← Product Code KJJ · K162311 # Straumann PrefGel (K162311) _Institut Straumann AG · KJJ · Mar 7, 2017 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K162311 ## Device Facts - **Applicant:** Institut Straumann AG - **Product Code:** KJJ - **Decision Date:** Mar 7, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use Straumann PrefGel is intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear layer. ## Device Story Straumann PrefGel is a neutral EDTA gel (24% edetate disodium in carboxymethyl cellulose) used during periodontal surgery. The clinician applies the gel topically to exposed root surfaces. The EDTA chemically removes the smear layer produced by mechanical debridement, exposing the underlying collagenous matrix of the dentin. This exposure facilitates the linking of fibrin in blood clots to the root surface, potentially improving periodontal healing. The device is supplied in a pre-filled syringe with a blunt cannula for application. The current submission introduces updated primary, secondary, and tertiary packaging materials and configurations compared to the predicate, while the therapeutic formulation remains unchanged. ## Clinical Evidence No new clinical data was provided. Substantial equivalence is supported by bench testing, including clean room qualification (ISO 14644-1), packaging equipment validation (ISO 11607), transport validation (ISTA 2A), biocompatibility (ISO 10993-1, -5, -18), and sterilization validation (ISO 11135, ISO 11737-2, ISO 10993-7). ## Technological Characteristics Therapeutic agent: 24% edetate disodium [EDTA] 2 H2O in carboxymethyl cellulose (CMC) gel. Primary package: Type I borosilicate glass syringe, poly-isoprene rubber tip cap/plunger, polystyrene plunger rod, polypropylene back stop. Secondary package: PETG thermoformed tray with Tyvek 1073B lid stock. Sterilization: Heat (121°C) for primary package; Ethylene oxide (EtO) for secondary package (SAL 10^-6). ## Predicate Devices - Straumann® PrefGel® ([K063812](/device/K063812.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed inside a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all capital letters and is evenly spaced around the circle. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K162311 510(k) Summary | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
+1 (978) 747-2509 | | Prepared By: | Christopher Klaczyk
Head of North American Regulatory Affairs
Institut 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 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. | | Indications For Use | Straumann PrefGel is intended for topical application onto
exposed root surfaces during periodontal surgery in order to
remove the smear layer. | | Intended Use: | PrefGel has been shown to effectively remove the smear-layer.
PrefGel has also been shown to produce a fibrillar collagenous
meshwork on the exposed and conditioned root surface by
selective removal of mineral. | | Materials: | Edetate disodium [EDTA] 2 H2O 24% neutral in carboxymethyl
cellulose (CMC) gel | | Technological
Characteristics: | This submission describes an alternate packaging system for the
Straumann® PrefGel® product. We have proposed changes to
the primary, secondary and tertiary packaging. The therapeutic
material (EDTA 2 H2O 24% neutral in CMC gel) remains
unchanged, as does the Indications For Use. The table that
follows provides a side-by-side comparison of the subject
device 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 consistent
with the ISO 11607 series of standards.
• Syringe filling labeling and assembly process validation.
• Transport validation per ISTA 2A to assure proposed
packaging adequately protects the product.
• Biocompatibility assessment per ISO 10993-1, ISO 10993-5
and ISO 10993-18.
• Ethylene oxide sterilization validation per ISO 11135 and
ISO 11737-2.
• Ethylene oxide residuals testing per ISO 10993-7.
• Simulated use validation to assure that clinicians will be able
to properly use the proposed Tip Cap. | | 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 | {4}------------------------------------------------ {5}------------------------------------------------ | Feature | Primary Predicate
Straumann® PrefGel®
(K063812) | Subject Device
Straumann® PrefGel® | Equivalence
Discussion | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For Use | Straumann PrefGel is intended for topical
application onto exposed root surfaces during
periodontal surgery in order to remove the
smear layer. | Straumann PrefGel is intended for topical
application onto exposed root surfaces during
periodontal surgery in order to remove the
smear layer. | Identical Indications For Use
The changes to the primary (syringe),
secondary (blister) and tertiary (Shelf box)
packaging of the subject devices do not result
in a modification in the Indications For Use. | | Therapeutic Material | 0.6 ml of edetate disodium [EDTA] 2 H2O
24% neutral in carboxymethyl cellulose
(CMC) gel | 0.6 ml of edetate disodium [EDTA] 2 H2O
24% neutral in carboxymethyl cellulose
(CMC) gel | Identical Therapeutic Material
The changes to the primary (syringe),
secondary (blister) and tertiary (Shelf box)
packaging of the subject devices do not affect
the formulation of the therapeutic material
contained within the primary package.
Because the therapeutic material is
unchanged, the Indications For Use have not
change. | | 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 Medical
Fluid 360)
Tip Cap (West Pharma poly-isoprene
rubber)
Plunger (West Pharma elastomer)
Plunger Rod (polystyrene)
Back Stop (polypropylene) | Equivalent Primary Package
The subject device will now use a glass
syringe with compatible plunger components.
The predicate uses a plastic syringe with
compatible plunger components. In both
cases the product contacting materials have
been shown to be compatible with the
therapeutic material. The addition of a back
stop is specific to the use of the glass syringe
and replicates functionality that is molded into
the predicate plastic syringe. | | Feature | Primary Predicate
Straumann® PrefGel®
(K063812) | Subject Device
Straumann® PrefGel® | Equivalence
Discussion | | Secondary Package | Thermoformed Tray (PETG)
Lid Stock
(Medical Paper) | Thermoformed Tray (PETG)
Lid Stock
(Tyvek 1073B) | Equivalent Secondary Package
The blister tray is the same material; only the
form has changed. Both the subject and
predicate lid stocks are accepted for sterile
barrier applications. The change to Tyvek
1073B adds additional durability and is
consistent with other products produced at
Biora AB. | | Tertiary Package | Bleached and printed cardboard | Bleached and printed cardboard | Equivalent Tertiary Package
The material used for the tertiary protective
packaging (i.e. shelf box) is the same. The
package configuration has been changed to
accept the larger secondary blister package.
The packaging has been verified to adequately
protect the product. | | Product Configurations | 5-Pack:
Five PrefGel Trays
Five Sterile Blunt Cannulae | 5-Pack:
Five PrefGel Trays
Five Sterile Blunt Cannulae | Identical Product Configuration
The changes to the primary (syringe),
secondary (blister) and tertiary (Shelf box)
packaging of the subject devices have not
resulted in a change to the product
configurations offered. The blunt cannulae
used with the subject devices are the same
ones 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 Package
The subject devices continue to be produced
in the same clean rooms, sterilizers and
aseptic conditions as the predicate devices
through the primary packaging (syringe)
stage. | | Feature | Primary Predicate
Straumann® PrefGel®
(K063812) | Subject Device
Straumann® PrefGel® | Equivalence
Discussion | | Sterility - Secondary | Ethylene oxide gas to a Sterility Assurance
Level (SAL) of 10-6 | Ethylene oxide gas to a Sterility Assurance
Level (SAL) of 10-6 | Identical Sterility of Secondary Package
The subject devices have been adopted into
the same EtO sterilization cycle as the
predicate device. This cycle has been
validated to an SAL of 10-6. New clean room
facilities have been built to accommodate the
secondary packaging operations internal to
Biora AB-this operation is no longer out-
sourced. | {6}------------------------------------------------ {7}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/device/K162311](https://fda.innolitics.com/device/K162311) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com