(101 days)
Not Found
Not Found
No
The document describes a mechanical pulmonary-assist device and does not mention any AI or ML components or functionalities.
Yes
The device is intended to prevent atelectasis and hyper-ventilate a patient, which are therapeutic interventions for respiratory insufficiency.
No
Explanation: The device is described as a "pulmonary-assist device intended to hyper-ventilate a patient" and its primary function is to prevent atelectasis by forcing gas into the patient. There is no indication that it is used to diagnose a medical condition.
No
The device description explicitly states it is a "pulmonary-assist device" that involves "forcing a volume of fresh gas into the patient via compression of the ventilator bag," which describes a physical, hardware-based 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 about a person's health.
- Device Function: The SIMS Hyperinflation Bag System is a pulmonary-assist device that directly interacts with the patient's respiratory system by forcing gas into the lungs. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states it's for "hyper-ventilate a patient" and "prevent atelectasis," which are direct patient treatments.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffering from respiratory insufficiency. Typical treatment consists of hyperinflating the patient's lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak pressure is controlled by the user and monitored by means of a user-supplied manometer or optional disposable manometer.
Product codes
73 NHK
Device Description
The SIMS Hyperinflation Bag System is a pulmonary-assist device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's lung
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Avia Toney Smiths Industries Medical Systems (SIMS) 5100 Tice Street Ft. Myers, FL 33905
K970785 Re: SIMS Hyperinflation Bag System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NHK
Dear Ms. Toney:
This letter corrects our substantially equivalent letter of June 13, 1997, regarding the SIMS
A This in in I his letter corrects our substantally equivalent reater except code as 73 BZD. This is in error, 115 permission product code is 73 NHK as indicated above.
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section JTQ(s) premained in the may better marketed in interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manced promoted in the Medical Device American Food Drug commerce prior to May 28, 1970, the chacinent auto the Federal Food, Drug, devices that have been recassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the device, sayeet to tirements for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Fet mercial success and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified abovey into existing major regulations affecting your device can
may be subject to such additional controls. The Mac 800 to 800 to 900 to additio may be subject to such additional controls: Extronic of the 200 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may
11 be found in the Code of I caefal Tregaration of the Federal Register.
1
Page 2 – Ms. Avia Toney
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ Issualice or a subscription with other requirements of the Act
that FDA has made a determination that your device complies . Your must that FDA has made a decemination that your as read by other Federal agencies. You must or any Federal statules and regulations administered of registration and listing (21 light, increasing as sot comply with all the Act s requirements, morams, comments as senses as and CFR Part 807); labeling (21 CFR Part 800); good market 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you wooding of substantial equivalence of your device to a legally premarket notification. The PDA intellig of substantial offer 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 If you desire specific advice for your device director devices), please contact the Office of additionally 21 CFK Part 807.10 for in Vitto discussions on the promotion and advertising of Compliance at (101) 594-4046. Additionally, No quest of (301) 594-4639. Also, please note the Office of your device, prease comate the envereference to premarket notification' (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket in a la color the regulation entitled, "Misoraliung of reference to printer the Act may be obtained from the Other general miormation on your responsionated and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (600) 056 2011 6:3 gov