(114 days)
No
The summary describes a mechanical implant and surgical instruments, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is intended to treat fractures, which is a therapeutic purpose.
No
The Flow-Nail is intended to treat fractures and deliver bone void fillers, not to diagnose conditions.
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 a cap. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Flow-Nail is for the treatment of bone fractures. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a surgical implant (intramedullary nail system) made of titanium alloy. This is a physical device used within the body, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
The Flow-Nail is a surgical device used for orthopedic repair.
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 sliding fenestrated lag screw, anti-rotation screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur
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)
Mechanical testing demonstrates the substantial equivalence of the Flow-Nail relative to the identified predicates when subjected to static and dynamic compression bending loads.
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.
K120715, K091566, K032244, K103533, K021008
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.
K062630, K072355, K090242, K101557
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.
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K140601 Page 1 of 2
| 510(k) Summary | JUL 02 2014 | |
|---|---|---|
| Device Trade Name: | Flow-Nail | |
| Manufacturer: | Flow-FX, LLC | |
| 19110 Darvin Drive | ||
| Mokena, Illinois 60448 | ||
| 708.390.2290 | ||
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | ||
| Washington, DC 20005 | ||
| 202.552.5800 | ||
| Date Prepared: | June 4, 2014 | |
| Common Name: | Intramedullary Fixation Rod | |
| Classification: | 21 CFR 888.3020 | |
| 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 sliding fenestrated lag screw, anti-rotation screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136.
Predicate Devices:
The Flow-Nail was shown to be substantially equivalent to the Zimmer Natural Nail System (K120715 and K091566), Stryker Gamma 3 Nail System (K032244), and AOS Trochanteric Nail (K103533 and K021008). The Flow-Nail is compatible for use with injectable BVFs.
1
Substantial Equivalence:
The table below summarizes the substantial equivalence of the Flow-Nail to predicate devices with respect to its intended use, design, materials, available sizes, mechanical performance, and ability to deliver BVF to a defect site.
| Subject Device | Predicates | |||
|---|---|---|---|---|
| Flow-Nail | Zimmer Natural Nail | Stryker Gamma 3 Nail | ||
| System | AOS Trochanteric | |||
| Nail System | ||||
| (K021008) | ||||
| Intended Use | Intended for temporary fracture fixation and stabilization of the bone. | |||
| Indications | ||||
| for Use | The FlowNail 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. | Indications for the use | |||
| of the Cephalomedullary | ||||
| nails include: |
- Compound and simple
shaft fractures - Proximal, metaphyseal
and distal shaft
fractures - Segmental fractures
- Comminuted fractures
- Fractures involving
osteopenic and
osteoporotic bone - Pathological fractures
- Fractures with bone
loss - Pseudoarthrosis, non-
union, mal-union and
delayed union - Periprosthetic fractures
- Surgically created
defects such as
osteotomies - Intertrochanteric and
subtrochanteric
fractures | The intended use of the
subject Trochanteric
Gamma 3 Nail is identical
to that of the predicate
Trochanteric Dyax and
Gamma Nails. The
product is intended for use
in stabilizing various types
of intertrochanteric
fractures of the femur. | The AOS Trochanteric
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. |
| Components | IM Nail; Lag Screw | IM Nail; Lag Screw | IM Nail; Lag Screw | IM Nail; Lag Screw |
| Materials | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Nail Sizes | Within predicate
range | A range of sizes to
accommodate various
patient anatomies | A range of sizes to
accommodate various
patient anatomies | A range of sizes to
accommodate
various patient
anatomies |
| Lag Screw
Sizes | Within predicate
range | A range of lengths to
accommodate various
patient anatomies | A range of lengths to
accommodate various
patient anatomies | A range of lengths to
accommodate
various patient
anatomies |
| Mechanical
Performance | Mechanical testing demonstrates the substantial equivalence of the Flow-Nail relative to the
identified predicates when subjected to static and dynamic compression bending loads. | | | |
| BVF
Delivery | Yes | No | No | No |
| BVF
Delivery
System | The qualification testing (i.e., Injectability Testing, Experimental Void Fill Imaging Studies,
Static Extraction Torque, BVF Property characterization), was performed with ETEX Beta-bsm
and CarriGen (K062630, K072355, K090242, K101557). | | | |
2
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is centered and appears to be the title or heading of a document or organization. The font is simple and clear, making the text easily readable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2014
Flow-FX. LLC % Ms. Michelle McDonough Senior Associate, Regulatory and Clinical Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K140601
Trade/Device Name: Flow-Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 4, 2014 Received: June 5, 2014
Dear Ms. McDonough:
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
3
Page 2 - Ms. Michelle McDonough
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Laurence D. Coyne -A
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use
K140601 510(k) Number (if known):
Device Name: Flow-Nail
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
in the color control contrôlean comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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