The Medline Vacu-line Suction Aspirator is a portable, AC-powered device to be used on general patient population excluding neonatal due to pressure range, to supply a vacuum source adequate within the stated operating vacuum range, to aspirate fluids from respiratory airway. Intended use in home care or hospital environments.

Device Description

Medline Vacu-line Suction Aspirator is an AC powered medical suction aspirator that is intended to remove saliva, thick mucus and other secretions from the patient's airway or respiratory system. The device is intended to be used by healthcare facilities and in homecare. The device is small in size, lightweight and easy to carry allowing it to be portable. The main structure of the suction device includes vacuum pump, vacuum gauge, pressure regulating valve, and is to be used in conjunction with accessories like suction tubing, air filters, and canisters (these accessories are outside the scope of this submission). The Medline Vacu-line Suction Aspirator is a non-sterile device and can be used on multiple patients when following the proper cleaning techniques detailed in the instruction for use, but the accessories are all single patient use and should be disposed of properly and in accordance with their respective instructions for use. The device is a high vacuum/low flow with a vacuum gauge of minimum vacuum range 21.15 ± 4.86 kPa to maximum vacuum range 82.84 ± 1.84 kPa, 2.5 grade and a flow rate of ≥14L/min. The power supply for the device is AC 120 voltage (60Hz) and can be used continuously for up to 30 minutes. The device has a sound level of 66.81 ± 1.37 dB in an open atmosphere and 68.42 ± 0.93 dB in a closed atmosphere. The canister bottles are 850cc, single patient use and disposable. This devices uses an Inline Hydrophobic filter that has a pore size of 0.45 microns; the filter blocks bacteria from entering the vacuum and it will prevent liquid from entering the vacuum pump and tubing.

AI/ML Overview

The document provided describes the Medline Vacu-line Suction Aspirator, a medical device, and its non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a table format with corresponding results for some parameters, but it provides performance specifications of the proposed device as part of the "Summary of Non-Clinical Testing" and "Summary of Technological Characteristics." I will present these as the de facto acceptance criteria and reported performance.

Parameter	Acceptance Criteria (from "Summary of Technological Characteristics" or implied from "Performance Testing")	Reported Device Performance (from "Performance Testing (Bench)")
Air Flow Rate	Not explicitly stated as acceptance criteria, but predicate is "High Vacuum/ High Flow" and proposed is "High Vacuum/Low Flow". The device has a flow rate of ≥14L/min.	Average airflow rate of 24 ± 1.1 L/min
Minimum Vacuum Range	16.20 ~ 84.68 kPa (stated as vacuum range for the proposed device)	21.15 ± 4.86 kPa
Maximum Vacuum Range	16.20 ~ 84.68 kPa (stated as vacuum range for the proposed device)	82.84 ± 1.84 kPa
Working Current	1.5 Amps (stated as Input Current for the proposed device)	Average working current of 1.2 ± 0.0 Amps
Noise Level (Open Atmosphere)	Not explicitly stated as acceptance criteria. Device has a sound level of 66.81 ± 1.37 dB.	66.81 ± 1.37 dB
Noise Level (Closed Atmosphere)	Not explicitly stated as acceptance criteria. Device has a sound level of 68.42 ± 0.93 dB.	68.42 ± 0.93 dB
Working Mode	<30 continuous minutes	"can be used continuously for up to 30 minutes" (from description)
Cleaning Validation	Cleaning without affecting performance or appearance	Cleaned 150 times with Microkill+ alcohol-based wipes, without affecting performance or appearance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size (number of devices tested) for the performance bench testing (Air Flow Rate, Pressure Test, Working Current, Noise Level) or the cleaning validation. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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)

This section is not applicable as this document relates to the regulatory submission for a medical device (suction aspirator) and the testing performed is non-clinical bench testing, not a study involving human subjects or expert assessment of clinical data to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3.

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

This section is not applicable. The device is an AC-powered suction aspirator, not an AI-powered diagnostic or imaging device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable, as the device is not an algorithm or AI system. The testing performed was standalone bench testing of the physical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical performance and safety testing, the "ground truth" or reference standards would be:

Physical measurements: Calibrated instruments and established engineering standards for flow rate, pressure, current, and noise level.
Observed effect: For cleaning validation, the "ground truth" was the observed lack of degradation in performance or appearance after repeated cleaning cycles.

