Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties, sterility, and compatibility of skull pins, with no mention of AI or ML algorithms for analysis, prediction, or decision-making.

Therapeutic

No
The device is described as a disposable skull pin used for rigid fixation during neurosurgical procedures, stabilizing the head, rather than directly treating a disease or condition.

Diagnostic

No

The device description indicates that the skull pins are used to stabilize a patient's head during neurosurgical procedures, and the listed performance studies are related to physical properties and safety (e.g., strength, sterility, biocompatibility), not diagnostic capabilities. There is no mention of the device providing information for diagnosis, only aiding in surgical procedures.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a disposable physical device (skull pins made of stainless steel or titanium) used in combination with a skull clamp and headrest system. It is a hardware component used for rigid fixation during surgery.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for providing rigid fixation during surgical procedures (craniotomies and spinal surgery) in combination with a skull clamp. This is a mechanical function performed directly on the patient's body.
Device Description: The device is a physical pin inserted into the skull. It's a surgical tool for stabilization.
Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, etc.
Input Imaging Modality: While imaging is mentioned for the Titanium pins, it's for confirming placement or for intra-operative guidance, not for the device itself to perform a diagnostic test on a biological sample.

In summary, the DORO® Sterile Disposable Skull Pins are a surgical instrument used for mechanical fixation during procedures, not a device used for in vitro diagnostic testing of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DORO® Sterile Disposable Skull Pin is indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

Product codes (comma separated list FDA assigned to the subject device)

HBL

Device Description

DORO® Sterile Disposable Skull Pins are a disposable device. These are delivered sterile (gamma-sterilization), ready for use, and are intended to be disposed after one use.

DORO® Sterile Disposable Skull Pins are available in 2 different types (Stainless steel & Titanium) and 2 different sizes (Adult & Pediatric).

DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest Systems, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures.

Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one single skull pin is inserted in the opposite side.

DORO® Sterile Disposable Skull Pins (Titanium) are used when Intra-Operative X-Ray-, CTor MR Imaging of the patient is used.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skull, head, neck, spine

Indicated Patient Age Range

The disposable skull pin is not intended for use on infants or children under 5 years of age.

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 DORO® Sterile Disposable Skull Pins (Stainless steel & Titanium) have been tested as a system and single device. Tests performed include:

Axial Load, and Creep Test: Pass - The Pins are able to withstand typical static loads w/ additional safety factor w/o plastic deformation and an accepted distension.
Shear Test: Pass - The Pins are able to withstand typical shear force w/ additional safety factor w/o spatial locomotion.
Transport Validation: Pass - The utilized packing system for the skull pins is capable to protect those against visible damage.
Packing Integrity Test: Pass - The utilized sterile barrier system as well as the blister pack was proven to perform efficiently, safely, and effectively.
System Handling Test: Pass - Skull Pins performer safely and effectively.
Input Materials: Pass - All utilized materials are accepted for medical use.
Biocompatibility Test: Pass - The skull pins obtain no cell growth inhibiting character. No chemical substance above harmful threshold was detected.
Color Coding: Pass - Differentiation between designated patient populations as well as different applications is possible due to different colors utilized for the plastic pin collets.
Sterility Test: Pass - VDmax validation as well as dye penetration test have proven the sterility of the product at delivery status as well as at the end of shelf life.
MR-Compatibility (for Titanium pins): Pass - The skull pins are MR conditional.

Testing confirmed that the performance of the DORO® Sterile Disposable Skull Pins meets the product specification of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K163322, K941558, K073163

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.4460 Neurosurgical head holder (skull clamp).

(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains 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.

June 2, 2020

Pro Med Instruments GmbH Muhammad Zubair Regulatory Affairs Manager Boetzinger Str. 38 Freiburg, 79111 De

Re: K193438

Trade/Device Name: DORO Sterile Disposable Skull Pins (Stainless Steel), DORO Sterile Disposable Skull Pins (Titanium) Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: April 29, 2020 Received: May 4, 2020

Dear Muhammad Zubair:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

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 (OS) 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. Acting 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) K193438

Device Name

DORO Sterile Disposable Skull Pins (Stainless steel & Titanium)

Indications for Use (Describe)

Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

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

DATE:

June 2, 2020

DOCUMENT NUMBER:

K193438

APPLICANT:

Pro Med Instruments GmbH Bötzinger Straße 38 79111 Freiburg im Breisgau Germany Tel: + 49 (0) 761 384 222 10 Fax: +49 (0) 761 384 222 81 E-Mail: pmi@pmisurgical.com

CONTACT PERSON:

Name: Muhammad Zubair Position: Regulatory Affairs Manager Tel.: +49 761 384 222 67 E-Mail: ra@pmisurgical.com

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1. Device Name

Trade Name:	DORO® Sterile Disposable Skull Pins
Common Name:	Skull Pins
Device Classification Name:	Holder, head, neurosurgical (skull clamp)

2. Classification / Product Code

DORO® Sterile Disposable Skull Pins can be classified according to following device name and product code:

| Device | Regulation
Description | Regulation
Medical
Specialty | Review
Panel | Product
Code | Regulation
Number | Device
Classification |
|-------------------------------------------------|-----------------------------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------|
| Holder, head,
neurosurgical
(skull clamp) | Neurosurgical
head holder
(skull clamp) | Neurology | Neurology | HBL | 882.4460 | 2 |

Predicate Device 3.

Subject Device 1: DORO® Sterile Disposable Skull Pins (Stainless Steel)

Subject Device	Predicate Device	510(k) Number	510(k) Holder
DORO® Sterile
Disposable Skull Pins
(Stainless Steel)

Model:

(3006-00
Stainless Steel,
Adult, Blue)
(3006-50
Stainless Steel,
Adult, Black) | TZ Skull Pin
Adult | K163322 | TZ
Medical, Inc. |
| 3. (3006-10
Stainless Steel,
Pediatric,
Yellow) | Mayfield Child
Disposable Skull Pin | K941558 | OHIO MEDICAL INSTRUMENT
CO., INC. |

5

Device	Predicate Device	510(k) Number	510(k) Holder
DORO® Sterile Disposable Skull Pins (Titanium)
Model:

(3006-20 Titanium, Adult, Orange)
(3006-30 Titanium, Pediatric, Green) | Limited Artifact Skull Pin

Mayfield Child Disposable Skull Pin | K073163

K941558 | Dinkier Surgical Devices, Inc.

OHIO MEDICAL INSTRUMENT CO., INC. |

Subject Device 2: DORO® Sterile Disposable Skull Pins (Titanium)

4. Device Description

DORO® Sterile Disposable Skull Pins are a disposable device. These are delivered sterile (gamma-sterilization), ready for use, and are intended to be disposed after one use.

DORO® Sterile Disposable Skull Pins are available in 2 different types (Stainless steel & Titanium) and 2 different sizes (Adult & Pediatric).

DORO® Sterile Disposable Skull Pins (Stainless Steel) 4.1.

DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest Systems, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures.

Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one single skull pin is inserted in the opposite side.

DORO® Sterile Disposable Skull Pins (Titanium) 4.2.

DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest System, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures.

Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one skull pin is inserted in the opposite side.

DORO® Sterile Disposable Skull Pins (Titanium) are used when Intra-Operative X-Ray-, CTor MR Imaging of the patient is used.

6

5. Indications for Use

The DORO® Sterile Disposable Skull Pin is indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

Technological Characteristics 6.

The technological characteristics of DORO® Sterile Disposable Skull Pins are the same as the technological characteristics of the predicate device.

