(84 days)
Not Found
No
The summary describes a passive, non-resorbable dura replacement device made of biosynthesized cellulose. There is no mention of any computational or analytical functions, let alone AI/ML.
Yes
The device is intended for use in the repair of dural defects, functioning as a mechanical layer to protect and repair the dural defect and prevent CSF leakage, which directly treats a medical condition.
No
Explanation: The device is intended for surgical repair of dural defects as a dura replacement, functioning as a mechanical layer, not for diagnosing conditions.
No
The device description clearly states that the device is composed of biosynthesized cellulose and water, functioning as a mechanical layer. This indicates a physical, implantable device, 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 for the repair of dura mater, which is a surgical procedure performed directly on a patient. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device is a physical implant made of biosynthesized cellulose and water, designed to function as a mechanical layer. This is consistent with a surgical implant, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the SyntheCel® Dura Replacement Devices are medical devices used in surgery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
SyntheCel® Dura Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device Description
SyntheCel® Dura Replacement Devices (Onlay and Substitute) are composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Replacement Devices function as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Replacement Devices are immunologically inert and have demonstrated minimal foreign body response. They are non-resorbable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dura mater
Indicated Patient Age Range
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)
Clinical Testing Data: Clinical data were collected to evaluate the safety and effectiveness of the SyntheCel® Dura Replacement Devices as compared to the Control. The objective of this study was to demonstrate that the SyntheCel® Dura Replacement Devices are substantially equivalent to other dura replacement products that were previously cleared for marketing by FDA. A total of 99 patients were enrolled, randomized and treated (62 in the investigational SyntheCel® treatment group and 37 in the control group) at 8 clinical sites. Patients were evaluated intra-operatively and immediately post-operatively (1 - 10 days) followed by evaluations at one (1) month, three (3) months and six (6) months. Complications and adverse events, device-related or not, were evaluated over the course of the clinical trial. At each evaluation time-point, the primary and secondary clinical outcome parameters were evaluated. Safety and effectiveness was assessed in all randomized subjects. Primary Efficacy Endpoint: The primary endpoint was based on the findings up to and including the 6 month follow-up visit. An individual patient's treatment was considered successful if and only if the following criterion was met: Success was defined as absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of surgical site. The results of overall success analyses indicate that the SyntheCel® is non-inferior to the dura replacement control group.
Non-Clinical Testing Data: Mechanical testing was performed for tensile strength, burst strength, and suture pull-out strength on samples of SyntheCel® Dura Replacement Devices and the predicates, DuraGen and Dura-Guard. All samples were prepared per respective instructions. SyntheCel® Dura Replacement Device performance was found to be comparable in tensile strength, burst strength, and suture pull-out strength. An animal study was performed comparing the SyntheCel® Dura Replacement Devices and predicate devices in a Rabbit Durotomy Implant Study. The results noted at necropsy show no meningitis, CSF leakage, evidence of infection, hydrocephalus, device vascularization, nor significant hemorrhage in any of the animals regardless of the implant type. Overall, the SyntheCel® Dura Substitute performed no different than the other predicate dura substitute materials. An additional Rabbit Durotomy Implant Study Model was performed using SyntheCel® Dura Replacement Devices. This study was conducted by NAMSA following GLPs. According to the conclusion, the SyntheCel® Dura Replacement Devices showed no evidence of a toxic leachable or local adverse effect. Biocompatibility testing according to standards set forth in ISO 10993 demonstrated that the material is non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic. Pyrogenicity was evaluated using the Limulus Amebocyte Lysate (LAL) test on the final sterilized SyntheCel® device and found to be less than 0.06 EU/ml (Endotoxin Units / ml) per FDA's Guidance Document for Dura Substitute Devices. All SyntheCel® Dura Replacement Device lots will be tested to ensure they are less than 0.06 EU/ml and will be labeled non-pyrogenic.
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.
K950956, K973706, K982282, K982180, K021477
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
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).
0
K113071
JAN - 9 2012
1.0 SUMMARY OF INFORMATION REGARDING SAFETY AND EFFECTIVENESS [510(k) Summary] per the requirements 21 CFR 807.92
Page I of 3 Date Prepared January 03, 2012 Submitter SYNTHES 1301 Goshen Parkway West Chester, PA 19380 United States of America Contact Andrea M. Tasker tasker.andrea@synthes.com phone: (610) 719-6920 Trade Name SyntheCel® Dura Replacement Devices, SyntheCel® Dura Onlay, SyntheCel® Dura Substitute Common Name Dura Replacement Device Classification Dura Substitute Name Classification 21 CFR 882.5910 Device Class I I Review Panel Neurology Product Code(s) GXQ Predicate Devices Bio-Vascular's Dura-Guard (K950956, K973706,K982282) Integra Lifescience's DuraGen (K982180) Gore - Preclude MVP (K021477) SyntheCel® Dura Replacement Devices (Onlay and Substitute) are Device Description composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Replacement Devices function as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Replacement Devices are immunologically inert and have demonstrated minimal foreign body response. They are non-resorbable. Intended Use SyntheCel® Dura Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.
