(262 days)
No
The summary describes a mechanical bone distraction system and does not mention any AI or ML components or capabilities.
No
The device is described as a "bone stabilizer and lengthening (and/or transport) device" for correcting "congenital deficiencies or post-traumatic defects of the cranium," which directly indicates a structural and functional role in the body, rather than a therapeutic (treatment) role.
No
The device is described as a bone stabilizer and lengthening/transport device for correcting congenital deficiencies or post-traumatic defects, which are therapeutic functions, not diagnostic.
No
The device description explicitly states that the device consists of physical components such as the distractor body, footplates, extension arms, and bone screws, indicating it is a hardware-based medical device.
Based on the provided information, the DePuy Synthes CMF Distraction System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is described as a "bone stabilizer and lengthening (and/or transport) device" for "correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required". This describes a surgical implant and procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "modular distractor system" consisting of "distractor body, footplates, extension arms, and bone screws". These are physical components used in surgery.
- No mention of in vitro testing: There is no mention of analyzing samples (blood, tissue, etc.) or performing any tests outside of the body.
- Performance Studies: The performance studies focus on the mechanical properties and biocompatibility of the device, as well as clinical literature discussing its surgical application. This is typical for a surgical implant, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The DePuy Synthes CMF Distraction System does not fit this description.
N/A
Intended Use / Indications for Use
The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.
Cranium
The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.
Product codes
PBJ
Device Description
DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, and infants. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs as detailed in the table below.
The distractor body is first secured to bone using footplates and screws, and then activation of the distractor is accomplished through the rotation of an advancement/lead screw with an activation instrument percutaneously.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium
Indicated Patient Age Range
Adults and pediatric patients.
The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.
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 data demonstrates that the technological differences of the CMFD System do not raise new questions of safety and efficacy with respect to the predicate devices, and therefore support substantial equivalence:
Test Name: Reversing Prevention
Test Method Summary: Anatomically simulated spinning and vibration of the subject distractor and the previous design of CMFD.
Results: The subject device does not reverse unintentionally under the same conditions where the previous design of CMFD reversed.
Test Name: Construct bending strength
Test Method Summary: Four-point bend test setup of a subject device construct in comparison to the predicate KLS Zurich Distraction System's Arnaud Distractor, and analysis comparing the subject design to the previous design of CMFD.
Results: The CMFD construct is stronger than the predicate KLS Arnaud distractor, and the design changes relative to the previous design in K060138 do not affect the strength of the distractor construct.
Test Name: Torque Input/Force Output and Construct Torsional Strength
Test Method Summary: This testing challenged the construct in torsion by applying an increasing torque (torque input) to the activation end of the device through an extension arm until failure of the device occurred.
Results: The device is capable of outputting the force required to distract bone in the cranium without failing.
Test Name: Extension arm interface tensile strength
Test Method Summary: This testing challenged the interface between the distractor and extension arm to ensure the interface can withstand a tensile force based on a human factors benchmark.
Results: The redesigned CMFD meets the same human factors benchmark as the previous design of CMFD.
Test Name: Biocompatibility
Test Method Summary: All subject devices with the exception of the modified distractor bodies utilize the same materials and manufacturing processes as the predicate devices cleared in K060138, and therefore biocompatibility testing was not provided. For the modified distractor bodies, a risk based assessment per ISO 10993-1 was conducted, and supporting biocompatibility testing was provided.
Results: The results of biocompatibility risk assessment and testing demonstrate that the material change to the distractor body does not raise new questions of safety or efficacy with respect to biocompatibility.
Test Name: Steam Sterilization Validation
Test Method Summary: The sterilization parameters were validated using the "overkill" method as referenced in Annex D of ANSI/AAMI/ISO 17665-1 in order to assure a Sterility Assurance Level (SAL) of 10-6.
Results: The devices may be effectively steam sterilized by the proposed parameters, which are the same parameters as the previous design of CMFD.
Test Name: Endotoxin Testing
Test Method Summary: Endotoxin levels for finished subject devices were quantified using a Kinetic Turbidimetric method.
Results: The subject devices meet the maximum endotoxin testing limit of 2.15 EU/device.
Clinical performance data: Clinical literature discussing the application of the previous design of CMFD (K060138) in the cranium is provided in this submission. A literature review was conducted and seven articles were identified discussing the use of the previous design of CMFD (K060138) in the cranium. The previous design of CMFD (K060138) was identified through narrative descriptions, x-rays, and/or images within the articles.
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
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
December 7, 2017
Synthes USA Products, LLC Nicholas Fountoulakis Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K170818
Trade/Device Name: Craniomaxillofacial Distraction System (CMFD) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Non-alterable Cranioplasty Plate Regulatory Class: Class II Product Code: PBJ Dated: November 8, 2017 Received: November 9, 2017
Dear Mr. Fountoulakis:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carlos L. Pena -S
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) K170818
Device Name
Craniomaxillofacial Distraction System (CMFD)
Indications for Use (Describe)
The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.
