DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
Device Facts
| Record ID | K193438 |
|---|---|
| Device Name | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) |
| Applicant | Pro Med Instruments GmbH |
| Product Code | HBL · Neurology |
| Decision Date | Jun 2, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4460 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for 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.
Device Story
Disposable skull pins for use with skull clamps to provide rigid head and neck fixation during neurosurgical and spinal procedures. Available in stainless steel (MR unsafe) and titanium (MR conditional) versions for adult and pediatric patients. Pins are inserted into the rocker arm and opposite side of a skull clamp. Titanium version allows for intra-operative X-ray, CT, or MR imaging. Device is supplied sterile via gamma irradiation for single-patient use. Healthcare providers (surgeons) install pins into headrest systems to stabilize the patient's head, facilitating surgical access and precision.
Clinical Evidence
Bench testing only. Testing included axial load and creep tests, shear tests, transport validation, packing integrity, system handling, biocompatibility (cytotoxicity and chemical analysis), color coding verification, sterility testing (VDmax and dye penetration), and MR compatibility for titanium models. All tests passed.
Technological Characteristics
Materials: Stainless Steel 1.4034 or Titanium Grade 5 (Ti-6Al-4V) with PA6 polymer base. Sensing/Actuation: Mechanical fixation via skull clamp. Energy: None. Form factor: Adult/Pediatric pins. Connectivity: None. Sterilization: Gamma irradiation. Software: None.
Indications 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. Not intended for use on infants or children under 5 years of age.
Regulatory Classification
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.
Predicate Devices
- TZ Skull Pin Adult (K163322)
- Mayfield Child Disposable Skull Pin (K941558)
- Limited Artifact Skull Pin (K073163)
Submission Summary (Full Text)
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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
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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:
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<br>Description | Regulation<br>Medical<br>Specialty | Review<br>Panel | Product<br>Code | Regulation<br>Number | Device<br>Classification |
|-------------------------------------------------|-----------------------------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------|
| Holder, head,<br>neurosurgical<br>(skull clamp) | Neurosurgical<br>head holder<br>(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<br>Disposable Skull Pins<br>(Stainless Steel)<br><br>Model:<br><br>1. (3006-00<br>Stainless Steel,<br>Adult, Blue)<br>2. (3006-50<br>Stainless Steel,<br>Adult, Black) | TZ Skull Pin<br>Adult | K163322 | TZ<br>Medical, Inc. |
| 3. (3006-10<br>Stainless Steel,<br>Pediatric,<br>Yellow) | Mayfield Child<br>Disposable Skull Pin | K941558 | OHIO MEDICAL INSTRUMENT<br>CO., INC. |
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| Device | Predicate Device | 510(k) Number | 510(k) Holder |
|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------|
| DORO® Sterile Disposable Skull Pins (Titanium)<br>Model:<br>1. (3006-20 Titanium, Adult, Orange)<br><br>2. (3006-30 Titanium, Pediatric, Green) | Limited Artifact Skull Pin<br><br>Mayfield Child Disposable Skull Pin | K073163<br><br>K941558 | Dinkier Surgical Devices, Inc.<br><br>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<br>(New Device) | TZ Medical, Inc.<br>(Predicate Device) | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DORO® Sterile Disposable Skull Pins<br>(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<br>utilized in a skull clamp and is applied to the<br>patient's skull to hold their head and neck<br>securely in a particular position when rigid<br>fixation is desired. The skull clamp is<br>indicated for use in open and percutaneous<br>craniotomies as well as spinal surgery when<br>rigid fixation is necessary. | The TZ Medical skull pin is placed in a<br>clamp and is applied to the patient's skull<br>to hold their head and neck securely in a<br>particular position when rigid fixation is<br>desired. The clamp is indicated for use in<br>open and percutaneous craniotomies as<br>well as spinal surgery when rigid fixation<br>is necessary. | |
| Indication for Use | Indicated for use in combination with a skull<br>clamp in open and percutaneous craniotomies<br>as well as spinal surgery when rigid fixation is<br>necessary. | Indicated for use in open and<br>percutaneous craniotomies as well as<br>spinal surgery when rigid fixation is<br>necessary. | |
