The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, lliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle Lateral Stabilization. Medial Stabilization. Midfoot Reconstruction. Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Hip Acetabular Labral Repair

Device Description

The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are tapered fasteners with an eyelet at the distal tip and circumferential barbs used to secure the implant in bone and provide suture fixation without the need for knot tying. After passing through the target tissue, sutures are passed through the distal eyelet of the anchor, it is pounded into place which secures both the anchor and the suture in place. This is the same design and insertion technique as the predicate Knotless PEEK CF Push-In Suture Anchors. The predicate device was originally provided in 3.5mm and 4.5mm diameters and this 510(k) will expand that size range to include 2.8mm and 5.5mm options. The Knotless PEEK Push-In Suture Anchor is made from polyetheretherketone (PEEK) and the Knotless PEEK CF Push-In Suture Anchors are made from carbon fiber polyetheretherketone (PEEK CF). The Parcus predicate device is comprised of carbon fiber polyetheretherketone (PEEK CF). The Parcus reference devices consist of devices comprised of either PEEK or PEEK CF. The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are provided sterile with a single use suture passer and either with or without a single use inserter.

AI/ML Overview

This document describes the Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors. The provided text is a 510(k) summary for a medical device and, as such, does not contain information about acceptance criteria or a detailed study proving the device meets those criteria in the context of diagnostic performance or AI model evaluation.

The "Summary Performance Data" section briefly mentions that the device was evaluated for "strength and elongation under cycle loading and ultimate failure conditions" and that "Results were compared with test data for the predicate device and demonstrated substantial equivalency." This indicates mechanical testing was performed to demonstrate that the new device performs comparably to an existing, legally marketed device (the predicate).

However, the document does not provide specific numerical acceptance criteria for these mechanical tests, nor does it detail the specific results. It also does not involve any AI, image analysis, or human reader performance evaluation, and therefore, many of the requested points are not applicable.

Below is an attempt to address the request based only on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical strength under cycle loading comparable to predicate	Evaluation of strength and elongation under cycle loading demonstrated substantial equivalency with the predicate device.
Mechanical strength under ultimate failure conditions comparable to predicate	Evaluation of ultimate failure conditions demonstrated substantial equivalency with the predicate device.
Biocompatibility comparable to predicate and reference devices	Assessment of biocompatibility did not raise concerns, as materials and manufacturing are same/similar to predicate/reference devices.
Endotoxin levels meet specifications (non-pyrogenic)	LAL testing concluded the device meets endotoxin limit specifications and does not raise concerns regarding pyrogenicity.

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the mechanical performance tests. The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from internal testing conducted by Parcus Medical, LLC. The testing is for a new device attempting to prove substantial equivalence to a predicate, so it is a prospective evaluation of the new device's performance against existing data or concurrent testing of the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device performance study, not a study requiring expert interpretation of diagnostic data.

4. Adjudication method for the test set
Not applicable. This is a mechanical device performance study.

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 document pertains to a physical medical device (suture anchors) and does not involve AI, image analysis, or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical device.

7. The type of ground truth used
For the mechanical tests, the "ground truth" (or reference) was the performance data of the predicate device (Parcus Knotless PEEK CF Suture Anchors, K113730) for "strength and elongation under cycle loading and ultimate failure conditions." For biocompatibility, the ground truth was based on the known materials and manufacturing processes of the predicate and reference devices. For pyrogenicity, it was an endotoxin limit specification.

8. The sample size for the training set
Not applicable. This document describes the testing of a physical medical device and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established
Not applicable. This document describes the testing of a physical medical device and does not involve a "training set" in the context of machine learning or AI.

Summary

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January 23, 2020

Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243

Re: K193295

Trade/Device Name: Parcus Knotless PEEK and PEEK CF Push-In 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: January 7, 2020 Received: January 8, 2020

Dear Paul Vagts:

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 medical devices and radiation-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

510(k) Number (if known) K193295

Device Name

Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor

Indications for Use (Describe)

The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder	Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
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Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Knee Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Hand/Wrist Reconstruction, TFCC.
Acetabular Labral Repair Hip

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) CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K193295 Page 1 of 2

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Surgical Innovation | Customer Driven

510(k) Summary – K193295
510(k) Owner & Submitter:	Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243
Company Contact:	Paul VagtsPhone: (941)755-7965Fax: (941)755-6543
Date Prepared:	January 16th, 2020
Device Trade Name:	Knotless PEEK and PEEK CF Push-In SutureAnchor
Common Name:	Fastener, Fixation, Non-Degradable, Soft Tissue
Device Class:	Class II
Classification Name:	21 CFR 888.3040 - Product Code MBI
Predicate Device:	Parcus Knotless PEEK CF Suture Anchors, K113730,cleared 1/17/2012
Reference Devices:	Parcus Twist PEEK Suture Anchors, K120942, cleared4/20/2012.
	Parcus SLIK Anchors, K170327, cleared 3/30/2017.
	Parcus SLIK Fix Screws, K170877, cleared 6/2/2017

Device Description:

PARCUSMEDICAL.COM

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Surgical Innovation | Customer Driven

Intended Use:

The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.

Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, lliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Lateral Stabilization. Medial Stabilization. Midfoot Reconstruction. Foot/Ankle Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Hip Acetabular Labral Repair

Substantial Equivalence Summary:

The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are very similar to the predicate Parcus 35 and 45 Knotless PEEK CF Push-In Suture Anchors in that they both feature the same design, both utilize the same surgical technique, both are comprised of the same or similar material and both are intended for the same indications. In addition, the proposed and predicate devices are all packaged in the same fashion using the same materials, are sterilized using the same ETO sterilization cycle, and all share the same 5-year shelf life. An assessment of the biocompatibility of the proposed devices did not raise any concerns as they are comprised of the same material manufactured in the same fashion using the same equipment as the predicate and reference devices stated above that are currently marketed by Parcus Medical. LAL testing has been conducted on a representative devices comprised of the same materials and it was concluded that the Knotless PEEK and PEEK CF Push-In Suture Anchor meet the endotoxin limit specifications and do not raise any additional concerns regarding pyrogenicity.

Summary Performance Data:

The Knotless PEEK and PEEK CF Push-In Suture Anchors were evaluated and testing was conducted side by side with the predicate device. Devices were assembled to test blocks and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.

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.