(104 days)
Not Found
No
The summary describes a mechanical implant system for bone fixation and fusion. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes.
The device is intended to facilitate bone healing, and is indicated for use for small bone fractures and osteotomy fixation and for distal phalangeal inter-digital fusion of the fingers and toes, which are all therapeutic purposes.
No
The device is an intramedullary small joint arthrodesis/fusion system used for fixation of osteotomies, fractures, and reconstruction. It is a treatment device, not a diagnostic one.
No
The device description clearly details physical implants (threaded Proximal Module and Screw) and surgical instruments (Cannulated Drills, Guide Wires, and Driver/Depth Gauge instruments) made of titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to facilitate bone healing following fracture fixation and for fusion of small bones in the fingers and toes. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a surgical implant (a screw system) used to stabilize bones. It is physically inserted into the patient's body. IVD devices are used to examine samples (like blood, urine, tissue) outside the body to diagnose or monitor conditions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Agent Medical - ArthroBridge System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones, distal phalangeal inter-digital, fingers, toes, foot, hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No nonclinical testing was used in the determination of substantial equivalence. An engineering/dimensional comparison to the predicate devices was performed to demonstrate Substantial Equivalence (SE).
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.
K024233, K040356, K130298, K122031, K990804, K081149
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with three faces in profile, representing health and well-being. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
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
1
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
2
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)
3
510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| NAME OF FIRM: | Agent Medical, LLC
1145 Gaskins Road,
Suite 102
Richmond, VA 23238
USA |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372
Tel. No. 952-492-5858
e-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
| SUBSTANTIALLY
EQUIVALENT 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) |
| ------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
DEVICE DESCRIPTION:
| | 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. |
| INTENDED USE: | 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. |
| EQUIVALENCE: | 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. |
| SUMMARY OF TECH-
NOLOGICAL
CHARACTERISTICS | 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 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) |