The Aspiration Pump is a portable suction / aspirator / vacuum system which is used to remove debris, blood and other bodily fluids through the application of continuous negative pressure. The Aspiration Pump includes two suction / vacuum ports on the input side, each with individual flow control valves and standard 6% Luer taper connectors. A 500cc collection bag is attached to the output side of the Aspiration Pump for collection of removed debris, blood and bodily fluids.

AI/ML Overview

The Rex Medical Aspiration Pump is a powered suction pump intended for general suction use in hospitals or clinics. The provided document is a 510(k) Summary, which details the device's characteristics and the testing performed to demonstrate its substantial equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a single, consolidated table. Instead, it lists various non-clinical performance tests and their outcomes (Pass/Fail) and compares the device's design features with predicate devices. Based on the "Summary of Aspiration Pump Backflow Testing," a specific acceptance criterion is stated:

Acceptance Criteria	Reported Device Performance
No backflow when a 45psi minimum back pressure is applied.	All tests passed. The liquid aspiration pump did not allow any backflow of fluids.

For other tests, such as pressure, battery life, voltage comparison, IPA resistance, flow rate, and maximum volume, the report simply states "Pass," indicating that the device met the predefined acceptance criteria for these tests, although the specific numerical criteria are not detailed in this summary.

Study Details

The document refers to a series of non-clinical performance tests (in vitro and in vivo studies, and testing to standards) to demonstrate the safety and effectiveness of the Rex Medical Aspiration Pump and its substantial equivalence to predicate devices. No human clinical trials were performed.

Sample sizes used for the test set and the data provenance:
- Backflow Testing: Two liquid aspiration pumps were each tested three times, totaling 6 test runs.
- Other In-vitro and In-vivo testing: Specific sample sizes for other tests (Pressure Study, Battery Life Study, Flow Rate Study, Efficacy Study, etc.) are not specified in this summary.
- Data Provenance: The studies were internal company tests or performed by third-party testing labs (e.g., UL Test Report). The country of origin of the data is not explicitly stated, but given the FDA submission, it's likely conducted in the US or under internationally recognized standards. The studies are by nature prospective tests performed on the device prototypes or production samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- As this is a non-clinical device that performs a physical function (suction), the "ground truth" is established through engineering and scientific measurements and adherence to technical specifications, not through expert clinical consensus on interpretations. Therefore, there is no mention of experts establishing ground truth in the context of clinical interpretation, as it is not applicable. The tests would be performed by qualified engineers or technicians.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretations or disagreements among experts need to be resolved. For non-clinical performance tests, results are objectively measured against predefined specifications.
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:
- Not applicable. This device is a physical medical instrument (a suction pump), not an AI algorithm for diagnostic imaging or similar applications where human readers' performance would be evaluated with or without AI assistance. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument, not a software algorithm. Its performance is intrinsically standalone in the sense that it performs its function (suction) independent of human-in-the-loop diagnostic decision-making.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is based on predefined engineering specifications, international standards (e.g., ISO, AAMI, ASTM), and the expected physical behavior of a medical suction pump, such as flow rates, vacuum pressure, battery life, and absence of backflow.
The sample size for the training set:
- Not applicable. This device is a physical medical instrument subject to engineering testing. It does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical medical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

January 30, 2018

Rex Medical, L.P. % Ms. Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K173389

Trade/Device Name: Rex Medical Aspiration Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: January 12, 2018 Received: January 16, 2018

Dear Ms. Goldstein-Falk:

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, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -

S3

For 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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Indications for Use

510(k) Number (if known) K173389

Device Name Rex Medical Aspiration Pump

Indications for Use (Describe) The Aspiration Pump is intended for general suction use in hospitals or clinics.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K173389

Submitter:	Rex Medical, L.P.555 E. North Ln, Suite 5035Conshohocken, PA 19428
Contact Person:	Ms. Susan D. Goldstein-FalkOfficial Correspondent for Rex Medical55 Northern Blvd., Suite 200Great Neck, New York 11021TEL: (516) 829-0451FAX: (516) 466-3427Email: sgoldstein@mdiconsultants.com
Date Prepared:	January 30, 2018
Trade Name:	Rex Medical Aspiration Pump
Common Name:	Pump, Portable, Aspiration (Manual or Powered)
Regulation Name:	Pump, Portable, Aspiration (Manual or Powered)
Regulation Number:	21 CFR 878.4780
Product Code:	BTA
Device Class:	Class II

Predicate Device(s): Primary: K051758, Penumbra Aspiration Pump Reference: K971749, EasyGo Aspirator, Precision Medical, Inc.

