(253 days)
Not Found
No
The summary describes a calcium phosphate cement for bone repair and augmentation. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description, intended use, or performance studies. The studies focus on material properties, biocompatibility, and in-vivo performance.
Yes
This device is a calcium phosphate cement intended to repair cranial defects and augment or restore bony contour in the craniofacial skeleton, which directly treats a physiological condition (bone defects) and restores structure/function.
No
Explanation: The device is a bone cement intended for repair and augmentation of cranial defects. Its purpose is to physically mend or add to existing bone structure, not to diagnose a condition or disease.
No
The device description clearly states it is a "sterile dual paste system, provided pre-filled in a double barrel delivery syringe system, which is calcium phosphate based." This describes a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to repair bone defects in the craniofacial skeleton. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a self-setting cement that is injected into the body to harden and form bone-like material. This is a therapeutic device used for structural repair.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information about a patient's health.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. DirectInject is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
DirectInject is a self-setting, calcium phosphate cement intended to repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects not intrinsic to the stability of the bony structure. It is also intended for augmentation or restoration of bony contour in the craniofacial skeleton to include the cranial and zygomatic bones. DirectInject is intended to repair cranial defects with a surface area of 4 cm2 or less.
DirectInject is indicated for patients in whom skeletal growth is complete. It can be used in patients with surgically created bone defects.
Product codes
GXP
Device Description
Stryker DirectInject consists of a sterile dual paste system, provided pre-filled in a double barrel delivery syringe system, which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is injectable, moldable and biocompatible. The injected cement paste will harden under normal body conditions to form hydroxyapatite, which is the principle mineral constituent of bone. The contents are supplied sterile for single patient use in sizes of 3 cc, 5 cc, and 10 cc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurosurgical burr holes, contiguous craniotomy cuts, other cranial defects, craniofacial skeleton, cranial and zygomatic bones.
Indicated Patient Age Range
patients in whom skeletal growth is complete.
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)
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing:
The biocompatibility evaluation for the Stryker DirectInject 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,
- ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and . Testing Within a Risk Management Process," as recognized by FDA.
- FDA draft guidance "Use of International Standard ISO- 10993, "Biological . Evaluation of Medical Devices Part 1: Evaluation and Testing", issued April 23, 2013
Tests performed: Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Genotoxicity (Bacterial reverse mutation, Mouse lymphoma Assay, Mouse peripheral blood micronucleus study), Haemocompatibility, Sub-Chronic Toxicity, Chronic toxicity, Neurotoxicity (8 weeks).
Performance Bench Testing:
Completed per the requirements of 'Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA'.
Tests performed:
Chemical Characterization: X-ray diffraction, Fourier Transform Infrared Spectroscopy, X-ray Fluorescence.
Physical Properties: Porosity.
Performance: pH testing, Setting time, Dimensional stability, Setting reaction temperature, Injectability force, Compressive Strength, Max supported defect strength, Shelf life Assessment.
In-Vivo Testing:
The in-vivo local effects of Stryker DirectInject were evaluated in a sheep and rabbit model, by macroscopic and histological evaluation of the tissue in the treatment areas. These studies demonstrated that Stryker DirectInject is stable, osteoconductive, and integrates with the bone tissue surrounding the defect site.
Clinical Testing:
Clinical testing was not required as a basis for substantial equivalence.
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
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2015
Stryker Craniomaxillofacial Mr. Nathan Van Sweden Senior Manager, Regulatory Affairs 750 Trade Centre Wav. Suite 200 Portage, Michigan 49002
Re: K143661 Trade/Device Name: DirectInject® Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: July 31, 2015 Received: August 3, 2015
Dear Mr. Van Sweden,
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,
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) K143661
Device Name DirectInject
Indications for Use (Describe)
DirectInject is a self-setting, calcium phosphate cement intended to repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects not intrinsic to the stability of the bony structure. It is also intended for augmentation or restoration of bony contour in the craniofacial skeleton to include the cranial and zygomatic bones. DirectIniect is intended to repair cranial defects with a surface area of 4 cm2 or less.
