(183 days)
The manual resuscitator is intended for use on patients requiring total or intermittent airway support. Provides positive pressure ventilation and allows spontaneous breathing either with a 22mm inner diameter face mask port or through an artificial airway having a 15mm outer diameter connection.
The Rusch Manual Resuscitator is intended for manual ventilation of patients with air or air enriched oxygen The resuscitator is manufactured as either an adult, pediatric, or infant model, intended to treat an adult child, or infant respectively
The product consists of a face mask, bag, valve, reservoir bag, and tubing with connector for introduction of oxygen enriched air. The valve is made from K-Resin and the other main components mentioned above are made from PVC. The cushion mask is clear to permit easy patient monitoring and is mounted on a 360° swivel for convenience. The bag is textured to give a positive grip.
This document is a 510(k) summary for a medical device (Rusch Manual Resuscitator Bag), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert reviews.
Therefore, many of the requested elements regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from the provided text. The document is essentially a regulatory submission, not a scientific study report.
Here's an analysis based on the information provided in the extract:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission aims to prove substantial equivalence based on design, construction, and intended use, rather than quantitative performance against specific criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No performance study or test set data is described. The submission focuses on device description and comparison to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No experts were used to establish ground truth for a test set, as no such test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned as there is no described test set or expert review process.
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 MRMC study was done, nor is there any mention of AI assistance. This device is a manual resuscitator bag.
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)
No ground truth data (in the context of a performance study) is mentioned. The ground for substantial equivalence is based on comparison to a legally marketed predicate device.
8. The sample size for the training set
No training set is mentioned.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned.
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Substantial Equivalence 510(k)Summary
Rusch Manual Resuscitator Bag
To Whom it may concern
Ref: K993194
Date: September 17th 1999
Submitter/ Contact - Name and Address
Ronald J. Young Director, Manufacturing Operations Rusch Inc. 2450 Meadowbrook Parkway Duluth, GA 30096
Telephone: (770) 623-0816 (770) 623-1829 Fax:
Device Details:
Common/ Usual Name: Rusch Manual Resuscitator Bag
Classification Name: Manual Emergency Ventilator (Resuscitator)
Predicate Legally Marketed Device: Baxter Adult/ Pedi/ Infant Resuscitator Bag: K924610
Page 1 of 2
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DESCRIPTION OF THE DEVICE
The product consists of a face mask, bag, valve, reservoir bag, and tubing with connector for introduction of oxygen enriched air. The valve is made from K-Resin and the other main components mentioned above are made from PVC. The cushion mask is clear to permit easy patient monitoring and is mounted on a 360° swivel for convenience. The bag is textured to give a positive grip.
INTENDED USE
The manual resuscitator is intended for use on patients requiring total or intermittent airway support. Provides positive pressure ventilation and allows spontaneous breathing either with a 22mm inner diameter face mask port or through an artificial airway having a 15mm outer diameter connection.
Technological Characteristics of the Device
The device is equivalent is design and construction to the Engineered Medical Systems Manual Resuscitator Bag
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2000
Mr. Ronald Young Rusch, Inc. 2450 Meadowbrook Parkway Duluth, GA 30096
Re: K993194 Rusch Manual Resuscitator Bag Regulatory Class: II (two) Product Code: 73 BTM December 21, 1999 Dated: Received: January 10, 2000
Dear Mr. Young:
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 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). 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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. Ronald Young
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/dsma/dsmamain.html".
Sincerely yours,
tow Hill indublen for
James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 5 of
RESPONSE PAGE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Rusch Manual Resuscitator is intended for manual ventilation of patients with air or air enriched oxygen The resuscitator is manufactured as either an adult, pediatric, or infant model, intended to treat an adult child, or infant respectively
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lea Hill Wotton
(Division Sign Off)
(Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
(Optional Format 3-10-98)
PRESCRIPTION USE X
OVER THE COUNTER USE
§ 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).