(122 days)
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.
GEISTER vessel dilators
This is a 510(k) premarket notification for a medical device (GEISTER Vessel Dilators), not a study report for an AI/ML device. Therefore, the document does not contain information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth types related to an AI/ML study.
The document is an FDA letter stating that the GEISTER Vessel Dilators are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. It outlines the regulatory classification, product code, and indications for use of the device.
To directly answer your request based on the provided document:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This document does not contain information relevant to an AI/ML device study. It is a 510(k) clearance letter for a Class II surgical vessel dilator and discusses substantial equivalence to predicate devices, not performance against specific acceptance criteria in a study format typically associated with AI/ML.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable for this type of document.
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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:
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
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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
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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.
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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
§ 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).