(162 days)
No
The device description and performance studies focus on the mechanical properties and delivery system of suture anchors, with no mention of AI or ML.
Yes
The device is described as a "Suture Anchor Delivery System" used for "fixation of ligament, tendon, bone, or soft tissue to bone" in procedures like "Rotator Cuff Repair" and "Achilles Tendon Repair." These functions are therapeutic as they involve restoring or repairing damaged tissues in the body.
No
The device description and intended use clearly state that these are suture anchors used for fixation of tissue to bone during surgical procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a delivery system for anchors made of PEEK, which are physical implants used in surgical procedures. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a "delivery system for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone." This is a surgical implant and delivery system used within the body during a procedure.
- Intended Use: The intended uses listed are all surgical procedures involving the repair or reconstruction of musculoskeletal tissues. These are not diagnostic tests performed on specimens outside the body.
The device is a surgical implant and its associated delivery system, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Apollo Medial, Medial with Needles, and Apollo XT Suture Anchor:
Shoulder
- Rotator Cuff Repair
- Bankart Repair
- SLAP Lesion Repair
- Biceps Tenodesis
- Acromio-Clavicular Separation Repair
- Deltoid Repair
- Capisular Shift or Capsulolabral Reconstruction
Foot/Ankle
- Lateral Stabilization
- Medial Stabilization
- Achilles Tendon Repair
Knee
- Medial Collateral Ligament Repair
- Lateral Collateral Ligament Repair
- Posterior Oblique Ligament Repair
- Illiotibial Band Tenodesis
Elbow
- Biceps Tendon Reattachment
- Ulnar or Radial Collateral Ligament Reconstruction
Hip
- Capsular Repair
- Acetabular Labral Repair
Apollo Knotless Anchor:
Shoulder
- Rotator Cuff Repair
- Bankart Repair
- SLAP Lesion Repair
- Biceps Tenodesis
- Acromio-Clavicular Separation Repair
- Deltoid Repair
- Capisular Shift or Capsulolabral Reconstruction
Wrist/Hand
- Scapholunate Ligament Reconstruction
- Ulnar/Radial Collateral Ligament Reconstruction
Foot/Ankle
- Lateral Stabilization
- Medial Stabilization
- Achilles Tendon Repair/Reconstruction
- Hallux Valgus Reconstruction
- Mid- and Forefoot Reconstruction
Elbow
- Biceps Tendon Reconstruction
- Ulnar or Radial Collateral Ligament Reconstruction
- Lateral Epicondylitis Repair (PEEK Anchor Only)
Knee
- Medial Collateral Ligament Repair
- Lateral Collateral Ligament Repair
- Posterior Oblique Ligament Repair
- Joint Capsule Closure
- Iliotibial Band Tenodesis
- Patellar Ligament/Tendon Repair
Product codes
MBI
Device Description
Apollo Family
The Apollo Medial Suture Anchor, Medial with Needles, XT Suture Anchor, Knotless Anchor Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only.
Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, shoulder, foot/ankle, elbow, and hand/wrist, Hip
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)
Axial Pull-Out per ASTM F543-17 testing was conducted to confirm the material additive did not introduce any new risk.
