(90 days)
The Intradyn Pediatric Hemostasis Introducers are designed to facilitate percutaneous introduction of catheters into the vascular system of pediatric patients while minimizing blood loss.
Hemostasis introducers are used to insert catheters into the vascular system without significant blood loss. The hemostasis valve attached to the sheath is the method of achieving the prevention of blood loss. The valve allows for the introduction of a catheter and provides a tight seal around the catheter being introduced, thus preventing excessive leakage of blood. A procedure to use this device would typically begin with a clinician using an introducer needle to create a puncture hole and then introducing a guidewire into the vasculature. A dilator and sheath are then threaded over the guidewire, and the dilator is removed and discarded. The clinician can then use the introducer sheath with the hemostasis valve to pass catheters through while minimizing blood loss. The introducers are to be used with a catheter of the same size as the designated sheath size, however a catheter one French size smaller may be used with all 4 French and larger introducers.
The pediatric introducer sets consist of a Teflon introducer sheath, hemostasis valve with a side port extension tube bonded to a three-way stopcock, polyethylene or nylon (3 Fr. Size) dilator and optional guidewire. The pediatric hemostasis introducer sheaths will range in size from 3 - 6 French and will have a sheath length of 7 cm. The guidewire sizes for use with these introducers will be 0.018 -0.021 inches.
The provided text is a 510(k) summary for the Intradyn™ Pediatric Hemostasis Introducers. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically seen with performance data for AI/ML-enabled devices or other complex systems.
Instead, this 510(k) focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices through similarities in materials, functionality, design, manufacturing, sterilization processes, and indications for use.
Therefore, for most of your requested points, the information is not available in the provided document.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not provided. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific performance metrics against defined acceptance criteria for the new device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of submission. This 510(k) does not describe a clinical performance study with a test set of data. It relies on the established safety and efficacy of the predicate devices.
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)
Not applicable. No ground truth establishment related to clinical performance data is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring 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
Not applicable. This device is not an AI/ML-enabled medical device, nor does the document describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm; it's a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No specific ground truth related to performance data is mentioned. The "ground truth" in a 510(k) for substantial equivalence often refers to the regulatory precedent and established safety/effectiveness of predicate devices.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" described in this 510(k) is a comparison to predicate devices to demonstrate substantial equivalence, not a performance study measuring specific acceptance criteria.
- Rationale: The manufacturer asserts that the Intradyn™ Pediatric Hemostasis Introducers are "identical in materials, functionality, design and manufacturing and sterilization processes" to previously cleared B. Braun Medical Inc. Hemostasis Introducers (K894446 and K955820). They also state the pediatric introducers are "similar in indications for use and size" to the Fast-Cath introducers by Daig Corporation (K910861), and that the slightly smaller French size "does not raise any new issues of safety and efficacy."
- Outcome: The FDA concurred with the substantial equivalence determination, allowing the device to be marketed.
This approach is common for devices seeking 510(k) clearance when they are similar enough to existing devices that new clinical performance data is not deemed necessary to establish safety and efficacy.
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FEB - 5 2004
510(k) Summary 7.0
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2597 |
|---|---|
| Contact: Amy Smith, RA Specialist | |
| DEVICE NAME: | Intradyn™ Pediatric Hemostasis Introducers |
| COMMON OR USUALNAME: | Hemostasis Introducers |
| DEVICECLASSIFICATION: | Catheter Introducer, 21 CFR 870.1340, Product Code DYB |
| PREDICATE DEVICE: | B. Braun Medical Inc.Angeion Hemostasis Valve Introducer, K894446B. Braun Medical Inc.Braun Hemostasis Introducers, K955820Daig CorporationFast-Cath Hemostasis Introducer, K910861 |
| DESCRIPTION: | Hemostasis introducers are used to insert catheters into thevascular system without significant blood loss. Thehemostasis valve attached to the sheath is the method ofachieving the prevention of blood loss. The valve allowsfor the introduction of a catheter and provides a tight scalaround the catheter being introduced, thus preventingexcessive leakage of blood. A procedure to use this devicewould typically begin with a clinician using an introducerneedle to create a puncture hole and then introducing aguidewire into the vasculature. A dilator and sheath arethen threaded over the guidewire, and the dilator isremoved and discarded. The clinician can then use theintroducer sheath with the hemostasis valve to passcatheters through while minimizing blood loss. Theintroducers are to be used with a catheter of the same sizeas the designated sheath size, however a catheter oneFrench size smaller may be used with all 4 French andlarger introducers. |
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The pediatric introducer sets consist of a Teflon introducer sheath, hemostasis valve with a side port extension tube bonded to a three-way stopcock, polyethylene or nylon (3 Fr. Size) dilator and optional guidewire. The pediatric hemostasis introducer sheaths will range in size from 3 - 6 French and will have a sheath length of 7 cm. The guidewire sizes for use with these introducers will be 0.018 -0.021 inches.
The Intradyn™ Pediatric Hemostasis Introducers is INTENDED USE: designed to facilitate percutaneous introduction of catheters into the vascular system of pediatric patients while minimizing blood loss.
SUBSTANTIAL EQUIVALENCE:
The Intradyn Pediatric Hemostasis Introducers are identical in materials, functionality, design and manufacturing and sterilization processes to the existing B. Braun Medical Inc. Hemostasis Introducers addressed in submissions K894446 and K955820. The pediatric introducers are similar in indications for use and size to the Fast-Cath introducers currently marketed by Daig Corporation (K910861). The smaller French size that will be available with the new Pediatric Hemostasis Introducers is not Intradyn significantly different than the predicate devices, and does not raise any new issues of safety and efficacy.
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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 a stylized image of an eagle or bird-like figure with three wave-like lines beneath it, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
B. Braun Medical Inc. Ms. Amy Smith Regulatory Affairs Specialist 901 Marcon Blvd Allentown, PA 18109
Re: K033527
Tradc/Device Name: Intradyn™ Pediatric Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 6, 2003 Received: November 7, 2003
Dear Ms. Smith:
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 I'DA has made a determination that your device complics 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
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Page 2 - Ms. Amy Smith
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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Bram D/Zuckerman, M.D. 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 of
KC33527 510(k) Number (if known): ___
Intradyn™ Pediatric Hemostasis Introducer Device Name:
Indications For Use:
The Intradyn Pediatric Hemostasis Introducers are designed to facilitate perculaneous introduction of catheters into the vascular system of pediatric patients while minimizing blood loss.
(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 __
fr
(Di
Division of Cardiovascular Devices)
510(K) Number: K033527
000000
§ 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).