(99 days)
Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient
Exsalta is an AC 110 V powered microprocessor controlled peristaltic suction pump used for clearance of airway secretions. The device is used on a desktop, or shelf. This peristaltic suction pump with touch screen controls is designed for suction procedures where low airflow is desired. Exsalta (the pump) is a reusable device. The accessories are single use.
This document is a 510(k) premarket notification for a medical device called Exsalta, a powered suction pump. The FDA has reviewed the submission and determined the device is substantially equivalent to a legally marketed predicate device.
Unfortunately, the provided text does not contain the detailed acceptance criteria for specific performance metrics or a study demonstrating that the device meets those criteria with statistical significance. Instead, it broadly states that "The subject device met all performance criteria" based on non-clinical testing.
Here's an analysis of what information is present and what is missing, structured according to your request:
1. A table of acceptance criteria and the reported device performance
The document provides some specifications for the Exsalta device and compares them to its predicate (Medela Vario 8/18/ci Suction Pumps K153663). However, it does not explicitly state "acceptance criteria" in the format of pass/fail thresholds for specific performance tests. It lists specifications and general compliance with standards.
| Attribute | Predicate Vario 8/18/ci (K153663) | Proposed Device (Exsalta) | "Acceptance Criteria" (Implicit from specifications and standards) | Reported Device Performance |
|---|---|---|---|---|
| Regulation | 21CFR 878.4780 | 21CFR 878.4780 | N/A (Regulatory classification) | Met |
| Product Code | BTA | BTA | N/A (Regulatory classification) | Met |
| Indications for Use | Aspiration and removal of surgical fluids, etc. (similar) | Help evacuate saliva, mucous, vomit, etc. (similar) | Similar to predicate | Met |
| Environment of Use | Professional healthcare facility environment | Professional healthcare facility environment | Similar to predicate | Met |
| Flow liters/min | Vario 8/8 c/i: 8 L/min; Vario 18: Not specified | 1.4 L/min | Consistent with intended use/safe operation | (Stated as 1.4 L/min fixed) |
| Maximum vacuum mmHg/kPa | Vario 8/8 c/i: -68 mmHg / -9 kPa; Vario 18: -563 mmHg / -75 kPa; Vario 18 c/i: -413 mmHg / -55 kPa | 60-300 mmHg / 8-40 kPa | Within appropriate range for medical suction (e.g., ISO 10079-1) | (Stated as 60-300 mmHg / 8-40kPa) |
| Therapy modes | Continuous / Intermittent | Continuous | Appropriate for intended use | (Stated as Continuous) |
| Power Source | AC versions: various; AC/DC versions: various | AC-120V, 60 Hz, 2A | Functionality under specified power | Met |
| Electrical Protection | Class II | Class I | Compliance with electrical safety standards (AAMI/ANSI ES 60601-1) | Met |
| Ingress Protection | IP21 | IP21 | Maintained as per predicate | Met |
| Applied Part Type | CF | B | Safety for applied parts (AAMI/ANSI ES 60601-1) | Met |
| Operating Ambient Temp | +5...+40°C | +5 to 40°C | Operation within specified temperature range | Met |
| Operating Ambient Humidity | 15...93% R.L. | 15 to 93% RH | Operation within specified humidity range | Met |
| Operating Pressure | 70-106 kPa | 70 to 106 kPa | Operation within specified atmospheric pressure range | Met |
| Storage Ambient Temp | -25 to +70°C | -25 to +70°C | Storage suitability | Met |
| Storage Ambient Humidity | 15 to 93% RH | 15 to 93% RH | Storage suitability | Met |
| Storage Pressure | 70-106 kPa | 70 to 106 kPa | Storage suitability | Met |
| Standards Compliance | AAMI/ANSI ES60601-1:2005, IEC 60601-1-2: 2007, ISO 10079-1: 2009 | AAMI/ANSI ES60601-1:2005 + A1: 2012, IEC 60601-1-2: 2014, ISO 10079-1: 2015 | Compliance with updated versions of relevant safety and performance standards | Met (as stated) |
| Safety Features | Not detailed in comparison table | Suction circuit/collection container isolation, viral filter, full container float valve/microprocessor stop. | Effective protection against contamination and overflow | "Providing for safe handling and disposal" (Stated) |
| Flow Control | Mechanical regulator | Touch screen slide bar with digital display | User-friendly and accurate vacuum level adjustment | (Stated as Touch screen controlled) |
| Vacuum Regulation | Mechanical regulator | Microprocessor controlled Proportional valve, Mechanical regulator | Accurate and responsive vacuum control | (Stated as Microprocessor controlled) |
