(69 days)
Not Found
Not Found
No
The summary describes a physical introducer catheter and does not mention any software, algorithms, or AI/ML related terms.
No
The device is described as an introducer catheter used to facilitate the placement of other devices into the vascular system, not to provide therapy itself.
No
The device is described as an introducer catheter used to facilitate the placement of other medical devices, not to diagnose a condition.
No
The device description explicitly states it is a "catheter," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placement of devices into the vascular system. This is a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is an introducer catheter inserted into the vascular system. This is a medical device used for a procedural purpose.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural – to aid in the insertion of other devices into the body.
N/A
Intended Use / Indications for Use
TO FACILITATE THE PLACEMENT OF DEVICES SUCH AS GUIDEWIRES, INDWELLING CENTRAL VENOUS CATHETERS, PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS, AND MIDLINE CATHETERS INTO THE VASCULAR SYSTEM.
Product codes
FOZ
Device Description
The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
The Becton Dickinson Infusion Therapy Systems INTROSYTE™ brand, INSYTE® brand and SPLIT SECOND® brand introducer catheters and the Teleflex, Inc. Percutaneous Introducer Set.
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).
0
Becton Dickinson Infusion Therapy Systems 9450 South State Street Sandy, Utah 84070 FEB 2 6 1998 (801) 565-2300 (801) 565-2740 Fax
Image /page/0/Picture/2 description: The image shows the words "BECTON DICKINSON" stacked on top of each other. The words are written in a bold, sans-serif font. The letters are all capitalized and black. The words are slightly slanted to the right.
SUMMARY OF SAFETY AND EFFICACY
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A. The submitter's name, address, telephone number, contact person, and date of preparation.
Submitted by Becton Dickinson Infusion Therapy Systems Inc., 9450 South State Street, Sandy, UT 84070. Contact: C. J. Welle. Telephone: 801-565-2535. Prepared: December 18, 1997. -
B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.
Name: Introducer Catheter Brand: INTROSYTE™ PRECISION INTRODUCER Common Name: Introducer Catheter Classification Name: Intravascular Catheter (80 FOZ) -
C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:
Predicate Device: The Becton Dickinson Infusion Therapy Systems INTROSYTE™ brand, INSYTE® brand and SPLIT SECOND® brand introducer catheters and the Teleflex, Inc. Percutaneous Introducer Set. -
D. A description of the device that is the subject of the Premarket Notification submission.
The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle. -
E. Statement of intended use of the device.
The intended use is to facilitate the placement of other devices such as guidewires, central venous catheters, peripherally inserted central venous catheters, and midline catheters in the vascular system. -
F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above.
002 . .. .. . .
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The proposed catheter differs from the INSYTE® brand introducer catheter in that it is splittable; however, the intended use is the same. It is similar to the INTROSYTE™ brand introducer, the SPLIT SECOND® brand introducer catheter and the Teleflex, Inc. Percutaneous Introducer Set in that all are splittable and all are introducer catheters.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
003 . NU
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 1998
Mr. C.J. Welle Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070
K974764 Re : INTROSYTE™ Catheter Trade Name: Regulatory Class: II FOZ Product Code: December 18, 1997 Dated: Received: December 19, 1997
Dear Mr. Welle:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood 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. ਖ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Welle
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,
Timothy A. Ulatowski
Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CELEBRATING THE FIRST ONE HUNDRED: 1897-1997
Becton Dickinson Infusion Therapy Systems 9450 South State Street Saiidy, Utab 84070-3234 Talephone: (801) 565-2300 Fax: (801) 565-2740
December 18, 1997
INDICATIONS FOR USE
510(k) Number: K 9 74 7 64
Device Name: INTROSYTE™ Catheters
Indications for Use: TO FACILITATE THE PLACEMENT OF DEVICES SUCH AS GUIDEWIRES, INDWELLING CENTRAL VENOUS CATHETERS, PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS, AND MIDLINE CATHETERS INTO THE VASCULAR SYSTEM.
Patriosa Cusenite
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Dental, Infection Cor ntrol, and General Hospital Device 5 1 Olk) Namissiption Use: OR
(Per 21 CFR 801.109)
Over-The -Counter Use:
001
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