(70 days)
Not Found
No
The summary describes a mechanical device (screws) for soft tissue to bone reattachment and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is described as a "Parces SLIK Fix Screw" specifically designed for "soft tissue to bone reattachment procedures" across various anatomical sites (e.g., Shoulder, Knee, Foot/Ankle). Its function in repairing ligaments and tendons directly indicates a therapeutic purpose.
No
This device is designed for soft tissue to bone reattachment procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device is made from physical materials (PEEK or Carbon Fiber Reinforced PEEK) and is a screw designed for surgical implantation. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue to bone reattachment procedures" in various anatomical locations. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "screw" made from PEEK or PEEK CF, designed for physical attachment. This is a surgical implant, not a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, controls, or analytical instruments
The device is a surgical implant used to physically repair injuries.
N/A
Intended Use / Indications for Use
The Parces SLIK Fix Screw is in soft tissue to bone reattachment procedures. Specific indications are the following:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bicepair, Biceps Tenodesis, Capsular Shift or Capsulolabral Repair, Fictorial Sepairion Repair, SLAP Lesion Repair,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Olique Ligament Repair, Extra Capsular Reconstruction, Lateral Conaleral Ligament Repar, Posterior Oblique Ligare Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion
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 Fix Screws are designed for use in the attachment of soft tissue to bone. The screws are made from either Polyetheretherketone (PEEK) or Carbon Fiber Reinforced Polyethersether only in Chiler Polyen Fiber PEEK) or Carbon Fiber Reinforced Polyetheretherketone (PEEK CF) and utilize a PEEK washer for graft/suture positioning. The Parcus SLiK Fix Screws 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 Fix Screws were evaluated and testing was conducted on the worst case configurations. Devices were assembled and testing was conducted on the worst case configuration strength and elongation under cycle loading and ultimate failure conditions. In addition, insertion torque and failure torque values were determined in order the necessary safety factor existen during insertion of the device were determined in order the necessary safety fac during insertion of the device. Results were compared with the necessary safety factor exis demonstrated substantial equivalency 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
Image /page/0/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Parcus Medical, LLC Mr. Paul Vagts Director of Regulatory Affairs/Quality Assurance 6423 Parkland Drive Sarasota, Florida 34243
June 2, 2017
Re: K170877
Trade/Device Name: Parcus SLiK Fix Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 21, 2017 Received: March 24, 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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)
Device Name Parcus SLiK Fix Screw
Indications for Use (Describe)
The Parces SLIK Fix Screw is in soft tissue to bone reattachment procedures. Specific indications are the
following:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bicepair, Biceps Tenodesis, Capsular Shift or Capsulolabral Repair, Fictorial Sepairion Repair, SLAP Lesion Repair,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Olique Ligament Repair, Extra Capsular Reconstruction, Lateral Conaleral Ligament Repar, Posterior Oblique Ligare
Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion
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) | |
|---|---|
| ------------------------------------------------- | -- |
2 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
K170877 Page 1 of 2
Image /page/3/Picture/1 description: The image shows the logo for PARCUS MEDICAL, LLC. The logo features a red square with a white curved line on the left side, followed by the word "PARCUS" in blue, block letters. Below "PARCUS" is the phrase "MEDICAL, LLC." also in blue.
510(k) Summary
| Submitter: | Parcus Medical, LLC
6423 Parkland Dr
Sarasota, FL 34243 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Joan Rubendall
Phone: (941)755-7965
Fax: (941)755-6543 |
| Date Prepared: | May 30, 2017 |
| Device Trade Name: | Parcus SLiK Fix Screw |
| Common Name: | Interference Screw/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 PEEK CF Interference
Screws (K091093, cleared 9/30/09), 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 Fix Screws are designed for use in the attachment of soft tissue to bone. The screws are made from either Polyetheretherketone (PEEK) or Carbon Fiber Reinforced Polyethersether only in Chiler Polyen Fiber PEEK) or Carbon Fiber Reinforced
Polyetheretherketone (PEEK CF) and utilize a PEEK washer for graft/suture positioning. The Parcus SLiK Fix Screws are provided sterile.
Intended Use:
The Parcus SLiK Fix Screws are intended for use in soft tissue to bone reattachment procedures.
Specific indications are the following: Specific indications are the following:
| 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. |
Page 16 of 223
4
Image /page/4/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The logo is in blue and red. The text "K170877 Page 2 of 2" is in the upper right corner of the image.
Substantial Equivalence Summary:
The Parcus SLiK Fix Screws 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 in they are
same indications. While the Slik Eix Screws are ebetashons, and are intended fo same indications. While the Science are shorter his comparable fashing Parcus I for the
and larger in diameter than existing Parcus Suture that the existing Parcus Interfer and larger in diameter than existing Parcus Suture Anchors, testing has shown that the combination of these features does not raise any concerns regarding the safety or efficacy of the device. List in the combination testing was conducted on a comparable device and it was concluded that the SLik .
raise any addition a comparable device and it was concluded that the SLiK Fix Screws do not raise any addition concerns regarding pyrogenicity.
Summary Performance Data:
The SLiK Fix Screws were evaluated and testing was conducted on the worst case configurations. Devices were assembled and testing was conducted on the worst case configuration
strength and elongation under well be discussion in a test fixture. Devices were evaluated f strength and elongation under cycle loading and ultimate failure conditions. In addition, insertion torque and failure torque values were determined in order the necessary safety factor existen
during insertion of the device were determined in order the necessary safety fac during insertion of the device. Results were compared with the necessary safety factor exis
demonstrated substantial equivalency demonstrated substantial equivalency.
Page 17 of 223
Fax 1.941.755.6543