The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery.

The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm.

The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm.

Device Description

The Meridian™ Cranial Perforator is a sterile packed, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery, driven by powered sources having a standardized and commonly used Hudson fitting clutch. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. Both versions are available for burr-hole diameters of Ø6. Ø7 and Ø11 mm.

The Meridian™ 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. An integrated clutch mechanism prevents plunging of the perforator tip into the underlying dura and parenchyma tissue. The device is a Class II (USA) device and classified IIa in Europe (EEC).

The Meridian™ Cranial Perforator is a device similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra-Cut models DGR-II and Codman Disposable Perforators etc ... )

The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM.

AI/ML Overview

The Adeor Meridian™ Cranial Perforator is a sterile, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery. Its primary function is to automatically release and stop perforating once a specific cranial bone thickness is reached, preventing plunging into underlying tissue.

Here's an analysis of its acceptance criteria and the study proving it meets these criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Meridian™ Cranial Perforator are primarily centered around its ability to automatically release and stop perforation at specified bone thicknesses, and its general mechanical functionality.

Acceptance Criteria	Reported Device Performance
Automatic release at ≥ 3 mm cranial bone thickness (standard adult perforator)	The device automatically released and stopped cutting as soon as the thin remaining pad of material became elastic in wood and animal bone tests. On animal cadavers, the release mechanism worked reliably, and a clear bone pad was formed.
Automatic release at ≥ 1.5 mm cranial bone thickness (pediatric perforator)	The device automatically released and stopped cutting as soon as the thin remaining pad of material became elastic in wood and animal bone tests. On animal cadavers, the release mechanism worked reliably, and a clear bone pad was formed. (The document states both versions are available with this feature, and the general performance section covers "the release mechanism," implying it functioned for both. Specific separate testing for the 1.5mm criteria is implied but not separately detailed here beyond the general statement.)
Reliable mechanical functionality (e.g., cutting performance, no friction, no skidding, firm rotation, plain surface finish)	Samples of each model were used to drill holes in wood and animal bone to verify mechanical functionality. All tests were performed satisfactorily with positive remarks: - No friction observed between rotating cutting parts. - No skidding of the device on animal cadaver bone. - A firm axial rotation and no wobbling observed. - A plain and even surface of the perforated bone and on the bone flap was observed.
Sterility Assurance Level (SAL) of < 10⁻⁶	The investigation indicated microbial contamination was inactive by 4.8 kGy irradiation. The Gamma irradiation method ensures effective conditions (SAL < 10⁻⁶) for sterilization with a minimum dose of 25 kGy. The sterilization process was validated according to ISO 11137-1:2006, ISO 11137-2:2006, and ISO 11137-3:2006.
Compatibility with Hudson fitting clutches	The device is stated to be driven by powered sources having a standardized and commonly used Hudson fitting clutch. This is a design specification, confirmed by the "Hudson" fitting listed in the comparative table. No specific performance test is cited beyond design commonality.
Burr-hole diameters (Ø6, Ø7, Ø11 mm)	The device is available for these burr-hole diameters. No specific performance test is cited beyond product availability.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions that "Samples of each model were used to drill holes in wood and animal bone." It also states "On animal cadavers (pig head and calf shoulder) the release mechanism worked reliable and a clear bone pad has been formed..."

Test Set Sample Size: The exact number of "samples of each model" is not specified. For the animal cadaver testing, it refers to "animal cadavers (pig head and calf shoulder)," implying at least one of each, but the total number of perforators tested on them is not given.
Data Provenance: The animal cadaver testing used biological material (pig head and calf shoulder) which would be considered an in vitro/ex vivo study environment. The country of origin for this testing is not explicitly stated in the provided text. The company is based in Germany. The sterilization validation refers to international standards recognized by FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

No explicit mention of experts establishing ground truth for the mechanical performance testing is provided in the document. The performance bench testing appears to be objective measurements/observations rather than subjective expert assessments requiring a "ground truth" establishment in the traditional sense of clinical studies (e.g., for diagnostic accuracy). The "satisfactory" remarks and observations like "no friction," "no skidding," "firm axial rotation," and "plain and even surface" would likely be criteria directly observed and measured/assessed by the testing personnel (e.g., engineers, technicians).

