(141 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the cranial plates and screws, with no mention of AI or ML technology.
No.
The device is used for reconstruction, stabilization, and rigid fixation of non-loadbearing areas after procedures or fractures, which are structural interventions rather than therapeutic treatments that address or cure a disease or condition.
No
The device is described as an implantable system (plates and screws) for reconstruction, stabilization, and rigid fixation of the cranial skeleton after trauma or surgery. It is a treatment device, not a diagnostic one.
No
The device description explicitly details physical components made of titanium alloy, including plates, screws, mesh, and instrumentation, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "selective trauma of cranial skeleton, cranial surgery and reconstructive procedures." This involves direct surgical intervention on the patient's body.
- Device Description: The description details bone plates, screws, mesh, and instrumentation used for "reconstruction, stabilization and/or rigid fixation of non loadbearing areas subsequent to craniotomy, craniectomy and cranial fractures." These are all physical implants and tools used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens.
The Innovasis Cranial System is a surgical implant system used in vivo (within the living body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Innovasis Cranial System is intended for use in selective trauma of cranial surgery and reconstructive procedures.
Product codes
GWO, GXR, HBW
Device Description
The Innovasis Cranial System Bone Plates are comprised of a variety of shapes and sizes intended for reconstruction, stabilization and/or rigid fixation of non loadbearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). The single use devices are a variety of low profile plates and anchoring screws that fixate bone pieces together in the cranial area of the patient. The design features include:
- Commercially Pure Titanium or 6 Al 4V Titanium Alloy
- Straight and Square plates
- Double Y plates
- Burr hole plates
- Plates with Shunts
- Self-Drilling/Self-Tapping Screws
- Mesh
- Instrumentation to customize size, shape and placement of implants
- Compact sterilization tray to optimize organization of implants
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial area
Indicated Patient Age Range
adults and adolescents (age 12 and higher)
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)
(Non-clinical)—Performance testing per ASTM F543-13, F582-99 for 3 point bend (or 4 point bend), axial compression, foam axial pullout, and torque to failure and F2129-08 for corrosion support the safety of the subject devices and demonstrate that the Innovasis Cranial System devices should perform as intended in the specified use conditions.
Torsion Properties: The torsional testing of the bone screws was performed by hand as these were very small screw samples. Both subject and predicate sample groups were tested identically so comparisons could be made accurately.
Results: The mean torsional strength for the subject screws exceeded the strength of the predicate screws thereby demonstrating substantial equivalence.
Static Axial Pullout: ASTM F543-13
Results: The mean pullout force for the subject screws exceeded the pullout force of the predicate screws thereby demonstrating substantial equivalence.
Static Axial Compression: A domed superior test load applied to center of specimen to measure Stiffness, Peak Force, and Displacement at Peak Force.
Results: The mean bending stiffness, Peak Force and Displacement at deformation of the Rev. 3 subject plate exceeded the bending stiffness, Peak Force and Displacement at deformation of the predicate plate demonstrating substantial equivalence.
Static 3 Point Bend: ASTM F382-99 (08) Three-point bend instead of four-point bend testing was performed on the predicate and subject double "Y" samples due to their shortened length. Comparisons between the two groups could still be made to determine equivalence.
Results: The mean bending stiffness of the subject plates met or exceeded the bending stiffness of the predicate plate demonstrating substantial equivalence.
Static 4 Point Bend: ASTM F382-99 (08)
Results: The mean bending stiffness of the subject plates met or exceeded the bending stiffness of the predicate plate demonstrating substantial equivalence.
Corrosion: ASTM F2129-08
Results: The data show the corrosion resistance of the subject plates met or exceeded the corrosion resistance of the predicate plate thereby passing the requirement in the protocol and demonstrating substantial equivalence.
Biocompatibility: A biocompatibility evaluation for the ICS implants was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Results: The implants are composed of known biocompatible material [ASTM F67 Commercially Pure Titanium (plates and mesh) and ASTM F136 6Al4V Titanium for Surgical Implants (Screws)]. Testing was conducted to ensure manufacturing process did not add contamination. Test battery included Pyrogen Testing (LAL) and Cytotoxicity testing (MEM) All test results were below cutoff (pass).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three faces in profile, one behind the other. The figures are connected by a flowing ribbon-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2014
Innovasis, Inc. Marshall McCarty Director QA/RA 614 E. 3900 South Salt Lake City, Utah 84107
K141644 Trade/Device Name: Innovasis Cranial System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: October 8, 2014 Received: October 9, 2014
Dear Mr. McCarty,
Re:
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
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 yours,
Carlos L. Pena -5)/△
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) K141644
Device Name Innovasis Cranial System
Indications for Use (Describe)
The Innovasis Cranial System is intended for use in selective trauma of cranial surgery and reconstructive procedures.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for Innovasis. The logo is in black and features the word "INNOVASIS" in a bold, sans-serif font. Below the main logo, there is a tagline that reads "INNOVATE / INVOLVE / INVENT" in a smaller font. The logo appears to be for a company that focuses on innovation and invention.
