(99 days)
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.
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 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 device in question is the DReal™, a handheld bone-removal device. The provided document is a 510(k) Pre-market Notification for the DReal™, demonstrating its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary indicates that for each performance test, the device "passed the test" and "The acceptance criteria were met." However, specific quantitative acceptance criteria values are generally not detailed in this type of summary. The table below lists the performance tests and the reported results:
| Test | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| GLP Cytotoxicity per ISO 10993-5 | Non-cytotoxic (less than grade 2 reactivity) | Non-cytotoxic |
| ISO- intracutaneous in Rabbits (irritation) per ISO 10993-10 | Not irritant (difference between test article extract and control is low) | Not irritant |
| Sensitization per ISO 10993-10 | Not considered a sensitizer (no evidence of delayed dermal contact) | Not considered a sensitizer |
| Systemic toxicity per ISO 10993-11 | Nontoxic (no mortality or evidence of systemic toxicity) | Nontoxic |
| Systemic toxicity USP pyrogen Study per ISO 10993-11 | Nonpyrogenic (total rise of rabbit temperatures within USP limits) | Nonpyrogenic |
| LAL test per NAMSA LAL SOP | Acceptable (less than 0.06 EU/ml) | Acceptable |
| Sterilization, Packaging, and Shelf Life Testing | ||
| Sterilization validation (ISO 11137-1) | Compliance with ISO 11137-1 | Successfully completed |
| Shelf life and packaging testing (including integrity, simulated use) | Support for labeled shelf life and packaging integrity | Successfully completed |
| Performance Testing | ||
| Simulated use testing (material removal, durability, integrity on hard tissue) | Efficacy, durability, and integrity for bone removal in clinical settings | Passed the test |
| Temperature Testing (tissue necrosis) | Compliance with safety requirements regarding tissue necrosis | Passed the test |
| Slippage testing (motor compatibility) | Compatibility with specified motors | Passed the test |
| Simulated distribution testing/transportation validation (Chatter testing) | Compatibility with ASTM D4169-09 and ASTM D4332-13 | Passed the test |
| Fatigue test (durability on hard tissue) | Durability and integrity for intended use | Passed the test |
| Motor compatibility | Compatibility with specified motors | Passed the test |
| Excessive Vibration | Compatibility with specified motor without malfunction | Passed the test |
| Animal Feasibility Test (safety and performance in spine) | Safety and performance for intended use in the spine | Passed the test |
| Cadaver Feasibility Test (performance in spine) | Performance for intended use in the spine (gross bone volume reduction) | Passed the test |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The sample sizes are specific to the biological tests performed (e.g., rabbits for irritation, guinea pigs for sensitization, mice for systemic toxicity). Specific numerical sample sizes beyond the general animal models are not explicitly stated in this summary.
- Sterilization, Packaging, and Shelf Life Testing: Sample sizes are not specified, but the tests were performed on device samples.
- Performance Testing:
- Animal Feasibility Test: One live adult (7 months) pig.
- Cadaver Feasibility Test: One skeletally mature human cadaver.
- For other performance tests (simulated use, temperature, slippage, chatter, fatigue, motor compatibility, excessive vibration), the sample size of devices tested is not specified in this summary.
- Data Provenance: Not explicitly stated, but given the manufacturer is Carevature Medical Ltd. in Israel, it is likely that the testing (especially feasibility tests) was conducted there or arranged through a contract research organization. The studies are assumed to be prospective as part of the premarket notification process for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is not typically required or provided in a 510(k) summary for mechanical surgical devices. The "ground truth" for these tests primarily relies on objective measurements against established engineering and biological standards (e.g., ISO, ASTM, USP standards) and direct observation by qualified technicians and researchers conducting the tests.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnostic or AI-based devices. For this mechanical surgical device, the "adjudication" is inherent in passing or failing objective engineering and biocompatibility tests against predefined standards. There is no mention of a separate expert adjudication process for these tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. These studies are relevant for diagnostic devices where human readers interpret images, and the AI's assistance to human readers is evaluated. The DReal™ is a surgical tool, not a diagnostic imaging AI.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The DReal™ is a mechanical surgical device operated by a surgeon, not an algorithm. Its performance is evaluated through its physical properties, safety, and functionality, not as a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth for this device is based on several objective measures and established standards:
- Biocompatibility: In vitro and in vivo testing against ISO and USP standards.
- Sterilization, Packaging, and Shelf Life: Validation against ISO standards.
