(94 days)
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.
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 prepare the medullary cavity • A cannulated hexalobe driver
The provided text is a 510(k) Summary for the ExsoMed ITN Cannulated Screw System, which is a medical device for bone fixation. It does not contain information about an AI/ML-based medical device. Therefore, I cannot address most of the questions regarding acceptance criteria, study design, ground truth, or expert involvement as they pertain to AI/ML models.
However, I can extract the information that is present regarding the non-clinical performance testing for this physical medical device.
Here's a breakdown of what the document does provide:
1. A table of acceptance criteria and the reported device performance
The document states that "Bench testing studies were conducted to demonstrate the equivalence of the new and predicate devices." It lists the tests conducted and then broadly states, "The results from these evaluations demonstrated that the subject screws performed comparably to the predicate device."
It does not provide a specific table with acceptance criteria thresholds (e.g., minimum torque required) and precise numerical results for the ExsoMed ITN Cannulated Screw System. It only mentions that the results were "comparable" to the predicate.
| Acceptance Criteria (Not explicitly stated with numerical values) | Reported Device Performance |
|---|---|
| Torsional Properties Per ASTM F543-13 Annex 1 | Performed comparably to the predicate device. |
| Driving Torque Testing Per ASTM F543-13 Annex 2 | Performed comparably to the predicate device. |
| Pullout per ASTM F543-13 Annex 3 | Performed comparably to the predicate device. |
| Self-Tapping Performance per ASTM F543-13 Annex 4 (SpikeScrew only) | Performed comparably to the predicate device. |
| 4 point bending per ASTM F1264-14 | Performed comparably to the predicate device. |
| Pyrogenicity per Kinetic Chromogenic LAL Assay | Performed comparably to the predicate device. |
Regarding the remaining points, the document pertains to a physical medical device (cannulated screw system) and not an AI/ML diagnostic or predictive tool. Therefore, the following AI/ML-centric questions cannot be answered from the provided text:
- Sample sizes used for the test set and the data provenance: Not applicable to this physical device's non-clinical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical screw's mechanical properties is derived from physical measurements and established ASTM standards, not expert medical opinion on images.
- Adjudication method: Not applicable.
- 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: Not applicable. This is for a physical device, not an AI assistance tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" for performance is based on established engineering standards (ASTM) and physical measurements.
- The sample size for the training set: Not applicable. This device is not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
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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
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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
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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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510(k) Summary
This 510(k) Summary is presented in compliance with 21 CFR 807.92
| DEVICE NAME | EXSOMED™ ITN CANNULATED SCREW SYSTEM |
|---|---|
| OWNER/SUBMITTERINFORMATION | ExsoMed Holding Company, LLC7227 N. 16th Street, Suite 245Phoenix, Arizona 85020 |
| DATE OFPREPARATION | May 25, 2017 |
| CONTACT | Richard L. KovachChief Executive OfficerTel: (602) 466-3186Email: rkovach@ExsoMed.com |
| DEVICE NAME ANDCLASSIFICATION | Trade Name: ExsoMed ITN Cannulated Screw SystemCommon Name: Screw, Fixation, BoneClassification: 21 CFR 888.3040, IIProduct Code: HWC |
| INTENDED USE | The ExsoMed ITN Cannulated Screw System isintended for fixation of intra-articular and extra-articularfractures and non-unions of small bones and smallbone fragments; arthrodesis of small joints;bunionectomies and osteotomies, including scaphoidand other carpal bones, metacarpals, tarsals,metatarsals, patella, ulnar styloid, capitellum, radialhead and radial styloid. |
| DEVICEDESCRIPTION | The ExsoMed ITN Cannulated Screw System is astainless-steel bone screw system designed for bonefixation. The headless design of the screw allows forthe screw to be countersunk below the surface of thebone.The screws are offered in one thread diameter (4.0mmdistal / 4.5mm proximal) and lengths between 35 and75mm.The screws are designed for permanent implantation.Screw implantation is facilitated by the use of threeaccessory devices provided in a separate procedurekit:• 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 |
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| prepare the medullary cavity• A cannulated hexalobe driver | |
|---|---|
| PREDICATEDEVICE(S) | PrimaryPredicate: SYNTHES 3.0MM HEADLESSCOMPRESSION SCREWSCommon Name: Screw, Fixation, BoneManufacturer: SYNTHES (USA)K Number: K050636Clearance Date: 04/21/2005 |
| SecondaryPredicate: ASNIS III CANNULATED SCREWSYSTEMCommon Name: Screw, Fixation, BoneManufacturer: HOWMEDICA OSTEONICS CORP.K Number: K000080Clearance Date: April 3, 2000 | |
| ReferencePredicate: ExsoMed™ SMALL BONE SCREWSYSTEMCommon Name: Screw, Fixation, BoneManufacturer: ExsoMed Holding Company, LLCK Number: K171407Clearance Date: August 18, 2017 | |
| PREDICATEDESCRIPTIONFROM LABELING | The Synthes 3.0 mm Headless Compression Screwsare cannulated and are self-drilling / self-tapping with astardrive mechanism, and have a threaded head whichcan be countersunk into the bone. The screws areavailable in short and long thread lengths ranging from10 mm to 40 mm. The screws are available in StainlessSteel and a Titanium Alloy. |
| The Asnis III Cannulated Screw System consists ofself-tapping cannulated screws and thecorresponding washers. All devices in the system areprovided sterile and non-sterile. The threaddiameters are 4.0, 5.0. 6.5, and 8.0mm. They are eitherfully or partially threaded. All screws areRecords processed under self-drilling and self-tapping.There are washers corresponding to the 4.0mm andthe 5.0mm screws respectively and one washer fittingfor both diameters, 6.5mm and 8.0mm. |
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| COMPARISON OFTECHNOLOGICALCHARACTERISTICS | The ExsoMed ITN Cannulated Screw SystemHas the same intended use as the predicateOdevices.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 isOsimilar to the predicate devices.Both the subject devices and the predicates areOinserted into bone with the assistance of thedriver bone fixation. |
|---|---|
| NON-CLINICALPERFORMANCETESTING | Bench testing studies were conducted to demonstratethe equivalence of the new and predicate devices. Thefollowing tests were conducted:Torsional Properties Per ASTM F543-13 Annex01Driving Torque Testing Per ASTM F543-13OAnnex 2Pullout per ASTM F543-13 Annex 3OSelf-Tapping Performance per ASTM F543-130Annex 4 (SpikeScrew only)4 point bending per ASTM F1264-14●Pyrogenicity per Kinetic Chromogenic LAL●AssayThe results from these evaluations demonstrated thatthe subject screws performed comparably to thepredicate device. |
| CONCLUSION | The subject, Exsomed ITN Cannulated Screw System,and the predicate device have the same technologicalcharacteristics, method of use, and materials.The performance testing completed and comparison oftechnological characteristics of the predicates and thesubject device demonstrate the subject devices aresubstantially equivalent. |
§ 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.