(391 days)
The Amron International Treatment Hood is intended to provide a means to administer gas/oxygen/air to a patient by a clinician in clinical multiplace or monoplace chamber systems.
The Amron International Oxygen Treatment Hood, Model 8891, was designed for easy use and cost effective operation within a multiplace or monoplace hyperbaric chamber. The hood assembly is placed over a person's head for treating a person with a gas such as oxygen. The assembly includes a reusable neck ring which fits over a user's head, a tubular latex neck seal with one end connected to the neck ring and the other configured to fit around the user's neck, and a transparent hood fastened to a hood ring that can be sealed against the neck ring. Supply and exhaust tubes direct gas into and out the hood through ports located on the neck ring, The supply and exhaust locations allow oxygen to circulate easily throughout the hood increasing performance while reducing noise levels. Supply gas also helps cool the user reducing potential overheating and continuously defogs the hood's optical window.
The provided text is a 510(k) summary for the Amron International Treatment Hood (K011592) and an FDA clearance letter. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically expected for an AI/ML medical device.
This document details the submission of a conventional medical device and focuses on establishing substantial equivalence to a predicate device (Sea-Long Medical Treatment Hood, K010659) through a comparison of technological characteristics. The "studies" mentioned are non-clinical tests run to evaluate performance, not clinical studies involving patient data or AI/ML algorithms.
Therefore, most of the requested information (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training sets) is not applicable to this type of device and submission.
Here's a breakdown of what can be extracted and why other parts cannot:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document implies that the "acceptance criteria" were essentially demonstrating functional equivalence to the predicate device (Sea-Long Treatment Hood, K010659) across several key performance indicators and technological characteristics. The FDA's clearance indicates that the Amron device "is substantially equivalent" to the predicate.
Reported Device Performance:
| Technological Characteristics | Amron Treatment Hood (K011592) Performance/Description | Sea-Long Treatment Hood (K010659) (Predicate) |
|---|---|---|
| Physical Size & Shape of Treatment Hood | 12"Ø x 12" High cylinder shape | Same |
| Vinyl Hood with Ring | Clear vinyl hood attached to hood ring with viewing window | Same |
| Neck Ring | Offset neck ring with o-ring | Same |
| Supply & Exhaust Connectors | Molded in 22 mm connectors located on front of neck ring | Same |
| Multi-Access Port | Molded in and located on front of neck ring between supply & exhaust connectors | Same |
| Neck Seal | Attached to neck ring and seals around patient's neck | Same |
| Intended Use | For use in hyperbaric Oxygen Therapy (HOT) | Same |
| Non-clinical tests (evaluated) | Oxygen and carbon dioxide levels, flow characteristics, sealing, fogging, cooling effect on patient, noise level | (Implied to be comparable or substantially equivalent) |
Study Proving Acceptance: The study comprised "Non-clinical tests" run for performance at different flow rates and ATA (atmospheres absolute). The conclusion was that the Amron International Treatment Hood "was found to be functionally identical to the Sea-Long Treatment Hood and their technological characteristics are the same."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This was a physical device, and the "tests" were non-clinical performance evaluations, not data-driven tests on a 'test set' of patient data.
- Data Provenance: Not applicable for the same reason.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in the context of AI/ML or diagnostic devices involving expert review is not relevant here. The "ground truth" for this device would be established engineering specifications and performance benchmarks, not expert labels on data.
4. Adjudication method for the test set:
- Not Applicable. No multiple expert review or adjudication process is described for this type of device evaluation.
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:
- No. This is not an AI/ML device, nor one designed to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this device is its adherence to design specifications and its functional performance (e.g., maintaining specific oxygen/CO2 levels, flow characteristics, sealing, cooling, noise level) as demonstrated by non-clinical engineering tests, not by expert consensus on biological data or pathology.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this device.
