(94 days)
No
The summary describes a mechanical bone screw system and its associated tools. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are bench tests of mechanical properties.
No
A therapeutic device is one that treats or cures a disease or condition. This device is a bone fixation system that provides mechanical support for bones; it does not treat or cure a disease or condition.
No
The device is a system of screws and accessory tools used for fixation of fractures and non-unions, and for arthrodesis or osteotomies. It is a treatment device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a "stainless-steel bone screw system" and includes physical components like screws, K-wires, a reamer, a depth gauge, and a driver. 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 clearly states that the device is for the fixation of bones and joints within the body. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a bone screw system designed for implantation. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely mechanical support and fixation within the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ExsoMed ITN Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The ExsoMed ITN Cannulated Screw System is a stainless-steel bone screw system designed for bone fixation. The headless design of the screw allows for the screw to be countersunk below the surface of the bone. The screws are offered in one thread diameter (4.0mm distal / 4.5mm proximal) and lengths between 35 and 75mm. The screws are designed for permanent implantation. Screw implantation is facilitated by the use of three accessory devices provided in a separate procedure kit:
• A K-wire to be used as a guide
• A cannulated reamer to be used over the K-wire to create the desired pilot hole
• A depth gauge to determine the appropriate screw length
• A cannulated hexalobe driver
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
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)
Bench testing studies were conducted to demonstrate the equivalence of the new and predicate devices. The following tests were conducted:
Torsional Properties Per ASTM F543-13 Annex 1
Driving Torque Testing Per ASTM F543-13 Annex 2
Pullout per ASTM F543-13 Annex 3
Self-Tapping Performance per ASTM F543-13 Annex 4 (SpikeScrew only)
4 point bending per ASTM F1264-14
Pyrogenicity per Kinetic Chromogenic LAL Assay
The results from these evaluations demonstrated that the subject screws performed comparably to 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.
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
§ 888.3040 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ExsoMed Holdings Company, LLC Mr. Richard Kovach President/CEO 7227 N. 16th Street. Suite 245 Phoenix, Arizona 85020
September 1, 2017
Re: K171558
Trade/Device Name: ExsoMed ITN Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 13, 2017 Received: August 16, 2017
Dear Mr. Kovach:
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 Part 801); medical device reporting (reporting of medical device
1
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 (DICE) 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" (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 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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171558
Device Name ExsoMed ITN Cannulated Screw System
Indications for Use (Describe)
The ExsoMed ITN Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
| 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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3
510(k) Summary
This 510(k) Summary is presented in compliance with 21 CFR 807.92
| DEVICE NAME | EXSOMED™ ITN CANNULATED SCREW SYSTEM |
|---|---|
| OWNER/SUBMITTER | |
| INFORMATION | ExsoMed Holding Company, LLC |
| 7227 N. 16th Street, Suite 245 | |
| Phoenix, Arizona 85020 | |
| DATE OF | |
| PREPARATION | May 25, 2017 |
| CONTACT | Richard L. Kovach |
| Chief Executive Officer | |
| Tel: (602) 466-3186 | |
| Email: rkovach@ExsoMed.com | |
| DEVICE NAME AND | |
| CLASSIFICATION | Trade Name: ExsoMed ITN Cannulated Screw System |
| Common Name: Screw, Fixation, Bone | |
| Classification: 21 CFR 888.3040, II | |
