(84 days)
No
The device description and performance studies focus solely on the mechanical properties and design of bone plates and screws. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
This device is a therapeutic device because it is an implantable system designed to repair fractures and fusions of the hand and wrist, which directly treats a medical condition.
No
The device is a metallic implant system designed for the repair of fractures and fusions in the hand and wrist, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a set of implantable metallic bone plates and screws, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "repair of fractures and fusions of the hand and wrist." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "implantable metallic bone plates, locking and non-locking screws." These are physical implants used to stabilize bones.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The Exsomed Wrist Plating System is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Exsomed Wrist Plating System is intended for the repair of fractures and fusions of the hand and wrist.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Exsomed Wrist Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of straight tubular plates of varying lengths as well as a 4-hole carpal fusion plate. Screws are provided for plate fixation in locking and non-locking versions and in Ø2.5 and Ø3.2mm diameters. All of the Implants are made from Titanium Alloy (Ti-6AL-4VELI) per ASTM F136 and are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and wrist
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 per ASTM F382-17 Annex 1 was performed on the Exsomed Wrist Plating System straight plate and the Synthes predicate device. This showed that the Exsomed Wrist Plating System had a higher bending strength and bending stiffness than the predicate device.
Mechanical testing of the Exsomed screws' ultimate torsional strength and insertion and removal torque was performed. The results were compared and demonstrated that the screws did not introduce new issues of safety or effectiveness with respect to insertion and removal torque. Engineering analysis of torsional strength, bending strength and resistance to pullout was conducted on the Exsomed screws and predicate device screws. The results demonstrated that the Exsomed screws do not introduce a new worst case with respect to bending stress, torsional stress and resistance to axial pullout when compared to the predicate devices.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
December 3, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Exsomed Corporation Michael Zwolinski Senior Engineering Designer 135 Columbia, Suite 201 Aliso Viejo, California 92656
Re: K192473
Trade/Device Name: Exsomed Wrist Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 9, 2019 Received: September 10, 2019
Dear Michael Zwolinski:
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.
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
1
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 (OS) 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 mediation-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,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K192473
Device Name Exsomed Wrist Plating System
Indications for Use (Describe)
The Exsomed Wrist Plating System is intended for the repair of fractures and fusions of the hand and wrist.
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
Submitter Information
| Submitters Name:
Address: | Exsomed Corporation
135 Columbia, Suite 201
Aliso Viejo, California 92656 |
|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Prepared By:
Contact Person:
Date Prepared:
Device Information | 855.397.6633
949.240.6633
Michael Zwolinski,
Michael Zwolinski
8/8/19 |
| Trade Name: | Wrist Plating System |
| Common Name: | Fixation Plate |
| Classification Name: | Plate,Fixation,Bone |
| Device Classification: | Single/multiple component metallic bone fixation appliances and
Accessories.
Class II per 21 CFR 888.3030
Panel: Orthopedic, |
| Product Code: | HRS,HWC |
| Material Composition: | Titanium Alloy (Ti-6AL-4VELI) |
| Device Description: | The Exsomed Wrist Plating System is a set of implantable metallic
(Titanium Alloy) bone plates, locking and non-locking screws of various
lengths. The system consists of a series of straight tubular plates of
varying lengths as well as a 4-hole carpal fusion plate. Screws are
provided for plate fixation in locking and non-locking versions and in
Ø2.5 and Ø3.2mm diameters. All of the Implants are made from
Titanium Alloy (Ti-6AL-4VELI) per ASTM F136 and are provided non-
sterile. |
| Predicate Devices: | The primary predicate device is the existing Synthes Modular Hand System
cleared under 510(k) K030310. Additional predicates include the BIOMET
ALPS Hand Fracture System (K081546) and reference device Exsomed
Innate (K171558). |
| Indications for Use: | The Exsomed Wrist Plating System is intended for the repair of fractures
and fusions of the hand and wrist. |
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| Technological Characteristics: | The Exsomed Wrist Plating System has been compared to the previously
cleared predicate devices in regards to indications for use, materials,
and sizes. The Exsomed Wrist Plating system offers plates in similar
lengths, widths, and thicknesses as the predicate devices as well as
locking and non-locking screws in similar diameters and lengths as the
predicate devices. All the Implants in the wrist plating system are
manufactured from the same titanium alloy as the Biomet ALPS
Predicate (K081546). The Exsomed Wrist Plating System is different
from the predicates because the straight plates have a slightly different
overall shape than those of the predicate and because The Exsomed
system also includes a contoured carpal fusion plate that has transverse
screw holes to secure the plate and perform joint arthrodesis. These
comparisons demonstrate substantial equivalence to the predicate
devices. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Analysis: | Mechanical testing per ASTM F382-17 Annex 1 was performed on the
Exsomed Wrist Plating System straight plate and the Synthes predicate
device. This showed that the Exsomed Wrist Plating System had a
higher bending strength and bending stiffness than the predicate
device.
Mechanical testing of the Exsomed screws' ultimate torsional strength |
and insertion and removal torque was performed. The results were compared and demonstrated that the screws did not introduce new issues of safety or effectiveness with respect to insertion and removal torque. Engineering analysis of torsional strength, bending strength and resistance to pullout was conducted on the Exsomed screws and predicate device screws. The results demonstrated that the Exsomed screws do not introduce a new worst case with respect to bending stress, torsional stress and resistance to axial pullout when compared to the predicate devices.
- Conclusion: Based upon comparisons against the predicate devices, Exsomed concludes that the Wrist Plating System is substantially equivalent to the previously cleared predicate devices.