(265 days)
Not Found
No
The device description and performance studies focus on the material properties and biological integration of a collagen-based dura substitute, with no mention of AI or ML.
No.
A dura substitute is an implant used to repair the dura mater, acting as a structural replacement rather than a device for treating or curing a disease or medical condition.
No
Explanation: This device is a dura substitute implant used for repair of the dura mater, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a dura substitute implant made of physical materials (collagen from bovine pericardium and split hide) and describes its physical properties and implantation method. There is no mention of software as part of the device itself.
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 substitute for the repair of the dura mater." This describes a surgical implant used directly in the body to replace or repair tissue.
- Device Description: The description details a physical implant made of collagen, designed to be surgically placed.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the physical, mechanical, and biocompatibility properties of the implant, as well as its performance in an animal model as a dura substitute. These are typical evaluations for surgical implants, not IVDs.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. Lyoplant® Onlay is an in vivo (within the body) surgical implant.
N/A
Intended Use / Indications for Use
Lyoplant® Onlay is indicated as a dura substitute for the repair of the dura mater.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device Description
Lyoplant Onlay is a dura substitute implant made of pure collagen that is obtained from bovine pericardium and bovine split hide.
Lyoplant Onlay can be laid on the defect, or sutured depending upon surgeon preference. After implantation, it is gradually broken down enzymatically and is replaced by the body's own connective tissue. The appropriate size implant is selected depending on the area of application and is cut to size depending on the size of the defect. Lyoplant Onlay is supplied sterile and packaged as a single piece.
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
Not Found
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)
Physical, mechanical, and biocompatibility testing have been performed on Lyoplant Onlay in accordance with the FDA quidance for industry for Dura Substitute Devices and has demonstrated the performance of Lyoplant Onlay as a dura substitute.
The following tests were conducted as recommended in the FDA quidance on Dura Substitute Devices:
- Device Thickness.
- Tensile Strength.
- Suture Retention Strenath.
- Burst Strength
- Shrink Temperature Range.
- Surface Structure.
- Delamination.
- Chemical Characterization.
The following biocompatibility testing was conducted in accordance with ISO 10993-1:
- Cytotoxicity.
- Maximization Sensation Study
- Intracutaneous Study
- Systematic Toxicity.
- Genotoxicity.
- Hemolysis
- Muscle Implantation.
Additionally, an animal study was conducted using thirty-four (34) pigs. The study was designed to investigate the safety and efficacy of Lyoplant® Onlay as a dura onlay graft in an in vivo model. Suturable DuraGen" and autologous periosteum were used as control materials. Animals were sacrificed at one (1) month and six (6) months at which time gross and histologic assessment was made. Results of the study demonstrate superior handling of Lvoplant® Onlay and Suturable DuraGen™ over periosteum with a trend for better adhesion to dura and CSF tightness for Lyoplant® Onlay. Periosteum, which was sutured, had the highest intraoperative CSF tightness. Duraplasty time with periosteum was significantly higher (14.4±2.7 min) compared with Lyoplant® Onlay (2.8±0.8 min) or Suturable DuraGen™ (3.0±0.5 min). Tissue integration by fibroblast infiltration was observed after one (1) month for all devices. More adhesions between graft and cortex were observed with Suturable DuraGen ™ compared with Lyoplant® Onlay and periosteum. No relevant adhesions between leptomeninges and Lyoplant® Onlay were observed and all devices showed comparable lymphocytic reaction of the brain. All devices were completely integrated after six (6) months. Lyoplant® Onlay and Suturable DuraGen™ showed a trend for an enhanced lymphocytic reaction of the brain parenchyma compared with periosteum. Implant rejection was not observed in any animals but several deaths occurred overall in the periosteum (n=3) and Suturable DuraGen™(n=4) cohorts.
Results of in vitro, in vivo, and biocompatibility testing demonstrate that Lyoplant Onlay performs in accordance with its specifications and is substantially equivalent in safety and effectiveness to the predicate devices Lyoplant , Suturable DuraGen, and Durepair.
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
K122791 Page 1 of 3
C. 510(K) SUMMARY As required by 21 CFR 807.92
JUN 0-4 2013
LYOPLANT® ONLAY
September 10, 2012
Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Registration No .: 2916714
CONTACT: Denise R. Adams, Requlatory Affairs Specialist 610-984-9076 (phone) 610-791-6882 (fax) denise.adams@aesculap.com (email)
| TRADE NAME: | Lyoplant® Onlay |
|---|---|
| COMMON NAME: | Dura Substitute |
| REGULATION: | Dura Substitute |
| CLASS: | II |
| PRODUCT CODE: | GXQ |
| REGULATION: | 882.5910 |
| REVIEW PANEL: | Neurology |
INTENDED USE
Lyoplant Onlay is indicated as a dura substitute for the repair of the dura mater.
DEVICE DESCRIPTION
Lyoplant Onlay is a dura substitute implant made of pure collagen that is obtained from bovine pericardium and bovine split hide.
Lyoplant Onlay can be laid on the defect, or sutured depending upon surgeon preference. After implantation, it is gradually broken down enzymatically and is replaced by the body's own connective tissue. The appropriate size implant is selected depending on the area of application and is cut to size depending on the size of the defect. Lyoplant Onlay is supplied sterile and packaged as a single piece.
TECHNOLOGICAL CHARACTERISTICS
Lyoplant Onlay is available as single use, sterile, flexible sheets of pure collagen with adequate tear resistance and handling properties, impermeability to CSF, and satisfactory biocompatibility, thus fulfilling the requirements of a dura substitute as described in FDA's quidance document for Dura Substitute Devices.