Cranium
The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, and adults.
| 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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1. 510(k) Summary
Date Prepared: November 7, 2017
1.1.Submitter
Primary Contact: Nicholas Fountoulakis Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-6553 nfounto@its.jnj.com
Alternate Contact:
Susan Lewandowski Associate Director, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5852 slewand2@its.jnj.com
1.2.Device
Name of Device: Craniomaxillofacial Distraction System (CMFD) Common or Usual Name(s): Cranial Distraction System Classification Name(s): Preformed nonalterable cranioplasty plate Regulatory Class: Class II - 882.5330 Product Code: PBJ Review Panel: Neurology
1.3.Predicate Devices
Primary Predicate: Zurich Distraction System's Arnaud Distractor (K010139) Additional Predicate: Synthes Craniomaxillofacial Distraction System (K060138)
1.4.Indications for Use
The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.
Cranium
- . The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.
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1.5.Device Description
DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, and infants. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs as detailed in the table below.
| Distractor Body | Footplates | Extension Arms | Bone Screws | |
|---|---|---|---|---|
| Dimensions | 10, 15, 20, 25, | |||
| 30, 35, and 40 | ||||
| mm lengths | Cloverleaf and | |||
| mesh designs | ||||
| Accept 1.5, 2.0, | ||||
| and 2.4 mm | ||||
| diameter screws | Rigid lengths are | |||
| 20, 40, and 60 | ||||
| mm | ||||
| Flexible lengths | ||||
| are 30, 40, and | ||||
| 60 mm | 1.5, 2.0, and 2.4 | |||
| mm diameter | ||||
| 4 – 12 mm | ||||
| lengths | ||||
| Materials | TAN (ASTM F1295) L605 (ASTM F90) CoCrMo (ASTM F1537) MP35N (ASTM F562) | CP2 and CP4 Titanium (ASTM F67) | TAN (ASTM F1295) L605 (ASTM F90) MP35N (ASTM F562) Silicone (ASTM F2042) | CP Titanium (ASTM F67) TAN (ASTM F1295) |
The distractor body is first secured to bone using footplates and screws, and then activation of the distractor is accomplished through the rotation of an advancement/lead screw with an activation instrument percutaneously.
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1.6.Comparison to Predicate Devices
| System/Device Name | Synthes Craniomaxillofacial
Distraction System | KLS Zurich Distraction System's
Arnaud Distractor | Synthes Craniomaxillofacial
Distraction System (previous
design) |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The DePuy Synthes CMF
Distraction System is intended for
use as a bone stabilizer and
lengthening (and/or transport)
device.
The DePuy Synthes CMF
Distraction System is indicated for
correction of congenital
deficiencies or post-traumatic
defects of the cranium, where
gradual bone distraction is
required in adults and pediatric
patients. DePuy Synthes CMF
Distraction System is intended for
single use only.
Cranium
The 1.5 mm and 2.0 mm
mesh and cloverleaf
footplates and screws are
intended for infants,
children, adolescents, and
adults. | The Zurich Distraction System
includes devices intended as a
bone stabilizer and lengthening
(and/or transport) device when
correction of congenital
deficiencies or post traumatic
defects of the mandible (including
ramus, body, alveolar ridge, palate,
symphysis), midface, and cranial
bones require gradual distraction. | The Synthes Craniomaxillofacial
Distraction System (CMF
Distraction System) is intended for
use as a bone stabilizer and
lengthening (and/or transport)
device for correction of congenital
deficiencies or post-traumatic
defects of the mandibular body
and ramus where gradual bone
distraction is required.
