(231 days)
Not Found
No
The device description details a purely mechanical, disposable manual resuscitator with valves and a bag. There is no mention of any computational or adaptive elements that would suggest AI/ML.
Yes
The device is described as a "pulmonary-assist device intended to provide respiratory support," which directly relates to treating a patient's condition (respiratory distress).
No
The device is described as a "pulmonary-assist device" and "emergency manual ventilators" intended to "provide respiratory support." Its function is to assist breathing, not to diagnose a condition.
No
The device description clearly outlines physical components such as a compressible ventilator bag, valves, connectors, and optional accessories like face masks and manometers. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "pulmonary-assist device intended to provide respiratory support." It directly interacts with the patient's respiratory system to deliver air or oxygen.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is purely mechanical assistance for breathing.
Therefore, the 1st Response Infant and Pediatric Manual Resuscitators fall under the category of respiratory support devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 1st Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of 10 kg (22 lbs) and 10 kg (22 lbs) and
§ 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
Image /page/0/Picture/0 description: The image shows the logo for Smiths Industries Medical Systems. The logo consists of the word "sims" in a stylized font, with a solid black circle above the "i". To the right of "sims" are the words "SMITHS INDUSTRIES" in a bold, sans-serif font, with the words "Medical Systems" below in a smaller, serif font. The words "SMITHS INDUSTRIES" and "Medical Systems" are underlined.
JAN 18 2000
SIMS Portex Inc.
10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703
H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY:
COMPANY INFORMATION:
SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Manager, Regulatory Affairs
PREPARATION DATE OF SUMMARY:
May 28, 1999
TRADE NAME:
1st Response Infant Manual Resuscitator 1st Response Pediatric Manual Resuscitator
COMMON NAME:
Manual Resuscitator
PRODUCT CLASS/CLASSIFICATION:
Class II, 73 BTM, 21 CFR 868.5915
PREDICATE DEVICE(S):
Hudson Respiratory Care Inc., Temecula California, Neonate Manual Resuscitator, Cat. No. 5360 and Pediatric Manual Resuscitator, Cat. No. 5365.
SIMS Portex Inc., Ft. Myers Florida, 1st Response Infant Manual Resuscitator, Cat. No. 008027MP and 1st Response Pediatric Manual Resuscitator Cat. No. 008120
1
DESCRIPTION:
The 1st Response infant and pediatric manual resuscitators are disposable, single use emergency manual ventilators. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends.
The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservoir or tube reservoir. These reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used.
The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15mm ID x 22 mm OD patient connector, exhalation port, manometer port, and a pressure limiting valve (PLV).
The device is provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.
INDICATIONS FOR USE:
Infant Manual Resuscitator
The 18 Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of 10 kg (22 lbs) and 10 kg (22 lbs) and ✓ |
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| OR Over-The-Counter Use | |
| 510(k) Number | K991861 |