(90 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical skull pin, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to immobilize the head during neurosurgical procedures, which is a supportive function, not a direct therapeutic intervention that treats or cures a disease or condition.
No
The device is described as a skull pin used to hold the head and neck securely in position during surgery for rigid fixation, indicating a therapeutic or intraoperative function, not a diagnostic one.
No
The device description explicitly states it is a "sterile cervical traction skull pin manufactured from implant grade 316L stainless steel alloy," indicating it is a physical hardware device, not software. The performance studies also focus on the mechanical properties and biocompatibility of the physical pin.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is used to physically hold a patient's head and neck during surgery. This is a direct interaction with the patient's body for surgical support, not for testing samples taken from the body.
- Device Description: The device is a sterile skull pin made of stainless steel, designed for physical immobilization.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The performance studies focus on the mechanical strength and biocompatibility of the pin, not on its ability to detect or measure substances in a sample.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This skull pin does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HBL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's skull, head and neck, cervical
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Skull Pin System Testing
- Test Method Summary: To demonstrate skull pin perform safely and effectively in the 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.) Apply maximum force allowed by skull clamp for specified time period. Inspect deformation of skull pins.
- Results: Skull pins are safe to use in all 3 skull clamps
Skull Pin testing
- Test Method Summary: To test the radial loading skull pin subjected in the 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 for specified time period. Inspect deformation of skull pins.
- Creep test: Apply axial load, radial load for specified time frame, Inspect deformation of skill pins.
- Results: The pins for both the max load and creep tests held the load for the required amount of time without slipping or material failure.
Cytotoxicity study using the ISO Elution method
- Test Method Summary: Evaluate cytotoxic effects using in vitro mammalian cell culture. Study was conducted following the ISO 10993-5 (2009) standard.
- Results: Skull pin extract showed no evidence of causing cell lysis or toxicity
Sensitization: ISO Guinea Pig maximization Sensitization Test
- Test Method Summary: Evaluate the potential to cause delayed dermal contact sensitization in a guinea pig maximization test. Study was conducted following the ISO 10993-10 (2010) standard.
- Results: 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
- Test Method Summary: Evaluate the potential to cause irritation in rabbits. Study was conducted following the ISO 10993-10 (2010) standard.
- Results: Test article met requirements of the test.
ISO Systemic Toxicity in Mice
- Test Method Summary: Evaluate skull pin's acute systemic toxicity in mice. Study was conducted following the ISO 10993-11 (2006) standard.
- Results: No mortality or evidence of systemic toxicity from the skull pin extracts injected into mice.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
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.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| Submitter Name and Address: | TZ Medical, Inc.
17750 SW Upper Boones Ferry Rd #150
Portland, OR 97224
Phone: 503-639-0282
FAX: 503-639-0239 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Lubisich
Management Representative
TEL: 503-639-0282
FAX: 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.
4
| | In preparation for surgery three skull pins are installed in a compatible skull
clamp (such as the V. Mueller Spetzler Skull Clamp or the Integra Mayfield Skull
Clamp). Two skull pins are inserted in the rocker arm side of the clamp and a
single skull pin is inserted on the opposite side. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Testing was conducted to evaluate the performance characteristics of the TZ
Skull Pin. |
| 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. |
| 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 Disposable | ||
| Skull Pins | Mayfield Adult Disposable | ||
| Skull Pins | |||
| (K923789) | (K932860) | ||
| Intended 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. | Used with head holders to | ||
| clamp the patient's skull and | |||
| hold the head and neck in | |||
| position during surgical | |||
| procedures. | Used with head holders to | ||
| clamp the patient's skull and | |||
| hold the head and neck in | |||
| position during surgical | |||
| procedures. The MAYFIELD | |||
| Disposable Adult Skull Pins | |||
| are indicated for use with a | |||
| MAYFIELD Skull clamp that is | |||
| placed on the patient's skull | |||
| to hold their head and neck | |||
| in a particular position during | |||
| surgical procedures when | |||
| rigid skeletal fixation is | |||
| desired. | |||
| Indications for | |||
| Use | Indicated for use in open and | ||
| percutaneous craniotomies | |||
| as well as spinal surgery | |||
| when rigid fixation is | |||
| necessary. | Indicated for use in open and | ||
| percutaneous craniotomies | |||
