(56 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical application of the anchors, with no mention of AI or ML.
Yes
The device is described as "designed for use in the attachment of soft tissue to bone" for various repairs across multiple anatomical sites (e.g., Rotator Cuff Repair, Ligament Repair). These applications directly aim to treat or alleviate a medical condition, which aligns with the definition of a therapeutic device.
No
The device is described as an anchor for attaching soft tissue to bone, used in various repair and reconstruction procedures. Its function is to fix tissue, not to diagnose a condition.
No
The device description clearly states the device is made from physical materials (PEEK or PEEK CF) and is provided sterile, indicating it is a physical implantable device, not software.
Based on the provided information, the Parcus SLiK Anchors are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the attachment of soft tissue to bone during surgical procedures. This is a direct surgical intervention on the body.
- Device Description: The device is a physical implant (anchor) made of PEEK or PEEK CF, designed to be placed within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the mechanical properties of the anchor (strength, elongation, torque) and its ability to function as a surgical implant, not on diagnostic accuracy or analytical performance.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Parcus SLiK Anchors are a surgical implant used for repair and reconstruction, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Parcus SLIK 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, Biceps Tenair, 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Parcus SLiK Anchors are designed for use in the attachment of soft tissue to bone. The devices are made from either Polyetheretherketone (PEEK) or Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). The Parcus SLiK 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 SLiK Anchors were evaluated and testing was conducted on the worst case configurations. Devices were assembled per the DFU and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. In addition, insertion torque and failure torque values were determined in order to ensure the necessary safety factor exists during insertion of the device. Results were compared with test data for the predicate devices 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.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2017
Parcus Medical, LLC Mr. Paul Vagts Director of Regulatory Affairs/Ouality Assurance 6423 Parkland Drive Sarasota, Florida 34243
Re: K170327
Trade/Device Name: Parcus SLiK 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 31, 2017 Received: February 2, 2017
Dear Mr. 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. 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 of medical device
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/9 description: The image shows the name "Mark N. Melkerson -S" in a large, sans-serif font. The text is dark gray against a white background. The letters are evenly spaced and clearly legible.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration
Indications for Use
510(k) Number (if known) K170327
Device Name Parcus SLiK Anchors
Indications for Use (Describe)
The Parcus SLIK 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, Biceps Tenair, 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The word "PARCUS" is written in large, blue, sans-serif font. To the left of the word is a red square with a curved white line running through it. Below the word "PARCUS" is the phrase "MEDICAL, LLC." written in a smaller, blue, sans-serif font.
510(k) Summar
| 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 31, 2017 |
| Device Trade Name: | Parcus SLiK Anchor |
| Common Name: | Suture Anchor |
| Device Class: | Class II |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue 21 CFR
888.3040 - Product Code MBI |
| Predicate Device: | The predicate devices are the Parcus 35/45 Knotless PEEK
CF Push-In Suture Anchors (K113730, cleared 1/17/12) and
the Parcus Twist PEEK Suture Anchors (K120942, cleared
4/20/12) |
Device Description:
The Parcus SLiK Anchors are designed for use in the attachment of soft tissue to bone. The devices are made from either Polyetheretherketone (PEEK) or Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). The Parcus SLiK Anchors are provided sterile.
Intended Use:
Call 1.941.755.7965
The Parcus SLiK Anchors are indicated for the attachment of soft tissue to bone. These products are 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. |
Substantial Equivalence Summary:
The Parcus SLiK Anchors are very similar to the predicate Parcus Medical devices in that they are comprised of the same materials, are manufactured in comparable fashions, and are intended for the same indications. While the SLiK Anchors are offered without suture (like the Knothess predicate) and feature a thread-in insertion technique (like the Twist predicate), testing has shown that the
| PARCUSMEDICAL.COM |
|---|
| 6423 Parkland Drive, Sarasota, FL 34243 |
| Page 16 of 226 |
Fax 1.941.755.6543
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Image /page/4/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The word "PARCUS" is in large, blue, stylized letters. To the left of the word is a red square with a white curved line inside. Below the word "PARCUS" is the phrase "MEDICAL, LLC." in smaller, blue letters.
combination of these features does not raise any concerns regarding the safety or efficacy of the device. LAL testing was conducted on a comparable device and it was concluded that the SLiK Anchors do not raise any addition concerns regarding pyrogenicity.
Summary Performance Data:
The SLiK Anchors were evaluated and testing was conducted on the worst case configurations. Devices were assembled per the DFU and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. In addition, insertion torque and failure torque values were determined in order to ensure the necessary safety factor exists during insertion of the device. Results were compared with test data for the predicate devices and demonstrated substantial equivalency.