6.1. DORO® Sterile Disposable Skull Pins (Stainless Steel)

| Company | pro med instruments GmbH
(New Device) | TZ Medical, Inc.
(Predicate Device) | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DORO® Sterile Disposable Skull Pins
(Stainless steel) | TZ Skull Pin Adult | |
| Regulation Number | 882.4460 | 882.4460 | |
| Class | 2 | 2 | |
| Code | HBL | HBL | |
| 510(k) number | K193438 | K163322 | |
| Intended Use | The DORO® Sterile Disposable Skull Pin is
utilized in a skull clamp and is applied to the
patient's skull to hold their head and neck
securely in a particular position when rigid
fixation is desired. The skull clamp is
indicated for use in open and percutaneous
craniotomies as well as spinal surgery when
rigid fixation is necessary. | The TZ Medical skull pin is placed in a
clamp and is applied to the patient's skull
to hold their head and neck securely in a
particular position when rigid fixation is
desired. The clamp is indicated for use in
open and percutaneous craniotomies as
well as spinal surgery when rigid fixation
is necessary. | |
| Indication for Use | Indicated for use in combination with a skull
clamp in open and percutaneous craniotomies
as well as spinal surgery when rigid fixation is
necessary. | Indicated for use in open and
percutaneous craniotomies as well as
spinal surgery when rigid fixation is
necessary. | |
| Material | Stainless Steel 1.4034 with a polymer base
PA6 | 316L (1.4404 ) Stainless Steel | |
| Size | Adult | Adult | |
| Dimension | | | |
| Tip to Shoulder
Distance | Adult: 0.5 Inches | Adult: 0.5 Inches | |
| Width of back | Adult: 0.31 inches | Adult:0.31 inches | |
| O-ring | 3006-00
Stainless Steel,
Adult, Blue
3006-50
Stainless Steel,
Adult, Black | No O-Ring
Nitrile butadiene
rubber (NBR) O-
Ring
Silicone O-Ring | |
| | pro med instruments GmbH
(New Device) | | TZ Medical, Inc.
(Predicate Device) |
| Company | | | |
| Manufacturing | 3006-00
Stainless Steel,
Adult, Blue

3006-50
Stainless Steel,
Adult, Black | The pin insert is
machined according to
the dimensions
specified, and cleaned
afterwards. The Pin
collet is injection-
molded around the
Pin insert in controlled
environmental
conditions.

Adult:

7

8

Pediatric:

9

| Company | pro med instruments GmbH
(New Device) | OHIO MEDICAL INSTRUMENT CO.,
INC.
(Predicate Device) | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Manufacturing | 3006-10
Stainless Steel,
Pediatric, Yellow

