(181 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the material properties and mechanical function.
Yes.
The device is intended for use as a dura replacement for the repair of dura mater, which is a therapeutic function.
No
The device is a dura replacement for the repair of dura mater, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is composed of biosynthesized cellulose and water, functioning as a mechanical layer, indicating it is a physical implant, 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 in adults, which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical material (biosynthesized cellulose and water) intended to function as a mechanical layer to protect and repair a dural defect.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples taken from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are designed for such testing.
The device is a surgical implant/material used in vivo (within the living body), not in vitro (in glass/outside the living body).
N/A
Intended Use / Indications for Use
SyntheCel® Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
SyntheCel® Dura Onlay is intended for use as a dura replacement for the repair of dura mater in adults.
Product codes (comma separated list FDA assigned to the subject device)
GXQ, GXO
Device Description
SyntheCel® Dura Onlay is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Onlay functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Onlay is immunologically inert and has demonstrated minimal foreign body response. It is 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)
No new clinical performance data were collected in support of this submission. Clinical data were previously collected to evaluate the safety and effectiveness of the SyntheCel® Dura Replacement Devices (including SyntheCel® Dura Repair and SyntheCel® Dura Onlay) as compared to the Control. This data was included in K113071. The SyntheCel® Dura Replacement Devices (including SyntheCel® Dura Repair and SyntheCel® Dura Onlay) were demonstrated to be substantially equivalent to other legally marketed dura replacement products in terms of safety and efficacy.
No new non-clinical performance data were collected in support of this submission.
Mechanical testing data were previously collected to support substantial equivalence of SyntheCel® Dura Onlay to predicate devices. This data was included in K113071. Tensile strength, and burst strength were tested and SyntheCel® Dura Onlay was demonstrated to be substantially equivalent to predicate devices.
Biocompatibility testing according to standards set forth in ISO 10993 previously demonstrated that the material is non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic. This data was included in K113071.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5910 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
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A small registered trademark symbol is located to the right of the word. A horizontal line is located underneath the word.
DEC 16 2013
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510(k) Summary -- SyntheCcl® Dura Onlay
| Date Prepared | November 13, 2013 | ||
|---|---|---|---|
| Submitter | Synthes | ||
| 1301 GOSHEN PARKWAY | |||
| West Chester, PA 19380 | |||
| United States of America | |||
| Contact | Heather L. Guerin, Ph.D., P.E. | ||
| guerin.heather@synthes.com | |||
| phone: (610) 719-5432 | |||
| Device Name | SyntheCel® Dura Onlay | ||
| Classification | 21 CFR 882.5910 (Dura Substitute) | ||
| Device Class | 2 | ||
| Product Code(s) | GXQ | ||
| Predicate Devices | SyntheCel Dura Replacement Devices (K113071) | ||
| Device Description | SyntheCel® Dura Onlay is composed of biosynthesized cellulose and | ||
| water with a unique construction of non-woven, interconnected | |||
| cellulose fibers. SyntheCel® Dura Onlay functions as a mechanical layer | |||
| which protects and repairs the dural defect while preventing further | |||
| CSF leakage. SyntheCel® Dura Onlay is immunologically inert and has | |||
| demonstrated minimal foreign body response. It is non-resorbable. | |||
| Indications for Use | SyntheCel® Dura Onlay is intended for use as a dura replacement for | ||
| the repair of dura mater in adults. | |||
| Technological | |||
| Characteristics | SyntheCel® Dura Onlay | ||
| (K131792) | SyntheCel Dura | ||
| Replacement Devices | |||
| (K113071) | |||
| Indications | |||
| for Use | SyntheCel® Dura Onlay is | ||
| intended for use as a | |||
| dura replacement for the | |||
| repair of dura mater in | |||
| adults. | SyntheCel® is 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 |
| | | | |
| | Contra-
indications | Must not be implanted in
patients who have known
allergy or sensitivity to
the implant materials
(cellulose). | into place.
Same |
| | Material | Biosynthesized cellulose | Same |
| | Dimensions | 1in x 1in (2.5cm x 2.5cm)
1in x 3in (2.5cm x 7.5cm)
2in x 2in (5.0cm x 5.0cm)
3in x 3in (7.5cm x 7.5cm)
4in x 5in (10.0cm x
12.0cm) | Same. |
| | Function | Conforms to contours of
brain. | Same |
| | Resorbability | Non-resorbable | Same |
| | Sterilization | Sterilized by irradiation | Same |
| Clinical
Performance Data | No new clinical performance data were collected in support of this
submission. Clinical data were previously collected to evaluate the
safety and effectiveness of the SyntheCel® Dura Replacement Devices
(including SyntheCel® Dura Repair and SyntheCel® Dura Onlay) as
compared to the Control. This data was included in K113071. The
SyntheCel® Dura Replacement Devices (including SyntheCel® Dura
Repair and SyntheCel® Dura Onlay) were demonstrated to be
substantially equivalent to other legally marketed dura replacement
products in terms of safety and efficacy. | | |
| Non-Clinical
Performance Data | No new non-clinical performance data were collected in support of this
submission.
Mechanical testing data were previously collected to support
substantial equivalence of SyntheCel® Dura Onlay to predicate devices.
This data was included in K113071. Tensile strength, and burst strength
were tested and SyntheCel® Dura Onlay was demonstrated to be
substantially equivalent to predicate devices.
Biocompatibility testing according to standards set forth in ISO 10993
previously demonstrated that the material is non-irritating, non-
sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, and non-
pyrogenic. This data was included in K113071.
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. | | |
1
@ SYNTHES®
.
:
.
2
Image /page/2/Picture/0 description: The image contains the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo. There is a horizontal line below the word. The logo has a registered trademark symbol.
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.
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and the comments of the comments of the comments of the comments of
1999 - 1999 - 1999
| Substantial
Equivalence to
Predicate Devices | Based on the information presented in this submission, the proposed
changes to SyntheCel® Dura Onlay do not raise new questions of safety
and effectiveness. Therefore, it can be concluded that the SyntheCel®
Dura Onlay is substantially equivalent to the predicate device. |
| ---------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
and the control control control control controllers and
.
1
.
and the same of the same of the same
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three curved lines resembling a stylized human figure. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002
December 16, 2013
Synthes® (USA) % Heather Guerin, Ph.D., P.E. Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380
Re: K131792
Trade/Device Name: SyntheCel® Dura Repair and SyntheCel® Dura Onlay Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXO Dated: November 13, 2013 Received: November 14, 2013
Dear Dr. Guerin:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Heather Guerin, Ph.D., P.E.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Carlos Peña, Ph.D. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131792
Device Name: SyntheCel® Dura Repair and SyntheCel® Dura Onlay
Indications For Use:
ంగా విశాఖ ?
SyntheCel® Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
SyntheCel® Dura Onlay is intended for use as a dura replacement for the repair of dura mater in adults.
Prescription Use > (Part 21 CFR 801 Subpart D)
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 Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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