(316 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are mechanical tests.
Yes
The device is intended for fixation of proximal interphalangeal joint arthrodesis, which is a treatment for certain foot conditions.
No
The device is an implant for fixation of joint arthrodesis, not a tool for diagnosing medical conditions.
No
The device description clearly states it is an "intramedullary implant" made from PEEK-OPTIMA®, which is a physical material designed for surgical implantation. This is a hardware device, not software.
Based on the provided information, the DUAFIT® Interphalangeal implant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The DUAFIT® implant is a surgical implant intended for fixation of bones within the body. It is a physical device used in the body, not a tool for analyzing samples from the body.
The description clearly states its purpose is for "fixation of proximal interphalangeal joint arthrodesis of the lesser toes" and describes it as an "intramedullary implant, designed to act as a bone fastener". This aligns with the definition of a surgical implant, not an IVD.
N/A
Intended Use / 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.
Product codes
HWC
Device Description
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.
Sizes: The DUAFIT® interphalangeal implant is available in various angles (straight / 0° - 10° - 17°) and lengths (size 1 to 4, corresponding to 11 to 20mm).
Material: The DUAFIT® interphalangeal implant is manufactured from Polyetheretherketone PEEK-OPTIMA®, polymer from Invibio®, as per ASTM 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 gamma irradiation.
Place of use: The DUAFIT® interphalangeal implant is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal joint of the lesser toes.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, or outpatient surgery center
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)
The following tests were performed to demonstrate that the DUAFIT interphalangeal implant is substantially equivalent to other predicate devices: - Static four-point bending test - Cyclic four-point bending test. The results of these studies showed that the DUAFIT interphalangeal implant met the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 SAS
28 chemin du Petit Bois
69130 Ecully - France
Phone: +33.4.72.29.26.26
Fax: +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 Estrin
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Fax: (301) 294-0126
Email: estrin@yourFDAconsultant.com |
| Authorized Agent in the
United States | Norman Estrin
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Fax: (301) 294-0126
Email: 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 fastener
Class II |
| Device Product
Code and Panel | HWC: screw, fixation, bone
87 orthopedics |
| Device Description | 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. |
| | Sizes:
The DUAFIT® interphalangeal implant is available in various angles
(straight / 0° - 10° - 17°) and lengths (size 1 to 4, corresponding to 11
to 20mm).
Material: |
| | The DUAFIT® interphalangeal implant is manufactured from
Polyetheretherketone PEEK-OPTIMA®, polymer from Invibio®, as per
ASTM 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 gamma
irradiation. |
| | Place of use:
The DUAFIT® interphalangeal implant is indicated for use in a
hospital, or outpatient surgery center where sterile field may be created
and 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 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 |
1
.
and the commend of the comments of
.
:
:
.
.
and the comments of the comments of
2
:
| 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. |
| | |
.
.
.
.
: : : :
.
:
ので、その他の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の
3
|
| Substantial
Equivalence
Summary | The DUAFIT® interphalangeal implant has similar indications for use and
technological characteristics when compared to the predicate devices. | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Summary Performance
Data | The following tests were performed to demonstrate that the DUAFIT
interphalangeal implant is substantially equivalent to other predicate
devices:
- Static four-point bending test
- Cyclic four-point bending test.
The results of these studies showed that the DUAFIT interphalangeal
implant met the acceptance criteria. | |
| CONCLUSION | Based on the evaluations performed, the design and indications of
the DUAFIT® interphalangeal implant are substantially equivalent
to the predicate devices identified in the 510(k) submission. No new
materials or processes are used in the development of this implant.
In addition, the results of the testing performed by the test lab
indicated that the implants performed as expected for each test.
The DUAFIT® interphalangeal implants are acceptable for the
application. | |
:
.
:
:
: 上一篇: .
4
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
5
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
6
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
.