(105 days)
The STROPP(TM) System is intended for use with a suture in metatarsal ligament and tendon repairs.
The STROPP™ System is sterile packaged kit to include implants and instruments for plantar plate repair. Implants are 3.0 mm or 3.5 mm diameters and range in length from 6 mm to 12 mm. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, an inserter, Kwires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system.
The provided text describes a 510(k) premarket notification for a medical device called the STROPP™ (Single Tunnel Repair of Plantar Plate) System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than a device's standalone performance compared to a set of acceptance criteria.
Therefore, the input text does not contain the information requested in sections 1-9 regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement in the context of a new device's performance validation against a defined set of criteria.
The information provided is specific to the regulatory process for demonstrating substantial equivalence for a Class II medical device, which typically involves comparing the new device's characteristics (design, materials, intended use, performance testing) to those of legally marketed predicate devices.
Here's what can be extracted, interpreted based on the context of a 510(k):
1. A table of acceptance criteria and the reported device performance
- The document does not explicitly state acceptance criteria for a new device's performance in a standalone study. Instead, it refers to demonstrating "statistical equivalence to current plantar plate repair options" for construct pull-through testing. This means the performance of the STROPP™ system was compared against existing methodologies or devices, rather than a predefined absolute threshold.
- Reported Device Performance:
- "The construct pull through testing demonstrated statistical equivalence to current plantar plate repair options and that the STRoPP™ System introduces no additional failure modes."
- "The cadaveric testing resulted in no damage to the bone, implant or suture."
- "All testing met the specified acceptance criteria and raised no new issues of safety or effectiveness." (This "acceptance criteria" likely refers to the equivalence criteria mentioned above or other internal design specifications, not external performance benchmarks specified in the document.)
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The text mentions "test samples that are representative of the finished device" for construct pull-through testing and "cadaveric simulated use testing" but does not give a number for either.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests appear to be laboratory-based ("simulated use model," "cadaveric simulated use testing").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not mentioned. The studies focus on mechanical performance and simulated use, not diagnostic accuracy requiring expert interpretation.
4. Adjudication method for the test set
- This information is not applicable and not mentioned. The studies focus on mechanical performance.
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 information is not applicable and not mentioned. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a physical medical device, not an algorithm. Therefore, this question is not directly applicable. However, the performance testing described is analogous to a "standalone" mechanical performance evaluation of the device itself (construct pull-through, cadaveric testing).
7. The type of ground truth used
- For the construct pull-through test: It appears the "ground truth" was the mechanical strength or failure point, compared against existing "plantar plate repair options."
- For the cadaveric testing: The "ground truth" was the observation of "damage to the bone, implant or suture."
8. The sample size for the training set
- This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- This device is not an AI/ML algorithm.
{0}------------------------------------------------
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2016
CrossRoads Extremity Systems, LLC Mr. Vernon Hartdegen Sr. Vice President of Operations 6055 Primacy Parkway, Suite 140 Memphis, Tennessee 38119
Re: K160118
Trade/Device Name: STROPP™ (Single Tunnel Repair of Plantar Plate) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 14, 2016 Received: March 17, 2016
Dear Mr. Hartdegen:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name STROPP(TM) System
Indications for Use (Describe)
The STROPP(TM) System is intended for use with a suture in metatarsal ligament and tendon repairs.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
| Date: | April 27, 2016 |
|---|---|
| Device Name: | Single Tunnel Repair of Plantar Plate (STROPPTM) System |
| Company: | CrossRoads Extremity Systems6055 Primacy Parkway, Suite 140Memphis, TN 38119 USAPhone: 901.221.8406 |
| Primary Contact: | Vernon Hartdegen, Sr. VP of Operations901.221.8406vhartdegen@crextremity.com |
| Trade Name: | Single Tunnel Repair of Plantar Plate (STROPPTM) System |
| Common Name: | Suture Retention Device |
| Classification: | Class II |
| Regulation: | 21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener |
| Panel: | 87 - Orthopedic |
| Product Code: | MBI |
| Predicate Device: | Primary PredicateK133229 Titanium Suture AnchorMTP Solutions (Smith Nephew Hat Trick Lesser ToeRepair System)Additional Predicate |
| K133235 Threaded PEEK K-WireMTP Solutions (Smith Nephew Hat Trick Lesser ToeRepair System) |
Device Description:
The STROPP™ System is sterile packaged kit to include implants and instruments for plantar plate repair. Implants are 3.0 mm or 3.5 mm diameters and range in length from 6 mm to 12 mm. Implants are packaged with the following manual surgical
{4}------------------------------------------------
instruments for general use: a needle, needle passer, an inserter, Kwires and distractor.
The implants are compatible with Size 0 suture; suture is not included with the system.
Indications for Use:
The STROPP™ System is intended for use with a suture in metatarsal ligament and tendon repairs.
Materials:
The STRoPP™ device is composed of polyetheretherketone (PEEK) per ASTM F2026.
Substantial Equivalence:
The subject STROPP™ System is substantially equivalent to the primary predicate device, K133229 (MTP Solutions Titanium Suture Anchor; Smith Nephew Hat Trick Lesser Toe Repair System) in intended use, surgical technique and principle of operation. The subject STROPP™ System is substantially equivalent to the additional predicate device, K133235 (MTP Solutions Threaded PEEK K-wire; Smith Nephew Hat Trick Lesser Toe Repair System) in its material of construction. The differences in technological characteristics between the predicates and the subject device do not raise any new or different questions of safety and effectiveness and is thereby substantially equivalent to the predicate devices.
The primary predicate device (K133229) contains threads for bone engagement that also interact with the suture. The subject device is a smooth press-fit device with no sharp edges or features to potentially impart damage to the suture. Both the subject and primary predicate (K133229) devices utilize a single bone tunnel technique and require the suture knot to be tied over the shoulder of the device. The primary predicate device (K133229) is manufactured from titanium alloy and the subject device is manufactured from PEEK (ASTM F2026), which is the same material as the additional predicate device (K133235). The primary predicate device (K133229) is available in one diameter (2.5mm) and the subject device is provided in two diameters (3.0mm and 3.5mm). The additional sizes of the subject device allow the surgeon to determine the optimal device size based on patient anatomy and bone quality. The primary predicate (K133229) is indicated for use with suture in the foot along with multiple expanded indications. While the indications for use of the subject device are encompassed in the indications for use of the primary predicate (K133229), they match exactly the indication for use of the additional predicate (K133235).
Performance Testing:
Non-clinical performance testing of the STROPP™ System has been performed to demonstrate substantial equivalence. Testing has been performed on test samples that are representative of the finished device. Non-clinical testing included
{5}------------------------------------------------
construct pull through testing in a simulated use model utilizing various suture materials to determine if the STRoPP™ construct could withstand the pull through forces that may be present in vivo. The construct pull through testing demonstrated statistical equivalence to current plantar plate repair options and that the STRoPP™ System introduces no additional failure modes. In addition, cadaveric simulated use testing was conducted to evaluate the interaction between the implant, bone and suture. The cadaveric testing resulted in no damage to the bone, implant or suture. All testing met the specified acceptance criteria and raised no new issues of safety or effectiveness. Based on the non-clinical test results, it can be concluded that the subject STRoPP™ System is substantially equivalent and is safe and effective for the intended use.
N/A