(296 days)
Not Found
No
The description focuses on a mechanical automatic stop mechanism based on bone thickness, not AI/ML. There are no mentions of AI, ML, or related concepts like training/test sets.
No
The device is a surgical tool used for cranium perforation, not for treating or rehabilitating a condition.
No
The device is described as a single-use surgical device for cranium perforation, used for drilling burr holes through the skull. Its function is to perform a surgical action (drilling), not to identify or analyze a disease or condition for diagnosis.
No
The device description clearly states it is a single-use surgical device for cranium perforation with an automatic stop mechanism, indicating it is a physical hardware device. The performance studies also focus on biocompatibility, sterilization, packaging, and cutting performance, all related to a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as a "single-use surgical device for cranium perforation." This clearly indicates a surgical procedure performed directly on a patient's body.
- Device Description: The description details a mechanical device used for drilling holes in the skull during surgery. It mentions being driven by a surgical motor.
- Anatomical Site: The device is used on the "cranium," which is a part of the human body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform any tests on samples.
The evoDrill Cranial Perforators are surgical instruments used during a surgical procedure, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.
Product codes
HBF
Device Description
The evonos evoDrill cranial perforator are single-use for trephining the cranial bone. The perforators have an automatic stop mechanism that stops the trephination process as soon as the skull bone has been pierced. The two variants evoDrill cranial perforator 3-flutes and evoDrill cranial perforator 4-flutes are available in two versions that are suitable for different bone thicknesses.
The first version is used from bone thicknesses of 3mm, the second version is used for trepanation with bone thicknesses between 1mm and 3mm. Both variants are available in four different diameters.
The evonos evoDrill 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. The evonos evoDrill cranial perforator are devices similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra Cut Automatic Cranial Drill DGR-1 #200-241; DGR-II #200-251 and Codman Disposable Perforators 26-1222, 26-1223). The evonos evoDrill cranial perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 RPM to 1500 RPM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium (skull bone)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility
Method: The device is classified as an externally communicating devices in contact with tissue/bone for a limited duration (≤24hr). Biocompatibility testing was addressed in accordance with ISO 10993 as described in FDA's Biocompatibility Guidance.
Results: All biocompatibility testing confirmed that the device fulfills the biocompatibility requirements considering contact area and duration.
Sterilization and packaging validation testing
Method: Sterilization validation testing in accordance with ISO 11137-1, ISO 11137-2, ISO 11607-1 and ISO 11607-2.
Results: All tested specimen confirm that devices are sterile and the SAL of 10-6 is met. Shelf-Life validation confirmed the integrity of the product and packaging of the defined shelf-life, labeled on the device.
Cutting Performance
Method: The performance of the subject device was evaluated for automatic stop function mechanism, maximum number of uses, drilling time and device geometry for establishing substantial equivalency to the predicate.
Results: All tested specimen confirmed that the overall cutting performance related to the autostop function mechanism, drilling time and surface structure fulfilled the acceptance criteria
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.(b)
Classification. Class II (performance standards).
0
March 6, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Evonos GmbH & Co. KG Jörg Mans CEO Stockacher Strasse 134 Tuttingen, Baden-Württemberg 78532 Germany
Re: K231403
Trade/Device Name: evoDrill 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: December 8, 2023 Received: December 8, 2023
Dear Jörg Mans:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Pierce -S
Sincerely, Digitally signed by Adam D.
Adam D. Pierce -S Date: 2024.03.06 17:22:17 -05'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231403
Device Name evoDrill Cranial Perforator
Indications for Use (Describe)
The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.
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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4
510(k) Summary
Date Prepared: March 6, 2024
Owner's Name (21 CFR 807.92(a)(1):
| Company Name: | evonos GmbH & CO. KG |
|---|---|
| Company Address: | Stockacher Strasse 134 |
| D-78532 Tuttlingen, Germany |
| Contact Person: | Jörg Mans |
|---|---|
| Company Telephone: | + 49 7461-965774-50 |
| Company Fax: | + 49 7461-965774-89 |
| Email-Address: | j.mans@evonos.de |
Trade Name, Common Name, Classification (21 CFR 807.92(a)(2))
| Device Trade Name: | evonos evoDrill Cranial Perforator |
|---|---|
| Device Common Name: | Disposable Cranial Perforator |
| Device Classification Name: | Drills, Burrs, Trephines & Accessories (Compound, Powered) |
| Device Classification: | Class II |
| Classification Code: | HBF |
| Regulation Number: | 21 CFR 882.4305 |
Predicate Device Names (21 CFR 807.92(a)(3))
- Acra Cut Automatic Cranial Drill (DGR-1 #200-241; DGR-II #200-251) (K892866) (Primary) -
- -Codman Disposable Perforators 26-1221 (K933894)
5
DEVICE DESCRIPTION
The evonos evoDrill cranial perforator are single-use for trephining the cranial bone. The perforators have an automatic stop mechanism that stops the trephination process as soon as the skull bone has been pierced. The two variants evoDrill cranial perforator 3-flutes and evoDrill cranial perforator 4-flutes are available in two versions that are suitable for different bone thicknesses.
