(28 days)
Not Found
No
The summary describes a mechanical orthopedic implant and surgical instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The Flow-Nail is intended to treat fractures of the femur. Treating an injury or disease is a therapeutic act.
No
The device is described as a system for treating fractures of the femur and delivering bone void fillers, which are therapeutic functions, not diagnostic.
No
The device description explicitly states that the Flow-Nail is a "dynamic compression trochanteric nail system" and lists physical components made of titanium alloy, such as an intramedullary nail, screws, and surgical instruments. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat bone fractures (proximal fractures of the femur) and deliver bone void fillers. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a surgical implant (intramedullary nail system) made of titanium alloy. This is a medical device used in surgery, not a reagent or instrument for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Flow-Nail does not fit this description.
N/A
Intended Use / Indications for Use
The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a fenestrated lag screw, anti-rotation screw, cortical screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The purpose of this Special 510(k) is to add Flow-Nail with Laglock to the Flow-Nail System. The components are provided non-sterile, for single use, by prescription only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Performance testing included:
- Compression Bending Strength Dynamic per ASTM F384
- Compression Bending Strength Static per ASTM F384
Results of non-clinical performance and analyses demonstrate that the Flow-Nail with Laglock is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 13, 2022
Flow-FX, LLC % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs Mcra, Ilc. 803 7th Street NW Washington, District of Columbia 20001
Re: K221115
Trade/Device Name: Flow-Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: April 15, 2022 Received: April 15, 2022
Dear Hollace Rhodes:
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.
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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 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,
Lixin Liu, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221115
Device Name Flow-Nail
Indications for Use (Describe)
The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of the Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.
| 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) |
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510(k) Summary
| Manufacturer: | Flow-FX, LLC
9301 West 191st Street
Mokena, Illinois 60448
815.531.4424 |
|--------------------|------------------------------------------------------------------------------------------|
| Contact: | Patrick J. Sweeney, MD
Chief Executive Officer
p.sweeney@flow-fx.net |
| Prepared By: | MCRA, LLC
803 7th Street NW, 3rd Floor
Washington, DC 20001
Phone: 202.552.5800 |
| Date Prepared: | May 13, 2022 |
| Device Trade Name: | Flow-Nail |
| Common Name: | Intramedullary Fixation Rod |
| Classification: | 21 CFR 888.3020 |
| Class: | Class II |
| Product Code: | HSB |
Indications for Use:
The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.
Device Description:
The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a fenestrated lag screw, anti-rotation screw, cortical screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The purpose of this Special 510(k) is to add Flow-Nail with Laglock to the Flow-Nail System. The components are provided non-sterile, for single use, by prescription only.
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Predicate Device
Flow-FX's Flow-Nail (K140601); 21 CFR 888.3020; Class II
Substantial Equivalence Discussion
The subject Flow-Nail with Laglock is substantially equivalent to the predicate Flow-Nail (K140601) with respect to indications, material, design, function, and performance. The information summarized in the Design Control Activities Summary demonstrates that the Flow-Nail with Laglock met the pre-determined acceptance criteria for the verification activities.
Non-Clinical Performance Data
Performance testing included:
- Compression Bending Strength Dynamic per ASTM F384 ●
- Compression Bending Strength Static per ASTM F384 ●
Results of non-clinical performance and analyses demonstrate that the Flow-Nail with Laglock is as safe, as effective, and performs as well as the predicate device.
Substantial Equivalence Conclusion
Substantial equivalence of Flow-Nail with Laglock to the predicate Flow-Nail device is based on the following:
- . Both devices have the same intended use.
- Both devices operate using the same fundamental scientific technology. .
- Both devices share similar functional and technological characteristics via similar . operational principles.
Evaluation of the risk and performance data referenced in this 510(k) submission demonstrate that the subject Flow-Nail with Laglock is as safe and effective for its intended use and is substantially equivalent to Flow-Nail.