(117 days)
No
The summary describes a mechanical device for fastening membranes during bone regeneration and does not mention any AI or ML components or functions.
No.
The device is described as a fastening device for membranes during bone regenerative treatment and facilitates bone formation, but it does not directly treat or diagnose a disease or condition itself.
No
Explanation: The provided text describes devices (Membrane Tacks and Screws) used for fastening membranes during bone regenerative treatment. Their function is purely mechanical, and they do not gather or analyze data to diagnose a condition.
No
The device description clearly states the device is made of titanium and used with instruments made of stainless steel, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment and are clinically implanted directly into the body. They are physical devices used in a surgical procedure, not tests performed on samples outside the body.
The device description and intended use align with a surgical implant or accessory used in a clinical setting, not an in vitro diagnostic device.
N/A
Intended Use / 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 three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.
Product codes
DZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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 is not required to establish substantial equivalence in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K083561, K090452, K113376, K081851, K150669
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 Ltd
Windsor House
Cornwall Road
Harrogate, HG1 2PW, UK
Establishment Registration Number: 3005846524 |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cherita James
M Squared Associates, Inc.
127 West 30th St
9th Floor
New York, New York 10001
Ph: 347-954-0624
Fax: 702-562-9797
E-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 | Substantial
Equivalence |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Membrane Tack | Meisinger Tac (only) | |
| 510(k) No. | K201561 | K130682 | |
| | Image: Neoss Membrane Tack | Image: Hager and Meisinger GmbH Meisinger Tac | Device designs are
similar and suitable for
their intended use. |
| Product Code | DZL Intraosseous fixation
screw | DZL Intraosseous fixation screw | Substantially
equivalent |
| Intended Use | Membrane Tacks 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. | Meisinger Tacs are used for the
fixation of membranes
(resorbable membranes
nonresorbable membranes) to the
bone structure. Tacs are intended
for single use only. | Substantially
equivalent.
Both devices have the
same intended use
(membrane fastening)
for the same
anatomical site (oral
cavity) during bone
regeneration.
Though not specified
by Neoss, the
membrane tacks are
intended for use with
both resorbable
membranes
nonresorbable
membranes.
Meisinger has not
specified the duration
and implantation
details however this |
| | Neoss | Hager and Meisinger GmbH | Substantial
Equivalence |
| | | | can be assumed by the
intention of the
application of a dental
membrane.
The differences in the
indication statements
do not represent a
difference in the
intended use clinically
and do not affect the
safety and
effectiveness of the
subject device. |
| Material
Composition | Titanium alloy grade 5
(ASTM F136) | Titanium alloy grade 5 (ASTM
F136) | Substantially
equivalent |
| Dimensions | Head diameter 2.5mm,
Length 3.0mm | Head diameter 2.5mm, Length
3.5mm | The Neoss device is
within the range of
dimensions of the
predicate and other
commercially
available tacks |
| Handling and
placement | Pick up the Tack by firmly
pushing the Tack
Positioning Instrument,
Insert thru membrane and
gently tap Tack with mallet | Pick up the Tack by firmly
pushing the Tack Positioning
Instrument, Insert thru membrane
and gently tap with mallet | |
| Removal | pry the head of the Tack
from the underlying
membrane using a thin and
flat tool, such as a scalpel
blade. | Unknown for Tacs | The Neoss Membrane
Tack is removed by
similar methods to
currently marketed
dental membrane
tacks. |
| Bone stability | Barbed tip | Barbed tip | Substantially
equivalent |
| Duration of use | 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. | unknown | The duration of use for
the Neoss products is
the same as other
commercially
available tacks, they
are intended to be
removed at the time
healing is achieved |
| Sterility | sterile | delivered non-sterile/
autoclavable | Packaging,
sterilization and
transport have been
validated. |
| Reprocessing | No - single use | No – single use | Substantially
equivalent |
| Biocompatible | Yes, materials and
manufacturing process | Yes, materials | Neoss Tacks
manufacturing
processes and
cleaning |
| Neoss | Hager and Meisinger GmbH | Substantial
Equivalence | |
| | | materials are evaluated
for biocompatibility
for their intended use. | |
| | | Meisinger processing
is unknown, but
material is the same. | |
5
6
| | Neoss | Osteogenics | Substantial
Equivalence |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Membrane Screw | Pro-Fix Screw (only) | |
| 510(k) No. | K201561 | K093719 | |
| Product Code | DZL Intraosseous fixation screw | DZL Intraosseous fixation
screw | Substantially equivalent |
| | Image: Membrane Screw | Image: Pro-Fix Screw | Device designs are
similar and suited for
intended use. |
| Intended Use | 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. | The Pro-FixTM Precision
Fixation System is used to
stabilize, fixate and/or support
bone grafts, bone filling
materials and/or barrier
membranes used for
regeneration of bone in the
oral cavity. | Same intended use for
fixation of membranes
only.
Osteogenics has not
specified the duration
and implantation details
however this can be
assumed by the
intention of the
application of a dental
membrane.
The differences in the
indication statements do
not represent a
difference in the
intended use clinically
and do not affect the
safety and effectiveness
of the subject device. |
| Material
Composition | Titanium alloy grade 5 (ASTM
F136) | Titanium alloy grade 5
(ASTM F136) | Same material |
| Dimensions | Diameter Head 2.6mm, Thread
1.5mm & length 3.2mm | Diameter: Thread 1.5mm,
length 3.mm | Comparable screw
dimensions and
performance testing
confirms adequate for
intended use |
| | Neoss | Osteogenics | Substantial |
| | | | Equivalence |
| Handling and
placement | Pick up the Screw by firmly
pushing the tip of a Neoss
Implant Inserter into the head of
the Screw, Insert the Screw
through the membrane into the
bone applying a torque of less
than 10 Ncm. | Cruciform driver | Neoss has confirmed
instrument performs as
intended for placement. |
| Removal | unscrew the Membrane Screws
using the tip of a Neoss Implant
Inserter | Unknown | Neoss has confirmed
instrument performs as
intended for removal |
| Duration of use | 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. | 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 | Substantially equivalent
duration of use |
| Sterility | sterile | sterile | Substantially equivalent |
| Reprocessing | No-single use | No-single use | Substantially equivalent |
| Biocompatible | Yes, material and manufacturing
processes | Yes, materials | Neoss Tacks
manufacturing processes
and materials are
evaluated for
biocompatibility for
their intended use.
Osteogenics processing
is unknown, but
material 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 a | |
| sterilization 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.