| Vacuum Gauge | Analog vacuum gauge | Digital vacuum display | Clear and accurate vacuum reading | (Stated as Digital display) |
Note: The "Reported Device Performance" column reflects what the document states the device features or complies with, rather than quantitative results from a specific study against predefined acceptance criteria. The document claims "The subject device met all performance criteria" after listing non-clinical tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: This information is not provided in the document. The filing is for a physical medical device (powered suction pump), not an AI/software device that would typically have a test "dataset" for performance evaluation in the context of your request. The testing mentioned (Shelf-life/Aging, Software V&V, IEC 60601-1, IEC 60601-1-2, ISO 10079-1:2015) refers to engineering and quality assurance tests on the device hardware and software. It does not involve a "test set" of patient data as assumed by the prompt.
- Data Provenance: Not applicable, as there's no patient data "test set" involved in this type of device clearance based on the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As this is a hardware medical device (a suction pump), there wouldn't be a "ground truth for the test set" established by experts in the context of clinical interpretation or diagnosis. Performance is evaluated against engineering specifications and international standards through non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" requiring adjudication in the context of clinical agreement or AI output.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The document explicitly states: "No human clinical testing was performed." and "No animal testing was performed." This device is a powered suction pump, not an AI or imaging device where MRMC studies would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of AI performance. While "Software Verification and Validation" was performed, this refers to the embedded software controlling the pump's mechanical functions, not a standalone AI algorithm for interpretation or diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this device, "ground truth" would relate to the physical and electrical safety and performance of the pump itself, verified through engineering tests against industry standards (e.g., ISO 10079-1 for medical suction equipment, IEC 60601-1 for electrical safety).
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning or a training set.
In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and compliance with recognized non-clinical performance and safety standards. It does not provide information about clinical studies, expert-adjudicated test sets, or AI performance metrics, as these are not relevant to the type of device being cleared. The device met "all performance criteria" through non-clinical testing, but specific acceptance thresholds and detailed test results are not included in this summary.
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September 16, 2022
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DRW Medical % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K221676
Trade/Device Name: Exsalta Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: August 18, 2022 Received: August 18, 2022
Dear Paul Dryden:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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)
Device Name Exsalta
Indications for Use (Describe)
Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient
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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| Date Prepared: | 18-Aug-22 |
|---|---|
| DRW Medical, LLC2710 Concord RoadAston PA 19014 USATel - 610-996-5308 | |
| Official Contact: | Dan Tatum- President |
| Submission Correspondent: | Paul DrydenProMedic, LLCSt. Petersburg, FL |
| Proprietary or Trade Name: | Exsalta |
| Common/Usual Name:Classification CFR:Classification Code:Classification Name:Class: | Powered Suction Pump21 CFR 878.4780BTAPump, Portable, Aspiration (Manual Or Powered)Class II |
| Predicate Device: | Medela Vario 8/18/ci Suction Pumps K153663 |
Device Description:
Exsalta is an AC 110 V powered microprocessor controlled peristaltic suction pump used for clearance of airway secretions. The device is used on a desktop, or shelf. This peristaltic suction pump with touch screen controls is designed for suction procedures where low airflow is desired.
