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510(k) Data Aggregation
(223 days)
The Alternating Leg Pressure® (ALP®) VasQcare™ System is a non-invasive system for reducing the incidence of deep vein thrombosis. The application of external intermittent pneumatic compression has six effects:
- Increases blood flow velocity
- Reduces the risk of deep vein thrombosis
- Enhances blood circulation
- Reduces pain and swelling
- Reduces wound healing time
- Aids in the treatment and healing of stasis dermatitis, venous stasis, arterial and diabetic leg ulcers, chronic vein insufficiency and reduction of edema in the lower limbs
The ALP® VasQcare™ System consists of a pump and a pair of single use calf sleeves. The pump provides intermittent cycles of compressed air, which alternately inflate the calf sleeves. The compression, when applied properly to the patient, increases blood velocity back to the heart and helps to prevent deep vein thrombosis.
The pump operates on timed cycles consisting of approximately 12 seconds of inflation where the calf sleeve compresses the limb followed by approximately 48 seconds of deflation where there is no pressure applied to the limb. Each limb compresses once per minute.
The ALP® VasQcare™ System may be used on patients at risk for developing deep vein thrombosis and in conjunction with medical therapy for high-risk patients.
Currie Medical Specialties (CMS) ALP® VasQcare™ System provides intermittent pneumatic pressure to a patient's leg for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse, which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The VasQcare™ pump controller predicates the inflation and deflation sequence.
This FDA 510(k) summary for the ALP® VasQcare™ System does not contain the level of detail typically found in a study demonstrating device performance against specific acceptance criteria in the manner requested.
The document states that "Bench testing was conducted to ensure that the new design did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices." It also mentions testing against standards like IEC 60601-1-1, 60601-1-6, and 60601-1-11 for electrical safety, EMC, mechanical integrity, and environmental/life cycle. However, it does not provide specific acceptance criteria or the reported device performance measurements for these tests.
The document explicitly states: "Per the requirements of 21 CFR 807, clinical data, non-clinical bench testing and the information provided within this 510(k) pre-market submission, Currie Medical Specialties, Inc., concludes that the ALP® VasQcare™ System performs in a manner that is substantially equivalent to the predicate devices listed above." This indicates clinical data was part of the submission, but its details are not included in this summary.
Given the information provided, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, expert involvement, or adjudication methods, as these details are not present in the provided text.
Here's what can be inferred and what cannot:
Information NOT available in the provided text:
- Specific Acceptance Criteria and Reported Device Performance: No explicit numerical acceptance criteria or performance metrics (e.g., specific pressure ranges, flow rates, failure rates) are mentioned. The document relies on a general statement of "no compromise" and "substantially equivalent."
- Sample sizes used for the test set and data provenance: No information on the number of devices or subjects tested, or where the data came from.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no ground truth establishment for a test set is described.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No mention of such a study or any associated effect sizes.
- Standalone (algorithm only) performance: Not applicable, as this is a medical device, not an AI algorithm in the typical sense.
- Type of ground truth used: Not applicable, as specific clinical or performance studies with defined ground truth are not detailed.
- Sample size for the training set: Not applicable, as this is not an AI/ML device in the context of a training set.
- How the ground truth for the training set was established: Not applicable.
What little can be extracted from the document related to "acceptance criteria" and "study":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Inferred/General) |
|---|---|
| Electrical Safety, EMC, Mechanical Integrity, Environmental, and Life Cycle Performance | "The ALP® VasQcare™ has performance characteristics that are substantially equivalent to the predicate devices." (Evaluated against IEC 60601-1-1, 60601-1-6, 60601-1-11) |
| Biocompatibility | "Biocompatibility of the ALP® VasQcare™ System is not affected" (Due to identical materials as predicate device K112311). |
| Functional Equivalence to Predicate Devices (especially in terms of pressure levels and cycles) | "This submission is intended for use of the pump at pressure levels of 45 mm Hg." (Implied acceptance that it meets this pressure. Predicate devices also operate at this pressure). |
| Pneumatic Compression Cycle Timing | "Approximately 12 seconds of inflation... followed by approximately 48 seconds of deflation... Each limb compresses once per minute." (Implied adherence to this operational spec). |
Details of the "Study" (Bench Testing and Equivalence Rationale):
- Study Type: Non-clinical bench testing. The document states "clinical data" was part of the 510(k) submission, but details of any clinical study are not provided in this summary.
- Objective: To ensure the new design "did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices."
- Specific Tests Mentioned:
- Electrical safety
- EMC (Electromagnetic Compatibility)
- Mechanical integrity
- Environmental testing
- Life cycle testing
- Biocompatibility assessment (based on material equivalence)
- Standards Used: IEC 60601-1-1, 60601-1-6, and 60601-1-11.
- Accreditation: Tests were "confirmed by an accredited third-party."
In summary, this document is a 510(k) summary for FDA submission, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with specific acceptance criteria and performance metrics for a novel technology. The "study" described is primarily bench testing to ensure the new device performs similarly and safely to existing, legally marketed devices.
