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).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Apollo Suture Anchor System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study involving human readers or AI.

Therefore, many of the requested elements regarding acceptance criteria, study design, ground truth, and human-in-the-loop performance are not applicable to this type of regulatory submission and are not found in the provided text.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "table of acceptance criteria" with numerical targets for clinical performance metrics (like sensitivity, specificity, AUC for AI, or improvement in human reader performance). Instead, it relies on demonstrating equivalence through various engineering and material tests.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility (ISO 10993-1)	"Biocompatibility was established according to ISO 10993-1."
Bacterial Endotoxins (for implantable components)	"Bacterial Endotoxin testing meets pyrogen limit specifications." (Determined using LAL testing).
Mechanical Performance (Axial Pull-Out)	"Axial Pull-Out per ASTM F543-17 testing was conducted to confirm the material additive did not introduce any new risk." (The implicit acceptance criterion is that the performance is comparable to or better than the predicate, or at least not worse, suggesting the material additive does not negatively impact the established mechanical properties.) The document doesn't state specific numerical pull-out strength values, but implies acceptable performance.
Material Equivalence (Solvay Zeniva PEEK)	The materials (Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK) "share a MAF" (Master Access File, indicating they are known and acceptable materials). The additional configurations of Solvay Zeniva PEEK (ZA-600 and ZA-600 CF) are considered substantially equivalent to the predicate.
Suture Equivalence (UHMWPE)	An additional UHMWPE suture manufacturer is proposed, and its sutures "have been demonstrated to be substantially equivalent to those used in the predicate device."
Sterilization and Shelf-Life	"The subject and predicate devices are offered sterile (EtO), and have a shelf-life of 2 years." (Implicitly, the device successfully maintains sterility and functionality for this duration).
Intended Use & Indications for Use Equivalence	The device is intended for the "same indications" and "same fundamental technology" as the predicate. The Indications for Use are explicitly listed for various anatomical regions and repairs (Shoulder, Foot/Ankle, Knee, Elbow, Hip, Wrist/Hand). The acceptance is that the device can safely and effectively be used for these stated indications, similar to the predicate.
Overall Substantial Equivalence	"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."

2. Sample size used for the test set and the data provenance:

This document describes a 510(k) submission based on bench testing (e.g., mechanical, biocompatibility) and comparison to a predicate device, not a clinical test set with patient data for an AI/device performance study. Therefore, there's no "test set" in the context of a dataset of patient cases. The "samples" would refer to the physical devices or materials used for the specified laboratory tests. The provenance is internal testing by Valeris Medical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As this is not an AI or diagnostic device that requires expert review of clinical images/data for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical case adjudication process described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this type of device lies in:

Material properties and standards: e.g., ASTM F2026 for PEEK, ISO 10993-1 for biocompatibility, ASTM F543-17 for mechanical testing.
Predicate device's established performance: The predicate's prior clearance serves as a benchmark for safety and effectiveness.
Laboratory test results: Measuring physical properties like pull-out strength and endotoxin levels against pre-defined specifications.

8. The sample size for the training set:

Not applicable. This is not an machine learning/AI device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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

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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

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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

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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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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FORM FDA 3881 (7H7)

Page 2 of 2

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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 NBuilding 200, Suite 210Marietta, GA 30062
Telephone	888-404-3980 Ext 105
Fax	770-575-4052
Contact Person	Brendan ThiesMedical Device Engineer
Address	Valeris Medical200 Cobb Pkwy NBuilding 200, Suite 210Marietta, GA 30062
Telephone	888-404-3980 Ext 105
Fax	770-575-4052
Email	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 andTitan Screws	K142230	Valeris Medical

Description	Apollo FamilyThe Apollo Medial Suture Anchor, Medial with Needles, XT Suture Anchor,Knotless Anchor Delivery Systems are delivery systems for anchors foruse in fixation of ligament, tendon, bone, or soft tissue to bone in knee,shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchorsconsist of cannulated anchors with integrated suture attachment orseparate suture punch eyelet. The Anchors are provided loaded onindividual inserters with and without integrated sutures, sterile, for singleuse only.Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600CF30 PEEK (ASTM F2026).
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Description

Apollo FamilyThe Apollo Medial Suture Anchor, Medial with Needles, XT Suture Anchor,Knotless Anchor Delivery Systems are delivery systems for anchors foruse in fixation of ligament, tendon, bone, or soft tissue to bone in knee,shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchorsconsist of cannulated anchors with integrated suture attachment orseparate suture punch eyelet. The Anchors are provided loaded onindividual inserters with and without integrated sutures, sterile, for singleuse only.Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600CF30 PEEK (ASTM F2026).

