K Number
K111748
Manufacturer
Date Cleared
2011-11-23

(154 days)

Product Code
Regulation Number
870.5800
Panel
CV
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pulsar Scientific device is not a life-supporting or life-sustaining device. It is a new, prescription use only [21 CFR 801 Subpart D] device for use with restricted mobility and non-ambulatory patients, or other patients as deemed appropriate by the physician. It is not intended for over-the-counter use [21 CFR 801 Subpart C]. The device is intended to function as an intermittent, external pneumatic compression device. The intended therapy of the device is to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding in blood flow back to the heart, to increase blood flow to various body areas, as determined by the physician, to aid in the reduction and control of edema and venous stasis ulcers.

Indications For Use:

Compression therapy - Including, but not limited to:

  • Decrease the risk of deep venous thrombosis (DVT); .
  • Aid the blood flow back to the heart: .
  • Treat and assist healing of cutaneous ulceration (wounds). reduce wound healing time, . enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications;
  • Treatment of pain and swelling of acute periarticular processes, treatment of pain and . swelling following mobilization of shoulder stiffness under anesthesia, treatment of pain · and swelling postoperatively for bones, joints and soft tissue, treatment of pain and
  • swelling caused by musculoskeletal contusions and athletic injury;
  • Treatment of disorders associate with vascular or lymphatic insufficiency such as . Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic edema;
  • Reduction of edema associated with soft tissue injuries such as ligament sprains, . postoperative edema, and burns.

Thermal therapy - Including but not limited to:

  • Reduction of general edema (swelling); ●
  • Reduction of edema associated with soft tissue injuries such as ligament sprains ● postoperative edema, and burns;
  • Treatment of pain and swelling of acute periarticular processes, treatment of pain and . swelling following mobilization of shoulder stiffness under anesthesia, treatment of pain and swelling postoperatively for bones, joints and soft tissue, treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.
Device Description

The Recovery+ device is comprised of an electronically controlled, compartmentalized reusable pump used with a variety of single-patient use inflatable anatomical cuffs/wraps. The unit is light-weight and portable. The Recovery+ thermal component with standard pressure component and the DVT component (DVTherapy) of the pump are housed in separate compartments so that they can be used together, separately, or removed for portable usage of the DV.Therapy component. For purposes of this application we will refer to the components as the Recovery+ thermal compression unit and the DVTherapy unit.

The Recovery+ device is designed to provide compression therapy and/or thermal therapy (cold or hot). The therapies may be used together or separately, as ordered by the physician. The thermal therapy provides chilled or heated fluid to the cuff affixed on an extremity therapy site and compresses the treatment site for optimum performance and fluid transfer. The compression therapy is accomplished by air pumped through the cuffs, which are affixed on an extremity therapy site, to provide intermittent, sequential pressure. This facilitates venous flow towards the center of the body and simulates the muscle contraction and blood flow of ambulation.

The device utilizes microprocessor control with multiple sensors to ensure patient safety and system functionality, and to provide consistent and repeatable therapy modalities. Indicators are both visual on the unit display and audible. Settings are in place to detect any potentially unsafe situation and to terminate therapy to protect the patient and the system. The unit is light weight and portable. The thermal compression runs only on 115 VAC while the DVT unit can operate on batteries, connected to 115 VAC mains, or while docked in the thermal compression unit. The thermal compression unit has internal power supply while the DVT unit has an external power supply. The unit is protectively housed in a plastic shell, except for the outer membrane switch, the plastic quick-connect locks for tub connection, and an external power supply input jack.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Pulsar Scientific Recovery+ and DVTherapy devices, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The 510(k) summary for the Pulsar Scientific Recovery+ and DVTherapy devices does not explicitly list quantitative acceptance criteria for performance metrics in a tabular format, nor does it provide specific measured performance data against such criteria.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices through various tests. The core "acceptance criteria" are implied to be achieving performance characteristics that are substantially equivalent to or superseding the listed predicate devices for the various modalities offered.

However, the document does state performance characteristics that were verified:

Acceptance Criteria (Implied)Reported Device Performance
Safety Certifications- Conformed to UL 60601-1, CSA C22.2 NO 601.1, and CENELEC EN 60601-1.
Electromagnetic Compatibility (EMC)- Verified (emissions, immunity, safety).
Mechanical Integrity- Verified.
Environmental Performance- Verified.
Life Cycle Testing- Verified.
Pressure Delivery- Equivalent to predicate devices.
Cuff Fill Time- Equivalent to predicate devices.
Cycle Time- Equivalent to predicate devices.
Temperature Management- Equivalent to predicate devices. Controlled cooling from 43ºF to 49ºF; heating to 105ºF.
System Operation- Equivalent to predicate devices.

Important Note: The concept of "acceptance criteria" for a 510(k) submission, especially for devices like external pneumatic compression systems, often revolves around demonstrating safety and effectiveness compared to existing legally marketed devices, rather than meeting specific quantitative thresholds for, say, diagnostic accuracy.

Study Information

The provided document describes non-clinical validation testing but explicitly states that clinical testing was not performed. Therefore, several typical questions regarding clinical studies, experts, and ground truth are not applicable in this context.

  1. Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used. The validation was based on non-clinical bench testing.
  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established, as no clinical study was performed.
  3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was used.
  4. 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-assisted diagnostic tool, and no MRMC study was conducted.
  5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm/AI. Its performance is inherent in its electromechanical function.
  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical validation, "ground truth" would correspond to established engineering standards, performance specifications (e.g., target pressure, temperature range), and comparison against the performance of legally marketed predicate devices. The document implies compliance with these engineering and safety standards.
  7. The sample size for the training set: Not applicable. No training set was used, as this is a non-AI medical device that does not involve machine learning.
  8. How the ground truth for the training set was established: Not applicable. No training set was used.

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).