(353 days)
No
The summary describes a system of physical bone tacks and associated instruments made of titanium alloy, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for stabilization during bone tissue regeneration and repair, which are therapeutic interventions.
No
The device is described as a system of bone tacks used for the stabilization of membranes during bone tissue regeneration and repair. Its function is to physically secure membranes, not to diagnose a condition.
No
The device description explicitly states the system consists of bone tacks and associated instrumentation, which are physical hardware components made of titanium alloy.
Based on the provided text, 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 or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the MC Bio Supertack tacks are physical devices made of titanium alloy used for the stabilization of membranes during bone regeneration and repair in the maxillofacial or mandibular area. This is a surgical/implantable device, not a diagnostic test performed on a sample.
- Lack of Diagnostic Information: The text does not mention any analysis of biological samples, detection of biomarkers, or any other activity related to diagnosing a condition.
Therefore, the MC Bio Supertack system falls under the category of a surgical or implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial or mandibular area, maxillofacial or mandibular bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K022790, K130682, K973180, K101835, K122069
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/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.
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 (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
2
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) |
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
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.
4
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 |
|---|---|---|
| TECHNICAL | ||
| DRAWING | ||
| FEATURES | ||
| 3mm TACK | 1-Lenticular Head. | |
| 2-Tapered Head | ||
| 3-No thread on the shaft | ||
| 4-Barb at the tip | 1-Lenticular Head. | |
| 2-Tapered Head | ||
| 3-No thread on the shaft | ||
| 4-Barb at the tip | ||
| TECHNICAL | ||
| DRAWING | ||
| FEATURES | ||
| 5mm TACK | 1-Lenticular Head. | |
| 2-Tapered Head | ||
| 3-No thread on the shaft | ||
| 4-Barb at the tip | 1-Lenticular Head. | |
| 2-Tapered Head | ||
| 3-No thread on the shaft | ||
| 4-Barb at the tip | ||
| Use | To stabilize Barrier Membranes onto | |
| cortical bone plates | To stabilize Barrier Membranes onto | |
| cortical bone plates | ||
| Tack | ||
| MATERIAL | Ti 6Al 4V | Ti 6Al 4V |
| Tack | ||
| NOMINAL | ||
| LENGTH | 3mm - 5mm | 3mm - 4mm – 5mm |
| Tack HEAD | ||
| DIAMETER | 2.475 mm | 2.50 mm |
| Sterility | ||
| condition (out of | ||
| the firm) of the | ||
| tacks | NON-STERILE | NON-STERILE |
| Recommended | ||
| Sterilization | ||
| method | Steam | Steam |
5
EliKa Technologies 209 Madison Ave. - Suite D Monrovia, CA 91016
MC Bio Supertack
Annex 1 R.4
May 25, 2016
| Way to take the
tack from the
tack holder and
to carry it to the
placement site | Pressing the Insertion Instrument on
the Head of the tack | Pressing the Insertion Instrument on the
Head of the tack |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Placement of the
tack in the
cortical bone | By a firm tap with the hammer on the
Insertion instrument | By a firm tap with the hammer on the
Insertion instrument |
| Stabilization of
the tack in the
Bone | The tack has a barb at the tip | The tack has a barb at the tip |
| Removing from
the bone | The head tack has two tapered external
areas, that allow to dislodge the tack by
using a periosteal elevator, scalpel or
other thin flat instrument | The head tack has two tapered external
areas, that allow to dislodge the tack by
using a periosteal elevator, scalpel or other
thin flat instrument |
| Re-use of the
tack | Not RECOMMENDED | MC Bio Supertacks are for single use only
therefore reuse of the tacks is NOT
recommended |
| Maximum
duration of
implantation | Time not defined | MC Bio Supertack tacks are not intended
for long-term implantation, but should be
removed upon completion of the healing
process |
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
6
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.