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510(k) Data Aggregation
(399 days)
TAMPA HYPERBARIC ENT.
Intended use of our device is to correct tissue hypoxia for treatment of:
*Air or gas embolisms
*Decompression sickness
Carbon monoxide poisoning with or without cyanide complications
Smoke inhalation
Exceptional blood loss or anemia
Clostridial myonecrosis (gangrene)
Selected problem chronic wounds
Crush injury, compartment syndrome and acute traumatic ischemias
Compromised skin grafts
Osteomyelitis
Thermal burns
Osteoradionecrosis (radiation burns)
Necrotizing soft tissue infections
*In gas embolism and decompression sickness hyperbaric oxygenation van be used as a primary therapy. In the other indications hyperbaric oxygenation is an adjunctive treatment to further primary medical intervention.
Tampa Hyperbaric Monoplace Chamber
Stainless steel; supine patient position on gurney; eight acrylic viewports on 36" diameter chamber. All interior materials cleaned for oxygen service. Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy.
The provided text is a 510(k) premarket notification letter and summary for a medical device, specifically a hyperbaric chamber. It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.
However, the provided text does not contain any information about acceptance criteria, a study proving device performance against acceptance criteria, or any of the detailed diagnostic performance metrics (e.g., sample size, provenance, expert qualifications, study types like MRMC or standalone performance, ground truth methods, or training set details).
The document is a regulatory submission for premarket notification, focusing on establishing substantial equivalence to an existing device based on physical characteristics and intended use, rather than a clinical performance study demonstrating diagnostic efficacy using specific acceptance criteria.
Therefore, I cannot provide the requested information.
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(318 days)
TAMPA HYPERBARIC ENT.
Decompression sickness; Carbon monoxide with or without cyanide poisoning; Smoke inhalation; Exceptional blood loss; Clostridial myonecrosis; Crush injury, compartment syndrome and acute traumatic ischemias; Selected Problem Wounds; Compromised skin grafts; Osteomyelitis; Osteoradionecrosis; Thermal burns; Necrotizing soft tissue infections.
This hyperbaric chamber is generally safe and effective when used within documented parameters relative to decompression table times for repeitive use. The intake and exhaust valves are sized (½") to slow the time required for full compression and decompression. This provides a fail-safe method for filling the chamber with air and alternately releasing the air prior to egress. It requires 15 minutes to fill the chamber to the optimum working pressure (15 psig) and 8 minutes to depressurize the chamber. While this is slower than most chambers already on the market the longer time is actually more comfortable for the patients. Incidental temporary side-effects (i.e. eardrum pain or damage and psychological anxicty) arc rare if contraindications are screened and the attendant monitors the occupant. While some more serious side-effects (i.e. collapsed lung and oxygen toxicity) were documented in other similar hyperharic chambers, those problems were evoked at greater pressures with the increased risk of those type medical misadventures. On the other hand, this device has the relief valve designed to limit pressure to 21 psig. This added feature effectively limits risk and assures overall safety to hyperbaric chambers already in commercial use.
The chamber uses an in-swinging steel hatch door with a rubber "O" ring in the contacting face. There is no latch or other device to lock. A reasonable push against the hatch while the air pressure rises will initiate hatch closure. Air pressure holds the hatch securely closed. There are no high voltage devices placed inside this hyperbaric chamber. There are no new technological materials used. There are manual air pressure valves to prevent inadvertent or unauthorized changes. There are no exposed sharp edges in tank construction. The construction is mechanically stable and has no exposed moving parts. The hyperbaric chamber is secure from vibration and offers 3/8 inch thick steel protection to the occupants in the unlikely event of an outside catastrophe. The occupants have an internal emergency release valve for additional security. The tank construction is coated to withstand fluid spills. The chamber is certified to operate within specifications up to 150° F and has been hydrostatically tested to assure performance. The surface temperature of the chamber does not increase during its operation. The air is certified pure breathing quality. There are no wires in the device that could risk strangulation. This device is intended to have operator assistance to monitor the activity inside and outside the hyperbaric chamber .
There are four small chairs bolted inside the chamber along a certified welded angle iron. This allows patients to sit during the hyperbaric sessions. There is adequate room for these four chairs to be removed and replaced with two cots bolted along the same angle iron without welding any new metal to the chamber (new welds would void certification). There are two certified viewports for visual inspection of the occupants.
Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Effectiveness: | Raise absolute air pressure to double partial pressure of oxygen. | "This device raises the absolute air pressure to a level that has been documented to double the partial pressure of oxygen in breathing quality air." (Implies it meets this criterion) |
| Effectiveness: | Increase partial pressure of oxygen in body tissues. | "This effectively raises the available partial pressure of oxygen during normal inspiration. With the addition of higher percentages of oxygen via oronasal mask the partial pressure of oxygen in body tissues can be increased 10 times above natural atmospheric conditions." (Implies it meets this criterion) |
| Safety: | Safe and effective when used within documented parameters. | "This hyperbaric chamber is generally safe and effective when used within documented parameters relative to decompression table times for repetitive use." (Implies it meets this criterion) |
| Safety: | Fail-safe method for filling and depressurizing chamber. | "The intake and exhaust valves are sized (½") to slow the time required for full compression and decompression. This provides a fail-safe method for filling the chamber with air and alternately releasing the air prior to egress." (Implies it meets this criterion) |
| Safety: | Fill time to 15 psig. | "It requires 15 minutes to fill the chamber to the optimum working pressure (15 psig)..." (Meets this criterion) |
| Safety: | Depressurization time. | "... and 8 minutes to depressurize the chamber." (Meets this criterion) |
| Safety: | Limit pressure. | "this device has the relief valve designed to limit pressure to 21 psig." (Meets this criterion) |
| Safety: | Hatch closure mechanism. | "The chamber uses an in-swinging steel hatch door with a rubber 'O' ring in the contacting face. There is no latch or other device to lock. A reasonable push against the hatch while the air pressure rises will initiate hatch closure. Air pressure holds the hatch securely closed." (Meets this criterion for secure closure based on design.) |
| Safety: | Absence of high voltage, new technology, sharp edges. | "There are no high voltage devices placed inside this hyperbaric chamber. There are no new technological materials used. ... There are no exposed sharp edges in tank construction." (Meets these explicit criteria) |
| Mechanical Stability: | Secure from vibration, mechanically stable. | "The construction is mechanically stable and has no exposed moving parts. The hyperbaric chamber is secure from vibration..." (Meets these explicit criteria) |
| Protection: | 3/8 inch thick steel protection. | "...offers 3/8 inch thick steel protection to the occupants..." (Meets this explicit criterion) |
| Safety: | Internal emergency release valve. | "The occupants have an internal emergency release valve for additional security." (Meets this explicit criterion) |
| Material Compatibility: | Coated to withstand fluid spills. | "The tank construction is coated to withstand fluid spills." (Meets this explicit criterion) |
| Operating Conditions: | Operate within specifications up to 150°F. | "The chamber is certified to operate within specifications up to 150° F..." (Meets this explicit criterion) |
| Performance Testing: | Hydrostatically tested for performance. | "...and has been hydrostatically tested to assure performance." (Meets this explicit criterion) |
| Material Compatibility: | No toxic materials in contact with patient/operator. | "No toxic materials come into contact with the patient, operator or attendant." (Meets this explicit criterion) |
| Air Quality: | Certified pure breathing quality air. | "The air is certified pure breathing quality." (Meets this explicit criterion) |
| Design: | No wires to risk strangulation. | "There are no wires in the device that could risk strangulation." (Meets this explicit criterion) |
| Certification (General): | Certified by American Society of Mechanical Engineers (ASME). | "Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy." (Meets this criterion for both predicate and our device, indicating compliance with industry standard) |
| Comparison (Intended Use): | Must align with predicate device's intended use (except where noted) | "All the prior listed indications except air or gas embolism." (Acknowledged difference from predicate; implied acceptance for the listed indications.) |
| Comparison (Safety Features): | Comparable safety features to predicate devices. | Comparison tables detail specific safety features and operational methods (e.g., manual vs. electric controls, hatch design, fire safety) which are presented as either equivalent or with justification for differences (e.g., manual controls are safe). |
| Comparison (Physical Char.): | Comparable physical characteristics to predicate devices. | Comparison tables detail materials (Carbon steel vs. Stainless steel), patient positioning, attendant access, pressurization methods, and monitoring systems, which aim to demonstrate substantial equivalence while noting differences. |
Study Proving Device Meets Acceptance Criteria:
The document states: "This hyperbaric device has passed clinical trial tests to verify that it does indeed raise the available partial pressure of oxygen in body tissues."
This is the primary statement regarding a study's completion to meet the effectiveness criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document simply mentions "clinical trial tests" without providing details on the number of subjects or cases involved in these trials.
- Data Provenance: The document does not specify the country of origin for the clinical trial data. It states the manufacturer is located in Tampa, Florida, implying US provenance, but this is not explicitly confirmed for the clinical trial data itself. The trials are described as prospective, indicated by "This hyperbaric device has passed clinical trial tests to verify that it does indeed raise the available partial pressure of oxygen in body tissues," suggesting the device was tested to verify its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document mentions "clinical trial tests" but does not detail how the results were adjudicated or if expert consensus was used to define "raising the available partial pressure of oxygen in body tissues."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No specific MRMC comparative effectiveness study is mentioned. The document focuses on the performance of the device itself, not on differences in human reader performance with or without AI assistance. This device is a hyperbaric chamber, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a hyperbaric chamber, not a standalone algorithm. Its performance is measured directly by its physical and physiological effects, not by an algorithm's output.
7. Type of Ground Truth Used
- For the effectiveness claim ("raise the available partial pressure of oxygen in body tissues"), the ground truth would likely be physiological measurements (e.g., arterial blood gas analysis, transcutaneous oxygen monitoring) confirming the elevated partial pressure of oxygen in body tissues after hyperbaric treatment. The document states this was verified via "clinical trial tests," implying objective, measurable outcomes.
- For safety claims, the ground truth would be a combination of:
- Engineering specifications and tests: (e.g., hydrostatic testing, pressure limit, valve sizing, material thickness).
- Observational data from clinical use: (e.g., incidence of side effects, comfort levels).
- Compliance with standards: (e.g., ASME certification).
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device (hyperbaric chamber), not a machine learning model, and therefore does not have a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
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