(213 days)
The Cheen Houng Pocket Rescue is indicated for mouth to mask ventilation of a nonbreathing adult.
Exhaled Air Pulmonary Resuscitators
The provided text is a 510(k) summary for the "Pocket Rescue" Exhaled Air Pulmonary Resuscitator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study data with acceptance criteria and performance metrics in the way a new, high-risk device might.
Based on the provided document, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary states, "The Cheen Houng Enterprise Co., Ltd. Exhaled Air Pulmonary Resuscitators are similar in intended use, design, material selection, performance and function to Exhaled Air Pulmonary Resuscitators which are currently legally and safely marketed in the United States. No new technological characteristics that could affect safety or effectiveness have been introduced." This indicates a comparison to a predicate device's existing performance, but no specific acceptance criteria or new performance data for the Pocket Rescue are detailed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission is a 510(k) for substantial equivalence, not a report of a new clinical study with a specified test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. There is no mention of an expert panel or ground truth establishment relevant to a clinical study for this device.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. A 510(k) for a device like a manual resuscitator is unlikely to involve an MRMC study.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The device is a manual resuscitator, not an AI algorithm.
7. Type of Ground Truth Used
This information is not provided. Given the nature of the device and the 510(k) submission, a "ground truth" as typically understood in AI/imaging studies is not relevant here.
8. Sample Size for the Training Set
This information is not applicable. The device is a manual medical tool, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
Summary of Device and Approval Process:
The Cheen Houng Enterprise Co., Ltd. "Pocket Rescue" Exhaled Air Pulmonary Resuscitator was granted 510(k) clearance (K970688) by the FDA on September 26, 1997. The basis for clearance was a demonstration of substantial equivalence to existing legally marketed Exhaled Air Pulmonary Resuscitators. The submission argues that the device is "similar in intended use, design, material selection, performance and function" and introduces "no new technological characteristics that could affect safety or effectiveness."
The indicated use for the Cheen Houng Pocket Rescue is "for mouth to mask ventilation of a nonbreathing adult," with an optional oxygen port. This process relies on a comparison to a predicate device's established safety and effectiveness, rather than new, independent clinical trials with explicit acceptance criteria and performance data for the submitted device itself.
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Page 14 CHEEN HOUNG ENTERPRISE CO. LTD.
23, ALLEY 11, LANE 65, SAN DREEN ST., SHULIN (238) TAIPEI SHENG, TAIWAN, R.O.C. FAX: 886-2-689-2468 TEL: 886-2-689-2001
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
SEP 26 1997
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The Cheen Houng Enterprise Co., Ltd. Exhaled Air Pulmonary Resuscitators are similar in intended use, design, material selection, performance and function to Exhaled Air Pulmonary Resuscitators which are currently legally and safely marketed in the United States. No new technological characteristics that could affect safety or effectiveness have been introduced.
Therefore, it is our conclusion that the Cheen Houng Enterprise Co., Ltd. Exhaled Air Pulmonary Resuscitators are safe and effective for their intended function.
Signature Jay Wang
President of Cheen Houng Enterprise Co., Ltd.
Date 2/5/97
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community or collaboration. The figure is rendered in a simple, graphic style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 26 1997
Mr. Jay Wanq Cheen Houng Enterprise Co., Ltd. 23, Alley 11, Lane 65, San Dreen Street Shulin (238) Taipei Sheng Taiwan R.O.C.
K970688 Re : "Pocket Rescue" Regulatory Class: II (two) Product Code: 73 KGB August 10, 1997 Dated: Received: August 15, 1997
Dear Mr. Wang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jay Wang
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
The Cheen Houng Pocket Rescue is indicated for mouth to mask ventilation of a nonbreathing adult.
Charles Cido for AAC
✓ with optional oxygen port
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices £970668 510(k) Number_
OT/
presingtion ase
§ 868.5570 Nonrebreathing mask.
(a)
Identification. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.