Device Description

Patient Contacting Components:

There are no patient contacting components for the Rex Medical Aspiration Pump. The pump connects to a catheter and is never place directly into the body of vasculature. The pump only aspirates and does not infuse any substances into the body.

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The Aspiration Pump is used in conjunction with suction tubes, catheters, etc. to remove surgical fluids, tissues, bodily fluids and infectious materials from a wound, patient's airway or espiratory system during surgery. During procedural use, the collection bag is kept on the same surface as the Aspiration Pump so that they are at the same elevation. The Aspiration Pump has two flow control valves that can be attached to other devices with a standard luer connection. The Aspiration Pump is activated by pressing the ON/OFF switch and deactivated by pressing the switch again.

The Aspiration Pump contains an over-pressure safety device which will cease device operation during an over-pressure situation. An over-pressure situation can occur if fluid contained within the collection bag exceeds the collection bag's maximum capacity. A red L.E.D. will illuminate during an over-pressure situation and will remain illuminated until the over-pressure state is resolved.

Indication for Use:

The Rex Medical Aspiration Pump is intended for general suction use in hospitals or clinics.

Comparison to the 510(k) Cleared Device:

The Rex Medical Aspiration Pump is substantially equivalent to the Penumbra Aspiration Pump (K051758).

Discussion of Similarities:

The Rex Medical Aspiration Pump and Penumbra Aspiration Pump are both design to connect to other devices such as catheters and sheaths with a standard luer connection and provide general suction. Both pumps provide a continuous suction through the creation on negative pressure in a closed system.

The Rex Medical Aspiration Pump and EasyGo Aspirator are both compact, portable pumps with similar indications for use. Both pumps are powered with batteries (DC) and provide continuous suction with comparable vacuum pressure.

Discussion of Differences:

The Rex Medical Aspiration Pump is a compact, portable, single use device that is powered by a 12V DC battery. Contrarily, the Penumbra pump is a large, reusable pump that is powered by 110V AC and plugged into a standard wall outlet. The collection cannister and aspiration tubing are single use disposable and are replaced for each use.

The Rex Medical Aspiration Pump differs with the EasyGo Aspirator in a few key aspects. The Rex Medical Pump is a single use disposable pump as opposed to re-usable. The Rex Medical Aspiration Pump feature an inline pressure switch as opposed to a floating valve. Additionally, the EasyGo Aspirator can be recharged.

