(90 days)
The Parcus 3.5mm PEEK CF Push-In 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
The Parcus 3.5mm PEEK CF Push-In Suture Anchors are tapered fasteners with barbs for use in attachment of soft tissue to bone. The devices are made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). The Push-In Suture Anchors are provided sterile.
The provided document is a 510(k) summary for the Parcus 3.5mm PEEK CF Push-In Suture Anchor. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on performance data. However, it does not describe an AI/ML-driven device or study. Therefore, the following information cannot be extracted from the provided text.
Acceptance Criteria and Study for an AI/ML Device:
Since the provided document pertains to a physical medical device (suture anchor) and not an AI/ML-driven device, the following categories are not applicable. The document describes a "Summary Performance Data" section which details a mechanical pull-out strength test for the suture anchor, not an AI model's performance.
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Table of acceptance criteria and the reported device performance:
- The document states: "The Parcus 3.5mm PEEK CF Push-In Suture Anchors were placed in prepared holes and the pull out strength was measured. Test results were compared to the results for the Parcus V-LoX PEEK CF Suture Anchors as well as the Smith & Nephew BioRaptor 2.9 and demonstrated substantial equivalence."
- It does not provide specific acceptance criteria values (e.g., minimum pull-out strength in Newtons) nor the precise numerical performance results of the Parcus anchor or the predicate devices. It only states that the results demonstrated "substantial equivalence."
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Sample size used for the test set and the data provenance: Not applicable for an AI/ML device study. For the mechanical test, the sample size is not explicitly stated. The nature of the data is mechanical test results, not clinical or image data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device requiring expert ground truth for classification or detection.
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Adjudication method for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/ML device. For the mechanical test, the "ground truth" would be the direct measurement of pull-out strength in a lab setting.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a 510(k) submission for a physical medical device (suture anchor) and does not contain information related to an AI/ML device or its performance study against specific acceptance criteria relevant to AI/ML.
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KJO2326(pg 1/2)
Image /page/0/Picture/1 description: The image shows the logo for PARCUS Medical, LLC. The logo features a stylized, geometric design for the word "PARCUS" in bold, black letters. To the right of the name is the text "Medical, LLC" in a smaller font size.
NOV 1 5 2010
SURGICAL INNOVATION >> VALUE DRIVEN
510(k) Summary
| Submitter: | Parcus Medical, LLC839 South Neenah Ave.Sturgeon Bay, WI 54234 |
|---|---|
| Company Contact: | Barton BracyPhone: (920) 746-2972Fax: (920) 746-2974 |
| Date Prepared: | August 13, 2010 |
| Trade Name: | Parcus 3.5mm PEEK CF Push-In 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 3.5mm PEEK CF Push-In Suture Anchors are tapered fasteners with barbs for use in attachment of soft tissue to bone. The devices are made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). The Push-In Suture Anchors are provided sterile.
Intended Use:
The Parcus 3.5mm PEEK CF Push-In 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.
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
{1}------------------------------------------------
Medical, LLC
SURGICAL INNOVATION >> VALUE DRIVEN Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Foot/Ankle Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Substantial Equivalence Summary:
The Parcus 3.5mm PEEK CF Push-In Suture Anchors are similar to the Parcus V-LoX PEEK CF Suture Anchors in that they are made of the same material, manufactured in a similar manner, and have similar indications. While the method of fixation differs, push-in barbs versus threads, it does not raise any new concerns regarding safety and efficacy.
The Parcus 3.5mm PEEK CF Push-In Suture Anchors are similar in design to the Smith & Nephew BioRaptor 2.9. Both anchors are barbed and pushed in rather than threaded. Although the BioRaptor is listed as 2.9mm, this is the minor diameter and the actual outer diameter is 3.5mm while the Push-In Suture Anchors come in a 3.5mm outer diameter. Though the material differs, PEEK CF versus a bioabsorbable polymer, it does not raise any new concerns regarding safety and efficacy.
Therefore the Parcus 3.5mm PEEK CF Push-In Suture Anchors are substantially equivalent to the predicate devices listed above. Any differences between the Push-In Suture Anchors and the predicate devices are considered minor and do not raise any safety and efficacy concerns.
Summary Performance Data:
The Parcus 3.5mm PEEK CF Push-In Suture Anchors were placed in prepared holes and the pull out strength was measured. Test results were compared to the results for the Parcus V-LoX PEEK CF Suture Anchors as well as the Smith & Nephew BioRaptor 2.9 and demonstrated substantial equivalence.
839 S NEENAH AVE., STURGEON BAY, WI 54235
1-877-746-2972
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and has its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Parcus Medical, LLC % Mr. Barton Bracy 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54234
Re: K102326
Trade/Device Name: Parcus 3.5mm PEEK CF Push-In Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: August 13, 2010 Received: August 17, 2010
NOV 1 5 2010
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 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-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.
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Page 2 - Mr. Barton Bracy
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Brown
Mark N. Melkersof Director Division of Surgical. Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 当02326(gg 1/1)
NOV 1 5 2010
Device Name: Parcus 3.5mm PEEK CF Push-In Suture Anchor
Indications for Use:
The Parcus 3.5mm PEEK CF Push-In 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 LesionRepair, Biceps Tenodesis, Capsular Shift or CapsulolabralReconstruction, 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, AchillesTendon Repair, Hallux Valgus Reconstruction, Metatarsal LigamentRepair. |
| Elbow | Tennis Elbow Repair, Biceps Tendon Reattachment. |
| Hand/Wrist | Scapholunate Ligament Reconstruction, Ulnar or Radial CollateralLigament Reconstruction, TFCC |
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
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)
Sontu
(Division Sign Off) for mxm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page 13 of 226
§ 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.