(131 days)
The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside.
Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal or tracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks.
The SIMEX Subglottic Aspiration System models cuff S are lightweight portable or stationary suction/aspiration pumps for medical suction procedures where secretions, blood and other body fluids must be removed. The SIMEX cuff M and cuff S are designed for the application of intermittent aspiration of fluids which is particularly useful in the aspiration of subglottic secretions. Applications range from hospital, emergency care, and acute care facilities.
These pumps are designed and engineered for the proper and effective aspiration of subglottic secretion via intermittent suction. The pump can be set to operate (aspirate) anywhere from 1-60 seconds and to pause from 1-60 minutes. The factory setting is 10 seconds of aspiration time and 10 minutes of pause time and pressure of 100 mbar vacuum. SIMEX cuff M and cuff S suction pumps remove oral and/or gastric secretions from above the tracheal and or endotracheal tube cuff before they can be aspirated by the patient, using intermittent suction to remove subglottic secretions.
There are two models of the SIMEX Subglottic Aspiration System, Models cuff M and cuff S. The two models differ in their housing and collection canister configuration. Both models have the same overall system operation and software. The moving and electrical components of both models are housed in a molded, compact plastic housing. The units include attachment for an external power supply and/or a battery charger.
This document is a 510(k) premarket notification for the SIMEX Subglottic Aspiration System, not a study report. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets them in a clinical context.
The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical (bench) testing and a feature comparison. It does not present a clinical study with human readers, ground truth established by experts for a test set, or multi-reader multi-case (MRMC) comparative effectiveness.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the context of clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, it details performance characteristics against engineering standards and comparison to predicate device specifications.
| Performance Metric / Acceptance Criteria (Implied) | Reported Device Performance (SIMEX Subglottic Aspiration System cuff M and cuff S) |
|---|---|
| Electrical Safety (IEC 60601-1-2) | Meets requirements for IEC 60601-1-2 including National Differences for the US. |
| Electromagnetic Interference (EMI) | Meets electromagnetic interference requirements of the above standards. |
| Operational Lifetime | Capable of operating for more than 2000 hours. |
| Adequate Performance in Simulated Use Environment | Adequately performs when tested in a simulated use environment across the operating parameters of the pumps. |
| Vacuum Pressure | Max Pressure: 300 mbar (225 mmHg) |
| Flow Rate | 8 liters/min |
| Intermittent Operation Range | Programmed to: 1-60 sec On, 1-60 min Off (Factory setting: 10 sec On, 10 min Off, 100 mbar vacuum) |
| Physical Characteristics (e.g., Weight, Collection Container, etc.) | Comparable to predicate devices, as detailed in the "Feature Comparison Chart". |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in a clinical sense. The testing described is "bench testing" and "simulated use environment," meaning it was conducted on the physical device itself or in a laboratory setup, not on a set of clinical cases or patient data.
- Data Provenance: The testing was non-clinical (bench testing). No country of origin for clinical data is applicable. The data is entirely retrospective technical test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of clinical evaluation, is typically established by medical experts for diagnostic or prognostic tasks. This document describes technical device performance, not a clinical diagnostic aid.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This device is a medical pump, not an AI diagnostic tool that assists human readers in interpreting clinical cases. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is designed for AI/algorithm-based devices. The SIMEX Subglottic Aspiration System is a physical medical device (a pump), not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The bench testing of the pump itself can be considered its "standalone" performance, as it operates independently according to its design specifications.
7. The Type of Ground Truth Used
The ground truth for the performance metrics described (electrical safety, EMI, operational lifetime, vacuum pressure, flow rate) is based on engineering standards and design specifications. For example, the "ground truth" that the device meets IEC 60601-1-2 is based on the results of tests conducted against the requirements of that standard. This is not clinical ground truth like pathology, expert consensus, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning model.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2014
SIMEX Medizintechnik, GmbH FloSure Technologies LLC % Mr. Hamid Khosrowshahi President P.O. Box 123 Tarrytown, New York 10591
Re: K141255
Trade/Device Name: SIMEX Subglottic Aspiration System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA Dated: August 19, 2014 Received: August 21, 2014
Dear Mr. Khosrowshahi:
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.
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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
for
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141255
Device Name SIMEX Subglottic Aspiration System
Indications for Use (Describe)
The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside.
Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal or tracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SIMEX Medizintechnik GmbH 510(k) Premarket Notification SIMEX Subglottic Aspiration System
510(k) Summary
| Date Prepared: | September 15, 2014 | |||||
|---|---|---|---|---|---|---|
| Sponsor andManufacturer: | SIMEX Medizintechnik, GmbHPost Box 1207D-78649. Deisslingen, GermanyFDA Registration Number 3005813597 | |||||
| 510(k) Contact: | Mr. Hamid KhosrowshahiFloSure Technologies LLCPO Box 123Tarrytown, New York, 10591Telephone: 914-772-7326e-mail : hkhosrow@optonline.net | |||||
| Trade Name: | SIMEX Subglottic Aspiration SystemModels cuff M and cuff S | |||||
| Classification: | Powered Suction PumpFDA 21 CFR 878.4780Class II | |||||
| Product Code: | BTA - Pump, Portable, Aspiration (Manual or Powered) |
Predicate Devices:
Medela® Vario 8/18/ci Secretion & Surgical Aspirator System 510(k) K061205 Medela AG Product Code BTA
SIMEX Suction Pumps 510(k) K061133 Novaspine LLC Product Code BTA
SIMEX EX200 and EX300 Negative Pressure Wound Therapy System 510(k) K113291 SIMEX Medizitechnik GmbH Product Code OMP
Indications for Use:
The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside.
Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks.
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Device Description:
The SIMEX Subglottic Aspiration System models cuff S are lightweight portable or stationary suction/aspiration pumps for medical suction procedures where secretions, blood and other body fluids must be removed. The SIMEX cuff M and cuff S are designed for the application of intermittent aspiration of fluids which is particularly useful in the aspiration of subglottic secretions. Applications range from hospital, emergency care, and acute care facilities.
These pumps are designed and engineered for the proper and effective aspiration of subglottic secretion via intermittent suction. The pump can be set to operate (aspirate) anywhere from 1-60 seconds and to pause from 1-60 minutes. The factory setting is 10 seconds of aspiration time and 10 minutes of pause time and pressure of 100 mbar vacuum. SIMEX cuff M and cuff S suction pumps remove oral and/or gastric secretions from above the tracheal and or endotracheal tube cuff before they can be aspirated by the patient, using intermittent suction to remove subglottic secretions.
There are two models of the SIMEX Subglottic Aspiration System, Models cuff M and cuff S. The two models differ in their housing and collection canister configuration. Both models have the same overall system operation and software. The moving and electrical components of both models are housed in a molded, compact plastic housing. The units include attachment for an external power supply and/or a battery charger.
Non-Clinical Testing (Bench):
The SIMEX Subglottic Aspiration System cuff M and cuff S are manufactured in accordance with FDA Quality System Regulations and EEC Directive 93/42/EEC Annex IX. Testing for electrical safety was conducted to ensure it meets the requirements for IEC 60601-1-2 including the National Differences for the US. Testing also demonstrated that the pumps meet the electromagnetic interference requirements of the above standards.
Bench testing of the SIMEX Subglottic Aspiration Systems cuff M and cuff S demonstrated that pumps are capable of operating for more than 2000 hours and can adequately perform when tested in a simulated use environment across the operating parameters of the pumps.
Substantial Equivalence:
The SIMEX Subglottic Aspiration System cuff M and cuff S are substantially equivalent to other powered suction pumps used for aspiration of secretions from the patient's airway or respiratory system. The SIMEX Subglottic Aspiration System, like it's predicates is used for aspiration of secretions from a patient's airway or respiratory system. The SIMEX system uses the same basic technology of other similar suction pumps and performs the same function by applying negative pressure to aspirate accumulated materials.