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(62 days)
The Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) are recommended for the use in pediatric patients for whom external compression the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.
Currie Medical Specialties (CMS) ALP® pediatric compression sleeves are compression devices, which when attached to the ALP® 501 Pump System, provide intermittent pneumatic pressure to a patient's leg for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse, which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The inflation and deflation sequence is predicated by the ALP® 501 Pump System controller.
The provided document describes a 510(k) premarket notification for the "Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)." This is a medical device, and the submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy through a traditional clinical study with acceptance criteria often seen in AI/ML performance evaluations. Therefore, many of the requested categories (like MRMC study, effect size, number of experts, adjudication method, sample size for training set) are not applicable in this context.
Instead, the submission focuses on bench testing to ensure that design changes (specifically smaller sizing for pediatric use) do not negatively impact the device's fundamental performance, safety, and efficacy compared to the predicate device.
Here's an attempt to structure the information based on the provided document, acknowledging the limitations given the nature of the submission:
Acceptance Criteria and Study for Currie Medical ALP Pediatric Calf Compression Sleeves
The submission for the Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device (K955853 – Healthcare Service & Supply Pump ALP 501 System). The "acceptance criteria" and "study" are therefore focused on demonstrating that the new device, primarily due to smaller sizing for pediatric use, maintains the performance and safety characteristics of the predicate device through bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
This table is constructed from the bench testing details provided. The acceptance criteria are implicitly that the performance of the pediatric sleeves should not be compromised compared to the predicate device, or meet specific thresholds to ensure functionality.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary from Bench Testing) |
|---|---|
| No bladder leaks at 3 psi | Bladders did not leak at 3 psi |
| Bladder seal strength > 5 lbs | Bladder seal pulled apart at > 5 lbs of force |
| Velcro adhesion maintained at 2 psi | Velcro adhesion remained intact at 2 psi |
| Consistent inflation/deflation time to 40 mm Hg | Product integrity remained the same compared to the predicate device, demonstrating consistent inflation/deflation to 40 mm Hg. |
| Biocompatibility maintained | Biocompatibility not affected due to identical materials as predicate. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes (number of sleeves or bladders tested) for each bench test. The provenance is internal bench testing conducted by Currie Medical Specialties, Inc. (non-clinical, in-house testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was bench testing against engineering specifications and predicate device performance, not a clinical study requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. This was bench testing against engineering specifications, not a clinical study requiring adjudication.
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 a compression sleeve, not an AI/ML-driven diagnostic or assistive device. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (compression sleeve), not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for this submission is based on engineering specifications and the established performance characteristics of the legally marketed predicate device (K955853). The goal was to show that the new pediatric device performs equivalently to the predicate in key functional aspects.
8. The sample size for the training set
Not applicable. This refers to a medical device's engineering and performance evaluation, not an AI/ML model's training.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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(92 days)
The intended use of this device, as well as the predicate device, is to provide external limb compression in order to artificially imitate the pumping action of the leg muscles. This provides muscle contraction required by the venous return system, thereby helping to prevent venous stasis and subsequent thrombosis and embolism. The cyclic and alternating inflation of the garments closely simulates the normal healthy pumping action of the limb muscles to stimulate deep venous blood flow and the reactivation or increase in the body's fibrinolytic system.
The Currie Medical Reprocessed ALP Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.
Currie Medical Specialties (CMS) ALP reprocessed compression sleeves are compression devices, which when attached to the ALP 501 Pump System, provide intermittent, sequentially gradient pressure to a patients leg/foot for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf, thigh or foot. The inflation and deflation sequence is predicated by the ALP 501 Pump System controller.
This document is a 510(k) summary for the Currie Medical Reprocessed ALP® Calf, Thigh and Foot Compression Sleeves. It describes the device's technical characteristics, intended use, and the "Summary of Comparison Tests (Non-Clinical Tests)" conducted to demonstrate substantial equivalence to predicate devices.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the specified performance characteristics that were tested.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bladder Leak Test: Bladders do not leak when pressurized to 3 psi. | "Bladders were pressurized to 3 psi to ensure the bladders did not leak at this pressure and were not affected by reprocessing." (Implied: Passed, no leaks detected) |
| Bladder Seal Pull Test: Bladder seals remain intact at > 5 lbs of force. | "Bladder seal was pulled apart at > 5 lbs of force to demonstrate the seals wore intact and were not affected by reprocessing." (Implied: Passed, seals intact at > 5 lbs) |
| Velcro Functionality Test: Velcro adhesion remains intact when bladders are pressurized to 2 psi. | "Velcro functionality test was performed where bladders were pressurized to 2 psi to determine velcro adhesion remained intact at this pressure and were not affected by reprocessing." (Implied: Passed, velcro adhesion remained intact) |
| Inflation-Deflation Time Test: Product integrity (inflation to 40 mm Hg and pressure monitoring over time) remains the same as the predicate device. | "Inflation-deflation time test was performed to demonstrate product integrity remained the same in comparison to the predicate device. This required the devices to be inflated to 40 mm Hg and monitor the pressure over time. The series of data demonstrated that the reprocessing did not affect the performance, or the safety and efficacy of the device." (Implied: Passed, consistent with predicate) |
| Biocompatibility: Reprocessing does not affect biocompatibility. | "Reprocessing did not affect the biocompatibility of the device." (Implied: Passed) |
| Overall Performance/Safety/Efficacy: Substantially equivalent to predicate devices (K955853 & K964188). | "The Currie Medical Specialties ALP® Reprocessed Calf, Thigh, and Foot Compression Sleeves have demonstrated that they perform as safe and effective as the ALP® non-sterile predicate devices (K955853 & K964188) and are substantially equivalent to the predicate devices." (Claimed) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of devices) used for each bench test. It refers to "bladders," "bladder seal," and "bladders" for the respective tests, implying multiple units were tested, but no specific number is given.
