(316 days)
The DUAFIT® Interphalangeal implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes. Examples include: Rigid or semi-rigid deformity of the PIP joint Revision of failed arthroplasty or arthrodesis 2nd toe shortening.
The DUAFIT® interphalangeal implant is an intramedullary implant, designed to act as a bone fastener for proximal interphalangeal arthrodesis of the lesser rays. Design is a combination of a proximal taper with barbs and a distal blade for enhanced stabilization. It is made available in multiple lengths and diameters, and in 3 different angles. The implant is manufactured from PEEK-OPTIMA®, polymer from Invibio®, and is designed for single use only.
The provided text describes a medical device (DUAFIT® interphalangeal implant) and its regulatory submission. It focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria for a new AI/ML device or a comparative effectiveness study with human readers.
Therefore, the requested information elements related to AI/ML device performance, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or cannot be extracted from the given document.
The document primarily covers the engineering and regulatory aspects of a physical medical implant.
However, I can extract information related to the device's performance demonstration.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is substantially equivalent to predicate devices for its intended use and design. | The technological characteristics of the DUAFIT® interphalangeal implant are the same as the characteristics of predicate devices in terms of intended use and design, including features like insertion into bone, tapered barded design, blade design, cannulated design, straight/angled design, PEEK material, and equivalent size range. |
| Mechanical properties are at least equivalent to the predicate device (Merete MetaToe). | Results from testing confirmed that the DUAFIT® interphalangeal implant is at least equivalent to the Merete MetaToe EndoSorb (K100414) in terms of mechanical properties. |
| Performance in specific mechanical tests (static and cyclic four-point bending) meets criteria. | The DUAFIT® interphalangeal implant met the acceptance criteria for the static four-point bending test and the cyclic four-point bending test. The implants performed as expected for each test. |
| Biocompatibility (implied from material and predicate equivalence) | The DUAFIT® interphalangeal implant is manufactured from PEEK-OPTIMA®, polymer from Invibio®, as per ASTM 2026, a material used in predicate devices (e.g., Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586), Parcus PEEK CF push-in suture anchor (K102326), and Synchro Toegrip (K133477)), suggesting established biocompatibility. |
| Sterilization effective (implied) | The DUAFIT® interphalangeal implant is supplied sterile, using gamma irradiation. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the mechanical tests (static and cyclic four-point bending). Data provenance is not explicitly stated beyond "testing performed by the test lab," but it is implicitly from product-specific laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical implant, not an AI/ML diagnostic device requiring expert interpretation for ground truth. Performance was demonstrated through engineering bench testing.
4. Adjudication method for the test set
Not applicable. Performance was determined through objective mechanical testing, not by human adjudication of interpreted data.
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-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used
The ground truth for the device's performance was established through engineering bench testing (static four-point bending test and cyclic four-point bending test) against established mechanical performance criteria, and comparison to predicate devices' mechanical properties.
8. The sample size for the training set
Not applicable. This is a physical medical implant, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical implant, not a machine learning model.
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JUL 3 0 2014
z8, chemin du Petil Bois
69130 Ecully – FRANCE
1 LL -33 (0)4 72 29 26 25
FA> +33 (0)4 73 29 26 29
contact@in2bones.com www.r. madanes com
For
| Sponsor identification | In2Bones SAS28 chemin du Petit Bois69130 Ecully - FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29 |
|---|---|
| Establishment registration number | New company. Will register following FDA clearance(Owner/Operator Number: 10046803) |
| Date of preparation | July 23, 2014 |
| Contact person | Norman EstrinEstrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Fax: (301) 294-0126Email: estrin@yourFDAconsultant.com |
| Authorized Agent in theUnited States | Norman EstrinEstrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Fax: (301) 294-0126Email: estrin@yourFDAconsultant.com |
| Proprietary Name | Duafit® interphalangeal implant |
| Common name | Intramedullary bone fastener |
| Device classification regulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastenerClass II |
| Device ProductCode and Panel | HWC: screw, fixation, bone87 orthopedics |
| Device Description | The DUAFIT® interphalangeal implant is an intramedullary implant,designed to act as a bone fastener for proximal interphalangealarthrodesis of the lesser rays.Design is a combination of a proximal taper with barbs and a distalblade for enhanced stabilization. |
| It is made available in multiple lengths and diameters, and in 3different angles.The implant is manufactured from PEEK-OPTIMA®, polymer fromInvibio®, and is designed for single use only. | |
| Sizes:The DUAFIT® interphalangeal implant is available in various angles(straight / 0° - 10° - 17°) and lengths (size 1 to 4, corresponding to 11to 20mm).Material: | |
| The DUAFIT® interphalangeal implant is manufactured fromPolyetheretherketone PEEK-OPTIMA®, polymer from Invibio®, as perASTM 2026. It does not have any coating. | |
| Single use:The DUAFIT® interphalangeal implant is designed for single use only. | |
| Sterilization:The DUAFIT® interphalangeal implant is supplied sterile, using gammairradiation. | |
| Place of use:The DUAFIT® interphalangeal implant is indicated for use in ahospital, or outpatient surgery center where sterile field may be createdand maintained. | |
