(353 days)
The MC Bio Supertack tacks are used for the stabilization of absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area.
The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.
General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.
The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio SUPERTACK system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.
Gnereral patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.
The MC Bio SUPERTACK System consists of 3mm, 4mm and 5mm bone tacks and associated instrumentation.
The tacks material consist of Titanium alloy, as specified in ASTM F136 STANDARD for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy, anodized blue color.
The devices are provided non-sterile.
This document is a 510(k) premarket notification for a medical device called the "MC BIO SuperTack" tack, which is used for stabilizing absorbable membranes during bone tissue regeneration and repair in the maxillofacial or mandibular area. The document establishes substantial equivalence to a predicate device (SALVIN Bone Tack) rather than presenting a study for acceptance criteria and reported device performance in the typical sense of a diagnostic or AI device.
Therefore, the requested information (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, training set information) is not applicable to this submission, as it is a device clearance based on substantial equivalence, not a performance study as would be seen for a new diagnostic algorithm or a clinical trial.
However, I can extract the information on non-clinical testing performed to establish equivalence:
Non-Clinical Testing and Equivalence Conclusion:
Instead of acceptance criteria and device performance in a clinical or diagnostic context, the submission focuses on demonstrating substantial equivalence to a predicate device (SALVIN Bone Tack 3mm and 5mm) through technological comparisons and non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance / Result |
|---|---|---|
| MTT cytotoxicity | No cytotoxic potential (similar to predicate material) | No Cytoxic Potential |
| Sterilization validation | Validated steam sterilization cycle (similar to predicate) | Steam Sterilization cycle validated |
| Flexional test | Acceptable mechanical properties (comparison to predicate) | Reduction of max stress value vs. predicate |
| Technological Features Comparison | Substantially equivalent to predicate device (SALVIN Bone Tack) for: | |
| - Design (head, shaft, barb) | Lenticular Head, Tapered Head, No thread on shaft, Barb at tip | Same as predicate |
| - Material | Ti 6Al 4V | Same as predicate |
| - Nominal Length | 3mm, 4mm, 5mm (predicate was 3mm, 5mm) | 3mm, 4mm, 5mm |
| - Head Diameter | 2.475 mm (for predicate) | 2.50 mm |
| - Sterility condition | Non-sterile (out of firm) | Non-sterile |
| - Recommended Sterilization | Steam | Steam |
| - Way to take/carry tack | Pressing Insertion Instrument on Head | Same as predicate |
| - Placement | Firm tap with hammer on Insertion Instrument | Same as predicate |
| - Stabilization | Barb at the tip | Same as predicate |
| - Removal | Two tapered external areas for dislodging | Same as predicate |
| - Re-use | Not recommended/Single use only | Same as predicate |
| - Implantation Duration | Not intended for long-term implantation, remove after healing | Time not defined (for predicate), but new device explicit about removal after healing |
2. Sample size used for the test set and the data provenance:
- Not applicable for this type of submission. The mechanical and biocompatibility tests are conducted on test samples of the device, not a "test set" of patient data. The document does not specify the number of samples used for these non-clinical tests. Data provenance for such tests would be from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth here is based on engineering standards (ASTM F136), laboratory test results for biocompatibility, and manufacturing specifications, not expert clinical consensus on a patient dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 is not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Established laboratory test standards (MTT cytotoxicity using cell cultures).
- For sterilization: Validated sterilization cycle aligned with established medical device sterilization standards.
- For mechanical properties: Engineering flexional tests compared against the properties of the predicate device.
- For design/material: Comparison to technical drawings and material specifications (ASTM F136) of the predicate device and the new device.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable.
Conclusion from The Document:
The submission concludes that the MC Bio Supertack tacks are "substantially equivalent" to the legally marketed predicate device based on:
- Engineering inspections
- Dimensional and technological comparisons
- MTT cytotoxicity test results
- Sterilization validation
- Flexional test results
- Material (Titanium alloy as specified in ASTM F136 standard)
- Intended Use
- Manufacturing process (anodization for blue color does not modify biocompatibility).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
Eli-Ka Technologies Mr. Luigi Girotto 209 Madison Ave.-Suite D Monrovia, CA 91016
Re: K151540
Trade/Device Name: MC BIO "SuperTack " tack 3mm, 4mm and 5mm Regulation Number: 21 CFR 872.4880 Regulation Name: Intra-osseous fixation screw or wire Regulatory Class: II Product Code: DZL Dated: Mav 28, 2015 Received: April 27, 2016
Dear Mr. Girotto:
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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good 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.
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 yours,
Tina Kiang
-s
for Erin Keith, M.S. 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) K151540
Device Name
MC BIO Supertack tack 3mm, 4mm and 5mm
Indications for Use (Describe)
The MC Bio Supertack tacks are used for the stabilization of absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area.
The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.