8. The sample size for the training set

This section is not applicable as there is no mention of a training set. This is a medical device, not an AI/ML model that requires training.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Summary

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May 4, 2021

Medline Industries, Inc. Kelsey Closen Regulatory Affairs Specialist Three Lake Drive Northfield, Illinois 60093

Re: K203135

Trade/Device Name: Medline Vacu-line Suction Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: March 30, 2021 Received: April 1, 2021

Dear Kelsey Closen:

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 equiv alence 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 mediation-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/cdrl-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,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203135

Device Name Medline Vacu-line Suction Aspirator

Indications for Use (Describe)

The Medline Vacu-line Suction Aspirator is a portable, AC-powered device to be used on general patient population excluding neonatal due to pressure range, to supply a vacuum source adequate within the stated operating vacum range, to aspirate fluidsfrom respiratory airway. Intended use in home care or hospital environments.

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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Image /page/3/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in white, stacked on top of a white abstract star shape. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592

Contact Person

Kelsey Closen Regulatory Affairs Specialist Phone: 847-949-2283 Email: KClosen@medline.com

Summary Preparation Date May 4, 2021

Type of 510(k) Submission Traditional

Device Name / Classification

Trade Name: Medline Vacu-line Suction Aspirator Common Name: Powered suction pump Classification Name: Pump, Portable, Aspiration (manual or powered) Product Code: BTA Classification Panel: General & Plastic Surgery Regulatory Class: II Regulation Number: 21 CFR 878.4780

Predicate Device

EasyGoVac K140179

Device Description

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Image /page/4/Picture/1 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst symbol. The starburst is composed of four elongated triangles converging at a central point, creating a dynamic and eye-catching design. A small gray rectangle is visible in the upper right corner of the image.

Medline Industries. Inc Three Lakes Drive Northfield. IL 60093

includes vacuum pump, vacuum gauge, pressure regulating valve, and is to be used in conjunction with accessories like suction tubing, air filters, and canisters (these accessories are outside the scope of this submission). The Medline Vacu-line Suction Aspirator is a non-sterile device and can be used on multiple patients when following the proper cleaning techniques detailed in the instruction for use, but the accessories are all single patient use and should be disposed of properly and in accordance with their respective instructions for use. The device is a high vacuum/low flow with a vacuum gauge of minimum vacuum range 21.15 ± 4.86 kPa to maximum vacuum range 82.84 ± 1.84 kPa, 2.5 grade and a flow rate of ≥14L/min. The power supply for the device is AC 120 voltage (60Hz) and can be used continuously for up to 30 minutes. The device has a sound level of 66.81 ± 1.37 dB in an open atmosphere and 68.42 ± 0.93 dB in a closed atmosphere. The canister bottles are 850cc, single patient use and disposable. This devices uses an Inline Hydrophobic filter that has a pore size of 0.45 microns; the filter blocks bacteria from entering the vacuum and it will prevent liquid from entering the vacuum pump and tubing.

