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

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.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Straumann Jason Membrane," detailing its regulatory classification, indications for use, and a comparison to a predicate device. It also lists various performance data that were validated, such as packaging, sterilization, biocompatibility, and shelf life, including an animal study. However, specific acceptance criteria for these tests or the detailed results demonstrating that the device meets them are not provided. Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the other requested details about a study.

Summary

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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

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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)

K173562

Device Name

Straumann® Jason® Membrane

Indications for Use (Describe)

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 RoadAndover, MA 01810
	Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and Quality+1 (978) 747-2509
	Prepared By &Secondary Contact:	Christopher KlaczykHead of Regulatory Affairs & ComplianceInstitut 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 collagenmembrane used in maxillofacial surgery, implantology,periodontology, oral surgery and endodontology as a barriermembrane to support guided tissue regeneration (GTR) andguided bone regeneration (GBR), for covering implants and forperiodontal tissue regeneration. Jason membrane is producedfrom porcine pericardium in a standardized, controlledpurification process. When dry Jason Membrane is a whitecollagen matrix with a very dense fiber structure. It possessessufficient rigidity and stability for a broad variety of intendeduses. Jason Membrane possesses a physiological neutral pH-

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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:

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

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Materials:	Jason Membrane is manufactured from the pericardium ofdomestic swine. The chemical content of 10 cm2 JasonMembrane is:• 30 - 40 mg collagen type I• 5 - 10 mg purified water• Up to 10% salts as sodium phosphate
TechnologicalCharacteristics:	A comparison of the relevant technological characteristicsbetween the subject and primary predicate devices is providedin the table that follows.
Performance Data:	• Validation of Primary and Secondary barrier packaging perISO 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 10993-5o Sensitization per ISO 10993-10o Irritation per ISO 10093-10o Subchronic Toxicity per ISO 10993-11o Genotoxicity per ISO 10993-3• Implantation per ISO 10993-6o Material mediated pyrogenicity per Ph.Eur.• Viral Inactivation per ISO 22442-3• Validation of shelf life per ASTM F1980 using ageaccelerated and real-time aged samples• Physicochemical Characterization per ASTM F2212• Tensile strength testing• Suture pull-out strength testing• Straumann sponsored animal study assessing soft tissueinfiltration and membrane resorption kinetics of the subjectdevice in an intra-oral critical size defect GBR model
Conclusions:	Based upon our assessment of the design and applicableperformance data, the subject devices have been determined tobe substantially equivalent to the identified predicate devices.

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Feature	SUBJECT DeviceStraumann Jason Membrane	Primary PREDICATE DeviceVitala Porcine Collagen Membrane(K141177)	Equivalence Discussion
Indicationsfor Use	Jason Membrane alone or in combinationwith suitable augmentation materials (likeautogenous bone, allogeneic, xenogeneic oralloplastic bone replacement materials) isindicated for immediate or delayed guidedtissue and bone regeneration.• in case of surgical bone defects and bonewall defects• in the context of sinus floor augmentationand for support of the Schneiderianmembrane• in the context of maxillary ridgeaugmentation• in the context of maxillary ridgereconstruction for prosthetic treatment• in the context of a treatment offenestration defects• in case of periodontal bone defects (one tothree-wall defects, class I and II furcationdefects)• in case of dehiscence defects• after apicoectomy, cystectomy, resectionof retained teeth and resection of otherbone lesions• in extraction sockets after toothextractions• in case of immediate or delayedaugmentation around implants inextraction sockets	Vitala Porcine Derived Collagen Membraneis intended for use during the process ofguided bone regeneration (GBR) and guidedtissue regeneration (GTR) as abiodegradable barrier for:• Simultaneous use with implants;• Augmentation around implants placed inimmediate extraction sockets;• Augmentation around implants placed indelayed extraction sockets;• Localized ridge augmentation for laterimplantation;• Alveolar ridge reconstruction for prosthetictreatment;• Alveolar ridge preservation consequent totooth extraction;• Filling of bone defects after root resection,cystectomy, or removal of retained teeth;• Over the window in lateral window sinuselevation procedures;• Furcation defects in multi-rooted teeth;• Treatment of recession defects, togetherwith a coronally positioned flap;• In implants with vertical bone loss due toinfection, only with satisfactorydebridement and implant surfacedisinfection;• GBR of dehiscence defects; and• GTR in periodontal defects.	EquivalentThe indications for the subject device are asubset of the indications for the predicatedevice.
Feature	SUBJECT DeviceStraumann Jason Membrane	Primary PREDICATE DeviceVitala Porcine Collagen Membrane(K141177)	Equivalence Discussion
Mode ofAction	Jason functions as a barrier when appliedbetween bone graft material and soft tissue.The membrane serves as a bioresorbablescaffold that is eventually remodeled,resorbed, and replaced by host tissue.	Vitala functions as a barrier when appliedbetween bone graft material and soft tissue.The membrane serves as a bioresorbablescaffold that is eventually remodeled,resorbed, and replaced by host tissue.	Identical
OperatingPrinciples	Cell-OcclusiveImplantableResorbableBiocompatible	Cell-OcclusiveImplantableResorbableBiocompatible	Identical
Material	Intact purified collagen tissue	Intact purified collagen tissue	Identical
CollagenSource	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	EquivalentBoth devices are provided in clinicallyrelevant sizes for intra-oral surgicalprocedures
ResorptionTime	Substantially resorbed by 12 Weeks	Substantially resorbed by 26 Weeks	EquivalentWhile the subject device resorbs morequickly than the primary predicate, theendurance of the desired barrier properties issufficient to assure adequate new borneformation without soft tissue infiltration.
SterilizationMethod	Ethylene Oxide	Irradiation	EquivalentBoth the subject and predicate devicesachieve a Sterility Assurance Level of 10-6.
Sterility	Sterile, SAL 10-6	Sterile, SAL 10-6	Identical
Feature	SUBJECT DeviceStraumann Jason Membrane	Primary PREDICATE DeviceVitala Porcine Collagen Membrane(K141177)	Equivalence Discussion
Single Use/Reuse	Single use only	Single use only	Identical
Packaging	Double pouch pack	Double blister pack	EquivalentBoth devices are provided in two layers ofsterile barrier packaging. Both devicesfacilitate the aseptic delivery of the steriledevice into the sterile surgical field.

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Regulation Number and Section

§ 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.