(174 days)
Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
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.
The provided document is a 510(k) premarket notification for the DORO® Sterile Disposable Skull Pins. This document asserts the substantial equivalence of the new device to legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I describe an MRMC comparative effectiveness study or details about the training set.
The document focuses on demonstrating substantial equivalence for a physical medical device (skull pins) by comparing its technological characteristics and performance testing results to those of predicate devices. It does not involve AI/ML components or studies of human reader performance.
However, I can extract information related to the performance data provided for the physical device:
1. Table of Acceptance Criteria and Reported Device Performance (as listed in the document for the physical device):
| Test | Acceptance Criteria (Implied by action 'Confirms ability to withstand' or 'Confirms acceptance', and 'Pass' result) | Reported Device Performance |
|---|---|---|
| DORO® Sterile Disposable Skull Pins (Stainless Steel & Titanium) | ||
| Axial Load, and Creep Test | Ability to withstand typical loads with additional safety factor without plastic deformation and with an accepted distension. | Pass: The Pins are able to withstand typical static loads w/ additional safety factor w/o plastic deformation and an accepted distension. |
| Shear Test | Ability of the skull pins and its interface with the cranial bone to withstand typical shear force with additional safety factor without spatial locomotion. | Pass: The Pins are able to withstand typical shear force w/ additional safety factor w/o spatial locomotion. |
| Transport Validation | Capability of the transport packaging as well as the 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. |
| Packing Integrity Test | 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. | Pass: The utilized sterile barrier system as well as the blister pack was proven to perform efficiently, safely, and effectively. |
| System Handling Test | Safe and effective utilization of the skull pins with skull clamps without negative impact on utilized single-use gloves. | Pass: Skull Pins performed safely and effectively. |
| Input Materials | Acceptance of utilized materials of the skull pins for medical use prior biocompatibility test. | Pass: All utilized materials are accepted for medical use. |
| Biocompatibility Test | Biocompatibility of the skull pins by cytotoxicity test and chemical analysis of utilized materials (no cell growth inhibiting character, no chemical substance above harmful threshold). | Pass: The skull pins obtain no cell growth inhibiting character. No chemical substance above harmful threshold was detected. |
| Color Coding | 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. | 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 | Sterility of the skull pins as well as the maintained sterility of the skull pins at the end of the product's shelf life. | 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. |
| DORO® Sterile Disposable Skull Pins (Titanium) | ||
| MR-Compatibility | MR-Compatibility of the skull pins dedicated for the utilization in conjunction with MRT scanner utilizing the worst-case product. | Pass: The skull pins are MR conditional. |
2. Sample size used for the test set and the data provenance:
The document describes performance testing of physical properties of the skull pins (e.g., axial load, shear, sterility, biocompatibility) and packaging, not a study involving a "test set" of medical images or patient data in the typical sense of AI/ML evaluation. The specific sample sizes for these engineering and material tests are not detailed in this 510(k) summary, beyond indicating that "worst-case product" was utilized for some tests. The data provenance is from the manufacturer's internal testing (Pro Med Instruments GmbH, Germany). The tests are not clinical studies, so terms like "retrospective or prospective" do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to the type of device and testing described. Ground truth for a physical device's performance tests would typically involve established engineering standards, material specifications, and validated laboratory procedures, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or adjudication of medical data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document is for a physical medical device (skull pins), not an AI/ML diagnostic or assistive device. Thus, there is no mention of MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the physical device, the "ground truth" for the performance tests would be defined by engineering specifications, material standards (e.g., ISO, ASTM), and validated test methodologies. For example, for the "Axial Load and Creep Test," the ground truth is the specified load and deformation limits that the device must withstand. For "Biocompatibility," the ground truth is the absence of cytotoxicity or harmful chemical substances as per established biocompatibility standards.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML model.
In summary, the provided document is a regulatory submission for a physical medical device focusing on substantial equivalence based on material properties, design, and mechanical performance testing, rather than an AI/ML device requiring clinical validation or human reader studies.
