(183 days)
Not Found
No
The document describes a manual resuscitator with standard components and does not mention any AI or ML capabilities.
Yes.
The device is a manual resuscitator, which is used for positive pressure ventilation in patients requiring airway support, indicating its role in treatment and maintenance of patient health.
No
The device is a manual resuscitator, which is used to provide ventilation and airway support, not to diagnose a condition. Its function is to assist breathing, not detect or identify diseases or conditions.
No
The device description clearly lists physical components such as a face mask, bag, valve, reservoir bag, and tubing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing manual ventilation and airway support to patients. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details components like a face mask, bag, and valves, which are all related to delivering air or oxygen to a patient's lungs. There are no components or functions related to analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Language: The text does not contain any language related to diagnosis, testing, analysis of samples, or determining a medical condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This manual resuscitator operates in vivo (on the body) to support breathing.
N/A
Intended Use / Indications for 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.
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
Product codes
73 BTM
Device Description
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.
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 resuscitator is manufactured as either an adult, pediatric, or infant model, intended to treat an adult child, or infant respectively
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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
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
1
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
2
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
4
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