(104 days)
The Agent Medical - ArthroBridge System is intended to facilitate bone healing following reduction and fracture fixation of the small bones.
The Agent Medical - ArthroBridge System is indicated for use for small bone fractures and osteotomy fixation and for distal phalangeal inter-digital fusion of the fingers and toes.
The Agent Medical - ArthroBridge System is not for spinal use.
The Agent Medical - ArthroBridge System is an intramedullary small joint arthrodesis/fusion system for fixation of osteotomies, fractures and reconstruction of the phalanges of the lesser digits in the foot and hand. The Agent Medical - ArthroBridge System is a 2-piece cannulated compression screw system composed of 1). A threaded Proximal Module (in a 4.0, 4.5 & 5.0mm size) that is placed within the proximal phalangeal medullary canal, and 2). A Screw with low profile head (in lengths of 25, 30, 35, 40, 45 and 50mm) that is introduced/threaded into the previously inserted Proximal Module. The Proximal Module is cannulated to fit over an insertion instrument and the Screw is cannulated to fit over a .035" K-wire for guided insertion of both components within the phalangeal digit medullary canal. The threaded advancement of the Screw body within the stationary threaded Proximal Module allows internal compression across the debrided digit joint space for stabilization and eventual fusion/ arthrodesis – and for bone fixation and joint deformity correction. The threaded Proximal Module and Screw with low profile head are manufactured from high strength Ti6Al4V ELI Titanium Alloy with an Anodized Type II surface. Disposable, single use, Cannulated Drills, Guide Wires, and Driver/Depth Gauge instruments are available for insertion of the system. Removal (when necessary) of the device is carried out percutaneously. All Implants and Instruments are packaged 'Sterile' for single use. The method of sterilization is Ethylene Oxide.
This document, K142528, is a 510(k) premarket notification for a medical device called the "Agent Medical - ArthroBridge System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria. Therefore, the information typically found in a study proving a device meets acceptance criteria for diagnostic performance (like sensitivity, specificity, or AUC) is not present in this document.
Here's a breakdown of what is available in the document, and what is not applicable or not provided for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable / Not provided. For a 510(k) for a bone fixation device, the "acceptance criteria" are not reported as statistical performance metrics (like sensitivity/specificity) but rather as demonstrations of substantial equivalence in design, materials, and intended use as compared to predicate devices. There are no performance metrics reported in the way they would be for a diagnostic AI device.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. This document describes a medical device for bone fixation, not an AI or diagnostic system that would have a "test set" in the context of performance evaluation.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable / Not provided. This concept of "experts establishing ground truth" is relevant for diagnostic performance studies, not for this type of device submission.
4. Adjudication Method:
- Not applicable / Not provided. Adjudication methods are typically used in clinical trials or diagnostic studies where there's a need to resolve discrepancies in expert interpretations of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:
- No, a MRMC study was not done. This is a bone fixation system, not a diagnostic AI device that would participate in such a study for comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This describes a mechanical bone fixation device, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable / Not provided. The concept of "ground truth" as pathology, outcomes data, or expert consensus is used in diagnostic algorithm evaluations, not for a substantial equivalence demonstration of a bone fixation device.
8. The Sample Size for the Training Set:
- Not applicable / Not provided. This is a physical medical device, not an AI/ML algorithm that would have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided. See explanation for #8.
What the document does describe related to deeming the device acceptable:
The document states that the FDA reviewed the 510(k) premarket notification and "determined the device is substantially equivalent... to legally marketed predicate devices." This is the core "acceptance criteria" for a 510(k) pathway.
The study that proves the device meets this acceptance criteria (i.e., substantial equivalence) is summarized as follows:
- Equivalence Statement: "The Agent Medical - ArthroBridge System is Substantially Equivalent(SE) to the predicate systems (as listed). No nonclinical testing was used in the determination of substantial equivalence." (Page 4)
- Summary of Technological Characteristics: "The Agent Medical - ArthroBridge System is Similar in Material, Design, and Indications to the listed predicate devices." (Page 4)
- Conclusion: "The Agent Medical - ArthroBridge System has similar indications for use, materials, dimensions, and designs when compared to the predicate devices. An engineering/dimensional comparison to the predicate devices was performed to demonstrate Substantial Equivalence (SE). Based on these similarities, the Agent Medical – ArthroBridge System is substantially equivalent to the predicates identified in the 510(k)." (Page 4)
In essence, for this specific bone fixation device, the "acceptance criteria" are met by demonstrating that its indications for use, materials, dimensions, and design are sufficiently similar to already legally marketed predicate devices. The "study" was an engineering/dimensional comparison to these predicate devices, which led to the conclusion of substantial equivalence.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2014
Agent Medical, LLC % Mr. Al Lippincott Engineering Consulting Services, Incorporated 3150 E. 200th Street Prior Lake, Minnesota 55372
Re: K142528
Trade/Device Name: Agent Medical - ArthroBridge System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 16, 2014 Received: October 28, 2014
Dear Mr. Lippincott:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Al Lippincott
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 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) NUMBER: DEVICE NAME: Agent Medical - ArthroBridge System
The Agent Medical ArthroBridge System is intended to facilitate bone healing following reduction and fracture fixation of the small bones.
