Straumann PrefGel by INSTITUT STRAUMANN AG

Straumann PrefGel is a neutral EDTA formulation intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear-layer. Mechanical debridement of a root surface inevitably produces a smear-layer, which in turn may prevent or retard periodontal healing. Exposure of collagen fibers may be important for linking fibrin in the blood clot to the root surface. Clinical studies with PrefGel have demonstrated the ability to remove the smear-layer and to expose the collagenous matrix of dentin surfaces.

AI/ML Overview

This document ([K162311](https://www.accessdata.fda.gov/cdrh_docs/pdf16/[K162311](https://510k.innolitics.com/search/K162311).pdf)) describes the Straumann PrefGel, a neutral EDTA formulation for topical application on exposed root surfaces during periodontal surgery to remove the smear layer. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily by detailing changes to the packaging system while asserting that the therapeutic material and indications for use remain unchanged. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance of the packaging and manufacturing processes to ensure the safety and effectiveness of the unchanged therapeutic material.

Here's an analysis of the provided information, framed as a response to your request, but with the understanding that this device is a chemical product and not an AI/ML powered device. Therefore, no AI/ML specific sections can be filled.

1. A table of acceptance criteria and the reported device performance

Since this is not an AI/ML enabled device, typical metrics like sensitivity, specificity, or AUC are not applicable. The acceptance criteria and performance are based on maintaining the safety and efficacy of the original product through changes in packaging and manufacturing processes.

Acceptance Criteria/Test	Reported Device Performance
Clean room qualification (per ISO14644-1)	Qualified
Secondary packaging equipment qualification (consistent with ISO 11607 series)	Qualified
Syringe filling, labeling, and assembly process validation	Validated
Transport validation (per ISTA 2A)	Adequately protects the product
Biocompatibility assessment (per ISO 10993-1, ISO 10993-5, and ISO 10993-18)	Assessed (The therapeutic material is unchanged, implying continued biocompatibility.)
Ethylene oxide sterilization validation (per ISO 11135 and ISO 11737-2)	Validated to a Sterility Assurance Level (SAL) of 10-6
Ethylene oxide residuals testing (per ISO 10993-7)	Tested
Simulated use validation (to assure proper use of the proposed Tip Cap)	Validated (Clinicians will be able to properly use the proposed Tip Cap)
Primary Package (Syringe)	Equivalent to predicate (glass syringe with compatible plunger components, back stop added for glass syringe functionality)
Secondary Package (Blister)	Equivalent to predicate (same material blister tray, Tyvek 1073B lid stock with additional durability)
Tertiary Package (Shelf box)	Equivalent to predicate (same material cardboard, changed configuration to accept larger secondary blister)
Sterility - Primary (In syringe)	Identical to predicate (produced in same clean rooms, sterilizers, and aseptic conditions)
Sterility - Secondary (After blister packaging)	Identical to predicate (adopted into same EtO sterilization cycle as predicate, validated to SAL of 10-6, new clean room facilities for internal packaging)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical or diagnostic performance for the device itself, as the therapeutic material remains unchanged. The studies described are engineering and manufacturing validations. Therefore, sample sizes would be implicit in standard validation protocols for each specific test (e.g., a certain number of syringes for filling validation, a certain number of packages for transport validation). The provenance is from Institut Straumann AG (Switzerland) and Straumann USA, LLC (USA), as the submitter and manufacturer are based there. The studies are prospective in nature, as they are validations of new or modified manufacturing processes and packaging.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is not a diagnostic device and no clinical or diagnostic "ground truth" was established for a test set in the conventional sense. The "ground truth" here is adherence to engineering and quality standards, established by qualified personnel in the respective fields (e.g., sterilization experts, packaging engineers, biocompatibility specialists).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a diagnostic device that requires expert adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a chemical product for topical application and does not involve human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or an AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on:

Engineering and Manufacturing Standards: Adherence to international standards (e.g., ISO 14644-1 for clean rooms, ISO 11607 series for packaging, ISO 11135 for sterilization, ISO 10993 series for biocompatibility).
Functional Equivalence: Demonstration that the new packaging components and processes perform equivalently to or better than the predicate device's components and processes, ensuring the therapeutic material's integrity and safe delivery.
Simulated Use: Validation that the device can be properly used by clinicians.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not have a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2017

Institut Straumann Ag % Jennifer Jackson Director Of Regulatory Affairs And Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K162311

Trade/Device Name: Straumann PrefGel Regulation Number: 21 CFR None Regulation Name: None Regulatory Class: Unclassified Product Code: KJJ Dated: February 5, 2017 Received: February 7, 2017

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

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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 devicerelated 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 Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,

Susan Runno DDS, MA

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® PrefGel®

Indications for Use (Describe)

Straumann PrefGel is intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear layer.

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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K162311 510(k) Summary

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and Quality+1 (978) 747-2509
Prepared By:	Christopher KlaczykHead of North American Regulatory AffairsInstitut Straumann AG+41 61 965 1260
Date Prepared:	March 7, 2017
Product Code(s):	KJJ
Device Class:	Unclassified (pre-amendments device)
Classification Reg.:	N/A
Classification Panel:	Dental
Classification Name:	Cleanser, root canal
Proprietary Name:	Straumann® PrefGel®
Predicate Device(s):	K063812, Straumann® PrefGel® (Institut Straumann AG)
Reference Device(s)	None
Device Description:	Straumann PrefGel is a neutral EDTA formulation intended fortopical application onto exposed root surfaces duringperiodontal surgery in order to remove the smear-layer.Mechanical debridement of a root surface inevitably produces asmear-layer, which in turn may prevent or retard periodontalhealing. Exposure of collagen fibers may be important forlinking fibrin in the blood clot to the root surface. Clinicalstudies with PrefGel have demonstrated the ability to removethe smear-layer and to expose the collagenous matrix of dentinsurfaces.
Indications For Use	Straumann PrefGel is intended for topical application ontoexposed root surfaces during periodontal surgery in order toremove the smear layer.
Intended Use:	PrefGel has been shown to effectively remove the smear-layer.PrefGel has also been shown to produce a fibrillar collagenousmeshwork on the exposed and conditioned root surface byselective removal of mineral.
Materials:	Edetate disodium [EDTA] 2 H2O 24% neutral in carboxymethylcellulose (CMC) gel
TechnologicalCharacteristics:	This submission describes an alternate packaging system for theStraumann® PrefGel® product. We have proposed changes tothe primary, secondary and tertiary packaging. The therapeuticmaterial (EDTA 2 H2O 24% neutral in CMC gel) remainsunchanged, as does the Indications For Use. The table thatfollows provides a side-by-side comparison of the subjectdevice to the predicate device.
Performance Data:	Test data to support the evaluation of the Straumann® PrefGel®product has been included directly or by reference as follows:• Clean room qualification per ISO14644-1.• Secondary packaging equipment qualification consistentwith the ISO 11607 series of standards.• Syringe filling labeling and assembly process validation.• Transport validation per ISTA 2A to assure proposedpackaging adequately protects the product.• Biocompatibility assessment per ISO 10993-1, ISO 10993-5and ISO 10993-18.• Ethylene oxide sterilization validation per ISO 11135 andISO 11737-2.• Ethylene oxide residuals testing per ISO 10993-7.• Simulated use validation to assure that clinicians will be ableto properly use the proposed Tip Cap.
