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510(k) Data Aggregation
(35 days)
The ORwell™ Fluid Collection and Disposal System is intended to be used in the Operating Rooms, Surgical Centers, and Doctors' Offices to collect and dispose of fluid waste.
The ORwell™ Fluid Collection and Disposal System consists of three (3) components:
- Mobile Unit
- Disposal Station
- Disposable Collection Disc (hereinafter referred to as "Disposable Disc," "Collection Disc," or "Disc")
The Mobile Unit is a portable unit that provides its own source of vacuum and houses the Disposable Collection Disc which is used to collect fluid waste and small debris from the surgical site. The amount of suction can be regulated by the end user via the simple user interface on the Mobile Unit.
The Disposable Collection Disc is a single use disposable that collects fluid waste from the surgical procedure. It has four ports to allow for the collection of fluid from various instruments during the procedure. Additionally, the Disc features an attached flexible liner in which collected fluid is contained.
The Disposal Station is a stationary unit located in a utility area plumbed with water inlet and outlet lines. After the surgical procedure, the Mobile Unit is moved to the utility area where it interfaces with and locks into the Disposal Station. After the Mobile Unit is locked into place, the Disposal Station automatically empties the Collection Disc, sending the surgical fluid waste into the hospital's waste water system. The evacuation process also collapses the Disc to allow for easy disposal.
The provided text describes a 510(k) premarket notification for a medical device, the ORwell™ Fluid Collection and Disposal System. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove the device meets them in the context of, for example, a diagnostic AI or imaging device.
Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of regulatory submission and information provided.
However, I can extract the acceptance criteria (referred to as "performance attributes" in the document) and the reported device performance from the provided text as it relates to the comparison with predicate devices.
1. A table of acceptance criteria and the reported device performance:
The document describes "performance attributes" that were found acceptable for the intended use and compares them to predicate devices. It also outlines specific testing for the ORwell system.
| Design Feature / Acceptance Criteria | Predicate Device Performance (Stryker Neptune K012991) | Proposed Device Performance (ORwell™ Fluid Collection and Disposal System) | Comments / Proof of Meeting Criteria |
|---|---|---|---|
| Indications for Use | Collect and dispose of surgical fluid waste, and collect smoke. | Intended to collect and dispose of surgical fluid waste. | The new device and the predicate K040239 have the same claim of removing fluid. Removal of smoke evacuation feature does not raise new risks. |
| Closed System | Protects hospital personnel from splashes and biohazard exposure. | Protects hospital personnel from splashes, biohazard exposure, cross-contamination, and cleanliness issues. | The addition of protecting against cross-contamination and cleanliness issues does not raise new questions regarding safety. |
| Fluid Collection Disposable | Manifold and Canister | Manifold and Collection Liner | The addition of a collection liner for containment of waste fluid does not raise new questions regarding safety. |
| Product Code | FYD, Apparatus, Exhaust, Surgical (K012991) / BTA, Powered Suction Pump (K040239) | BTA, Powered Suction Pump | SAME (compared to K040239) |
| FDA Regulation, 21 CFR | 878.5070 (K012991) / 878.4780 (K040239) | 878.4780 | SAME (compared to K040239) |
| Dimensions - Mobile Unit | 18" width x 25" depth x 51" height | 23" width x 28" depth x 47" height | Dimensional differences do not affect safety or effectiveness. |
| Dimensions - Disposal Station | 25" width x 22" depth x 21.5" height | 34" width x 15" depth x 50" height | Dimensional differences do not affect safety or effectiveness. |
| Mobile Unit Electrical Requirements | UL 2601 Compliant, AC Powered, 110 V, 16 Amps | UL 60601-1 Compliant, AC Powered, 115 V, 12 Amps | Voltage and amperage differences do not raise new questions of safety and effectiveness. |
| Disposal Station Electrical Requirements | 120 V, 3 Amps | 115 V, 4 Amps | Voltage and amperage differences do not raise new questions of safety and effectiveness. |