The Agent Medical - ArthroBridge System is indicated for use for small bone fractures and osteotomy fixation and for distal phalangeal inter-digital fusion of the fingers and toes.
The Agent Medical - ArthroBridge System is not for spinal use.
Prescription Use XXXX -AND/OR Over-The-Counter-Use
(Per 21 CFR 801 Subpart D)
(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)
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510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| NAME OF FIRM: | Agent Medical, LLC1145 Gaskins Road,Suite 102Richmond, VA 23238USA |
|---|---|
| 510(k) FIRM CONTACT: | Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372Tel. No. 952-492-5858e-mail: allippincott@msn.com |
-
December 9, 2014 DATE:
TRADE NAME: Agent Medical – ArthroBridge System -
COMMON NAME: Intramedullary Bone and Compression Screw System
-
Screw, Fixation, Bone DEVICE NAME:
-
Smooth or Threaded Metallic Bone Fixation Fastener, CLASSIFICATION: Class II (21 CFR, Sec. 888.3040)
DEVICE PRODUCT CODE: HWC
| SUBSTANTIALLYEQUIVALENT DEVICE | Integra/Kinetikos – KMI Kompressor™ Compression Screw(K024233 & K040356)BioPro - Kwick-Wire™ Universal Screw System (K130298)Nextremity - Nextra™ Hammertoe Correction System (K122031)Pioneer/Tornier – StayFuse™ Intramedullary Fusion Device (K990804)BioPro - Go-Ez™ Screw System (K081149) |
|---|---|
| ------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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DEVICE DESCRIPTION:
| The Agent Medical - ArthroBridge System is an intramedullary small jointarthrodesis/fusion system for fixation of osteotomies, fractures andreconstruction of the phalanges of the lesser digits in the foot and hand.The Agent Medical - ArthroBridge System is a 2-piece cannulatedcompression screw system composed of 1). A threaded Proximal Module(in a 4.0, 4.5 & 5.0mm size) that is placed within the proximal phalangealmedullary canal, and 2). A Screw with low profile head (in lengths of 25,30, 35, 40, 45 and 50mm) that is introduced/threaded into the previouslyinserted Proximal Module. The Proximal Module is cannulated to fit overan insertion instrument and the Screw is cannulated to fit over a .035" K-wire for guided insertion of both components within the phalangeal digitmedullary canal. The threaded advancement of the Screw body within thestationary threaded Proximal Module allows internal compression acrossthe debrided digit joint space for stabilization and eventual fusion/arthrodesis – and for bone fixation and joint deformity correction. Thethreaded Proximal Module and Screw with low profile head aremanufactured from high strength Ti6Al4V ELI Titanium Alloy with anAnodized Type II surface. Disposable, single use, Cannulated Drills,Guide Wires, and Driver/Depth Gauge instruments are available forinsertion of the system. Removal (when necessary) of the device iscarried out percutaneously. All Implants and Instruments are packaged | |
|---|---|
| 'Sterile' for single use. The method of sterilization is Ethylene Oxide. | |
| INTENDED USE: | The Agent Medical - ArthroBridge System is intended to facilitate bonehealing following reduction and fracture fixation of the small bones.The Agent Medical - ArthroBridge System is indicated for use for smallbone fractures and osteotomy fixation and for distal phalangeal inter-digital fusion of the fingers and toes.The Agent Medical ArthroBridge System is not for spinal use. |
| EQUIVALENCE: | The Agent Medical - ArthroBridge System is SubstantiallyEquivalent(SE) to the predicate systems (as listed). No nonclinical testingwas used in the determination of substantial equivalence. |
| SUMMARY OF TECH-NOLOGICALCHARACTERISTICS | The Agent Medical - ArthroBridge System is Similar in Material,Design, and Indications to the listed predicate devices. |
| CONCLUSION: | The Agent Medical - ArthroBridge System has similar indications for use,materials, dimensions, and designs when compared to the predicatedevices. An engineering/dimensional comparison to the predicate deviceswas performed to demonstrate Substantial Equivalence (SE). Based onthese similarities, the Agent Medical – ArthroBridge System issubstantially equivalent to the predicates identified in the 510(k) |
§ 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.