(99 days)
None
No
The device description and performance studies focus on the mechanical properties and intended use of a suture anchor, with no mention of AI or ML capabilities.
Yes
The device, a suture anchor, is used for soft tissue fixation to bone in various anatomical locations to repair injuries and facilitate healing, which falls under the definition of a therapeutic device.
No
The device description clearly states its purpose is for "fixation of soft tissue to bone," which is a treatment or surgical function, not a diagnostic one. The "Intended Use" section lists various surgical repair procedures, none of which involve diagnosis.
No
The device description clearly states it is a threaded suture anchor manufactured from PEEK material, preloaded on a disposable driver assembly. This describes a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical fixation of soft tissue to bone in various anatomical locations. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a threaded suture anchor manufactured from PEEK material, preloaded with suture. This is a physical implant used during surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Aevumed PHANTOM™ suture anchors are intended to be used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures:
· Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.
· Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Product codes
MBI
Device Description
The Aevumed PHANTOM ™ Anchor with HS Fiber ™ suture is a threaded suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable driver assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM ™ Anchor with HS Fiber ™ are pre-loaded with or without needles. The Aevumed PHANTOM ™ Suture Anchor are available in diameter sizes: 5.5mm and 6.5mm. They are offered sterile and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, and elbow
Indicated Patient Age Range
Patients age 18 and older. Contraindication: Not for use across growth plates in patients who are not skeletally mature.
Intended User / Care Setting
The Aevumed PHANTOM™ suture anchor is prescribed by the physician.
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
The substantial equivalence is based on non-clinical data. Both the Aevumed PHANTOM™ suture anchor and predicate device were mechanically tested for the following: Torsional Strength, Driving torque, Pullout Strength.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a symbol of a stylized human figure. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2018
Aevumed, Inc. % Carol Rutkowski Partner, Pyxa Solutions Pyxa Solutions LLC 1034 West Thomas Road Plymouth Meeting, Pennsylvania 19462
Re: K180464
Trade/Device Name: AEVUMED PHANTOM Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 30, 2018 Received: April 30, 2018
Dear Ms. Rutkowski:
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 forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
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 (if known) K180464
Device Name AEVUMED PHANTOM Suture Anchors
Indications for Use (Describe)
The Aevumed PHANTOM™ suture anchors are intended to be used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures:
· Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.
· Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. Premarket Notification 510(k) Summary
| MANUFACTURER /
SPONSOR: | Aevumed Inc.
877 Richards Rd.
Wayne, PA 19807 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Saif Khalil, Ph.D.
Chief Operating Officer
Phone: (610) 745-7284
Fax: (610) 783-0307 |
| TRADE NAME : | Aevumed PHANTOM TM Suture Anchor |
| COMMON NAME: | Suture Anchor |
| DEVICE
CLASSIFICATION: | Smooth or threaded metallic bone fixation fasteners, classified as
Class II, product code MBI, Regulation 21 CFR 888.3040 |
| PREDICATE DEVICE: | Arthrex Corkscrew FT, 510(k) number K061665. |
| DEVICE DESCRIPTION: | The Aevumed PHANTOM TM Anchor with HS Fiber TM suture is a threaded suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable driver assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM TM Anchor with HS Fiber TM are pre-loaded with or without needles. The Aevumed PHANTOM TM Suture Anchor are available in diameter sizes: 5.5mm and 6.5mm. They are offered sterile and are for single use only. |
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TECHNOLOGICAL The proposed Aevumed PHANTOM™ Anchors with HS Fiber™ CHARACTERISTICS: suture are similar to the predicate Arthrex Corkscrew FT (K061665) in that they share the same intended use, have the same anchor materials and principal operation . The devices do not raise different questions of safety and effectiveness. The Aevumed PHANTOM™ suture anchors are intended to be INDICATIONS FOR USE: used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps ● Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, ● Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair. ● Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral ● Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament . Reconstruction. INTENDED POPULATION: Patients age 18 and older. Contraindication: Not for use across growth plates in patients who are not skeletally mature. The Aevumed PHANTOM™ suture anchor is prescribed by the physician. The substantial equivalence is based on non-clinical data. Both the NON-CLINICAL TESTS: Aevumed PHANTOM™ suture anchor and predicate device were mechanically tested for the following: Torsional Strength ● ● Driving torque Pullout Strength. ●
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Version 1.0 FINAL
SAFETY& PERFORMANCE:
The Aevumed PHANTOM™ Anchor is substantially equivalent to the Arthrex Corkscrew FT Suture Anchor. The data support the safety of the device and demonstrate that the Aevumed PHANTOM™ device should perform as intended in the specified use conditions and performs comparably to the predicate device that is currently marketed for the same intended use. Any differences between the Aevumed PHANTOM™ suture anchor and the Arthrex Corkscrew FT are considered minor and do not raise questions concerning safety and efficacy.