(90 days)
For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.
16 Et 18 french versions of the Braun Hemostasis Introducer with silicone gasket, in lengths of 10 - 40 cm.
The provided document is a 510(k) summary for a medical device (catheter introducer and vessel dilator) and does not contain information about a study proving device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. It focuses on demonstrating substantial equivalence to previously cleared devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies in the context of AI/ML, human readers, ground truth, or training sets from this document.
The document mainly includes:
- Device Classification and Common Name: Catheter introducer and Vessel dilator (21 CFR 870.1340 and 870.1310).
- Substantial Equivalence: A comparison table demonstrating similarities to predicate devices (K894446, K931743, K871153, K930057, K945396).
- Device Description: 16 and 18 French versions of the Braun Hemostasis Introducer with specific gasket and length details.
- Intended Use: For percutaneous introduction of catheters into the vasculature while preventing blood backflow.
- Summary/Comparison of Technological Characteristics: Detailed comparison of labeling, packaging, intended use, physical characteristics (French sizes, lengths, materials), and anatomical sites with predicate devices.
This document is for a traditional medical device submission and does not describe a study involving algorithms, AI, or human reader performance.
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SUMMARY OF SAFETY AND EFFECTIVENESS 11.
Applicant Name & Address:
B. Braun Medical Inc., Cardiovascular Division, 13000 Hwy 55 Minneapolis, MN 55441-3813 (612) 559-3370
Barbara Atzenhoefer, Regulatory Affairs Manager Contact:
December 19, 1995 Date Prepared:
Common or Usual Name: Catheter introducer and Vessel dilator for percutaneous catheterization
Device Classification Name:
Introducer: 21 CFR Reference- 870.1340, Class II Panel- 74 DYB
11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
Dilator: 21 CFR Reference- 870.1310, Class II, Panel- 74 DRE
Substantial Equivilance:
| 510(k) # | Product | Manufacturer |
|---|---|---|
| K894446 | Angeion Hemostasis Valve Introducer Kit | B. Braun Cardiovascular - MN |
| K931743 | Burron Cardiovascular Angestat | B. Braun Cardiovascular - MN |
| K871153 | ANGETEAR Tear-away Introducer Kits | B. Braun Cardiovascular - MN |
| K930057 | Fluoro-tip Hemostasis Introducer Set | B. Braun Cardiovascular - MN |
| K945396 | Fluoro-tip Hemostasis Introducer Set | B. Braun Cardiovascular - MN |
Device Description:
16 Et 18 french versions of the Braun Hemostasis Introducer with silicone gasket, in lengths of 10 - 40 cm. Statement of Intended Use:
For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood. Summary/Comparision of Technological Characteristics:
| Characteristic | Braun Hemostasis Introducers | K894446 Hemostasis Introducer | K931743 Angestat | K871153 ANGETEAR | |
|---|---|---|---|---|---|
| A) Labeling/Pkg | |||||
| Labels & IFUs | See Attachment B | All Braun Hemostasis IntroducerLabel formats are identical | All Braun HemostasisIntroducer Label formats areidentical | same informationprovided on pouch andbox labels as onhemostasis labels | |
| Expiration Dating | 2 years | 2 years | 2 years | 4 years | |
| Pyrogen Free | Yes | Yes | Yes | Yes | |
| Packaging | Tyvek/Polymylar pouch | Tyvek/Polymylar pouch | Tyvek/Polymylar pouch | Tray w/ tyvek lid w/in atyvek/polymylar pouch | |
| B) Intended Use | percutaneous introduction ofcatheters into the vasculaturewhile minimizing the backflowof blood | percutaneous introduction ofcatheters into the vasculaturewhile minimizing the backflow ofblood | percutaneous introduction ofcatheters into the vasculaturewhile minimizing the backflowof blood | percutaneousintroduction of cathetersinto the vasculature | |
| C) Physical Char. | |||||
| Available french sizes | 4-18 french | 5-14 french | 4-15 french | 4-16 french | |
| Lengths | 10-40 cm | 12-24 cm | 15-32 cm | 16-30 cm | |
| gasket material | silicone | Natural rubber | silicone | none | |
| sheath material | FEP with BaSO₄ | FEP teflon with BaSO₄ | FEP with BaSO₄ | polyethylene withbismuth subcarbonate | |
| dilator material | high density polyethylene withbismuth subcarbonate | polyethylene with bismuthsubcarbonate | polyethylene with bismuthsubcarbonate | FEP with BaSO₄ orpolyethylene withbismuth subcarbonate | |
| D) Anatomical Sites | vasculature | vasculature | vasculature | vasculature |
§ 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).