(90 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the TZ Skull Pin Adult device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Skull Pin System Testing (using specified skull clamps) | The skull pins must perform safely and effectively in the specified skull clamps (V. Mueller Spetzler Skull Clamp-Model # M-1500; Integra Mayfield Skull Clamp-Model # A-1059; Integra Mayfield Skull Clamp-Model # A-2000) when subjected to the maximum force allowed by the skull clamp for a specified time period. No unacceptable deformation should occur. | Skull pins are safe to use in all 3 skull clamps. |
| Skull Pin Testing (Max Load Test) | The pins must hold the applied axial and radial loads for the required amount of time without slipping or material failure. | The pins held the load for the required amount of time without slipping or material failure. |
| Skull Pin Testing (Creep Test) | The pins must hold the applied axial and radial loads for the specified time frame without slipping or material failure. | The pins held the load for the required amount of time without slipping or material failure. |
| Cytotoxicity (ISO Elution method) | No evidence of causing cell lysis or toxicity. (Based on ISO 10993-5 (2009) standard). | Skull pin extract showed no evidence of causing cell lysis or toxicity. |
| Sensitization (ISO Guinea Pig maximization Sensitization Test) | No evidence of causing delayed dermal contact sensitization. (Based on ISO 10993-10 (2010) standard). | Skull pin extract showed no evidence of causing delayed dermal contact sensitization in the guinea pig. Skull pin was not considered a sensitizer in this test. |
| Irritation (ISO intracutaneous Study in Rabbits) | Meet the requirements of the test. (Based on ISO 10993-10 (2010) standard). | Test article met requirements of the test. |
| ISO Systemic Toxicity in Mice | No mortality or evidence of systemic toxicity. (Based on ISO 10993-11 (2006) standard). | No mortality or evidence of systemic toxicity from the skull pin extracts injected into mice. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample sizes (number of pins or animals) for each specific test in the "Summary of Performance Testing" section. It refers to testing being conducted but provides general results rather than specific numerical data for each test condition. The studies are laboratory-based and use animal models for biocompatibility tests (guinea pigs, rabbits, mice) and mechanical testing of the pins. Data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The tests performed are primarily mechanical and biological (biocompatibility) evaluations based on established international standards (ASTM and ISO), not human reader evaluations or clinical trials. The "ground truth" for these tests is defined by the specific parameters and outcomes outlined in the referenced standards (e.g., absence of cell lysis, holding a load without failure).
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies to establish a consensus ground truth. The tests described are objective, laboratory-based evaluations against predetermined criteria.
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
This information is not applicable. The TZ Skull Pin is a physical medical device (neurosurgical skull pin), not an AI algorithm or an imaging device to be read by human experts. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant to this device's submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. As explained above, this device is a physical skull pin, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance tests (Skull Pin System Testing, Max Load Test, Creep Test) is defined by the pass/fail criteria of established engineering standards, specifically ASTM F1831-97 (implicitly referenced for performance) and the general requirement that the device performs safely and effectively without material failure or slipping.
For the biocompatibility studies (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity), the ground truth is defined by the objective criteria and endpoints specified in the relevant international ISO standards (ISO 10993-5, ISO 10993-10, ISO 10993-11), such as the absence of cell lysis, dermal contact sensitization, irritation, or systemic toxicity.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this physical medical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submitter Name and Address: | TZ Medical, Inc.17750 SW Upper Boones Ferry Rd #150Portland, OR 97224Phone: 503-639-0282FAX: 503-639-0239 |
|---|---|
| Contact Person: | John LubisichManagement RepresentativeTEL: 503-639-0282FAX: 503-639-0239 |
| 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)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 skullclamp (such as the V. Mueller Spetzler Skull Clamp or the Integra Mayfield SkullClamp). Two skull pins are inserted in the rocker arm side of the clamp and asingle skull pin is inserted on the opposite side. | |
|---|---|
| Testing was conducted to evaluate the performance characteristics of the TZSkull Pin. | |
| Indications for Use: | The TZ Medical skull pin is placed in a clamp and is applied to the patient's skullto hold their head and neck securely in a particular position when rigid fixationis desired. The clamp is indicated for use in open and percutaneouscraniotomies 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.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 DisposableSkull Pins | Mayfield Adult DisposableSkull Pins | |
| (K923789) | (K932860) | ||