| Product Code: HWC | |
| INTENDED USE | The ExsoMed ITN Cannulated Screw System is |
| intended for fixation of intra-articular and extra-articular | |
| fractures and non-unions of small bones and small | |
| bone fragments; arthrodesis of small joints; | |
| bunionectomies and osteotomies, including scaphoid | |
| and other carpal bones, metacarpals, tarsals, | |
| metatarsals, patella, ulnar styloid, capitellum, radial | |
| head and radial styloid. | |
| DEVICE | |
| DESCRIPTION | The ExsoMed ITN Cannulated Screw System is a |
| stainless-steel bone screw system designed for bone | |
| fixation. The headless design of the screw allows for | |
| the screw to be countersunk below the surface of the | |
| bone. | |
| The screws are offered in one thread diameter (4.0mm | |
| distal / 4.5mm proximal) and lengths between 35 and | |
| 75mm. | |
| The screws are designed for permanent implantation. | |
| Screw implantation is facilitated by the use of three | |
| accessory devices provided in a separate procedure | |
| kit: | |
| • A K-wire to be used as a guide | |
| • A cannulated reamer to be used over the K-wire to create the desired pilot hole | |
| • A depth gauge to determine the appropriate screw length |
4
| | prepare the medullary cavity
• A cannulated hexalobe driver |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PREDICATE
DEVICE(S) | Primary
Predicate: SYNTHES 3.0MM HEADLESS
COMPRESSION SCREWS
Common Name: Screw, Fixation, Bone
Manufacturer: SYNTHES (USA)
K Number: K050636
Clearance Date: 04/21/2005 |
| | Secondary
Predicate: ASNIS III CANNULATED SCREW
SYSTEM
Common Name: Screw, Fixation, Bone
Manufacturer: HOWMEDICA OSTEONICS CORP.
K Number: K000080
Clearance Date: April 3, 2000 |
| | Reference
Predicate: ExsoMed™ SMALL BONE SCREW
SYSTEM
Common Name: Screw, Fixation, Bone
Manufacturer: ExsoMed Holding Company, LLC
K Number: K171407
Clearance Date: August 18, 2017 |
| PREDICATE
DESCRIPTION
FROM LABELING | The Synthes 3.0 mm Headless Compression Screws
are cannulated and are self-drilling / self-tapping with a
stardrive mechanism, and have a threaded head which
can be countersunk into the bone. The screws are
available in short and long thread lengths ranging from
10 mm to 40 mm. The screws are available in Stainless
Steel and a Titanium Alloy. |
| | The Asnis III Cannulated Screw System consists of
self-tapping cannulated screws and the
corresponding washers. All devices in the system are
provided sterile and non-sterile. The thread
diameters are 4.0, 5.0. 6.5, and 8.0mm. They are either
fully or partially threaded. All screws are
Records processed under self-drilling and self-tapping.
There are washers corresponding to the 4.0mm and
the 5.0mm screws respectively and one washer fitting
for both diameters, 6.5mm and 8.0mm. |
5
| COMPARISON OF
TECHNOLOGICAL
CHARACTERISTICS | The ExsoMed ITN Cannulated Screw System
Has the same intended use as the predicate
O
devices.
Has the same indications for use as the
●
predicate devices.
Is manufactured from the same materials as the
●
predicate devices.
The range of sizes of the subject screws are is
O
similar to the predicate devices.
Both the subject devices and the predicates are
O
inserted into bone with the assistance of the
driver bone fixation. |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NON-CLINICAL
PERFORMANCE
TESTING | Bench testing studies were conducted to demonstrate
the equivalence of the new and predicate devices. The
following tests were conducted:
Torsional Properties Per ASTM F543-13 Annex
0
1
Driving Torque Testing Per ASTM F543-13
O
Annex 2
Pullout per ASTM F543-13 Annex 3
O
Self-Tapping Performance per ASTM F543-13
0
Annex 4 (SpikeScrew only)
4 point bending per ASTM F1264-14
●
Pyrogenicity per Kinetic Chromogenic LAL
●
Assay
The results from these evaluations demonstrated that
the subject screws performed comparably to the
predicate device. |
| CONCLUSION | The subject, Exsomed ITN Cannulated Screw System,
and the predicate device have the same technological
characteristics, method of use, and materials.
The performance testing completed and comparison of
technological characteristics of the predicates and the
subject device demonstrate the subject devices are
substantially equivalent. |