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510(k) Data Aggregation
(431 days)
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg
This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.
The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP.
The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.
Foremount Disposable PVC Resuscitators are portable medical devices used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. They consist of Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional Diverter Ring, PEEP Valve and Manometer. Foremount Disposable PVC Resuscitators come in three sizes along with a ventilation bag:
- . Infant - Less than or equal to 10 kg
- Child less than or equal to 23 kg ●
- Adult Greater than 23 kg. ●
The ventilation bags are available in three sizes based upon the intended patient population. They are provided with masks in three sizes (#1 - Infant, #3 - Child, and #5 - Adult). The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 40 cmH2O pop off valve for Child and Infant models. The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 60 cmH2O pop off valve for Adult models.
This is a 510(k) premarket notification for the Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories, including a PEEP valve and a disposable manometer. The submission aims to demonstrate substantial equivalence to previously cleared devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define "acceptance criteria" in a dedicated table for each device component with specific numerical targets. Instead, it demonstrates performance by comparing the Foremount devices to their respective predicates or by stating that the device meets relevant ISO standards.
We can infer the acceptance criteria are met if the Foremount device's specifications and performance fall within acceptable limits defined by the predicate devices and applicable ISO standards.
Inferred Acceptance Criteria and Reported Device Performance (Resuscitator)
| Characteristic | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance (Foremount) |
|---|---|---|
| General | ||
| Indications for Use | Single patient use manual resuscitator for hospital, transport, emergency, and post-hospital care to temporarily ventilate in given body mass ranges. | Same as predicate: Infant ≤ 10Kg, Child ≤ 23 Kg, Adult > 23 Kg (for Models A1, B1); Adult > 23 Kg (for Models A2, B2) |
| Patient Population | Infant ≤ 10Kg, Child ≤ 23 Kg, Adult > 23 Kg | Same as predicate |
| Environment of Use | Hospital, transport, emergency, post-hospital care | Same as predicate |
| Duration of Use | Single patient, disposable < 24 hours | Single patient, disposable < 24 hours |
| Operational Temperature | -18°C ~ 50°C | -18°C ~ 50°C |
| Storage Temperature | -40°C ~ 60°C | -40°C ~ 60°C |
| Functional Performance (ISO 10651-4 and others) | ||
| Dimensions (Size) | Adult: 570x190 mm, Child: 510x190 mm, Infant: 430x180 mm (Predicate) | Adult: 445x190 mm, Child: 350x177 mm, Infant: 325x165 mm. Note: Differences in dimensions were assessed and did not raise new safety/effectiveness concerns. |
| Ventilation Bag Volume | Adult 1500 ml, Child 600ml, Infant 280 ml (Predicate) | Adult 1700 ml, Child 500 ml, Infant 320 ml. Note: Differences in volume were assessed and did not raise new safety/effectiveness concerns, as ISO 10651-4 specifies minimum requirements. |
| Oxygen Collection Bag Volume | Adult 1000 ml, Child 1000 ml, Infant 500 ml (Predicate) | Adult 1000 ml, Child 1000 ml, Infant 600 ml |
| Max Stroke Volume (single hand) | Adult 700 ml, Child 360 ml, Infant 150 ml (Predicate) | Adult 650 ml, Child 370 ml, Infant 180 ml. Note: Differences in volume were assessed and did not raise new safety/effectiveness concerns as ISO 10651-4 specifies minimum requirements. |
| Dead Space | 4.5 ml (measured) / 6.8 ml (labeled) for all sizes (Predicate) | ~ 3.8 ml for all sizes |
| Inspiratory Resistance | Infant: ≤ 0.5cm H2O, Child: ≤ 0.7cm H2O, Adult: ≤ 3.3cm H2O (Predicate) | Infant: 0.5cm H2O, Child: 0.5cm H2O, Adult: 3cm H2O |
| Expiratory Resistance | Infant: ≤ 0.8cm H2O, Child: ≤ 0.8cm H2O, Adult: ≤ 2.6cm H2O (Predicate) | Infant: 0.5cm H2O, Child: 0.5cm H2O, Adult: 2.8 cmH2O |
| Supplemental Oxygen % | Comparable to predicate at various flow rates and tidal volumes (e.g., Infant Vt-70ml x 20bpm: 91/97/99% at 2/5/10 lpm) | Infant Vt-70ml x 20bpm: 90/98/98% at 2/5/10 lpm (and other comparable values). |
| Pop-Off or Pressure Limiting | 40 cm H2O (Infant/Child), 60 cm H2O (Adult) | 40 cm H2O (Infant/Child), 60 cm H2O (Adult) |
| Ability to add PEEP valves | Yes, 0-20 cm H2O | Yes, 0-20 cm H2O |
| Patient connectors | 15 / 22 mm (standard) | 15 / 22 mm |
| PEEP valve fittings | 22 / 30 mm (standard) | 22 / 30 mm |
| Biocompatibility | Non-cytotoxic, non-sensitizers, non-irritants; meets ISO 10993-5, -10, -11; ISO 18562-2 for PM2.5 and inorganic gases. | Found to be non-cytotoxic, non-sensitizers, non-irritants. Tests for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Gas emission (VOC), PM2.5, Inorganic gases (Ozone, CO, CO2) were performed. |
| Materials | PVC, Polycarbonate, Silicone (Predicate) | PVC, Polycarbonate, Silicone |
| Conical connectors | Meets ISO 5356-1 | Meets ISO 5356-1 |
| Shelf-life | 3 years (Predicate) | 5 years. Note: This is a difference, but the document concludes no new safety or effectiveness concerns are raised. |
Inferred Acceptance Criteria and Reported Device Performance (PEEP Valve)
| Characteristic | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance (Foremount) |
|---|---|---|
| Indications for Use | Single patient use PEEP valve for hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric. | Same as predicate |
