NeuroLine Disposable Cranial Perforator with Hudson end

K213228 · Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. · HBF · Jun 20, 2022 · Neurology

Device Facts

• Record ID: K213228
• Device Name: NeuroLine Disposable Cranial Perforator with Hudson end
• Applicant: Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
• Product Code: HBF · Neurology
• Decision Date: Jun 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4305
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

NeuroLine Disposable Cranial Perforator is a single-use, sterile cutting tool designed for cranial bone trephination. It features a Hudson-type connection for compatibility with standard surgical driver units. The device utilizes a mechanical clutch mechanism that automatically disengages when resistance to bone ceases, preventing over-penetration after passing through the skull. It is intended for use by surgeons in clinical settings. The device is available in various diameters (6/9 mm, 7/11 mm, 9/13 mm, 11/14 mm) and is selected based on skull thickness (minimum 1.5 mm or 3.0 mm). By automating the stop function, the device reduces the risk of accidental dural injury, providing a safer surgical outcome for the patient.

Clinical Evidence

Bench testing only. Performance evaluated for automatic stop function, drilling time, and device geometry. Biocompatibility testing conducted per ISO 10993. Sterilization validation performed per ISO 11137 and ISO 11607. All tests passed.

Technological Characteristics

Material: Stainless steel. Principle: Mechanical clutch-based automatic stop. Form factor: Disposable cranial drill with Hudson connection. Sizes: 6/9 mm, 7/11 mm, 9/13 mm, 11/14 mm. Sterilization: Gamma radiation.

Indications for Use

Indicated for creating holes in the skull bone for patients requiring cranial trephination.

Regulatory Classification

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.

Predicate Devices

• ACRA-CUT Standard and Disposable Cranial perforator (K833266)

Reference Devices

• EasyDrill Autostop Cranial Perforator (K141455)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

#### 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}------------------------------------------------

# 510(k) Summary

## Date Prepared: June 14, 2022

### Applicant:

EMD Kft.

Bartok Bela u. 113/B Debrecen, Hungary 4031

Tel .: [phone]

Fax.: [phone]

### Contact Person:

Gergo Ujvari – International Sales Manager

E-mail: [e-mail]

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.

K833266

K141455

{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<br>Cranial Perforator with<br>Hudson End | ACRA-CUT Standard and<br>Disposable Cranial<br>Perforator | EasyDrill Autostop Cranial<br>Perforator |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | EMD Endoszkop Muszer Gyarto<br>es Kereskedelmi Kft. | Acra-Cut Inc. | Micromar Industria e Comercio<br>Ltda. |
| 510(k) number | K213228<br>(Subject Device) | K833266<br>(Predicate Device) | K141455<br>(Reference Device) |
| Specified hole<br>sizes | 6/9 mm, 7/11 mm, 9/13mm,<br>11/14 mm | Similar | 6/9 mm, 7/11 mm, 11/14 mm |
| Indication for<br>use | NeuroLine perforators are<br>designed to make holes in<br>the skull bone. The<br>perforators have an<br>integrated safety mechanism<br>that releases automatically<br>after passing through the<br>bone and stops drilling. | Similar | The EasyDrill Cranial Perforator is a<br>sterile, single use cutting device<br>intended for performing cranial<br>bone trephination. |
| Operating<br>principles | Same | Same | Same |
| Device Material | Stainless steel | Similar | Stainless steel |

{5}------------------------------------------------

| Sterilization | Sterile<br>(Gamma Radiation) | Sterile | Sterile<br>(Gamma Radiation) |
|-------------------------|------------------------------|---------|------------------------------|
| Reusable<br>/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<br>devices in contact with tissue/bone for a limited duration<br>(≤24hr). Biocompatibility testing was addressed in<br>accordance with ISO 10993 as described in FDA's<br>Biocompatibility Guidance. | Pass |
| Sterilization and packaging<br>validation testing | Sterilization validation testing in accordance with ISO<br>11137-1, ISO 11137-2, ISO 11607-1 and ISO 11607-2. | Pass |
| Bench Testing | The performance of the subject device was evaluated for<br>automatic stop function mechanism, maximum number of<br>uses, drilling time and device geometry for establishing<br>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.