The Synthes CMF Distraction
System is intended for single use
only. The Synthes Pediatric CMF
Distraction System is intended for
use as a bone stabilizer and
lengthening (and/or transport)
device for correction of congenital
deficiencies or post-traumatic
defects of the mandibular body
and ramus where gradual bone
distraction is required in children
under the age of 12 months. The
Synthes Pediatric CMF Distraction
System is intended for single use
only. |
| Contraindications | The Synthes CMF Distraction
System is contraindicated for | | Use of the Synthes CMF Distraction
System is contraindicated in |
| System/Device Name | Synthes Craniomaxillofacial
Distraction System | KLS Zurich Distraction System's
Arnaud Distractor | Synthes Craniomaxillofacial
Distraction System (previous
design) |
| | patients sensitized to nickel, cobalt
chromium, silicone or
molybdenum. | | patients previously sensitized to
nickel |
| Where Used | Hospital, home | Hospital, home | Hospital, home |
| System Features | Modular design includes body,
plates, and removable activation
arms | Pre-assembled distractor body and
plates with removable and non-
removable activation arm | Modular design includes body,
plates, and removable activation
arms |
| | Surgeon and Patient Facing
Instrumentation | Surgeon and Patient Facing
Instrumentation | Surgeon and Patient Facing
Instrumentation |
| Distractor Body
Specifications | End and center translating 10 - 40 mm lengths | End and center translating 20 mm and 30 mm lengths | End and center translating 10 - 40 mm lengths |
| | Accommodates left and right
placement Available with or without
universal joint Spring clip to prevent
inadvertent reversing | Accommodates left and right
placement Available with or without
universal joint (2.0 mm size) | Accommodates left and right
placement Available with or without
universal joint |
| Plate Specifications | Cloverleaf and mesh designs Symmetric design May be cut and bent Fixed with 1.5, and 2.0 mm | Mesh design Symmetric design May be cut and bent Fixed with 1.5, and 2.0 mm | Cloverleaf, mesh, and elevated
mesh designs Symmetric design May be cut and bent Fixed with 1.0, 1.3, 1.5, and 2.0 mm |
| System/Device Name | Synthes Craniomaxillofacial
Distraction System | KLS Zurich Distraction System's
Arnaud Distractor | Synthes Craniomaxillofacial
Distraction System (previous
design) |
| | Fixed with 2.0 and 2.4 mm Emergency Screws Fixed with 2.0 mm Locking Screws | Fixed with 1.8, and 2.3 mm Emergency Screws | Fixed with 1.2, 1.7, 2.0, 2.4 mm PlusDrive Emergency Screws Fixed with 2.0 mm Locking Screws |
| Extension Arm
Specifications | Point of activation moved away from distractor for patient access Rigid and flexible options May be removed without surgical procedure Rigid lengths are 20, 40, and 60 mm Flexible lengths are 30, 40, and 60 mm May be combined to increase length | Point of activation moved away from distractor for patient access Rigid and flexible options (2.0 mm size) May be removed without surgical procedure (2.0 mm size) Rigid lengths are 25, 33, 35, 43, 45, 50, and 53 mm Flexible lengths are 30, 33, 40, and 50 mm (2.0 mm size) May be combined to increase length (2.0 mm size) | Point of activation moved away from distractor for patient access Rigid and flexible options May be removed without surgical procedure Rigid lengths are 20, 40, and 60 mm Flexible lengths are 30, 40, and 60 mm May be combined to increase length |
| Operating Principle(s) | Advancement/lead screw
adjustment of metallic plate and
screw construct to achieve
distraction osteogenesis | Advancement/lead screw
adjustment of metallic plate and
screw construct to achieve
distraction osteogenesis | Advancement/lead screw
adjustment of metallic plate and
screw construct to achieve
distraction osteogenesis |
| Materials | Distractor Bodies:
Titanium Alloy TAN (ASTM F1295) Chromium Cobalt L605 (ASTM F90) CoCrMo (ASTM F1537) MP35N (ASTM F562) | Distractor Body:
Titanium Alloy TAV (ASTM F136) | Distractor Bodies:
Titanium Alloy TAN (ASTM F1295) Chromium Cobalt L605 (ASTM F90) |
| System/Device Name | Synthes Craniomaxillofacial
Distraction System | KLS Zurich Distraction System's
Arnaud Distractor | Synthes Craniomaxillofacial
Distraction System (previous
design) |
| | Plates:
CP2 or CP4 Titanium (ASTM F67)
Extension Arms:
Titanium Alloy
• TAN (ASTM F1295)
Chromium Cobalt
• L605 (ASTM F90)
• MP35N (ASTM F562)
Silicone (ASTM F2042) | Plates:
CP Titanium (ASTM F67)
Extension Arms:
Titanium Alloy
• TAV (ASTM F136) | Plates:
CP2 or CP4 Titanium (ASTM F67)
Extension Arms:
Titanium Alloy
• TAN (ASTM F1295)
Chromium Cobalt
• L605 (ASTM F90)
• MP35N (ASTM F562)
Silicone (ASTM F2042) |
| | Screws:
• TAN (ASTM F1295) | Screws:
• CP Titanium (ASTM F67) | Screws:
• CP Titanium (ASTM F67)
• TAN (ASTM F1295) |
| Sterility | Nonsterile
Sterilized to SAL of 10-6 via steam
(moist-heat) prior to use | Nonsterile
Sterilized via steam (moist-heat)
prior to use | Nonsterile
Sterilized to SAL of 10-6 via steam
(moist-heat) prior to use |
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1.6.1. Summary Comparison of Intended Use
Both the subject DePuy Synthes CMFD System and the KLS Zurich Distraction System's Arnaud Distractor (K010139) are indicated for correction of congenital deficiencies or post-traumatic defects of the cranium where gradual bone distraction is required. Additionally, clinical literature is provided in this submission discussing the effective use of the previous design of Synthes CMF Distraction System (K060138) in cranial distraction osteogenesis. The proposed use of the subject CMFD in the cranium does not constitute a new intended use not already addressed by the predicate device.
