(287 days)
The SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: Air or Gas Embolism; Carbon Monoxide / Smoke Inhalation; Compromised Skin Grafts and Flaps; Crush Injuries / Acute Traumatic Ischemia; Decompression Sickness; Enhanced Healing in Selected Problem Wounds; Exceptional Blood Loss (Anemia); Gas Gangrene (Clostridia Myonecrosis); Intracranial Abscess; Necrotizing Soft Tissue Infections; Radiation Tissue Damage (Osteoradionecrosis); Refractory Osteomyelitis; Thermal Burns.
The SIGMA Elite Series Hyperbaric Chambers and their predicate devices have the same intended use; as a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA. The SIGMA Elite Series Hyperbaric Chambers and their predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with pure oxygen, and the patient breathes the chamber atmosphere. Also, in each of the chambers, the pressure-time profile (i.e. the rate and direction of pressure change and the time held at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or an automatic electronic system. The purpose of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is safe and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance.
The provided text is for a 510(k) submission for a hyperbaric chamber, which is a medical device, and does not involve AI or algorithms that would have a "reported device performance" in the typical sense of diagnostic metrics like sensitivity or specificity.
Therefore, the specific information requested in the prompt, such as "reported device performance," "sample size," "ground truth," "MRMC study," and "training set," is not applicable to this type of device submission.
Instead, the acceptance criteria for this device are demonstrated by its compliance with recognized industry standards for design, manufacturing, and safety. The "study" that proves the device meets these criteria is a series of engineering and safety tests to ensure it adheres to these standards.
Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the difference in device type:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Compliance) | Reported Device Performance (Demonstrated Compliance) |
|---|---|
| ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, 2003 Edition | Device is designed and manufactured in accordance with this standard. (Implies passing pressure vessel construction requirements) |
| ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy, 2002 Edition | Device is designed and manufactured in accordance with this standard. (Implies passing safety requirements for human occupancy in pressure vessels) |
| NFPA 99, Standard for Health Care Facilities, Chapter 19, Hyperbaric Facilities, 2005 Edition | Device is designed and manufactured in accordance with this standard. (Implies compliance with fire and life safety requirements for hyperbaric facilities) |
| CAN/CSA C22.2 60601-1-1-02 Safety Requirements for Medical Electrical Systems, 2002 Edition | Device is designed and manufactured in accordance with this standard. (Implies meeting safety requirements for medical electrical systems) |
| EN60601-1-2:2002 EMC Standard for Medical Devices, 2002 Edition | Device is designed and manufactured in accordance with this standard. (Implies compliance with electromagnetic compatibility requirements for medical devices) |
| Intended Use | The SIGMA Elite Series Hyperbaric Chambers and their predicate devices have the same intended use: as a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA. Testing indicated that the devices meet the referenced standards. The device is substantially equivalent to legally marketed predicate devices for the conduct of hyperbaric oxygen therapy. (Implies functional performance for safe delivery of hyperbaric oxygen therapy at specified pressure, with controlled pressure-time profile and oxygen ventilation rate.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore not provided in the document. As a physical medical device (hyperbaric chamber), the "test set" would refer to the chambers themselves undergoing engineering and safety testing, not a dataset of patient information or images. The "provenance" would be the manufacturing location and standard compliance testing, not 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)
This is not applicable to the submission for a hyperbaric chamber. The "ground truth" for this device is compliance with engineering and safety standards, validated through testing by qualified engineers and technicians, not by medical experts interpreting results from the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review for diagnostic performance. For a hyperbaric chamber, it's about meeting quantifiable engineering and safety standards through documented testing, not subjective assessment.
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
There was no MRMC comparative effectiveness study done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This submission is for a physical medical device (hyperbaric chamber) and does not involve AI or human readers in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a hyperbaric chamber, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness relies on adherence to established engineering, safety, and medical device standards (ASME, NFPA, CAN/CSA, EN standards). These standards themselves represent a form of "ground truth" in terms of what constitutes a safe and functional hyperbaric chamber, based on collective expert consensus in engineering and healthcare safety fields.
8. The sample size for the training set
This is not applicable. There is no "training set" for a hyperbaric chamber in the context of an algorithm or AI.
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set" for this type of device.
