(64 days)
Not Found
No
The summary describes a mechanical implant for CMC arthroplasty and does not mention any software, algorithms, or AI/ML capabilities.
No.
The README describes an implantable device used in surgical arthroplasty, not a therapeutic device for treatment or rehabilitation.
No
Explanation: The device is an implantable medical device used for CMC arthroplasty, not for diagnosing a condition. Its function is to replace or reconstruct the CMC joint.
No
The device description explicitly states the device is comprised of medical grade titanium, PEEK-OPTIMA™, and UHMWPE, which are hardware components.
No, 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, tissue) to provide information about a person's health.
- Device Description: The Parcus ATLAS is described as a device comprised of titanium, PEEK, and UHMWPE, designed for use in CMC arthroplasty. Arthroplasty is a surgical procedure to replace or repair a joint.
- Intended Use: The intended use is explicitly stated as "CMC Arthroplasty," which is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates that this is an implantable device used in a surgical procedure, not a device used to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Parcus ATLAS is indicated for CMC Arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Parcus ATLAS is designed for use in CMC arthroplasty. The ATLAS is comprised of medical grade titanium, PEEK-OPTIMA™ from Invibio™, and UHMWPE. The ATLAS is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
CMC Arthroplasty (referring to the carpometacarpal joint, typically of the thumb)
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 ATLAS was evaluated in order to ensure that all worst case conditions were considered. The individual performance of the components of this device was evaluated using and straight tensile loading. The ultimate strength and elongation of the construct were considered and the ATLAS was determined to be safe and effective for use in CMC arthroplasty. The performance of the ATLAS as a system is determined to be substantially equivalent to that of the predicate component devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ultimate strength and elongation
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.
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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243
Re: K190375
Trade/Device Name: Parcus ATLAS Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 22, 2019 Received: March 25, 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K190375 Page 1 of 1
Indications for Use
510(k) Number (if known): K190375
Device Name: Parcus ATLAS
Indications for Use:
The Parcus ATLAS is indicated for CMC Arthroplasty.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(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)
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Image /page/3/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The logo is in blue and red. The text "K190375 Page 1 of 1" is in the upper right corner of the image.
Surgical Innovation | Customer Dri
| 510(k) Summary | |
|---|---|
| 510(k) Owner: | Parcus Medical, LLC |
| 6423 Parkland Dr | |
| Sarasota, FL 34243 | |
| Company Contact: | Paul Vagts |
| Phone: (941)755-7965 | |
| Fax: (941)755-6543 | |
| Date Prepared: | March 21, 2019 |
| Device Trade Name: | Anatomic Thumb Ligament Arthroplasty System (ATLAS) |
| Common Name: | Thumb Joint Repair System |
| Device Class: | Class II |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue 21 CFR |
| 888.3040 - Product Code MBI | |
| Predicate Device: | K122805 - Draw Tight Anchors, cleared 2/5/13 |
Device Description:
The Parcus ATLAS is designed for use in CMC arthroplasty. The ATLAS is comprised of medical grade titanium, PEEK-OPTIMA™ from Invibio™, and UHMWPE. The ATLAS is provided sterile.
K152711 - GFS Naked, cleared 12/10/15
Intended Use:
The Parcus ATLAS is indicated for use in CMC arthroplasty.
Substantial Equivalence Summary:
The Parcus ATLAS is a combination of two different cleared Parcus Medical devices that can be used together in order to complete an anatomic CMC arthroplasty. This is achieved by inserting the Draw Tight Suture Anchor into the 2nd metacarpal and then using the tails of the suture anchor and a GFS Naked to secure the 1st metacarpal. The materials, manufacturing processes, packaging, sterilization and shelf-life of this device were considered and found to all be nearly identical to that of the predicate devices. The sterilization validation and shelf life study that were previously conducted were determined to be sufficient and therefore no additional testing was deemed necessary. From a performance aspect, the use of the ATLAS components is nearly identical to that of the original device's cleared indications and any differences have been determined to be insignificant. LAL testing has been conducted on each component individually and it was concluded that even when assembled together, the ATLAS does not raise any additional concerns regarding pyrogenicity.
Summary Performance Data:
The Parcus ATLAS was evaluated in order to ensure that all worst case conditions were considered. The individual performance of the components of this device was evaluated using and straight tensile loading. The ultimate strength and elongation of the construct were considered and the ATLAS was determined to be safe and effective for use in CMC arthroplasty. The performance of the ATLAS as a system is determined to be substantially equivalent to that of the predicate component devices.