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| SIMEX SubglotticAspiration Systemcuff M and cuff SSIMEX MedizintechnikGmbH | SIMEXSuctionpumps(K061133)NovaSpineLLC | Medela®Vario 8/18/ciSecretion andSurgicalAspirator(K061205)Medela AG | SIMEX EX200 and EX300NPWT pumps(K113291)SIMEX MedizintechnikGmbH | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Product Code | BTA | BTA | BTA | OMP | |||||||||
| Technology | Vacuum pump transmitsnegative pressure througha tubing system andcollection container andconnects to a suctioncatheter | Vacuumpumptransmitsnegativepressurethrough atubing systemand collectioncontainer andconnects to asuctioncatheter | Vacuum pumptransmitsnegativepressurethrough atubing systemand collectioncontainer andconnects to asuctioncatheter | Vacuum pump transmitsnegative pressure througha tubing system andcollection container andconnects to a suctioncatheter | |||||||||
| Manual (Analog) /Digital Operation | Digital Pressure Gauge andLogic-microprocessor | Manual(analog)SuctionPressureRegulator | Manual(analog)SuctionPressureRegulator | Digital Pressure GaugeandLogic-microprocessor | |||||||||
| Constant/IntermittentOperation | Intermittent | Constant | Constant orIntermittent | Constant or Intermittent | |||||||||
| Intermittent Range(On/Off time) | Programmed to:1-60 sec On1-60 min Off | N/A | 8 Seconds On4 Seconds Off16 Seconds On8 Seconds Off32 Seconds Off16 Seconds Off | Programmed to:2-10 min On2-10 min Off | |||||||||
| Max Pressure | 300 mbar (225 mmHg) | 600 mmHg(801 mbar) | 563 mmHg(751 mbar)68 mmHg (91mbar) | 200 (mmHg) (267 mbar) | |||||||||
| Flow Rate(liters/min) | 8 liters/min | 18-28liters/min | 8 liters/min –Vario 818 liters/min –Vario 18 | 8 liters/min | |||||||||
| Power (AC/DC,Voltage/Hz) | 12 V DC100/240VAC,50/60 Hz | 12 V DC115/230VAC,50/60 Hz | 12 V DC115/230VAC,50/60 Hz | 12 V DC100/240VAC,50/60 Hz | |||||||||
| Electrical ProtectionClass | Type BF | Type BF | Type BF | Type BF | |||||||||
| Rechargeable Battery | 7.4 V, 4.4 Ah – Lithium –Ion | 12V, 2.1 Ah,Ni-MH | 12V Ni-MH | 7.4 V, 4.4 Ah – Lithium –Ion | |||||||||
| ContainsHydrophobicMicrobial Filter | Yes | Yes | Yes | Yes | |||||||||
| Weight (kg) | cuff M1.2 kg | cuff S2.2 kg | 3.2 kg - 3.9kg | 5.1 kg | EX2001.2 kg | EX3002.2 kg | |||||||
| Intake Hose | (mm ID) | cuff M | 4 mm | cuff S | 6 mm | 6mm-10mm | 6 mm | EX200 | 4 mm | EX300 | 6 mm |
Feature Comparison Chart
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SIMEX Medizintechnik GmbH 510(k) Premarket Notification SIMEX Subglottic Aspiration System
| SIMEX SubglotticAspiration Systemcuff M and cuff SSIMEX MedizintechnikGmbH | SIMEXSuctionpumps(K061133)NovaSpineLLC | Medela®Vario 8/18/ciSecretion andSurgicalAspirator(K061205)Medela AG | SIMEX EX200 and EX300NPWT pumps(K113291)SIMEX MedizintechnikGmbH | |||
|---|---|---|---|---|---|---|
| Collection Container | cuff M | cuff S | Reusablecollectioncontainers anddisposablecollectionliners(solidifieravailable) | Reusable anddisposablecollectioncontainers anddisposablecollectionliners(solidifieravailable) | EX200 | EX300 |
| Disposablecanisterwith gellingagent andintegratedfilter andsuctiontubing | Reusable(singlepatient use)outercanisterwithdisposablelinercontaininggellingagent andintegratedfilter.Suctiontubingprovidedseparately | Reusablecollectioncontainers anddisposablecollectionliners(solidifieravailable) | Reusable anddisposablecollectioncontainers anddisposablecollectionliners(solidifieravailable) | Disposablecanisterwithgellingagent andintegratedfilter andsuctiontubing | Reusable(singlepatient use)outercanisterwithdisposablelinercontaininggellingagent andintegratedfilter.Suctiontubingprovidedseparately | |
| Container Volume | cuff M | cuff S | 1000 cc | 1000 cc | EX200 | EX300 |
| 250 cc | 1000 cc | 250 cc | 1000 cc | |||
| Carrying Bag fortransporting pump | Yes | Yes | Yes | Yes |
Conclusion:
The SIMEX Subglottic Aspiration System Models cuff M and cuff S are substantially equivalent to the commercially marketed predicate devices and do not raise new issues of safety and effectiveness.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.