4. Adjudication Method for the Test Set

Not applicable. There is no indication of subjective assessments by multiple individuals requiring an adjudication method. The performance bench testing focuses on objective, measurable mechanical functionality and observation of device behavior.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for the evaluation of a mechanical surgical device like a cranial perforator. MRMC studies are typically used to assess diagnostic accuracy or the impact of AI assistance on human interpretation of medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a mechanical surgical tool, not an AI algorithm. Its performance is inherent to its design and mechanical function, with human operation being an integral part of its use.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is the objective physical behavior of the device (e.g., whether it stops perforating at the correct depth, whether it exhibits friction, skidding, or wobbling, and the quality of the cut). This is established through direct observation and measurement during the bench testing on wood, animal bone, and animal cadavers.

For sterility, the ground truth is established by scientific validation against recognized international standards (ISO 11137 series) that define a Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set

Not applicable. The Meridian™ Cranial Perforator is a mechanical device, not a machine learning or AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this mechanical device.

Summary

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K121253

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510(k) Summarv

JUL 1 7 2012

Submitter:	adeor Medical Technologies GmbHKirchpaltz 182049 PullachGermany
Contact Person:	Fabio von ZeppelinGeneral Manager
	Phone: +49 (0)89-744 42 398Fax: +49 (0)89-744 24 809
Preparation Date:	April 16th, 2012
Trade Name:	Meridian™ Cranial Perforator
Common Name:	Cranial Perforator
Classification Name:	Neurological surgical devices

Device Description:

The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM.

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Image /page/1/Picture/1 description: The image shows the logo for Adeor. The logo consists of a cluster of black dots in the upper left corner, arranged in a pattern that resembles a constellation or a network. To the right of the dots is the word "adeor" in lowercase, sans-serif font. The overall design is simple and modern.

Intended Use:

The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery

Indications for Use:

Predicate Devices:

K933894, K071931	2	Disposable Perforators	2	Codman & Shurtleff, Inc.
K833266	3	Automatic Cranial Drill(Perforator)	3	Acra Cut, Inc.

Substantial Equivalence:

The Meridian™ Cranial Perforator is substantially equivalent to the currently marketed Acra-Cut DGR-II and Codman 26-1221 based on the device's similarity to the predicate devices in indications, principle of operations, materials and design. The predicate and subject devices are marketed in the European Union as substantially equivalent.

Technological Characteristics Comparison:

	Acra-Cut Inc.	Codman	Adeor
Parameters:	DGR-II	26-1221	Meridian
Class	II	II	II
Indications for Use:	The Acra-Cut DGR-I isdesigned toautomatically releaseand stop uponpenetration of bone thatis at least 3 mm thick.The DGR-II perforator isfor use on thin skull/skullareas such as pediatric,temporal andsuboccipital areas. Theyare designed toautomatically releaseand stop uponpenetration of bone asthin as 1 mm.	The Codman DisposablePerforator is for use inperforating the cranium.When properly used, it isdesigned toautomatically disengageonce perforation isaccomplished and whenpressure is removedfrom the drill point.	The Meridian™Perforator is a, single-usesurgical device forcranium perforation. Thedevice automaticallyreleases and stopsperforating at cranialbone thickness of atleast 3 mm.The Meridian™ pediatricperforators automaticallyrelease and stopperforating at cranialbone thickness of atleast 1.5 mm.
Dimensions and design:	similar	similar	similar
Materials	Plastic/ stainless steel	Plastic/stainless steel	Plastic/stainless steel
Fitting	Hudson	Hudson	Hudson
Principle of operation	similar	similar	similar
Cutting Performance	similar	similar	similar

05_510(k)_Summary rev. 01.doc

Page 2 of 4

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Burr hole diameters Ø	Ø 5/8,7/11,11/14 mm	Ø 6/9, 7/11, 11/14 mm	Ø 6/9, 7/11, 11/14 mm
Release mechanism	automatic	automatic	automatic
Rotation speed	800 RPM	Not-known	800-1200 RPM
Cutting performance	similar	similar	similar
Single-use supply	Gamma sterile	Gamma sterile	Gamma sterile

The technological characteristics of the subject device are based on the same cranial perforator technology as the predicate devices. Substantial equivalence of the Meridian™ Adeor cranial perforator is based upon the comparison to predicate device's characteristics.