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	Primary PredicateStraumann® PrefGel®(K063812)	Subject DeviceStraumann® PrefGel®	EquivalenceDiscussion
Indications For Use	Straumann PrefGel is intended for topicalapplication onto exposed root surfaces duringperiodontal surgery in order to remove thesmear layer.	Straumann PrefGel is intended for topicalapplication onto exposed root surfaces duringperiodontal surgery in order to remove thesmear layer.	Identical Indications For UseThe changes to the primary (syringe),secondary (blister) and tertiary (Shelf box)packaging of the subject devices do not resultin a modification in the Indications For Use.
Therapeutic Material	0.6 ml of edetate disodium [EDTA] 2 H2O24% neutral in carboxymethyl cellulose(CMC) gel	0.6 ml of edetate disodium [EDTA] 2 H2O24% neutral in carboxymethyl cellulose(CMC) gel	Identical Therapeutic MaterialThe changes to the primary (syringe),secondary (blister) and tertiary (Shelf box)packaging of the subject devices do not affectthe formulation of the therapeutic materialcontained within the primary package.Because the therapeutic material isunchanged, the Indications For Use have notchange.
Primary Package	Syringe Barrel (COC, TOPAS® 6013)Siliconization: (NuSil MED 361 &MED1-4158)Tip Cap (bromobutyl rubber)Plunger (bromobutyl rubber)Plunger Rod (polypropylene)	Syringe Barrel (Type I borosilicate glass)Siliconization: (Dow Corning MedicalFluid 360)Tip Cap (West Pharma poly-isoprenerubber)Plunger (West Pharma elastomer)Plunger Rod (polystyrene)Back Stop (polypropylene)	Equivalent Primary PackageThe subject device will now use a glasssyringe with compatible plunger components.The predicate uses a plastic syringe withcompatible plunger components. In bothcases the product contacting materials havebeen shown to be compatible with thetherapeutic material. The addition of a backstop is specific to the use of the glass syringeand replicates functionality that is molded intothe predicate plastic syringe.
Feature	Primary PredicateStraumann® PrefGel®(K063812)	Subject DeviceStraumann® PrefGel®	EquivalenceDiscussion
Secondary Package	Thermoformed Tray (PETG)Lid Stock(Medical Paper)	Thermoformed Tray (PETG)Lid Stock(Tyvek 1073B)	Equivalent Secondary PackageThe blister tray is the same material; only theform has changed. Both the subject andpredicate lid stocks are accepted for sterilebarrier applications. The change to Tyvek1073B adds additional durability and isconsistent with other products produced atBiora AB.
Tertiary Package	Bleached and printed cardboard	Bleached and printed cardboard	Equivalent Tertiary PackageThe material used for the tertiary protectivepackaging (i.e. shelf box) is the same. Thepackage configuration has been changed toaccept the larger secondary blister package.The packaging has been verified to adequatelyprotect the product.
Product Configurations	5-Pack:Five PrefGel TraysFive Sterile Blunt Cannulae	5-Pack:Five PrefGel TraysFive Sterile Blunt Cannulae	Identical Product ConfigurationThe changes to the primary (syringe),secondary (blister) and tertiary (Shelf box)packaging of the subject devices have notresulted in a change to the productconfigurations offered. The blunt cannulaeused with the subject devices are the sameones used for the predicate devices.
Sterility - Primary	Cleanroom environment, sterilization by heat(121℃) and aseptic technique.	Cleanroom environment, sterilization by heat(121℃) and aseptic technique.	Identical Sterilization of Primary PackageThe subject devices continue to be producedin the same clean rooms, sterilizers andaseptic conditions as the predicate devicesthrough the primary packaging (syringe)stage.
Feature	Primary PredicateStraumann® PrefGel®(K063812)	Subject DeviceStraumann® PrefGel®	EquivalenceDiscussion
Sterility - Secondary	Ethylene oxide gas to a Sterility AssuranceLevel (SAL) of 10-6	Ethylene oxide gas to a Sterility AssuranceLevel (SAL) of 10-6	Identical Sterility of Secondary PackageThe subject devices have been adopted intothe same EtO sterilization cycle as thepredicate device. This cycle has beenvalidated to an SAL of 10-6. New clean roomfacilities have been built to accommodate thesecondary packaging operations internal toBiora AB-this operation is no longer out-sourced.

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Regulation Number and Section

N/A