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Table 1: Comparison Chart

Design Feature	Proposed DeviceRex MedicalAspiration Pump	Predicate DevicePenumbraAspiration PumpK051758	Comments	Alternate Predicate DevicePrecision MedicalEasyGo AspiratorK971749	Comments
Indications forUse	Intended for generalsuction use in hospitals or clinics.	Intended for generalsuction use in hospitals or clinics.	SAME	Intended for use in the homecareor hospital environment.	SIMILAR
Closed System	YES	YES	SAME	YES	SAME
Fluid CollectionDisposal	Disposable, collection bag	Disposable collection canister.	Rex Medical AspirationPump utilizes a bag asopposed to a container. Thebag is more beneficial toshipping and packaging butdoes not affect productsafety or efficacy.	Disposable collection canister.	Rex Medical AspirationPump utilizes a bag asopposed to a container. Thebag is more beneficial toshipping and packaging butdoes not affect productsafety or efficacy.
Product Code	BTA	BTA, JCX	SIMILAR	BTA	SAME
FDA Regulation,21 CFR	878.4780	878.4780	SAME	878.4780	SAME
Dimensions -Mobile Unit	6" X 4.125" X 2.5"	Est. 16" X 10" X 8"	Smaller unit to take up lessoperating table space andbecome less intrusive to thephysician.	12" X 9.5" X 10.2"	Smaller unit to take up lessoperating table space andbecome less intrusive to thephysician.
Weight -MobileUnit	1.5 lbs	Unknown	From the size of the pump, itcan be assumed that it issubstantially heavier.	11 lbs	Rex Medical AspirationPump is lighter as it requiressmaller battery & pump foroperation.
ElectricalRequirements	12V DC powered, standalone	100-115V AC	Uses wall outlet vs. batterypowered.	12V DC powered, re-chargeable.AC adapter for re-charging.	SAME (When Portable)
Suction Source	Integrated vacuum pump	Integrated vacuum pump	SAME	Integrated vacuum pump	SAME
Mobile UnitVacuum Range	5-28 inHG, depending on diameterof attached suction tubing	29inHG Max, varies depending ondiameter of attached suctiontubing	SIMILAR	2-21 inHG depending on diameterof attached suction tubing &vacuum control knob.	The vacuum pressuregenerates adequate flowrates to aspirate materialsand fluids with varieddiameters of tubing. Ahigher maximum vacuumpressure increases theeffectiveness with smalldiameter catheters.The aspiration flow rate issufficient to effectivelyaspirate material and fluids.
Flow Rate	22 - 650 mL/min H₂Odepending on catheter used	42 - 480 mL/mindepending on catheter used	SIMILAR	14 Lpm Air, Under AC Power	SAME
Run Time	45min Minimum	Infinite	AC powered does not have aruntime.	45min Minimum	SAME
VacuumRegulator	None	Regulator Valve	Rex Medical AspirationPump's vacuum is based onflow and volumetric load.Maximal vacuum isregulated by designedsupplied voltage parameterwhich is non-adjustable.	Regulator Valve	Rex Medical AspirationPump's vacuum is based onflow and volumetric load.Maximal vacuum isregulated by designedsupplied voltage parameterwhich is non-adjustable.
Fluid SuctionFilter	None	Inline Filter	Rex Medical AspirationPump does not require afilter, as the collection unit isdownstream of the pump.	Bacterial Filter	Rex Medical AspirationPump does not require afilter, as the collection unit isdownstream of the pump.
Single PatientUse	Single	Single use cannister and aspirationtubing. Reusable pump.	Rex Medial Aspiration Pumpis designed and marketed asa onetime use device.	Reusable	Rex Medial Aspiration Pumpis designed and marketed asa onetime use device.
HoldingContainerCapacity	500 mL	1000 mL		800 mL
Suction Mode	Continuous	Continuous	SAME	Continuous	SAME
OTC orPrescription	Prescription	Prescription	SAME	Prescription	SAME
OverflowPreventionMechanism	Integrated Pressure Switch	None	Rex Medical AspirationPump utilizes a pressureswitch which ceases deviceoperation when a positive	Float Shut-off	Rex Medical AspirationPump utilizes a pressureswitch which ceases deviceoperation when a positive
			pressure of 3psi (±10%) isreached on the output sideof the pump. This preventssystem operation if adownstream tube is kinkedor if the volume of fluidwithin the collection bagexceeds 500 mL.		pressure of 3psi (±10%) isreached on the output sideof the pump. This preventssystem operation if adownstream tube is kinkedor if the volume of fluidwithin the collection bagexceeds 500 mL.
Suction Inlet PortDimensions	.125" ID with Luer Connector	0.071" – 0.110" ID with LuerConnector	SIMILAR	.125" ID	Rex Medical AspirationPump is compatible withLuer fittings commonlyfound on catheters usedwithin the surgical field.

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Non-Clinical Performance Testing:

Testing information demonstrating safety and effectiveness of the Rex Medical Aspiration Pump in the intended environment of use is supported by testing that was conducted in accordance with Guidance on the Content of Premarket Notification Submissions for portable aspiration pumps.

