(100 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical application of a physical implant (suture anchor), with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is a surgical implant (suture anchor) used for attaching soft tissue to bone, which assists in repair and reconstruction, but it does not directly administer therapy to treat a condition itself.
No
The device is a medical implant (suture anchor) used for attaching soft tissue to bone, not for diagnosing conditions.
No
The device description clearly states it is a physical implantable device made of Carbon Fiber Reinforced PEEK CF, not software.
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.
- Device Description and Intended Use: The description clearly states that the Parcus PEEK CF Push-In Suture Anchors are "tapered fasteners with barbs for use in attachment of soft tissue to bone." The intended uses are all surgical procedures involving the repair and reconstruction of ligaments, tendons, and other soft tissues within the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. It is a physical implant used during surgery.
Therefore, based on the provided information, the Parcus PEEK CF Push-In Suture Anchors are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Parcus 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.
- Hip Acetabular Labral Repair (3.0mm only)
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI
Device Description
The Parcus 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 in 3.0mm and 4.5mm diameters.
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, Hip
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 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
Image /page/0/Picture/0 description: The image shows the logo for PARCUS Medical, LLC. The logo is black and white and features the word "PARCUS" in large, bold letters. To the right of the logo is the text "Medical, LLC" in a smaller font. Above the logo is the text "K102162".
SURGICAL INNOVATION >> VALUE DRIVEN
NO.V. 1 0 2010
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: | July 23, 2010 |
| Trade Name: | Parcus PEEK CF Push-In Suture Anchors |
| 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 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 in 3.0mm and 4.5mm diameters.
Intended Use:
The Parcus 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, lliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
839 S NEENAH AVE., STURGEON BAY, WI 54235 >> 1-877-746-2972 >> www.parcusmedical.com
Page 1 of 2
Image /page/0/Picture/16 description: The image contains the text "Cago Toror 27". The text is written in a simple, sans-serif font. The number 27 is written in a slightly smaller font size than the words "Cago Toror". The text is black and the background is white.
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Image /page/1/Picture/0 description: The image shows the logo for PARCUS Medical, LLC. Above the logo is the text K102162. The logo is black and white and features the company name in a bold, sans-serif font. The words "Medical, LLC" are smaller and to the right of the main logo.
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. -
Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Hip Acetabular Labral Repair (3.0mm only)
Substantial Equivalence Summary:
The Parcus 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 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 3.0mm and 4.5mm outer diameters. Though the material differs, PEEK CF versus a bioabsorbable polymer, it does not raise any new concerns regarding safety and efficacy.
Therefore the Parcus 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 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.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
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
NOV 1 0 2010
Re: K102162
Trade/Device Name: Parcus PEEK CF Push-In Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: October 20, 2010 Received: October 20, 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. 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-related adverse events) (21 CFR 803); 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
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): K102162
Device Name: _Parcus PEEK CF Push-In Suture Anchors
NOV 1 0 2010
Indications for Use:
The Parcus 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. |
| Hip | Acetabular Labral Repair (3.0mm only) |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Oruta for mxm
(Division Sign Off)
(Disson Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102162
Page 13 of 222