(161 days)
The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair
The Parcus Titanium Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.
The provided text pertains to the 510(k) premarket notification for the "Parcus Titanium Interference Screws." This is a medical device for orthopedic fixation, specifically for ligaments and tendons. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than a study evaluating the performance of a diagnostic AI device against acceptance criteria. Therefore, most of the requested information regarding AI device-specific acceptance criteria and studies (such as MRMC studies, human-in-the-loop performance, expert qualifications for ground truth, sample sizes for training/test sets concerning AI, etc.) is not applicable to this document.
However, I can extract information related to the device's performance testing where described, as it serves a similar purpose to acceptance criteria demonstration for physical medical devices.
Here's an analysis based on the closest applicable information in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Pull-out Strength | Demonstrated no significant differences compared to competitive devices (based on K083619 submission). |
| Insertion Torque | Demonstrated no significant differences compared to competitive devices (based on K083619 submission). |
| Pyrogenicity (LAL testing) | Concluded that the device does not raise any additional concerns regarding pyrogenicity. |
| Substantial Equivalence (to Predicate Device K083619) | Determined to be the exact same device as the predicate, with the only changes being the inclusion of MR Conditional parameters into the Instructions for Use. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions that pull-out strength and insertion torque were measured for the smallest (7mm), largest (12mm), and an intermediate size of the Parcus Titanium Interference Screws. The exact number of samples for each size is not specified in this document.
- Data Provenance: The performance data for pull-out strength and insertion torque is referenced as being included with the submission of K083619 (the predicate device). This suggests the performance data was likely generated through in-vitro mechanical testing. The country of origin for this data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This medical device is a physical fixation screw, not an AI diagnostic device. Ground truth as typically understood for AI studies (e.g., expert consensus on image interpretation) is not applicable here. The "ground truth" for this device's performance would be the direct measurements of mechanical properties.
4. Adjudication method for the test set
N/A - As above, adjudication methods for expert disagreement on ground truth are not applicable to the mechanical testing of a physical medical device.
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
N/A - This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI algorithm.
7. The type of ground truth used
For the mechanical performance testing (pull-out strength, insertion torque), the ground truth is the direct physical measurement of these properties, likely using laboratory equipment. For pyrogenicity, the ground truth is established through LAL testing laboratory results. For substantial equivalence, the "ground truth" is the physical and functional characteristics of the device itself compared to a legally marketed predicate device.
8. The sample size for the training set
N/A - This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
N/A - As above, no training set for an AI model.
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February 22, 2021
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Parcus Medical, LLC Aleiandra Anderson QA Specialist 6423 Parkland Drive Sarasota, Florida 34243
Re: K202662/S001
Trade/Device Name: Parcus Titanium Interference Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: January 5, 2021 Received: January 19, 2021
Dear Alejandra Anderson:
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 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
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K202662 - Alejandra Anderson
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 mediation-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. 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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known) K202662
Device Name
Parcus Titanium Interference Screw
Indications for Use (Describe)
The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair
Type of Use (Select one or both, as applicable)
网 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Number: K202662 Received Date: 09/14/2020
K202662 Page 1 of 1
| 510(k) Summary | |
|---|---|
| 510(k) Owner & Submitter: | Parcus Medical, LLC |
| 6423 Parkland Dr | |
| Sarasota, FL 34243 | |
| Company Contact: | Alejandra Anderson |
| Phone: (941)755-7965 | |
| Fax: (941)755-6543 | |
| Date Prepared: | August 21st, 2020 |
| Device Trade Name: | Parcus Titanium Interference Screws |
| Common Name: | Interference Screws |
| Device Class: | Class II |
| Classification Name: | 21 CFR 888.3040 - Product Code MBI |
Predicate Device:
Parcus Titanium Interference Screws, K083619, Cleared March 6, 2009.
Device Description:
The Parcus Titanium Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length. Intended Use:
The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Substantial Equivalence Summary:
The Parcus Titanium Interference Screw is equivalent to the predicate Parcus Titanium Interfere Screws because they are the exact same device. No changes from the existing device are proposed with the exception of the inclusion of the MR Conditional parameters into the Instructions for Use. LAL testing has been tested on the Parcus Titanium Interference Screws and it was concluded that the Parcus Titanium Interference Screws do not raise any additional concerns regarding pyrogenicity.
Summary Performance Data:
The pull-out strength and insertion torque were measured for the smallest (7mm) and largest (12mm) Parcus Titanium Interference Screws as well as an intermediate size. As described above, no changes to the physical device are being made and therefore additional side by side comparisons were not deemed necessary. Based on the performance data included with the submission of K083619, the results of the insertion torque testing and pullout force demonstrated that there were no significant differences between the Parcus Titanium Interference Screw and the competitive devices.
§ 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.