(117 days)
Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.
Membrane Tacks and Membrane Screws are regenerative membrane fastening devices available in 3mm length. The Membrane Tack is used in conjunction with a Tack Positioning Instrument, while the Membrane Screw is applied with the Neoss Implant Inserter. Regenerative membranes are designed to prevent ingrowth of gingival soft tissue into bony defects, in order to facilitate the bone formation during the repair process of the defect. Membrane Tacks and Screws are made of titanium while related instruments are made in stainless steel. The Membrane fastening devices are single-use only while the instruments are for multiple use.
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of AI or machine learning models.
The document is a 510(k) premarket notification for "Membrane Screws and Membrane Tacks," which are physical medical devices used in bone regenerative treatment. The content focuses on demonstrating substantial equivalence to predicate devices based on material composition, dimensions, intended use, and general performance characteristics (sterilization, shelf life, biocompatibility, instrument cleaning, and insertion/removal forces).
Therefore, I cannot provide the requested information, which includes details about:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size and data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC studies and effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.).
- Training set sample size and ground truth establishment.
The document explicitly states that "Clinical data is not required to establish substantial equivalence in this submission," further indicating a lack of clinical study data relevant to AI/ML performance evaluation.
{0}------------------------------------------------
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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 5, 2020
Neoss Limited c/o Cherita James Regulatory Consultant M Squared Associates, Inc. 127 West 30th St. Floor 9 New York, New York 10001
Re: K201561
Trade/Device Name: Membrane Screws and Membrane Tacks Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: September 23, 2020 Received: September 25, 2020
Dear Cherita James:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 Part 803) for devices or post-marketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K201561
Device Name Membrane Tacks and Membrane Screws
Indications for Use (Describe)
Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------
510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for the Membrane Tacks and Membrane Screws 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
| Sponsor: | Neoss LtdWindsor HouseCornwall RoadHarrogate, HG1 2PW, UKEstablishment Registration Number: 3005846524 |
|---|---|
| Contact: | Cherita JamesM Squared Associates, Inc.127 West 30th St9th FloorNew York, New York 10001Ph: 347-954-0624Fax: 702-562-9797E-mail: CJames@MSquaredAssociates.com |
| Date of Submission: | October 2, 2020 |
|---|---|
| Proprietary Name: | Membrane Tacks and Membrane Screws |
| Common Name: | Intraosseous Tacks, Screws |
| Regulatory Class: | II |
| Regulation: | 872.4880 |
| Product Code: | DZL |
| Predicate Device(s): | Meisinger Tacs, Hager and Meisinger GmbH K130682 |
Pro-fix Membrane Fixation Screws, Osteogenics K093719
Device Description: Membrane Tacks and Membrane Screws are regenerative membrane fastening devices available in 3mm length. The Membrane Tack is used in conjunction with a Tack Positioning Instrument, while the Membrane Screw is applied with the Neoss Implant Inserter. Regenerative membranes are designed to prevent ingrowth of gingival soft tissue into bony defects, in order to facilitate the bone formation during the repair process of the defect. Membrane Tacks and Screws are made of titanium while related instruments are made in stainless steel. The Membrane fastening devices are single-use only while the instruments are for multiple use.
{4}------------------------------------------------
Indications for Use: Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of implantation of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.
Comparison to predicate device.
The claim of substantial equivalence of the Membrane Tacks and Membrane Screws to the products identified above is based on the comparison of the intended use, product technical characteristics, performance characteristics and product handling.