Bacterial Endotoxin testing meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 11, 2020
Valeris Medical Brendan Thies Medical Device Engineer 200 Cobb Pkwy N, Building 200, Suite 210 Marietta, Georgia 30062
Re: K192810
Trade/Device Name: Apollo Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 11, 2020 Received: February 13, 2020
Dear Mr. Thies:
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
1
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) 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 (OS) 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,
Laura C. Rose, Ph.D. Acting Assistant 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K192810
Device Name
Apollo Suture Anchor System
Indications for Use (Describe)
Apollo Medial, Medial with Needles, and Apollo XT Suture Anchor:
Shoulder
- · Rotator Cuff Repair
- · Bankart Repair
- · SLAP Lesion Repair
- · Biceps Tenodesis
- · Acromio-Clavicular Separation Repair
- · Deltoid Repair
- · Capisular Shift or Capsulolabral Reconstruction
Foot/Ankle
- · Lateral Stabilization
- · Medial Stabilization
- · Achilles Tendon Repair
Knee
- · Medial Collateral Ligament Repair
- · Lateral Collateral Ligament Repair
- · Posterior Oblique Ligament Repair
- · Illiotibial Band Tenodesis
Elbow
- · Biceps Tendon Reattachment
- · Ulnar or Radial Collateral Ligament Reconstruction
Hip
- · Capsular Repair
- · Acetabular Labral Repair
3
Apollo Knotless Anchor:
Shoulder
- · Rotator Cuff Repair
- · Bankart Repair
- · SLAP Lesion Repair
- · Biceps Tenodesis
- · Acromio-Clavicular Separation Repair
- · Deltoid Repair
- · Capisular Shift or Capsulolabral Reconstruction
Wrist/Hand
- · Scapholunate Ligament Reconstruction
- · Ulnar/Radial Collateral Ligament Reconstruction
Foot/Ankle
- · Lateral Stabilization
- · Medial Stabilization
- · Achilles Tendon Repair/Reconstruction
- · Hallux Valgus Reconstruction
- · Mid- and Forefoot Reconstruction
Elbow
- · Biceps Tendon Reconstruction
- · Ulnar or Radial Collateral Ligament Reconstruction
- · Lateral Epicondylitis Repair (PEEK Anchor Only)
Knee
- · Medial Collateral Ligament Repair
- · Lateral Collateral Ligament Repair
- · Posterior Oblique Ligament Repair
- · Joint Capsule Closure
- · Iliotibial Band Tenodesis
- · Patellar Ligament/Tendon 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (7H7)
Page 2 of 2
4
510(k) Summary (as required by 21 CFR 807.92)
| (as required by 21 CFR 807.92) | |
|---|---|
| Date Prepared | February 11, 2020 |
| Manufacturer | Valeris Medical |
| Address | 200 Cobb Pkwy N |
| Building 200, Suite 210 | |
| Marietta, GA 30062 | |
| Telephone | 888-404-3980 Ext 105 |
| Fax | 770-575-4052 |
| Contact Person | Brendan Thies |
| Medical Device Engineer | |
| Address | Valeris Medical |
| 200 Cobb Pkwy N | |
| Building 200, Suite 210 | |
| Marietta, GA 30062 | |
| Telephone | 888-404-3980 Ext 105 |
| Fax | 770-575-4052 |
| Brendan@Valerismedical.com |
| Trade Name | Apollo Suture Anchor System | |
|---|---|---|
| Common Name | Screw, Fixation, Bone | |
| Panel Code | Orthopaedics/87 | |
| Classification Name | Fastener, Fixation, Nondegradable, Soft Tissue | |
| Class | Class II | |
| Regulation Number | 21 CFR 888.3040 | |
| Product Code | MBI | |
| Name of Predicate Device | 510(k) # | Manufacturer |
| Apollo Suture Anchor System and | ||
| Titan Screws | K142230 | Valeris Medical |
| Description | Apollo Family
The Apollo Medial Suture Anchor, Medial with Needles, XT Suture Anchor,
Knotless Anchor Delivery Systems are delivery systems for anchors for
use in fixation of ligament, tendon, bone, or soft tissue to bone in knee,
shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors
consist of cannulated anchors with integrated suture attachment or
separate suture punch eyelet. The Anchors are provided loaded on
individual inserters with and without integrated sutures, sterile, for single
use only.
Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600
CF30 PEEK (ASTM F2026). |
| ------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Indications and
| Intended Use | Apollo Medial, Medial with Needles, and Apollo XT Suture Anchor: |
|---|---|
| Shoulder | |
| • Rotator Cuff Repair | |
| • Bankart Repair | |
| • SLAP Lesion Repair | |
| • Biceps Tenodesis | |
| • Acromio-Clavicular Separation Repair | |
| • Deltoid Repair | |
| • Capisular Shift or Capsulolabral Reconstruction | |
| Foot/Ankle | |
| · Lateral Stabilization | |
| • Medial Stabilization | |
| · Achilles Tendon Repair | |
| Knee | |
| · Medial Collateral Ligament Repair | |
| • Lateral Collateral Ligament Repair | |
| · Posterior Oblique Ligament Repair | |
| • Illiotibial Band Tenodesis | |
| Elbow | |
| · Biceps Tendon Reattachment | |
| • Ulnar or Radial Collateral Ligament Reconstruction | |
| Hip | |
| · Capsular Repair | |
| • Acetabular Labral Repair | |
| Apollo Knotless Anchor: | |
| Shoulder | |
| • Rotator Cuff Repair | |
| • Bankart Repair | |
| · SLAP Lesion Repair | |
| · Biceps Tenodesis | |
| · Acromio-Clavicular Separation Repair | |
| · Deltoid Repair | |
| • Capisular Shift or Capsulolabral Reconstruction | |
| Wrist/Hand | |
| • Scapholunate Ligament Reconstruction | |
| • Ulnar/Radial Collateral Ligament Reconstruction | |
| Foot/Ankle | |
| · Lateral Stabilization | |
| • Medial Stabilization | |
| · Achilles Tendon Repair/Reconstruction | |
| • Hallux Valgus Reconstruction | |
| • Mid- and Forefoot Reconstruction | |
| Elbow | |
| · Biceps Tendon Reconstruction | |
| • Ulnar or Radial Collateral Ligament Reconstruction | |
| · Lateral Epicondylitis Repair (PEEK Anchor Only) | |
| Knee | |
| • Medial Collateral Ligament Repair | |
| · Lateral Collateral Ligament Repair | |
| · Posterior Oblique Ligament Repair | |
| · Joint Capsule Closure | |
| • Iliotibial Band Tenodesis | |
| · Patellar Ligament/Tendon Repair |
5
6
| Technological
Characteristics
and Substantial
Equivalence | Documentation was provided to demonstrate that the Subject device,
Apollo Suture Anchor System is substantially equivalent to the Predicate
Apollo Suture Anchor System and Titan Screws (K142230). The Subject
device is substantially equivalent to the predicate device in intended use,
indications for use, materials, technological characteristics, performance
and labeling.
Materials: The subject device is very similar to the predicate device in
that they are both fabricated from Solvay ZENIVA PEEK; the subject
device will offer additional configurations Solvay Zeniva PEEK (ZA-600
and ZA-600 CF). These materials share a MAF.
An additional suture manufacturer is being proposed that will provide
UHMWPE sutures that have been demonstrated to be substantially
equivalent to those used in the predicate device.
Design Features: The additional configuration of the subject device
anchor is the same design as the predicate but with the suture or tape
pre-threaded for ease of use. Needles will be attached to certain
configurations of the subject device to provide additional options for the
user.
Other minor design enhancements to instruments used with the system
have been made in an effort for continuous improvement, including
addition of lateral suture whips and modifications to handles.
Sterilization and Shelf-Life: The subject and predicate devices are
offered sterile (EtO), and have a shelf-life of 2 years.
Biocompatibility: Biocompatibility was established according to ISO
10993-1. Bacterial endotoxins for the implantable components are
determined using LAL testing to meet endotoxin limit specifications.
The subject device is substantially equivalent to the predicate device in
that they are comprised of similar materials, share the same fundamental
technology, are intended for the same indications and utilize similar
designs. They are capable of achieving fixation in the same way. |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | Axial Pull-Out per ASTM F543-17 testing was conducted to confirm the
material additive did not introduce any new risk.
Bacterial Endotoxin testing meets pyrogen limit specifications. |
| Conclusion | Based on the intended use, indications for use, technological
characteristics, and comparison to the predicate device, the Subject
device has been shown to be substantially equivalent to the legally
marketed predicate device and is safe and effective for the intended use. |