(135 days)
No
The device description and performance studies focus on the material properties and mechanical performance of the dura repair product, with no mention of AI or ML.
Yes
The device is indicated as a dura replacement for the repair of dura mater, functioning as a mechanical layer to protect and repair dural defects and prevent CSF leakage, which directly treats a medical condition.
No
The device description indicates that SYNTHECEL® Dura Repair functions as a mechanical layer for repairing dura mater and preventing CSF leakage, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it 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 "as a dura replacement for the repair of dura mater in adults." This describes a surgical implant used to physically repair tissue within the body.
- Device Description: The description details a material composed of biosynthesized cellulose and water that functions as a "mechanical layer." This is consistent with a medical device used for structural repair, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. SYNTHECEL® Dura Repair is a surgical implant used within the body for structural repair.
N/A
Intended Use / Indications for Use
SYNTHECEL Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.
Product codes
GXQ
Device Description
SYNTHECEL® Dura Repair is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SYNTHECEL® Dura Repair functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SYNTHECEL® Dura Repair 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
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 (K113071) as compared to the Control.
Mechanical testing data was collected to support substantial equivalence of SYNTHECEL® Dura Repair to predicate devices. Burst strength and suture pull-out strength were tested and SYNTHECEL® Dura Repair was demonstrated to be substantially equivalent to predicate devices. Biocompatibility testing according to standards set forth in ISO 10993-1 demonstrated that the material is non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, non-pyrogenic and of appropriate pH. Device packaging was justified via prior shelf-life qualification. Sterilization was validated per ISO 11137-1, ISO 11137-2, and AAMI TIR29. Dose substantiation qualification was performed to encompass the larger size per ISO 11137-2 and AAMI TIR33. Additionally, packaging was rationalized by prior data and further transit qualification was performed to support the new carton and shipping configurations related to the larger size offering.
Key Metrics
Not Found
Predicate Device(s)
SYNTHECEL® Dura Replacement Devices (K113071), SYNTHECEL® Dura Repair (K131792)
Reference Device(s)
Durepair Dura Regeneration Matrix (K161370)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 28, 2022
Synthes (USA) Products, LLC Doug Steinberger Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K212943
Trade/Device Name: SYNTHECEL Dura Repair Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: December 22, 2021 Received: December 27, 2021
Dear Doug Steinberger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212943
Device Name SYNTHECEL Dura Repair
Indications for Use (Describe)
SYNTHECEL Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.
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)
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| Date Prepared | January 28, 2022 |
|---|---|
| Submitter | Synthes (USA) Products LLC |
| 1230 Wilson Drive | |
| West Chester, PA 19380 | |
| Contact | Doug Steinberger |
| (419) 307-0674 (phone) | |
| DSTEINB1@ITS.JNJ.COM | |
| Device Name | SYNTHECEL® Dura Repair |
| Regulation Number | 21 CFR 882.5910 |
| Device Class | 2 |
| Product Code(s) | GXQ |
| Predicate Devices | SYNTHECEL® Dura Replacement Devices (K113071) |
| SYNTHECEL® Dura Repair (K131792) | |
| Reference Device | Durepair Dura Regeneration Matrix (K161370) |
| Device Description | SYNTHECEL® Dura Repair is composed of biosynthesized cellulose and |
| water with a unique construction of non-woven, interconnected cellulose | |
| fibers. SYNTHECEL® Dura Repair functions as a mechanical layer which | |
| protects and repairs the dural defect while preventing further CSF leakage. | |
| SYNTHECEL® Dura Repair is immunologically inert and has demonstrated | |
| minimal foreign body response. It is non-resorbable. | |
| Indications for Use | SYNTHECEL® Dura Repair is indicated as a dura replacement for |
| the repair of dura mater in adults. | |
| Technological | |
| Characteristics | The SYNTHECEL® Dura Repair is equivalent to the predicate devices (K113071 |
| & K131792) in terms of intended use. Both are designed for dura replacement | |
| for the repair of dura mater. The material, physical properties, resorbability, | |
| and mechanical performance are identical to the predicate devices. This | |
| submission covers a larger size offering that is dimensionally different in length | |
| and width compared to predicates but is similar in length and width to the | |
| largest Durepair product (K161370) as a reference. | |
| 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 (K113071) as compared to the | |
| Control. | |
| Non-Clinical | |
| Performance Data | Mechanical testing data was collected to support substantial equivalence of |
| SYNTHECEL® Dura Repair to predicate devices. Burst strength and suture pull- | |
| out strength were tested and SYNTHECEL® Dura Repair was demonstrated to | |
| be substantially equivalent to predicate devices. | |
| Biocompatibility testing according to standards set forth in ISO 10993-1 | |
| demonstrated that the material is non-irritating, non-sensitizing, non- | |
| mutagenic, non-cytotoxic, non-hemolytic, non-pyrogenic and of appropriate | |
| pH. | |
| Device packaging was justified via prior shelf-life qualification. Sterilization was | |
| validated per ISO 11137-1, ISO 11137-2, and AAMI TIR29. Dose substantiation | |
| qualification was performed to encompass the larger size per ISO 11137-2 and | |
| AAMI TIR33. Additionally, packaging was rationalized by prior data and further | |
| transit qualification was performed to support the new carton and shipping | |
| configurations related to the larger size offering. | |
| Substantial | |
| Equivalence to | |
| Predicate Devices | Based on the information presented in this submission, the proposed |
| changes do not raise new questions of safety and effectiveness. | |
| Therefore, it can be concluded that the SYNTHECEL® Dura Repair is | |
| substantially equivalent to the predicate device. |
510(k) Summary – SYNTHECEL Dura Repair
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