(167 days)
The Parcus V-LoX™ PEEK CF 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. Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial 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. Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.
The Parcus V-LoX™ PEEK CF Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). It comes preloaded with two #2 sutures either with or without attached needles, and is available in two different diameters, 5.5mm and 6.5mm.
-
Device Name: Parcus V-LoX™ PEEK CF Suture Anchor
-
Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull out strength | Substantially equivalent to Parcus V-LoX Titanium Suture Anchors |
| Insertion torque | Substantially equivalent to Parcus V-LoX Titanium Suture Anchors |
-
Sample Size Used for the Test Set and Data Provenance: Not explicitly stated. The document mentions "Test results were compared to the results for the Parcus V-LoX Titanium Suture Anchors," implying a comparative test, but specific sample sizes are not provided. The data provenance (country of origin, retrospective/prospective) is not mentioned.
-
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. The study involved mechanical testing, not a clinical assessment requiring expert ground truth for interpretation.
-
Adjudication Method: Not applicable, as no expert adjudication of clinical outcomes was performed.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC comparative effectiveness study was done. The study focused on mechanical performance.
-
Standalone Performance: Yes, a standalone performance study was done in terms of mechanical properties (pull-out strength and insertion torque) of the device itself.
-
Type of Ground Truth Used: The "ground truth" for the mechanical testing was the objective measurement of pull-out strength and insertion torque. The comparison was made against the performance of a legally marketed predicate device (Parcus V-LoX Titanium Suture Anchors).
-
Sample Size for the Training Set: Not applicable. This was a mechanical performance study, not an AI or machine learning study requiring a training set.
-
How Ground Truth for the Training Set Was Established: Not applicable, as there was no training set.
{0}------------------------------------------------
K091094 p. 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for PARCUS Medical, LLC. The logo features the word "PARCUS" in a stylized, sans-serif font. To the right of the word "PARCUS" is the text "Medical, LLC" in a smaller font.
SURGICAL INNOVATION >> VALUE DRIVEN
510(k) Summary
SEP 3 0 2009
| Submitter: | Parcus Medical, LLC839 South Neenah Ave.Sturgeon Bay, WI 54234 |
|---|---|
| Company Contact: | Barton BracyPhone: (920) 746-2972Fax: (920) 746-8665 |
| Date Prepared: | April 13, 2009 |
| Trade Name: | Parcus V-LoX™ PEEK CF Suture Anchor |
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue21 CFR 888.3040 - Product Code HWC and MBI |
Predicate Devices:
Device Description:
The Parcus V-LoX PEEK CF Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). It comes preloaded with two #2 sutures either with or without attached needles, and is available in two different diameters, 5.5mm and 6.5mm.
Intended Use:
The Parcus V-LoX™ PEEK CF 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.
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for PARCUS Medical, LLC. The logo features a stylized "P" symbol followed by the text "PARCUS" in large, blocky letters. To the right of "PARCUS" and in smaller font is the text "Medical, LLC".
SURGICAL INNOVATION >> VALUE DRIVEN
-
Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow Tennis Elbow Repair, Biceps Tendon Reattachment. -
Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.
Substantial Equivalence Summary:
The Parcus V-LoX PEEK CF Suture Anchors are essentially the same as the Parcus V-LoX Titanium Suture Anchors aside from the difference in material.
The only difference between the materials for the Parcus V-LoX PEEK CF Suture Anchor and the Smith & Nephew TWINFIX FT PK is that the Parcus Suture Anchor is carbon reinforced. Carbon fibers have been used clinically for more than 20 years as a reinforcement component for implant materials without obvious leachable-related biocompatibility reactions. Furthermore, there are currently several medical device implants on the market made from PEEK CF (e.g. Zimmer Spine BAK® Vista® Radiolucent Interbody Fusion System and the Depuy Spine OCELOT™ Stackable Cage System).
Therefore the Parcus V-LoX PEEK CF Suture Anchor is substantially equivalent to the predicate devices listed above in which the basic features and intended uses are the same. Any differences between the V-LoX PEEK CF Suture Anchor and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness.
Summary Performance Data:
The Parcus V-LoX PEEK CF Suture Anchors were placed in prepared holes and the pull out strength and insertion torque was measured. Test results were compared to the results for the Parcus V-LoX Titanium Suture Anchors and demonstrated substantial equivalence.
Page 16 of 144
839 S NEENAH AVE., STURGEON BAY, WI 54235
1-877-746-2972
{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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
SEP 3 0 2009
Parcus Medical, LLC c/o Mr. Barton Bracy VP Marketing and Product Development 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54235
Re: K091094
Trade/Device Name: Parcus V-Lox™ PEEK CF Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. MBI Dated: September 23, 2009 Received: September 30, 2009
Dear Mr. Bracy:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
{3}------------------------------------------------
Page 2 - Mr. Barton Bracy
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
Sincerely yours,
Mark N. Milken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _Parcus V-LoX™ PEEK CF Suture Anchor
Indications for Use:
The Parcus V-LoX™ PEEK CF Suture 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 Shoulder Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee Medial Collateral Ligament Repair, Lateral Collatera! Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, lliotibial 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.
Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use _ (21 CFR 801 Subpart C)
ম
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
on My M Concurrence of CDRH, Office of Device Evaluation (ODE)
ivision Sign-Off, Division of Surgical, Orthopedic, and Restorative Devices
Page 13 of 144
510(k) Number K091694
§ 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.