| Suction Source | On-Board Pump | On-Board Pump | SAME |
| Mobile Unit Vacuum Range | 0-19" Hg | 0-19" Hg | SAME. Testing: "Vacuum Level Operating Range verification that, with regulator, vacuum operating range is within spec" was performed. Results: "Vacuum level operating range was found to be the same at 0" – 19" Hg". |
| Flow Rate (Fluid Suction) | Approximately 4.9 LPM (at maximum) | On 100% vacuum must be ≥ 5.0 LPM | Requirement Met: "Requirement met (using water) for high volume." Also, "maximum fluid suction flow rate was found to be comparable with ORwell™ performing at approximately 5 liters/minute and the predicate at approximately 4.9 liters/minute." |
| Vacuum Regulator | Knob-Controlled Bleeder Valve | Knob-Controlled Bleeder Valve | SAME |
| Fluid Suction Filter | HEPA, 99.97% efficiency @ 0.3 microns | HEPA, 99.97% efficiency @ 0.3 microns | SAME. Testing: "HEPA Filter Efficiency and Life - verification that filter assembly is HEPA efficient and has a life of ≥ 500 hours" was performed. |
| Emergency Back-Up Port | Yes | Yes | SAME |
| Single Patient Use | Single or Multiple Patients | Single Patient Use | The indication for single use increases clinician/patient safety by not allowing contaminated devices to be left in the OR for prolonged periods. This change does not raise new questions regarding effectiveness. |
| Canister Capacity | 20 L | 20 L | SAME |
| Suction Mode | Continuous | Continuous | SAME |
| OTC or Prescription | OTC | Prescription (RX only) | Devices are intended to be used in operating rooms, surgical centers, and doctor's offices. |
| Overflow Prevention Mechanism | Yes | Yes | SAME. Testing: "Overflow Valve Fluid Ingress overflow valve tested for fluid ingress effectiveness" was performed. |
| Pre-Filter | Single Use Disposable | Single Use Disposable | SAME |
| Suction Inlet Port Dimensions | 3/8 inch inner diameter | 1/4 inch inner diameter | Port size and design based off of currently acceptable Cardinal Health suction canister design. |
| Principles of Operation | Fluid and smoke suctioned; mobile unit docks for disposal; contents pumped into tank/drain. | Fluid suctioned; mobile unit docks for disposal; contents pumped directly into hospital waste line; disposable includes collection liner. | The manifold in the predicate has been augmented into a disposable in the proposed device. This enhances safety. |
| "Almost Full" Sensor | Not specified | Testing: "verification that light illuminates and audible alarm sounds at the appropriate pre-determined level" was performed. | |
| Fluid Trap Shutoff | Not specified | Testing: "fluid trap assembly tested for fluid ingress effectiveness" was performed. | |
| Disposal Station Valve Drip Prevention | Not specified | Testing: "verification that no dripping results after the fluid disposal process" was performed. | |
| Disposal Port Valve Opening Pressure | Not specified | Testing: "verification that the valve will prevent user from being exposed to biohazards" was performed. | |
| Instructions for Use | Not specified | Testing: "ORwell™ system tested for safe operation when being used per instructions for use" was performed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is primarily engineering performance testing to demonstrate equivalence, not clinical testing with patient data.
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)
This information is not applicable as the document describes technical/engineering performance testing, not diagnostic accuracy based on expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no human interpretation or ground truth adjudication described.
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
This information is not applicable as the device is a fluid collection and disposal system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the engineering performance tests would be the established engineering specifications, standards, and comparison data from the predicate device. For example, the "ground truth" for the vacuum range is 0-19" Hg, and the device was tested to verify it met this. The "ground truth" for filter efficiency is HEPA standard (99.97% @ 0.3 microns).
8. The sample size for the training set
This information is not applicable as the device is an electro-mechanical system, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is an electro-mechanical system, not an AI model.
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