(98 days)
Not Found
No
The summary describes a mechanical bone screw system and its associated surgical tools. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are bench tests of mechanical properties.
No.
The device is used for surgical fixation of bones and not for therapeutic purposes like treating a disease or condition.
No
The device description states it is used for "surgical fixation of small bones, bone fragments, and osteotomies" and "implantation is facilitated by use of accessories." This indicates a treatment or surgical device, not a diagnostic one.
No
The device description explicitly states it is a system of stainless steel compression bone screws and associated hardware (K-wire, drill, driver) contained in sterile kits. This 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 "surgical fixation of small bones, bone fragments, and osteotomies." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "stainless steel compression bone screw" used for implantation. This is a surgical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The description of the ExsoMed ArcPhix and ArrowPhix does not involve any such testing of specimens.
The device is clearly intended for surgical intervention and is classified as a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ExsoMed ArcPhix and ArrowPhix are indicated for use in the surgical fixation of small bones, bone fragments, and osteotomies. The devices are not indicated for soft tissue fixation.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Exsomed Small Screw system are stainless steel compression bone screws contained in sterile procedure kits.
The ArcPhix screws are offered in two lengths, 28mm or 36mm by 3.2mm with an 18-degree bend.
The ArrowPhix is a straight screw 26mm by 2.5mm.
Implantation is facilitated by use of accessories provided in a sterile kit:
• Implant
• K-wire used as a guide
Drill to prepare the bones to receive the implant Hexalobe driver for insertion of the bone screw
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones, bone fragments, and osteotomies
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)
Bench testing studies were conducted to demonstrate the performance of the subject 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)
Engineering analysis has been conducted demonstrating that the subject devices outperform the SBI Autofix screws in torsional and bending strength. Additionally, endotoxin testing has been completed on the subject device. The results from these evaluations demonstrated that the ArcPhix and ArrowPhix perform in a substantially equivalent manner 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.
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
§ 888.3040 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ExsoMed Holding Company, LLC Richard L. Kovach Chief Executive Officer 7227 N. 16th Street. Suite 245 Phoenix, Arizona 85020
August 18, 2017
Re: K171407
Trade/Device Name: ExsoMed ArcPhix and ExsoMed ArrowPhix Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: July 25, 2017 Received: July 25, 2017
Dear Richard 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 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 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) K171407
Device Name
ExsoMed ArcPhix and ExsoMed ArrowPhix
Indications for Use (Describe)
ExsoMed ArcPhix and ArrowPhix are indicated for use in the surgical fixation of small bones, bone fragments, and osteotomies. The devices are not indicated for soft tissue fixation.
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™ SMALL BONE SCREW SYSTEM |
|---|---|
| OWNER/SUBMITTER | |
| INFORMATION | ExsoMed Holding Company, LLC |
| 7227 N. 16th Street, Suite 245 | |
| Phoenix, Arizona 85020 | |
| DATE OF | |
| PREPARATION | May 12, 2017 |
| CONTACT | Richard L. Kovach |
| Chief Executive Officer | |
| Tel: (602) 466-3186 | |
| Email: rkovach@ExsoMed.com | |
| DEVICE NAME AND | |
| CLASSIFICATION | Trade Name: ExsoMed ArcPhix and ExsoMed |
| ArrowPhix | |
| Common Name: Screw, Fixation, Bone | |
| Classification: 21 CFR 888.3040, II | |
| Product Code: HWC | |
| INTENDED USE | The ArcPhix and ArrowPhix are intended for |
| permanent fixation of small bones and small bone | |
| joints. | |
| INDICATIONS FOR | |
| USE | ExsoMed ArcPhix and ArrowPhix are indicated for |
| use in the surgical fixation of small bones, bone | |
| fragments, and osteotomies. The devices are not | |
| indicated for soft tissue fixation. | |
| DEVICE | |
| DESCRIPTION | The Exsomed Small Screw system are stainless |
| steel compression bone screws contained in sterile | |
| procedure kits. | |
| The ArcPhix screws are offered in two lengths, | |
| 28mm or 36mm by 3.2mm with an 18-degree bend. | |
| The ArrowPhix is a straight screw 26mm by 2.5mm. | |
| Implantation is facilitated by use of accessories | |
| provided in a sterile kit: | |
| • Implant | |
| • K-wire used as a guide | |
| Drill to prepare the bones to receive the implant Hexalobe driver for insertion of the bone screw | |
| PREDICATE | |
| DEVICE(S) | Primary Predicate: |
| Name of Device: SBI AutoFix system | |
| Manufacturer: Small Bone Innovations | |
| International S.A. | |
| K Number: K052576 | |
| Approval Date: 11/07/2005 | |
| PREDICATE | |
| PRINCIPALS OF | |
| OPERATION | Small bone screws, delivered in a sterile kit |
| including implantation instrumentation | |
| COMPARISON OF | |
| TECHNOLOGICAL | |
| CHARACTERISTICS | The ExsoMed Small Screws have the same intended use as the predicate device. are manufactured from the same materials as the predicate devices. range of sizes of the subject screws are is similar to the predicate device. Both the subject devices and the predicates are inserted into bone with the assistance of the driver for compression of the fracture and stabilization of the bone. |
| NON-CLINICAL | |
| PERFORMANCE | |
| TESTING | Bench testing studies were conducted to demonstrate the performance of the subject 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) Engineering analysis has been conducted demonstrating that the subject devices outperform the SBI Autofix screws in torsional and bending strength. |
| CONCLUSION | Additionally, endotoxin testing has been completed on the subject device. |
| The results from these evaluations demonstrated that the ArcPhix and ArrowPhix perform in a substantially equivalent manner to the predicate device. | |
| The Exsomed Small Bone screws and the predicate devices have the same technological characteristics, method of use, and materials. | |
| The performance testing, engineering analysis and comparison of technological characteristics of the predicate and the subject devices demonstrate the subject devices are substantially equivalent. |
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