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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
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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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DATE:
June 2, 2020
DOCUMENT NUMBER:
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 | RegulationDescription | RegulationMedicalSpecialty | ReviewPanel | ProductCode | RegulationNumber | DeviceClassification |
|---|---|---|---|---|---|---|
| Holder, head,neurosurgical(skull clamp) | Neurosurgicalhead 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® SterileDisposable Skull Pins(Stainless Steel)Model:1. (3006-00Stainless Steel,Adult, Blue)2. (3006-50Stainless Steel,Adult, Black) | TZ Skull PinAdult | K163322 | TZMedical, Inc. |
| 3. (3006-10Stainless Steel,Pediatric,Yellow) | Mayfield ChildDisposable Skull Pin | K941558 | OHIO MEDICAL INSTRUMENTCO., INC. |
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| Device | Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|---|
| DORO® Sterile Disposable Skull Pins (Titanium)Model:1. (3006-20 Titanium, Adult, Orange)2. (3006-30 Titanium, Pediatric, Green) | Limited Artifact Skull PinMayfield Child Disposable Skull Pin | K073163K941558 | 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.
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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 isutilized in a skull clamp and is applied to thepatient's skull to hold their head and necksecurely in a particular position when rigidfixation is desired. The skull clamp isindicated for use in open and percutaneouscraniotomies as well as spinal surgery whenrigid fixation is necessary. | The TZ Medical skull pin is placed in aclamp and is applied to the patient's skullto hold their head and neck securely in aparticular position when rigid fixation isdesired. The clamp is indicated for use inopen and percutaneous craniotomies aswell as spinal surgery when rigid fixationis necessary. | |
| Indication for Use | Indicated for use in combination with a skullclamp in open and percutaneous craniotomiesas well as spinal surgery when rigid fixation isnecessary. | Indicated for use in open andpercutaneous craniotomies as well asspinal surgery when rigid fixation isnecessary. | |
| Material | Stainless Steel 1.4034 with a polymer basePA6 | 316L (1.4404 ) Stainless Steel | |
| Size | Adult | Adult | |
| Dimension | |||
| Tip to ShoulderDistance | Adult: 0.5 Inches | Adult: 0.5 Inches | |
| Width of back | Adult: 0.31 inches | Adult:0.31 inches | |
| O-ring | 3006-00Stainless Steel,Adult, Blue3006-50Stainless Steel,Adult, Black | No O-RingNitrile butadienerubber (NBR) O-RingSilicone O-Ring | |
| pro med instruments GmbH(New Device) | TZ Medical, Inc.(Predicate Device) | ||
| Company | |||
| Manufacturing | 3006-00Stainless Steel,Adult, Blue3006-50Stainless Steel,Adult, Black | The pin insert ismachined according tothe dimensionsspecified, and cleanedafterwards. The Pincollet is injection-molded around thePin insert in controlledenvironmentalconditions.The pin is machinedaccording to thedimensions specified,and cleanedafterwards. Assemblyof the O-ring takesplace in controlledenvironmentalconditions. | The pin is machined to the dimensionsspecified. O-Ring is placed on device whenmanufacturing and cleaning is completed. |
| Preparation forsurgery | None, the pins are supplied sterile in a 3-packpouch ready for use | None, the pins are supplied sterile in a 3-pack pouch ready for use | |
| Method of Use | Typically , three pins are installed inreceptacles of the head holder | Typically, three pins are installed inreceptacles of the head holder | |
| ClampCompatibility | DORO® Sterile Disposable Skull Pins arecompatible with all the models of Doro brandskull clamps | V. Mueller Spetzler Skull Clamp-Model #M-1500Integra Mayfield Skull Clamp- Model # A-1059Integra Mayfield Skull Clamp- Model # A-2000 | |
| MR Compatibility | MR Unsafe | MR Unsafe | |
| Method ofSterilization | Gamma Irradiation | Ethylene Oxide | |
| Use | Disposable; Single-Patient Use only | Disposable; Single-Patient Use only | |
| Packaging | Medical grade packaging (sealedTYVEK/Blister) | Medical grade packaging (sealedTYVEK (flexible film pouches) | |
| Company | pro med instruments GmbH(New Device) | OHIO MEDICAL INSTRUMENT CO.,INC.(Predicate Device) | |
| Device Name | DORO® Sterile Disposable Skull Pins(Stainless steel) | Mayfield Child Disposable Skull Pin | |
| Regulation Number | 882.4460 | 882.4460 | |
| Class | 2 | 2 | |
| Code | HBL | HBL | |
| 510(k) number | K193438 | K941558 | |
| Intended Use | The DORO® Sterile Disposable Skull Pin isutilized in a skull clamp and is applied to thepatient's skull to hold their head and necksecurely in a particular position when rigidfixation is desired. The skull clamp isindicated for use in open and percutaneouscraniotomies as well as spinal surgery whenrigid fixation is necessary. | Information not publically available in 510(k) summary | |