The first version is used from bone thicknesses of 3mm, the second version is used for trepanation with bone thicknesses between 1mm and 3mm. Both variants are available in four different diameters.
| Item Number | Item Description | Inner
Diameter | Outer
Diameter | Bone
Thickness |
|-------------|-------------------------------------------------|-------------------|-------------------|-------------------|
| 26-000002 | evoDrill Cranial Perforator 9/6/1mm, 3-flutes | 6mm | 9mm | 1-3mm |
| 26-000003 | evoDrill Cranial Perforator 9/6/3mm, 3-flutes | 6mm | 9mm | > 3mm |
| 26-000004 | evoDrill Cranial Perforator 11/7/1mm, 3-flutes | 7mm | 11mm | 1-3mm |
| 26-000005 | evoDrill Cranial Perforator 11/7/3mm, 3-flutes | 7mm | 11mm | > 3mm |
| 26-000006 | evoDrill Cranial Perforator 13/9/1mm, 3-flutes | 9mm | 13mm | 1-3mm |
| 26-000007 | evoDrill Cranial Perforator 13/9/3mm, 3-flutes | 9mm | 13mm | > 3mm |
| 26-000008 | evoDrill Cranial Perforator 14/11/1mm, 3-flutes | 11mm | 14mm | 1-3mm |
| 26-000009 | evoDrill single use, Ø14/11mm, 3mm, 3-flutes | 11mm | 14mm | > 3mm |
| Item Number | Item Description | Inner
Diameter | Outer
Diameter | Bone
Thickness |
|-------------|-------------------------------------------------|-------------------|-------------------|-------------------|
| 26-409061 | evoDrill Cranial Perforator 9/6/1mm, 4-flutes | 6mm | 9mm | 1-3mm |
| 26-409063 | evoDrill Cranial Perforator 9/6/3mm, 4-flutes | 6mm | 9mm | > 3mm |
| 26-411071 | evoDrill Cranial Perforator 11/7/1mm, 4-flutes | 7mm | 11mm | 1-3mm |
| 26-411073 | evoDrill Cranial Perforator 11/7/3mm, 4-flutes | 7mm | 11mm | > 3mm |
| 26-413091 | evoDrill Cranial Perforator 13/9/1mm, 4-flutes | 9mm | 13mm | 1-3mm |
| 26-413093 | evoDrill Cranial Perforator 13/9/3mm, 4-flutes | 9mm | 13mm | > 3mm |
| 26-414111 | evoDrill Cranial Perforator 14/11/1mm, 4-flutes | 11mm | 14mm | 1-3mm |
| 26-414113 | evoDrill Cranial Perforator 14/11/3mm, 4-flutes | 11mm | 14mm | > 3mm |
Table 1: Item Description
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The evonos evoDrill 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. The evonos evoDrill cranial perforator are devices similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra Cut Automatic Cranial Drill DGR-1 #200-241; DGR-II #200-251 and Codman Disposable Perforators 26-1222, 26-1223). The evonos evoDrill cranial perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 RPM to 1500 RPM.
Image /page/6/Picture/2 description: The image shows a medical drill being used on a bone. The drill is labeled "evoDrill Made in Germany 14-11-1". The drill is silver with a blue handle. The bone is tan and brown.
Picture 1: Schematic illustration of the bone perforation
INDICATIONS FOR USE
The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.