- Performance Testing (Simulated Use, Temperature, Fatigue, etc.): Objective measurements of mechanical properties, material removal efficacy, temperature generation, durability, and compatibility against predefined engineering specifications and regulatory standards (e.g., ASTM).
- Feasibility Tests (Animal and Cadaver): Direct observation of safety, performance, and gross bone volume reduction in a controlled environment.
8. The Sample Size for the Training Set
This question is not applicable. The DReal™ is a mechanical device, not an AI or machine learning algorithm that requires a training set. Its design and manufacturing are based on engineering principles and materials science.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for this mechanical surgical device.
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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
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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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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.
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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 Attachmentsand Cutting Accessories | SEJUSTIFICATION | |
|---|---|---|---|
| 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™ isintended to be used with high-speed compatible electric andpneumatic motors | The MIS Attachments andCutting Accessories areintended to be used with theStrykerConsolidated Operating RoomEquipment (CORE Consoleand electric and pneumaticmotors | Same-Substantiallyequivalent |
| When used with these motors,it is intended to cut bone bydrilling, reaming, decorticating,shaping, dissecting, shavingand smoothing forneurosurgical and spinalapplications. | When used with these motors,the MIS Attachments andCutting Accessories areintended to cut bone in thefollowing manner: drilling,reaming, decorticating,shaping, dissecting, shaving,and smoothing for thefollowing medical applications:Neuro; Spine; Ear, Nose, andThroat(ENT)/Otorhinolaryngology;and Endoscopic applications. | DifferentThe DReal™ haslimitedindications thanthe Stryker MISattachments. Thespecificindications are asubset of alreadyclearedindications forthe predicatedevice. | |
| Specific applications includelaminectomy/laminotomy andcraniotomy/craniectomy/ skullbase cuts < 1cm3. | Specific applications includeCraniotomy/Craniectomy,Laminotomy/Laminectomy,Minimally Invasive Surgery(MIS) Spine, ExpandedEndonasal Approach(EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.These devices are also usable inthe preparation for theplacement of screws, metal,wires, pins, and other fixationdevices. | ||
| Carevature Medical DReal™ | Stryker MIS Attachmentsand Cutting Accessories | SEJUSTIFICATION | |
| PatientPopulation | GeneralPrescription medical device | GeneralPrescription medical device | Same |
| Function | • The subject CarevatureDReal™ models act as aninterface between the high speedmotors and the cuttingaccessories• Carevature DReal™ modelsare intended as a location for theuser to hold and grip the devicesystem | • The predicate Stryker MISAttachments act as an interfacebetween the high speed motorsand the cutting accessories• The predicate MISattachments are intended as alocation for the user to holdand grip the device system.MIS Attachments and CuttingAccessories are intended to cutbone and used in the preparationfor the placement of screws,metal, wires, pins, and otherfixation devices | Same |
| Contraindications | None known | None known | Same |
| Type of operation | Open surgical procedures | Open surgical procedures | Same |
| Conditions forUse | DReal™– Single Use | Attachments – ReusableCutting accessories – Single use | SameCarevatureDReal™ devicesare unifiedattachments andcuttingaccessoriestherefore, a singleuse |
| Sterilization | DReal™– supplied sterile,gamma irradiated | Attachments– sterilized by theuserCutting accessories – suppliedsterile, gamma irradiated | SimilarCarevatureDReal™ devicesare unifiedattachments andcuttingaccessoriestherefore,sterilized by themanufacturer |
| Carevature Medical DReal™ | Stryker MIS Attachmentsand Cutting Accessories | SEJUSTIFICATION | |
| Main Materials | Commonly used medical grademetals and plastics:The handle is made ofSteralloy, a USP-6 plasticmaterial The central shaft is madeof medical grade stainlesssteel The cutter is made ofmedical grade stainlesssteel | Commonly used medical grademetals and plastics | SameBoth the subjectand the predicateare comprised ofsimilar materials.DifferentThe DReal™ hasno color strip;instead, thevarious modelsare designated onthe single-useouter and inner-packaging. |
| PackagingConfiguration | Carevature DReal™ products -double sterile sealed pouchesand corresponding cardboardbox. | Attachments - Retention insert ina rigid cartonMIS Cutting Accessories –sealed chevron style pouchsterile barrier system | SimilarCarevatureDReal™ modelsare unifiedattachments andcutting accessoriestherefore, packedin sterile sealedway |
