(141 days)
Not Found
No
The description focuses on the mechanical safety features of the catheter and does not mention any AI or ML components.
No.
The device is described as a short-term intravascular catheter used for sampling blood and administering fluids or medication, and it primarily functions as a safety device to prevent needle sticks. It does not actively treat a disease or condition.
No
The device is described as allowing the sampling of blood and administration of fluids or medication, and features a needle-shielding mechanism for safety. It does not mention diagnosing a condition or disease.
No
The device description clearly states it is a physical intravascular catheter with a needle-shielding mechanism, manufactured with conventional medical grade materials. It is a hardware device.
Based on the provided information, the VantageCath™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "sample blood and administer fluids or medication intravenously." This describes a device used for direct patient intervention (accessing the bloodstream) and delivering substances, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description focuses on its function as an intravascular catheter with a safety feature for needle sticks. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any other elements typically associated with IVD devices used for testing biological specimens.
In summary, the VantageCath™ is a medical device used for accessing the vascular system for therapeutic and diagnostic (blood sampling) purposes in vivo, not for performing tests on samples in vitro.
N/A
Intended Use / Indications for Use
The VantageCath™ is an intravascular catheter that allows the health care practitioner to sample blood and administer fluids or medication intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused, and the duration of therapy. The VantageCath™ catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle- shielding barrel, the catheter hub and needle assembly components are automatically separated.
Product codes
FOZ
Device Description
The VantageCath™ is a short-term intravascular catheter that includes a needle-shielding feature. After threading the catheter into the vein, the sharps safety feature is activated and the needle is retracted into the cylindrical needle shield. The catheter hub and needle assembly components are automatically separated. It is manufactured with conventional medical grade, biocompatible materials. It operates as a safety device by providing a sharps safety feature, thus minimizing the opportunity for accidental needle sticks. It is supplied sterile for single use only.
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
any patient population
Intended User / Care Setting
health care practitioner
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)
Standard biocompatibility tests were performed on the VantageCath™ to establish device safety. The tests and assays performed are typically performed for these medical devices. All tests were performed in accordance with US FDA General Program Memorandum #G95-1 and Part- 10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by Edwards Lifesciences LLC Quality Laboratory. The studies indicate that the VantageCath™ is biocompatible and safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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K073471/
APR 30 2008
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ADVANTAGE MEDICAL DEVICES Today's Innovation for Tomorrow's Healthcare Advantage
510(k) SUMMARY
| Submitted by: | Gaylene Fisch
Advantage Medical Devices
740 Lomas SantaFe Drive, Suite 210
Solana Beach, CA 92075
858-436-8543 (phone)
848-436-8545 (fax)
E-mail: gaylene@advmeddevices.com |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Smith, Ph.D., RAC
Bentley Biomedical Consulting, LLC
28241 Crown Valley Parkway, Suite 510
Laguna Niguel, CA 92677
949-340-7261 (phone)
949-340-7141 (fax)
E-mail: jrsmith@bentleybiomed.com |
| Date Prepared: | November 26, 2007 |
| Device Trade Name: | VantageCath™ |
| Device Common Name: | Intravascular Catheter |
| Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than
30 days |
| Device Class: | II |
| Procode: | FOZ |
| CFR Reference: | 880.5200 |
| Predicate Device: | BD Nexiva™ Closed IV Catheter System
BD Insyte™ Autoguard Intravascular Catheter |
| Predicate 510(k) #: | K032843 (BD Nexiva)/K971339 (BD Insyte Autoguard) |
| Device Description: | The VantageCath™ is a short-term intravascular catheter that includes a needle-shielding feature. After threading the catheter into the vein, the sharps safety feature is activated and the needle is retracted into the cylindrical needle shield. The catheter hub and needle assembly components are automatically separated.
It is manufactured with conventional medical grade, biocompatible materials. It operates as a safety device by providing a sharps safety feature, thus minimizing the opportunity for accidental needle sticks.
It is supplied sterile for single use only. |
Corporate Office
711 S. Carson St. Suite 4 Carson City, NV 89701 775-881-3489
Sales Office: 740 LOMAS SANT FE DR., SUITE 210
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ADVANTAGE MEDICAL DEVICES TODAY'S INNOVATION FOR TOMORROW'S HEALTHCARE ADVANTAGE
| Intended Use: | The VantageCath™ is an intravascular catheter that allows the health care practitioner to sample blood and administer fluids or medication intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused, and the duration of therapy. The VantageCath™ catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle- shielding barrel, the catheter hub and needle assembly components are automatically separated. |
|---|---|
| Technology Comparison: | The VantageCath™ is substantially equivalent to the predicate devices. The new device and predicate devices are similar in function, composition, and intended use. |
| Nonclinical Testing: | Standard biocompatibility tests were performed on the VantageCath™ to establish device safety. The tests and assays performed are typically performed for these medical devices. All tests were performed in accordance with US FDA General Program Memorandum #G95-1 and Part- 10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by Edwards Lifesciences LLC Quality Laboratory. The studies indicate that the VantageCath™ is biocompatible and safe for its intended use. |
Conclusion of Comparison: The VantageCath™ is substantially equivalent to the currently-marketed predicate devices.
Corporate Office 711 S. Carson St. Suite 4 Carson City, NV 89701
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advantage Medical Devices C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
APR 3 0 2008
Re: K073471
Trade/Device Name: VantageCathTM Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 15, 2008 Received: April 17, 2008
Dear Mr. Conry:
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 vour 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.
3
Page 2 - Mr. Conry
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.
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 (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.
Saute Y. Michae Oms.
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
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ADVANTAGE MEDICAL DEVICES Today's Innovation for Tomorrow's Healthcare Advantage
INDICATIONS FOR USE
510(k) Number (if known):
VantageCath™ Device Name:
Indications for Use:
The VantageCath™ is a short-term intravascular catheter which allows health care practitioner to sample blood and administer fluids or medication intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused, and the duration of therapy.
The VantageCath™ catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle-shielding barrel, the catheter hub and needle assembly components are automatically separated.
Prescription Use X
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
AND/OR
(21 CFR 807 Subpart C)
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Antun
Coneurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073471
Corporate Office 711 S. Carson St. Suite 4 CARSON CITY, NV 89701 775-881-3489
Sales Office: 740 Lomas Sant FE DR., Suite 210 SOLANA BEACH, CA. 92075 858-436-8543