DirectInject is indicated for patients in whom skeletal growth is complete. It can be used in patients with surgically created bone defects.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 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
510(k) Summary
This section provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
- I. SUBMITTER
| 510(k) Owner: | Stryker Leibinger GmbH& Co. KG
Boetzinger Strasse 41
D-79111 Freiburg, Germany |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/ Contact
Person: | Nathan Van Sweden
Stryker Craniomaxillofacial
750 Trade Centre Way
Portage, MI 49002
Phone: 269-389-3419
Fax: 877-648-7114 |
| Date prepared: | August 31, 2015 |
| II. DEVICE | |
| Trade Name: | DirectInject® |
| Common or Usual
name: | Methyl methacrylate for cranioplasty |
| Classification
name: | Methyl methacrylate for cranioplasty (882.5300) |
| Regulatory Class: | Class II |
| Product Code: | GXP |
III. PREDICATE DEVICE
Primary Predicate: Stryker Injectable Cement – K060763 This predicate has not been subject to a design-related recall.
Secondary Predicate: BoneSource HAC - K021440 This predicate has not been subject to a design-related recall.
4
DEVICE DESCRIPTION IV.
Stryker DirectInject consists of a sterile dual paste system, provided pre-filled in a double barrel delivery syringe system, which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is injectable, moldable and biocompatible. The injected cement paste will harden under normal body conditions to form hydroxyapatite, which is the principle mineral constituent of bone. The contents are supplied sterile for single patient use in sizes of 3 cc, 5 cc, and 10 cc.
V. INTENDED USE/INDICATIONS FOR USE
DirectInject is a self-setting, calcium phosphate cement intended to repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects not intrinsic to the stability of the bony structure. It is also intended for augmentation or restoration of bony contour in the craniofacial skeleton to include the cranial and zygomatic bones. DirectInject is intended to repair cranial defects with a surface area of 4 cm2 or less.
DirectInject is indicated for patients in whom skeletal growth is complete. It can be used in patients with surgically created bone defects.
| | Subject Device | Primary Predicate –
K060763 | Secondary Predicate
– K021440 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | DirectInject is a self-
setting, calcium
phosphate cement
intended to repair
neurosurgical burr
holes, contiguous
craniotomy cuts and
other cranial defects
not intrinsic to the
stability of the bony
structure. It is also
intended for
augmentation or
restoration of bony
contour in the | Stryker® Injectable
Cement is a self-setting
calcium phosphate
cement indicated to fill
bony voids or gaps of
the skeletal system (i.e.
extremities,
craniofacial, spine, and
pelvic).
These defects may be
surgically created or
osseous defects created
from traumatic injury to
the bone. The Stryker
Injectable Cement is
indicated only for bony
voids or gaps that are | BoneSource® is a self-
setting, calcium
phosphate cement
intended for use in the
repair of neurosurgical
burr holes, contiguous
craniotomy cuts and
other cranial defects
as well as in the
augmentation or
restoration of bony
contour in the
craniofacial skeleton |
TABLE 5-1: COMPARISON OF INDICATIONS FOR USE
Traditional 510(k)
Stryker DirectInject
5
stryker®
| craniofacial skeleton to
include the cranial and
zygomatic bones.
DirectInject is
intended to repair
cranial defects with a
surface area of 4 cm² or
less.
DirectInject is
indicated for patients
in whom skeletal
growth is complete. It
can be used in patients
with surgically created
bone defects. | not intrinsic to the
stability of the bony
structure.
Stryker® Injectable
Cement cured in situ
provides an open
void/gap filler that can
augment provisional
hardware (e.g., K-
Wires, plates, screws)
to help support bone
fragments during the
surgical procedure. The
cured cement acts only
as a temporary support
media and is not
intended to provide
structural support
during the healing
process.
Stryker® Injectable
Cement is a self-setting,
calcium phosphate
cement intended for use
in the repair of
neurosurgical burr
holes, contiguous
craniotomy cuts and
other cranial defects as
well as in the
augmentation or
restoration of bony
contour in the
craniofacial
skeleton. |
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
The Indications for Use statement for the Subject device is not identical to the Primary predicate device Stryker Injectable Cement; the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both devices have intended use. The Primary
6
predicate is indicated for a wider anatomical range of the skeletal system (i.e. extremities, craniofacial, spine, and pelvic). The Indications for use of the Stryker DirectInject falls within the scope of the broader Indications for Use statement of the Primary predicate device.