| Neoss | Hager and Meisinger GmbH | SubstantialEquivalence | |
|---|---|---|---|
| Membrane Tack | Meisinger Tac (only) | ||
| 510(k) No. | K201561 | K130682 | |
| Image: Neoss Membrane Tack | Image: Hager and Meisinger GmbH Meisinger Tac | Device designs aresimilar and suitable fortheir intended use. | |
| Product Code | DZL Intraosseous fixationscrew | DZL Intraosseous fixation screw | Substantiallyequivalent |
| Intended Use | Membrane Tacks areintended for fasteningmembranes during boneregenerative treatment.These membrane fasteningmeans are in direct bodycontact, intended fortemporary use only.Membrane fastening meansare submerged andclinically implanted morethan 30 days with anexpected duration ofimplantation of three tonine months or until boneregeneration is completetaking into account whichmembrane and bonegrafting materials are beingused. | Meisinger Tacs are used for thefixation of membranes(resorbable membranesnonresorbable membranes) to thebone structure. Tacs are intendedfor single use only. | Substantiallyequivalent.Both devices have thesame intended use(membrane fastening)for the sameanatomical site (oralcavity) during boneregeneration.Though not specifiedby Neoss, themembrane tacks areintended for use withboth resorbablemembranesnonresorbablemembranes.Meisinger has notspecified the durationand implantationdetails however this |
| Neoss | Hager and Meisinger GmbH | SubstantialEquivalence | |
| can be assumed by theintention of theapplication of a dentalmembrane.The differences in theindication statementsdo not represent adifference in theintended use clinicallyand do not affect thesafety andeffectiveness of thesubject device. | |||
| MaterialComposition | Titanium alloy grade 5(ASTM F136) | Titanium alloy grade 5 (ASTMF136) | Substantiallyequivalent |
| Dimensions | Head diameter 2.5mm,Length 3.0mm | Head diameter 2.5mm, Length3.5mm | The Neoss device iswithin the range ofdimensions of thepredicate and othercommerciallyavailable tacks |
| Handling andplacement | Pick up the Tack by firmlypushing the TackPositioning Instrument,Insert thru membrane andgently tap Tack with mallet | Pick up the Tack by firmlypushing the Tack PositioningInstrument, Insert thru membraneand gently tap with mallet | |
| Removal | pry the head of the Tackfrom the underlyingmembrane using a thin andflat tool, such as a scalpelblade. | Unknown for Tacs | The Neoss MembraneTack is removed bysimilar methods tocurrently marketeddental membranetacks. |
| Bone stability | Barbed tip | Barbed tip | Substantiallyequivalent |
| Duration of use | implanted more than 30days with an expectedduration of implantation ofthree to nine months oruntil bone regeneration iscomplete taking intoaccount which membraneand bone grafting materialsare being used. | unknown | The duration of use forthe Neoss products isthe same as othercommerciallyavailable tacks, theyare intended to beremoved at the timehealing is achieved |
| Sterility | sterile | delivered non-sterile/autoclavable | Packaging,sterilization andtransport have beenvalidated. |
| Reprocessing | No - single use | No – single use | Substantiallyequivalent |
| Biocompatible | Yes, materials andmanufacturing process | Yes, materials | Neoss Tacksmanufacturingprocesses andcleaning |
| Neoss | Hager and Meisinger GmbH | SubstantialEquivalence | |
| materials are evaluatedfor biocompatibilityfor their intended use. | |||
| Meisinger processingis unknown, butmaterial is the same. |
{5}------------------------------------------------
{6}------------------------------------------------
| Neoss | Osteogenics | SubstantialEquivalence | |
|---|---|---|---|
| Membrane Screw | Pro-Fix Screw (only) | ||
| 510(k) No. | K201561 | K093719 | |
| Product Code | DZL Intraosseous fixation screw | DZL Intraosseous fixationscrew | Substantially equivalent |
| Image: Membrane Screw | Image: Pro-Fix Screw | Device designs aresimilar and suited forintended use. | |
| Intended Use | Membrane Screws are intendedfor fastening membranes duringbone regenerative treatment.These membrane fastening meansare in direct body contact,intended for temporary use only.Membrane fastening means aresubmerged and clinicallyimplanted more than 30 days withan expected duration ofimplantation of three to ninemonths or until bone regenerationis complete taking into accountwhich membrane and bonegrafting materials are being used. | The Pro-FixTM PrecisionFixation System is used tostabilize, fixate and/or supportbone grafts, bone fillingmaterials and/or barriermembranes used forregeneration of bone in theoral cavity. | Same intended use forfixation of membranesonly.Osteogenics has notspecified the durationand implantation detailshowever this can beassumed by theintention of theapplication of a dentalmembrane.The differences in theindication statements donot represent adifference in theintended use clinicallyand do not affect thesafety and effectivenessof the subject device. |
| MaterialComposition | Titanium alloy grade 5 (ASTMF136) | Titanium alloy grade 5(ASTM F136) | Same material |
| Dimensions | Diameter Head 2.6mm, Thread1.5mm & length 3.2mm | Diameter: Thread 1.5mm,length 3.mm | Comparable screwdimensions andperformance testingconfirms adequate forintended use |
| Neoss | Osteogenics | Substantial | |
| Equivalence | |||
| Handling andplacement | Pick up the Screw by firmlypushing the tip of a NeossImplant Inserter into the head ofthe Screw, Insert the Screwthrough the membrane into thebone applying a torque of lessthan 10 Ncm. | Cruciform driver | Neoss has confirmedinstrument performs asintended for placement. |
| Removal | unscrew the Membrane Screwsusing the tip of a Neoss ImplantInserter | Unknown | Neoss has confirmedinstrument performs asintended for removal |
| Duration of use | implanted more than 30 days withan expected duration ofimplantation of three to ninemonths or until bone regenerationis complete taking into accountwhich membrane and bonegrafting materials are being used. | implanted more than 30 dayswith an expected duration ofimplantation of three to ninemonths or until boneregeneration is completetaking into account whichmembrane and bone graftingmaterials are being used | Substantially equivalentduration of use |
| Sterility | sterile | sterile | Substantially equivalent |
| Reprocessing | No-single use | No-single use | Substantially equivalent |
| Biocompatible | Yes, material and manufacturingprocesses | Yes, materials | Neoss Tacksmanufacturing processesand materials areevaluated forbiocompatibility fortheir intended use.Osteogenics processingis unknown, butmaterial is the same. |
{7}------------------------------------------------
{8}------------------------------------------------
Technological Characteristics
The Membrane Screws and Membrane Tacks are substantially equivalent to the predicates identified above with regard to materials, dimensions, product packaging and placement and removal methods.
