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510(k) Data Aggregation
(175 days)
The LD Q-IPC III is a system to prevent DVT(Deep Vein Thrombosis) by improving the blood velocity of patients.
Leg Compression
The use of the product with Calf Cuff and Thigh Cuff is indicated for:
- Deep vein thrombosis and pulmonary embolism prophylaxis.
Foot Compression
The use of the product with Foot Cuff is indicated for:
- Circulation enhancement.
- Deep vein thrombosis prophylaxis.
- Edema-Acute.
- Edema-Chronic.
- Extremity pain incident to trauma or surgery.
- Leg Ulcers.
- Venous stasis /Venous insufficiency.
The LD Q-IPC III Intermittent pneumatic compression device is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition.
The LD Q-IPC III Intermittent pneumatic compression device consists of the controller, the Tubing Sets and single-patient used cuff. The cuff includes calf cuffs, thigh cuffs and foot cuffs.
The controller will deliver air to the cuffs and sequentially pressurize them. Cuffs will be pressurized from the distal air chamber to the proximal air chamber. After the compression, the controller will allow an interval time for vein refilling, before the controller starts to pressurize the cuffs again. The cycles will be repeated throughout the time the unit is in use or for the duration of the default operating time.
The provided document is a 510(k) premarket notification for an intermittent pneumatic compression device (LD Q-IPC III) and primarily focuses on establishing substantial equivalence to a predicate device (Veinoflow SCD, LBTK-M-I 5001).
Based on the information provided in the document, here's an analysis of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds (e.g., a certain percentage of DVT reduction). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing the device's technical specifications and intended use against the predicate device.
Table: Acceptance Criteria (Implied by Substantial Equivalence) and Reported Device Performance
| Feature/Parameter | Implied Acceptance Criteria (via Predicate Device) | Reported Device Performance (LD Q-IPC III) |
|---|---|---|
| Intended Use/Indications | Same as predicate device: DVT prophylaxis, circulation enhancement, edema reduction, extremity pain, leg ulcers, venous stasis/insufficiency. | Same as predicate device: Prevents DVT by improving blood velocity. Indicated for DVT and pulmonary embolism prophylaxis (leg compression), and circulation enhancement, DVT prophylaxis, acute/chronic edema, extremity pain, leg ulcers, venous stasis/insufficiency (foot compression). (Pages 2, 5) |
| Classification Information | Same as predicate device: Class II, Product Code JOW, Cardiovascular Panel. | Same as predicate device: Class II, Product Code JOW, Cardiovascular Panel. (Page 4) |
| Design Principle | Same as predicate device (pneumatic compression to improve blood velocity). | Same as predicate device: Pneumatic compression device delivering air to cuffs, sequentially pressurizing them from distal to proximal, followed by an interval for vein refilling. Cycles repeat. (Page 4-5) |
| Compression Type | Same as predicate device: Sequential, Gradient for thigh/calf, Uniform for foot. | Same as predicate device: Thigh cuffs & calf cuffs: Sequential, Gradient; Foot cuffs: Uniform. (Page 5) |
| Deflation Time | Same as predicate device: 2-3s. | Same as predicate device: 2-3s. (Page 5) |
| Default Inflatable Interval | Same as predicate device: 48s. | Same as predicate device: 48s. (Page 5) |
| Adjustable Inflatable Interval | Same as predicate device: 24s, 48s, 60s. | Same as predicate device: 24s, 48s, 60s. (Page 5) |
| Adjustable Pressure | Same as predicate device: Thigh/calf: 30-60 mmHg; Foot: 120-140 mmHg. | Same as predicate device: Thigh cuffs & calf cuffs: 30-60 mmHg; Foot cuffs: 120-140 mmHg. (Page 5) |
| Mode of Operation | Same as predicate device: Continuous. | Same as predicate device: Continuous. (Page 5) |
| Application Mode | Similar to predicate device (single/dual thigh/calf/foot compression). | Similar to predicate device: Single/Dual thigh cuffs, Single/Dual calf cuffs, Single/Dual foot cuffs Compression. (Predicate also had "Simultaneous single thigh cuffs and single calf cuffs Compression," which the new device does not explicitly list.) (Page 5) |
| Bed Hook, Power Cord Storage | Present in predicate device. | Present in new device. (Page 5) |
| Microprocessor Control | Present in predicate device. | Present in new device. (Page 6) |
| Biocompatibility | Compliance with ISO10993 standards. | Compliance with ISO10993-1, ISO10993-5 (In Vitro cytotoxicity), ISO10993-10 (irritation and skin sensitization). (Page 7) |
| Electrical Safety | Compliance with IEC60601-1. | Compliance with IEC60601-1:2005+CORR.1(2006)+CORR.2(2007). (Page 7) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC60601-1-2. | Compliance with IEC60601-1-2:2007. (Page 7) |
| Software Verification | Following FDA guidance. | Carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (Page 7) |
| Differences noted: | Predicate has battery, different default pressure, and more alarms. | New device does not have a battery. Default pressure for thigh/calf is 45 mmHg (predicate: 40 mmHg). New device has fewer types of alarms. (The document states these differences are "slight and do not influence the effectiveness and safety of the device.") (Pages 5, 7) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical study with a "test set" of patients or data in the way one would for a diagnostic algorithm or a comparative clinical trial. This submission is for a physical medical device (intermittent pneumatic compression device), not an AI/ML-based diagnostic or prognostic tool.
The "testing" performed was non-clinical (bench testing, standards compliance) rather than patient-based data collection.
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. There was no clinical "test set" and thus no ground truth established by experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical "test set" 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 is not an AI-assisted diagnostic device, and no MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm, and the concept of "standalone performance" for an algorithm does not apply. The device's performance is inherently "standalone" in its function as a compression device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of a clinical test set. The "ground truth" for this submission are the established safety and performance standards (IEC, ISO) and the specifications of the legally marketed predicate device. The device is shown to meet these standards and be substantially equivalent to the predicate.
8. The sample size for the training set
Not applicable. This is a physical device submission and does not involve AI/ML models requiring a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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