The Parcus Actiflip is used for fixation of bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repari (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.

Device Description

The Parcus ActiFlip device consists of a titanium implantable button that is mounted onto an inserter shaft that allows for placement and deployment of the button. ActiFlip is available in three (3) configurations, with or without UHMWPE suture – Naked (without suture), CINCH, WHIP.

AI/ML Overview

The provided text is a 510(k) summary for the Parcus ActiFlip device. It outlines the device's indications for use, its characteristics, and how its substantial equivalence to predicate devices was established. However, it explicitly states that "Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices" and that "Performance was established based on acceptance criteria with the rationale that the new specific indications...do not introduce a worst-case for mechanical performance of the subject device."

This type of submission for a medical device (a 510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance through a clinical trial with specific performance metrics and acceptance criteria for algorithm-based diagnostic or prognostic devices.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-driven diagnostic devices. Specifically, it lacks:

A table of acceptance criteria and reported device performance: No such table or performance metrics are provided. The "performance" mentioned refers to mechanical performance, not diagnostic accuracy.
Sample size used for the test set and data provenance: No test dataset details are given.
Number of experts used to establish ground truth and qualifications: Not applicable as there's no clinical data or ground truth establishment for a diagnostic study.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was performed or is mentioned.
Standalone (algorithm-only) performance: Not applicable as this is a physical implant, not an algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable as there's no algorithm training mentioned.
How ground truth for the training set was established: Not applicable.

The document describes a physical medical device (a fixation fastener), not an AI/ML-driven diagnostic or image analysis tool. The "performance" mentioned is mechanical validation (implicitly, by showing it's not a 'worst-case' scenario compared to predicates), not the type of performance evaluation relevant to AI diagnostics.

Summary

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October 6, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

Parcus Medical LLC. Calen Southern, MS Senior Specialist, Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243

Re: K212739

Trade/Device Name: ActiFlip Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: August 25, 2021 Received: August 30, 2021

Dear Calen Souther:

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

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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. 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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Indications for Use

510(k) Number (if known) K212739

Device Name ActiFlip

Indications for Use (Describe)

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)

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510(k) Summary

The information contained herein is being provided in accordance with the requirements of 21CFR 807.92(c).

Date Prepared:	October 6, 2021		ActiFlip	ActiFlip	Miti Suture Anchor
Applicant:	Parcus Medical, LLC.6423 Parkland Dr.Sarasota, FL 34243	510(k) clearance	Subject Device	K192750, K202259	K111000, K201083
Official Correspondent:	Calen Souther, MSSenior Specialist, Regulatory AffairsPhone: (770) 616-1389Email: csouther@anika.com	Manufacturer	Parcus Medical	Parcus Medical	Parcus Medical
Trade/Proprietary Name:	ActiFlip	Common Name	Fastener, Fixation, Non-degradable, Soft tissue	Fastener, Fixation, Non-degradable, Soft tissue	Fastener, Fixation, Non-degradable, Soft Tissue
Common Name:	Fastener, Fixation, Non-degradable, Soft Tissue	Regulation	21 CFR 888.3040	21 CFR 888.3040	21 CFR 888.3040
Regulation Name:	Smooth or threaded metallic bone fixation fastener	Class Name	Smooth or threaded metallic bone fixation fastener	Smooth or threaded metallic bone fixation fastener	Smooth or threaded metallic bone fixation fastener
Device Class:	Class II	Class	Class II	Class II	Class II
Regulation Number:	21 CFR 888.3040	Product Code	MBI	MBI	MBI
Product Code:	MBI	Indication for Use	The Parcus ActiFlip is used for fixation of bone to bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repair(minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, FDL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.	The Parcus ActiFlip is used for fixation of bone to bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.	The Parcus Miti 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, 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.
	Predicate Device Information: ActiFlip - K192750 (cleared January 16, 2020), K202259(cleared October 28, 2020)	Material	Medical grade titanium, UHMWPE suture	Medical grade titanium, UHMWPE suture	Medical grade titanium, UHMWPE suture
	Miti Suture Anchors – K111000 (cleared July 28, 2011), K201083 (clearedJuly 23, 2020)	Single use only	Yes	Yes	Yes
	Reason for 510(k) submission: The purpose of this Traditional 510(k) is to obtain clearance for indicationsof soft tissue fixation in the foot and ankle for ActiFlip.	Sterility	Sterile, EO	Sterile, EO	Sterile, EO
Description of Device:	The Parcus ActiFlip device consists of a titanium implantable buttonthat is mounted onto an inserter shaft that allows for placement anddeployment of the button. ActiFlip is available in three (3) configurations,with or without UHMWPE suture – Naked (without suture), CINCH, WHIP.	Shelf-life	5-years	5-years	5-years
Indications for Use:	The Parcus ActiFlip is used for fixation of bone or soft tissue tobone, and is intended as a fixation post, a distribution bridge, or fordistributing suture tension over areas of ligament or tendon repair in theknee, shoulder, and elbow and may include the following indications:anterior cruciate ligament, posterior cruciate ligament, pectoralis repair(minor/major), biceps tendon repair and reattachment (distal/proximal),acromioclavicular repair, and ulnar collateral ligament reconstruction.

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The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, FDL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.

Device Characteristics

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Non-clinical Testing

Performance was established based on acceptance criteria with the rationale that the new specific indications of FHL Tendon Transfer, FDL Tendon Transfer, Posterior Tibialis Tendon Transfer, and Anterior Tibialis Tendon Transfer do not introduce a worst-case for mechanical performance of the subject device.

Clinical Data

Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices.

Conclusion

The Parcus ActiFlip device is substantially equivalent to the predicate devices in which the basic design features, materials, packaging, sterility, shelf life, and intended uses are the same.

The data and comparison of the technological characteristics within this submission demonstrate that the subject device is substantially equivalent to the predicate devices when used in accordance with the indications for 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.