510(k) Summary
- l. Submitter: Innovasis, Inc. 614 E. 3900 South Salt Lake Citv. UT 84107
- Contact: Marshall C. McCarty Phone: (801) 261-2236 Fax: (801) 261-3758 mmccarty@innovasis.com
Date Prepared: November 7, 2014
II. Device
| Name of Device: | Innovasis® Cranial System |
|---|---|
| Common or Usual Name: | Bone Plate, Bone Screw for Cranial Fixation |
- Classification: Regulation No.: 21 CFR 882.5320 Class 2, Product Code: GWO Regulation No.: 21 CFR 882.5360 Class 2, Product Code: HBW Regulation No.: 21 CFR 882.5250 Class 2, Product Code: GXR
III. Predicate Device
Jeil Medical Products LeForté Neuro System Bone Plate K112812 This predicate has not been subject to a design-related recall.
IV. Device Description:
The Innovasis« Cranial System Bone Plates are comprised of a variety of shapes and sizes intended for reconstruction, stabilization and/or rigid fixation of non loadbearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). The single use devices are a variety of low profile plates and anchoring screws that fixate bone pieces together in the cranial area of the patient. The design features include:
- · Commercially Pure Titanium or 6 Al 4V Titanium Alloy
- · Straight and Square plates
- · Double Y plates
- Burr hole plates
- · Plates with Shunts
- · Self-Drilling/Self-Tapping Screws
- Mesh
- · Instrumentation to customize size, shape and placement of implants
- · Compact sterilization tray to optimize organization of implants
4
Image /page/4/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in bold, sans-serif font. The "A" in "INNOVASIS" is stylized to look like a triangle with a line extending from the top right corner. Below the main logo, in a smaller font, are the words "INNOVATE / INVOLVE / INVENT".
V. Indications for Use
The Innovasis® Cranial System is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
VI. Comparison of Technological Characteristics with the Predicate Device
| Innovasis® ICS | Jeil LeForté Neuro System | |
|---|---|---|
| Indications | The Innovasis® Cranial System is intended for use | |
| in selective trauma of cranial skeleton, cranial | ||
| surgery and reconstructive procedures. | The Leforté Neuro System is intended for use in | |
| selective trauma of cranial skeleton, cranial surgery | ||
| and reconstructive procedures. | ||
| Material | ASTM F67 Commercially Pure Grade 2 Titanium | |
| (plates), Grade 3 Titanium (mesh) and ASTM F136 | ||
| 6AI4V Titanium for Surgical Implants (Screws) | ASTM F67 Commercially Pure Grade 2 Titanium | |
| (plates), Grade 3 Titanium (mesh) and ASTM F136 | ||
| 6AI4V Titanium for Surgical Implants (Screws) | ||
| Additional plates offered in ASTM F67 Grade 1 and 3 | ||
| Features | Straight and Square plates | |
| Double Y plates | ||
| Burr hole plates | ||
| Plates with Shunts | ||
| Self-Drilling/Self-Tapping Screws | ||
| Mesh | ||
| Instrumentation to customize size, shape and | ||
| placement of implants | Straight and Square plates | |
| Double Y plates | ||
| Burr hole plates | ||
| Plates with Shunts | ||
| Self-Drilling/Self-Tapping Screws | ||
| Mesh | ||
| Gap, Curved, X-shape, Y, Quad and Calvarium plates | ||
| Instrumentation to customize size, shape and | ||
| placement of implants | ||
| Dimensions | Plates Straight, Double Y and Square, 2, 4, 6 and | |
| 12 holes; Burr hole plates 6 holes 15mm diameter, | ||
| 5 holes 15mm, 6 holes 22mm and 5 holes 22mm. | ||
| All plates and mesh are 0.648 +/-0.025mm | ||
| Mesh 98mm x 98mm | ||
| Screws: 1.6 x 3mm, 1.6 x 4mm, 1.6 x 5mm, 1.9 x | ||
| 4mm | Plates Straight, Double Y and Square, 2, 4, 6 and 12 | |
| holes; Burr hole plates 6 holes 15mm diameter, 5 | ||
| holes 15mm, 6 holes 22mm and 5 holes 22mm. | ||
| Mesh 98mm x 98mm | ||
| Above plates and mesh are 0.62mm | ||
| Additional plates and mesh offered in thickness 0.3 to | ||
| 0.5mm, including Gap Plates (3 sizes) | ||
| Curved, X-shape, Quad and Calvarium plates are | ||
| offered in other Jeil LeForté configurations | ||
| Screws: 1.6 x 3mm, 1.6 x 4mm, 1.6 x 5mm, 1.9 x | ||
| 4mm | ||
| 2.2 x 5mm and 1.4 x 1.9mm screws are offered in | ||
| other Jeil LeForté configurations. | ||
| Surface | Plate: Electropolish | Plate: Anodized |
| Treatment | Screw: N/A | Screw: N/A |
| Sterilization | Sold Non-Sterile to be | |
| Steam Sterilized | Sold Non-Sterile to be | |
| Steam Sterilized |
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Image /page/5/Picture/0 description: The image shows the logo for Innovasis. The logo is in black and features the company name in bold, sans-serif font. Below the company name is the tagline "Innovate / Involve / Invent" in a smaller font size.
