(76 days)
Devices (K-Wires and Steinmann Pins) are intended to be used as:
- · Guide wires for osteosynthesis implants
- · Accessories for external fixation (Steinmann Pins)
- · Implants according to principles of fracture management
The SMV Scientific K-Wire and Pin consists of K-Wire and Pins in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided nonsterile. All devices are manufactured from medical grade Stainless Steel or Titanium alloys.
This document is a 510(k) clearance letter for the "SMV Scientific K-Wire and Pins." It does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML device. The device described here is a physical medical device (K-wires and Steinmann pins), and its clearance is based on substantial equivalence to a predicate device, not on a performance study with acceptance criteria.
Therefore, I cannot provide the requested information. The document explicitly states:
"Testing, therefore, was not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices."
This indicates that the clearance was based on engineering analysis and comparison to a predicate device, not on a performance study that would generate the kind of data requested (acceptance criteria, reported device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.).
{0}------------------------------------------------
October 25, 2018
Image /page/0/Picture/1 description: The image contains the logo of 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Summit MedVentures % Meredith May Vice President Empirical Consulting LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K182171
Trade/Device Name: SMV Scientific K-Wire and Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDW, HTY Dated: July 13, 2018 Received: August 10, 2018
Dear Meredith May:
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 (OS) 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,
Peter G. Allen -S 2018.10.25 23:44:02 -04'00'
Mark N. Melkerson FOR 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: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K182171
Device Name
SMV Scientific K-Wire and Pins
Indications for Use (Describe)
Devices (K-Wires and Steinmann Pins) are intended to be used as:
- · Guide wires for osteosynthesis implants
- · Accessories for external fixation (Steinmann Pins)
· Implants according to principles of fracture management
Type of Use (Select one or both, as applicable) [ ] Over-The-Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D) 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}------------------------------------------------
5.510(K) SUMMARY
| Submitter's Name: | Summit MedVentures |
|---|---|
| Submitter's Address: | 7500 Rialto Blvd, Bldg 1, Ste 225Austin, TX 78738 |
| Contact Person: | Meredith Lee May MS, RACEmpirical Consulting719.337.7579MMay@EmpiricalConsulting.com |
| Date Summary was Prepared: | 13 Jul 18 |
| Trade or Proprietary Name: | SMV Scientific K-Wire and Pins |
| Common or Usual Name: | Wire Bone / K-Wire; Cerciage Wire, Steinmann Pin |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | JDW, HTY |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SMV Scientific K-Wire and Pin consists of K-Wire and Pins in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided nonsterile. All devices are manufactured from medical grade Stainless Steel or Titanium alloys.
INDICATIONS FOR USE
Devices (K-Wires and Steinmann Pins) are intended to be used as:
- · Guide wires for osteosynthesis implants
- · Accessories for external fixation (Steinmann Pins)
- · Implants according to principles of fracture management
TECHNOLOGICAL CHARACTERISTICS
SMV Scientific K-Wire and Pins are made from 316L Stainless Steel per ASTM F138 or ISO 5823-3 or Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or ISO 5832-1. The subject and predicate devices have similar technological characteristics, including intended use, materials of manufactur, design, dimensions, and sizes.
| 510k Number | Trade or Proprietary orModel Name | Manufacturer | PredicateType |
|---|---|---|---|
| K131459 | aap Wire Bone / K-Wire;Cerciage Wire, SteinmannPin | aap Implantante AG | Primary |
PERFORMANCE DATA
An engineering analysis including material and dimensional comparison of the SMV Scientific K-Wire and Pins and the predicate device was performed. The SMV Scientific K-Wire and Pins
{4}------------------------------------------------
K182171 Page 2 of 2
are equivalent in physical dimensions and materials to the identified predicate devices. Testing, therefore, was not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices.
CONCLUSION
The similarity in indications for use and overall technological characteristics, and engineering analysis data lead to the conclusion that the SMV Scientific K-Wire and Pins are substantially equivalent to the predicate device.
§ 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.