Exsalta (the pump) is a reusable device. The accessories are single use.
Exsalta complies with the following FDA recognized standards:
- AAMI ANSI ES 60601-1: 2005 +A1: 2012 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Collateral standard: Electromagnetic Disturbances Requirements ● and Tests
- ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction . equipment [Including: Amendment 1 (2018)]
Safety Features:
The suction circuit and collection container isolate suction contents from the room and from the pump, providing for safe handling and disposal. The collection container is under positive pressure and has three ports. A first port is where the patient media is pumped into the container. The second port provides an air vent to the atmosphere. The air vent port incorporates a viral filter to protect the atmosphere from patient media. When the container is full the internal liguid float valve closes, and the air vent closes. The third port has a tube that extends to the internal pressure sensor for communication with the microprocessor. When the collection container is full and activates the float valve, the increase in pressure signals the microprocessor to stop the pump.
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The pump provides a clinician with the ability to adjust vacuum levels without changing the flowrate. The flow rate is fixed by the ID of the pump tube (6.4mm) and the pump RPMs (400) which is constant. The user may select any vacuum limit from 60-300 mmHg vacuum and the flow rate remains at ~1.4 L/min.
Specifications:
Vacuum: Medium Vacuum, 8-40 kPa, (60-300 mmHg,) low flow - 1.4 L/min at max vacuum. Vacuum measured from Zero level – atmosphere +/- 10%
Electrical: AC-120V, 60 Hz, 2A
Operating/Storage Ranges
Operating: +5°C to +40 °C Storage: 25°C to +70 °C Humidity Limits: 15 to 93% RH (non-condensing) Atmospheric Pressure: 700 hPA-1060 hPA
Indications for Use:
Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient.
Patient Population:
The Exsalta is indicated for patients that may require aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
Environments of use:
Medical facilities.
We present the proposed device vs. the predicate in the Table below.
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510(k) Summary Page 3 of 6
| Attribute | Predicate Vario 8/18/ci | Proposed Device | ||
|---|---|---|---|---|
| Regulation | 21CFR 878.4780 | 21CFR 878.4780 | ||
| Product Code | BTA - Pump, Portable, Aspiration (manual or powered) | BTA - Pump, Portable, Aspiration (manual or powered) | ||
| Indications for Use | The Medela Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal in either "constant" or "intermittent" mode. | Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patent | ||
| Environment of Use | Professional healthcare facility environment | Professional healthcare facility environment | ||
| User Interface | ||||
| User Control | On/off switch for Vario 18 / 8 versionsOn/off/intermittent switch for Vario c/i versionsVacuum regulator, press knob to turn | On / Off switchTouch Panel | ||
| Visual Indicator | Vacuum gaugeLED for battery operation | Vacuum gauge uses Digital DisplayVarious screens for control, use and maintenance of the device | ||
| Accessories | Patient tubing connectors (with and without coupling pieces)Reusable lids, jarsDisposable linersDisposable jarsConnectors and TubingFilters | Disposable Connectors and TubingDisposable Collection jarDisposable Filters | ||
| Flow liters/min | Vario 8 / Vario 8 c/I 8 liters/min | 1.4 liters/min | ||
| Maximum vacuum mmHg/kPa | Vario 8 / Vario 8 c/i-68mmHg-9kPa | Vario 18563mmHg-75kPa | Vario 18 c/i-413 mmHg-55 kPa | 60-300 mmHg8 - 40 kPa |
| Attribute | Predicate Vario 8/18/ci | Proposed Device | ||
| Therapy modes | Vario 8 andVario 18Continuous | Vario 8 c/i and Vario 18c/iContinuous / intermittent | Continuous | |
| Power Source | AC versions:230-240V, 50/60 Hz, 90 VA120V, 60 Hz, 70 VA | AC/DC versions:100-240V, 50/60 Hz, 80 VA | AC-120V, 60 Hz, 2A | |
| ElectricalProtection Type | Class II | Class I | ||