1
K113071
510(k) Summary (continued)
| Technological
Characteristics | The SyntheCel® Dura Replacement Devices are similar to the three
predicate devices (Bio-Vascular-Dura-Guard, Integra Lifesciences-
DuraGen, and Gore-Preclude MVP) in terms of intended use. All three
are intended for dura replacement for the repair of dura mater.
The SyntheCel® Dura Replacement Devices are similar to the two
predicate devices (Bio-Vascular-Dura-Guard, Integra Lifesciences-
DuraGen) in terms of physical properties (form, size, physical integrity,
thickness, suturability, drapability, conformability).
The SyntheCel® Dura Replacement Devices are similar to the predicate
device (Gore-Preclude MVP) in terms of resorbability. Both are non-
resorbable. |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Testing
Data | Clinical data were collected to evaluate the safety and effectiveness of
the SyntheCel® Dura Replacement Devices as compared to the Control.
The objective of this study was to demonstrate that the SyntheCel® Dura
Replacement Devices are substantially equivalent to other dura
replacement products that were previously cleared for marketing by
FDA. A total of 99 patients were enrolled, randomized and treated (62
in the investigational SyntheCel® treatment group and 37 in the control
group) at 8 clinical sites.
Patients were evaluated intra-operatively and immediately post-
operatively (1 - 10 days) followed by evaluations at one (1) month, three
(3) months and six (6) months. Complications and adverse events,
device-related or not, were evaluated over the course of the clinical trial.
At each evaluation time-point, the primary and secondary clinical
outcome parameters were evaluated. Safety and effectiveness was assessed in all randomized subjects.
Primary Efficacy Endpoint: The primary endpoint was based on the
findings up to and including the 6 month follow-up visit. An individual
patient's treatment was considered successful if and only if the following
criterion was met:
Success was defined as absence of CSF fistula (drainage from wound or
sinus) and pseudomeningocele within 6 months post-operatively
confirmed by radiographic evaluation and physical examination of
surgical site.
The results of overall success analyses indicate that the SyntheCel® is
non-inferior to the dura replacement control group. |
| Non-Clinical
Testing Data | Mechanical testing was performed for tensile strength, burst strength,
and suture pull-out strength on samples of SyntheCel® Dura
Replacement Devices and the predicates, DuraGen and Dura-Guard. All
samples were prepared per respective instructions. SyntheCel® Dura
Replacement Device performance was found to be comparable in tensile
strength, burst strength, and suture pull-out strength.
An animal study was performed comparing the SyntheCel® Dura
Replacement Devices and predicate devices in a Rabbit Durotomy
Implant Study. The results noted at necropsy show no meningitis, CSF
leakage, evidence of infection, hydrocephalus, device vascularization,
nor significant hemorrhage in any of the animals regardless of the
implant type. Overall, the SyntheCel® Dura Substitute performed no
different than the other predicate dura substitute materials.
An additional Rabbit Durotomy Implant Study Model was performed
using SyntheCel® Dura Replacement Devices. This study was
conducted by NAMSA following GLPs. According to the conclusion,
the SyntheCel® Dura Replacement Devices showed no evidence of a
toxic leachable or local adverse effect.
Biocompatibility testing according to standards set forth in ISO 10993
demonstrated that the material is non-irritating, non-sensitizing, non-
mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic.
Pyrogenicity was evaluated using the Limulus Amebocyte Lysate (LAL)
test on the final sterilized SyntheCel® device and found to be less than
0.06 EU/ml (Endotoxin Units / ml) per FDA's Guidance Document for
Dura Substitute Devices. All SyntheCel® Dura Replacement Device
lots will be tested to ensure they are less than 0.06 EU/ml and will be
labeled non-pyrogenic. |
| Substantial
Equivalence to
Predicate Devices | Based on the information presented in this submission, which includes
mechanical testing, pre-clinical testing, animal testing, and clinical
testing, the SyntheCel® Dura Replacement Devices do not raise new
questions of safety and effectiveness. Therefore, it can be concluded
that the SyntheCel® Dura Replacement Devices are substantially
equivalent to the predicate devices for dura replacement devices in
commercial distribution for use as a dura replacement for the repair of
dura mater. |
·
2
510(k) Summary (continued)
3 Page 3
(end of summary)
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 9 2012
Synthes c/o Ms. Andrea M. Tasker CMF Regulatory Affairs Manager, Synthes 1301 Goshen Parkway West Chester, PA 19380
Re: K113071
Trade/Device Name: SyntheCel® Dura Replacement Devices Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXO Dated: October 14, 2011 Received: October 18, 2011
Dear Ms. Tasker:
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
4
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of K Part 607), accimig (21 CFR 803); good manufacturing practice requirements as set do records and the overse oversion (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 n you http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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Indications for Use
K113071 510(k) Number (if known):_
SyntheCel® Dura Replacement Devices Device Name:
Indications For Use:
SyntheCel® Dura Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off)
ision of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
K11307 510(k) Number