(234 days)
No
The device description and intended use clearly define a resorbable collagen membrane for guided tissue and bone regeneration, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies listed are standard biocompatibility, sterilization, and physical property tests for a medical device of this type.
Yes
The device is a completely resorbable collagen membrane used in various surgical procedures to support guided tissue regeneration and bone regeneration, which are therapeutic interventions.
No
Explanation: The device is a resorbable collagen membrane used for guided tissue and bone regeneration, acting as a barrier. It does not identify or analyze a disease or condition.
No
The device description clearly states it is a physical collagen membrane produced from porcine pericardium, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical procedures related to bone and tissue regeneration. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a resorbable collagen membrane implanted into the body. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The device is a surgical implant used to support tissue and bone regeneration during various dental and maxillofacial procedures.
N/A
Intended Use / Indications for Use
Jason Membrane alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is indicated for immediate or delayed guided tissue and bone regeneration.
- in case of surgical bone defects and bone wall defects ●
- . in the context of sinus floor augmentation and for support of the Schneiderian membrane
- . in the context of maxillary ridge augmentation
- in the context of maxillary ridge reconstruction for prosthetic treatment
- . in the context of a treatment of fenestration defects
- in case of periodontal bone defects (one to three-wall defects, class I and II furcation defects)
- in case of dehiscence defects
- after apicoectomy, cystectomy, resection of retained teeth . and resection of other bone lesions
- . in extraction sockets after tooth extractions
- . in case of immediate or delayed augmentation around implants in extraction sockets
Product codes
NPL
Device Description
Jason® Membrane is a completely resorbable collagen membrane used in maxillofacial surgery, implantology, periodontology, oral surgery and endodontology as a barrier membrane to support guided tissue regeneration (GTR) and guided bone regeneration (GBR), for covering implants and for periodontal tissue regeneration. Jason membrane is produced from porcine pericardium in a standardized, controlled purification process. When dry Jason Membrane is a white collagen matrix with a very dense fiber structure. It possesses sufficient rigidity and stability for a broad variety of intended uses. Jason Membrane possesses a physiological neutral pH-value. Jason Membrane typically resorbs within 12 weeks after implantation.
Jason Membrane is offered in three sizes as shown below.
Article No. | Size | Content
BS-681520 | 15 × 20 mm | 1 membrane
BS-682030 | 20 × 30 mm | 1 membrane
BS-683040 | 30 × 40 mm | 1 membrane
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
- Validation of Primary and Secondary barrier packaging per ISO 11607-2
- Validation of transport packaging per ASTM D4169
- Validation of sterilization parameters per ISO 11135
- Biocompatibility per ISO 10993-1 and the following:
- Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10
- Irritation per ISO 10093-10
- Subchronic Toxicity per ISO 10993-11
- Genotoxicity per ISO 10993-3
- Implantation per ISO 10993-6
- Material mediated pyrogenicity per Ph.Eur.
- Viral Inactivation per ISO 22442-3
- Validation of shelf life per ASTM F1980 using age accelerated and real-time aged samples
- Physicochemical Characterization per ASTM F2212
- Tensile strength testing
- Suture pull-out strength testing
- Straumann sponsored animal study assessing soft tissue infiltration and membrane resorption kinetics of the subject device in an intra-oral critical size defect GBR model
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name, "U.S. Food & Drug Administration," written in blue text to the right of the square.
Institut Straumann AG % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K173562
Trade/Device Name: Straumann Jason Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: June 7, 2018 Received: June 8, 2018
Dear Jennifer Jackson:
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.
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 of medical device-related adverse events) (21 CFR 803); good
July 9, 2018
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Straumann® Jason® Membrane
Indications for Use (Describe)
Jason Membrane alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is indicated for immediate or delayed guided tissue and bone regeneration.