VII. Performance Data
(Non-clinical)—Performance testing per ASTM F543-13, F582-99 for 3 point bend (or 4 point bend), axial compression, foam axial pullout, and torque to failure and F2129-08 for corrosion support the safety of the subject devices and demonstrate that the Innovasis Cranial System devices should perform as intended in the specified use conditions.
| Test | Test Method Summary | Results |
|---|---|---|
| Torsion | ||
| Properties | ASTM F543-13 The torsional testing of the bone screws | |
| was performed by hand as these were very small screw | ||
| samples. Both subject and predicate sample groups | ||
| were tested identically so comparisons could be made | ||
| accurately. | The mean torsional strength for the subject screws | |
| exceeded the strength of the predicate screws | ||
| thereby demonstrating substantial equivalence. | ||
| Static Axial | ||
| Pullout | ASTM F543-13 | The mean pullout force for the subject screws |
| exceeded the pullout force of the predicate screws | ||
| thereby demonstrating substantial equivalence. | ||
| Static Axial | ||
| Compression | A domed superior test load applied to center of | |
| specimen to measure Stiffness, Peak Force, and | ||
| Displacement at Peak Force. | The mean bending stiffness, Peak Force and | |
| Displacement at deformation of the Rev. 3 subject | ||
| plate exceeded the bending stiffness, Peak Force | ||
| and Displacement at deformation of the predicate | ||
| plate demonstrating substantial equivalence. | ||
| Static 3 Point | ||
| Bend | ASTM F382-99 (08) Three-point bend instead of four- | |
| point bend testing was performed on the predicate and | ||
| subject double "Y" samples due to their shortened | ||
| length. Comparisons between the two groups could still | ||
| be made to determine equivalence. | The mean bending stiffness of the subject plates met | |
| or exceeded the bending stiffness of the predicate | ||
| plate demonstrating substantial equivalence. | ||
| Static 4 Point | ||
| Bend | ASTM F382-99 (08) | The mean bending stiffness of the subject plates met |
| or exceeded the bending stiffness of the predicate | ||
| plate demonstrating substantial equivalence. | ||
| Corrosion | ASTM F2129-08 | The data show the corrosion resistance of the |
| subject plates met or exceeded the corrosion | ||
| resistance of the predicate plate thereby passing the | ||
| requirement in the protocol and demonstrating | ||
| substantial equivalence. | ||
| Biocompatibility | A biocompatibility evaluation for the ICS implants was | |
| conducted in accordance with the FDA Blue Book | ||
| Memorandum #G95-1 "Use of International Standard | ||
| ISO-10993, 'Biological Evaluation of Medical Devices | ||
| Part 1: Evaluation and Testing," May 1, 1995, and | ||
| International Standard ISO 10993-1 "Biological | ||
| Evaluation of Medical Devices -Part 1: Evaluation and | ||
| Testing Within a Risk Management Process," as | ||
| recognized by FDA. | The implants are composed of known biocompatible | |
| material [ASTM F67 Commercially Pure Titanium | ||
| (plates and mesh) and ASTM F136 6Al4V Titanium | ||
| for Surgical Implants (Screws)]. Testing was | ||
| conducted to ensure manufacturing process did not | ||
| add contamination. Test battery included Pyrogen | ||
| Testing (LAL) and Cytotoxicity testing (MEM) All test | ||
| results were below cutoff (pass). |
6
Image /page/6/Picture/0 description: The image shows the word "INNOVASIS" in bold, black letters. The "A" in the word is stylized with a line going through it. Below the word "INNOVASIS" are the words "INNOVATE / INVOLVE / INVENT" in a smaller font size.
VIII. Conclusions
The Innovasis Cranial System has been subjected to risk analysis, engineering analysis and testing to recognized standards. The predicate device, K112812 LeForte Neuro System was cleared based on the results of non-clinical data. In consideration of the following evaluated parameters subject and predicate device performance data were compared to support the safety of the subject devices:
- · Design configurations
- · Applied mechanical loads
- · Product sizes and shapes
- · Materials used
- · Biocompatibility requirements
- · Manufacturing and processing methods
- Shelf life
The evaluations demonstrate that the Innovasis Cranial System devices should perform as intended in the specified use conditions.