1.6.2. Summary Comparison of Technological Characteristics
The major technological differences between the subject CMFD in comparison to predicate KLS Zurich Distraction System's Arnaud Distractor (K010139) are:
- The subject device features a reversing prevention mechanism while the predicate does ● not. Non-clinical performance data of the reversing prevention mechanism demonstrates its efficacy.
- . The subject device is made of commercially pure titanium alloy (TAN), cobalt chromium alloys (L605, MP25N, and CoCrMo), and silicone while the predicate is made of titanium and titanium alloy (TAV). However, these materials were used in other implantable components of the previous design of CMFD and are materials with established biocompatibility.
1.7.Non-clinical performance data
Non-clinical performance data demonstrates that the technological differences of the CMFD System do not raise new questions of safety and efficacy with respect to the predicate devices, and therefore support substantial equivalence:
| Test Name | Test Method Summary | Results |
|---|---|---|
| Reversing Prevention | Anatomically simulated | |
| spinning and vibration of the | ||
| subject distractor and the | ||
| previous design of CMFD. | The subject device does not | |
| reverse unintentionally under | ||
| the same conditions where | ||
| the previous design of CMFD | ||
| reversed. | ||
| Construct bending strength | Four-point bend test setup of | |
| a subject device construct in | ||
| comparison to the predicate | ||
| KLS Zurich Distraction | ||
| System's Arnaud Distractor, | ||
| and analysis comparing the | ||
| subject design to the | ||
| previous design of CMFD. | The CMFD construct is | |
| stronger than the predicate | ||
| KLS Arnaud distractor, and | ||
| the design changes relative | ||
| to the previous design in | ||
| K060138 do not affect the | ||
| strength of the distractor | ||
| construct. | ||
| Torque Input/Force Output | ||
| and Construct Torsional | ||
| Strength | This testing challenged the | |
| construct in torsion by | ||
| applying an increasing torque | ||
| (torque input) to the | ||
| activation end of the device | ||
| through an extension arm | ||
| until failure of the device | ||
| occurred. | The device is capable of | |
| outputting the force required | ||
| to distract bone in the | ||
| cranium without failing. | ||
| Extension arm interface | ||
| tensile strength | This testing challenged the | |
| interface between the | ||
| distractor and extension arm | ||
| to ensure the interface can | ||
| withstand a tensile force | ||
| based on a human factors | ||
| benchmark. | The redesigned CMFD meets | |
| the same human factors | ||
| benchmark as the previous | ||
| design of CMFD. | ||
| Biocompatibility | All subject devices with the | |
| exception of the modified | ||
| distractor bodies utilize the | ||
| same materials and | ||
| manufacturing processes as | ||
| the predicate devices cleared | ||
| in K060138, and therefore | ||
| biocompatibility testing was | ||
| not provided. | ||
| For the modified distractor | ||
| bodies, a risk based | ||
| assessment per ISO 10993-1 | ||
| was conducted, and | ||
| supporting biocompatibility | ||
| testing was provided. | The results of | |
| biocompatibility risk | ||
| assessment and testing | ||
| demonstrate that the | ||
| material change to the | ||
| distractor body does not | ||
| raise new questions of safety | ||
| or efficacy with respect to | ||
| biocompatibility. | ||
| Steam Sterilization Validation | The sterilization parameters | |
| were validated using the | ||
| "overkill" method as | ||
| referenced in Annex D of | ||
| ANSI/AAMI/ISO 17665-1 in | ||
| order to assure a Sterility | ||
| Assurance Level (SAL) of 10-6. | The devices may be | |
| effectively steam sterilized by | ||
| the proposed parameters, | ||
| which are the same | ||
| parameters as the previous | ||
| design of CMFD. | ||
| Endotoxin Testing | Endotoxin levels for finished | |
| subject devices were | ||
| quantified using a Kinetic | ||
| Turbidimetric method. | The subject devices meet the | |
| maximum endotoxin testing | ||
| limit of 2.15 EU/device. |
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1.8.Clinical performance data
Clinical literature discussing the application of the previous design of CMFD (K060138) in the cranium is provided in this submission. A literature review was conducted and seven articles were identified discussing the use of the previous design of CMFD (K060138) in the cranium. The previous design of CMFD (K060138) was identified through narrative descriptions, x-rays, and/or images within the articles.
1.9.Substantial Equivalence
Results of non-clinical performance testing, discussions of clinical literature, and comparison to predicate devices included in this submission demonstrate that:
- Technological differences of the CMFD System in comparison to the predicate devices does not raise new questions of safety and efficacy
- The proposed CMFD System has the same intended use as the predicate devices
It is concluded that the information provided in this submission supports substantial equivalence.