| Material | Stainless Steel 1.4034 with a polymer base<br>PA6 | 316L (1.4404 ) Stainless Steel | |
| Size | Adult | Adult | |
| Dimension | | | |
| Tip to Shoulder<br>Distance | Adult: 0.5 Inches | Adult: 0.5 Inches | |
| Width of back | Adult: 0.31 inches | Adult:0.31 inches | |
| O-ring | 3006-00<br>Stainless Steel,<br>Adult, Blue<br>3006-50<br>Stainless Steel,<br>Adult, Black | No O-Ring<br>Nitrile butadiene<br>rubber (NBR) O-<br>Ring<br>Silicone O-Ring | |
| | pro med instruments GmbH<br>(New Device) | | TZ Medical, Inc.<br>(Predicate Device) |
| Company | | | |
| Manufacturing | 3006-00<br>Stainless Steel,<br>Adult, Blue<br><br>3006-50<br>Stainless Steel,<br>Adult, Black | The pin insert is<br>machined according to<br>the dimensions<br>specified, and cleaned<br>afterwards. The Pin<br>collet is injection-<br>molded around the<br>Pin insert in controlled<br>environmental<br>conditions.<br><br>The pin is machined<br>according to the<br>dimensions specified,<br>and cleaned<br>afterwards. Assembly<br>of the O-ring takes<br>place in controlled<br>environmental<br>conditions. | The pin is machined to the dimensions<br>specified. O-Ring is placed on device when<br>manufacturing and cleaning is completed. |
| Preparation for<br>surgery | None, the pins are supplied sterile in a 3-pack<br>pouch ready for use | | None, the pins are supplied sterile in a 3-<br>pack pouch ready for use |
| Method of Use | Typically , three pins are installed in<br>receptacles of the head holder | | Typically, three pins are installed in<br>receptacles of the head holder |
| Clamp<br>Compatibility | DORO® Sterile Disposable Skull Pins are<br>compatible with all the models of Doro brand<br>skull clamps | | V. Mueller Spetzler Skull Clamp-Model #<br>M-1500<br>Integra Mayfield Skull Clamp- Model # A-<br>1059<br>Integra Mayfield Skull Clamp- Model # A-<br>2000 |
| MR Compatibility | MR Unsafe | | MR Unsafe |
| Method of<br>Sterilization | Gamma Irradiation | | Ethylene Oxide |
| Use | Disposable; Single-Patient Use only | | Disposable; Single-Patient Use only |
| Packaging | Medical grade packaging (sealed<br>TYVEK/Blister) | | Medical grade packaging (sealed<br>TYVEK (flexible film pouches) |
| Company | pro med instruments GmbH<br>(New Device) | OHIO MEDICAL INSTRUMENT CO.,<br>INC.<br>(Predicate Device) | |
| Device Name | DORO® Sterile Disposable Skull Pins<br>(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 is<br>utilized in a skull clamp and is applied to the<br>patient's skull to hold their head and neck<br>securely in a particular position when rigid<br>fixation is desired. The skull clamp is<br>indicated for use in open and percutaneous<br>craniotomies as well as spinal surgery when<br>rigid fixation is necessary. | Information not publically available in 510<br>(k) summary | |
| Indication for Use | Indicated for use in combination with a skull<br>clamp in open and percutaneous craniotomies<br>as well as spinal surgery when rigid fixation is<br>necessary. | Information not publically available in 510<br>(k) summary | |
| Recommended Age<br>of use | The disposable skull pin is not intended for<br>use on infants or children under 5 years of<br>age. | The disposable skull pin is not intended for<br>use on infants or children under 5 years of<br>age. | |
| Material | Stainless Steel 1.4034 with a polymer base<br>PA6 | Information not publically available in 510<br>(k) summary | |
| Size | Pediatric | Pediatric | |
| Dimension | | | |
| Tip to Shoulder<br>Distance | Pediatric: 0.4 Inches | Information not publically available in 510<br>(k) summary | |
| Width of back | Pediatric: 0.31 inches | Information not publically available in 510<br>(k) summary | |
| O-ring | 3006-10<br>Stainless Steel,<br>Pediatric, Yellow | Information not publically available in 510<br>(k) summary | |
### Adult:
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## Pediatric:
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| Company | pro med instruments GmbH<br>(New Device) | OHIO MEDICAL INSTRUMENT CO.,<br>INC.<br>(Predicate Device) | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Manufacturing | 3006-10<br>Stainless Steel,<br>Pediatric, Yellow<br><br>The pin insert is<br>machined according to<br>the dimensions<br>specified, and cleaned<br>afterwards. The Pin<br>collet is injection-<br>molded around the<br>Pin insert in controlled<br>environmental<br>conditions. | Information not publically available in 510<br>(k) summary | |
| Preparation for<br>surgery | None, the pins are supplied sterile in a 3-pack<br>pouch ready for use | Information not publically available in 510<br>(k) summary | |
| Method of Use | Typically, three pins are installed in<br>receptacles of the head holder | Information not publically available in 510<br>(k) summary | |
