(49 days)
The Metasurg DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
- Hammer toe deformity
- Claw toe deformity
- Mallet toe deformity
- Other deformities of the feet and hands
The Metasurg DigiFuse implants are intended for single use only.
The Metasurg DigiFuse Implant is a one-piece threaded device made of titanium intended to be implanted into the medullary bone of the lesser digits. The implant is offered in 4 variations consisting of the combination of 2.0mm and 2.5mm threads and 0° and 10° blades.
The provided text describes a 510(k) summary for the Metasurg DigiFuse Implant and the FDA's decision letter. This document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and design/dimensional comparisons. It does not contain information about a clinical study with acceptance criteria and device performance as typically expected for advanced diagnostic or AI-driven medical devices.
Therefore, many of the requested elements for a study proving device acceptance criteria cannot be extracted from this specific document.
Here's a breakdown of what can be inferred or is explicitly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable.
This document outlines a regulatory submission based on substantial equivalence to predicate devices, not a clinical study with performance metrics against predefined acceptance criteria. The "acceptance criteria" here are implicitly related to the similarity of intended use, material, and design to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable.
There is no mention of a "test set" in the context of clinical data or image analysis. The comparison is based on the design and dimensional characteristics of the device itself relative to predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable.
No ground truth establishment by experts is described as this is not a study evaluating human or algorithm performance against a known truth.
4. Adjudication Method
Not Applicable.
No adjudication method is relevant as there are no judgments being made by experts on a test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not Applicable.
No MRMC study was conducted or mentioned, as this is a device clearance based on substantial equivalence, not a comparative effectiveness study involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not Applicable.
This device is an implant, not an algorithm. Therefore, no standalone algorithm performance study was done.
7. Type of Ground Truth Used
Not Applicable.
No ground truth (expert consensus, pathology, outcomes data) was used in the context of a performance study as described here. The "truth" for substantial equivalence is the existing regulatory status and established characteristics of the predicate devices.
8. Sample Size for the Training Set
Not Applicable.
There is no mention of a "training set" as this is not a machine learning or AI-driven device.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
No ground truth for a training set was established.
Summary of what the document does provide in relation to regulatory acceptance:
- Basis for Acceptance: Substantial equivalence to predicate devices.
- Key Comparison Points: Similar indications, physical dimensions, and material (titanium and/or stainless steel).
- Predicate Devices:
- Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
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K111536 1/2
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510(k) Summary
JUL 2 1 2011
| Date Prepared: | May 19, 2011 |
|---|---|
| Sponsor: | Metasurg16350 Park Ten Place, Suite 101Houston, TX 77084 |
| Company Contact: | Joshua ScottPhone: (281) 398-5656Fax: (281) 398-5660 |
| Device Trade Name: | Metasurg DigiFuse Implant |
| Classification Name: | Smooth & threaded metallic bone fixation fasteners (21CFR 888.3040, Product Code HWC, Class II) |
| Common Name: | Intramedullary Bone Fastener |
| Predicate Devices: | OsteoMed Ext. 2.0/2.4 Cannulated Screw System (K062863)Wright Medical Pro-Toe (K101165)NEWDEAL K-Wire (K022599) |
| Device Description: | The Metasurg DigiFuse Implant is a one-piece threaded devicemade of titanium intended to be implanted into the medullarybone of the lesser digits. The implant is offered in 4 variationsconsisting of the combination of 2.0mm and 2.5mm threads and0° and 10° blades. |
| Intended Usage: | The Metasurg DigiFuse implant is indicated for the fixation ofosteotomies and reconstruction of the lesser phalanges duringprocedures to correct deformities of the toes and fingers.· Hammer toe deformity· Claw toe deformity· Mallet toe deformity· Other deformities of the feet and handsThe Metasurg DigiFuse implants are intended for single use only. |
| Material: | Titanium Alloy (Ti 6Al-4V ELI) |
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K1115 36$\frac{2}{2}$
- Technological Characteristics: The Metasurg DigiFuse implant and the other legally marketed predicate devices listed in this summary have similar indications, physical dimensions and are constructed of titanium and/or stainless steel.
- A design and dimensional comparison was performed to establish Substantial Equivalence: substantial equivalence to the legally marketed predicate devices listed in this summary.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Metasurg % Mr. Joshua Scott 16350 Park Ten Place Suite 101 Houston, Texas 77084
JUL 2 1 2011
Re: K111536
Trade/Device Name: Metasurg DigiFuse Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 31, 2011 Received: June 2, 2011
Dear Mr. Scott:
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.
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
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Page 2 – Mr. Joshua Scott
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance 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,
E. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KIII 234
510(k) Number: Pending
Device Name: Metasurg DigiFuse Implant
Indications for Use:
The Metasurg DigiFuse implant is indicated for the fixation of osteotomies and . reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
- Hammer toe deformity �
- Claw toe deformity �
- Mallet toe deformity 0
- Other deformities of the feet and hands �
The Metasurg DigiFuse implants are intended for single use only.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WIRTE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkern
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111536
Section 4 - Page 1 of 1
§ 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.