(157 days)
Not Found
No
The summary describes a hydrogel material and its physical properties and performance, with no mention of AI or ML.
Yes
The device is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures, including the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets. These are all therapeutic applications.
No.
The device is a biodegradable, synthetic hydrogel material intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures. It acts as a barrier to support bone regeneration and does not perform any diagnostic function.
No
The device description clearly outlines physical components (syringes, activator, applicator tip) and a material (hydrogel) that is applied to the body. It is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Straumann MembraGel is "intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures." This describes a therapeutic or regenerative function within the body.
- Device Description: The description details a material that is applied directly to a surgical site to act as a barrier and support tissue regeneration. This is an in-vivo application.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. Straumann MembraGel does not perform this function.
The device is a surgical material used in vivo to support tissue regeneration, not a diagnostic tool used in vitro on patient samples.
N/A
Intended Use / Indications for Use
Straumann MembraGel is a biodegradable, synthetic, in situ forming hydrogel material. It is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets. Because MembraGel is not self-supporting, it must be used in combination with a bone graft material in order to maintain space under the membrane.
Product codes
NPK
Device Description
Straumann® MembraGel is a sterile, synthetic, degradable barrier membrane for single patient use. It is composed of two liquid poly(ethylene glycol) (PEG) compounds forming a hydrogel upon mixing. Straumann MembraGel is applied as a viscous liquid and gels on the application site within approximately 20 to 50 seconds. Straumann MembraGel acts as a barrier that inhibits non-osteogenic soft tissue cells of the overlying soft tissue from entering the defect site thereby supporting undisturbed regeneration of alveolar bone. Degradation of Straumann MembraGel by hydrolysis starts during normal wound healing. Straumann MembraGel must be stored refrigerated between 2-8°C (36-46°F). The application volume of Straumann MembraGel is 0.8 ml for approximately 5-7cm² coverage.
The Straumann MembraGel kit contains:
- Two glass syringes each filled with a PEG component (PEG A and PEG B) mounted in a plastic holder.
- Two plastic syringes each filled with an activator (Activator A and Activator B) in a plastic holder.
- One applicator tip (a static mixer connected to an adapter).
All components are delivered sterile and must be used immediately after opening of the blister packaging in an aseptic surgical environment. See Instructions for use handling instructions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral tissue components, peri-implant defects, bone defects, deficient alveolar ridges, extraction sockets
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)
Verification and validation testing were performed to ensure that the Straumann MembraGel functions as intended and that the modification did not impact the essential performance of the MembraGel. The testing performed on the MembraGel included:
- Biocompatibility:
- Cytotoxicity: Cytotoxic measurements results equal to or less than the predicate. Results: Non-cytotoxic.
- Acute Systemic Toxicity: Acute Systemic Toxicity results equal to or less than the predicate. Results: Non-toxic.
- SQ Implantation (4 Weeks) - Rabbits: SQ Implantation results equal to or less than the predicate. Results: Slight Irritant (Response noted was typical for similar absorbable materials subcutaneously implanted).
- Gelation time: Acceptance criteria: 20-50 sec. Results: Passed.
- In-vitro water uptake of the gelled product: Acceptance criteria: Less than 20%wt within 4h after gelation. Results: Passed.
- In-vitro degradation pattern and time: Acceptance criteria: Following a defined degradation kinetics ending in complete disintegration of the MembraGel. Results: Passed.
The results from the testing conducted, demonstrated that the Straumann MembraGel functions as intended and met pre-determined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Straumann MembraGel (K082111)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the Straumann logo. The logo consists of a stylized symbol on the left and the word "straumann" in bold, sans-serif font on the right. The symbol appears to be two parallel lines angled upwards, creating a sense of forward movement.
510(k) SUMMARY
DEC 1 6 2010
A. Submitter's Information
| Name: | Straumann US (on behalf of Institut Straumann AG) |
|---|---|
| Address: | 60 Minuteman Road |
| Andover, MA 01810 | |
| Phone: | (800) 448-8168, ext 2575 |
| Fax Number: | 978-747-0023 |
| Contact Person: | Janet C. Kay, Director Regulatory Affairs |
B. Date Summary Prepared: August 17, 2010
C. Device Name:
| Propriety Name: | Straumann MembraGel |
|---|---|
| Common/Usual Name: | Bone grafting material |
| Classification Name: | Barrier, Synthetic, Intraoral |
| Classification Number: | Class II Part 872.3930 |
| Product Code/Review Panel | NPK |
D. Predicate Device Name:
- Straumann MembraGel (K082111, 5/22/09) .
