TZ SKULL PIN Adult

K163322 · Tz Medical, Inc. · HBL · Feb 23, 2017 · Neurology

Device Facts

• Record ID: K163322
• Device Name: TZ SKULL PIN Adult
• Applicant: Tz Medical, Inc.
• Product Code: HBL · Neurology
• Decision Date: Feb 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4460
• Device Class: Class 2

Indications for Use

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.

Device Story

TZ Skull Pin is a sterile, single-patient-use cervical traction skull pin; manufactured from implant-grade 316L stainless steel. Device is installed in sets of three into compatible skull clamps (e.g., V. Mueller Spetzler, Integra Mayfield) by neurosurgeons during craniotomies or spinal surgeries. Pins provide rigid skeletal fixation to immobilize the patient's head and neck relative to the torso. Output is mechanical stabilization of the surgical site; enabling precise surgical access. Device is MR unsafe. Benefits include secure, stable positioning during complex neurosurgical procedures.

Clinical Evidence

Bench testing only. Performance testing included maximum load and 24-hour creep tests per ASTM F1831-97, confirming stability in compatible skull clamps. Biocompatibility testing conducted per ISO 10993 standards: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), and Systemic Toxicity (ISO 10993-11). All tests met requirements with no evidence of toxicity, lysis, or sensitization.

Technological Characteristics

Material: 316L stainless steel. Components: Pin point, silicone O-ring. Dimensions: 0.5-inch tip-to-shoulder distance, 0.31-inch back width. Energy: None (mechanical). Sterilization: Ethylene Oxide. Compatibility: V. Mueller Spetzler (M-1500), Integra Mayfield (A-1059, A-2000). Single-patient use.

Indications for Use

Indicated for use in open and percutaneous craniotomies and spinal surgery requiring rigid fixation of the head and neck in adult patients.

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

• Mayfield Adult Disposable Steel Skull Pins (K923789)
• Mayfield Adult Disposable Steel Skull Pins (K932860)

Submission Summary (Full Text)

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

February 23, 2017

TZ Medical, Inc. Mr. John Lubisich President 17750 SW Upper Boones Ferry Rd, Suite #150 Portland, OR 97224

Re: K163322

Trade/Device Name: TZ Skull Pin Adult Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: November 21, 2016 Received: November 25, 2016

Dear Mr. Lubisich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Michael J. Hoffmann -S

for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K163322

Device Name TZ Skull Pin Adult

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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| Submitter Name and Address: | TZ Medical, Inc.<br>17750 SW Upper Boones Ferry Rd #150<br>Portland, OR 97224<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Lubisich<br>Management Representative<br>TEL: [phone]<br>FAX: [phone] |
| Date of Summary: | Nov. 18, 2016 |
| Trade name/Proprietary: | TZ Skull Pin |
| Common Name: | Skull Pins |
| Model Number: | SP-001 |
| Classification Name: | Neurosurgical Head Holder (Skull Clamp) |
| Classification: | Class II, per 21 CFR 882.4460 |
| Panel: | Neurology |
| Product Code: | HBL |
| Predicate Device: | |

| Product | 510(k)<br>Number |
|--------------------------------------------|------------------|
| Mayfield Adult Disposable Steel Skull Pins | K923789 |
| Mayfield Adult Disposable Steel Skull Pins | K932860 |

Device Description: The TZ Skull Pin is a sterile cervical traction skull pin manufactured from implant grade 316L stainless steel alloy. The TZ Skull Pin is used during neurosurgical procedures to immobilize the head in reference to the torso and to provide cervical immobilization.

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| | In preparation for surgery three skull pins are installed in a compatible skull<br>clamp (such as the V. Mueller Spetzler Skull Clamp or the Integra Mayfield Skull<br>Clamp). Two skull pins are inserted in the rocker arm side of the clamp and a<br>single skull pin is inserted on the opposite side. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Testing was conducted to evaluate the performance characteristics of the TZ<br>Skull Pin. |
| Indications for Use: | The TZ Medical skull pin is placed in a clamp and is applied to the patient's skull<br>to hold their head and neck securely in a particular position when rigid fixation<br>is desired. The clamp is indicated for use in open and percutaneous<br>craniotomies as well as spinal surgery when rigid fixation is necessary. |
| Contraindications: | Not indicated for use in an MR environment. |
| Compatibility Information: | The TZ Medical Skull Pin is placed in a compatible skull clamp such as the V.<br>Mueller Spetzler Skull Clamp or the Integra Mayfield Skull Clamp |

Comparison to Predicate Devices:

The substantial equivalence of the TZ Skull Pin is based on an equivalence to the predicate devices in intended use, technological characteristics and indications for use:

| | Proposed Medical Device | Predicate Device | Predicate Device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TZ Skull Pin | Mayfield Adult Disposable Skull Pins | Mayfield Adult Disposable Skull Pins |
| | | (K923789) | (K932860) |
| Applicant | TZ Medical | Ohio Medical Instrument Co., Inc. | Ohio Medical Instrument Co., Inc. |
| Regulation Number | 882.4460 | 882.4460 | 882.4460 |
| Product Code | HBL | HBL | HBL |
| | Proposed Medical Device | Predicate Device | Predicate Device |
| | TZ Skull Pin | Mayfield Adult Disposable<br>Skull Pins | Mayfield Adult Disposable<br>Skull Pins |
| | | (K923789) | (K932860) |
| Intended Use | The TZ Medical skull pin is<br>placed in a clamp and is<br>applied to the patient's skull<br>to hold their head and neck<br>securely in a particular<br>position when rigid fixation is<br>desired. The clamp is<br>indicated for use in open and<br>percutaneous craniotomies<br>as well as spinal surgery<br>when rigid fixation is<br>necessary. | Used with head holders to<br>clamp the patient's skull and<br>hold the head and neck in<br>position during surgical<br>procedures. | Used with head holders to<br>clamp the patient's skull and<br>hold the head and neck in<br>position during surgical<br>procedures. The MAYFIELD<br>Disposable Adult Skull Pins<br>are indicated for use with a<br>MAYFIELD Skull clamp that is<br>placed on the patient's skull<br>to hold their head and neck<br>in a particular position during<br>surgical procedures when<br>rigid skeletal fixation is<br>desired. |
| Indications for<br>Use | Indicated for use in open and<br>percutaneous craniotomies<br>as well as spinal surgery<br>when rigid fixation is<br>necessary. | Indicated for use in open and<br>percutaneous craniotomies<br>as well as spinal surgery<br>when rigid fixation is<br>necessary. | Indicated for use in open and<br>percutaneous craniotomies<br>as well as spinal surgery<br>when rigid fixation is<br>necessary. |
| Material | 316L Stainless Steel | The pin point is 17-4PH<br>stainless steel and the<br>polymer base is ABS plastic. | The pin point is 17-4PH<br>stainless steel and the<br>polymer base is ABS plastic. |
| Dimensions | | | |
| Tip to<br>Shoulder<br>Distance | 0.5 Inches | 0.5 Inches | 0.5 Inches |
| Width of<br>back | 0.31 inches | 0.31 inches | 0.31 inches |
| O-ring | Silicone O-Ring | Silicone O-Ring | Silicone O-Ring |
| Manufacturing | The pin is machined to the<br>dimensions specified. O-Ring<br>is placed on device when<br>manufacturing and cleaning<br>is completed. | The pin is machined to the<br>dimensions specified. O-Ring<br>is placed on device when<br>manufacturing and cleaning<br>is completed. | The pin is machined to the<br>dimensions specified. O-Ring<br>is placed on device when<br>manufacturing and cleaning<br>is completed. |
| Preparation for<br>surgery | None, the pins are supplied<br>sterile in a 3-pack pouch<br>ready for use | None, the pins are supplied<br>sterile in a 3-pack pouch<br>ready for use | None, the pins are supplied<br>sterile in a 3-pack pouch<br>ready for use |
| | Proposed Medical Device | Predicate Device | Predicate Device |
| | TZ Skull Pin | Mayfield Adult Disposable<br>Skull Pins | Mayfield Adult Disposable<br>Skull Pins |
| | | (K923789) | (K932860) |
| Method of Use | Typically, three pins are<br>installed in receptacles of the<br>head holder | Typically, three pins are<br>installed in receptacles of the<br>head holder | Typically, three pins are<br>installed in receptacles of the<br>head holder |
| Performance<br>Testing | ASTM F1831-97: | ASTM F1831-97: | ASTM F1831-97: |
| | Passed maximum load test | Passed maximum load test | Passed maximum load test |
| | Passed 24 hour load test | Passed 24 hour load test | Passed 24 hour load test |
| Clamp<br>compatibility | V. Mueller Spetzler Skull<br>Clamp-Model # M-1500<br>Integra Mayfield Skull Clamp-<br>Model # A-1059<br>Integra Mayfield Skull Clamp-<br>Model # A-2000 | All generations of MAYFIELD<br>brand Skull Clamps (REF A-<br>1013, A-1014, A-1059, A-<br>1108, or A-2000), MAYFIELD<br>brand Radiolucent Skull<br>Clamps (REF A-1058 or A-<br>2002), and the Improved<br>GARDNER brand Skull Clamp<br>(REF A-1035) when rigid<br>skeletal fixation is required<br>Not compatible with Original<br>GARDNER brand Skull Clamp | All generations of MAYFIELD<br>brand Skull Clamps (REF A-<br>1013, A-1014, A-1059, A-<br>1108, or A-2000), MAYFIELD<br>brand Radiolucent Skull<br>Clamps (REF A-1058 or A-<br>2002), and the Improved<br>GARDNER brand Skull Clamp<br>(REF A-1035) when rigid<br>skeletal fixation is required<br>Not compatible with Original<br>GARDNER brand Skull Clamp |
| MR<br>compatibility | MR unsafe | MR unsafe | MR unsafe |
| Method of<br>Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Use | Disposable; Single-Patient<br>Use Only | Disposable; Single-Patient<br>Use Only | Disposable; Single-Patient<br>Use Only |
| Packaging | Medical grade packaging<br>(sealed TYVEK/flexible film<br>pouches) | Medical grade packaging<br>(sealed TYVEK/flexible film<br>pouches) | Medical grade packaging<br>(sealed TYVEK/flexible film<br>pouches) |