1
Page 2 of 3
PERFORMANCE DATA
Physical, mechanical, and biocompatibility testing have been performed on Lyoplant Onlay in accordance with the FDA quidance for industry for Dura Substitute Devices and has demonstrated the performance of Lyoplant Onlay as a dura substitute.
The following tests were conducted as recommended in the FDA quidance on Dura Substitute Devices:
- Device Thickness .
- Tensile Strength .
- Suture Retention Strenath .
- . Burst Strength
- Shrink Temperature Range .
- Surface Structure .
- Delamination .
- Chemical Characterization .
The following biocompatibility testing was conducted in accordance with ISO 10993-1:
- Cytotoxicity .
- . Maximization Sensation Study
- . Intracutaneous Study
- Systematic Toxicity .
- Genotoxicity .
- . Hemolysis
- Muscle Implantation .
Additionally, an animal study was conducted using thirty-four (34) pigs. The study was designed to investigate the safety and efficacy of Lyoplant® Onlay as a dura onlay graft in an in vivo model. Suturable DuraGen" and autologous periosteum were used as control materials. Animals were sacrificed at one (1) month and six (6) months at which time gross and histologic assessment was made. Results of the study demonstrate superior handling of Lvoplant® Onlay and Suturable DuraGen™ over periosteum with a trend for better adhesion to dura and CSF tightness for Lyoplant® Onlay. Periosteum, which was sutured, had the highest intraoperative CSF tightness. Duraplasty time with periosteum was significantly higher (14.4±2.7 min) compared with Lyoplant® Onlay (2.8±0.8 min) or Suturable DuraGen™ (3.0±0.5 min). Tissue integration by fibroblast infiltration was observed after one (1) month for all devices. More adhesions between graft and cortex were observed with Suturable DuraGen ™ compared with Lyoplant® Onlay and periosteum. No relevant adhesions between leptomeninges and Lyoplant® Onlay were observed and all devices showed comparable lymphocytic reaction of the brain. All devices were completely integrated after six (6) months. Lyoplant® Onlay and Suturable DuraGen™ showed a trend for an enhanced lymphocytic reaction of the brain parenchyma compared with periosteum. Implant rejection was not observed in any animals but several deaths occurred overall in the periosteum (n=3) and Suturable DuraGen™(n=4) cohorts.
2
Results of in vitro, in vivo, and biocompatibility testing demonstrate that Lyoplant Onlay performs in accordance with its specifications and is substantially equivalent in safety and effectiveness to the predicate devices Lyoplant , Suturable DuraGen, and Durepair,
SUBSTANTIAL EQUIVALENCE
Lyoplant Onlay, Lyoplant, Suturable DuraGen, and Durepair have similar technological characteristics. These devices are available as single use, sterile, flexible sheets of pure collagen with adequate tear resistance and handling properties, impermeability to CSF, and satisfactory biocompatibility, thus fulfilling the requirements of a dura substitute.
The device modifications described in this premarket notification are substantially equivalent to the predicate device Lyoplant Dura Substitute cleared via K970851. Suturable DuraGen cleared via K043427, and Durepair cleared via K041000. Anv technological differences between Lyoplant Onlay and the predicate devices do not raise new types of safety or effectiveness issues.
| | Lyoplant Onlay
(subject device) | Lyoplant K970891
Aesculap | Suturable DuraGen
K043247 Integra
LifeSciences | Durepair K041000
Medtronic |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Lyoplant Onlay is
indicated as a dura
substitute for the
repair of the dura
mater. | Intended as a dura
mater substitute in
neurological
procedures for soft
tissue reconstruction
of damaged, impaired,
or missing tissue. | Indicated as a dura
substitute for the repair
dura mater | Durepair® is
indicated as a dura
substitute for the
repair of the dura
mater. |
| Contra-
indications | • Infected areas
• Open cranial trauma
• Open spina bifida
• As a replacement for
mechanically stressed
connective tissue
structures
• As a substitute for
parts in the arterial
system or the cardiac
wall
• If there are known
allergies to proteins of
bovine origin | • Infected areas
• Open cranial trauma
• Open spina bifida
• As a replacement for
mechanically stressed
connective tissue
structures
• As a substitute for
parts in the arterial
system or the cardiac
wall | • For patients with a
known history of
hypersensitivity to
bovine derived materials
• Should be used with
caution in infected
regions | • Durepair is not
designed, sold, or
intended for use
except as indicated.
• Durepair should not
used for patients
with a known history
of hypersensitivity to
collagen products.
• Durepair should be
used with caution in
regions where an
infection exists. |
| Type of
Collagen | bovine pericardium
and bovine split hide | bovine pericardium | bovine Achilles tendon | bovine skin |
| Application | Onlay or suture | Suture | Onlay or suture | Onlay or suture |
| Sterilization | EtO | EtO | EtO | EtO |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with outstretched wings, with three wavy lines below it, possibly representing water or waves.
June 4, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Aesculap, Inc. % Ms. Denise R. Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
Re: K122791
Trade/Device Name: Lyoplant® Onlay Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: April 29, 2013 Received: April 30, 2013
Dear Ms. Adams
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
4
Page 2 - Ms. Denise R. Adams
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Kesia Y Alexander -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Genter-for-Devices-and-Radiological-Health
Enclosure
5
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K122791
Device Name: Lyoplant® Onlay
Indication for Use:
Lyoplant® Onlay is indicated as a dura substitute for the repair of the dura mater.
Prescription Use X Over-the-Counter Use or (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Tieuvi Hī 2013.05.22 22
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD) 510 (k) Number K122791