(90 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a suture anchor, with no mention of AI or ML capabilities.
Yes
The device is intended for the attachment of soft tissue to bone for various repairs and reconstructions, which are therapeutic interventions.
No
This device is a surgical implant designed for reattaching soft tissue to bone, not for diagnosing medical conditions. Its purpose is to physically repair injuries, as described in the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device description explicitly states the device is made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF) and is a physical fastener, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description: The description clearly states the device is a "tapered fastener with barbs for use in attachment of soft tissue to bone." This is a physical implant used within the body during surgery.
- Intended Use: The intended use is for "attachment of soft tissue to bone" in various anatomical locations. This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / 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:
- 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.
- Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Foot/Ankle Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
- Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI
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.
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 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.
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
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, LLC
839 South Neenah Ave.
Sturgeon Bay, WI 54234 |
|----------------------|-----------------------------------------------------------------------------------------------|
| Company Contact: | Barton Bracy
Phone: (920) 746-2972
Fax: (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 Tissue
21 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.
3
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
4
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 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 |
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 ________________________________________________________________________________________________________________________________________________________________
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