| Indication for Use | Indicated for use in combination with a skullclamp in open and percutaneous craniotomiesas well as spinal surgery when rigid fixation isnecessary. | Information not publically available in 510(k) summary | |
| Recommended Ageof use | The disposable skull pin is not intended foruse on infants or children under 5 years ofage. | The disposable skull pin is not intended foruse on infants or children under 5 years ofage. | |
| Material | Stainless Steel 1.4034 with a polymer basePA6 | Information not publically available in 510(k) summary | |
| Size | Pediatric | Pediatric | |
| Dimension | |||
| Tip to ShoulderDistance | 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 | 3006-10Stainless Steel,Pediatric, Yellow | Information not publically available in 510(k) summary |
Adult:
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Pediatric:
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| Company | pro med instruments GmbH(New Device) | OHIO MEDICAL INSTRUMENT CO.,INC.(Predicate Device) | |
|---|---|---|---|
| Manufacturing | 3006-10Stainless Steel,Pediatric, YellowThe pin insert ismachined according tothe dimensionsspecified, and cleanedafterwards. The Pincollet is injection-molded around thePin insert in controlledenvironmentalconditions. | Information not publically available in 510(k) summary | |
| Preparation forsurgery | None, the pins are supplied sterile in a 3-packpouch ready for use | Information not publically available in 510(k) summary | |
| Method of Use | Typically, three pins are installed inreceptacles of the head holder | Information not publically available in 510(k) summary | |
| ClampCompatibility | DORO® Sterile Disposable Skull Pins arecompatible with all the models of Doro brandskull clamps | Information not publically available in 510(k) summary | |
| MR Compatibility | MR Unsafe | Information not publically available in 510(k) summary | |
| Method ofSterilization | 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 (sealedTYVEK/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 Pinis utilized in a skull clamp and is appliedto the patient's skull to hold their headand neck securely in a particularposition when rigid fixation is desired.The skull clamp is indicated for use inopen and percutaneous craniotomies aswell as spinal surgery when rigid fixationis necessary. | Limited Artifact Skull Pins are used with ahead holder device that is placed on thepatients'skull to hold their head and neck in aparticular position during surgical procedureswhen rigid skeletal fixation is desired. | |
| Indication for Use | Indicated for use in combination withskull clamp in open and percutaneouscraniotomies as well as spinal surgerywhen rigid fixation is necessary. | Indicated for use in open and percutaneouscraniotomies and spinal surgeries when rigidskeletal fixation is necessary and during intra-operative use within a MR environment ratedup to and including a 1.5 Tesla magnetic Field | |
| Material | Titanium Grade 5 (Ti-6Al-4V) with apolymer base PA6 | The pin tip is Titanium 6Al-4V and thepolymer base is PEEK with 10% carbon filler | |
| Dimension | |||
| Tip to ShoulderDistance | 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 | 3006-20Titanium, Adult,Orange)No O-Ring | O-Ring | |
| Manufacturing | The pin insert is machined according tothe dimensions specified, and cleanedafterwards. The Pin collet is injection-molded around the Pin insert incontrolled environmental conditions. | The pin tip is machined to the dimensionslisted on the pin tip drawing.The pin tip is injection molded to thedimensions listed on the pin base drawing. | |
| Preparation forsurgery | None, the pins are supplied sterile in a3-pack pouch ready for use. | None, the pin are supplied sterile in a 3-packpouch 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) | |
| ClampCompatibility | DORO® Sterile Disposable Skull Pins arecompatible with all the models of Dorobrand skull clamps | Information not publically available in 510 (k)summary | |
| MR Compatibility | MR ConditionalMain magnetic field strength: 1.5 Tesla or 3 Tesla | MR Conditional | |
| Method ofSterilization | Gamma Irradiation | radiation sterilized | |
| Use | Disposable; Single-Patient Use only | ||
| Packaging | Medical grade packaging (sealedTYVEK/Blister) | Medical grade packaging (sealedTYVEK/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 Pinis utilized in a skull clamp and is appliedto the patient's skull to hold their headand neck securely in a particularposition when rigid fixation is desired.The skull clamp is indicated for use inopen and percutaneous craniotomies aswell as spinal surgery when rigid fixationis necessary. | Information not publically available in 510 (k)summary | |