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Indications andIntended 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 ReconstructionFoot/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

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TechnologicalCharacteristicsand SubstantialEquivalence	Documentation was provided to demonstrate that the Subject device,Apollo Suture Anchor System is substantially equivalent to the PredicateApollo Suture Anchor System and Titan Screws (K142230). The Subjectdevice is substantially equivalent to the predicate device in intended use,indications for use, materials, technological characteristics, performanceand labeling.Materials: The subject device is very similar to the predicate device inthat they are both fabricated from Solvay ZENIVA PEEK; the subjectdevice will offer additional configurations Solvay Zeniva PEEK (ZA-600and ZA-600 CF). These materials share a MAF.An additional suture manufacturer is being proposed that will provideUHMWPE sutures that have been demonstrated to be substantiallyequivalent to those used in the predicate device.Design Features: The additional configuration of the subject deviceanchor is the same design as the predicate but with the suture or tapepre-threaded for ease of use. Needles will be attached to certainconfigurations of the subject device to provide additional options for theuser.Other minor design enhancements to instruments used with the systemhave been made in an effort for continuous improvement, includingaddition of lateral suture whips and modifications to handles.Sterilization and Shelf-Life: The subject and predicate devices areoffered sterile (EtO), and have a shelf-life of 2 years.Biocompatibility: Biocompatibility was established according to ISO10993-1. Bacterial endotoxins for the implantable components aredetermined using LAL testing to meet endotoxin limit specifications.The subject device is substantially equivalent to the predicate device inthat they are comprised of similar materials, share the same fundamentaltechnology, are intended for the same indications and utilize similardesigns. They are capable of achieving fixation in the same way.
Performance Data	Axial Pull-Out per ASTM F543-17 testing was conducted to confirm thematerial additive did not introduce any new risk.Bacterial Endotoxin testing meets pyrogen limit specifications.
Conclusion	Based on the intended use, indications for use, technologicalcharacteristics, and comparison to the predicate device, the Subjectdevice has been shown to be substantially equivalent to the legallymarketed predicate device and is safe and effective for the intended use.

TechnologicalCharacteristicsand SubstantialEquivalence

Documentation was provided to demonstrate that the Subject device,Apollo Suture Anchor System is substantially equivalent to the PredicateApollo Suture Anchor System and Titan Screws (K142230). The Subjectdevice is substantially equivalent to the predicate device in intended use,indications for use, materials, technological characteristics, performanceand labeling.Materials: The subject device is very similar to the predicate device inthat they are both fabricated from Solvay ZENIVA PEEK; the subjectdevice will offer additional configurations Solvay Zeniva PEEK (ZA-600and ZA-600 CF). These materials share a MAF.An additional suture manufacturer is being proposed that will provideUHMWPE sutures that have been demonstrated to be substantiallyequivalent to those used in the predicate device.Design Features: The additional configuration of the subject deviceanchor is the same design as the predicate but with the suture or tapepre-threaded for ease of use. Needles will be attached to certainconfigurations of the subject device to provide additional options for theuser.Other minor design enhancements to instruments used with the systemhave been made in an effort for continuous improvement, includingaddition of lateral suture whips and modifications to handles.Sterilization and Shelf-Life: The subject and predicate devices areoffered sterile (EtO), and have a shelf-life of 2 years.Biocompatibility: Biocompatibility was established according to ISO10993-1. Bacterial endotoxins for the implantable components aredetermined using LAL testing to meet endotoxin limit specifications.The subject device is substantially equivalent to the predicate device inthat they are comprised of similar materials, share the same fundamentaltechnology, are intended for the same indications and utilize similardesigns. They are capable of achieving fixation in the same way.

Performance Data

Axial Pull-Out per ASTM F543-17 testing was conducted to confirm thematerial additive did not introduce any new risk.Bacterial Endotoxin testing meets pyrogen limit specifications.

Conclusion

Based on the intended use, indications for use, technologicalcharacteristics, and comparison to the predicate device, the Subjectdevice has been shown to be substantially equivalent to the legallymarketed predicate device and is safe and effective for the intended use.

Regulation Number and Section

§ 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.