General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.
| 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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May 25, 2016
510(k) Summary
510 (k) OWNER: Eli-Ka Technologies, 209 Madison Ave. - Suite D, Monrovia, CA 91016 - USA Tel: 626-256-3674 Fax: 626-205-3994 Email: elika@matheengines.com
Contact: Luigi Girotto Tel: 626-256-3674 Email: elika@matheengines.com
MANUFACTURER NAME: MC Bio s.r.l., Via Cavour 2, 22074 LOMAZZO (CO) - ITALY Tel.: +39 02 36714256 - +39 02 36714257 - Fax: +39 02 36714261 - Email: administration@coneimplant.com
Trade Name: MC BIO "SuperTack " tack 3mm, 4mm and 5mm
Common Name: Tack, Pin, Membrane fixation system
Classification Name: Intra-osseous fixation screw or wire
Product Code: DZL
Classification Regulation: 21 CFR 872.4880
Class: II
PREDICATE DEVICE ( PRIMARY ): K100182 - SALVIN Bone Tack 3mm and 5mm
REFERENCE PREDICATE DEVICE :
| Company | Trade Name | 510 ( k ) Summary |
|---|---|---|
| Biohorizons Implant Systems, Inc. | The AutoTac SystemTM Titanium Tack | KO22790 |
| Hager & Meisinger GmbH | Meisinger MEITAC | K130682 |
| IMTEC Corporation | IMTEC Bone Tack | K973180 |
| Porex Surgical, Inc | Medpore Fixation System- cranial | K101835 |
| Lancer Orthodontics | Storm Mini Screw | K122069 |
DEVICE DESCRIPTION: The MC Bio SUPERTACK System consists of 3mm, 4mm and 5mm bone tacks and associated instrumentation.
The tacks material consist of Titanium alloy, as specified in ASTM F136 STANDARD for Wrought
Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy, anodized blue color.
The devices are provided non-sterile.
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EliKa Technologies 209 Madison Ave. - Suite D Monrovia, CA 91016
MC Bio Supertack
INTENDED USE: The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio SUPERTACK system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in
maxillofacial or mandibular bone.
Gnereral patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.
TECHNOLOGICAL FEATURES: as described in this submission the MC Bio SUPERTACK is substantially equivalent to the predicate or to other devices cleared by the agency for commercial distribution in the United States. The analysis of the mechanical properties, the indication for use, the materials, the labelling etc., between the predicate and the subject device, have demonstrated that the MC Bio SUPERTACK is substantially equivalent to the predicate.
| Device | Salvin Bone Tack System | MC Bio Supertack System |
|---|---|---|
| TECHNICALDRAWINGFEATURES3mm TACK | 1-Lenticular Head.2-Tapered Head3-No thread on the shaft4-Barb at the tip | 1-Lenticular Head.2-Tapered Head3-No thread on the shaft4-Barb at the tip |
| TECHNICALDRAWINGFEATURES5mm TACK | 1-Lenticular Head.2-Tapered Head3-No thread on the shaft4-Barb at the tip | 1-Lenticular Head.2-Tapered Head3-No thread on the shaft4-Barb at the tip |
| Use | To stabilize Barrier Membranes ontocortical bone plates | To stabilize Barrier Membranes ontocortical bone plates |
| TackMATERIAL | Ti 6Al 4V | Ti 6Al 4V |
| TackNOMINALLENGTH | 3mm - 5mm | 3mm - 4mm – 5mm |
| Tack HEADDIAMETER | 2.475 mm | 2.50 mm |
| Sterilitycondition (out ofthe firm) of thetacks | NON-STERILE | NON-STERILE |
| RecommendedSterilizationmethod | Steam | Steam |
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EliKa Technologies 209 Madison Ave. - Suite D Monrovia, CA 91016
MC Bio Supertack
Annex 1 R.4
May 25, 2016
| Way to take thetack from thetack holder andto carry it to theplacement site | Pressing the Insertion Instrument onthe Head of the tack | Pressing the Insertion Instrument on theHead of the tack |
|---|---|---|
| Placement of thetack in thecortical bone | By a firm tap with the hammer on theInsertion instrument | By a firm tap with the hammer on theInsertion instrument |
| Stabilization ofthe tack in theBone | The tack has a barb at the tip | The tack has a barb at the tip |
| Removing fromthe bone | The head tack has two tapered externalareas, that allow to dislodge the tack byusing a periosteal elevator, scalpel orother thin flat instrument | The head tack has two tapered externalareas, that allow to dislodge the tack byusing a periosteal elevator, scalpel or otherthin flat instrument |
| Re-use of thetack | Not RECOMMENDED | MC Bio Supertacks are for single use onlytherefore reuse of the tacks is NOTrecommended |
| Maximumduration ofimplantation | Time not defined | MC Bio Supertack tacks are not intendedfor long-term implantation, but should beremoved upon completion of the healingprocess |
NON-CLINICAL TESTING:
| Test | Result |
|---|---|
| MTT cytotoxicity | No Cytoxic Potential |
| Sterilization validation | Steam Sterilization cycle validated |
| Flexional test | Reduction of max stress value vs. predicate |
As described in the submission, engineering inspections, dimensional and technological comparisons and the MTT cytotoxicity test have demonstrated the equivalence with the predicate.
The Blue color of the MC Bio Supertack , obtained by anodization of the titanium, does not modify the biocompatibility of the material: Titanium alloy as specified in the ASTM F136 standard.
CONCLUSION: the function and intended use, material, possible product have been evaluated as acceptable and equivalent to predicated device
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EliKa Technologies 209 Madison Ave. - Suite D Monrovia, CA 91016
MC Bio Supertack
Annex 1 R.4
May 25, 2016
Based on the information provided in the summary, we conclude that the MC Bio Supertack tacks are equivalent to the legally marketed predicate device described.
§ 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.