| Clamp<br>Compatibility | DORO® Sterile Disposable Skull Pins are<br>compatible with all the models of Doro brand<br>skull clamps | Information not publically available in 510<br>(k) summary | |
| MR Compatibility | MR Unsafe | Information not publically available in 510<br>(k) summary | |
| Method of<br>Sterilization | Gamma Irradiation | Information not publically available in 510<br>(k) summary | |
| Use | Disposable; Single-Patient Use only | Information not publically available in 510<br>(k) summary | |
| Packaging | Medical grade packaging (sealed<br>TYVEK/Blister) | Information not publically available in 510<br>(k) summary | |
| Company | pro med instruments GmbH<br>(New Device) | Dinkier Surgical Devices, Inc.<br>(Predicate Device) | |
| Device Name | DORO® Sterile Disposable Skull Pins<br>(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<br>is utilized in a skull clamp and is applied<br>to the patient's skull to hold their head<br>and neck securely in a particular<br>position when rigid fixation is desired.<br>The skull clamp is indicated for use in<br>open and percutaneous craniotomies as<br>well as spinal surgery when rigid fixation<br>is necessary. | Limited Artifact Skull Pins are used with a<br>head holder device that is placed on the<br>patients'skull to hold their head and neck in a<br>particular position during surgical procedures<br>when rigid skeletal fixation is desired. | |
| Indication for Use | Indicated for use in combination with<br>skull clamp in open and percutaneous<br>craniotomies as well as spinal surgery<br>when rigid fixation is necessary. | Indicated for use in open and percutaneous<br>craniotomies and spinal surgeries when rigid<br>skeletal fixation is necessary and during intra-<br>operative use within a MR environment rated<br>up to and including a 1.5 Tesla magnetic Field | |
| Material | Titanium Grade 5 (Ti-6Al-4V) with a<br>polymer base PA6 | The pin tip is Titanium 6Al-4V and the<br>polymer base is PEEK with 10% carbon filler | |
| Dimension | | | |
| Tip to Shoulder<br>Distance | Adult: 0.5 Inches | Information not publically available in 510 (k)<br>summary | |
| Width of back | Adult: 0.31 inches | Information not publically available in 510 (k)<br>summary | |
| O-ring | 3006-20<br>Titanium, Adult,<br>Orange)<br>No O-Ring | O-Ring | |
| Manufacturing | The pin insert is machined according to<br>the dimensions specified, and cleaned<br>afterwards. The Pin collet is injection-<br>molded around the Pin insert in<br>controlled environmental conditions. | The pin tip is machined to the dimensions<br>listed on the pin tip drawing.<br>The pin tip is injection molded to the<br>dimensions listed on the pin base drawing. | |
| Preparation for<br>surgery | None, the pins are supplied sterile in a<br>3-pack pouch ready for use. | None, the pin are supplied sterile in a 3-pack<br>pouch ready for use. | |
| Method of Use | Typically , three pins are installed in | Typically , three pins are installed in | |
| Company | pro med instruments GmbH<br>(New Device) | Dinkier Surgical Devices, Inc.<br>(Predicate Device) | |
| Clamp<br>Compatibility | DORO® Sterile Disposable Skull Pins are<br>compatible with all the models of Doro<br>brand skull clamps | Information not publically available in 510 (k)<br>summary | |
| MR Compatibility | MR Conditional<br>Main magnetic field strength: 1.5 Tesla or 3 Tesla | MR Conditional | |
| Method of<br>Sterilization | Gamma Irradiation | radiation sterilized | |
| Use | Disposable; Single-Patient Use only | | |
| Packaging | Medical grade packaging (sealed<br>TYVEK/Blister) | Medical grade packaging (sealed<br>TYVEK/flexible film pouches) | |
| Company | pro med instruments GmbH<br>(New Device) | OHIO MEDICAL INSTRUMENT CO., INC.<br>(Predicate Device) | |
| Device Name | DORO® Sterile Disposable Skull Pins<br>(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<br>is utilized in a skull clamp and is applied<br>to the patient's skull to hold their head<br>and neck securely in a particular<br>position when rigid fixation is desired.<br>The skull clamp is indicated for use in<br>open and percutaneous craniotomies as<br>well as spinal surgery when rigid fixation<br>is necessary. | Information not publically available in 510 (k)<br>summary | |
| Indication for Use | Indicated for use in combination with<br>skull clamp in open and percutaneous<br>craniotomies as well as spinal surgery<br>when rigid fixation is necessary. | Information not publically available in 510 (k)<br>summary | |
| Recommended Age<br>of Use | The disposable skull pin is not intended<br>for use on infants or children under 5<br>years of age. | The disposable skull pin is not intended for<br>use on infants or children under 5 years of<br>age. | |
| Material | Titanium Grade 5 (Ti-6AI-4V) with a<br>polymer base PA6 | Information not publically available in 510 (k)<br>summary | |
| Size | Pediatric…
