(298 days)
Not Found
No
The summary describes a biodegradable hydrogel material for guided bone regeneration and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures, which is a therapeutic purpose.
No
The device, Straumann MembraGel, is described as a biodegradable, synthetic hydrogel material intended to aid in tissue regeneration, acting as a barrier membrane. Its purpose is therapeutic (tissue regeneration) rather than diagnostic (identifying a condition or disease).
No
The device is described as a "biodegradable, synthetic, in situ forming hydrogel material" and a "sterile, synthetic, biodegradable barrier membrane," indicating it is a physical material, not software.
Based on the provided information, Straumann MembraGel is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Straumann MembraGel's Intended Use: The intended use of Straumann MembraGel is to aid in the regeneration and integration of oral tissue components in vivo (within the living body) during surgical procedures. It is a material implanted into the body, not a test performed on a sample outside the body.
- Device Description: The description confirms it is a sterile, synthetic, biodegradable barrier membrane for single patient use, intended for use in vivo.
Therefore, Straumann MembraGel falls under the category of a medical device used for surgical procedures and tissue regeneration, not an in vitro diagnostic device.
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 reqeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets.
Because Straumann 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 (comma separated list FDA assigned to the subject device)
NPK
Device Description
Straumann® MembraGel is a sterile, synthetic, biodegradable barrier membrane for single patient use. It is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral tissue, peri-implant, bone defects, 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)
Not Found
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
§ 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
Section L 510(k) Summary
1. Applicant's Name and Address
Straumann US (on behaif of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Contact Person: Lisa Quaglia Director, Regulatory Affairs
MAY 22 2009
2. Name of the Device
| Trade Name: | Straumann® MembraGel |
|---|---|
| Common Name: | Bone grafting material |
| Classification Name: | Barrier, Synthetic, Intraoral |
| Regulation Number: | §872.3930 |
Legally Marketed Device to which Equivalence is Claimed (Predicate Device) 3.
BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration (K050446)
ATRISORB® FreeFlow™ GTR Barrier (K982865)
4. Description of the Device
Straumann® MembraGel is a sterile, synthetic, biodegradable barrier membrane for single patient use. It is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures.
5. Intended Use of the Device
Straumann® MembraGel is a biodedradable, synthetic, in situ forming hydrogel material. It is intended to aid in the regeneration and integration of oral tissue components in quided bone regeneration procedures. This includes the surgical treatment of periimplant defects, bone defects, deficient alveolar ridges, and extraction sockets.
Because Straumann® MembraGel is not self supporting it must be used in combination with a bone graft material in order to maintain space under the membrane.
6. Technological Characteristics
The proposed Straumann® MembraGel is substantially equivalent to the currently marketed devices. The intended use is the same as the intended uses of the predicate devices. The proposed hydrogel has the similar material composition, basic design and fundamental operating principles to the currently marketed devices.
Straumann US Page 6 of 24
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is printed in black and white.
Public Health Service
22 2009 MAY
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institut Straumann AG C/o Ms. Lisa M. Quaglia Regulatory Affairs Director Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K082111
Trade/Device Name: Straùmann® MembraGel Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: May 21, 2009 Received: May 22, 2009
Dear Ms. Quaglia:
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.
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.
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Page 2- Ms. Quaglia
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours. ling for Assem
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
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 reqeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets.
Because Straumann MembraGel is not self supporting it must be used in combination with a bone graft material in order to maintain space under the membrane.
Kein Muley for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082111
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
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)
Page 1 of 1
510(k) Submission: Straumann® MembraGel K082111/A3 - Response to FDA Questions Proprietary and Confidential May 21, 2009 ·
Straumann US Page 7 of 24