(90 days)
The Introcan® Safety™ IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.
The Introcan Safety IV Catheter consists of an over-the-needle catheter with a safety clip feature. Upon removal of the needle from the catheter, the safety clip is automatically secured over the needle tip as it exits the catheter hub. The Introcan Safety IV Catheter is available in sizes ranging from 14 Gauge through 24 Gauge.
The provided text is a 510(k) summary for the Introcan® Safety™ IV Catheter from 2002. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria or a study that quantitatively proves the device meets those criteria with performance metrics, sample sizes, or details about ground truth establishment.
The document primarily focuses on establishing substantial equivalence to previously cleared devices. It states: "The Introcan Safety IV Catheter includes the same materials, construction, design, and safety clip feature as the Introcan Safety IV Catheter previously cleared under the B. Braun Medical Inc. Premarket Notification, K982805." It also mentions a new indication for use as an introducer catheter, which is similar to a previously cleared device (K013304).
Without a dedicated performance study described within the provided text, it's impossible to create the requested table or answer most of the detailed questions about sample sizes, ground truth, expert qualifications, or MRMC studies.
Therefore,Based on the provided 510(k) summary, the following information can be extracted:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not present specific quantitative acceptance criteria or detailed device performance metrics derived from a study. Instead, it relies on demonstrating substantial equivalence to predicate devices based on materials, construction, design, and safety features.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the given document. The submission focuses on substantial equivalence rather than reporting on a new performance study with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the given document. The concept of "ground truth" and expert consensus is not applicable here as no specific diagnostic or performance study is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the given document. No performance study with adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not mentioned in the provided document. This device is an IV catheter, not an AI-assisted diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical instrument (IV catheter), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable as there is no mention of a performance study requiring ground truth establishment in the provided document.
8. The sample size for the training set
This information is not applicable as the device is an IV catheter and not an AI/machine learning system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
Summary of what the document does provide regarding acceptance:
The primary "acceptance criteria" appear to be based on the device's design, materials, construction, and safety features being substantially equivalent to the predicate devices. The document states:
- "The Introcan Safety IV Catheter includes the same materials, construction, design, and safety clip feature as the Introcan Safety IV Catheter previously cleared under the B. Braun Medical Inc. Premarket Notification, K982805."
- Its new indication for use as an introducer catheter is "the same indication previously cleared for Becton Dickinson Infusion Therapy Systems Inc.'s Premarket Notification, BD Introsyte™ Precision Introducer, BD Introsyte™ Autoguard™ Shielded Introducer, K013304."
Therefore, the "study" proving the device meets acceptance criteria is effectively the comparison against predicate devices to demonstrate substantial equivalence, rather than a clinical or performance study with quantified metrics. The FDA's letter states: "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..." This determination by the FDA serves as the regulatory "acceptance."
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JUL 3 2002
| 7.0 | 510(k) Summary |
|---|---|
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2280Contact: Patricia D. Wilson, Regulatory Affairs Specialist |
| DEVICE NAME: | Introcan® Safety™ IV Catheter |
| COMMON OR USUALNAME: | Safety Intravascular Catheter / Safety Introducer Catheter |
| DEVICECLASSIFICATION: | Class II, 21 CFR § 880.5200: Intravascular Catheter and21 CFR § 870.1340: Catheter Introducer |
| PREDICATE DEVICE: | B. Braun Medical Inc. Introcan Safety IV Catheter (K982805)B. Braun Medical Inc. Introducer Catheter (Kit component ofK810460 / K810461)Becton Dickinson Infusion Therapy Systems Inc., BD Introsyte™Autoguard™ Shielded Introducer (K013304) |
| DESCRIPTION: | The Introcan Safety IV Catheter consists of an over-the-needlecatheter with a safety clip feature. Upon removal of the needlefrom the catheter, the safety clip is automatically secured over theneedle tip as it exits the catheter hub. The Introcan Safety IVCatheter is available in sizes ranging from 14 Gauge through 24Gauge. |
| INTENDED USE: | The Introcan Safety IV Catheter is a passive anti-needle stickdevice to provide venous or arterial access for the infusion offluids, drugs, and/or blood components, or to facilitate theplacement of Vascular Access devices such as guidewires,indwelling central venous catheters, peripherally inserted centralcatheters, and midline catheters into the vascular system. |
| SUBSTANTIALEQUIVALENCE: | The Introcan Safety IV Catheter includes the same materials,construction, design, and safety clip feature as the Introcan SafetyIV Catheter previously cleared under the B. Braun Medical Inc.Premarket Notification, K982805. The Introcan Safety IV Catheteris also similar in materials and design, with the exception of thesafety clip feature, as the introducer catheter previously cleared asa kit component under the B. Braun Medical Inc. Premarket |
B Braun Medical Inc.
510(k) Premarket Notification
Introcan Safety IV Catheter
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Notifications, Burron Percutaneous Introducer Set (K810460) and Burron Central Vein Catherization Kit (K810461). The new indication for the Introcan Safety IV Catheter, for use as an introducer catheter, is the same indication previously cleared for Becton Dickinson Infusion Therapy Systems Inc.'s Premarket Notification, BD Introsyte™ Precision Introducer, BD Introsyte™ Autoguard™ Shielded Introducer, K013304.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 - 2002 JUL
B. Braun Medical, Inc c/o Ms. Patricia D. Wilson Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, PA 18109-9341
K021094 Re: Introcan® Safety™ IV Catheter Regulation Number: 870.1340 Regulation Name: Catheter introducer. Regulatory Class: II (two) Product Code: 74 DYB Dated: April 3, 2002 Received: April 4, 2002
Dear Ms. Wilson:
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.
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. Patricia D. Wilson
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,
Dale Tuh
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.0
Page ·
| 510(k) Number (if known): | K021094 |
|---|---|
| --------------------------- | --------- |
Introcan® Safety™ IV Catheter Device Name:
Indications For Use:
The Introcan® Safety™ IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
n Sign-Off vision of Cardiovascular and Respiratory Dev
510(k) Number
B. Braun Medical Inc. 510(k) Premarket Notification Introcan Safety IV Catheter
000005
§ 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).