Performance Standards:

Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act.

Performance testing:

Substantial equivalence of the Meridian™ Adeor cranial perforator is based upon the comparison to predicate device's technical characteristics, indications, principle of operations, materials, design, and sterile supply as a single-use medical device.

Performance Bench Testing:

Samples of each model were used to drill holes in wood and animal bone to verify its mechanical functionality similar to predicate devices. The release mechanism worked reliable on both materials and stopped cutting as soon as the thin remaining pad of material became elastic.

On animal cadavers (pig head and calf shoulder) the release mechanism worked reliable and a clear bone pad has been formed which can easily be removed from the bur-hole. All tests have been performed satisfactory with the following positive remarks: The release mechanism worked reliable on several bur-holes. There was no friction observed between the rotating cutting parts. There has been no skidding of the subject device on the animal cadaver bone. A firm axial rotation and no wobbling of the subject device have been observed. A plain and even surface of the perforated bone and on the bone flap was observed. (See "Performance Bench testing protocol" for details in Chapter 18)

Sterilzation Process Validation:

The sterilization process is based on international Standards ISO 11137-1:2006, ISO 11137-2:2006 and ISO 11137-3:2006 which are recognized by FDA, as well.

The sterilization dose of 25 kGy has been validated according to ISO 11137-1:2006, ISO 11137-2:2006 (see Validation Report: Radiation Sterilization for product family "Perforators" n. PR/7-5-0-331). Latest revalidation has been performed 05-24-2012.

The sterilization process according to standards ISO 11137-1:2006, ISO 11137-2:2006 and ISO 11137-3:2006 has been validated (see Validation Report: Radiation Sterilization "HiCut & Perforators" n. V 7-5-0-235 R).

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The Test Report no. 100239-10 (see annex) investigation indicates that any microbial contamination of the device (average bioburden of three independent lots < 2 cfu/sample) was inactive by the irradiation of 4.8 kGy (according to prEN ISO 111137-2) Therefore, the Gamma irradiation method ensures effective conditions (sterility assurance level (SAL) < 10 6) for the sterilization of the product by application of a minimum dose of 25 kGy.

Final Sterilization Process Assessment:

It can be confirmed that the requirements of the standards ISO 11137-1:2006. ISO 11137-2:2006 and ISO 11137-3:2006 and the validation protocol V 7-5-0-235 P with regard to the validation of the sterilization procedure for the product group "Perforators" are met. It could be shown that the documented procedure of a routine sterilization with >25 kGy ensures a SAL < 10°.

Conclusion:

Substantial equivalence of the Meridian ™ Adeor cranial perforator in comparison to predicate device's the currently marketed Acra Cut DGR-I/II and Codman 26-1221 is demonstrated with regard to the similarity of device characteristics, described functionality. for the same indications of use, and sterile supply as a single-use medical device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Adeor Medical Technologies GmbH c/o Mr. Fabio von Zeppelin General Manager Kirchplatz 1 Pullach Germany 82049

JUL 1 7 2012

Re: K121253

Trade/Device Name: Meridian™ 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: April 19, 2012 Received: April 27, 2012

Dear Mr. Zeppelin:

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.

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Page 2 - Mr. Fabio von Zeppelin

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Qula. Thum, MD f

Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

KI21253

Device Name:

Meridian™ Cranial Perforator

Indications for Use:

The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm.

The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm.

The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm.

Pediatric: for bone thickness of at least 1.5 mm:	For bone thickness of at least 3.0 mm:
PER 6-9-SP	PER 6-9-S
PER 7-11-SP	PER 7-11-S
PER 11-14-SP	PER 11-14-S

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divisi
Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
Prescription Use.
0-010000011000

510(k) Number K121253

(Per 21 CFR 801.109)

04_Indications_for_Use_Statement.doc

Regulation Number and Section

§ 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).