(294 days)
The Cork Medical Products Nisus Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.
Cork Medical Products has developed a negative pressure wound therapy system. The Cork Medical Products Nisus Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.
The components included within the Cork NPWT System are:
- Nisus Negative Pressure Wound Therapy Pump
- Nisus NPWT Canister 250-mL
- Nisus Pump Battery Charger
- Cork Medical Products NPWT Wound Dressing Kit – Medium
- Cork Medical Products NPWT Wound Dressing Kit - Large
This document is a 510(k) premarket notification for the "Cork Medical Products Nisus Negative Pressure Wound Therapy System." It details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for each performance test in a tabular format with corresponding reported performance metrics for the Cork Medical Products Nisus NPWT System. Instead, it states that "All biocompatibility test results were negative and passed the pre-defined test acceptance criteria," and that nonclinical tests were conducted "to ensure the Cork Medical Products Nisus Negative Pressure Wound Therapy System is substantially equivalent to the Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing." This implies the acceptance criteria for the nonclinical tests were equivalence to the predicate device's performance characteristics.
The comparison table on pages 5 and 6 provides a direct comparison of technical data between the new device and the predicate device. This essentially serves as the 'performance' of both devices that the FDA used to determine substantial equivalence.
Here's a summarized table based on the provided "Predicate Product Comparison Table" and "Nonclinical Tests" section, inferring acceptance criteria as being substantially equivalent to the predicate:
| Acceptance Criteria (Inferred: Substantially equivalent to Predicate Device) | Cork Medical Products Nisus NPWT System Performance | Predicate Device (Genadyne A4 Wound Dressing Vacuum System Kit) Performance | Study Type |
|---|---|---|---|
| PUMP - TECHNICAL DATA | Nonclinical Tests | ||
| Suction Capacity | 4 liters / minute | 5 liters / minute | Head to head performance testing |
| Maximum Vacuum Pressure | 220-mmHg | 230-mmHg | Head to head performance testing |
| Power Requirements | 18 VDC, 2A | 24 VDC, 1A | Head to head performance testing |
| Battery Type | Li-ion | Ni-MH | Comparison of specifications |
| Dimensions | 151 x 108 x 71-mm (~6 x 4.3 x 2.8-inches) | 200 x 180 x 80-mm (~7.9 x 7.1 x 3.1-inches) | Comparison of specifications |
| Weight | 0.575-kg (~1.27-lb) | 1.36-kg (~3-lb) | Comparison of specifications |
| Reusable | Yes | Yes | Comparison of specifications |
| Sterile | Non-sterile | Non-sterile | Comparison of specifications |
| Compliance | IEC 60601-1:2005, 3rd Edition (AAMI ES 60601-1, CAN/CSA C22.2 No. 60601-1-08, EN 60601-1) | ||
| IEC 60601-1-2:2007 | |||
| IEC 60601-1-6:2010 / IEC 62366:2010 | |||
| IEC 60601-1-11:2010 | UL 60601-1 | ||
| CAN/CSA C22.2 No. 601-1-M90 | Comparison of specifications | ||
| Storage & Shipping Conditions | -25°C (-13°F) without relative humidity control to 44°C (111°F) up to 93% relative humidity (non-condensing) | -18°C to +43°C (0°F to 110°F) | |
| Relative Humidity 10% to 95% | |||
| 700 – 1060 mbar Atmospheric pressure | Comparison of specifications | ||
| Environmental Conditions | Operating Temperature: 18°C to 34°C (65°F to 94°F) | ||
| Operating Relative Humidity: 10% - 95% | |||
| Operating Pressure: 700-hPA – 1060-hPA (10.15-atm – 15.37-atm) atmospheric pressure | 18°C to 34°C (65°F to 94°F) Relative Humidity 10% to 95% | ||
| 700 – 1060 mbar Atmospheric pressure | Comparison of specifications | ||
| ACCESSORIES | |||
| Canisters | 250-mL disposable canister | ||
| Canister includes hydrophobic membrane filter and liquid solidifier | 800-mL disposable canister with a built-in hydrophobic shut off filter for overflow protection | Comparison of specifications | |
| Wound Dressing Kit | Wound Foam: Reticulated polyether based polyurethane foam (A30M) | ||
| Wound Drape: Transparent polyurethane film with adhesive backing | |||
| Port Pad Assembly: Silicone port pad, Port Pad Skirt (Transparent polyurethane film with adhesive backing), Drainage tubing, Luer connector, Pinch clamp | K082676: | ||
| Non-adherent gauze | |||
