(213 days)
Not Found
Not Found
No
The summary describes a simple manual ventilation device and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as "Exhaled Air Pulmonary Resuscitators" and is indicated for "mouth to mask ventilation of a nonbreathing adult" which is an emergency life-support function, not a therapeutic treatment for disease or condition.
No
Explanation: The device is indicated for "mouth to mask ventilation of a nonbreathing adult," which is a treatment or rescue function, not a diagnostic one.
No
The device description "Exhaled Air Pulmonary Resuscitators" and the intended use "mouth to mask ventilation" clearly indicate a physical, hardware-based device, not software.
Based on the provided information, the Cheen Houng Pocket Rescue is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "mouth to mask ventilation of a nonbreathing adult." This is a direct medical intervention on a patient, not a test performed on a sample taken from the body.
- Device Description: The description "Exhaled Air Pulmonary Resuscitators" further reinforces its function as a respiratory support device used directly on a patient.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in samples
- Diagnosis or monitoring of diseases based on sample analysis
Therefore, the Cheen Houng Pocket Rescue is a medical device used for resuscitation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cheen Houng Pocket Rescue is indicated for mouth to mask ventilation of a nonbreathing adult.
Product codes
73 KGB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
2
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
3
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