| Ingress | IP21 | IP21 | ||
| Applied Part Type | CF | B | ||
| Operating AmbientTemperatures | +5...+40°C | +5 to 40°C | ||
| Operating AmbientHumidity | 15...93% R.L. | 15 to 93% RH | ||
| Operating Pressure | 70 - 106 kPa | 70 to 106 kPa | ||
| Storage AmbientTemperatures | -25 to +70°C | -25 to +70°C | ||
| Storage AmbientHumidity | 15 to 93% RH | 15 to 93% RH | ||
| Storage Pressure | 70 - 106 kPa | 70 to 106 kPa | ||
| Weight [kg] | 7.7lbs (3.5kg) (AC-version)9.3 lbs (4.2 kg) ( AC/DC-Version with NiMHBattery) | 12.3 pounds | ||
| Dimensions(hxwxd) | 15x7x11 inches / 380x170x285 mm | Height 5", Width 12", Depth 10" | ||
| Principles of Operation | ||||
| Suction aggregatetype | QuatroFlexTM AC or DC-Motor with flat belttransmission to the four piston/cylindermodules | Peristaltic |
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510(k) Summarv Page 5 of 6
| Attribute | Predicate Vario 8/18/ci | Proposed Device |
|---|---|---|
| Flow control | To adjust the level of suction, the regulatorknob has to be pressed inwards and turned inthe desired direction. The knob will be lockedwhen it's not pressed down to preventaccidental adjustment. The tubing is clampedand the user can use the gauge to adjust thesuction level.When the desired vacuum is reached, the knobcan be released. | Touch screen slide bar with digital display ofsuction level set |
| Vacuum Regulationtype | Mechanical regulator | Microprocessor controlled Proportional valveMechanical regulator |
| Vacuum Gauge type | Analog vacuum gauge | Digital vacuum display |
| Standards | AAMI/ANSI ES60601-1:2005IEC 60601-1-2: 2007ISO 10079-1: 2009 | AAMI/ANSI ES60601-1:2005 + A1: 2012IEC 60601-1-2: 2014ISO 10079-1: 2015 |
Substantial Equivalence Discussion and Rationale
The table above compares the key features of the proposed device with the identified predicate -Medela Vario 8/18/ci K153663. The comparison demonstrates that the proposed devices can be found to be substantially equivalent.
Indications for Use -
The indications for use are similar for the proposed device when compared to the predicate device.
Discussion - Both devices are indicated for bodily fluids (including vomit) or infectious materials from a patient's airway. Both devices have equivalent range of pressure and flow. Minor difference does not raise different concerns of risk than the predicate.
Technology and construction -
Both devices use electrical power to pump fluids into a reservoir.
Discussion - The subject devices uses a peristaltic pump whereas the predicate uses a piston pump. In either case similar pressures and flow are obtained. The differences do not raise different concerns of safety or effectiveness compared to the predicate.
Environment of Use -
The environments of use for the subject and predicate device are similar, namely clinical settings.
Discussion - The environments of use are identical.
Patient Population -
The patient population is similar to the predicate device.
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510(k) Summary Page 6 of 6
Discussion - The subject device provides a wide range of control in pressure and flow and will always be used by a trained clinician.
Non-clinical Testing
We performed a number of tests to demonstrate that the proposed device performed as intended. Testing includes:
- Shelf-life / Aging
- . Software Verification and Validation
- IEC 60601-1 ●
- . IEC 60601-1-2
- ISO 10079-1:2015 ●
The subject device met all performance criteria.
Animal
No animal testing was performed.
Clinical
No human clinical testing was performed.
Discussion of Differences –
There are no significant differences in critical function between the proposed device and the predicate device.
The performance testing has demonstrated that the subject device met the applicable standard performance requirements. The above table plus the risk analysis do not identify any new or different risks compared to the predicate.
Substantial Equivalence Conclusion
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.
§ 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.