The pin insert is
machined according to
the dimensions
specified, and cleaned
afterwards. The Pin
collet is injection-
molded around the
Pin insert in controlled
environmental
conditions. | Information not publically available in 510
(k) summary | |
| Preparation for
surgery | None, the pins are supplied sterile in a 3-pack
pouch ready for use | Information not publically available in 510
(k) summary | |
| Method of Use | Typically, three pins are installed in
receptacles of the head holder | Information not publically available in 510
(k) summary | |
| Clamp
Compatibility | DORO® Sterile Disposable Skull Pins are
compatible with all the models of Doro brand
skull clamps | Information not publically available in 510
(k) summary | |
| MR Compatibility | MR Unsafe | Information not publically available in 510
(k) summary | |
| Method of
Sterilization | Gamma Irradiation | Information not publically available in 510
(k) summary | |
| Use | Disposable; Single-Patient Use only | Information not publically available in 510
(k) summary | |
| Packaging | Medical grade packaging (sealed
TYVEK/Blister) | Information not publically available in 510
(k) summary | |
| Company | pro med instruments GmbH
(New Device) | Dinkier Surgical Devices, Inc.
(Predicate Device) | |
| Device Name | DORO® Sterile Disposable Skull Pins
(Titanium) | Limited Artifact Skull Pin | |
| Regulation Number | 882.4460 | 882.4460 | |
| Class | 2 | 2 | |
| Code | HBL | HBL | |
| 510(k) number | K193438 | K073163 | |
| Intended Use | The DORO® Sterile Disposable Skull Pin
is utilized in a skull clamp and is applied
to the patient's skull to hold their head
and neck securely in a particular
position when rigid fixation is desired.
The skull clamp is indicated for use in
open and percutaneous craniotomies as
well as spinal surgery when rigid fixation
is necessary. | Limited Artifact Skull Pins are used with a
head holder device that is placed on the
patients'skull to hold their head and neck in a
particular position during surgical procedures
when rigid skeletal fixation is desired. | |
| Indication for Use | Indicated for use in combination with
skull clamp in open and percutaneous
craniotomies as well as spinal surgery
when rigid fixation is necessary. | Indicated for use in open and percutaneous
craniotomies and spinal surgeries when rigid
skeletal fixation is necessary and during intra-
operative use within a MR environment rated
up to and including a 1.5 Tesla magnetic Field | |
| Material | Titanium Grade 5 (Ti-6Al-4V) with a
polymer base PA6 | The pin tip is Titanium 6Al-4V and the
polymer base is PEEK with 10% carbon filler | |
| Dimension | | | |
| Tip to Shoulder
Distance | Adult: 0.5 Inches | Information not publically available in 510 (k)
summary | |
| Width of back | Adult: 0.31 inches | Information not publically available in 510 (k)
summary | |
| O-ring | 3006-20
Titanium, Adult,
Orange)
No O-Ring | O-Ring | |
| Manufacturing | The pin insert is machined according to
the dimensions specified, and cleaned
afterwards. The Pin collet is injection-
molded around the Pin insert in
controlled environmental conditions. | The pin tip is machined to the dimensions
listed on the pin tip drawing.
The pin tip is injection molded to the
dimensions listed on the pin base drawing. | |
| Preparation for
surgery | None, the pins are supplied sterile in a
3-pack pouch ready for use. | None, the pin are supplied sterile in a 3-pack
pouch ready for use. | |
| Method of Use | Typically , three pins are installed in | Typically , three pins are installed in | |
| Company | pro med instruments GmbH
(New Device) | Dinkier Surgical Devices, Inc.
(Predicate Device) | |
| Clamp
Compatibility | DORO® Sterile Disposable Skull Pins are
compatible with all the models of Doro
brand skull clamps | Information not publically available in 510 (k)
summary | |
| MR Compatibility | MR Conditional
Main magnetic field strength: 1.5 Tesla or 3 Tesla | MR Conditional | |
| Method of
Sterilization | Gamma Irradiation | radiation sterilized | |
| Use | Disposable; Single-Patient Use only | | |
| Packaging | Medical grade packaging (sealed
TYVEK/Blister) | Medical grade packaging (sealed
TYVEK/flexible film pouches) | |
| Company | pro med instruments GmbH
(New Device) | OHIO MEDICAL INSTRUMENT CO., INC.
(Predicate Device) | |
| Device Name | DORO® Sterile Disposable Skull Pins
(Titanium) | Mayfield Child Disposable Skull Pin | |
| Regulation Number | 882.4460 | | |
| Class | 2 | 2 | |
| Code | HBL | HBL | |
| 510(k) number | K193438 | K941558 | |
| Intended Use | The DORO® Sterile Disposable Skull Pin
is utilized in a skull clamp and is applied
to the patient's skull to hold their head
and neck securely in a particular
position when rigid fixation is desired.
The skull clamp is indicated for use in
open and percutaneous craniotomies as
well as spinal surgery when rigid fixation
is necessary. | Information not publically available in 510 (k)
summary | |
| Indication for Use | Indicated for use in combination with
skull clamp in open and percutaneous
craniotomies as well as spinal surgery
when rigid fixation is necessary. | Information not publically available in 510 (k)
summary | |
| Recommended Age
of Use | The disposable skull pin is not intended
for use on infants or children under 5
years of age. | The disposable skull pin is not intended for
use on infants or children under 5 years of
age. | |
| Material | Titanium Grade 5 (Ti-6AI-4V) with a
polymer base PA6 | Information not publically available in 510 (k)
summary | |
| Size | Pediatric | Pediatric | |
| Dimension | | | |
| Tip to Shoulder
Distance | Pediatric: 0.4 Inches | Information not publically available in 510 (k)
summary | |
| Width of back | Pediatric: 0.31 inches | Information not publically available in 510 (k)
summary | |
| O-ring | 3006-30
Titanium,
Pediatric, Green | No O-Ring | Information not publically available in 510 (k)
summary |
| Manufacturing | The pin insert is machined according to
the dimensions specified, and cleaned
afterwards. The Pin collet is injection-
molded around the Pin insert in
controlled environmental conditions. | Information not publically available in 510 (k)
summary | |
| Preparation for
surgery | None, the pins are supplied sterile in a
3-pack pouch ready for use. | Information not publically available in 510 (k)
summary | |
| Method of Use | Typically , three pins are installed in | Information not publically available in 510 (k)
summary | |
| Company | pro med instruments GmbH
(New Device) | OHIO MEDICAL INSTRUMENT CO., INC.
(Predicate Device) | |
| Clamp
Compatibility | DORO® Sterile Disposable Skull Pins are
compatible with all the models of Doro
brand skull clamps | Information not publically available in 510 (k)
summary | |
| MR Compatibility | MR Conditional
Main magnetic field strength: 1.5
Tesla or 3 Tesla | Information not publically available in 510 (k)
summary | |
| Method of
Sterilization | Gamma Irradiation | Information not publically available in 510 (k)
summary | |
| Use | Disposable; Single-Patient Use only | Information not publically available in 510 (k)
summary | |
| Packaging | Medical grade packaging (sealed
TYVEK/Blister) | Information not publically available in 510 (k)
summary | |