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Summary of Technological Characteristics:

The TZ Skull Pins are equivalent in materials used, dimensions and design to the predicate devices. The Skull Pin is made of equivalent stainless steel material. All critical dimensions of the TZ Skull Pin are equivalent to the predicate device.

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Summary of Performance Testing:

| Test | Test Method Summary | Results |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Skull Pin System<br>Testing | To demonstrate skull pin perform safely and<br>effectively in the 3 skull clamps recommended in<br>the labelling (V. Mueller Spetzler Skull Clamp-<br>Model # M-1500; Integra Mayfield Skull Clamp-<br>Model # A-1059; Integra Mayfield Skull Clamp-<br>Model # A-2000.)<br>Apply maximum force allowed by skull clamp for<br>specified time period. Inspect deformation of<br>skull pins. | Skull pins are safe to use in all 3 skull<br>clamps |
| Skull Pin testing | To test the radial loading skull pin subjected in<br>the 3 skull clamps recommended in the labelling<br>(V. Mueller Spetzler Skull Clamp-Model # M-<br>1500; Integra Mayfield Skull Clamp-Model # A-<br>1059; Integra Mayfield Skull Clamp-Model # A-<br>2000.)<br>Max Load test: Apply axial load, radial load for<br>specified time period. Inspect deformation of<br>skull pins.<br>Creep test: Apply axial load, radial load for<br>specified time frame, Inspect deformation of skill<br>pins | The pins for both the max load and<br>creep tests held the load for the required<br>amount of time without slipping or<br>material failure. |
| Cytotoxicity<br>study using the<br>ISO Elution<br>method | Evaluate cytotoxic effects using in vitro<br>mammalian cell culture. Study was conducted<br>following the ISO 10993-5 (2009) standard. | Skull pin extract showed no evidence of<br>causing cell lysis or toxicity |
| Sensitization:<br>ISO Guinea Pig<br>maximization<br>Sensitization<br>Test | Evaluate the potential to cause delayed dermal<br>contact sensitization in a guinea pig<br>maximization test. Study was conducted<br>following the ISO 10993-10 (2010) standard. | Skull pin extract showed no evidence of<br>causing delayed dermal contact<br>sensitization in the guinea pig. Skull pin<br>was not considered a sensitizer in this<br>test. |
| Irritation:<br>ISO<br>intracutaneous<br>Study in Rabbits | Evaluate the potential to cause irritation in<br>rabbits. Study was conducted following the ISO<br>10993-10 (2010) standard. | Test article met requirements of the test. |
| ISO Systemic<br>Toxicity in Mice | Evaluate skull pin's acute systemic toxicity in<br>mice. Study was conducted following the ISO<br>10993-11 (2006) standard. | No mortality or evidence of systemic<br>toxicity from the skull pin extracts<br>injected into mice. |

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Conclusion: The TZ Skull Pin is assembled, packaged and sterilized in a similar manner as the predicate devices. The bench testing performed and type of clamps used for the proposed device and predicate devices is also similar. The TZ Skull Pin is similar to the predicate devices in the intended use, indications for use and the technological characteristics.

Based on the information provided, the TZ Skull Pin is substantially equivalent to the predicate devices, Mayfield Adult Disposable Steel Skull Pins (K923789 and K932860), and does not raise new issues of safety and effectiveness.