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The RadAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or leg, including: radial, brachial, dorsalis pedis or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in patients on anticoagulation therapy.

The RadAR™ Vascular Compression Devices consist of a strap with a housing with controls for device securement and adjustment, and a compression pad. The product is designed to reduce blood flow in the subject blood vessel compressed by the pad, while allowing blood flow in other vessels in the arm or the leg to promote hemostasis at the vascular puncture site. The user can delicately control the compression applied by the device without unfastening it. This allows gradual release of compression as hemostasis occurs and, at the user's discretion, permits blood flow into the compressed blood vessel during puncture site hemostasis. This device is not life supporting or life sustaining. The product is provided individually packaged. It is a sterile, single use device.

This FDA 510(k) summary for the RadAR™ Vascular Compression Devices (K142122) explicitly states that no new testing was deemed required, and no performance testing or clinical evaluations were submitted for this 510(k).

The basis for the device's acceptance is its substantial equivalence to previously cleared predicate devices, specifically:

1. The RadAR™ Vascular Compression Devices cleared under 510(k) K092503 (itself).
2. The HemoBand® manufactured by Innovations for Access, Inc. (K081740).

Therefore, based on the provided document, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: No new performance data was presented.
2. Sample size used for the test set and the data provenance: No new test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set was used.
4. Adjudication method for the test set: Not applicable as no new test set was used.
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 is a physical medical device, not an AI/software device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable as no new testing was performed for this submission.
8. The sample size for the training set: Not applicable as no new testing was performed for this submission.
9. How the ground truth for the training set was established: Not applicable as no new testing was performed for this submission.

The document indicates that the current 510(k) submission (K142122) is primarily to revise the indications for use for the RadAR™ Vascular Compression Devices. The manufacturer leveraged information and testing from the previous clearance (K092503) for the same device to support the substantial equivalence claim for the expanded indications.

Conclusion stated in the document:
"Previous testing on the submitted RadAR™ Vascular Compression Device has demonstrated that this device is as safe and as effective as the predicate devices."

This means the acceptance criteria and performance data for this device are implicitly tied to the previous 510(k) clearances and the performance characteristics of the predicate devices. The current submission did not involve new studies to generate new performance data.

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The RADAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

The RadAR " Vascular Compression Devices are compression devices used on the arm. Each device consists of a strap with a housing, a screw permanently inserted into the housing, and a movable compression pad. The product is designed to reduce blood flow in the blood vessel compressed by the pad while allowing blood flow in other vessels in the arm. The user can delicately control the compression applied by the device without unfastening it. This allows gradual release of compression as hemostasis occurs and, at the user's discretion, permits blood flow in the compressed vessel during puncture site hemostasis. The product is provided individually packaged. It is a sterile, single-use device.

This submission does not provide information on acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it states:

"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

Therefore, I cannot populate the requested information regarding acceptance criteria, device performance, study details, training set, or ground truth.

The document mainly focuses on establishing substantial equivalence to predicate devices based on design and intended use, rather than presenting a performance study with acceptance criteria.

Ask a specific question about this device