(81 days)
Not Found
Not Found
No
The document describes a simple pressure gauge and does not mention any AI or ML capabilities, image processing, or data analysis beyond basic measurement.
No.
The device is a monitor used to measure pressure, not to treat a condition. It lacks any therapeutic function.
Yes
Explanation: The device monitors patient airway pressure and cuff pressure to assure an adequate seal, which are measurements used to assess a patient's physiological state and inform clinical decisions.
No
The device description explicitly states it is a "pressure gauge" and measures pressure, implying a physical hardware component is involved in the measurement. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The NS Series Airway Pressure Monitors and Cuff Pressure Monitors directly measure physical parameters (airway pressure and cuff pressure) within a breathing circuit connected to a patient. They do not analyze biological specimens.
- Intended Use: The intended use is to monitor pressure during ventilation and to monitor endotracheal/tracheostomy tube balloon pressure, which are direct physiological measurements, not laboratory tests on samples.
Therefore, this device falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Instrumentation Industries, Inc. NS Series Airway Pressure Monitors are devices used to monitor patient airway pressure during ventilation within a breathing circuit. The pressure gauge is placed in the patient circuit at a point that provides optimal airway pressure readings.
These devices are intended to be used by or on the order of a physician.
During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall.
These devices are intended to be used by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
CAP
Device Description
The NS Airway Pressure Gauges are intended to measure airway pressures of up to 30, 60 or 120 cm. H20, dependent upon the specific model used.
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
Not Found
Intended User / Care Setting
used by or on the order of a physician.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Instrumentation Industries, Inc. - BE 148 - Preamendment device, Anesthesia Associates, Inc. Model # 00-199 - Preamendment device
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
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).
0
K08/778
Section 5
Page 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Instrumentation Industries, Inc. The logo consists of a rounded rectangle with a grid pattern inside, followed by the company name in bold, sans-serif font. Below the company name is the tagline "We make Respiratory Care Work!" in a smaller, italicized font.
SEP 1 2 2008
2990 Industrial Boulevard . Bethel Park, PA 15102-2536 Phone: 412-854-1133 US Toll-Free: 1-800-633-8577 Fax: 412-854-5668 www.iiimedical.com
Date Prepared: June 20, 2008 Revised: August 11, 2008 Contact Person: Edward C. Horey Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey
510(k) SUMMARY For NS Airway Pressure Monitors
| Trade Name | NS Series Vacuum/Pressure Gauges |
|---|---|
| Common Name | Pressure Monitor |
| Classification Name | Airway Pressure Monitor |
| Regulation | 21 CFR 868.2600 |
| Predicate Device | Instrumentation Industries, Inc. - BE 148 - Preamendment device |
| Anesthesia Associates, Inc. Model # 00-199 - Preamendment device | |
| Device Description | The NS Airway Pressure Gauges are intended to measure airway pressures of up to 30, 60 or 120 cm. H20, dependent upon the specific model used. |
| Intended Use of the Device | |
| NS 30-PBS | |
| NS 60-PBS | |
| NS 60-TRS | |
| NS 30-TRS | |
| NS 60-TBS | |
| NS 120-TRS | The Instrumentation Industries, Inc. NS Series Airway Pressure Monitors are devices used to monitor patient airway pressure during ventilation within a breathing circuit. The pressure gauge is placed in the patient circuit at a point that provides optimal airway pressure readings. |
| These devices are intended to be used by or on the order of a physician. | |
| NS 60-TBS-CP | |
| NS 60-TRS-CP | During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall. |
| These devices are intended to be used by or on the order of a physician. |
1
.
| Technological
Characteristics | Similarities:
- The function of the BE 148, the NS Series Pressure Gauges, and Anesthesia
Associates, Inc. Model # 00-199, are the same. All are analog-faced
manometers used to measure low pressures within a patient breathing circuit. - The performance of the BE 148, the NS Series Vacuum/Pressure Gauges
and Anesthesia Associates, Inc. Model # 00-199 are similar. - The anticipated usage of all of the devices is the same. All three types of
airway pressure monitors can be used to measure positive pressure as well as
negative. - The anticipated function and usage of the NS 60-TBS-CP, the NS 60-TRS-
CP and the Smith Portex Cuff Pressure Indicator are the same. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Differences:
The capacity varies among them:
- The BE 148 range = -60-0-60 cm H2O.
- The NS Series are offered in three pressure ranges: -30-0-30, -60-0-60,
-120-0-120 cm H2O. - The Anesthesia Associates, Inc. Model # 00-199 range = -40-0-80 cm H2O
- The Smith Portex Cuff Pressure Indicator measures only positive pressure
with a range of 0-60 cm H2O, while the NS Series CP monitors have a range
of -60-0-60 cm H2O. |
:
:
:
.
:
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2008
Ms. Doris F. Walter Regulatory Affairs/Quality Assurance Manager Instrumentation Industries, Incorporated 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102-2536
Re: K081778
Trade/Device Name: NS Series Airway Pressure Monitors NS Series Cuff Pressure Monitors Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: August 11, 2008 Received: August 13, 2008
Dear Ms. Walter:
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.
3
Page 2 - Ms. Walter
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
JH Samuel & Rend, n.y. for 4
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
This is an initial submission; no number has yet been assigned.
Statement of Indications for Use:
The Instrumentation Industries, Inc. NS Series Airway Pressure Monitors are devices used to monitor patient airway pressure during ventilation within a breathing circuit. The pressure gauge is placed in the patient circuit at a point that provides optimal airway pressure readings.
These devices are intended to be used by or on the order of a physician.
V Prescription Use (Part 21 CFR 801 Subpart D) And/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1774 10(k) Number:
5
Statement of Indications for Use:
B. During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall.
These devices are intended to be used by or on the order of a physician.
V Prescription Use (Part 21 CFR 801 Subpart D)
And/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1681774 510(k) Number: __