| Pressure range | 2.5 to 10 cmH2O; 5 to 20 cmH2O (Predicate) | 0 to 10 cmH2O; 5 to 20 cmH2O. Note: Broader lower range, but within similar operational function. |
| Adjustable | Yes (Predicate also had fixed options) | Yes |
| Accuracy | +/- 2 cmH2O | +/- 2 cmH2O |
| Connectors | 22 mm / 30 mm (standard) | 22 mm / 30 mm |
| Biocompatibility | Meets biocompatibility standards for externally communicating, limited duration use. | Externally communicating, limited duration of use (<24 hours). Materials are Polycarbonate, Silicone, Stainless Steel spring; passed biocompatibility testing. |
| Materials | Polycarbonate, Silicone, Stainless Steel spring (Predicate) | Polycarbonate, Silicone, Stainless Steel spring |
| Performance Testing | Accuracy, Repeatability, Effects of Aging, Drop Test, Conical fittings | All listed tests were performed. Results implicitly met 'acceptance criteria' by demonstrating substantial equivalence, though specific numerical results beyond accuracy were not detailed in the comparison table. |
Inferred Acceptance Criteria and Reported Device Performance (Disposable Manometer)
| Characteristic | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance (Foremount) |
|---|---|---|
| Indications for Use | Single patient use manometer for monitoring patient's airway pressure during ventilation, used with resuscitation systems. | Same as predicate |
| Pressure range | 0 to 60 cmH2O | 0 to 60 cmH2O |
| Markings | Increments of 10 cmH2O | Increments of 10 cmH2O |
| Accuracy | ±2 cmH2O @ 0-10 cmH2O, ±4 cmH2O @ 20 cmH2O, ±5 cmH2O @ 30-40 cmH2O, ±7 cmH2O @ 50-60 cmH2O (Predicate) | ±1 cmH2O @ 0-10 cmH2O, ±2 cmH2O @ 20-30 cmH2O, ±3 cmH2O @ 40-60 cmH2O. Note: The Foremount device reports better accuracy than the predicate. This difference is considered acceptable as it is a performance improvement. |
| Connectors | 15 / 22 mm (standard) | 15 / 22 mm |
| Biocompatibility | Meets biocompatibility standards for externally communicating, limited duration use. | Externally communicating, limited duration of use (<24 hours). Materials are Polycarbonate, Silicone, Stainless Steel Springs; passed biocompatibility testing. |
| Materials | Polycarbonate, Silicone, Stainless Steel Springs (Predicate) | Polycarbonate, Silicone, Stainless Steel Springs |
| Performance Testing | Accuracy, Repeatability, Effects of Aging, Drop Test, Conical fittings | All listed tests were performed. Results implicitly met 'acceptance criteria' by demonstrating substantial equivalence, though specific numerical results beyond accuracy were not detailed in the comparison table. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing. It does not specify a "test set" in terms of patient data. The testing involves physical samples of the devices.
- Sample Size: Not explicitly stated for each individual bench test. The nature of the tests (e.g., stroke volume, resistance, oxygen concentration, drop test, aging) implies a sufficient number of devices were tested to draw statistically valid conclusions for engineering verification.
- Data Provenance: This is bench testing data, originating from the manufacturer's testing facilities (Foremount Enterprise Co., Ltd. in Taichung City, Taiwan). It is prospective in that the testing was performed specifically for this 510(k) submission. No patient data (retrospective or prospective) is mentioned as this is a physical device rather than an AI/software device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as this submission concerns the hardware and functional performance of medical devices (resuscitators, PEEP valves, manometers) and involves bench testing against engineering standards and predicate device performance, not clinical studies involving expert interpretation of data or images.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication typically refers to the process of resolving disagreements between experts in clinical studies or image review. Bench testing results are objective measurements against specified standards or comparative measurements against predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI or imaging software where human readers' performance with and without AI assistance is evaluated on a set of cases. This submission is for a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a physical medical device. There is no "algorithm" or standalone AI component. Performance is assessed through comprehensive bench testing of the device's physical and functional attributes.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established by:
- Engineering Standards: Primarily ISO 10651-4:2002 (Lung ventilators - Particular requirements for operator-powered resuscitators) and ISO 5356-1:2004 (Anaesthetic and respiratory equipment - Conical connectors).
- Predicate Device Performance: The performance characteristics (e.g., stroke volume, resistance, oxygen concentration, accuracy for PEEP and manometer) of the legally marketed predicate devices (K082092 - GaleMed Dispo-Bag Manual Resuscitator and K122077 - Intersurgical - Airway Pressure Manometer) serve as a comparative benchmark.
- Biocompatibility Standards: ISO 10993 series and ISO 18562-2 for material safety.
8. The Sample Size for the Training Set
Not applicable. This submission is for hardware medical devices. There is no concept of a "training set" as there is no AI algorithm being developed or submitted. The devices are manufactured based on design specifications and then tested.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Since there is no "training set," the concept of establishing ground truth for it does not apply.
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