(145 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of the suture anchors, with no mention of AI or ML technology.
Yes.
The device is used for the attachment of soft tissue to bone to repair soft tissue injuries, which constitutes a therapeutic use.
No
The device is a surgical anchor used for attaching soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device is made from physical materials (UHMWPE and PEEK) and is a physical implant (suture anchors) for attaching soft tissue to bone. This is a hardware device, not software.
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 implant made of UHMWPE and PEEK, designed to be inserted into bone. This is a medical device used for structural support and fixation within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Parcus Draw Tight Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
- Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Shoulder Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Knee Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
- Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Foot/Ankle 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Parcus Draw Tight Anchors are designed for use in attachment of soft tissue to bone. The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and Polyetheretherketone (PEEK), The construct of the Draw Tight Anchors is such that when inserted into bone and deployed via the included suture, a suture ball is created in the prepared socket that provides the necessary fixation. The Draw Tight Anchors are designed to accommodate both sliding and fixed sutures to be used for soft tissue fixation and are 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 Parcus Draw Tight Anchors were placed in prepared holes and the pull out strength was measured. In addition to straight load to failure, the proposed device was also tested under cyclic loading conditions. Test results were compared to the results for the predicate devices and the Draw Tight Anchors demonstrated substantial equivalence in all aspects."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
k122805411
510(k) Summary
FEB 0 5 2013
| Submitter: | Parcus Medical, LLC
6423 Parkland Dr
Sarasota, FL 34243 |
|----------------------|---------------------------------------------------------------------------------------|
| Company Contact: | Paul Vagts
Phone: (941) 755-7965
Fax: (941) 755-6543 |
| Date Prepared: | February 4, 2013 |
| Trade Name: | Parcus Draw Tight Anchor |
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue
21 CFR 888.3040 - Product Code MBI |
Predicate Devices:
- Parcus 3.5mm PEEK CF Push-in Suture Anchors (K102326) ●
- Parcus Twist PEEK Suture Anchors (K120942) �
- Biomet Sports Medicine Juggerknot™ Soft Anchor (K110145) .
Device Description:
The Parcus Draw Tight Anchors are designed for use in attachment of soft tissue to bone. The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and Polyetheretherketone (PEEK), The construct of the Draw Tight Anchors is such that when inserted into bone and deployed via the included suture, a suture ball is created in the prepared socket that provides the necessary fixation. The Draw Tight Anchors are designed to accommodate both sliding and fixed sutures to be used for soft tissue fixation and are provided sterile.
Intended Use:
The Parcus Draw Tight Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
- Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Shoulder Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Knee Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
- Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Foot/Ankle 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.
1
Substantial Equivalence Summary:
The Parcus Draw Tight Anchors are similar to the predicate devices in that they are manufactured from the same or similar materials, presented to the end user in the same fashion and have the same or similar indications. When compared to the Parcus Twist PEEK Suture Anchors, the Draw Tight Anchors are identical in all of these aspects. While the method of fixation for the Draw Tight Anchor differs from that of the Parcus predicate devices, fixation due to a suture ball rather than a solid anchor body, it is very similar to that of the Biomet predicate device.
When compared to the Biomet predicate device, the specifications for the suture portion of the proposed device are included within that of the predicate. In addition, all of the indications for the proposed device are either identical or comparable to that of the predicate. As stated above, the method of fixation for both devices is similar in that it relies on the placement of suture into a prepared hole and the creation of a suture ball that holds the device in place.
From a performance point of view, the Draw Tight Anchors perform very comparably to that of the predicate devices. As shown in the data, the quality of the bone in which the device is implanted does affect the performance of the device. However, even in the worst case scenario the Draw Tight Anchors perform as intended and do not raise any concerns regarding the safety or efficacy of the device.
Therefore, the Parcus Draw Tight Anchors are substantially equivalent to the predicate devices listed above. Any differences between the Draw Tight Anchors and the predicate devices are considered minor and do not raise any safety and/or efficacy concerns.
Summary Performance Data:
The Parcus Draw Tight Anchors were placed in prepared holes and the pull out strength was measured. In addition to straight load to failure, the proposed device was also tested under cyclic loading conditions. Test results were compared to the results for the predicate devices and the Draw Tight Anchors demonstrated substantial equivalence in all aspects."
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
Letter dated: February 5, 2013
Parcus Medical, LLC % Mr. Paul Vagts RA/OA Manger 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54235
Re: K122805
Trade/Device Name: Parcus Draw Tight 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 10, 2013 Received: January 30, 2013
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. 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
3
Page 2 - Mr. Paul Vagts
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/uccr 1158001,h1n farc the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.
Mark N. Melkerson
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K122805 |
|---|---|
| Device Name: | Parcus Draw Tight Anchors |
Indications for Use:
The Parcus Draw Tight 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. |
AND/OR Prescription Use _ X (Part 21 CFR 801 Subpart D)
Over the Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices 2013.02.05 13:37:13 -05'00' -