- Data Provenance: The document describes "Bench testing was conducted." This implies the tests were performed in a laboratory or controlled setting. There is no information regarding country of origin for the data or if it was retrospective/prospective, as it's not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This document describes non-clinical bench testing for device reprocessing validation, not a study involving human experts for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. This document describes non-clinical bench testing. Adjudication methods are typically associated with human review or clinical study endpoints.
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 document describes non-clinical bench testing of a reprocessed medical device, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This document pertains to a physical medical device (compression sleeves), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this study is the performance of the predicate device. The reprocessed device's performance was compared against the known performance characteristics of the original, new device to demonstrate substantial equivalence. The tests also established "ground truth" for specific mechanical properties (no leaks at 3 psi, seals intact at > 5 lbs force, velcro intact at 2 psi).
8. The Sample Size for the Training Set
Not applicable. This document describes validation testing for a reprocessed medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning model in this context.
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(21 days)
The ALP® 501 RB Pump system is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both.
The ALP® 501 RB Pump System is intended for use by patients and medical professionals in treating many conditions, such as:
- Reduce the incidence of deep vein thrombosis (DVT) and pulmonary embolism due to the presence of risk factors for thrombosis formation
- Enhancement of arterial blood flow
- Reduction of post-operative pain and swelling
- Reduction of compartmental pressure after tissue trauma
The ALP® 501 RB Pump is a prescriptive, pneumatic compression device designed to apply compression to the lower limb. The ALP® 501 RB pump is compact this making it a portable ambulant system. The ALP® 501 RB pump provides the user with an option of battery operation in addition to the operation from the mains option. The ALP® 501 RB pump is easy to use and provides the user with three treatment options: compression of the foot, compression of the calf, or combined compression of both (one foot and one calf).
The foot and calf compression program fills a garment bladder and decompresses. The device is composed of three main sub-systems:
-
- A portable pneumatic pump unit,
-
- A pair of garments (calf and/or foot) and
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- Pneumatic connecting tubes.
Inflation and deflation of the garments are controlled by the pump system. The inflation and deflation produces a massage on the patient limb in order to stimulate the natural flow of the body fluids.
The provided text describes a 510(k) premarket notification for the ALP® 501 RB Pneumatic Compression System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria for performance metrics.
However, based on the information provided, we can infer the "acceptance criteria" and "device performance" in the context of demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety and Performance Equivalence to Predicate Device | "A series of safety and performance testing including comparative analysis between the ALP® 501 RB Pump system and the ALP® 501 Pump System demonstrated that the ALP® 501 RB Pump System is substantially equivalent to the ALP® 501 Pump System without raising new safety and/or effectiveness issues." |
| Functional Equivalence (Technological Characteristics) | The ALP® 501 RB is described as "substantially equivalent in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc., to the commercially available ALP® 501 Pump System." The changes noted are "the addition of an optional battery operated unit and change in inner components." |
| Intended Use Equivalence | The Indications for Use for the ALP® 501 RB are identical to those of the predicate device (ALP® 501 Pump System) as listed in the document. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an evaluative study with a distinct sample size. The testing conducted was a "series of safety and performance testing including comparative analysis" between the new device and its predicate. No specific number of devices or subjects is mentioned for this comparative analysis.
The data provenance is not explicitly stated, but given that both devices are commercial products or prototypes from Currie Medical Specialties Inc. in the USA, it is highly likely the testing was conducted prospectively by the manufacturer, possibly in a laboratory or simulated clinical setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes a submission for substantial equivalence based on engineering and performance testing, not a clinical study requiring expert assessment for ground truth determination (like image interpretation or pathology).
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. There was no expert "ground truth" to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes a comparison between two medical devices, one being the predicate for the other, and does not involve human readers interpreting cases with and without AI assistance.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device described is a physical pneumatic compression system, not an AI algorithm. Its performance is inherent in its mechanical operation, not a computational output that would precede human interaction.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety of the predicate device (ALP® 501 Pump System). The new device (ALP® 501 RB) was deemed to meet acceptance criteria by demonstrating that its performance and safety were equivalent to this existing, legally marketed device. The specific metrics for performance (e.g., pressure, cycle times, comfort, durability) are not detailed but would have been part of the internal safety and performance testing.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
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