(57 days)
No
The description focuses on the mechanical components and materials of a bone fixation system, with no mention of AI or ML. The performance studies are based on finite element analysis, not data-driven AI/ML methods.
No.
The device is described as an implant system (plates, screws, and instruments) for internal bone alignment and fixation of fractures, which is a structural support and fixation device rather than one that delivers a therapeutic effect.
No
The device is an implant system for surgical fixation of fractures, not a device used for diagnosis.
No
The device description explicitly details physical components such as plates, screws, and instruments, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones." This describes a surgical implant used to stabilize bone, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details plates, screws, and instruments used for "internal bone alignment and fixation of fractures." This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the Emerge Medical Distal Radius Set is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones.
Product codes
HRS
Device Description
The Emerge Medical Distal Radius Set will include 6 and 9 locking hole head variations with pairs of locking and non-locking holes in the shafts to be used with a variety and screws to be FDA cleared and offered as a system of implants to be used for internal bone alignment and fixation of fractures of the radius. The system features plates with six and nine hole head variations with three and five hole shafts, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F139-12).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius and other small bones.
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)
Static and Dynamic Bending of the Emerge Medical Distal Radius Set were evaluated via finite element analysis (FEA) demonstrating the predicate device was the worst case scenario. The results of this non-clinical testing show that the strength of the Emerge Medical Distal Radius Set is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3030 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
K140107 page 1 of 2
| Table 5-1 Summary Table | |
|---|---|
| Submitter: | Emerge Medical |
| Submitter's Name: | Michelle Potvin, Vice President of Quality Assurance |
| michelle.potvin@emergemedical.com | |
| Submitter's Address: | 720 S. Colorado Blvd. |
| Suite 550-S | |
| Denver, CO 80246 | |
| Submitter's Telephone: | 720.459.6392 |
| Submitter's Fax: | (800) 698.1440 |
| Contact Person: | Meredith L. May, MS, RAC |
| 719.337.7579 | |
| MMay@EmpiricalTesting.com | |
| Date Summary was Prepared: | 15 January 2014 |
| Trade or Proprietary Name: | Emerge Medical Distal Radius Set |
| Common or Usual Name: | Single/multiple component metallic bone fixation appliances |
| and accessories (§888.3030) | |
| Classification: | Class II per 21 CFR §888.3030 |
| Product Code: | HRS |
| Classification Panel: | Division of Orthopedic Devices |
5.510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Emerge Medical Distal Radius Set will include 6 and 9 locking hole head variations with pairs of locking and non-locking holes in the shafts to be used with a variety and screws to be FDA cleared and offered as a system of implants to be used for internal bone alignment and fixation of fractures of the radius. The system features plates with six and nine hole head variations with three and five hole shafts, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F139-12).
TECHNOLOGICAL CHARACTERISTICS
The Emerge Medical Distal Radius Set has the same or similar design, sizes, indications for use, and materials as the predicate systems. The sizes differ slightly, but present no new risks.
INDICATIONS FOR USE
The Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones.
The Emerge Medical Distal Radius Set is not intended for use with active or latent infection, osteoporosis, insufficient quantity or quality of bone/soft tissue, material sensitivity (if suspected tests should be performed prior to implantation), sepsis, patients who are unwilling or incapable
1
of following postoperative care instructions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The indication for use for the Emerge Medical Distal Radius Set is similar to that of the predicate devices listed in Table 5-2.
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K091644 | 2.4mm LCP Volar Column Distal Radius | |
| Plates | Synthes | |
| K012114 | Locking Distal Radius Plating System | Synthes |
Table 5-2 Predicate Devices
PERFORMANCE DATA
Static and Dynamic Bending of the Emerge Medical Distal Radius Set were evaluated via finite element analysis (FEA) demonstrating the predicate device was the worst case scenario. The results of this non-clinical testing show that the strength of the Emerge Medical Distal Radius Set is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Emerge Medical Distal Radius Set is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2014
Emerge Medical, Inc. % Ms. Meredith May MS, RAC Senior Manager Empirical Consulting 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K140107
Trade/Device Name: Emerge Medical Distal Radius Set Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: January 15, 2014 Received: January 15, 2014
Dear Ms. May:
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
3
Page 2 - Ms. Meredith May
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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.hum.
Sincerely yours,
Lori A. Wiggins
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 STATEMENT
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Expiration Date: December 31, 2013 |
| See PRA Statement on last page. |
| 510(k) Number (if known) | K140107 |
|---|---|
| Device Name | Emerge Medical Distal Radius Set |
| Indications for Use (Describe) | The Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones. |
| 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
| Elizabeth L.Frank -S |
|---|
| Division of Orthopedic Devices |
| FORM FDA 3881 (9/13) | PSC Publishing Services (301) 443-8740 EF |
|---|---|
| ---------------------- | ------------------------------------------- |
Emerge Medical Distal Radius Set
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