(277 days)
Not Found
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 technologies.
No
The device is a substitute material for damaged or missing dura mater, aiding in reconstruction, rather than providing therapy to a disease or condition.
No
Explanation: The device is a dura mater substitute used for reconstruction of damaged tissue, not for diagnosing medical conditions.
No
The device description clearly states it is a lyophilized dura substitute made of collagen derived from bovine pericardium, 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 as a dura mater substitute for soft tissue reconstruction during neurological procedures. This is a surgical implant used directly on the patient's tissue.
- Device Description: The device is a lyophilized collagen product derived from bovine pericardium, designed to be implanted.
- 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) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Lyoplant is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.
Product codes
GXQ
Device Description
The Lyoplant® device is a lyophilized dura substitute of pure collagen derived from bovine pericardium. The product is supplied sterile, non-pyrogenic and packaged as single or double pieces of varying sizes.
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)
Performance data and test findings relative to the biocompatibility, pyrogenicity, toxicity, sterility and clinical safety have been performed and are provided in the this document. A summary of these findings are noted below.
Preclinical Studies and Results 1.
The biocompatibility of Lyoplant has been thoroughly evaluated and addressed in numerous preclinical studies.
Through various sensitization, toxicity, and immunogenic testing, Lyoplant was found not to be a sensitizing agent under standard test procedures. The device was also found to be non-toxic and possess a weak or virtually non-reactive immunogenic potential.
Animal studies have shown the Lyoplant to be extremely well tolerated by tissues. No adverse cellular or allergic reactions were observed. The absence of giant cells demonstrates that Lyoplant is not recognized as a foreign body by the host. The implant is integrated completely into connective tissue.
2. Clinical Studies and Results
A clinical investigation also confirmed the excellent biocompatibility and handling properties of Lyoplant for human use. The implants showed development of connective tissue with no immunological or adverse response.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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/0 description: The image shows the logo for Aesculap. The logo consists of a black square containing a white circle with a symbol of a rod with a snake wrapped around it and a crown on top. To the right of the square is the word "AESCULAP" in large, bold, black letters.
DEC - 9 1997
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Lyoplant® Dura Substitute March 6, 1997
Submitted by:
Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Victoria Mackinnon (415) 876-7000 x346 Phone: (415) 589-3007 FAX:
Lyoplant® Dura substitute Product Name: Common Name: Dura substitute
Device Description
The Lyoplant® device is a lyophilized dura substitute of pure collagen derived from bovine pericardium. The product is supplied sterile, non-pyrogenic and packaged as single or double pieces of varying sizes.
Intended Use
Lyoplant is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.
Predicate Devices
Predicate devices are available in synthetic and organic materials (see table below).
| Device | Material Composition |
|---|---|
| Dura-Guard™ Dural Repair Patch | |
| (by Bio-Vascular, Inc.) | Glutaraldehyde cross-linked bovine |
| pericardium. | |
| Peri-Guard® Pericardium | |
| (by Bio-Vascular, Inc.) | Glutaraldehyde cross-linked bovine |
| pericardium. | |
| Neuro-Patch Dura Substitute | Polyesterurethane (PUR) |
| Preclude Dura Substitute | |
| (by W.L. Gore) | expanded polytetrafluoroethylene |
| (ePTFE) | |
| Dura Film (by Codman) | Silicone rubber sheet reinforced with |
| Dacron® polyester. | |
| Tutoplast® Dura substitute | |
| (by Biodynamics, Inc.) | Human dura composed of collagenous |
| connective tissue. |
1
LYOPLANT. S&E Summary, page 2.
Technological Characteristics
Lyoplant and its predicates have similar technological characteristics. All of these devices are available as sterile, thin flexible sheets with adequate tear resistance and handling properties, impermeability to CSF, and satisfactory biocompatibility, thus fulfilling the requirements of a dura substitute.
The technological differences between Lyoplant and the predicate devices do not raise new types of safety or effectiveness issues. The technological differences have been assessed by valid scientific and clinical methods. Physical, laboratory, animal and human clinical test methods have been performed and have proven the ability of Lyoplant to function as a dura substitute.
Performance Data
Performance data and test findings relative to the biocompatibility, pyrogenicity, toxicity, sterility and clinical safety have been performed and are provided in the this document. A summary of these findings are noted below.
Preclinical Studies and Results 1.
The biocompatibility of Lyoplant has been thoroughly evaluated and addressed in numerous preclinical studies.
Through various sensitization, toxicity, and immunogenic testing, Lyoplant was found not to be a sensitizing agent under standard test procedures. The device was also found to be non-toxic and possess a weak or virtually non-reactive immunogenic potential.
Animal studies have shown the Lyoplant to be extremely well tolerated by tissues. No adverse cellular or allergic reactions were observed. The absence of giant cells demonstrates that Lyoplant is not recognized as a foreign body by the host. The implant is integrated completely into connective tissue.
2. Clinical Studies and Results
A clinical investigation also confirmed the excellent biocompatibility and handling properties of Lyoplant for human use. The implants showed development of connective tissue with no immunological or adverse response.
2
Lyoplant, S&E Summary, page 3.
Manufacturing and Final Product Quality Testing 3.
Lyoplant is manufactured in compliance with Good Manufacturing Practice Regulations. In process and final product analytical, physical and microbiological testing assures that Lyoplant conforms to specifications prior to release.
The test data from the extensive in vitro and in vivo preclinical testing, and human clinical findings presented in the submission establish that Lyoplant is equivalent to predicate devices in its biocompatibility and it safety and effectiveness as a dura substitute.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1997
Ms. Victoria Mackinnon ·Manager, Regulatory Affairs AESCULAP® 1000 Gateway Boulevard South San Francisco, California 94080-7030
K970851 Re: Trade Name: Lyoplant Dura Substitute Regulatory Class: II Product Code: GXQ Dated: September 29, 1997 Received: October 1, 1997
Dear Ms. Mackinnon
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Victoria Mackinnon
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
INDICATION FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Lyoplant Dura Substitute
Indication for Use:
Lyoplant Dura Substitute presented in this submission is intended as a dura Lyoplant Dura Substitute presented in this Cashinotation of ' damaged, impaired, or missing tissue.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular Respiratory,
and Nepratica: Dove ας
510 Num
K970851