| as well as spinal surgery | |||
| when rigid fixation is | |||
| necessary. | Indicated for use in open and | ||
| percutaneous craniotomies | |||
| as well as spinal surgery | |||
| when rigid fixation is | |||
| necessary. | |||
| Material | 316L Stainless Steel | The pin point is 17-4PH | |
| stainless steel and the | |||
| polymer base is ABS plastic. | The pin point is 17-4PH | ||
| stainless steel and the | |||
| polymer base is ABS plastic. | |||
| Dimensions | |||
| Tip to | |||
| Shoulder | |||
| Distance | 0.5 Inches | 0.5 Inches | 0.5 Inches |
| Width of | |||
| 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 | ||
| dimensions specified. O-Ring | |||
| is placed on device when | |||
| manufacturing and cleaning | |||
| is completed. | The pin is machined to the | ||
| dimensions specified. O-Ring | |||
| is placed on device when | |||
| manufacturing and cleaning | |||
| is completed. | The pin is machined to the | ||
| dimensions specified. O-Ring | |||
| is placed on device when | |||
| manufacturing and cleaning | |||
| is completed. | |||
| Preparation for | |||
| surgery | None, the pins are supplied | ||
| sterile in a 3-pack pouch | |||
| ready for use | None, the pins are supplied | ||
| sterile in a 3-pack pouch | |||
| ready for use | None, the pins are supplied | ||
| sterile in a 3-pack pouch | |||
| ready for use | |||
| Proposed Medical Device | Predicate Device | Predicate Device | |
| TZ Skull Pin | Mayfield Adult Disposable | ||
| Skull Pins | Mayfield Adult Disposable | ||
| Skull Pins | |||
| (K923789) | (K932860) | ||
| Method of Use | Typically, three pins are | ||
| installed in receptacles of the | |||
| head holder | Typically, three pins are | ||
| installed in receptacles of the | |||
| head holder | Typically, three pins are | ||
| installed in receptacles of the | |||
| head holder | |||
| Performance | |||
| 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 | |||
| compatibility | V. Mueller Spetzler Skull | ||
| Clamp-Model # M-1500 | |||
| Integra Mayfield Skull Clamp- | |||
| Model # A-1059 | |||
| Integra Mayfield Skull Clamp- | |||
| Model # A-2000 | All generations of MAYFIELD | ||
| brand Skull Clamps (REF A- | |||
| 1013, A-1014, A-1059, A- | |||
| 1108, or A-2000), MAYFIELD | |||
| brand Radiolucent Skull | |||
| Clamps (REF A-1058 or A- | |||
| 2002), and the Improved | |||
| GARDNER brand Skull Clamp | |||
| (REF A-1035) when rigid | |||
| skeletal fixation is required | |||
| Not compatible with Original | |||
| GARDNER brand Skull Clamp | All generations of MAYFIELD | ||
| brand Skull Clamps (REF A- | |||
| 1013, A-1014, A-1059, A- | |||
| 1108, or A-2000), MAYFIELD | |||
| brand Radiolucent Skull | |||
| Clamps (REF A-1058 or A- | |||
| 2002), and the Improved | |||
| GARDNER brand Skull Clamp | |||
| (REF A-1035) when rigid | |||
| skeletal fixation is required | |||
| Not compatible with Original | |||
| GARDNER brand Skull Clamp | |||
| MR | |||
| compatibility | MR unsafe | MR unsafe | MR unsafe |
| Method of | |||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Use | Disposable; Single-Patient | ||
| Use Only | Disposable; Single-Patient | ||
| Use Only | Disposable; Single-Patient | ||
| Use Only | |||
| Packaging | Medical grade packaging | ||
| (sealed TYVEK/flexible film | |||
| pouches) | Medical grade packaging | ||
| (sealed TYVEK/flexible film | |||
| pouches) | Medical grade packaging | ||
| (sealed TYVEK/flexible film | |||
| pouches) |
5
6
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.
7
Summary of Performance Testing:
| Test | Test Method Summary | Results |
|---|---|---|
| Skull Pin System | ||
| Testing | To demonstrate skull pin perform safely and | |
| effectively in the 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.) | ||
| Apply maximum force allowed by skull clamp for | ||
| specified time period. Inspect deformation of | ||
| skull pins. | Skull pins are safe to use in all 3 skull | |
| clamps | ||
| Skull Pin testing | To test the radial loading skull pin subjected in | |
| the 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 for | ||
| specified time period. Inspect deformation of | ||
| skull pins. | ||
| Creep test: Apply axial load, radial load for | ||
| specified time frame, Inspect deformation of skill | ||
| pins | The pins for both the max load and | |
| creep tests held the load for the required | ||
| amount of time without slipping or | ||
| material failure. | ||
| Cytotoxicity | ||
| study using the | ||
| ISO Elution | ||
| method | Evaluate cytotoxic effects using in vitro | |
| mammalian cell culture. Study was conducted | ||
| following the ISO 10993-5 (2009) standard. | Skull pin extract showed no evidence of | |
| causing cell lysis or toxicity | ||
| Sensitization: | ||
| ISO Guinea Pig | ||
| maximization | ||
| Sensitization | ||
| Test | Evaluate the potential to cause delayed dermal | |
| contact sensitization in a guinea pig | ||
| maximization test. Study was conducted | ||
| following the 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 | Evaluate the potential to cause irritation in | |
| rabbits. Study was conducted following the ISO | ||
| 10993-10 (2010) standard. | Test article met requirements of the test. | |
| ISO Systemic | ||
| Toxicity in Mice | Evaluate skull pin's acute systemic toxicity in | |
| mice. Study was conducted following the ISO | ||
| 10993-11 (2006) standard. | No mortality or evidence of systemic | |
| toxicity from the skull pin extracts | ||
| injected into mice. |
8
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.