(80 days)
The Aevumed RAPID™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral Repair
The Aevumed RAPIDTM Suture Anchor with HS FiberTM suture is a suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed RAPIDTM Suture Anchors are available in diameter sizes: 2.4mm and 3.0mm. They are offered sterile and are for single use only
The provided text is a 510(k) premarket notification for a medical device (Aevumed RAPID™ Suture Anchors). It details the device's characteristics, indications for use, and a comparison to predicate devices, but does not describe a study involving AI or software, nor does it provide acceptance criteria and performance data in the context of an AI/software device evaluation.
Therefore, I cannot extract the information required in your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because the document describes a hardware medical device (suture anchors) and its mechanical testing, not a diagnostic or AI-driven system.
The "Non-clinical Tests" section mentions mechanical testing for pullout strength and states:
- Study: "Both the Aevumed RAPID™ Suture Anchor and predicate SutureTak™ Anchor (K140855) were mechanically tested for maximum pullout strength."
- Result: "The Aevumed RAPID™ Suture Anchor demonstrated significantly higher pullout strength in comparison to the predicate SutureTak™ Anchor (K140855)."
This is the only "performance" information related to a "study" in the document, and it pertains to the physical device's mechanical properties, not an algorithmic performance.
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March 17, 2023
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Aevumed, Inc. Saif Khalil, Ph.D. President & CEO 109 Great Valley Parkway Malvern, Pennsylvania 19355
Re: K223878
Trade/Device Name: Aevumed RAPID™ 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: December 23, 2022 Received: December 27, 2022
Dear Dr. Saif Khalil:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sara S. Thompson -S
For
Laurence D. Coyne, Ph.D. Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223878
Device Name Aevumed RAPID™ Suture Anchors
Indications for Use (Describe)
The Aevumed RAPID™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral Repair
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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.109 Great Valley ParkwayMalvern, PA 19355 |
|---|---|
| CONTACT: | Saif Khalil, Ph.D.Chief Operating OfficerPhone: (610) 601-6614email: skhalil@aevumed.com |
| DATE PREPARED: | March 5th, 2023 |
| TRADE NAME: | Aevumed RAPIDTM Suture Anchor |
| COMMON NAME: | Suture Anchor |
| DEVICECLASSIFICATION: | Smooth or threaded metallic bone fixation fasteners, classified asClass II, product code MBI, Regulation 21 CFR 888.3040 |
| PRIMARY PREDICATEDEVICE: | SutureTakTM Suture Anchor, 510(k) number K140855 |
| REFERENCE PREDICATEDEVICE: | Aevumed RAPIDTM Suture Anchor, 510(k) number K180464 |
| DEVICE DESCRIPTION: | The Aevumed RAPIDTM Suture Anchor with HS FiberTM suture is a suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed RAPIDTM Suture Anchors are available in diameter sizes: 2.4mm and 3.0mm. They are offered sterile and are for single use only |
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| Aevumed Inc.K223878 | Version 1.0 | March 2023Page 2 of 3 |
|---|---|---|
| TECHNOLOGICAL | ||
| CHARACTERISTICS: | The proposed RAPID™ Suture Anchors with HS Fiber™ suture issimilar to the predicate SutureTak™ Anchor (K140855) in thatthey share the same intended use, geometric design, material,operational principle, sterilization method, packaging, and shelflife. The minor differences between the modified RAPID™ SutureAnchors and predicate SutureTak™ Anchor (K140855) do notraise new questions of safety and effectiveness. | |
| INDICATIONS FOR USE: | The Aevumed RAPID™ Suture Anchors are intended to be usedfor suture or tissue fixation in the foot, ankle, knee, hand, wrist,elbow, shoulder, and hip. Specific indications are listed below: | |
| Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion●Repair, Biceps Tenodesis, Acromio-Clabicular SeparationRepair, Deltoid Repair, Capsular Shift or CapsulolabralReconstruction | ||
| Foot/Ankle: Lateral Stabilization, Medial Stabilization,●Achilles Tendon Repair, Metatarsal Ligament Repair, HalluxValgus Reconstruction, Digital Tendon Transfers, Mid-footReconstruction | ||
| Knee: Medial Collateral Ligament Repair, Lateral Collateral●Ligament Repair, Patellar Tendon Repair, Posterior ObliqueLigament Repair, Iliotibial Band Tenodesis | ||
| Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal●Ligament Reconstruction, Repair/Reconstruction of CollateralLigaments, Repair of Flexor and Extensor Tendons at the PIP,DIP, and MCP joints for all Digits, Digital Tendon Transfers | ||
| Elbow: Biceps Tendon Reattachment, Ulnar or Radial●Collateral Ligament ReconstructionHip: Capsular repair, Acetabular Labral Repair● | ||
| INTENDED | ||
| POPULATION: | Patients age 18 and older. Contraindication: Not for use acrossgrowth plates in patients who are not skeletally mature. TheAevumed RAPID™ Suture Anchor is prescribed by the physician. | |
| NON-CLINICAL TESTS: | The substantial equivalence is bases on non-clinical data. Both theAevumed RAPID™ Suture Anchor and predicate SutureTak™Anchor (K140855) were mechanically tested for maximum pulloutstrength. The Aevumed RAPID™ Suture Anchor demonstrated |
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significantly higher pullout strength in comparison to the predicate SutureTak™ Anchor (K140855).
The sterilization, packaging, pyrogenicity/endotoxin monitoring, biocompatibility, and shelf life of the Aevumed RAPID™ Suture Anchor are identical to the predicate device Aevumed RAPID™ Suture Anchor (K180464).
SAFETY& PERFORMANCE:
The Aevumed RAPID™ Suture Anchor is substantially equivalent to the predicate device. The data support the safety of the device and demonstrate that the Aevumed RAPID™ Suture Anchor 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 RAPID™ Suture Anchor and the predicate device are considered minor and do not raise questions concerning safety and efficacy.
§ 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.