| Indication for Use | Indicated for use in combination withskull clamp in open and percutaneouscraniotomies as well as spinal surgerywhen rigid fixation is necessary. | Information not publically available in 510 (k)summary | |
| Recommended Ageof Use | The disposable skull pin is not intendedfor use on infants or children under 5years of age. | The disposable skull pin is not intended foruse on infants or children under 5 years ofage. | |
| Material | Titanium Grade 5 (Ti-6AI-4V) with apolymer base PA6 | Information not publically available in 510 (k)summary | |
| Size | Pediatric | Pediatric | |
| Dimension | |||
| Tip to ShoulderDistance | 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 | 3006-30Titanium,Pediatric, Green | No O-Ring | Information not publically available in 510 (k)summary |
| Manufacturing | The pin insert is machined according tothe dimensions specified, and cleanedafterwards. The Pin collet is injection-molded around the Pin insert incontrolled environmental conditions. | Information not publically available in 510 (k)summary | |
| Preparation forsurgery | None, the pins are supplied sterile in a3-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) | |
| ClampCompatibility | DORO® Sterile Disposable Skull Pins arecompatible with all the models of Dorobrand skull clamps | Information not publically available in 510 (k)summary | |
| MR Compatibility | MR ConditionalMain magnetic field strength: 1.5Tesla or 3 Tesla | Information not publically available in 510 (k)summary | |
| Method ofSterilization | 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 (sealedTYVEK/Blister) | Information not publically available in 510 (k)summary |
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6.2. DORO® Sterile Disposable Skull Pins (Titanium)
Adult:
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Pediatric
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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 TestConfirms the ability of the skull pins to withstandtypical loads w/ additional safety factor utilizingthe worst-case product. | PassThe Pins are able to withstand typical staticloads w/ additional safety factor w/o plasticdeformation and an accepted distension. |
| Shear TestConfirms the ability of the skull pins and itsinterface with the cranial bone to withstandtypical shear force w/ additional safety factorutilizing the worst-case product. | PassThe Pins are able to withstand typical shear forcew/ additional safety factor w/o spatiallocomotion. |
| Transport ValidationConfirms the capability of the transport packingas well as the of product packaging to protectthe skull pins against hazards, which mayoccur during handling, storage, and transport byair or ground. | PassThe utilized packing system for the skull pins iscapable to protect those against visible damage. |
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| Packing Integrity Test | Pass |
|---|---|
| Confirms the capability of the sterile barriersystem of the blister pack as well as the blisterpack itself utilized for the skull pins whether it iseffective, efficient and safe to use. | The utilized sterile barrier system as well as theblister pack was proven to perform efficiently,safely, and effectively. |
| System Handling Test | Pass |
| Confirms safe and effective utilization of the skullpins w/ skull clamps w/o negative impact onutilized single-use gloves | Skull Pins performer safely and effectively. |
| Input Materials | Pass |
| Confirms the acceptance of utilized materials ofthe skull pins for medical use priorbiocompatibility test. | All utilized materials are accepted for medicaluse. |
| Biocompatibility Test | Pass |
| Confirms the biocompatibility of the skull pins bycytotoxicity test and chemical analysis of utilizedmaterials. | The skull pins obtain no cell growth inhibitingcharacter. No chemical substance above harmfulthreshold was detected. |
| Color Coding | Pass |
| Confirms the coloring of the plastic pin collets thatenables the user to differentiate between MRconditional and MR unsafe skull pins as well asbetween skull pins for the adult population andpediatric population. | Differentiationbetween designated patientpopulations as well as different applications ispossible due to different colors utilized for theplastic pin collets. |
| Sterility Test | Pass |
| Confirms the sterility of the skull pins as well asthe maintained sterility of the skull pins at the endof the product's shelf life. | VDmax validation as well as dye penetration testhave proven the sterility of the product at deliverystatus 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 pinsdedicated for the utilization in conjunction withMRT 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.
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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.
§ 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).