaller letters below it. There are two curved lines above and below the text, creating a circular shape around the logo. The colors are shades of blue. # Performance Testing Performance testing included the following: | Test | Test Method Summary | Results | |----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Simulated use testing | To demonstrate the performance of the DRealTM for its intended use: activation of the DRealTM on<br>a hard-tissue model to show efficacy (material<br>removal), durability and integrity for the removal<br>of material needed with the device' indications in<br>clinical settings. | The device<br>passed the test.<br>The acceptance<br>criteria were met. | | Temperature Testing | To demonstrate the compliance of the DRealTM to<br>safety requirements derived from tissue necrosis | The device<br>passed the test.<br>The acceptance<br>criteria were met. | | Slippage testing | To demonstrate the compatibility of the DRealTM<br>to the specified motors | The device<br>passed the test.<br>The acceptance<br>criteria were met. | | Simulated<br>distribution testing<br>transportation<br>validation (Chatter<br>testing) | To demonstrate the compatibility of the DRealTM<br>to ASTM D4169-09 and ASTM D4332-13 | The device<br>passed the test.<br>The acceptance<br>criteria were met. | | Fatigue test | To demonstrate the durability of the DRealTM for<br>its intended use.<br>Method: Activation of the DRealTM on a hard-<br>tissue (bone) to show durability and integrity<br>needed with the device' indications in clinical<br>settings. | The device<br>passed the test.<br>The acceptance<br>criteria were met. | | Motor compatibility | To demonstrate the compatibility of the DRealTM<br>to the specified motors | The device<br>passed the test.<br>The acceptance<br>criteria were met.<br>The motors that<br>are approved<br>appears on the<br>device IFU | | Excessive Vibration | To demonstrate the compatibility of the DRealTM<br>to the specified motor without malfunction | The device<br>passed the test.<br>The acceptance<br>criteria were met. | | Animal Feasibility<br>Test | To investigate the safety and performance of the<br>DRealTM for its intended use in the spine. One<br>live adult (7 months) pig was used. Intra-<br>operative performance, gross bone volume<br>reduction, and histopathological sections were | The device<br>passed the test.<br>The acceptance<br>criteria were met. | | Test | Test Method Summary | Results | | Cadaver Feasibility<br>Test | To investigate the performance of the DReal™ for its intended use in the spine. One skeletally<br>mature human cadaver was used. Gross bone<br>volume reduction was observed. | The device<br>passed the test.<br>The acceptance<br>criteria were met. | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for "carevature MEDICAL". The word "carevature" is in a sans-serif font, with the "c" in a darker shade of gray than the rest of the word. Below "carevature" is the word "MEDICAL" in a smaller, sans-serif font. Above and below the words is a curved line that is blue on the ends and fades to white in the middle. Conclusions: The tests met the predefined acceptance criteria and passed. ## VIII. CONCLUSIONS The DReal™ was determined to be substantially equivalent to the predicate device.