The following table provides the in vitro testing that was performed for the Rex Medical Aspiration Pump to show substantial equivalence to the predicate device:

Report Title	Pass / Fail
Aspiration Pump Pressure Study Technical Report	Pass
Aspiration Pump Battery Life Study Technical Report	Pass
Aspiration Pump Voltage Comparison Study Technical Report	Pass
Distal Assembly IPA Resistance Study Technical Report	Pass
EPEC Engineered Technologies Battery Sample StudyTechnical Report	Pass
Flow Rate of Rex Medical Aspiration Pump and PredicateDevice Technical Report	Pass
Battery Life of Rex Aspiration Pump and Predicate Device	Pass
Maximum Volume of Rex Medical Aspiration Pump andPredicate Device Technical Report	Pass
UL Test Report for Disposable Aspiration Pump, NT-Pump	Pass
Aspiration Pump Backflow Report	Pass

Table 2: In Vitro Testing

Summary of Aspiration Pump Backflow Testing:

The Rex Medical Aspiration Pump uses a liquid aspiration pump to aspirate fluid from the patient and into the collection bag. The liquid aspiration pump is designed to prevent back flow through the pump. The objective of the test is to verify that backflow does not occur. The acceptance criteria for the test is no backflow when a 45psi minimum back pressure is applied. Two liquid aspiration pumps were each tested three times. All tests passed. The liquid aspiration pump did not allow any backflow of fluids.

The following table provides the in vivo testing that was performed for the Rex Medical Aspiration Pump to show substantial equivalence to the predicate device:

Table 3: In Vivo Testing

Report Title	Pass / Fail
Aspiration Pump in vivo Fluid Flow Study Technical Report	Pass
Aspiration Pump in vivo Efficacy Study Technical Report	Pass

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Testing to Standards:

The following national and international standards were utilized for testing the subject device:

Table 2: Standards

Report Title	Pass / Fail
ISO 14161 (2009) Sterilization of Health Care Products- “Biological Indicators - Guidancefor The Selection, Use and Interpretation of Results”	Pass
BS EN ISO 11737-2 (2009) "Sterilization of Medical Devices - Microbiological Methods -Part 2: Tests of Sterility Performed in The Definition, Validation and Maintenance of ASterilization Process"	Pass
AAMI/ANSI/ISO 11135 (2014) "Sterilization of Health-Care Products - Ethylene Oxide -Requirements for The Development, Validation and Routine Control of a SterilizationProcess For Medical Devices"	Pass
ISO 11737-1 (2009) "Sterilization of Health Care Products - Microbiological Methods -Part 1: Determination Of The Population of Microorganisms On Product"	Pass
ISO 10993-7 (1995) "Biological Evaluation of Medical Devices - Part 7: Ethylene OxideSterilization Residuals"	Pass
ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10) "Medical Electrical Equipment - Part 1:General Requirements for Basic Safety And Essential Performance"	Pass
AAMI ANSI IEC 60601-1-2 (2007/(R)2012) “Medical Electrical Equipment - Part 1-2:General Requirements For Basic Safety And Essential Performance - Collateral Standard:Electromagnetic Compatibility - Requirements And Tests"	Pass
ASTM F 88 (2015) "Standard Test Method for Seal Strength of Flexible Barrier Materials"	Pass
ASTM D 4169 (2016) “Standard Practice for Performance Testing of Shipping Containersand Systems"	Pass
ASTM F1886 (2016) "Standard Test Method for Determining Integrity of Seals forFlexible Packaging By Visual Inspection"	Pass
ASTM F 2096 (2013) "Standard Test Method for Detecting Gross Leaks in Packaging byInternal Pressurization (Bubble Test)"	Pass
ISTA 2A (2012) "Packaged Products Weighting 150(lbs) or Less"	Pass

Clinical Performance Testing:

No clinical testing was conducted for this device.

Conclusion:

Conclusions based on aforementioned testing and information demonstrate the Rex Medical Aspiration Pump is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.