| Intended Use | The TZ Medical skull pin isplaced in a clamp and isapplied to the patient's skullto hold their head and necksecurely in a particularposition when rigid fixation isdesired. The clamp isindicated for use in open andpercutaneous craniotomiesas well as spinal surgerywhen rigid fixation isnecessary. | Used with head holders toclamp the patient's skull andhold the head and neck inposition during surgicalprocedures. | Used with head holders toclamp the patient's skull andhold the head and neck inposition during surgicalprocedures. The MAYFIELDDisposable Adult Skull Pinsare indicated for use with aMAYFIELD Skull clamp that isplaced on the patient's skullto hold their head and neckin a particular position duringsurgical procedures whenrigid skeletal fixation isdesired. |
| Indications forUse | Indicated for use in open andpercutaneous craniotomiesas well as spinal surgerywhen rigid fixation isnecessary. | Indicated for use in open andpercutaneous craniotomiesas well as spinal surgerywhen rigid fixation isnecessary. | Indicated for use in open andpercutaneous craniotomiesas well as spinal surgerywhen rigid fixation isnecessary. |
| Material | 316L Stainless Steel | The pin point is 17-4PHstainless steel and thepolymer base is ABS plastic. | The pin point is 17-4PHstainless steel and thepolymer base is ABS plastic. |
| Dimensions | |||
| Tip toShoulderDistance | 0.5 Inches | 0.5 Inches | 0.5 Inches |
| Width ofback | 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 thedimensions specified. O-Ringis placed on device whenmanufacturing and cleaningis completed. | The pin is machined to thedimensions specified. O-Ringis placed on device whenmanufacturing and cleaningis completed. | The pin is machined to thedimensions specified. O-Ringis placed on device whenmanufacturing and cleaningis completed. |
| Preparation forsurgery | None, the pins are suppliedsterile in a 3-pack pouchready for use | None, the pins are suppliedsterile in a 3-pack pouchready for use | None, the pins are suppliedsterile in a 3-pack pouchready for use |
| Proposed Medical Device | Predicate Device | Predicate Device | |
| TZ Skull Pin | Mayfield Adult DisposableSkull Pins | Mayfield Adult DisposableSkull Pins | |
| (K923789) | (K932860) | ||
| Method of Use | Typically, three pins areinstalled in receptacles of thehead holder | Typically, three pins areinstalled in receptacles of thehead holder | Typically, three pins areinstalled in receptacles of thehead holder |
| PerformanceTesting | 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 | |
| Clampcompatibility | V. Mueller Spetzler SkullClamp-Model # M-1500Integra Mayfield Skull Clamp-Model # A-1059Integra Mayfield Skull Clamp-Model # A-2000 | All generations of MAYFIELDbrand Skull Clamps (REF A-1013, A-1014, A-1059, A-1108, or A-2000), MAYFIELDbrand Radiolucent SkullClamps (REF A-1058 or A-2002), and the ImprovedGARDNER brand Skull Clamp(REF A-1035) when rigidskeletal fixation is requiredNot compatible with OriginalGARDNER brand Skull Clamp | All generations of MAYFIELDbrand Skull Clamps (REF A-1013, A-1014, A-1059, A-1108, or A-2000), MAYFIELDbrand Radiolucent SkullClamps (REF A-1058 or A-2002), and the ImprovedGARDNER brand Skull Clamp(REF A-1035) when rigidskeletal fixation is requiredNot compatible with OriginalGARDNER brand Skull Clamp |
| MRcompatibility | MR unsafe | MR unsafe | MR unsafe |
| Method ofSterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Use | Disposable; Single-PatientUse Only | Disposable; Single-PatientUse Only | Disposable; Single-PatientUse Only |
| Packaging | Medical grade packaging(sealed TYVEK/flexible filmpouches) | Medical grade packaging(sealed TYVEK/flexible filmpouches) | Medical grade packaging(sealed TYVEK/flexible filmpouches) |
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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 SystemTesting | To demonstrate skull pin perform safely andeffectively in the 3 skull clamps recommended inthe labelling (V. Mueller Spetzler Skull Clamp-Model # M-1500; Integra Mayfield Skull Clamp-Model # A-1059; Integra Mayfield Skull Clamp-Model # A-2000.)Apply maximum force allowed by skull clamp forspecified time period. Inspect deformation ofskull pins. | Skull pins are safe to use in all 3 skullclamps |
| Skull Pin testing | To test the radial loading skull pin subjected inthe 3 skull clamps recommended in the labelling(V. Mueller Spetzler Skull Clamp-Model # M-1500; Integra Mayfield Skull Clamp-Model # A-1059; Integra Mayfield Skull Clamp-Model # A-2000.)Max Load test: Apply axial load, radial load forspecified time period. Inspect deformation ofskull pins.Creep test: Apply axial load, radial load forspecified time frame, Inspect deformation of skillpins | The pins for both the max load andcreep tests held the load for the requiredamount of time without slipping ormaterial failure. |
| Cytotoxicitystudy using theISO Elutionmethod | Evaluate cytotoxic effects using in vitromammalian cell culture. Study was conductedfollowing the ISO 10993-5 (2009) standard. | Skull pin extract showed no evidence ofcausing cell lysis or toxicity |
| Sensitization:ISO Guinea PigmaximizationSensitizationTest | Evaluate the potential to cause delayed dermalcontact sensitization in a guinea pigmaximization test. Study was conductedfollowing the ISO 10993-10 (2010) standard. | Skull pin extract showed no evidence ofcausing delayed dermal contactsensitization in the guinea pig. Skull pinwas not considered a sensitizer in thistest. |
| Irritation:ISOintracutaneousStudy in Rabbits | Evaluate the potential to cause irritation inrabbits. Study was conducted following the ISO10993-10 (2010) standard. | Test article met requirements of the test. |
| ISO SystemicToxicity in Mice | Evaluate skull pin's acute systemic toxicity inmice. Study was conducted following the ISO10993-11 (2006) standard. | No mortality or evidence of systemictoxicity from the skull pin extractsinjected 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.
§ 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).