E. Description of the Device
Straumann® MembraGel is a sterile, synthetic, degradable barrier membrane for single patient use. It is composed of two liquid poly(ethylene glycol) (PEG) compounds forming a hydrogel upon mixing. Straumann MembraGel is applied as a viscous liquid and gels on the application site within approximately 20 to 50 seconds. Straumann MembraGel acts as a barrier that inhibits non-osteogenic soft tissue cells of the overlying soft tissue from entering the defect site thereby supporting undisturbed regeneration of alveolar bone. Degradation of
1
Straumann MembraGel by hydrolysis starts during normal wound healing. Straumann MembraGel must be stored refrigerated between 2-8°C (36-46°F). The application volume of Straumann MembraGel is 0.8 ml for approximately 5-7cm² coverage.
The Straumann MembraGel kit contains:
- Two glass syringes each filled with a PEG component (PEG A and PEG B) 1. mounted in a plastic holder.
- Two plastic syringes each filled with an activator (Activator A and Activator 2. B) in a plastic holder.
- One applicator tip (a static mixer connected to an adapter). 3.
All components are delivered sterile and must be used immediately after opening of the blister packaging in an aseptic surgical environment. See Instructions for use handling instructions.
F. Intended Use of the Device
Straumann MembraGel is a biodegradable, synthetic, in situ forming hydrogel material. It is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets. Because MembraGel is not self-supporting, it must be used in combination with a bone graft material in order to maintain space under the membrane.
G. Technological Characteristics
The proposed device is substantially equivalent to currently marketed device. The intended use is the same as the intended use of the predicate device. The proposed MembraGel has the same design and fundamental operating principles as the predicate device. The changes to the material composition had no impact to the final design of the product and remains substantially equivalent to the predicate device, Table 1 demonstrates the technological modifications made to MembraGel compared to the currently marketed predicate device.
101956
2
Table 1
| Features | Modified Straumann MembraGel | Straumann
MembraGel
K082111 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Operating
Principle | Straumann MembraGel is applied on the site in
liquid form through a syringe applicator | Identical |
| Physical
Properties | Initial swelling of Straumann MembraGel
samples meet internal specifications
Gelation time of the Straumann® MembraGel
kit between 20 and 50s
A degradation pattern meets internal
specifications including complete degradation of
the Straumann MembraGel. | Identical |
| Tissue
Occlusive
Properties | Tissue occlusive properties depend on the
physical properties of the PEG network, which is
governed density of the crosslink. Cell
occlusivity is determined by the degradation
pattern and time. Thus, tissue occlusive
properties were not impacted by this
modification. | Identical |
| Viscosity | The viscosity of the formulation is determined
by the Activators present in solution A and B.
These solutions were not impacted by the
modification described in this 510(k) | Identical |
| Water uptake
of the gelled
product | The modified device was required to meet the
original specification | Identical |
H. Performance Testing
Verification and validation testing were performed to ensure that the Straumann MembraGel functions as intended and that the modification did not impact the essential performance of the MembraGel. The Table 2 describes the testing performed on the MembraGel included:
3
Table 2
| Test performed | Acceptance criteria | Results |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Cytotoxic measurements results equal | |
| to or less than the predicate | Non-cytotoxic | |
| Acute Systemic | ||
| Toxicity | Acute Systemic Toxicity results equal | |
| to or less than the predicate | Non-toxic | |
| SQ Implantation (4 | ||
| Weeks) - Rabbits | SQ Implantation results equal to or | |
| less than the predicate | Slight Irritant1 | |
| Gelation time | 20-50 sec | Passed |
| In-vitro water | ||
| uptake of the gelled | ||
| product | Less than 20%wt within 4h after | |
| gelation | Passed | |
| In-vitro degradation | ||
| pattern and time | Following a defined degradation | |
| kinetics ending in complete | ||
| disintegration of the MembraGel | Passed |
1 Response noted was typical for similar absorbable materials subcutaneously implanted
I. Conclusion
The results from the testing conducted, demonstrated that the Straumann MembraGel functions as intended and met pre-determined acceptance criteria.
The Straumann MembraGel is a validated system. The results of performance testing, biocompatibility testing, and risk analysis indicate that the Straumann MembraGel is substantially equivalent to the named predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text appears to be part of a document or sign.
DEC 1 6 - 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Janet C. Kay Director, Regulatory Affairs Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
.Re: K101956
Trade/Device Name: Straumann MembraGel"" Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: December 6, 2010 Received: December 7, 2010
Dear Ms. Kay:
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.
5
Page 2- Ms. Kay
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 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
5l0(k) Number (if known)
Straumann MembraGel™ Device Name:
Indications for Use:
Straumann MembraGel is a biodegradable, synthetic, in situ forming hydrogel material. It is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets. Because MembraGel is not self-supporting, it must be used in combination with a bone graft material in order to maintain space under the membrane.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use _ (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punno
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: