(90 days)
DYB
Not Found
No
The device description and performance studies focus on mechanical features and material properties, with no mention of AI/ML terms or data-driven algorithms.
No.
The device, a catheter introducer, is used to facilitate placing a catheter, not for treating a disease or condition itself.
No
Explanation: The device is described as a catheter introducer, which is used to facilitate placing a catheter. Its purpose is to aid in a medical procedure, not to diagnose a condition. The provided information does not mention any diagnostic capabilities.
No
The device description explicitly states the product is a "splittable, polyethylene catheter introducer" and mentions "spring-activated needle-shielding technology," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "sheath used to facilitate placing a catheter through the skin into a vein or artery." This describes a device used for a medical procedure on a living patient, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical device (a splittable catheter introducer) used for accessing blood vessels. This aligns with a surgical or procedural device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The focus is on facilitating a physical procedure.
Therefore, the BD Introsyte™ products described are medical devices used for vascular access, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
As provided in 21 CFR 870.1340, a catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Product codes
74 DYB
Device Description
The BD Introsyte™ products identified in this 510(k) notification are splittable, polyethylene catheter introducers. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate spring-activated needle-shielding technology.
BD Introsyte introducers are available in sizes ranging from 16 to 24 gauge. BD Splittable Needle Introducers range from 16 to 24 gauge.
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Same as trade names listed above.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com
JUN 12 2002
Ko20834
Image /page/0/Picture/3 description: The image shows the BD logo, which consists of a stylized sun-like symbol on the left and the letters "BD" on the right. Below the letters, the word "Indispensable" is written in a smaller font. The logo is black and white and appears to be a company logo.
Indispensable to human health
| Premarket Notification [510(k)] Summary of Safety and Effectiveness for | |
|---|---|
| BD Introsyte™ Precision Introducer, BD Introsyte-N™ Precision Introducer, | |
| BD Introsyte™ Autoguard™ Shielded Introducer, | |
| BD Introsyte-N™ Autoguard™ Shielded Introducer, and | |
| BD Splittable Needle Introducer |
| Submitter: | Becton Dickinson Infusion Therapy Systems Inc. |
|---|---|
| Address: | 9450 South State Street |
| Sandy, UT 84070 | |
| Contact Person: | Leslie Wood, Manager, Regulatory Affairs |
| Telephone Number: | (801) 565-2504 |
| FAX Number: | (801) 565-2749 |
| Date Summary Prepared: | March 5, 2002 |
| Trade Names: | BD Introsyte™ Precision Introducer, |
| BD Introsyte-N™ Precision Introducer | |
| BD Introsyte™ Autoguard™ Shielded Introducer | |
| BD Introsyte-N™ Autoguard™ Shielded Introducer | |
| BD Splittable Needle Introducer | |
| Common Name: | Catheter Introducer |
| Classification Name: | Catheter Introducer |
| Predicate Devices: | Same as trade names listed above. |
Product Descriptions:
The BD Introsyte™ products identified in this 510(k) notification are splittable, polyethylene catheter introducers. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate spring-activated needle-shielding technology.
BD Introsyte introducers are available in sizes ranging from 16 to 24 gauge. BD Splittable Needle Introducers range from 16 to 24 gauge.
1
KO20834
Intended Use:
As provided in 21b CFR 870.1340, a catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
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 penetration and catheter drag.
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol of three human profiles facing right, with flowing lines suggesting movement or connection. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2002
Becton Dickinson Infusion Therapy Systems, Inc. Ms. Leslie Wood Manager, Regulatory Affairs 9450 South State Street Sandy, UT 84070
Re: K020834
BD Introsyte™ Precision Introducer BD Introsyte-N™ Precision Introducer BD Introsyte™ Autoguard™ Shielded Introducer BD Introsyte-N™ Autoguard™ Shielded Introducer BD Splittable Needle Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: 74 DYB Dated: March 13, 2002 Received; March 14, 2002
Dear Ms. Wood:
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.
3
Page 2 – Ms. Leslie Wood
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 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 vours.
V. Da. Tuleh
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1020834
INDICATIONS FOR USE
Device Name:
BD Introsyte™ Precision Introducer BD Introsyte-N™ Precision Introducer BD Introsyte™ Autoguard™ Shielded Introducer BD Introsyte-N™ Autoguard™ Shielded Introducer BD Splittable Needle Introducer
As provided in 21 CFR 870.1340, a catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Division of Cardiovascular & Respiratory Devices
510(k) Number K920834
Prescription Use
(Per 21 CFR 801.109)