(178 days)
The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems and Mapleson C breathing circuits.
The Intersurgical 7160030 Manometer is an inline manometer for monitoring the pressure delivered to patients via resuscitation systems and Mapleson C breathing circuits. The 7160030 manometer has an operating range of 0 - 60 mbar and a stated accuracy. of +/- 10mbar. The pressure is read where the internal red indicator disk lines up with the pressure indication mark on the outside of the transparent manometer cylinder. The 7160030 manometer specify the patient pressure via a brightly colored indicator. The indicator moves in one axis along a transparent cylinder. The diameter of the indicator is similar to that of the cylinder. A balance of the force exerted by the air in the system and the force exerted by a calibrated spring defines the indicator position. The display on each manometer is a similar size and the pressure is specified where the indicator lines up with number marked on the outside of the transparent cylinder. The Manometer connects to the resuscitator / Mapleson C system via a 3 way, 15mm Female/22mm Male - 22mm Female connector. The 3-way connector tapers are compliant with ISO 5356-1. The manometer can be rotated to the desired orientation for ease of use via a friction fit elastomeric elbow. The 7160030 Manometer is single patient use.
The Intersurgical 7160030 Manometer's acceptance criteria and performance are detailed in the provided document.
1. Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (from Predicate Device Ambu 322004000) | Reported Device Performance (Intersurgical 7160030) |
|---|---|---|
| Measurement limits | 0 - 60 cmH2O | 0 - 60 cmH2O |
| Display Increments | 5, 10, 15, 20, 30, 40, 60 cmH2O | 0, 10, 20, 30, 40, 50, 60 cmH2O |
| Stated Accuracy: | ||
| - at 10 cmH2O | ± 2 mbar | + 2 mbar |
| - at 20 cmH2O | ± 2 mbar | ± 4 mbar |
| - at 30 cmH2O | ± 2 mbar | ± 5 mbar |
| - at 40 cmH2O | ± 3 mbar | + 5 mbar |
| - at 50 cmH2O | N/A | ± 7 mbar |
| - at 60 cmH2O | ± 5 mbar | ± 7 mbar |
| Measured Accuracy: | ||
| - at 10 cmH2O | ± 2 mbar | ± 2 mbar |
| - at 20 cmH2O | ± 2 mbar | ± 4 mbar |
| - at 30 cmH2O | ± 2 mbar | ± 5 mbar |
| - at 40 cmH2O | ± 4 mbar | ± 5 mbar |
| - at 50 cmH2O | N/A | ± 7 mbar |
| - at 60 cmH2O | ± 6 mbar | ± 7 mbar |
| Standards Met | N/A | ISO 5356-1 |
| Biocompatibility | Unknown (for predicate) | ISO 10993 (testing for cytotoxicity, sensitization, and irritation) |
| Connectors | Proprietary ID 3.7mm | ISO 5356-1 (22M/15F - 22F) |
Note: The document only provides "stated accuracy" for the predicate at 10, 20, & 30 cmH2O as ± 2 mbar (singular value). It's assumed for clarity in the table that this applies individually. Similarly, "measured accuracy" for the predicate at 10, 20, & 30 cmH2O is also given as ± 2 mbar.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set regarding the accuracy measurements. It mentions "Nonclinical tests submitted to demonstrate substantial equivalence for the Manometers include Vertical and Horizontal Pressures, Weight and Size and Tapers when compared to the legally marketed device." However, the number of devices or measurements taken during these tests is not specified.
The data provenance is not explicitly mentioned as a country of origin or whether it was retrospective or prospective. It is implied to be from internal testing conducted by Intersurgical Incorporated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for device performance (e.g., pressure accuracy, physical dimensions) is established through instrument-based measurements and compliance with engineering standards, not through expert consensus.
4. Adjudication Method for the Test Set:
Not applicable. As the testing concerns objective device performance metrics, adjudication by experts for discrepancies is not relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices that involve human analysis of output (e.g., imaging devices with radiologists). The Intersurgical Manometer is a physical measurement device, so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance assessment was done. The "Summary of Testing" section describes nonclinical tests for Vertical and Horizontal Pressures, Weight, Size, and Tapers, as well as biocompatibility and connector compliance, all demonstrating the device's inherent performance.
