(88 days)
Not Found
No
The summary describes a guide wire, a mechanical device used in interventional procedures. There is no mention of software, algorithms, or any technology related to AI or ML. The comparison to predicate devices is based on materials, construction, and performance testing, not computational capabilities.
No
Justification: The device (guide wire) is intended to facilitate the placement and exchange of therapeutic devices, but it is not itself performing a therapeutic function. It is an accessory device in a therapeutic procedure.
No
The device is a guide wire used to facilitate the placement and exchange of other therapeutic devices, not to diagnose a condition.
No
The device description clearly states it is a "Guide Wire," which is a physical, hardware medical device used in interventional procedures. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SCIMED Luge Guide Wire is used to "facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures." This describes a device used within the body for a therapeutic procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description focuses on the physical construction and materials of a guide wire, which is a medical device used in interventional procedures.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Based on the provided information, the SCIMED Luge Guide Wire is a medical device used in interventional cardiology procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
Product codes
DQX
Device Description
The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The Luge Guide Wire is considered to be substantially equivalent to the currently marketed ChoICE, Sceptor and ChoICE PT Families of Guide Wires based on a comparison of the intended uses and designs and results of the testing and evaluations performed.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows a series of handwritten characters, possibly a word or a code. The characters are dark and bold against a light background, making them stand out. The handwriting appears somewhat stylized, with unique shapes and connections between the characters. It is difficult to determine the exact meaning or language of the characters without further context.
510(k) Notification SCIMED® Luge™ Guide Wire
| Summary of Safety and Effectiveness, cont. | Section 4 | |
|---|---|---|
| JAN 12 1998 | ||
| Intended Use | The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only. | |
| Summary of | ||
| Technological | ||
| Characteristics | The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires). | |
| Non-Clinical Test | ||
| Summary | The Luge Guide Wire is considered to be substantially equivalent to the currently marketed ChoICE, Sceptor and ChoICE PT Families of Guide Wires based on a comparison of the intended uses and designs and results of the testing and evaluations performed. |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
Image /page/1/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 top half of the circle. The bottom half of the circle contains a stylized symbol of three human profiles facing right, stacked on top of each other, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1998
Ms. Jill Townsend Regulatory Affairs Associate SCIMED Life Systems, Inc. One Scimed Place Maple Grove, MN 55311-1566
Re : K973945 SCIMED® Luge™ Guide Wire Requlatory Class: II (two) Product Code: DQX October 15, 1997 Dated: Received: October 16, 1997
Dear Ms. Townsend:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
2
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page_1___ of __ 1__
K973926
n/a
510(k) Number (if known):
Dental Implant Endosseous Device Name:
Indications For Use:
"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ewald Shipp
(Division Sian-Off and Ga 510k) Nu
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)