(91 days)
The Parcus Miti 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.
The Parcus V-lox™ Titanium 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
The Parcus Miti and V-lox Titanium Suture Anchors are a family of threaded, tapered fasteners for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136). It comes preloaded with either one, two, or three strands of sutures between 3-0 and #2 in size or suture tape between 1.4mm and 2.0mm wide. The suture and suture tape is available either with or without attached needles, and is provided sterile and attached to a driver. The Miti Suture Anchor is available in diameters of 2.0mm, 2.5mm and the V-lox Titanium Suture Anchor is available in diameters of 4.5mm, 5.0mm, 5.5mm and 6.5mm.
The provided text describes a 510(k) premarket notification for Parcus V-lox Titanium Suture Anchors and Parcus Miti Suture Anchors. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically associated with a new AI/software device. Instead, this document is a regulatory submission demonstrating substantial equivalence to previously cleared devices.
Here's an analysis of why the requested information cannot be fully provided based on the input:
- Type of Device: The devices are physical implants (suture anchors), not an AI or software device. The "performance data" section focuses on MR (Magnetic Resonance) compatibility, which is a safety evaluation for implanted medical devices, not an evaluation of diagnostic or treatment efficacy based on AI algorithms.
- Regulatory Pathway: A 510(k) submission primarily aims to demonstrate "substantial equivalence" to a predicate device, meaning it is as safe and effective as a device already on the market. This often involves comparing device specifications, materials, and intended use, and sometimes includes performance testing for specific safety attributes (like MR compatibility here), rather than clinical efficacy studies against acceptance criteria for a new mode of action.
Given this context, I will address the requested points as much as possible, clarifying where the information is not present due to the nature of the submission.
Acceptance Criteria and Device Performance
- 1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for diagnostic performance or treatment efficacy. The only performance data presented relates to MR compatibility.
| Acceptance Criterion (MR Compatibility) | Reported Device Performance (MR Conditional) |
|---|---|
| Magnetically Induced Force | Evaluated |
| Magnetically Induced Torque | Evaluated |
| Heating by RF Fields | Evaluated |
| Image Artifact | Evaluated |
| Overall Conclusion | The devices were determined to fit the definition of MR Conditional, establishing suitability for safe use under specific MR system conditions. (Specific numerical limits not provided in this summary) |
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "worst-case devices were selected for testing" for MR compatibility. However, it does not specify the exact sample size (number of devices tested) for the MR evaluation. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) as this was a laboratory-based physical test on the device itself, not a clinical data study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This point is not applicable. The MR compatibility testing is a physical measurement of the device's interaction with an MR environment, not a diagnostic or clinical assessment requiring expert consensus or ground truth in the medical sense.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This point is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for physical performance testing like MR compatibility.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This point is not applicable. The device is a physical medical implant (suture anchor), not an AI or software system that would involve human readers or AI assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable. The device is a physical medical implant, not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the MR compatibility testing, the "ground truth" would be the scientifically established physical limits and behaviors for MR safety as defined by FDA guidance and ASTM standards. It's a technical standard, not a medical "ground truth" derived from patient data.
- 8. The sample size for the training set
This point is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.
- 9. How the ground truth for the training set was established
This point is not applicable. There is no training set.
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July 23, 2020
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243
Re: K201083
Trade/Device Name: Parcus V-lox Titanium Suture Anchors, Parcus Miti 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: May 26, 2020 Received: May 29, 2020
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. 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
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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,
for
Laura 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
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Indications for Use
510(k) Number (if known) K201083
Device Name
Parcus Miti and V-lox Titanium Suture Anchors
Indications for Use (Describe)
The Parcus Miti 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 LigamentRepair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon AvulsionRepair. |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux ValgusReconstruction, Metatarsal Ligament Repair |
| Elbow: | Tennis Elbow Repair, Biceps Tendon Reattachment. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC. |
The Parcus V-lox™ Titanium 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 LigamentRepair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon AvulsionRepair. |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux ValgusReconstruction, 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 |
| 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)
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FORM FDA 3881 (7/17)
Page 1 of 1
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Image /page/3/Picture/13 description: The image shows the logo for Anika Therapeutics. The logo consists of a blue circular graphic on the left and the word "ANIKA" in blue capital letters on the right. The graphic appears to be a stylized letter "A" inside the circle.
