K Number
K192824
Device Name
Parcus Knotless AP Suture Anchors
Date Cleared
2019-11-02

(31 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Parcus Knotless AP Suture Anchors are indicated for the attachment of soft tissue to bone. This product is intended for the following indications: | Shoulder | Rotator Cuff Repair, Acromioclavicular Separation Repair,<br>Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or<br>Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion<br>Repair. | |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Knee | Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Posterior Oblique Ligament Repair, Extra Capsular<br>Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and<br>Tendon Avulsion Repair. | | Foot/Ankle | Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction,<br>Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal<br>Ligament Repair. | | Elbow | Tennis Elbow Repair, Biceps Tendon Reattachment. | | Hand/Wrist | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral<br>Ligament Reconstruction, TFCC. |
Device Description
The Parcus Knotless AP Suture Anchors consist of ribbed anchor bodies in 2.8mm, 4.5mm, and 5.5mm diameters. The anchor body is comprised of Parcus Medical's Advanced Polymer (AP) which is a formulation of ß-TCP and PLGA that has a proven record as a safe and effective absorbable material that has been used in the industry for over 10 years. This material has been developed such that it will maintain the necessary strength to insert successfully and provide the necessary resistance to pull-out long enough for the body to heal and then, over time, break down, be absorbed into the body and eventually replaced by bone. The presence of the osteoconductive ß-TCP will allow for boney replacement at the insertion site as the anchor is absorbed. Knotless AP Suture Anchors are provided with a single use suture threader and a single use driver. These devices are individually packaged and provided sterile.
More Information

Not Found

No
The device description focuses on the material composition and mechanical properties of a suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Yes
The device is described as a "Suture Anchor" indicated for orthopaedic repairs in various joints, which are procedures designed to treat or alleviate a medical condition.

No
The device is a suture anchor used for the attachment of soft tissue to bone, which is a therapeutic rather than a diagnostic function.

No

The device description clearly states that the device consists of physical components (ribbed anchor bodies, suture threader, driver) made of a specific material (ß-TCP and PLGA). This indicates a hardware medical device, not a software-only one.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "attachment of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
  • Device Description: The description details a physical implantable device (suture anchors) made of a specific material, along with associated surgical tools (suture threader and driver).
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.

IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair tissues within the body.

N/A

Intended Use / Indications for Use

The Parcus Knotless AP Suture Anchors are indicated for the attachment of soft tissue to bone. This product is intended for the following indications:

ShoulderRotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
KneeMedial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/AnkleLateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
ElbowTennis Elbow Repair, Biceps Tendon Reattachment.
Hand/WristScapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

Product codes

MAI

Device Description

The Parcus Knotless AP Suture Anchors consist of ribbed anchor bodies in 2.8mm, 4.5mm, and 5.5mm diameters. The anchor body is comprised of Parcus Medical's Advanced Polymer (AP) which is a formulation of β-TCP and PLGA that has a proven record as a safe and effective absorbable material that has been used in the industry for over 10 years. This material has been developed such that it will maintain the necessary strength to insert successfully and provide the necessary resistance to pull-out long enough for the body to heal and then, over time, break down, be absorbed into the body and eventually replaced by bone. The presence of the osteoconductive β-TCP will allow for boney replacement at the insertion site as the anchor is absorbed.

Knotless AP Suture Anchors are provided with a single use suture threader and a single use driver. These devices are individually packaged and provided sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Knee, Foot/Ankle, Elbow, Hand/Wrist

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)

The entire scope of the proposed Knotless AP Suture Anchor product family was considered and worst-case scenarios for various concerns were identified. Devices, or representative devices of the same material, were subjected to biocompatibility and benchtop testing such as pull-out strength and cyclic loading studies. Based on the results of this testing and comparison with the performance of the predicate devices or published acceptance criteria, the Parcus Knotless AP Suture Anchors are determined by Parcus Medical to be substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K183501

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K192824

Trade/Device Name: Parcus Knotless AP Suture Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: October 1, 2019 Received: October 2, 2019

Dear Mr. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

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.

Laurence D. Coyne, Ph.D. Acting Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality 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)

K192824 Device Name Parcus Knotless AP Suture Anchors

Indications for Use (Describe)

The Parcus Knotless AP Suture Anchors are indicated for the 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, Iliotibial 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. |

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Surgical Innovation | Customer Driv

510(k) Summary - K192824
Submitter:Parcus Medical, LLC
6423 Parkland Dr
Sarasota, FL 34243
Company Contact:Paul Vagts
Phone: (941)755-7965
Fax: (941)755-6543
Date Prepared:October 1st, 2019
Device Trade Name:Parcus Knotless AP Suture Anchor
Common Name:Suture Anchor
Device Class:Class II
Classification Name:Fastener, Fixation, Biodegradable, Soft Tissue 21 CFR
888.3030 - Product Code MAI
Predicate Device:The predicate device is the:
• Parcus Medical Twist AP Suture Anchor (K183501)
cleared March 15, 2019)

Device Description:

The Parcus Knotless AP Suture Anchors consist of ribbed anchor bodies in 2.8mm, 4.5mm, and 5.5mm diameters. The anchor body is comprised of Parcus Medical's Advanced Polymer (AP) which is a formulation of ß-TCP and PLGA that has a proven record as a safe and effective absorbable material that has been used in the industry for over 10 years. This material has been developed such that it will maintain the necessary strength to insert successfully and provide the necessary resistance to pull-out long enough for the body to heal and then, over time, break down, be absorbed into the body and eventually replaced by bone. The presence of the osteoconductive ß-TCP will allow for boney replacement at the insertion site as the anchor is absorbed.

Knotless AP Suture Anchors are provided with a single use suture threader and a single use driver. These devices are individually packaged and provided sterile.

4

Image /page/4/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The word "PARCUS" is in large, bold, blue letters, with a red square to the left of the "P". Below "PARCUS" is the phrase "MEDICAL, LLC." in smaller, blue letters.

Surgical Innovation | Customer Driven

Intended Use:

The Parcus Knotless AP Suture Anchors are indicated for the 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,
Iliotibial 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. |

Substantial Equivalence Summary:

The Parcus Knotless AP Suture Anchors are very similar to the predicate devices in that they are comprised of the same materials, have identical intended use, and have identical indications for use. Pyrogenicity testing was conducted on a representative device from the Parcus AP Suture Anchor product line. The results of this testing met the acceptance criteria described in the FDA recognized standard and therefore it was concluded that the Knotless AP Suture Anchors do not raise any additional concerns regarding pyrogenicity. Extensive biocompatibility and mechanical testing has been conducted on the Knotless AP Suture Anchors or representative devices of the same material and has demonstrated substantial equivalence between the Parcus Knotless AP Suture Anchors and the predicate devices.

Summary Performance Data:

The entire scope of the proposed Knotless AP Suture Anchor product family was considered and worst-case scenarios for various concerns were identified. Devices, or representative devices of the same material, were subjected to biocompatibility and benchtop testing such as pull-out strength and cyclic loading studies. Based on the results of this testing and comparison with the performance of the predicate devices or published acceptance criteria, the Parcus Knotless AP Suture Anchors are determined by Parcus Medical to be substantially equivalent to the predicate devices.