| Anti-microbial gauze | |||
| Transparent film dressing | |||
| Silicone flat drain | |||
| K092992: Polyurethane foam (A30M) | Comparison of specifications | ||
| Sterilization | Individual kit components individually sterilized by Ethylene Oxide or Gamma Irradiation | (cleared on K132004) - implied similar sterilization | Comparison of specifications |
| PERFORMANCE TESTS | Nonclinical Tests | ||
| Continuous Mode Low Pressure (40-mmHg) Test | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Continuous Mode Typical Pressure (125-mmHg) Test | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Continuous Mode High Pressure (200-mmHg) Test | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Intermittent Mode Test (high pressure: 125-mmHg, low pressure: 40-mmHg) | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Leakage Alarm Test | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Canister Full Alarm Test | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Blockage Alarm Test | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Operating Parameter Test | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Storage & Shipping Parameter Test | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Canister Real-Time Aging | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| Wound Dressing Kit Aging | Passed (implied by "substantially equivalent") | (Performance of predicate device) | Head to head performance testing |
| BIOCOMPATIBILITY | |||
| Cytotoxicity Test | Negative/Passed | (Implied standard biocompatibility) | ISO 10993 testing standards |
| Intracuteneous Reactivity Test | Negative/Passed | (Implied standard biocompatibility) | ISO 10993 testing standards |
| Sensitization Test | Negative/Passed | (Implied standard biocompatibility) | ISO 10993 testing standards |
2. Sample size used for the test set and the data provenance
- Sample size for nonclinical tests: Not explicitly stated for each test beyond "head to head performance testing," "Canister Real-Time Aging," and "Wound Dressing Kit Aging." For the biocompatibility tests, the sample size refers to the "wound foam and wound drape components" and "individual components included in the Cork Medical Products Wound Dressing Kit." Specific numbers are not provided.
- Data provenance: The tests were conducted internally by Cork Medical Products ("Cork Medical conducted head to head performance testing") and a Biocompatibility Risk Assessment was completed by "Nelson Laboratories." The data origin is thus from Cork Medical's testing and a third-party lab. No information about country of origin of the data or whether it was retrospective or prospective is mentioned, which is typical for premarket notifications focus on non-clinical engineering and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a negative pressure wound therapy system, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for its performance is derived from physical measurements (pressure, flow, alarm functionality) and standardized biocompatibility testing.
4. Adjudication method for the test set
Not applicable. As noted above, this device does not involve expert adjudication for establishing ground truth, as it's a mechanical/electrical device.
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 not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm, but a physical medical device.
7. The type of ground truth used
- Nonclinical Performance Tests: The "ground truth" for the nonclinical performance tests (e.g., pressure, alarms) was established through engineering and bench testing protocols using "simulated wound exudate" and a "wound test bed fixture." The implicit ground truth standard for these tests was the demonstrated performance of the legally marketed predicate device.
- Biocompatibility Tests: The ground truth was based on international standards, specifically ISO 10993 testing standards, with predefined acceptance criteria for cytotoxicity, intracutaneous reactivity, and sensitization.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have "training sets" in that context. Its performance is based on engineering design and testing, not learned data.
9. How the ground truth for the training set was established
Not applicable (as above).
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.