(99 days)
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No
The summary describes a synthetic material patch for dura mater repair and mentions no AI/ML components or functionalities.
Yes
The device is indicated as a dura mater substitute for soft tissue reconstruction of damaged, impaired, or missing tissue, which aligns with the definition of a therapeutic device designed to treat or alleviate a condition.
No
The device description clearly states its purpose as a dura mater substitute for tissue reconstruction, and the performance studies focus on its biocompatibility and tissue integration, not on diagnosing any condition.
No
The device description clearly states that Neuro-Patch is a microporous fabric manufactured from a synthetic material, indicating it is a physical, hardware-based device.
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 in neurological procedures for soft tissue reconstruction. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a synthetic fabric implant. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information. The device's function is purely structural and reconstructive.
Therefore, the Neuro-Patch device falls under the category of a surgical implant or medical device for tissue repair, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Neuro-Patch (like its predicate devices) is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.
Product codes
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Device Description
The Neuro-Patch device is a microporous fabric manufactured from a highly purified polyesterurethane (PUR), a synthetic material. The product is supplied sterile, non-pyrogenic and packaged as single or double pieces of varying sizes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Dura mater
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Preclinical Studies:
- Biocompatibility evaluation through various sensitization, toxicity, immunogenicity, and mutagenic testing.
- Neuro-Patch was found not to be a sensitizing agent, non-toxic, non-mutagenic, and possessed a weak or virtually non-reactive immunogenic potential.
- Animal studies showed Neuro-Patch to be extremely well tolerated by tissues.
- The fine-fiber microstructure facilitated rapid immigration of endogenous connective tissue cells.
- No adverse cellular or allergic reactions were observed, and absence of giant cells indicated it was not recognized as a foreign body.
- The implant was integrated completely into connective tissue.
Clinical Studies:
- A clinical investigation confirmed excellent biocompatibility and handling properties for human use.
- Implants showed rapid development of connective tissue with no immunological or adverse response.
Manufacturing and Final Product Quality Testing:
- Manufactured in compliance with Good Manufacturing Practice Regulations.
- In-process and final product analytical, physical, and microbiological testing assure conformity to specifications.
Key Metrics
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Predicate Device(s)
Dura Film (by Codman), Preclude Dura Substitute (by W.L. Gore), Tutoplast® Dura substitute (by Biodynamics, Inc.), Dura-Guard™ Dural Repair Patch (by Bio-Vascular, Inc.)
Reference Device(s)
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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
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Image /page/0/Picture/1 description: The image shows the word "AESCULAP" in a bold, sans-serif font. To the left of the word is a black square containing a white circle. Inside the white circle is a symbol resembling a staff with a snake coiled around it, topped with a crown. The "R" in "AESCULAP" has a small "®" symbol next to it, indicating that it is a registered trademark.
MAY 1 0 1996
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Neuro-Patch January 31, 1996
Aesculap®, Inc. Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Victoria Mackinnon (415) 876-7000 x346 Phone: FAX: (415) 589-3007
Neuro-Patch Product Name: Common Name: Dura substitute
Device Description
The Neuro-Patch device is a microporous fabric manufactured from a highly purified polyesterurethane (PUR), a synthetic material. The product is supplied sterile, non-pyrogenic and packaged as single or double pieces of varying sizes.
Intended Use
Neuro-Patch (like its predicate devices) 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 Film (by Codman) | Silicone rubber sheet reinforced with |
| Dacron® polyester. | |
| Preclude Dura Substitute | |
| (by W.L. Gore) | expanded polytetrafluoroethlene (ePTFE) |
| Tutoplast® Dura substitute | |
| (by Biodynamics, Inc.) | Human dura composed of collagenous |
| connective tissue. | |
| Dura-Guard™ Dural Repair | |
| Patch (by Bio-Vascular, Inc.) | Glutaraldehyde cross-linked bovine |
| pericardium. |
1
Neuro-Patch, S&E Summary, page 2.
Technological Characteristics
Neuro-Patch 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 Neuro-Patch 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 Neuro-Patch 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
The biocompatibility of Neuro-Patch has been thoroughly evaluated and addressed in numerous preclinical studies.
Through various sensitization, toxicity, immunogenicity and mutagenic testing, Neuro-Patch was found not to be a sensitizing agent under standard test procedures. The device was also found to be non-toxic. non-mutagenic and possess a weak or virtually non-reactive immunogenic potential.
Animal studies have shown the Neuro-Patch to be extremely well tolerated by tissues. The fine-fiber microstructure is characterized by intercommunicating pores with numerous openings on the surface. This facilitates rapid immigration of endogenous connective tissue cells. No adverse cellular or allergic reactions were observed. The absence of giant cells demonstrates that Neuro-Patch is not recognized as a foreign body by the host. The implant is integrated completely into connective tissue.
2
Neuro-Patch, S&E Summary, page 3.
2. Clinical Studies and Results
A clinical investigation also confirmed the excellent biocompatibility and handling properties of Neuro-Patch for human use. The implants showed rapid development of connective tissue with no immunological or adverse response
Manufacturing and Final Product Quality Testing 3.
Neuro-Patch is manufactured in compliance with Good Manufacturing Practice Regulations. In process and final product analytical, physical and microbiological testing assures that Neuro-Patch 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 Neuro-Patch is equivalent to predicate devices in its biocompatibility and it safety and effectiveness as a dura substitute.