Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-● Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Device Description

The ZipE® Knotless Tissue Repair and Attachment Devices are implantable soft tissue fixation and suture retention devices comprising of a resorbable pledge('button disc ("suture capture"), a titanium screw or biocomposite bone anchor ("plug"), an ultra-high polyethylene (UHMWPE) braided #2 suture having pre-tied half hitched protuberances along its length, a nitinol wire capture holder and a nitinol wire suture shuttle. All components are preloaded onto a stainless steel insertion driver having a TPE tip protector and a silicone O-ring encircling the diameter of the handle to hold the system in place. The implantable elements of the system are the bone anchor, suture and capture; the other components are part of the driver insertion system.

The capture is designed to interact with the knotted suture by locking with the protuberances on the suture so that once advanced across the protuberance, it cannot move backward. Once the anchor is inserted into the bone, the pushed down with the stainless steel driver, traveling forward over the knotted suture, preventing movement in the reverse direction, and thereby locking the repair tissue to the underlying tissue.

The ZipE® Knotless Tissue Repair and Attachment Devices come with all components pre-assembled into the insertion driver and ready to be operated by the user. Products may be sold separately.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the typical format of a medical device submission beyond the non-clinical testing listed. The document is an FDA 510(k) clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a clinical study with an AI component.

Here's a breakdown of what can be extracted and what is missing:

Information that can be extracted from the provided text:

Device Name: ZipE® Knotless Tissue Repair and Attachment Devices
Non-clinical Testing Performed:
- Bench testing (Static pullout testing, Cyclic pullout testing, Degradation testing, Insert Torque testing)
- Biocompatibility testing (Systemic toxicity, Reverse mutation, Intracutaneous injection, Kligman maximization, Micronucleus assay, Lymphoma mutagenesis, Intramuscular implantation, Pyrogen test, Systemic injection test, MEM elution test, Neutral red uptake test)
- Sterilization validation (Bioburden, EO residual testing, Endotoxin (LAL) Validation)
- Package and transportation testing (Transportation validation, Packaging testing, Accelerated aging)

Information that is not available in the provided text, as it pertains to AI-enabled device studies and clinical performance:

A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds) or report device performance against such criteria. The reported performance is only a list of non-clinical tests.
Sample sized used for the test set and the data provenance: Not applicable as no clinical study or AI performance evaluation is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Testing: None provided as a basis for substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

This document describes a traditional 510(k) clearance for a physical medical device (tissue repair and attachment devices), not an AI-enabled medical device. Therefore, the questions related to AI-specific performance criteria, ground truth, expert review, and clinical study designs (like MRMC) are not addressed by this submission. The "acceptance criteria" for this device were likely based on the successful completion of the listed non-clinical tests, demonstrating that the device meets safety and performance standards equivalent to predicate devices within an engineering context (e.g., pullout strength exceeding a certain threshold), rather than statistical performance metrics for diagnostic or prognostic accuracy.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2017

Ziptek, LLC % Janice Hogan Partner Hogan Lovells Us LLP 1835 Market Street 29th Floor Philadelphia, Pennsylvania 19103

Re: K162429 Trade/Device Name: ZipE® Knotless Tissue Repair and Attachment Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI, KGS Dated: February 10, 2017 Received: February 10, 2017

Dear Ms. Hogan:

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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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) K162429

Device Name

ZipE® Knotless Tissue Repair and Attachment Devices

Indications for Use (Describe)

The ZIPE® Knotless Tissue Repair and Attachment Devices are intended for fixation of tissue to tissue.

