(101 days)
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.
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.
This looks like a 510(k) clearance letter for the SIMS Hyperinflation Bag System. Unfortunately, the provided text does not contain the acceptance criteria or details of a study used to prove the device meets such criteria.
The document is purely administrative, confirming the substantial equivalence of the SIMS Hyperinflation Bag System to legally marketed predicate devices. It discusses regulatory product codes, general controls, and other administrative information related to market authorization.
To answer your request, I would need a different document, such as:
- A summary of safety and effectiveness (SSE), which often accompanies 510(k) submissions and details the studies conducted.
- The 510(k) submission itself, which would contain the full details of performance testing and acceptance criteria.
- Clinical study reports or bench testing reports for the device.
Without that specific information, I cannot provide the details you've requested about acceptance criteria and the supporting study.
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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.
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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 <cdrh/dsma/dsmamain.html
Sincerely yours,
Rola Mteh
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known)_
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to The SIMS Hypenmiation Bag Oyoton is unlike of fresh gas into the patient via nyper-ventilate a patient by foreing a venum atelectasis. It is designed for patients compression of the ventiator buy to provent treatment consists of hyperinflating
suffering from respiratory insufficiency. Typical treatment consists of hyperinfication suffeging from respiration insumblemes. Tploal treminating in a preset PEEP
the patient's lung over several respiration cycles, each teminating in a preset PEEP
the patient the patient's lung over several roopination of the is controlled by the user and (positive end expiratory pressure). T san proposeter or optional disposable manometer.
4970785
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Jansfel
(Division Sign-Off) Division of Cardiovascular, Res and Neurological De
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| 510(k) Number (if known) | K970785 |
|---|---|
| -------------------------- | --------- |
Device Name: __ SIMS Hyperinflation Bag System
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Ausfel
(Division Sign-Off) Division of Cardiovascular, Re and Neurological Dev 510(k) Num
§ 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).