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Image /page/0/Picture/0 description: The image shows the logo for AMRON International. The word "AMRON" is in large, bold, sans-serif font, with a wave-like design extending from the right side of the "N". Below "AMRON" is the word "INTERNATIONAL" in a smaller, bold, sans-serif font, set against a solid black rectangle. The logo is simple and professional, with a focus on the company name.
510(k) Summary for Amron International Treatment Hood (K011592)
Date
March 27, 2002
To
Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850
Submitter
Amron International Diving Supply, Inc. 759 West Fourth Avenue Escondido. CA 92025 Phone: (760) 746-3834 Fax: (760) 746-1508 Contact: Scott Ritchie
Name of Device
Proprietary Name: Amron Treatment Hood Common/Usual Name: Treatment Hood
Equivalent Device
Sea-Long Medical Treatment Hood, 510(k) No. K010659
Device Description
The Amron International Oxygen Treatment Hood, Model 8891, was designed for easy use and cost effective operation within a multiplace or monoplace hyperbaric chamber. The hood assembly is placed over a person's head for treating a person with a qas such as oxygen.
The assembly includes a reusable neck ring which fits over a user's head, a tubular latex neck seal with one end connected to the neck ring and the other configured to fit around the user's neck, and a transparent hood fastened to a hood ring that can be sealed against the neck ring.
Supply and exhaust tubes direct gas into and out the hood through ports located on the neck ring, The supply and exhaust locations allow oxygen to circulate easily throughout the hood increasing performance while reducing noise levels. Supply gas also helps cool the user reducing potential overheating and continuously defogs the hood's optical window.
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Image /page/1/Picture/0 description: The image shows the logo for AMRON International. The word "AMRON" is in large, bold, black letters, with a wave design extending from the right side of the "N". Below "AMRON" is the word "INTERNATIONAL" in smaller, bold, white letters against a black background. The logo appears to be for a company named AMRON International.
510(k) Summary for Amron International Treatment Hood (K011592)
Intended Use
The Amron International Treatment Hood is intended to provide a means to administer gas/oxygen/air to a patient by a clinician in clinical multiplace or monoplace chamber system.
Technological Characteristics of Amron Hood Compared to Predicate Device
Non-clinical tests were run for performance at different flow rates and ATA. Oxygen and carbon dioxide levels, flow characteristics, sealing, fogging, cooling effect on patient, and noise level were also evaluated.
The Amron International Treatment Hood was found to be functionally identical to the Sea-Long Treatment Hood and their technological characteristics are the same.
| TechnologicalCharacteristics | Amron Treatment Hood(K011592) | Sea-Long Treatment Hood(K010659) |
|---|---|---|
| Physical Size & Shape ofTreatment Hood | 12"Ø x 12" Highcylinder shape | Same |
| Vinyl Hood with Ring | Clear vinyl hood attached tohood ring with viewing window | Same |
| Neck Ring | Offset neck ring with o-ring | Same |
| Supply & Exhaust Connectors | Molded in 22 mm connectorslocated on front of neck ring | Same |
| Multi-Access Port | Molded in and located on frontof neck ring between supply &exhaust connectors | Same |
| Neck Seal | Attached to neck ring and sealsaround patient's neck | Same |
| Intended Use | For use in hyperbaric OxygenTherapy (HOT) | Same |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
JUN 1 9 2002
Amron International Diving Supply, Inc. c/o Ms. Norma F. Ockwig 759 West Fourth Avenue Escondido, CA 92025
Re: K011592
Amron Oxygen Treatment Hood Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II (two) Product Code: CBF Dated: undated Received: March 29, 2002
Dear Ms. Ockwig:
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 - Ms. Norma Ockwig
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely vours.
N. Olatunji
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K011592
Device Name: Amron International Treatment Hood
Indications for Use:
The Amron International Treatment Hood is intended to provide a means to administer gas/oxygen/air to a patient by a clinician in clinical multiplace or monoplace chamber systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
| Prescription Use |
|---|
| (Per 21 CFR 801.109) |
Division of Cardiovascular & Respiratory Devices
510(k) Number K011592
§ 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).