(184 days)
Not Found
No
The device description focuses on the material composition and physical properties of a biodegradable membrane and tacks for guided tissue regeneration. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for the surgical treatment of periodontal defects, pre-implant and peri-implant surgery, and for covering bone defects and empty sockets, which are all therapeutic interventions.
No.
The device is a biodegradable membrane system used in surgical procedures for tissue regeneration, not for diagnosing conditions.
No
The device description explicitly states that the device consists of physical components: membranes and tacks made of degradable co-polymers. This is a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 outside of the body (in vitro) to provide information about a person's health.
- Device Description and Intended Use: The Inion GTR™ Biodegradable Membrane System is a physical barrier membrane and tacks used during surgery to aid in tissue regeneration within the body. It is implanted directly into the patient.
- Lack of Diagnostic Function: The device does not analyze biological samples or provide diagnostic information. Its function is structural and regenerative within the body.
Therefore, the Inion GTR™ Biodegradable Membrane System is a surgical implant/device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Inion GTR™ Biodegradable Membrane System is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures (e.g. class II furcation defects, intrabony defects and recession type defects), for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
Product codes
LYC, NPK
Device Description
The Inion GTR™ Biodegradable Membrane System, intended to be used as a barrier membrane in GTR (guided tissue regeneration ) and GBR (guided bone regeneration), consists of membrancs and separately available tacks made of degradable co-polymers composed of L-lactic, D-lactic, glycolic acid and trimethylene carbonate.
The membrane provides a barrier that is stable over 8-12 weeks in vivo. Bioresorption takes place within one to two years. NMP (N-methyl-2-pyrrolidone) plasticizer temporarily softens the membrane and is used to facilitate the handling and shaping of the membrane. Plasticizer is added into the membrane just before the operation.
The membranes are fastened in position by using separately available Inion GTR™ tacks or commercially available resorbable sutures. The Inion GTR™ Biodegradable System tack looses its strength over 12-26 weeks in vitro with complete strength loss and resorption within two to four years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal, bone
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
MAR 3 1 2004
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K033074", underlined with a straight line. The characters are written in a simple, slightly irregular style, suggesting they were written quickly or by someone without formal calligraphy training. The contrast between the dark ink and the white background makes the characters easily readable.
Image /page/0/Picture/2 description: The image shows the word "INION" in large, bold, white letters against a black background. Below the word "INION" is the phrase "Intelligent Solution" in a smaller, italicized white font. The overall design is simple and modern, with a focus on the company name and its promise of intelligent solutions.
510(k) SUMMARY
Product: Inion GTR™ Biodegradable Membrane System Date: 09/19/2003
MANUFACTURER
Inion Ltd. Lääkärinkatu 2 FIN-33520 Tamperc
Contact Person: Hanna Marttila Regulatory Affairs Coordinator Lääkärinkatu 2 FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 601 Hanna.marttila@inion.fi
DEVICE NAME
Trade name: Inion GTR™ Biodegradable Membrane System Common/Usual Name: Biodegradable GTR™Membrane and Tacks
ESTABLISHMENT REGISTRATION NUMBER
9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
Classification panel: Dental Regulatory Class: Unclassified Bone Filling Augmentation Material has been assigned Product Code LYC.
GTR Membrane
Date: 19.9.2003 Status: Final
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PREDICATE DEVICES
- (1) Atrix Laboratories, Inc .; Atrisorb@Bioabsorbable Guided Tissue Regeneration (GTR) Barrier (K955838)
- (2) W.L. Gore & Associates, Inc .; Gore Resolut™ XT Regenerative Material (973594) and Gore OsseoQuest Regenerative Membrane (K973594)
- Geistlich- Pharma; Resor Pin Resorbable Membrane Pin (K972817) (3)
INTENDED USE
1.1 Indications for Use
The Inion GTR™ Biodegradable Membrane System is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures (e.g. class II furcation defects, intrabony defects and recession type defects), for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
1.2 Contraindications
The Inion GTR™ Biodegradable Membranc System should not be used in patients with active or potential infections, patient conditions including limited blood supply, when patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse), and in load bearing indications unless used in conjunction with traditional rigid fixation. There are currently no known additional contraindications to the use of the Inion GTR™ Biodegradable Membranc.
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The Inion GTR™ Biodegradable Membrane System, intended to be used as a barrier membrane in GTR (guided tissue regeneration ) and GBR (guided bone regeneration). consists of membrancs and separately available tacks made of degradable co-polymers composed of L-lactic, D-lactic, glycolic acid and trimethylene carbonate.
The membrane provides a barrier that is stable over 8-12 weeks in vivo. Bioresorption takes place within one to two years. NMP (N-methyl-2-pyrrolidone) plasticizer temporarily softens the membrane and is used to facilitate the handling and shaping of the membrane. Plasticizer is added into the membrane just before the operation.
2
The membranes are fastened in position by using separately available Inion GTR™ tacks or commercially available resorbable sutures. The Inion GTR™ Biodegradable System tack looses its strength over 12-26 weeks in vitro with complete strength loss and resorption within two to four years.
EQUIVALENCE TO MARKETED PRODUCTS
The Inion GTR™ Biodegradable Membrane System is substantially equivalent to those of the previously accepted and clinically successfully used biodegradable GTR membranes and tacks intended for similar indications.
Inion GTR™ Biodegradable Membranc System Atrisorb@Bioabsorbable Guided Tissue Regeneration (GTR) Barrier (K955838), Gore Resolut™ XT Regenerative Material and OsscoQuest Regenerative Membrane (K973594) and Resor Pin Resorbable Membrane Pin (K972817) have the same principles of operation and very similar design characteristics. Extensively testing demonstrates that the device is substantially equivalent to the predicate ones. Differences between the Inion GTR™ Biodegradable Membrane System and predicate devices do not raise any new questions of safety and effectiveness.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized image of a human figure embracing a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
OCT 1 0 2007
Ms. Hanna Marttila Regulatory Affairs Inion Limited Laakarinkatu 2 FIN-33520 Tampere FINLAND
Re: K033074 Trade Name: Inion GTR™ Biodegradable Membrane Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: January 13, 2004 Received: January 15, 2004
Dear Ms. Marttila:
This letter corrects our substantially equivalent letter of March 31, 2004.
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 (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.
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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); 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.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html
Sincerely yours,
Suyite Y. Michiu O.M.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Protecting and Promoting Public Health
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Indications for Use
510(k) Number (if known): K033074
Device Name: Inion GTR™ Biodegradable Membrane
Indications For Use:
The Inion GTR™ Biodegradable Membrane System is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures (e.g. class II furcation defects, intrabony defects and recession type defects), for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
Prescription Use
(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)
Susa Rumn
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental D
510(k) Number
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