(26 days)
The Boomerang™ Catalyst/Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Catalyst/Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
The Boomerang™ Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang Catalyst II System includes design modifications to minimize ooze from the tissue tract and promote the hemostasis process. The Boomerang Catalyst II System maintains the same indication for use as the Boomerang Catalyst System family of devices, formerly referred to as the Boomerang PlusWire System.
The Boomerang Catalyst II System consists of a sterile disposable Boomerang Catalyst II wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Catalyst II System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Catalyst II wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Catalyst II wire is deployed, which opens the flat, lowprofile Boomerang Disc within the lumen of the femoral artery. The introducer sheath is then removed from the vessel over the Boomerang Catalyst II wire and the low-profile Boomerang Disc conforms to the contours of the vessel and secures it against the intima, sealing the arteriotomy. As gentle tension is applied to the Boomerang Catalyst II wire, the sleeve covering the tensioning coil is gently retracted until the distal tip appears at the skin surface to expose the coated tensioning coil to the tissue tract. The applied tension is maintained by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Catalyst II wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Boomerang Catalyst II System.
The provided text is a 510(k) summary for the Cardiva Medical Boomerang™ Catalyst II System. A 510(k) summary is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish new performance criteria through clinical studies directly.
Based on the provided document, the device (Boomerang™ Catalyst II System) is being considered substantially equivalent to a predicate device (Cardiva Medical Boomerang™ Catalyst System, K070485) rather than being subject to a de novo approval pathway requiring specific acceptance criteria beyond demonstrating equivalence.
Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, clinical study results, sample sizes for test/training sets, expert qualifications, or ground truth establishment in the way one might expect for a primary clinical trial or AI/software validation.
However, I can extract the information that is present and explain why certain sections are not applicable or missing based on the nature of a 510(k) submission for substantial equivalence.
Here's a breakdown based on your request, explaining what is available and what is not:
1. A table of acceptance criteria and the reported device performance
- Not Applicable/Not Provided Directly in this Document.
- A 510(k) submission for substantial equivalence typically does not define new, quantitative clinical acceptance criteria in the same way as a de novo or PMA submission. Instead, the device is evaluated against the performance and safety profile of the predicate device.
- The document states: "The Boomerang Catalyst II System is substantially equivalent to the predicate device with regard to function, intended use, physical characteristics and performance testing."
- "Various testing which included bench and biocompatibility was performed on the Boomerang Catalyst II System to insure the product and the product materials were adequately tested and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe for the intended use of the device."
- This indicates that performance testing was done, but specific quantitative acceptance criteria and their corresponding results are not detailed in this summary. The "performance requirements" would implicitly be those demonstrated by the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided Directly.
- The document mentions "various testing which included bench and biocompatibility," but it does not describe clinical test sets, patient sample sizes, or data provenance (e.g., country of origin, retrospective/prospective). This often means the substantial equivalence was based primarily on engineering design, material equivalence, and non-clinical testing rather than new clinical trials with patient cohorts.
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/Not Provided.
- Since no clinical test set or ground truth establishment is described in this summary, information about experts and their qualifications is not present. This type of detail would be relevant for studies evaluating diagnostic accuracy or a new clinical endpoint, which is not the focus of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided.
- Similar to point 3, without a described clinical test set requiring ground truth establishment, there is no mention of adjudication methods.
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/Not Provided.
- This type of study is relevant for AI or diagnostic imaging devices. The Boomerang Catalyst II System is a physical medical device (vascular clamp) intended to promote hemostasis. It does not involve AI, image reading, or human interpretative tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable/Not Provided.
- As noted in point 5, this is a physical device, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided.
- For a substantial equivalence claim based on bench and biocompatibility testing for a physical device, the "ground truth" refers to established engineering standards, material properties, and biological safety profiles, rather than clinical outcomes or expert consensus for diagnostic interpretation. These are implicitly compared to the predicate.
8. The sample size for the training set
- Not Applicable/Not Provided.
- The concept of a "training set" is relevant for machine learning algorithms. This is a physical medical device, not an AI/ML product.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided.
- As noted in point 8, this is not an AI/ML product.
Summary of what the document focuses on regarding device performance and substantial equivalence:
- Device Description: The Boomerang™ Catalyst II System is described as a sterile, disposable wire and clip system that promotes hemostasis through temporary site-specific compression at a femoral access site.
- Intended Use/Indications for Use: To promote hemostasis at arteriotomy sites as an adjunct to manual compression, for 5F, 6F, or 7F introducer sheaths in femoral artery catheterization.
- Substantial Equivalence Claim: The Boomerang Catalyst II System is claimed to be substantially equivalent to the predicate device (Boomerang™ Catalyst System, K070485) "with regard to function, intended use, physical characteristics and performance testing."
- Performance Testing Mentioned: "Various testing which included bench and biocompatibility was performed... to insure the product and the product materials were adequately tested and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe for the intended use of the device."
In conclusion, this 510(k) summary for the Cardiva Medical Boomerang™ Catalyst II System indicates that the device met acceptance criteria by demonstrating substantial equivalence to an existing predicate device (K070485) through bench and biocompatibility testing. The document does not provide details on specific quantitative performance criteria, clinical study designs, sample sizes, or expert involvement, as these types of detailed studies are generally not required for a 510(k) submission based on substantial equivalence of a physical device with a known mechanism of action.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).