| Device | evoDrill | Codman Cranial Perforator | AcraCut Cranial Perforator |
|---|---|---|---|
| Manufacturer | evonos GmbH & Co. KG | Codman | AcraCut |
| 510(k) Number | K231403 | K933894 | K892866 |
| (subject device) | (Predicate Device) | (Predicate Device) | |
| Indications For | |||
| Use | The evoDrill Cranial Perforators | ||
| are single-use surgical devices | |||
| for cranium perforation. The | |||
| perforators with the 3mm step | |||
| automatically release and stop | |||
| perforating at cranial bone | |||
| thickness of at least 3mm. The | |||
| perforators with the 1mm step | |||
| automatically release and stop | |||
| perforating at cranial bone | |||
| thickness of at least 1mm. | The Codman disposable | ||
| Perforator is for use in | |||
| perforating the cranium. When | |||
| properly used, it is designed to | |||
| automatically disengage once | |||
| perforation is accomplished and | |||
| when pressure is removed from | |||
| the drill point. | The Acra Cut DGR-I, DGR-II and | ||
| DGR-0 are designed to | |||
| automatically release and stop | |||
| upon penetration of bone that is | |||
| at least 3mm thick. The DGR-II | |||
| perforator is for use at thin skull | |||
| areas such as pediatric, | |||
| temporal and suboccipital areas. | |||
| Thea are designed to | |||
| automatically release and stop | |||
| upon penetration of bone as | |||
| thin as 1mm. | |||
| Material | Plastic/ stainless steel / | ||
| Aluminium | Plastic/ stainless steel | Plastic/ stainless steel | |
| Fittings | Hudson | Hudson | Hudson |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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| Device | evoDrill | Codman Cranial Perforator | AcraCut Cranial Perforator |
|---|---|---|---|
| Manufacturer | evonos GmbH & Co. KG | Codman | AcraCut |
| 510(k) Number | K231403 | K933894 | K892866 |
| (subject device) | (Predicate Device) | (Predicate Device) | |
| Prinicpal of | |||
| operation | similar | similar | similar |
| Cutting | |||
| Performance | similar | similar | similar |
| Burr hole | |||
| diameter | 14/11mm; 13/9mm; 11/7mm; | ||
| 9/6mm | 14/11 mm; 11/8mm; 9/6mm | 14/11mm; 13/9mm; 11/7mm | |
| Bone Thicknesses | 1mm and thicker | 3mm and thicker | 1mm and thicker |
| Release | |||
| mechanism | Automatic spring-loaded release | ||
| mechanism; The inner drill is | |||
| coupled with the housing once | |||
| an axial force is applied on the | |||
| fitting and the tip of the drill has | |||
| to overcome resistance (bone), | |||
| so that the resistance is higher | |||
| than the spring force of the | |||
| couple mechanism. Once the | |||
| inner drill has pierced the skull | |||
| bone, the resistance drops so | |||
| that the spring pressure is | |||
| higher than the resistance and | |||
| the inner drill is decoupled | Similar | ||
| Automatic spring-loaded release | |||
| mechanism; The inner drill is | |||
| coupled with the housing once | |||
| an axial force is applied on the | |||
| fitting and the tip of the drill has | |||
| to overcome resistance (bone), | |||
| so that the resistance is higher | |||
| than the spring force of the | |||
| couple mechanism. Once the | |||
| inner drill has pierced the skull | |||
| bone, the resistance drops so | |||
| that the spring pressure is | |||
| higher than the resistance and | |||
| the inner drill is decoupled | Similar | ||
| Automatic spring-loaded release | |||
| mechanism; The inner drill is | |||
| coupled with the housing once | |||
| an axial force is applied on the | |||
| fitting and the tip of the drill has | |||
| to overcome resistance (bone), | |||
| so that the resistance is higher | |||
| than the spring force of the | |||
| couple mechanism. Once the | |||
| inner drill has pierced the skull | |||
| bone, the resistance drops so | |||
| that the spring pressure is | |||
| higher than the resistance and | |||
| the inner drill is decoupled | |||
| Rotation speed | 800 – 1500 rpm | 800 – 1200 rpm | 800 – 1200 rpm |
| How supplied | Sterile | ||
| Sterilized by Radiation | Sterile | ||
| Sterilized by Radiation | Sterile | ||
| Sterilized by Radiation | |||
| Number of | |||
| Cutting Flutes | 3 / 4 | 4 | 4 |
Table 2: Device Comparison
Based on the information summarized above, the proposed evoDrill Cranial Perforators are similar to the currently marketed predicate and reference devices in indications for use, design, principle of operation and device material. All perforators are supplied in sterilized using radiation and for single use only.
PERFORMANCE TESTING
The following performance data were provided in support of the substantial equivalence determination:
| Test | Method | Results |
|---|---|---|
| Biocompatibility | The device is classified as an externally | |
| communicating devices in contact with tissue/bone | ||
| for a limited duration (≤24hr). Biocompatibility | ||
| testing was addressed in accordance with ISO 10993 | ||
| as described in FDA's Biocompatibility Guidance. | All biocompatibility testing confirmed that | |
| the device fulfills the biocompatibility | ||
| requirements considering contact area and | ||
| duration. | ||
| Sterilization and | ||
| packaging validation | ||
| testing | Sterilization validation testing in accordance with ISO | |
| 11137-1, ISO 11137-2, ISO 11607-1 and ISO 11607-2. | All tested specimen confirm that devices | |
| are sterile and the SAL of 10-6 is met. | ||
| Shelf-Life validation confirmed the integrity | ||
| of the product and packaging of the defined | ||
| shelf-life, labeled on the device. |
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| Test | Method | Results |
|---|---|---|
| Cutting Performance | The performance of the subject device was evaluated for automatic stop function mechanism, maximum number of uses, drilling time and device geometry for establishing substantial equivalency to the predicate. | All tested specimen confirmed that the overall cutting performance related to the autostop function mechanism, drilling time and surface structure fulfilled the acceptance criteria |
Table 3: Performance Testing
CONCLUSION
Based on the similarities of the intended use/indications for use, technological and functional characteristics, and the results of the non-clinical performance testing, the evonos evoDrill Cranial Perforators, are substantially equivalent to the predicate devices.