FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Circulator Boot is an end diastolic pneumatic compression device made up of several components. A double walled plastic bag is placed over the leg of the patient and then placed inside a rigid plastic "boot". The boot is then attached to a valve system which is connected to an air supply. The valve is also connected to an EKG QRS monitor that times the compression cycle to occur after a variable (operator selectable) delay following the QRS signal.

AI/ML Overview

This 510(k) summary does not contain sufficient information to describe the acceptance criteria or a study that proves the device meets those criteria in the format requested. The document is a regulatory submission for premarket notification of a medical device, the "Circulator Boot," seeking substantial equivalence to existing devices. It focuses on device description, indications for use, and a comparison to predicate devices, but lacks detailed performance data or a study report with specific acceptance criteria.

Specifically, the following information is missing from the provided text to complete the requested table and study description:

A table of acceptance criteria and the reported device performance: The document mentions that the new model has "increased accuracy of timing and easier user interface" compared to the old model, with the new model being "accurate to within +/- 0.002 seconds" versus the old model's "+/- 0.05 seconds." This is a performance specification, but not a formally defined acceptance criterion that would be part of a study design to demonstrate safety and effectiveness. There are no other performance metrics or acceptance criteria provided.
Sample size used for the test set and the data provenance: No information on any test set size or data origin is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth experts is provided.
Adjudication method: No information on an adjudication method is provided.
Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not describe an MRMC study.
Standalone performance study: While it mentions improved timing accuracy, it does not describe a formal standalone performance study with detailed methodology, metrics, and acceptance criteria.
Type of ground truth used: No information on ground truth is provided.
Sample size for the training set: No information on a training set is provided, as this is not an AI/ML device in the modern sense.
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

Summary of available information related to performance:

The document primarily focuses on establishing "substantial equivalence" of the "Circulator Boot" to legally marketed predicate devices, as required for a 510(k) submission. The only performance-related detail provided is:

Improved Timing Accuracy: The new Circulator Boot model is accurate to within +/- 0.002 seconds, whereas the original model varied timing by as much as +/- 0.05 seconds. This indicates a technical improvement but is presented as a feature rather than the result of a formal study proving specific acceptance criteria.

Without more detailed information, it is impossible to complete the requested output.

Summary

Regulation Number and Section

§ 870.5225 External counter-pulsating device.

(a)
Identification. An external counter-pulsating device is a noninvasive, prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.(b)
Classification. (1) Class II (special controls) when the device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. The special controls for this device are:(i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition;
(ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules;
(iii) Software design and verification and validation must be appropriately documented;
(iv) The skin-contacting components of the device must be demonstrated to be biocompatible;
(v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and
(vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) for the following intended uses: Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 31, 2014, for any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other external counter-pulsating device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.