7. The Type of Ground Truth Used:
The ground truth used for performance validation was based on established measurement standards (e.g., pressure calibrations), physical measurements, and regulatory standards (ISO 10993-1 for biocompatibility, ISO 5356-1 for connectors).
8. The Sample Size for the Training Set:
Not applicable. The Intersurgical 7160030 Manometer is a mechanical device, not an AI/algorithmic system. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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K122077
Section 5 510(k) Summary of Safety and Effectiveness
JAN 1 0 2013
Name: INTERSURGICAL INCORPORATED 417 Electronics Parkway Address: Liverpool, NY 13088 Date: January 10, 2013 Contact Person: Michael Zalewski - VP RA/QA/CS Phone Number: 315-451-2900 X 202
Fax Number: 315-451-3696
Classification: 21 CFR 868.2600, Classification Name: Monitor, Airway Pressure Classification Product Code: 73 CAP
Predicate Devices:
The Ambu Disposable Pressure Manometer, REF 322004000 was chosen as a suitable predicate as the intended use and function is similar to that of the 7160030 In-line Manometer. The 7160030 and Ambu manometers are both intended for monitoring a patient's airway pressure. Both are intended for use in conjunction with a resuscitator and should only be used by personnel trained in resuscitation or airway management.
The devices have similar measurements limits and display increments. Both devices specify the pressure via a brightly colored indicator. In both devices the indicator moves in one axis along a transparent cylinder, the diameter of the indicator is similar to that of the cylinder. A balance of the force exerted by the air in the system and the force exerted by a calibrated spring defines the indicator position. The display on each manometer is a similar size and the pressure is specified where the indicator lines up with number marked on the outside of the transparent cylinder.
Description:
The Intersurgical 7160030 Manometer is an inline manometer for monitoring the pressure delivered to patients via resuscitation systems and Mapleson C breathing circuits.
The 7160030 manometer has an operating range of 0 - 60 mbar and a stated accuracy. of +/- 10mbar. The pressure is read where the internal red indicator disk lines up with the pressure indication mark on the outside of the transparent manometer cylinder.
The 7160030 manometer specify the patient pressure via a brightly colored indicator. The indicator moves in one axis along a transparent cylinder. The diameter of the indicator is similar to that of the cylinder. A balance of the force exerted by the air in the system and the force exerted by a calibrated spring defines the indicator position. The display on each manometer is a similar size and the pressure is specified where the indicator lines up with number marked on the outside of the transparent cylinder.
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Section 5 510(k) Summary of Safety and Effectiveness
The Manometer connects to the resuscitator / Mapleson C system via a 3 way, 15mm Female/22mm Male - 22mm Female connector. The 3-way connector tapers are compliant with ISO 5356-1. The manometer can be rotated to the desired orientation for ease of use via a friction fit elastomeric elbow.
The 7160030 Manometer is single patient use. The manometer is to be used in hospital, ambulance, and/or environments where resuscitation is required. The manometer must only be used by personnel trained in resuscitation and/or airway management.
Indications for Use:
The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems and Mapleson C breathing circuits.
Technological Characteristics Summary:
The intended use of the Intersurgical Manometer is comparable to the referenced predicate device. The comparison of the data shows similar values for the key performance characteristics. Proposed devices show similar values for measurement limits, display increments, and accuracy when compared to the legally marketed devices.
