(195 days)
No
The device description focuses on mechanical components and their interaction for tissue fixation. There is no mention of AI or ML in the intended use, device description, or the sections specifically checked for these terms. The performance studies are bench and biocompatibility tests, not related to algorithmic performance.
No.
The device is described as an "implantable soft tissue fixation and suture retention device" intended for "fixation of tissue to bone and tissue to tissue," which implies a mechanical function rather than a therapeutic one that would involve treating disease or dysfunction directly.
No
The device is described as an implantable soft tissue fixation and suture retention device intended for surgical repair of various tissues to bone or other tissues. Its function is to physically attach or repair tissues, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components including a resorbable pledge, titanium screw or biocomposite bone anchor, UHMWPE braided suture, nitinol wire capture holder and suture shuttle, and a stainless steel insertion driver. This is a physical medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of tissue to bone and tissue to tissue" for various surgical procedures. This is a therapeutic and structural function within the body.
- Device Description: The description details implantable components (bone anchor, suture, capture) and insertion tools. These are physical devices used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens for diagnostic purposes.
The device is a surgical implant and associated tools, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
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
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
Product codes
MAI, MBI, KGS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-clinical testing included:
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 (*Endotoxin testing is conducted on every batch of the device as part of the release test)
Package and transportation testing: Transportation validation, Packaging testing, Accelerated aging
Clinical Testing: None provided as a basis for substantial equivalence.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and clean, and it is easily recognizable.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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"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.
Form Approved: OMB No. 0910-0120
3
510(k) SUMMARY
ZIPE® Knotless Tissue Repair and Attachment Devices
| Preparation Date: | February 10, 2017 |
|---|---|
| Applicant/Sponsor: | Ziptek, LLC |
| 1250 S Tamiami Trl Ste 303 | |
| Sarasota, 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 Suture | |
| Anchor | 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:
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
4
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 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 |
5
| Sterilization validation | Bioburden
EO residual testing
Endotoxin (LAL) Validation (*Endotoxin testing is conducted on every batch of the device as part of the release test) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Package and
transportation testing | Transportation validation
Packaging testing
Accelerated 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.