SIMS HYPERINFLATION BAG SYSTEM

K970785 · Sims · NHK · Jun 13, 1997 · Anesthesiology

Device Facts

• Record ID: K970785
• Device Name: SIMS HYPERINFLATION BAG SYSTEM
• Applicant: Sims
• Product Code: NHK · Anesthesiology
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Pulmonary-assist device; manual hyperinflation bag system. Input: manual compression of ventilator bag by clinician. Operation: forces volume of fresh gas into patient lungs; provides hyperinflation over multiple respiration cycles; terminates cycles at preset positive end expiratory pressure (PEEP). Output: mechanical delivery of gas to patient. Usage: clinical setting; operated by healthcare professionals. Monitoring: peak pressure controlled by user; monitored via user-supplied or optional disposable manometer. Benefit: prevention of atelectasis in patients with respiratory insufficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual hyperinflation bag system; noncontinuous ventilator. Components include ventilator bag and optional disposable manometer. Peak pressure controlled manually by user. Class II device (Product Code 73 NHK).

Indications for Use

Indicated for patients suffering from respiratory insufficiency requiring hyper-ventilation to prevent atelectasis.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 26 2002

Ms. Avia Toney
Smiths Industries Medical Systems (SIMS)
5100 Tice Street
Ft. Myers, FL 33905

Re: K970785
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 Hyperinflation Bag System. Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 NHK as indicated above.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,


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): 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)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970785

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Page 1 of 1

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)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970785

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