(15 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or any related concepts like image processing or deep learning. The description focuses on a mechanical targeting system.
No.
The device is indicated for locating screw holes in IM nails to guide drilling, which is a surgical aid and not a direct therapeutic intervention. It assists in a procedural step rather than treating a disease or condition itself.
No
The device is indicated for use in locating screw holes in an intramedullary nail to guide a drill, which is a surgical guidance or assistive function, not a diagnostic one.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the Vector Targeting System includes hardware components in addition to any potential software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to locate screw holes in an intramedullary nail during surgery to guide a drill. This is a surgical guidance and targeting system used in vivo (within the body).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information about a person's health. This device does not involve the analysis of such specimens.
The device's function is entirely focused on assisting a surgical procedure directly on the patient's body.
N/A
Intended Use / Indications for Use
The Vector Medical, Inc. Vector Targeting System is indicated for use in locating (targeting) screw holes in an intramedullary (IM) nail in order to quickly and accurately guide the drill into the exact position to locate and drill the screw holes. The technique does not require the use of radiographic equipment.
Generally these nails are indicated for use in fractures in long bones such as the tibia or humerus, which require longitudinal stabilization.
Product codes
HSB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones such as the tibia or humerus.
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)
Not Found
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.
Not Found
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three heads, facing to the right. The eagle is composed of thick, curved lines that suggest feathers and movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2002
Ms. Erin McGurk Regulatory Affairs Representative Vector Medical, Inc. 1886 Lodgepole Drive Milton, Florida 32583
Re: K022225
Trade/Device Name: Vector Medical, Inc., Vector Targeting System Regulation Number: 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: July 7, 2002 Received: July 10, 2002
Dear Ms. McGurk:
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. Iisting 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 such 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); 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.
1
Page 2 – Ms. Erin McGurk
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Hypt Rhode
M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Applicant: | Vector Medical Inc. |
|---|---|
| 510(k) Number (if known): | K022225 |
| Device Name: | Vector Targeting System |
| Indications For Use: |
INDICATIONS:
The Vector Medical, Inc. Vector Targeting System is indicated for use in locating (targeting) screw holes in an intramedullary (IM) nail in order to quickly and 200 urately guide the drill into the exact position to locate and drill the screw holes. The toganique / 300 / H80 9 / พุ does not require the use of radiographic equipment.
Generally these nails are indicated for use in fractures in long bones such as the tibia or humerus, which require longitudinal stabilization.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Stupts Rlurls
Division Sign-Off) ivision of General, Restorative and Neurological Devices
510(k) Number KD22225