(197 days)
Not Found
No
The device description and performance testing focus on mechanical and electrical parameters (vacuum, flow rate, noise level, current) and do not mention any AI/ML components or functionalities.
Yes
The device is intended to aspirate fluids from the respiratory airway, which is a therapeutic action aimed at improving a patient's condition.
No
The device is described as a suction aspirator intended to remove fluids from the respiratory airway. Its function is therapeutic (fluid removal), not diagnostic (identifying a disease or condition).
No
The device description clearly outlines physical hardware components such as a vacuum pump, vacuum gauge, pressure regulating valve, and accessories like tubing, filters, and canisters. It is an AC-powered device with specified electrical and mechanical characteristics.
Based on the provided information, the Medline Vacu-line Suction Aspirator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "aspirate fluids from respiratory airway." This is a direct interaction with the patient's body to remove substances, not to perform tests on samples taken from the body.
- Device Description: The device is described as a "medical suction aspirator" that removes "saliva, thick mucus and other secretions from the patient's airway or respiratory system." This further reinforces its function as a physical removal device.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Medline Vacu-line Suction Aspirator's function is purely mechanical removal of fluids from the airway.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BTA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Respiratory airway
Indicated Patient Age Range
General patient population excluding neonatal.
Intended User / Care Setting
Home care or hospital environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Performance Testing (Bench):
- Air Flow Rate: The aspirator displayed an average airflow rate of 24± 1.1 L/min.
- Pressure Test: The aspirator displayed a 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:
- Electromagnetic Compatibility & Electrical Safety: IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-1:2012, IEC 60601-1-6:2010, EN ISO 10079-1:2015.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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
2
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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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
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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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
Characteristic | Proposed
Device | Predicate Device | Comparison
Analysis |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product Name | Medline Vacu-line
Suction Aspirator | EasyGoVac | N/A |
| 510(k)
Reference | K203135 | K140179
(mod
el PM66AC) | N/A |
| Product Owner | Medline Industries,
Inc. | Precision Medical | N/A |
| Product Code | BTA | BTA | Same |
| 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. | The
Easy
Go
Aspirator
provides
portable, AC
a
medical vacuum
powered
source. It is intended for use in
the homecare / health care
environments. | Same |
| Regulation
Number | 878.4780 | 878.4780 | Same |
| Design
Features | -Disposable canisters (850 cc
float and filter lids)
-Lid has shut off valve to
protects from overfill
-Portable, easy carry
-Light Weight
- Inline Hydrophobic Filter
-Vacuum gauge | -Reusable and disposable
containers (800cc/1200cc)
-Lid has a float shut off valve that
protects from overfill
-Portable, easy carry
-Light Weight
-Filters (inline, Bacterial or
Hydrophobic)
-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 or
Hydrophobic)
-Disposable or reusable
Canister (800/1200cc)
-800cc Inlet Adaptor Kit - Carry Bag
-AC Power Cord | Similar |
| Device
Dimensions | (L) 293 x (W) 192 x
(H) 245 mm | With Disposable
bottle- 218x 160x
204mm
With Reusable bottle-
186x160x 187mm | Different |
| Prescription vs.
OTC | Rx | Rx | Same |
| Sterile vs. Non-
Sterile | Non- Sterile | Non-Sterile | Same |
| Disposable
VS.
Non-
Disposable | Aspirator is reusable
accessories - single
patient use | Aspirator is reusable
accessories-
single
patient use, canister is
also 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 1200cc
Disposable and
reusable | Similar
(for
disposable canister) |
| Electrical
Requirements | Class II, Type BF | Class II, Type BF | Same |
| Equipment
Type | High Vacuum/Low
Flow | High Vacuum/ High
Flow | Different |
| Working Mode |