10

6.2. DORO® Sterile Disposable Skull Pins (Titanium)

Adult:

11

12

Pediatric

13

6.3. Summary of Technological Characteristics

DORO® Sterile Disposable Skull Pins (Stainless steel & Titanium) are substantially equivalent in intended use, indication for use, dimensions and design to the predicate devices. Therefore safety and effectiveness can be ensured for these items.

Performance Data 7.

The DORO® Sterile Disposable Skull Pins (Stainless steel & Titanium) have been tested as a system and single device. Tests were performed and the results are shown in the table below.

Test	Result
DORO® Sterile Disposable Skull Pins (Stainless Steel & Titanium)
Axial Load, and Creep Test
Confirms the ability of the skull pins to withstand
typical loads w/ additional safety factor utilizing
the worst-case product.	Pass
The Pins are able to withstand typical static
loads w/ additional safety factor w/o plastic
deformation and an accepted distension.
Shear Test
Confirms the ability of the skull pins and its
interface with the cranial bone to withstand
typical shear force w/ additional safety factor
utilizing the worst-case product.	Pass
The Pins are able to withstand typical shear force
w/ additional safety factor w/o spatial
locomotion.
Transport Validation
Confirms the capability of the transport packing
as well as the of product packaging to protect
the skull pins against hazards, which may
occur during handling, storage, and transport by
air or ground.	Pass
The utilized packing system for the skull pins is
capable to protect those against visible damage.

14

Packing Integrity Test	Pass
Confirms the capability of the sterile barrier
system of the blister pack as well as the blister
pack itself utilized for the skull pins whether it is
effective, efficient and safe to use.	The utilized sterile barrier system as well as the
blister pack was proven to perform efficiently,
safely, and effectively.
System Handling Test	Pass
Confirms safe and effective utilization of the skull
pins w/ skull clamps w/o negative impact on
utilized single-use gloves	Skull Pins performer safely and effectively.
Input Materials	Pass
Confirms the acceptance of utilized materials of
the skull pins for medical use prior
biocompatibility test.	All utilized materials are accepted for medical
use.
Biocompatibility Test	Pass
Confirms the biocompatibility of the skull pins by
cytotoxicity test and chemical analysis of utilized
materials.	The skull pins obtain no cell growth inhibiting
character. No chemical substance above harmful
threshold was detected.
Color Coding	Pass
Confirms the coloring of the plastic pin collets that
enables the user to differentiate between MR
conditional and MR unsafe skull pins as well as
between skull pins for the adult population and
pediatric population.	Differentiation
between designated patient
populations as well as different applications is
possible due to different colors utilized for the
plastic pin collets.
Sterility Test	Pass
Confirms the sterility of the skull pins as well as
the maintained sterility of the skull pins at the end
of the product's shelf life.	VDmax validation as well as dye penetration test
have proven the sterility of the product at delivery
status as well as at the end of shelf life.
Test	Result

DORO® Sterile Disposable Skull Pins (Titanium)

MR-Compatibility	Pass
Verifies the MR- Compatibility of the skull pins
dedicated for the utilization in conjunction with
MRT scanner utilizing the worst-case product.	The skull pins are MR conditional.

Testing confirmed that the performance of the DORO® Sterile Disposable Skull Pins meets the product specification of the device.

15

Conclusion: Substantial Equivalence 8.

DORO® Sterile Disposable Skull Pins(stainless steel & titanium) are used together with the DORO ® Headrest System, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures.

These devices are comparable in design, construction, intended use and performance characteristics to the predicate devices.

Based on available 510(k) information herein provided, DORO® Sterile Disposable Skull Pins are considered substantially equivalent to the predicate devices in terms of intended use, technology and performance specifications. There are no differences between the devices which may raise new issues concerning safety or effectiveness.