(160 days)
No
The document describes a mechanical and digital depth gauge and does not mention any AI or ML capabilities.
No.
The device is a measuring tool (depth gauge) used to facilitate the insertion of properly sized screws and implants, not to treat a condition.
No
The device is described as a "depth gauge measuring device" used for "measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants." This is a measurement function, not a diagnostic one. It does not identify a disease, condition, or state of health.
No
The device description explicitly states it is a "depth gauge measuring device" that mechanically measures and displays depth using an analog scale, in addition to a digital readout. This indicates a physical hardware component for measurement.
Based on the provided information, the Eidosmed EDG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Eidosmed EDG Function: The Eidosmed EDG is a depth gauge that measures the depth of a passageway in bone or other tissue within the body during a surgical procedure. It is a mechanical/electronic measuring tool used directly on the patient's tissue.
Therefore, the Eidosmed EDG is a surgical instrument or measuring device used in vivo (within the living body), not an IVD.
N/A
Intended Use / Indications for Use
The Eidosmed EDG is an electronic depth gauge, a measuring device intended for various medical purposes including, but not limited to, measuring the depth of a passageway in a bone or other tissue. The EDG enables the proper sizing of screws and implants in medical procedures.
Product codes
OOL
Device Description
The Eidosmed Electronic Depth Gauge (“EDG”) is a depth gauge measuring device intended for various medical purposes, including but not limited to, measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants. In addition to mechanically measuring and displaying depth using an analog scale, the EDG displays this information using a digital readout. The EDG, referred to as the EDG 4.0 version, is a completely disposable device. It is intended to be used on one patient, over the course of one surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone or other tissue
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)
Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device.
The results for the Gauge R & R testing resulted in a statistically significant value of 2.48% which signifies excellent precision. Additionally, the accuracy of EDG outperformed the accuracy of the analog device (with an alpha = .0005). Because both the EDG and the predicate device have below 10% values for GR&R, it can be concluded that the devices are substantially equivalent
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include a Gauge R & R testing value of 2.48% for precision, and an alpha = .0005 for accuracy.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
EIDOSMED LLC
DEC - 9 2009
EDG Depth Gauge
Page 1 of 2, 510(k) Summary
| Date Prepared | September 30, 2009 |
|---|---|
| Summay prepared by: | John Kim |
| Eidosmed LLC | |
| 2312 Wabansia Unit 1 | |
| Chicago IL 60647 | |
| Phone: (312) 450-5143 (P) | |
| johnkim@eidosmed.com | |
| Applicant | EIDOSMED LLC |
| 2312 Wabansia Unit 1 | |
| Chicago IL 60647 | |
| Phone: (312) 450-5143 | |
| Fax (312) 277-6464 | |
| Device Name | Electronic Depth Gauge |
| Trade Name | EDG |
| Common Name | Depth Gauge |
| Classification | Class: II |
| Product Code: OOL | |
| Regulation: 21 CFR 888.3030 | |
| Identification of | |
| Predicate Devices and | |
| Summary of Substantial | |
| Equivalence | The Electronic Depth Gauge is substantially equivalent with |
| respect to intended use, design, risks, device characteristics and | |
| performance aspects to: | |
| Acromed Interbody Depth Gauges, K873191 Buckman Co., Inc. | |
| Device Description | The Eidosmed Electronic Depth Gauge (“EDG”) is a depth gauge |
| measuring device intended for various medical purposes, including | |
| but not limited to, measuring the depth of a passageway in a bone | |
| or other tissue to enable insertion of properly sized screws and | |
| implants. In addition to mechanically measuring and displaying | |
| depth using an analog scale, the EDG displays this information | |
| using a digital readout. The EDG, referred to as the EDG 4.0 | |
| version, is a completely disposable device. It is intended to be | |
| used on one patient, over the course of one surgical procedure. |
1
EIDOSMED LLC EDG Depth Gauge Page 2 of 2, 510(k) Summary
.
| Intended Use and
Indications | The Eidosmed EDG is a depth gauge measuring device intended for
various medical purposes including but not limited to, measuring
the depth of a passageway in a bone or other tissue to enable
insertion of properly sized screws and implants. |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics and
Substantial Equivalence | The Eidosmed EDG has many similar technological characteristics
and is substantially equivalent to the predicate.
The method of use for the EDG device is exactly the same as the
predicate. Both devices use a hook inserted, in a linear motion,
into the passageway until the indented hook purchases the distal
end of the bone. The user then visually aligns the thumb slide with
the analog scale printed on the outer housing, correlating to the
depth of the bone. Finally, the hook is removed from the
passageway.
The material used in the EDG is also similar to those used in the
predicate. Both devices use medical grade 316 stainless steel for
the probe/hook inserted into the bone or tissue. The Lexan plastic
has been evaluated and found compliant to the most stringent
biocompatibility test standards.
Both the EDG and the predicate device have GR&R values well
below the 10% industry benchmark. |
| Performance
Testing/Data | Tests were performed on the device which demonstrated that the
device is safe and effective, performs comparably to and is
substantially equivalent to the predicate device.
The results for the Gauge R & R testing resulted in a statistically
significant value of 2.48% which signifies excellent precision.
Additionally, the accuracy of EDG outperformed the accuracy of
the analog device (with an alpha = .0005). Because both the EDG
and the predicate device have below 10% values for GR&R, it can
be concluded that the devices are substantially equivalent |
•
.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Eidosmed, LLC % Mr. Daniel Kamm Kamm & Associates 8726 Ferrara Ct. Naples, Florida 34114
DEC 9 2009
Re: K091992 Trade/Device Name: Eidosmed, Model EDG4.0 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: 'OOL Dated: October 31, 2009 Received: November 3, 2009
Dear Mr. Kamm:
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.
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-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.
3
Page 2 – Mr. Daniel Kamm
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Jonitu.z
Image /page/3/Picture/6 description: The image contains a signature that appears to read "Jen". The signature is written in a cursive style with a flourish on the "J" and a connecting stroke between the "e" and "n". The signature is in black ink against a white background.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K09 | 992 Device Name: Electronic Depth Gauge (EDG):
The Eidosmed EDG is an electronic depth gauge, a measuring device intended for various medical purposes including, but not limited to, measuring the depth of a passageway in a bone or other tissue. The EDG enables the proper sizing of screws and implants in medical procedures.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soutin
(Division Sign-Off) for mxm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091992
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