(122 days)
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No
The provided text describes a mechanical device (I.V. catheter) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
Explanation: The device is an I.V. catheter, which is used for vascular access, and while it's a medical device, its primary function as described (access to the vascular system; aids in prevention of needlestick injuries) is not to treat or alleviate a disease or condition, which is the definition of a therapeutic device. It's a tool for delivering therapies rather than being a therapy itself.
No
Explanation: The device is an I.V. Catheter intended for vascular access to "provide safe and reliable access to the vascular system for short term use". It is not used for diagnosing medical conditions.
No
The device description and intended use clearly describe a physical medical device (I.V. Catheter) and do not mention any software component.
Based on the provided information, the VanishPoint® I.V. Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for providing access to the vascular system for short-term use. This is a direct interaction with the patient's body for therapeutic or diagnostic access, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of substances, or providing information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The VanishPoint® I.V. Catheter is a device used on the patient for direct access to their circulatory system.
N/A
Intended Use / Indications for Use
The intended use of the VanishPoint® I.V. Catheter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint® I.V. Catheter aids in the prevention of needlestick injuries.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.
Public Health Service
SEP 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Michele M. Larios VP & General Counsel Retractable Technologies, Incorporated P.O. Box 9, 511 Lobo Lane Little Elm, Texas 75068-0009
Re: K051355
Trade/Device Name: Vanishpoint I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: II Product Code: FOZ Dated: August 10, 2005 Received: August 11, 2005
Dear Ms. Larios:
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.
1
Page 2 - Mr. Larios
Please be advised that FDA's issuance of a substantial equivalence determination does not r read that FDA has made a determination that your device complies with other requirements friedit that I Driving made statutes and regulations administered by other Federal agencies. or not rest of able 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 und illums (2) - ee it forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirelies as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 OF IC Food 1000. This letter 'ntification. The FDA finding of substantial equivalence of your device to a premarket notification of the 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), 11 you donto the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Clive
Shi, Jian, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of device evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VanishPoint® I.V. Catheter
Indications for Use:
The intended use of the VanishPoint® I.V. Catheter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint® I.V. Catheter aids in the prevention of needlestick injuries.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
15-
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Anton Dental Devices
510(k) Number: Jos 1355