Image /page/3/Picture/1 description: The image shows the text "K201083" in a simple, sans-serif font. The text is black against a white background. The characters are evenly spaced and clearly legible.
Image /page/3/Picture/2 description: The image shows the logo for "PARCUS MEDICAL, LLC". The logo is in blue and consists of the company name in a stylized font. Below the logo, the text "Parcus Medical has joined Anika" is displayed in a smaller, gray font.
| 510(k) Summary | |
|---|---|
| 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: | July 21st, 2020 |
| Device Trade Name: | • Parcus Miti Suture Anchors, |
| • Parcus V-lox Titanium Suture Anchors | |
| Common Name: | Suture Anchors |
| Device Class: | Class II |
| Classification Name: | 21 CFR 888.3040 - Product Code MBI |
| Predicate Device: | • K090075 (cleared March 6, 2009) – Parcus V-loxTitanium Suture Anchors, |
| • K111000 (cleared July 28, 2011) – Parcus MitiSuture Anchors |
Device Description:
The Parcus Miti and V-lox Titanium Suture Anchors are a family of threaded, tapered fasteners for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136). It comes preloaded with either one, two, or three strands of sutures between 3-0 and #2 in size or suture tape between 1.4mm and 2.0mm wide. The suture and suture tape is available either with or without attached needles, and is provided sterile and attached to a driver. The Miti Suture Anchor is available in diameters of 2.0mm, 2.5mm and the V-lox Titanium Suture Anchor is available in diameters of 4.5mm, 5.0mm, 5.5mm and 6.5mm.
Intended Use:
The Parcus Miti 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 Shoulder: 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,
Page 1 of 3 1-941-755-7965
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Image /page/4/Picture/1 description: The image shows the logo for Anika Therapeutics. The logo consists of a blue abstract symbol on the left and the word "ANIKA" in blue capital letters on the right. The symbol appears to be a stylized letter "V" inside a circle with a dot.
Image /page/4/Picture/2 description: The image shows the logo for "PARCUS MEDICAL, LLC." The logo is in blue and features a stylized font. Below the logo, the text "Parcus Medical has joined Anika" is written in a smaller, gray font. The text indicates a business relationship or acquisition.
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
- Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow:
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
The Parcus V-Iox™ Titanium 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 Shoulder: 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
Substantial Equivalence Summary:
The Parcus Miti and V-lox Titanium Suture Anchors are equivalent to the predicate Parcus Miti and V-lox Titanium Suture Anchors because they are the same devices. No changes from the existing device are proposed with the exception of the inclusion of the MR Conditional parameters into the applicable Instructions for Use. LAL testing has been tested on representative samples and it was concluded that neither the Miti nor the V-lox Titanium Suture Anchors raise any additional concerns regarding pyrogenicity.
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Image /page/5/Picture/0 description: The image contains the logo for the company "Anika". The logo consists of a blue circular graphic on the left, followed by the company name "ANIKA" in blue, sans-serif font. The graphic appears to be a stylized letter or symbol within the circle.
Image /page/5/Picture/1 description: The image shows the logo for PARCUS MEDICAL, LLC. The logo is in blue and features a stylized letter 'P' followed by the rest of the company name in a sans-serif font. Below the logo, there is a line of text that reads "Parcus Medical has joined Anika".
Summary Performance Data:
The Parcus Miti and V-lox Titanium Suture Anchors were evaluated for use in the MR Environment and were determined to fit the definition of MR Conditional. These titanium implants were evaluated based on the FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards, and worst-case devices were selected for testing. Devices were tested for magnetically induced force, magnetically induced torque, heating by RF fields, and image artifact. The results of this testing have been used to establish the MR system conditions suitable for safe use when these implants are present.
6423 Parkland Drive Sarasota, FL 34243 www.parcusmedical.com
§ 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.