(122 days)
Not Found
Not Found
No
The summary describes a mechanical device (vessel dilators) and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development and validation.
Yes
The device is used to enlarge or calibrate vessels during medical procedures and performs "various maneuvers of dilation," which are therapeutic actions.
No
The device is used to enlarge, calibrate, locate, trace, and measure, which are interventional or measurement functions, not primarily diagnostic ones for identifying a disease or condition. While it "locates orifices" or "traces abnormal vessels," this seems to be part of guiding a procedure rather than making a diagnosis.
No
The device description explicitly states "GEISTER vessel dilators," which are physical instruments used in surgical procedures. There is no mention of software as the primary component or function of the device.
Based on the provided information, the GEISTER vessel dilators are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes a device used during surgical procedures (coronary artery bypass, angioplasty) to physically manipulate vessels. This is an in vivo application, meaning it's used within a living organism.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a person's health.
The description clearly indicates a surgical tool used directly on the patient's anatomy, not a device for analyzing biological samples in a lab setting.
N/A
Intended Use / Indications for Use
GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Product codes
DWP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4475 Surgical vessel dilator.
(a)
Identification. A surgical vessel dilator is a device used to enlarge or calibrate a vessel.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes. There is also a small star above the bird.
:
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2003
GEISTER MEDIZINTECHNIK GmbH c/o Mr. Dagmar Maser Business Support International Amstel 320-I Netherlands 1017 AP
Re: K030788
Trade Name: GEISTER Vessel Dilators Regulation Number: 21 CFR 870.4475 Regulation Name: Surgical vessel dilator Regulatory Class: Class II (two) Product Code: DWP Dated: June 20, 2003 Received: June 23, 2003
Dear Mr. Maser:
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 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
1
Page 2 - Mr. Dagmar Maser
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Geister Medizintechnik GmbH
210(K) Interventional Cardiology Devices Branch - HFZ-450
510(k) Number
Device Name
K 030788
Classification/CFR
GEISTER Vessel Dilators
74 DWP / 870.4475
INDICATIONS FOR USE
GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRE, Office of Device Evaluation (ODE)
XQeater
(Division Sign-Off)
Division of Cardiovascular Devices
K030788
510(k) Number K030788
Prescription Use
(Per CFR 801 109)
OR
Over-The-Counter Use __
(Optional Format 1-2-95)
08/11/2003