| Available Style | Curved, Angled (45° and 75°),partially-hooded burr | Straight, Curved, Angled | SimilarThe curve andangle of the tipare intended toimprove its accessand visibilityDifferent• The DReal™possesses asharperangulation nearthe distal end• The DReal™possesses apartially-hoodedburr to provideprotection forsurroundingtissue |
| Carevature Medical DRealTM | Stryker MIS Attachmentsand Cutting Accessories | SEJUSTIFICATION | |
| Driving motor | The Carevature DRealTMmodels were validated to beused with the StrykerConsolidated Operating RoomEquipment (CORE Consoleand electric motors) | The MIS Attachments andCutting Accessories areintended to be used with theStryker Consolidated OperatingRoom Equipment (COREConsole and electric orpneumatic motors) | Same |
| Head StyleOffering | Match Head | Round, Diamond, Match Head | Similar |
| Diameter/HeadSize | 2.5 mm | 1.5 mm - 5.0 mm | Similar |
| Length | Shaft length 11cm | Two lengths 13 and 16 cm | Similar |
| Motor powersupply | Electric and Pneumatic | Electric and Pneumatic | Same |
| Speed | 10,000-40,000 rpm | 5,000-75,000 rpm | Similar |
| PneumaticPressureRecommendation | 120 psi (pounds per square inch) | 120 psi (pounds per square inch) | Same |
| Source ofActivation | Footswitch | Handswitch and Footswitch | Similar |
| Performance | 1. Shelf life testing2. Temperature Testing3. Slippage testing4. Simulated distribution testingtransportation validation(Chatter testing)5. Simulated use testing6. Fatigue test7. Motor compatibility8. Excessive vibrations | 1. Shelf life testing2. Temperature Testing3. Slippage testing4. Chatter testing5. Whip testing | SameWhip test wasdeemedunnecessary dueto the productdesign. Whippingeffect isinherently limitedto an acceptablevalue. |
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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.
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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.
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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.
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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 perISO 10993-5 | Less than grade 2 (mild reactivity) | Non-cytotoxic |
| ISO- intracutaneous inRabbits (irritation) perISO 10993-10 | The difference between each test articleextract overall mean score andcorresponding control was 0.0 and 0.1for test articles extract | Not irritant |
| Sensitization per ISO10993-10 | The test article showed no evidence ofcausing delayed dermal contact in theguinea pig | Not considered asensitizer |
| Systemic toxicity perISO 10993-11 | No mortality or evidence of systemictoxicity from the extracts injected intomice | Nontoxic |
| Systemic toxicity USPpyrogen Study per ISO10993-11 | The total rise of rabbit temperatureswas within acceptable USP limits | Nonpyrogenic |
| LAL test per NAMSALAL 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.
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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 ona hard-tissue model to show efficacy (materialremoval), durability and integrity for the removalof material needed with the device' indications inclinical settings. | The devicepassed the test.The acceptancecriteria were met. |
| Temperature Testing | To demonstrate the compliance of the DRealTM tosafety requirements derived from tissue necrosis | The devicepassed the test.The acceptancecriteria were met. |
| Slippage testing | To demonstrate the compatibility of the DRealTMto the specified motors | The devicepassed the test.The acceptancecriteria were met. |
| Simulateddistribution testingtransportationvalidation (Chattertesting) | To demonstrate the compatibility of the DRealTMto ASTM D4169-09 and ASTM D4332-13 | The devicepassed the test.The acceptancecriteria were met. |
| Fatigue test | To demonstrate the durability of the DRealTM forits intended use.Method: Activation of the DRealTM on a hard-tissue (bone) to show durability and integrityneeded with the device' indications in clinicalsettings. | The devicepassed the test.The acceptancecriteria were met. |
| Motor compatibility | To demonstrate the compatibility of the DRealTMto the specified motors | The devicepassed the test.The acceptancecriteria were met.The motors thatare approvedappears on thedevice IFU |
| Excessive Vibration | To demonstrate the compatibility of the DRealTMto the specified motor without malfunction | The devicepassed the test.The acceptancecriteria were met. |
| Animal FeasibilityTest | To investigate the safety and performance of theDRealTM for its intended use in the spine. Onelive adult (7 months) pig was used. Intra-operative performance, gross bone volumereduction, and histopathological sections were | The devicepassed the test.The acceptancecriteria were met. |
| Test | Test Method Summary | Results |
| Cadaver FeasibilityTest | To investigate the performance of the DReal™ for its intended use in the spine. One skeletallymature human cadaver was used. Gross bonevolume reduction was observed. | The devicepassed the test.The acceptancecriteria were met. |
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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.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).