Indications for Use

Summary of Technological Characteristics

DeviceCharacteristic	ProposedDevice	Predicate Device	ComparisonAnalysis
Product Name	Medline Vacu-lineSuction Aspirator	EasyGoVac	N/A
510(k)Reference	K203135	K140179(model PM66AC)	N/A
Product Owner	Medline Industries,Inc.	Precision Medical	N/A
Product Code	BTA	BTA	Same
Intended Use	The Medline Vacu-line SuctionAspirator is a portable, AC-powered device to be used ongeneral patient populationexcluding neonatal due topressure range, to supply avacuum source adequate withinthe stated operating vacuumrange, to aspirate fluids fromrespiratory airway. Intended usein home care or hospitalenvironments.	TheEasyGoAspiratorprovidesportable, ACamedical vacuumpoweredsource. It is intended for use inthe homecare / health careenvironments.	Same
RegulationNumber	878.4780	878.4780	Same
DesignFeatures	-Disposable canisters (850 ccfloat and filter lids)-Lid has shut off valve toprotects from overfill-Portable, easy carry-Light Weight- Inline Hydrophobic Filter-Vacuum gauge	-Reusable and disposablecontainers (800cc/1200cc)-Lid has a float shut off valve thatprotects from overfill-Portable, easy carry-Light Weight-Filters (inline, Bacterial orHydrophobic)-Vacuum gauge	Similar
Safety Features	-Overflow protection	-Overflow Protection	Same
Accessories	-Suction Tubing- Disposable canisters-Intermediate Tubing- Inline Hydrophobic Filter-Suction Catheter	-Suction tubing-Inline filter (Bacterial orHydrophobic)-Disposable or reusableCanister (800/1200cc)-800cc Inlet Adaptor Kit- Carry Bag-AC Power Cord	Similar
DeviceDimensions	(L) 293 x (W) 192 x(H) 245 mm	With Disposablebottle- 218x 160x204mmWith Reusable bottle-186x160x 187mm	Different
Prescription vs.OTC	Rx	Rx	Same
Sterile vs. Non-Sterile	Non- Sterile	Non-Sterile	Same
DisposableVS.Non-Disposable	Aspirator is reusableaccessories - singlepatient use	Aspirator is reusableaccessories-singlepatient use, canister isalso offer reusable	Same
Power	AC Only Model	AC only model(PM66AC)	Same
Voltage	AC 120V, 60Hz	AC 100-240V, 50-60Hz	Similar
Input Current	1.5 Amps	0.60-0.25 Amps	Different
Vacuum Range	16.20~ 84.68kPa	0~94kPa	Different
Canister	850cc Disposable	800cc and 1200ccDisposable andreusable	Similar(fordisposable canister)
ElectricalRequirements	Class II, Type BF	Class II, Type BF	Same
EquipmentType	High Vacuum/LowFlow	High Vacuum/ HighFlow	Different
Working Mode	<30 continuous minutes	15 minutes on, 15 minutes off within a 2 hour cycle	Different
OperatingTemperature	41° ~ 104° F (5° ~ 40°C)	0° ~ 122° F (-18° ~ 50°C)	Different
OperatingHumidity	≤93% Relative Humidity	95% Noncondensing	Different

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

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Image /page/5/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized white cross extending from the top and bottom of the word. The background is a solid dark blue color. The logo is simple and recognizable, commonly associated with medical supplies and healthcare products.

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, with a stylized white starburst symbol behind it. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.

ledline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Summary of Non-Clinical Testing

Non-clinical verification of the Medline Vacu-line Suction Aspirator has been conducted to evaluate its safety, performance and functionality. The results of these tests have demonstrated the overall safety of the proposed device and its effectiveness in accordance with relevant test methods, and ultimately support a substantial equivalence determination. Full performance testing reports for can be found in Appendix D.

Performance Testing (Bench)

The following testing was conducted on the Medline Vacu-line Suction Aspirator:

Air Flow Rate

The aspirator displayed an average airflow rate of 24± 1.1 L/min

Pressure Test

The aspirator displayed an minimum vacuum range of 21.15 ± 4.86 kPa and a maximum vacuum range of 82.84 ± 1.84 kPa

Working Current

The aspirator displayed an average working current of 1.2 ± 0.0 Amps

Noise Level

The aspirator displayed a noise level of 66.81 ± 1.37 dB in an open atmosphere and 68.42 ± 0.93 dB in a closed atmosphere

Other Testing

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Image /page/7/Picture/1 description: The image is a logo for Medline. The logo is set against a blue square background. The word "MEDLINE" is in white, bold, sans-serif font. A white star-like shape is behind the word "MEDLINE".

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Electromagnetic Compatibility & Electrical Safety

IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements for Basic . Safety and Essential Performance, Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11:2015 Medical Electrical Equipment -- Part 1-11: General Requirements for Basic ● Safety and Essential Performance- Collateral Standards: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
. IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010, Medical Electrical Equipment Part 1-6: General requirements for safety-Collateral Standard: Usability
EN ISO 10079-1:2015, Medical suction equipment -- Part 1: Electrically powered suction equipment

Cleaning Validation

A Cleaning validation was conducted by cleaning the suction aspirator 150 times with Microkill+ alcohol based wipes, without affecting the performance or appearance of the device.

Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Vacu-line Suction Aspirator is as safe and as effective for their intended use as the predicate device, EasyGoVac K140179.

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.