Medline Vacu-line Suction Aspirator

K203135 · Medline Industries, Inc. · BTA · May 4, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203135
• Device Name: Medline Vacu-line Suction Aspirator
• Applicant: Medline Industries, Inc.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: May 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Portable, AC-powered suction aspirator; removes saliva, mucus, and secretions from patient airways. Components include vacuum pump, vacuum gauge, pressure regulating valve, and disposable 850cc canister. Inline hydrophobic filter (0.45 micron) prevents liquid/bacteria ingress to pump. Operated by healthcare professionals or patients/caregivers in hospitals or home environments. Device provides high vacuum/low flow suction; output monitored via gauge. Clinical benefit: airway clearance. Device is non-sterile; reusable aspirator unit with single-patient-use accessories.

Clinical Evidence

Bench testing only. Performance testing included airflow rate (24 ± 1.1 L/min), vacuum pressure range (21.15 ± 4.86 kPa to 82.84 ± 1.84 kPa), noise levels, and working current. Safety testing included IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, and EN ISO 10079-1. Cleaning validation confirmed performance stability after 150 cycles.

Technological Characteristics

AC-powered (120V, 60Hz) portable suction pump. Class II, Type BF electrical safety. High vacuum/low flow. Includes vacuum gauge, pressure regulating valve, and 0.45-micron hydrophobic inline filter. Dimensions: 293 x 192 x 245 mm. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, EN ISO 10079-1.

Indications for Use

Indicated for general patient population, excluding neonates, requiring vacuum-assisted aspiration of fluids from the respiratory airway in home care or hospital settings.

Regulatory Classification

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.

Predicate Devices

• EasyGoVac (K140179)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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 ([e-mail]) or phone [phone] 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)

| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------------------|
| <div> <span>□ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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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: [phone] Email: [e-mail]

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

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

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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

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.

## Summary of Technological Characteristics

| Device<br>Characteristic | Proposed<br>Device | Predicate Device | Comparison<br>Analysis |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product Name | Medline Vacu-line<br>Suction Aspirator | EasyGoVac | N/A |
| 510(k)<br>Reference | K203135 | K140179<br>(mod<br>el PM66AC) | N/A |
| Product Owner | Medline Industries,<br>Inc. | Precision Medical | N/A |
| Product Code | BTA | BTA | Same |
| Intended Use | The Medline Vacu-line Suction<br>Aspirator is a portable, AC-<br>powered device to be used on<br>general patient population<br>excluding neonatal due to<br>pressure range, to supply a<br>vacuum source adequate within<br>the stated operating vacuum<br>range, to aspirate fluids from<br>respiratory airway. Intended use<br>in home care or hospital<br>environments. | The<br>Easy<br>Go<br>Aspirator<br>provides<br>portable, AC<br>a<br>medical vacuum<br>powered<br>source. It is intended for use in<br>the homecare / health care<br>environments. | Same |
| Regulation<br>Number | 878.4780 | 878.4780 | Same |
| Design<br>Features | -Disposable canisters (850 cc<br>float and filter lids)<br>-Lid has shut off valve to<br>protects from overfill<br>-Portable, easy carry<br>-Light Weight<br>- Inline Hydrophobic Filter<br>-Vacuum gauge | -Reusable and disposable<br>containers (800cc/1200cc)<br>-Lid has a float shut off valve that<br>protects from overfill<br>-Portable, easy carry<br>-Light Weight<br>-Filters (inline, Bacterial or<br>Hydrophobic)<br>-Vacuum gauge | Similar |
| Safety Features | -Overflow protection | -Overflow Protection | Same |
| Accessories | -Suction Tubing<br>- Disposable canisters<br>-Intermediate Tubing<br>- Inline Hydrophobic Filter<br>-Suction Catheter | -Suction tubing<br>-Inline filter (Bacterial or<br>Hydrophobic)<br>-Disposable or reusable<br>Canister (800/1200cc)<br>-800cc Inlet Adaptor Kit<br>- Carry Bag<br>-AC Power Cord | Similar |
| Device<br>Dimensions | (L) 293 x (W) 192 x<br>(H) 245 mm | With Disposable<br>bottle- 218x 160x<br>204mm<br>With Reusable bottle-<br>186x160x 187mm | Different |
| Prescription vs.<br>OTC | Rx | Rx | Same |
| Sterile vs. Non-<br>Sterile | Non- Sterile | Non-Sterile | Same |
| Disposable<br>VS.<br>Non-<br>Disposable | Aspirator is reusable<br>accessories - single<br>patient use | Aspirator is reusable<br>accessories-<br>single<br>patient use, canister is<br>also offer reusable | Same |
| Power | AC Only Model | AC only model<br>(PM66AC) | Same |
| Voltage | AC 120V, 60Hz | AC 100-240V, 50-<br>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 1200cc<br>Disposable and<br>reusable | Similar<br>(for<br>disposable canister) |
| Electrical<br>Requirements | Class II, Type BF | Class II, Type BF | Same |
| Equipment<br>Type | High Vacuum/Low<br>Flow | High Vacuum/ High<br>Flow | Different |
| Working Mode | <30 continuous minutes | 15 minutes on, 15 minutes off within a 2 hour cycle | Different |
| Operating<br>Temperature | 41° ~ 104° F (5° ~ 40°C) | 0° ~ 122° F (-18° ~ 50°C) | Different |
| Operating<br>Humidity | ≤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.