Both Membrane Tacks and Screws, like the predicate devices, are provided in a sterile form.
Performance Testing
Membrane Screws and Membrane Tacks are in conformity with the following standards.
| Standard | Recognition Number |
|---|---|
| EN ISO 11137-1:2015 Sterilization of health care products — Radiation —Part 1 Requirements for development, validation and routine control of asterilization process for medical devices | 14-428 |
| EN ISO 11137-2:2015 Sterilization of health care products — Radiation —Part 2 Establishing the sterilization dose | 14-409 |
| ISO 10993-1:2018 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process. | 2-258 |
Sterilization: A dose of 25 kGy is chosen as sterilization dose by gamma irradiation. Method VDmax25 according to standard EN ISO 11137-2 is applied for all Neoss products that are terminally sterilized (SAL 106). The Membrane Tacks and Screws are manufactured of the same material (Titanium alloy grade 5) and packaged identically to various 510k cleared Neoss Implant System (implants/abutments/screws K083561, K090452, K113376), which would be considered "worst case" for sterilization when compared to the Membrane Tacks and Screws.
Shelf life: Membrane Tacks and Screws are provided sterile for single patient use. They are delivered packaged in a PET blister with peel-open paper lid housed in a protective rigid plastic case. The packaging utilized is a standard packaging for terminally sterilized Neoss Implant Systems. The products sterilized with gamma irradiation and packaged as described above have been verified to support 5 years shelf life (Ageing Validation including accelerated ageing, real time ageing and peel force testing have been performed and are documented to support 5 year shelf life claim).
Biocompatibility: Membrane Tacks and Membrane Screws are characterized as permanent implants (up to 1 year), contacting tissue and bone. No new biocompatibility testing has been performed, as the subject devices are substantially equivalent to Neoss Access Abutment (K081851) and Crystaloc Abutment Screw (K150669) with regards to materials and processing. The Neoss patient contacting instruments
{9}------------------------------------------------
(implant inserter and tack positioning instrument) only have very brief / transitory contact with the body. No coating or lubricants are left in contact with body tissues after the devices are removed. Per ISO 10993-1:2018 section 5.3.2 such devices do not require biocompatibility testing.
Instrument cleaning and sterilization: Membrane Tack and Screw Cassette, Tack Positioning Instrument and Neoss Implant Inserter cleaning and sterilization recommendations were validated on more complex, multicomponent Neoss instruments of the same materials. Cleaning validations included soiling, mechanical cleaning, and residual testing for hemoglobin and protein. Sterilization parameters were evaluated to a SAL 10 ° using the biological indicator overkill method. Test articles were inoculated as outlined in AAMI TIR12 and sterilized using the validated full cycle sterilization parameters and dry time. Validation results confirmed the SAL was achieved with recommended parameters and no evidence of moisture.
Performance evaluations of the Membrane Tacks was conducted to evaluate the insertion and removal forces and found them to be comparable to the predicate device and acceptable for their intended use. Performance evaluations of the Membrane Screws was conducted to evaluate the insertion torque of the device and found them comparable to the values of the predicate device.
Clinical Data: Clinical data is not required to establish substantial equivalence in this submission.
Conclusion
Membrane Tacks and Membrane Screws substantially equivalent, to the Meisinger Tacs (K130682) and the Osteogenics Pro-fix Membrane Fixation Screws (K093719). They share similar indications for use, technological and performance characteristics.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.