(57 days)
No
The device description and performance studies focus on the mechanical properties and design of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the attachment of soft tissue to bone, which is a therapeutic function.
No
The device is described as a "tapered fastener with an eyelet" used for "attachment of soft tissue to bone" in various repairs. Its description and intended use clearly indicate it is a surgical implant for repair, not a device used to diagnose medical conditions or diseases.
No
The device is a physical implant (suture anchor) made of PEEK or PEEK CF, not a software program.
Based on the provided text, 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 (suture anchor) made of PEEK or PEEK CF, designed to be inserted into bone to secure sutures. This is a medical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Parcus Knotless PEEK and 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
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are tapered fasteners with an eyelet at the distal tip and circumferential barbs used to secure the implant in bone and provide suture fixation without the need for knot tying. After passing through the target tissue, sutures are passed through the distal eyelet of the anchor, it is pounded into place which secures both the anchor and the suture in place. This is the same design and insertion technique as the predicate Knotless PEEK CF Push-In Suture Anchors. The predicate device was originally provided in 3.5mm and 4.5mm diameters and this 510(k) will expand that size range to include 2.8mm and 5.5mm options. The Knotless PEEK Push-In Suture Anchor is made from polyetheretherketone (PEEK) and the Knotless PEEK CF Push-In Suture Anchors are made from carbon fiber polyetheretherketone (PEEK CF). The Parcus predicate device is comprised of carbon fiber polyetheretherketone (PEEK CF). The Parcus reference devices consist of devices comprised of either PEEK or PEEK CF. The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are provided sterile with a single use suture passer and either with or without a single use inserter.
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
Prescription Use
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 Knotless PEEK and PEEK CF Push-In Suture Anchors were evaluated and testing was conducted side by side with the predicate device. Devices were assembled to test blocks and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.
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.
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
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January 23, 2020
Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243
Re: K193295
Trade/Device Name: Parcus Knotless PEEK and 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: MBI Dated: January 7, 2020 Received: January 8, 2020
Dear Paul 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K193295
Device Name
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
Indications for Use (Describe)
The Parcus Knotless PEEK and 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. |
|---|---|
| ---------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Knee 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.
- Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
- Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Hand/Wrist Reconstruction, TFCC.
- Acetabular Labral Repair Hip
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
K193295 Page 1 of 2
Image /page/3/Picture/2 description: The image shows the logo for PARCUS MEDICAL, LLC. The logo is primarily blue, with a red graphic on the left side. The words "MEDICAL, LLC." are written in a smaller font size below the main text. There is also a small "2020" in the upper left corner.
Surgical Innovation | Customer Driven
| 510(k) Summary – K193295 | |
|---|---|
| 510(k) Owner & Submitter: | Parcus Medical, LLC |
| 6423 Parkland Dr | |
| Sarasota, FL 34243 | |
| Company Contact: | Paul Vagts |
| Phone: (941)755-7965 | |
| Fax: (941)755-6543 | |
| Date Prepared: | January 16th, 2020 |
| Device Trade Name: | Knotless PEEK and PEEK CF Push-In Suture |
| Anchor | |
| Common Name: | Fastener, Fixation, Non-Degradable, Soft Tissue |
| Device Class: | Class II |
| Classification Name: | 21 CFR 888.3040 - Product Code MBI |
| Predicate Device: | Parcus Knotless PEEK CF Suture Anchors, K113730, |
| cleared 1/17/2012 | |
| Reference Devices: | Parcus Twist PEEK Suture Anchors, K120942, cleared |
| 4/20/2012. | |
| Parcus SLIK Anchors, K170327, cleared 3/30/2017. | |
| Parcus SLIK Fix Screws, K170877, cleared 6/2/2017 |
Device Description:
The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are tapered fasteners with an eyelet at the distal tip and circumferential barbs used to secure the implant in bone and provide suture fixation without the need for knot tying. After passing through the target tissue, sutures are passed through the distal eyelet of the anchor, it is pounded into place which secures both the anchor and the suture in place. This is the same design and insertion technique as the predicate Knotless PEEK CF Push-In Suture Anchors. The predicate device was originally provided in 3.5mm and 4.5mm diameters and this 510(k) will expand that size range to include 2.8mm and 5.5mm options. The Knotless PEEK Push-In Suture Anchor is made from polyetheretherketone (PEEK) and the Knotless PEEK CF Push-In Suture Anchors are made from carbon fiber polyetheretherketone (PEEK CF). The Parcus predicate device is comprised of carbon fiber polyetheretherketone (PEEK CF). The Parcus reference devices consist of devices comprised of either PEEK or PEEK CF. The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are provided sterile with a single use suture passer and either with or without a single use inserter.
PARCUSMEDICAL.COM
4
Surgical Innovation | Customer Driven
Intended Use:
The Parcus Knotless PEEK and 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.
- Lateral Stabilization. Medial Stabilization. Midfoot Reconstruction. Foot/Ankle 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
Substantial Equivalence Summary:
The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are very similar to the predicate Parcus 35 and 45 Knotless PEEK CF Push-In Suture Anchors in that they both feature the same design, both utilize the same surgical technique, both are comprised of the same or similar material and both are intended for the same indications. In addition, the proposed and predicate devices are all packaged in the same fashion using the same materials, are sterilized using the same ETO sterilization cycle, and all share the same 5-year shelf life. An assessment of the biocompatibility of the proposed devices did not raise any concerns as they are comprised of the same material manufactured in the same fashion using the same equipment as the predicate and reference devices stated above that are currently marketed by Parcus Medical. LAL testing has been conducted on a representative devices comprised of the same materials and it was concluded that the Knotless PEEK and PEEK CF Push-In Suture Anchor meet the endotoxin limit specifications and do not raise any additional concerns regarding pyrogenicity.
Summary Performance Data:
The Knotless PEEK and PEEK CF Push-In Suture Anchors were evaluated and testing was conducted side by side with the predicate device. Devices were assembled to test blocks and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.