(100 days)
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)
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.
The document describes a 510(k) premarket notification for the "Parcus PEEK CF Push-In Suture Anchors" by Parcus Medical, LLC. The study provided is a performance comparison to predicate devices, focusing on demonstrating substantial equivalence rather than a detailed clinical trial with human subjects/readers.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pull-out strength comparable to predicate devices | "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." |
| Safety and Efficacy for intended use | Implied by "substantial equivalence" to predicate devices, which are already legally marketed and presumed safe and effective. |
| Mechanical characteristics suitable for soft tissue to bone attachment | Demonstrated through "pull out strength" measurements, indirectly showing the device's ability to secure tissue. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Test results" in plural, implying multiple tests, but does not provide specific numbers of anchors or tests conducted.
- Data Provenance: The study was a non-clinical in vitro or benchtop test comparing mechanical properties. It is not patient or human data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense. It's an engineering performance test.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This type of study (comparative mechanical performance of a medical device) does not involve experts establishing "ground truth" in the way a diagnostic imaging study would.
- The "ground truth" here is the measured mechanical pull-out strength of the device itself and its comparison to established predicate devices. The "experts" involved would likely be engineers or lab technicians conducting the tests according to established protocols. Their specific qualifications are not mentioned.
4. Adjudication Method for the Test Set
- Not applicable. This was a mechanical performance test, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was not a clinical or diagnostic study involving human readers or cases. It was a benchtop comparison of the mechanical properties of a suture anchor.
- Therefore, an effect size of human readers improving with AI vs. without AI assistance is not relevant or provided.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, a standalone performance study in the context of AI is not relevant.
7. Type of Ground Truth Used
- Measured Mechanical Properties: The "ground truth" was the measured pull-out strength of the suture anchors, obtained through direct physical testing. This is a form of objective physical measurement.
8. Sample Size for the Training Set
- Not applicable. This device is hardware, not an AI model. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing would be based on engineering principles and material science, potentially informed by prior device performance data, but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI algorithm, this question is not relevant. The performance of the predicate devices would have been established through their own testing and market history, and the design of the new device would be based on engineering specifications and material properties.
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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, LLC839 South Neenah Ave.Sturgeon Bay, WI 54234 |
|---|---|
| Company Contact: | Barton BracyPhone: (920) 746-2972Fax: (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 Tissue21 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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Page 16 of 222
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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
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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
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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
§ 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.