(330 days)
The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint.
The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement.
The Vilex cannulated metallic hemi implant is intended for single use only.
Vilex Cannulated Metallic Hemi Implant is a one-piece device intended to resurface the base of the proximal phalanx. It is similar in design to the predicate devices (BioPro K023684) and MetaSurg (K083469) in terms of articular surface shape and fixation. Implants will be offered in cobalt chrome or titanium, with or without Hydroxyapatite (HA) coated stem and back as an option.
The provided text is a 510(k) summary for a medical device (Vilex Cannulated Metallic Hemi Implant). It describes the device, its indications for use, and a claim of substantial equivalence to predicate devices. However, it does not include the detailed performance study information requested in the prompt.
Specifically, the document states: "Non-Clinical Test Data: Based on the engineering analysis, the Vilex implants are equivalent to predicates in terms of mechanical integrity and resistance to bending torques." This indicates that the primary evidence for this device's acceptance is based on engineering analysis and comparison to existing predicate devices, rather than a clinical study with detailed performance metrics, ground truth establishment, or human reader involvement.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
Acceptance Criteria and Device Performance Study for Vilex Cannulated Metallic Hemi Implant
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Integrity: The device must demonstrate mechanical integrity equivalent to predicate devices. | Equivalent: "Based on the engineering analysis, the Vilex implants are equivalent to predicates in terms of mechanical integrity..." |
| Resistance to Bending Torques: The device must demonstrate resistance to bending torques equivalent to predicate devices. | Equivalent: "...and resistance to bending torques." |
| Indications for Use: The device's indications for use must be comparable to legally marketed devices. | Comparable: "The methods used to establish equivalence are comparisons of indications for use..." |
| Materials of Construction: The device's materials must be comparable to legally marketed devices. | Comparable: "...materials of construction..." |
| Sizes: The device's sizes must be comparable to legally marketed devices. | Comparable: "...sizes..." |
| Shapes: The device's shapes must be comparable to legally marketed devices. | Comparable: "...and shapes..." |
2. Sample size used for the test set and the data provenance:
- Not applicable. This device's acceptance is based on an "engineering analysis" and comparison to predicate devices, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set requiring expert ground truth establishment is described. The evaluation was an engineering analysis.
4. Adjudication method for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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:
- No. This is a medical implant, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a medical implant, not an algorithm.
7. The type of ground truth used:
- Engineering Analysis/Predicate Device Specifications: The "ground truth" for the device's acceptance is based on its engineering properties matching those of previously approved predicate devices, along with comparable indications for use, materials, sizes, and shapes.
8. The sample size for the training set:
- Not applicable. This device's acceptance is based on engineering comparison, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set for a machine learning model is involved.
Summary:
The provided 510(k) summary for the Vilex Cannulated Metallic Hemi Implant demonstrates substantial equivalence through an engineering analysis and comparison to predicate devices in terms of mechanical integrity, resistance to bending torques, indications for use, materials, sizes, and shapes. This is a common pathway for medical device clearance, especially for devices similar to existing ones. It does not involve clinical studies with patient data, expert ground truth, or AI-related performance metrics.
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510(k) Summary, K102401
| Sponsor: | Vilex in Tennessee, Inc., 111 Moffitt St., McMinnville, TN 37110,931-474-7550 |
|---|---|
| Contact: | Sylvia Southard Date: July 8, 2011 |
| Device Name: | Cannulated Metallic Hemi Implant |
| Classification: | 21 CFR 888.3730 – Toe joint phalangeal (hemi-toe) polymer prosthesis, KWD |
| Predicate Devices: | K023684 Vilex Cannulated Metallic Hemi ImplantK041595 BioPro Hemi Joint with optional coatingK911378 Townley Great Toe Joint8: BioProK084369 Metasurg Hemi JointK081876 OsteoMed Resurfacing Metatarsal Implant with HA CoatingK971047 FUTURA Biomedical |
| Description of Device: | Vilex Cannulated Metallic Hemi Implant is a one-piece device intended toresurface the base of the proximal phalanx. It is similar in design to thepredicate devices (BioPro K023684) and MetaSurg (K083469) in terms ofarticular surface shape and fixation. Implants will be offered in cobalt chromeor titanium, with or without Hydroxyapatite (HA) coated stem and back as anoption. |
| Material: | Cobalt chrome molybdenum alloy or Titanium Ti6Al4V (optional). The implantmay be cemented to the phalanx or press-fit without cement. |
| Indications for Use: | The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant forthe metatarsophalangeal (MTP) joint, is indicated for use in the treatment ofpatients with degenerative and post-traumatic arthritis in the MTP joint in thepresence of good bone stock and integrity of the phalangeal base, along withthe following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus,and an unstable or painful MTP joint.The Vilex cannulated metallic hemi implant is intended to be used with bonecement or press fit without bone cement.The Vilex cannulated metallic hemi implant is intended for single use only. |
| Non-Clinical Test Data | Based on the engineering analysis, the Vilex implants are equivalent topredicates in terms of mechanical integrity and resistance to bending torques. |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Vilex Implants aresubstantially equivalent to other legally marketed devices with and without HAcoating. The methods used to establish equivalence are comparisons ofindications for use, materials of construction, sizes, shapes, and mechanicalintegrity analysis. |
| Establishment Reg. No.: | 1051526 |
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Vilex, Inc. % Ms. Sylvia Southard 111 Moffitt Street McMinnville, TN 37110
JUL 2 0 2011
Re: K102401
Trade/Device Name: Vilex Cannulated Metallic Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: July 8, 2011 Received: July 14, 2011
Dear Ms. Southard:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Ms. Sylvia Southard
device-related 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eunice 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
510(k) Number: K102401
Device Name: Vilex Cannulated Metallic Hemi Implant
Indications for Use:
The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint.
The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement.
The Vilex cannulated metallic hemi implant is intended for single use only.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for N. Melkerson
(Division Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102401
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.