The Indications for Use statement for the Subject device is not identical to the Secondary predicate device Bonesource HAC; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both devices have the same intended use.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The Stryker DirectInject is compared to its predicate devices for substantial equivalence based on the following criteria:
- A. Principle of Operation
- B. Technological Characteristics
A. Principle of Operation
The operating principle of the Stryker DirectIniect is to repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. It is also intended for the augmentation or restoration of bony contour in the craniofacial skeleton. The Subject device and Predicate devices have the same principle of operation.
B. Technological and Operational Characteristics
At a high level, the Subject device and Predicate devices are based on the following technological elements:
- Same operating principle: repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects.
- -Same area of application: Craniofacial (Cranial and Zygomatic Bones)
- Same duration of implantation: implant is osteointegrated via normal bone physiological conditions.
- -Similar control mechanism: The Subject device uses a dual syringe with pastes and a Mixer-Cannula, while the predicate devices use powder and liquid bases, a mixing apparatus and syringe (primary predicate).
- -Similar material formulation: Both the Primary and Secondary predicates and the Subject device form Hydroxyapatite cement, however, due to the paste form of the Subject device, a proprietary material formulation is used.
7
VII. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Stryker DirectInject 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,
- ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and . Testing Within a Risk Management Process," as recognized by FDA.
- FDA draft guidance "Use of International Standard ISO- 10993, "Biological . Evaluation of Medical Devices Part 1: Evaluation and Testing", issued April 23, 2013
Stryker DirectInject is considered a permanent implant, tissue/bone contacting greater than 30 days. The implant is Hydroxyapatite cement, the same as the Predicate devices.
| Test | Standard |
|---|---|
| Cytotoxicity | ISO-10993-5 |
| Irritation | ISO-10993-10 & ISO-10993-2 |
| Sensitization | ISO-10993-10 & ISO-10993-2 |
| Acute systemic toxicity | ISO-10993-11 & ISO-10993-2 |
| Genotoxicity: Bacterial reverse mutation | ISO-10993-3 |
| Genotoxicity: Mouse lymphoma Assay | ISO-10993-3 |
| Genotoxicity: Mouse peripheral blood micronucleus | |
| study | ISO-10993-3 & ISO-10993-2 |
8
Image /page/8/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and the letters are closely spaced together. There is a registered trademark symbol to the right of the letter "r". The overall impression is one of a strong, modern brand.
| Haemocompatibility | ISO-10993-4 & ASTM F756 |
|---|---|
| Sub-Chronic Toxicity | ISO-10993-11 & ISO-10993-2 |
| Chronic toxicity | ISO-10993-11 & ISO-10993-2 |
| Neurotoxicity (8 weeks) | ISO-10993-6 & ISO-10993-2 |
Performance Bench Testing
The following performance bench tests were completed per the requirements of 'Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA '.
| Characteristic | Test | Standard |
|---|---|---|
| Chemical Characterization | X-ray diffraction | International Centre for |
| Diffraction Data (ICDD) | ||
| Fourier Transform Infrared | ||
| Spectroscopy | N/A | |
| X-ray Fluorescence | N/A | |
| Physical Properties | Porosity | ASTM D4404-10, ASTM |
| D4284-12 | ||
| Performance | pH testing | USP |
| Setting time | N/A | |
| Dimensional stability | N/A | |
| Setting reaction temperature | N/A | |
| Injectability force | N/A |
TABLE 5-3 PERFORMANCE TESTING FOR STRYKER DIRECTINJECT
In addition to the test methods identified above, the following tests were performed to address risk identified or design requirements.
| Characteristic | Test | Standard |
|---|---|---|
| Performance | Compressive Strength | N/A |
| Performance | Max supported defect strength | N/A |
| Performance | Shelf life Assessment | ICH Q1A(R2) |
| TABLE 5-4 PERFORMANCE TESTING FOR STRYKER DIRECTINJECT | |
|---|---|
9
In-Vivo Testing
The following local effects in-vivo tests were performed as per the requirements of ISO-10993-2 and ISO-10993-6. The in-vivo local effects of Stryker DirectInject were evaluated in a sheep and rabbit model, by macroscopic and histological evaluation of the tissue in the treatment areas. These studies demonstrated that Stryker DirectInject is stable, osteoconductive, and integrates with the bone tissue surrounding the defect site.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence.
VIII. CONCLUSIONS
The results of the non-clinical data demonstrate the Stryker DirectInject will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.