(108 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of the implants, with no mention of AI or ML.
No.
The device is used for fixation of bone or soft tissue to bone and ligament/tendon repair, which is a structural or supportive function rather than a therapeutic one (i.e. treating a disease or condition).
No
Explanation: The device is described as "used for fixation of bone or soft tissue to bone" and for "fixation of ligaments and tendons." Its function is structural support and repair, not the diagnosis of a condition.
No
The device description explicitly states the devices are made from medical grade titanium and UHMWPE suture, indicating they are physical implants, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Parcus AcTiFlip and GFS Ultimate Hip devices are used for the fixation of bone or soft tissue to bone during surgical procedures. They are implants used within the body to repair ligaments and tendons.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples, detect substances, or provide diagnostic information about a patient's condition.
The device is a surgical implant used for structural support and fixation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Parcus AcTiFlip is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.
Product codes
MBI
Device Description
The Parcus AcTiFlip and GFS Ultimate Hip devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture and are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, elbow, hip
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 Parcus AcTiFlip and GFS Ultimate Hip devices were evaluated and testing was conducted on the worst case configurations. 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)
K133757, K152711, K162198, K190288
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 16, 2020
Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243
Re: K192750
Trade/Device Name: AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: October 18, 2019 Received: October 21, 2019
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
1
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-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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
Indications for Use (Describe)
The Parcus AcTiFlip is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.
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.
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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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Image /page/3/Picture/1 description: The image shows the logo for PARCUS MEDICAL, LLC. The word "PARCUS" is in large, blue, sans-serif font, with a red square and white curved line to the left of the word. Below the word "PARCUS" is the phrase "MEDICAL, LLC." in a smaller, blue, sans-serif font.
Surgical Innovation | Customer Driven
| 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: | January 15, 2020 |
| Device Trade Name: | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip w/ WHIP, |
| GFS Ultimate Hip | |
| Common Name: | Fastener, Fixation, Non-Degradable, Soft Tissue |
| Device Class: | Class II |
| Classification Name: | 21 CFR 888.3040 - Product Code MBI |
Predicate Device:
Parcus GFS II and GFS Mini, K133757, cleared 2/4/14; GFS Naked, K152711, cleared 12/10/15, Parcus GFS Ultimate, K162198, cleared 11/18/16; and Arthrex K190288, cleared 9/13/19.
Device Description:
The Parcus AcTiFlip and GFS Ultimate Hip devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture and are provided sterile.
Intended Use:
The Parcus AcTiFlip is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.
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Surgical Innovation | Customer Drive
Substantial Equivalence Summary:
The Parcus AcTiFlip Naked, AcTiFlip Cinch and AcTiFlip w/ WHIP devices are very similar to the predicate devices in that they are comprised of the same materials, intended for the same indications and utilize similar designs. The titanium button used by the AcTiFlip devices is very similar in design to that of the GFS Naked devices. The suture portion of the AcTiFlip Cinch builds upon the technology utilized by the GFS Ultimate. The suture used by the AcTiFlip w/ WHIP is manufactured by the same supplier as all other suture components and functions in a comparable manner.
The Parcus GFS Ultimate Hip device is very similar to the predicate Parcus Medical GFS Ultimate in that they are comprised of the same materials, intended for the same indications and utilize similar designs. The only difference is the use of an inserter for placement of the titanium button in the hip.
All AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip w/ WHIP and GFS Ultimate Hip are very similar to the Arthrex predicate in that they are all capable of achieving fixation using either extramedular or intramedular fixation.
LAL testing was conducted on a representative device comprised of the same materials manufactured in a comparable fashion and it was concluded that both the Parcus AcTiFlip and the GFS Ultimate Hip devices meet endotoxin limit specifications and do not raise any additional concerns regarding pyrogenicity.
Summary Performance Data:
The Parcus AcTiFlip and GFS Ultimate Hip devices were evaluated and testing was conducted on the worst case configurations. 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.