- in case of surgical bone defects and bone wall defects ●
- . in the context of sinus floor augmentation and for support of the Schneiderian membrane
- . in the context of maxillary ridge augmentation
- in the context of maxillary ridge reconstruction for prosthetic treatment
- in the context of a treatment of fenestration defects
- in case of periodontal bone defects (one to three-wall defects, class I and II furcation defects)
- in case of dehiscence defects
- after apicoectomy, cystectomy, resection of retained teeth and resection of other bone lesions
- in extraction sockets after tooth extractions
- . in case of immediate or delayed augmentation around implants in extraction sockets
Type of Use (Select one or both, as applicable)
|× Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 5. | 510(k) Summary | K173562 |
|---|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) | |
| 60 Minuteman Road | ||
| Andover, MA 01810 | ||
| Contact Person: | Jennifer M. Jackson, MS | |
| Director of Regulatory Affairs and Quality | ||
| +1 (978) 747-2509 | ||
| Prepared By & | ||
| Secondary Contact: | Christopher Klaczyk | |
| Head of Regulatory Affairs & Compliance | ||
| Institut Straumann AG | ||
| +41 61 965 1260 | ||
| Date Prepared: | July 6, 2018 | |
| Product Code(s): | NPL (21 CFR 872.3930) | |
| Device Class: | II | |
| (21 CFR 872.3930) | ||
| Classification Panel: | Dental | |
| Classification Name: | Bone grafting material (21 CFR 872.3930) | |
| Common Name | Barrier, animal source, intraoral | |
| Proprietary Name: | Straumann® Jason® Membrane | |
| Predicate Device(s): | K141177, Vitala® Porcine Derived Collagen Membrane | |
| (Osteogenics Biomedical) | ||
| Reference Device(s): | K050446, BIO-GIDE® (Geistlich) | |
| Device Description: | Jason® Membrane is a completely resorbable collagen | |
| membrane used in maxillofacial surgery, implantology, | ||
| periodontology, oral surgery and endodontology as a barrier | ||
| membrane to support guided tissue regeneration (GTR) and | ||
| guided bone regeneration (GBR), for covering implants and for | ||
| periodontal tissue regeneration. Jason membrane is produced | ||
| from porcine pericardium in a standardized, controlled | ||
| purification process. When dry Jason Membrane is a white | ||
| collagen matrix with a very dense fiber structure. It possesses | ||
| sufficient rigidity and stability for a broad variety of intended | ||
| uses. Jason Membrane possesses a physiological neutral pH- |
4
value. Jason Membrane typically resorbs within 12 weeks after implantation.
Jason Membrane is offered in three sizes as shown below.
| Article No. | Size | Content |
|---|---|---|
| BS-681520 | 15 × 20 mm | 1 membrane |
| BS-682030 | 20 × 30 mm | 1 membrane |
| BS-683040 | 30 × 40 mm | 1 membrane |
Picture of Device
Image /page/4/Picture/5 description: The image shows a white, rectangular object that appears to be made of a soft, textured material, possibly paper or fabric. The object is slightly crumpled and has a few wrinkles, which add to its tactile appearance. The background is a dark gray, which contrasts with the white object and makes it stand out. The lighting is soft and diffused, which creates a sense of depth and dimension.
Indications For Use:
Jason Membrane alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is indicated for immediate or delayed guided tissue and bone regeneration.
- in case of surgical bone defects and bone wall defects ●
- . in the context of sinus floor augmentation and for support of the Schneiderian membrane
- in the context of maxillary ridge augmentation
- in the context of maxillary ridge reconstruction for prosthetic treatment
- . in the context of a treatment of fenestration defects
- in case of periodontal bone defects (one to three-wall defects, class I and II furcation defects)
- in case of dehiscence defects
- after apicoectomy, cystectomy, resection of retained teeth . and resection of other bone lesions
- . in extraction sockets after tooth extractions
- . in case of immediate or delayed augmentation around implants in extraction sockets
5
| Materials: | Jason Membrane is manufactured from the pericardium of
domestic swine. The chemical content of 10 cm2 Jason
Membrane is:
• 30 - 40 mg collagen type I
• 5 - 10 mg purified water
• Up to 10% salts as sodium phosphate |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | A comparison of the relevant technological characteristics
between the subject and primary predicate devices is provided
in the table that follows. |
| Performance Data: | • Validation of Primary and Secondary barrier packaging per
ISO 11607-2
• Validation of transport packaging per ASTM D4169
• Validation of sterilization parameters per ISO 11135
• Biocompatibility per ISO 10993-1 and the following:
o Cytotoxicity per ISO 10993-5
o Sensitization per ISO 10993-10
o Irritation per ISO 10093-10
o Subchronic Toxicity per ISO 10993-11
o Genotoxicity per ISO 10993-3
• Implantation per ISO 10993-6
o Material mediated pyrogenicity per Ph.Eur.
