(264 days)
No
The description focuses on a mechanical clutch mechanism for automatic stopping, with no mention of AI/ML terms or data-driven decision making.
No.
The device is described as a single-use cutting device designed to make holes in the skull bone, which is a surgical tool, not a therapeutic device.
No
This device is a surgical tool designed to create holes in the skull bone, not to diagnose a condition or disease. Its function is purely mechanical for surgical procedures.
No
The device is a physical cutting tool designed to make holes in bone, with a mechanical safety mechanism. It is clearly a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The NeuroLine perforators are designed to physically create holes in the skull bone during surgical procedures. They are a surgical tool used directly on the patient's body.
- Lack of Diagnostic Testing: The description does not mention any analysis of biological samples or the provision of diagnostic information.
The device is a surgical instrument, not a diagnostic one.
N/A
Intended Use / Indications for Use
NeuroLine perforators are designed to make holes in the skull bone. The perforators have an integrated safety mechanism that releases automatically after passing through the bone and stops drilling.
Product codes (comma separated list FDA assigned to the subject device)
HBF
Device Description
The NeuroLine Disposable Cranial perforators (NLO-x/y-z) are single-use cutting devices that are packaged sterile and are used to perforate the skull bone. The perforator functions automatically, which means that it employs a clutch mechanism to automatically disenqage once perforation is accomplished and as the drill ceases to find resistance to bone.
The perforator has Hudson type connection and can connect to all the driver units with Hudson connection.
Perforators are offered in three different sizes: 6/9 mm, 7/13 mm and 11/14 mm. Sizes indicate hole diameters to be made by perforators in millimeters.
Perforators are also differentiated based on the thickness of skull bone. The NLO-x/y-3.0 perforators are used on skulls at least 3 mm thick, whereas NLO-x/y-1.5 ones are used on skulls at least 1.5 mm thick.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The following performance data were provided in support of the substantial equivalence determination:
Test: Biocompatibility
Method: The device is classified as an externally communicating devices in contact with tissue/bone for a limited duration (
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
June 20, 2022
EMD Endoszkop Muszer Gyarto es Kereskedelmi Kft. Gergo Ujvari Export Manager Bartok Bela u. 113/B Debrecen, Hajdu-Bihar 4031, Hungary
Re: K213228
Trade/Device Name: NeuroLine Disposable Cranial Perforator with Hudson end 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: May 13, 2022 Received: May 16, 2022
Dear Gergo Ujvari:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213228
Device Name
NeuroLine Disposable Cranial Perforator with Hudson End
Indications for Use (Describe)
NeuroLine perforators are designed to make holes in the skull bone. The perforators have an integrated safety mechanism that releases automatically after passing through the bone and stops drilling.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Date Prepared: June 14, 2022
Applicant:
EMD Kft.
Bartok Bela u. 113/B Debrecen, Hungary 4031
Tel .: +36-52-486-034
Fax.: +36-52-486-035
Contact Person:
Gergo Ujvari – International Sales Manager
E-mail: gergo.ujvari@emd.hu
Trade Name: NeuroLine Disposable Cranial Perforator with Hudson End
Common Name: Disposable Cranial Perforator
Classification name: 21CFR section 882.4305
Product Code: HBF
Device Classification: Class II
Predicate Device:
ACRA-CUT Standard and Disposable Cranial perforator
Reference Device:
EasyDrill Autostop Cranial Perforator
Device Description:
The NeuroLine Disposable Cranial perforators (NLO-x/y-z) are single-use cutting devices that are packaged sterile and are used to perforate the skull bone. The perforator functions automatically, which means that it employs a clutch mechanism to automatically disenqage once perforation is accomplished and as the drill ceases to find resistance to bone.
The perforator has Hudson type connection and can connect to all the driver units with Hudson connection.
Perforators are offered in three different sizes: 6/9 mm, 7/13 mm and 11/14 mm. Sizes indicate hole diameters to be made by perforators in millimeters.
Perforators are also differentiated based on the thickness of skull bone. The NLO-x/y-3.0 perforators are used on skulls at least 3 mm thick, whereas NLO-x/y-1.5 ones are used on skulls at least 1.5 mm thick.
4
Image /page/4/Figure/1 description: This image shows a table with specifications for different models of tools. The table lists the models NLO-6/9-1.5, NLO-7/11-1.5, NLO-9/13-1.5, NLO-11/14-1.5, NLO-6/9-3.0, NLO-7/11-3.0, NLO-9/13-3.0, and NLO-11/14-3.0. For each model, the table provides the dimensions A, B, and C in millimeters, as well as the application for which the tool is intended. The tools with 1.5 in the model name are for use on skulls at least 1.5mm thick, while the tools with 3.0 in the model name are for use on skulls at least 3mm thick.
Indications for Use:
NeuroLine perforators are designed to make holes in the skull bone. The perforators have an integrated safety mechanism that releases automatically after passing through the bone and stop drilling.
Comparison of technology characteristics
| Device | NeuroLine Disposable
Cranial Perforator with
Hudson End | ACRA-CUT Standard and
Disposable Cranial
Perforator | EasyDrill Autostop Cranial
Perforator |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | EMD Endoszkop Muszer Gyarto
es Kereskedelmi Kft. | Acra-Cut Inc. | Micromar Industria e Comercio
Ltda. |
| 510(k) number | K213228
(Subject Device) | K833266
(Predicate Device) | K141455
(Reference Device) |
| Specified hole
sizes | 6/9 mm, 7/11 mm, 9/13mm,
11/14 mm | Similar | 6/9 mm, 7/11 mm, 11/14 mm |
| Indication for
use | NeuroLine perforators are
designed to make holes in
the skull bone. The
perforators have an
integrated safety mechanism
that releases automatically
after passing through the
bone and stops drilling. | Similar | The EasyDrill Cranial Perforator is a
sterile, single use cutting device
intended for performing cranial
bone trephination. |
| Operating
principles | Same | Same | Same |
| Device Material | Stainless steel | Similar | Stainless steel |
5
| Sterilization | Sterile
(Gamma Radiation) | Sterile | Sterile
(Gamma Radiation) |
|-------------------------|------------------------------|---------|------------------------------|
| Reusable
/Single Use | Single Use | Similar | Single Use |
Based on the information summarized above, the proposed NeuroLine Disposable Cranial Perforator and with Hudson end are similar to the currently marketed predicate and reference devices in indications for use, design, principle of operation and device material. All perforators are offered sterile.
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. | Pass | |
| Sterilization and packaging | ||
| validation testing | Sterilization validation testing in accordance with ISO | |
| 11137-1, ISO 11137-2, ISO 11607-1 and ISO 11607-2. | Pass | |
| Bench Testing | 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. | Pass |
Conclusions
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 NeuroLine Disposable Cranial Perforator with Hudson end, are substantially equivalent to the predicate device, ACRA-CUT Standard and Disposable Cranial perforator.