| Characteristics | Intersurgical 7160030 | Ambu 322004000K 040991 |
|---|---|---|
| Intended use | The Intersurgical In-line manometer is intended to be used for monitoring the patient's airway pressure.The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation.The manometer is to be used with resuscitation systems and Mapleson C breathing circuits. | The Ambu Disposable Pressure Manometer is intended to be used for monitoring the patient's airway pressure. |
| Indications for use | Single patient use. | Single patient use. |
| Target population | All | All |
| Where used | Hospital, ambulance, and all other environments where patient resuscitation is required. Manometer must only be used by personnel trained in resuscitation and/or airway management. | Ambu Disposable Pressure Manometer must only be used by personnel trained in resuscitation and/or airway management. |
| Manometer size (Width xLength) | 17mm x 63mm | 22mm x 55mm |
| Weight | 20.3g | 6.7g |
Device Comparison Table
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Section 5 510(k) Summary of Safety and Effectiveness
| 22M/15F - 22F | ||
|---|---|---|
| Connections | IISO 5356-11 | Proprietary ID 3.7mm |
| Measurement limits | 0 - 60cmH20 | 0 - 60cmH20 |
| 0, 10, 20, 30, 40, 50, 60 | 5, 10, 15, 20, 30, 40, 60 | |
| Display Increments | cmH20 | cmH20 |
| Stated accuracy of the reading: | ||
| - at 10, 20 & 30 cmH2O | ± 2 mbar | |
| - at 10 cmH2O | + 2 mbar | |
| - at 20 cmH2O | ± 4 mbar | |
| - at 30 cmH2O | 1 5 mbar | |
| - at 40 cmH20 | + 5 mbar | 1 3 mbar |
| - at 50 cmH2O | ± 7 mbar | |
| - at 60 cmH2O | ± 7 mbar | ± 5 mbar |
| Measured accuracy: | ||
| - at 10, 20 & 30 cmH2O | ± 2 mbar | |
| - at 10 cmH2O | ± 2 mbar | |
| - at 20 cmH2O | ± 4 mbar | |
| - at 30 cmH2O | ± 5 mbar | |
| - at 40 cmH20 | ± 5 mbar | ± 4 mbar |
| - at 50 cmH2O | ± 7 mbar | |
| - at 60 cmH2O | ± 7 mbar | ± 6 mbar |
| Standards met | 150 5356-1 | |
| Materials | Polycarbonate, Stainlesssteel, Silicone, Latex free,PVC free | Polypropylene, Silicone, TPE,SAN, Steel, Latex free, PVCfree |
| Phthalate free | Unknown | |
| Phthalates | ||
| Biocompatibility | SO 10993 | Unknown |
| Sterility | No | NoTo be used with Ambu |
| To be used with | resuscitators or otherresuscitators hyperinflationbags, CPAP masks or | |
| Compatibility with the | Resuscitators and Mapleson | circuits, if specified by the |
| environment and other devices | C circuit | manufacturer |
Summary of Testing:
Nonclinical tests submitted to demonstrate substantial equivalence for the Manometers include Vertical and Horizontal Pressures, Weight and Size and Tapers when compared to the legally marketed device. All materials used in the Manometer have been evaluated according to tests outlined in ISO 10993-1 and meet the requirements of Bluebook Memo, General Program Memorandum G95-1 biocompatibility testing for cytotoxicity, sensitization, and irritation. The Manometer connectors meet the requirements of Anesthetic and respiratory equipment – conical connectors: Part 1: Cones and Sockets ISO 5356-1:2004.
5
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Section 5 510(k) Summary of Safety and Effectiveness
Substantial Equivalence:
Intersurgical Incorporated has demonstrated that the proposed device is safe and effective. It is considered to be substantially equivalent to the currently marketed predicate device which has been previously reviewed for market clearance by the FDA.
Premarket Notification [510(k)] Number
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a person embracing or supporting another, represented by flowing lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2013
Mr. Michael Zalewski Vice President, RA/QA/CS Intersurgical, Incorporated 417 Electronics Parkway LIVERPOOL NY 13088
Re: K122077
Trade/Device Name: 7160030 Manometer · Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: December 18, 2012 Received: December 26, 2012
Dear Mr. Zalewski:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Zalewski
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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Radiological Health
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Enclosure
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Section 4 Indications for Use Statement
510(k) Number (if known): K122077
Device Name: Product # 7160030 Manometer
Indications For Use:
The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems and Mapleson C breathing circuits.
Prescription Use XXX
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schultheis Jr 2013.01.10 10:54:16 -05.00
(Division Sign-Off) (Division Sign-Off)
Division of Anesthestology, General Hospital Division Control, Dental Devices
K122077 510(k) Number;
17
§ 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).