• Viral Inactivation per ISO 22442-3
• Validation of shelf life per ASTM F1980 using age
accelerated and real-time aged samples
• Physicochemical Characterization per ASTM F2212
• Tensile strength testing
• Suture pull-out strength testing
• Straumann sponsored animal study assessing soft tissue
infiltration and membrane resorption kinetics of the subject
device in an intra-oral critical size defect GBR model |
| Conclusions: | Based upon our assessment of the design and applicable
performance data, the subject devices have been determined to
be substantially equivalent to the identified predicate devices. |
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| Feature | SUBJECT Device
Straumann Jason Membrane | Primary PREDICATE Device
Vitala Porcine Collagen Membrane
(K141177) | Equivalence Discussion |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Jason Membrane alone or in combination
with suitable augmentation materials (like
autogenous bone, allogeneic, xenogeneic or
alloplastic bone replacement materials) is
indicated for immediate or delayed guided
tissue and bone regeneration.
• in case of surgical bone defects and bone
wall defects
• in the context of sinus floor augmentation
and for support of the Schneiderian
membrane
• in the context of maxillary ridge
augmentation
• in the context of maxillary ridge
reconstruction for prosthetic treatment
• in the context of a treatment of
fenestration defects
• in case of periodontal bone defects (one to
three-wall defects, class I and II furcation
defects)
• in case of dehiscence defects
• after apicoectomy, cystectomy, resection
of retained teeth and resection of other
bone lesions
• in extraction sockets after tooth
extractions
• in case of immediate or delayed
augmentation around implants in
extraction sockets | Vitala Porcine Derived Collagen Membrane
is intended for use during the process of
guided bone regeneration (GBR) and guided
tissue regeneration (GTR) as a
biodegradable barrier for:
• Simultaneous use with implants;
• Augmentation around implants placed in
immediate extraction sockets;
• Augmentation around implants placed in
delayed extraction sockets;
• Localized ridge augmentation for later
implantation;
• Alveolar ridge reconstruction for prosthetic
treatment;
• Alveolar ridge preservation consequent to
tooth extraction;
• Filling of bone defects after root resection,
cystectomy, or removal of retained teeth;
• Over the window in lateral window sinus
elevation procedures;
• Furcation defects in multi-rooted teeth;
• Treatment of recession defects, together
with a coronally positioned flap;
• In implants with vertical bone loss due to
infection, only with satisfactory
debridement and implant surface
disinfection;
• GBR of dehiscence defects; and
• GTR in periodontal defects. | Equivalent
The indications for the subject device are a
subset of the indications for the predicate
device. |
| Feature | SUBJECT Device
Straumann Jason Membrane | Primary PREDICATE Device
Vitala Porcine Collagen Membrane
(K141177) | Equivalence Discussion |
| Mode of
Action | Jason functions as a barrier when applied
between bone graft material and soft tissue.
The membrane serves as a bioresorbable
scaffold that is eventually remodeled,
resorbed, and replaced by host tissue. | Vitala functions as a barrier when applied
between bone graft material and soft tissue.
The membrane serves as a bioresorbable
scaffold that is eventually remodeled,
resorbed, and replaced by host tissue. | Identical |
| Operating
Principles | Cell-Occlusive
Implantable
Resorbable
Biocompatible | Cell-Occlusive
Implantable
Resorbable
Biocompatible | Identical |
| Material | Intact purified collagen tissue | Intact purified collagen tissue | Identical |
| Collagen
Source | Porcine pericardium | Porcine pericardium | Identical |
| Form | Membrane | Membrane | Identical |
| Color | White to off-white | White to off-white | Identical |
| Sizes | Variety of sizes | Variety of sizes | Equivalent
Both devices are provided in clinically
relevant sizes for intra-oral surgical
procedures |
| Resorption
Time | Substantially resorbed by 12 Weeks | Substantially resorbed by 26 Weeks | Equivalent
While the subject device resorbs more
quickly than the primary predicate, the
endurance of the desired barrier properties is
sufficient to assure adequate new borne
formation without soft tissue infiltration. |
| Sterilization
Method | Ethylene Oxide | Irradiation | Equivalent
Both the subject and predicate devices
achieve a Sterility Assurance Level of 10-6. |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Identical |
| Feature | SUBJECT Device
Straumann Jason Membrane | Primary PREDICATE Device
Vitala Porcine Collagen Membrane
(K141177) | Equivalence Discussion |
| Single Use/
Reuse | Single use only | Single use only | Identical |
| Packaging | Double pouch pack | Double blister pack | Equivalent
Both devices are provided in two layers of
sterile barrier packaging. Both devices
facilitate the aseptic delivery of the sterile
device into the sterile surgical field. |
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