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Perry Baromedical Corporation 510(k) Submission
:
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Page 10
JUN 1 1 2008
| Perry Baromedical Corporation | July 12, 2007 | |
|---|---|---|
| 510(k) SUMMARY | ||
| 1. | SubmitterInformation | Perry Baromedical Corporation (“PBC”)3660 Interstate Parkway, Riviera Beach, Florida 33404 |
| 2. | ContactInformation | John Crocker, Quality ManagerTel: (561) 840-0395 Ext. 206 Fax: (561) 840-0398 |
| 3. | Trade Name | SIGMA Elite XX Monoplace Hyperbaric ChamberWhere XX can be 34, 36, or 40 |
| 4. | Common Name | Hyperbaric Chamber |
| 5. | Device Class | Class II |
| 6. | Product Code | CBF |
| 7. | ProductClassification | per 21 CFR § 868.5470 |
| 8. | ClassificationPanel | Anesthesiology |
| 9. | PredicateDevices | Perry Baromedical's, SIGMA 34 (K990927)Sechrist Industry's, Sechrist 3300E/ER (K052713)Environmental Techtonics' BARA-MED (K020974) |
| 10. | DeviceDescription | The SIGMA Elite Series Hyperbaric Chambers and their predicate deviceshave the same intended use; as a prescription device intended for the wholebody administration of oxygen to a patient at pressures not exceeding 3 ATA.The SIGMA Elite Series Hyperbaric Chambers and their predicate deviceshave very similar general principles of operation. All of these chambers arepressurized and ventilated continuously with pure oxygen, and the patientbreathes the chamber atmosphere. Also, in each of the chambers, thepressure-time profile (i.e. the rate and direction of pressure change and thetime held at any particular pressure), as well as the oxygen ventilation rate ofany treatment, are controlled by the chamber's operator, either directly bymeans of a pneumatic or an automatic electronic system. The purpose of suchcontrols are to be able to conduct the particular hyperbaric oxygen treatmentprescribed by the physician in a way that is safe and comfortable for thepatient, and to be able to respond appropriately and effectively to anycontingency circumstance. |
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The SIGMA Olite Series of Hyperbaric Chambers is designed and manufactured in accordance with the applicable sections of:
- ASME Boiler and Pressure Vessel Code, Section VIII, Rules for . Construction of Pressure Vessels, Division 1, 2003 Edition
- ASME PVHO-1, Safety Standard for Pressure Vessels for Human . Occupancy, 2002 Edition
- NFPA 99, Standard for Health Care Facilities, Chapter 19, . Hyperbaric Facilities, 2005 Edition
- CAN/CSA C22.2 60601-1-1-02 Safety Requirements for Medical . Electrical Systems, 2002 Edition EN60601-1-2:2002
- EMC Standard for Medical Devices, 2002 Edition .
- These devices are to be used by properly trained personnel to deliver Intended Use 11. hyperbaric oxygen therapy as prescribed by the attending physician. Testing was indicated to demonstrate that the devices meet the standards 12. Performance Data referenced above.
- Clinical Tests None 13.
-
- Conclusion In all respects, the SIGMA Glite Series of Hyperbaric Chambers are substantially equivalent to one or more clinical monoplace hyperbaric chambers that are legally marketed for the conduct of hyperbaric oxygen therapy.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text surrounding a stylized image of an eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with its wings forming a protective shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 2008
Mr. John Crocker Quality Manager Perry Baromedical Corporation 3660 Interstate Parkway Riviera Beach, Florida 33404
Re: K072427
Trade/Device Name: SIGMA Elite 34, 36, and 40 Regulation Number: 21CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: May 29, 2008 Received: June 2, 2008
Dear Mr. Crocker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Crocker
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sayette Y. Michaud.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Perry Baromedical Corporation 510(k) Submission K072427
Supplemental Materials Request Page Amendment 9(a)
Indications for Use Statement
| 510(k) Number | K072427 |
|---|---|
| Device Name | SIGMA Elite 34, 36, and 40 |
| Indications for Use | The SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: Air or Gas EmbolismCarbon Monoxide / Smoke InhalationCompromised Skin Grafts and FlapsCrush Injuries / Acute Traumatic IschemiaDecompression SicknessEnhanced Healing in Selected Problem WoundsExceptional Blood Loss (Anemia)Gas Gangrene (Clostridia Myonecrosis)Intracranial AbscessNecrotizing Soft Tissue InfectionsRadiation Tissue Damage (Osteoradionecrosis)Refractory OsteomyelitisThermal Burns |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
(Division Sign-Off)Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
・
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ X (Per 21 CFR 801.109)
:
OR
Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
§ 868.5470 Hyperbaric chamber.
(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).