This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceos Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction. Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment. Tennis Elbow Repair. Ulnar or Radial Collateral Ligament Reconstruction o

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

Over-The-Counter Use (21 CFR 801

Subpart C)

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Form Approved: OMB No. 0910-0120

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510(k) SUMMARY

ZIPE® Knotless Tissue Repair and Attachment Devices

Preparation Date:	February 10, 2017
Applicant/Sponsor:	Ziptek, LLC1250 S Tamiami Trl Ste 303Sarasota, FL 34239
Contact Person:	Dr. William F. Bennett(941) 953-5509
Trade Name:	ZipE® Knotless Tissue Repair and Attachment Device
Common Name:	Soft Tissue Fixation Device

Classification Name:

MBI (888.3040) Fastener, fixation, nondegradable, soft tissue ●
MAI (888.3030) Fastener, fixation, biodegradable, soft tissue
KGS (878.4930) Retention device, suture

Predicate Devices:

Predicate	510(k) Number	Device	Manufacturer
Primary (metallic anchor)	K974847	Arthrex Parachute Corkscrew SutureAnchor	Arthrex, Inc.
Additional	K071704	Sleeve and Button Soft Tissue Devices	Biomet Sports Medicine
Primary (resorbable anchor)	K071177	Arthrex Biocomposite Suture Anchors	Arthrex, Inc.
Reference (material)	K983843	Arthrex Bio-Button	Arthrex, Inc.
Reference (material)	K151200	STRATAFIX™ Spiral MONOCRYL™Knotless Tissue Control Device	Ethicon, Inc.

Device Description:

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pushed down with the stainless steel driver, traveling forward over the knotted suture, preventing movement in the reverse direction, and thereby locking the repair tissue to the underlying tissue.

The ZipE® Knotless Tissue Repair and Attachment Devices come with all components pre-assembled into the insertion driver and ready to be operated by the user. Products may be sold separately.

Indications for Use:

The ZIPE® Knotless Tissue Repair and Attachment Devices are intended for fixation of tissue to bone and tissue to tissue.

This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-● Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Non-clinical Testing:

ZIPTEK LLC performed extensive non-clinical testing for the ZIPE® Knotless Tissue Repair and Attachment Devices, including:

Bench testing	Static pullout testingCyclic pullout testingDegradation testingInsert Torque testing
Biocompatibilitytesting	Systemic toxicityReverse mutationIntracutaneous injectionKligman maximizationMicronucleus assayLymphoma mutagenesisIntramuscular implantationPyrogen testSystemic injection testMEM elution testNeutral red uptake test

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Sterilization validation	BioburdenEO residual testingEndotoxin (LAL) Validation (*Endotoxin testing is conducted on every batch of the device as part of the release test)
Package andtransportation testing	Transportation validationPackaging testingAccelerated aging

Clinical Testing:

None provided as a basis for substantial equivalence.

Technological Characteristics:

The ZipE® Knotless Tissue Repair and Attachment Devices and the primary predicate Arthrex Parachute Corkscrew IK9748471 are similar in design, have the same intended use and similar indications, technological characteristics and principles of operation. The technological difference between them relies on the locking mechanism of the suture by the suture (button disc). The Sleeve and Button Anchor [K071704] also uses a button disc as a suture retention device as part of the anchoring system. The device anchor plug and the primary predicate Arthrex Biocomposite Anchors [K071177] are material and have the same intended use, similar indications, technological characteristics and principles of operation. The most significant technological difference relies on the eyelet design and suture attachment mechanisms. Some predicate devices have an eyelet and some do not; therefore, this does not represent a new design feature compared to other previously cleared suture anchors. The suture-capture material is made of a PLA/caprolactone is utilized as a copolymer with other suture materials, an example, the STRATAFIX Knotless Tissue Control Device [K151200]. The Arthrex Bio-Button [K983843] and the Arthrex Parachute Corkscrew [K974847] have a surgical button/capture made from the PLA family of materials.

Substantial Equivalence Summary:

The ZipE® Knotless Tissue Repair and Attachment Devices is substantially equivalent to predicate devices, which have the same intended use and similar technological characteristics. Minor differences between ZipE® Knotless Tissue Repair and Attachment Devices and the predicate devices do not raise different questions concerning safety and effectiveness and do not adversely impact the performance, function, or intended use of the device, as confirmed by performance testing. Thus, the ZipE® Knotless Tissue Repair and Attachment Devices are substantially equivalent to the predicates.

Regulation Number and Section

§ 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.