The Hsiner PEEP Valve is used in conjunction with manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure.

Device Description

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".

AI/ML Overview

The provided text is a 510(k) summary for the Hsiner Company Resuscitator/PEEP Valve. It details the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a detailed study report with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or human-in-the-loop studies.

Instead, the submission states that the Resuscitator complies with ASTM and ISO standards, and the PEEP valve complies with ISO standards for conical connectors, implying that the acceptance criteria are adherence to these established standards. The basis for clearance is substantial equivalence to existing legally marketed devices, not a de novo study proving new performance metrics.

Therefore, many of the requested details about a specific study and its acceptance criteria cannot be extracted from this document, as such a study (in the sense of defining new performance metrics and testing against them) was not the basis for this 510(k) submission.

Here's an attempt to answer the questions based solely on the provided text, highlighting what is not available:

Acceptance Criteria and Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Resuscitator:
1. Compliance with ASTM 940-93 "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans"	"The cresuscitator complies with ASTM 940-93..."
2. Compliance with ISO 8382:1988 "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans."	"...and ISO 8382:1988"
3. Equivalent design, materials, and performance to predicate resuscitators (K002846, K012842, K944301).	"The Hsiner Resuscitators...are equivalent in design, materials and performance to the Predicate devices..."
PEEP Valve:
1. Compliance with ISO 5356-1 "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets"	"...complying wit ISO 5356-1..."
2. Equivalent design, materials, and performance to predicate PEEP valves (K923976, K902062, K983920).	"The Hsiner...PEEP Valves are equivalent in design, materials and performance to the Predicate devices..."

Study Information (Based on Substantial Equivalence, not a de novo performance study)

Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable or not specified. The submission relies on adherence to established international standards and substantial equivalence, not a new test set generation with a specific 'sample size' of patients or cases.
- Data provenance: Not applicable. The "study" here is demonstrating compliance with existing standards and comparing to predicate devices.
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 clinical expert consensus is not part of this 510(k) submission. The "ground truth" for the device's performance is defined by the ASTM and ISO standards themselves and the performance of the predicate devices.
Adjudication method for the test set:
- Not applicable. There was no explicit "test set" in the context of expert review for clinical performance.
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:
- Not applicable. This device is a manual medical instrument (resuscitator, PEEP valve), not an AI/software device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used:
- For the Resuscitator: Adherence to ASTM 940-93 and ISO 8382:1988 performance specifications.
- For the PEEP Valve: Adherence to ISO 5356-1 connector standards and the established performance of predicate devices.
The sample size for the training set:
- Not applicable. This device does not use an AI or machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

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Hsiner Company Resuscitator/PEEP Valve 510(k) Submission

MAR 2 2 2006

K053466

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:

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

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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.

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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

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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

Regulation Number and Section

§ 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).