(99 days)
Not Found
No
The description focuses on a mechanical, spring-actuated valve and makes no mention of AI, ML, or any computational processing.
Yes.
The device provides positive end expiratory pressure, which is a therapeutic intervention used in ventilatory support.
No
The device description indicates it provides positive end expiratory pressure, which is a therapeutic function, not a diagnostic one. It is used to support ventilation rather than to identify a medical condition.
No
The device description clearly states it is a physical, adjustable, spring-actuated valve, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide positive end expiratory pressure in conjunction with ventilatory support equipment. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a mechanical valve that regulates pressure. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Hsiner PEEP Valve is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hsiner Resuscitator is used to manually administer ventilation to patients requiring assisted ventilation in emergency and hospital settings.
The Hsiner PEEP Valve is used in conjunction with manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure.
Product codes (comma separated list FDA assigned to the subject device)
BTM, BYE
Device Description
Resuscitator:
The Hsiner Resuscitator is used to manually administer ventilation to patients requiring assisted ventilation in emergency and hospital settings.
The Resuscitator complies with ASTM 940-93 "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans" and ISO 8382:1988 "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans." The cresuscitator is provided in three sizes, adult, child and infant, along with various attachments including face masks, reservoir valve sets, PEEP valves and oxygen tubing.
PEEP Valve:
The PEEP valve is an adjustable, spring actuated valve which when placed into a circuit provides positive end expiratory pressure for the patient. The PEEP vale is provided in two pressure ranges and several connector sizes complying wit ISO 5356-1 "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".
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
The cresuscitator is provided in three sizes, adult, child and infant
Intended User / Care Setting
emergency and hospital settings.
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)
The Hsiner Resuscitators and PEEP Valves are equivalent in design, materials and performance to the Predicate devices listed in Section 8.4. All the predicate devices listed in Section 8,4 utilize the same principles of operation and have the same intended use
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K002846, K012842, K 944301, K923976, K902062, K983920
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
Hsiner Company Resuscitator/PEEP Valve 510(k) Submission
MAR 2 2 2006
510(k) Summary 6.
In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.
Submitter Information 6.1.
Hsiner Company, LTD No. 13, Tyan Shin St., Taya Hsiang Taichung Hsien, Taiwan, ROC
Phone: +886-4-25664306
Registration No .: 3003862188 Owner/Operator No .: 9053474
6.2. Name of Device
Resuscitator :
Device Name Ventilator, Emergency, Manual (Resuscitator)
Product Code BTM Regulation # 868.5915
Device Class 2
PEEP Valve:
Device Name Attachment, Breathing, Positive, Positive End Expiratory Pressure Product Code BYE Regulation # 868.5965 Device Class 2
6.3. Substantially equivalent to:
Resuscitator :
- . Headstar Medical Products Manual Emergency Resuscitator (K002846).
- Ventlab Corporation V*Care Manual Resuscitator (K012842) .
- Hudson RCI Lifesaver Single Patient Use Manual Resuscitator (K 944301) . PEEP Valve:
- Ambu Single Patient Use PEEP Valve (K923976). �
- Hudson RCI Lifesaver Peep Valve (K902062) ●
- Engineered Medical Systems PEEP Valve (K983920) �
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Description of the device 6.4.
Resuscitator:
The Hsiner Resuscitator is used to manually administer ventilation to patients requiring assisted ventilation in emergency and hospital settings.
The Resuscitator complies with ASTM 940-93 "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans" and ISO 8382:1988 "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans." The cresuscitator is provided in three sizes, adult, child and infant, along with various attachments including face masks, reservoir valve sets, PEEP valves and oxygen tubing.
PEEP Valve:
The PEEP valve is an adjustable, spring actuated valve which when placed into a circuit provides positive end expiratory pressure for the patient. The PEEP vale is provided in two pressure ranges and several connector sizes complying wit ISO 5356-1 "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".
Intended Use of the Device 6.5.
Resuscitator:
The Hsiner Resuscitator is used to manually administer ventilation to patients requiring assisted ventilation in emergency and hospital settings.
PEEP Valve:
The Hsiner PEEP Valve is used in conjunction with manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure.
Comparison to Predicate Devices 6.6.
The Hsiner Resuscitators and PEEP Valves are equivalent in design, materials and performance to the Predicate devices listed in Section 8.4. All the predicate devices listed in Section 8,4 utilize the same principles of operation and have the same intended use
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is written around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2006
Hsinder Company, Limited C/O Mr. Tom Shanks Regulatory Specialist MDVentures 29201 Via Norte Temecula, California 92591
Re: K053466
Trade/Device Name: Hsiner PEEP Valve Regulation Number: 868.5915, 868.5965 Regulation Name: Manual emergency ventilator Regulatory Class: II Product Code: BTM, BYE Dated: March 13, 2006 Received: March 16, 2006
Dear Mr. Shanks:
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 (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 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.
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.
3
Page 2 - Mr. Tom Shanks
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 continue 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/dsma/dsmamain.html
Sincerely yours,
Susan Luna
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
4
Indications for Use
KD63460
510(k) Number (if known):
Hsiner PEEP Valve Device Name:
Indications for Use:
The Hsiner PEEP Valve is used in conjunction with manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alue Sullion
Jital Courses