(90 days)
Not Found
Not Found
No
The device description focuses on mechanical features like needle shielding and spring-activated retraction, with no mention of AI, ML, or related concepts.
No.
The device is an introducer catheter designed to facilitate the placement of other medical devices into the vascular system, not to directly treat a medical condition or disease.
No
The device, an introducer catheter, is used to "facilitate the placement of devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system." This indicates a functional role in assisting medical procedures (placement of other devices) rather than diagnosing conditions.
No
The device description explicitly details physical components such as catheters, needles, shielding features, springs, and buttons, indicating it is a hardware device, not software-only.
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 such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system." This describes a device used in vivo (within the body) for a procedural purpose (accessing the vascular system).
- Device Description: The description details a physical device (introducer catheter) used for accessing blood vessels. It does not mention any components or functions related to analyzing samples of human origin in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other bodily fluids for diagnostic purposes. The device's function is purely mechanical and procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
To facilitate the placement of devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.
Product codes (comma separated list FDA assigned to the subject device)
DBY
Device Description
The products identified in this 510(k) notification are splittable, polyethylene introducer catheters. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate springactivated needle-shielding technology. The Autoguard component incorporates a cylindrical needle-shielding barrel, a spring, a needle hub with flash chamber and hydrophobic flow control plug, and a needle. The useractivated Autoguard™ product has a button, which the user pushes to initiate the needle's retraction into the needle-shielding barrel.
The Introsyte introducers are available in sizes ranging from 14 to 24 gauge.
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)
Side-by-side testing of modified and unmodified devices was conducted to compare product attributes. Data have been provided to demonstrate that product performance and biocompatibility are substantially equivalent between the modified and unmodified devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
(a)
Identification. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
BD Medical Systems 9450 South State Street Sari y, Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com
JAN 0 2 2002
Image /page/0/Picture/3 description: The image contains the BD logo, which consists of a stylized sun and human figure inside a circle, followed by the letters 'BD' in bold font. Below the logo, the text 'Indispensable to human health' is printed in a smaller font size. The logo and text are all in black and white.
Premarket Notification [510(k)] Summary of Safety and Effectiveness for BD Introsyte™ Precision Introducer and BD Introsyte™ Autoguard™ Shielded Introducer
Becton Dickinson Infusion Therapy Systems Inc. Submitter: 9450 South State Street Address: Sandy, UT 84070 Leslie Wood, Manager, Regulatory Affairs Contact Person: (801) 565-2504 Telephone Number: (801) 565-2749 FAX Number: September 27, 2001 Date Summary Prepared: BD Introsvte™ Precision Introducer Trade Names: BD Introsyte ™ Autoguard™ Shielded Introducer Introducer Catheter Common Name: Introducer Catheter Classification Name: Same as trade names listed above. Predicate Devices:
Product Descriptions:
The products identified in this 510(k) notification are splittable, polyethylene introducer catheters. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate springactivated needle-shielding technology. The Autoguard component incorporates a cylindrical needle-shielding barrel, a spring, a needle hub with flash chamber and hydrophobic flow control plug, and a needle. The useractivated Autoguard™ product has a button, which the user pushes to initiate the needle's retraction into the needle-shielding barrel.
The Introsyte introducers are available in sizes ranging from 14 to 24 gauge.
1
Intended Use:
An introducer catheter is used to facilitate the placement of devices such as guide wires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.
Technological Characteristics Comparison:
The catheter design and technological characteristics have not changed. The lubrication systems used have been modified to make the manufacturing process 'ozone friendly.'
Nonclinical Tests Support Substantial Equivalence:
Side-by-side testing of modified and unmodified devices was conducted to compare product attributes.
Conclusions from Nonclinical Tests:
Data have been provided to demonstrate that product performance and biocompatibility are substantially equivalent between the modified and unmodified devices.
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 premarket 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 2 2002
Ms. Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Theraphy Systems Inc. 9450 South State Street Sandy, UT 84070
K013304 Re: R01350":
BD Introsyte™ Precision Introducer, BD Introsyte™ Autoguard™ Shielded Introducer Regulation Number: 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DBY Dated: October 3, 2001 Received: October 4, 2001
Dear Ms. Wood:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beener of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use blated in the encreat , 1976, the enactment date of the Medical Device Amendments, or to conimered province 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 inter be back as been a seem 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 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.
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Page 2 - Ms. Leslie Wood
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
K. Oerke Tell
Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
BD Introsyte™ Precision Introducer Device Name: BD Introsyte™ Autoguard™ Shielded Introducer
To facilitate the placement of devices such as guidewires, indwelling central 10 facilitate the placemont of covereed central catheters, and midline catheters into the vascular system.
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use: _ (per 21 CFR 801.109)
OR
Over-The Counter Use: ________________________________________________________________________________________________________________________________________________________
Division of Cardiovascular & Respiratory Devices
510(k) Number K013304
510(k) Lubrication System Indications for Use 8/1/01