| Predicate Devices | Newdeal K-wire (K022599) |
| Metasurg DigiFuse (K111536) | |
| Parcus PEEK CF push-in suture anchor (K102326) | |
| WMT Pro-Toe (K120645) | |
| Arrowhead Arrow-Lok (K112675) | |
| Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586) | |
| Merete MetaToe (K100414) | |
| Synchro Medical Toegrip (K143477) | |
| Indications for use: | The DUAFIT® interphalangeal implant is intended for fixation ofproximal interphalangeal joint arthrodesis of the lesser toes. |
| Examples include: | |
| - rigid or semi-rigid deformity of the PIP joint | |
| - revision of failed arthroplasty or arthrodesis | |
| - 2nd toe shortening |
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| Comparison of | The technological characteristics of the DUAFIT® interphalangeal implant are |
|---|---|
| Technological | the same as the characteristics of predicate devices in terms of intended use and |
| characteristics | design. All these implants have the following features: |
| Insertion into bone - the DUAFIT® interphalangeal implant and all | |
| predicate devices are intended for surgical implantation into bone for | |
| longer than 30 days. | |
| Tapered barded design in its proximal part - The DUAFIT®1 | |
| interphalangeal implant has similar tapered barded design in its proximal | |
| part, when compared to the Parcus PEEK CF push-in suture anchor | |
| (K102326). Smith and Nephew Bioraptor 2.3 PK suture anchor | |
| (K071586), Metasurg DigiFuse implant (K111536), WMT Pro-Toe | |
| (K120645), Merete MetaToe (K100414) and Synchro Toegrip | |
| (K133477). | |
| Blade design in its distal part - The DUAFIT® interphalangeal implant | |
| has similar blade design in its distal part, when compared to the | |
| Metasurg DigiFuse implant (K111536) and WMT Pro-Toe (K120645). | |
| Its shape is also similar to the distal part of the Synchro Toegrip | |
| (K133477). | |
| Canulated design: The DUAFIT® interphalangeal implant is available- | |
| with a similar canulated design, when compared to the Metasurg | |
| DigiFuse implant (K111536). | |
| Straight / Angled design: The DUAFIT® interphalangeal implant has- | |
| similar straight and angled design, when compared to the Metasurg | |
| DigiFuse implant (K111536), WMT Pro-Toe (K120645) , Arrowhead | |
| Arrow-Lok (K112675) and Synchro Toegrip (K133477) | |
| Made from PEEK: The DUAFIT® interphalangeal implant has exactly- | |
| the same raw material PEEK-OPTIMA®, polymer from Invibio", when | |
| compared to the Smith and Nephew Bioraptor 2.3 PK suture anchor | |
| (K071586). It has similar raw material, when compared to the Parcus | |
| PEEK CF push-in suture anchor (K102326) and Synchro Toegrip | |
| (K133477) . The Newdeal / Integra K-wire (K022599), the WMT Pro- | |
| Toe (K120645) and Arrowhead Arrow-Lok (K112675) are manufactured | |
| from stainless steel 316L, and the Metasurg DigiFuse implant is | |
| manufactured from Titanium Alloy TA6V. The Merete MetaToe is | |
| manufactured from EndoSorb PLGA bioabsorbable material. | |
| Equivalent size range: The DUAFIT® interphalangeal implant has | |
| similar size range, when compared to the Metasurg DigiFuse implant | |
| (K111536), WMT Pro-Toe (K120645), Arrowhead Arrow-Lok | |
| (K112675), Merete MetaToe (K100414) and Synchro Toegrip | |
| (K133477).The DUAFIT® interphalangeal implant has similar intended use and | |
| mechanical properties when compared to the Merete MetaToe EndoSorb(K100414). Results from testing confirmed that the DUAFIT® | |
| interphalangeal implant is at least equivalent to the predicate device. | |
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| SubstantialEquivalenceSummary | The DUAFIT® interphalangeal implant has similar indications for use andtechnological characteristics when compared to the predicate devices. | |
|---|---|---|
| Summary PerformanceData | The following tests were performed to demonstrate that the DUAFITinterphalangeal implant is substantially equivalent to other predicatedevices:- Static four-point bending test- Cyclic four-point bending test.The results of these studies showed that the DUAFIT interphalangealimplant met the acceptance criteria. | |
| CONCLUSION | Based on the evaluations performed, the design and indications ofthe DUAFIT® interphalangeal implant are substantially equivalentto the predicate devices identified in the 510(k) submission. No newmaterials or processes are used in the development of this implant.In addition, the results of the testing performed by the test labindicated that the implants performed as expected for each test.The DUAFIT® interphalangeal implants are acceptable for theapplication. |
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Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes that resemble waves or abstract wings. The emblem is positioned to the right of the text.
Public I lealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2014
In2Bones SAS % Norman F. Estrin, Ph.D. Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K132912
Trade/Device Name: DUAFIT* Interphalangeal Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: July 3. 2014 Received: July 9, 2014
Dear Dr. Estrin:
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. Iisting 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 is issuance of a substantíal equivalence determination docs 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 device-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Dr. Norman F. Estrin
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" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours, Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K132912 - page 1 of 1
Indications for Use
510(k) Number (if known): K132912
Device Name: DUAFIT** Interphalangeal Implant
Indications For Use: The DUAFIT® Interphalangeal implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes. Examples include: Rigid or semi-rigid deformity of the PIP joint Revision of failed arthroplasty or arthrodesis 2nd toe shortening.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ___________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet简介版rank -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132912
20000000
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.