Servo Guard

K182862 · Maquet Critical Care AB · CAH · Oct 21, 2019 · Anesthesiology

Device Facts

• Record ID: K182862
• Device Name: Servo Guard
• Applicant: Maquet Critical Care AB
• Product Code: CAH · Anesthesiology
• Decision Date: Oct 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Servo Guard is a bacterial/viral filter for applications in respiratory care. The filter is intended to be used in patient circuits to reduce the spread of viruses and bacteria from patient/personnel and to protect the patient circuits and ventilators from contamination. The filter shall only be used with the ventilators Servo-u, Servo-n, Servo-i and Servo-s.

Device Story

Servo Guard is a mechanical bacterial/viral filter for respiratory care; used in patient circuits to reduce cross-contamination between patients/personnel and protect ventilators from contamination. Device is a disposable accessory placed on the expiratory or inspiratory limb of a breathing circuit. Operates by mechanical filtration of gases; removes dust and microbiological matter. Used in clinical settings with specific ventilators (Servo-u, Servo-n, Servo-i, Servo-s). Healthcare providers install the filter in the circuit; output is filtered gas flow. Benefits include reduced risk of patient-to-patient or patient-to-equipment contamination.

Clinical Evidence

Bench testing only. Testing included filter efficiency (ISO 23328-1), bacterial/viral filtration efficiency (ASTM F2101-14), and biocompatibility of breathing gas pathways (ISO 18562-2, ISO 18562-3). Results confirmed filter efficiency >99.3% and BFE/VFE >99.999%. Particulate matter and VOC emissions were within acceptable safety limits.

Technological Characteristics

Mechanical filter; 150 ml volume; ISO 5356-1 M22/F15 inlet and F22 outlet connections; 75g weight; 3-year shelf life. Tested per ISO 23328-1, ASTM F2101-14, ISO 18562-2, and ISO 18562-3. Single-use, disposable.

Indications for Use

Indicated for neonatal to adult patient populations requiring respiratory care to reduce cross-contamination and protect ventilator circuits from bacterial/viral particles.

Regulatory Classification

Identification

A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.

Predicate Devices

• Servo Guard Model number 64 81 290 EH88E (K030071)

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 21, 2019

Maquet Critical Care AB % Mark Dinger Sr. Regulatory Affairs Specialist Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K182862

Trade/Device Name: Servo Guard Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: September 19, 2019 Received: September 20, 2019

Dear Mark Dinger:

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

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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) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic 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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# Indications for Use

510(k) Number (if known) K182862

Device Name Servo Guard

#### Indications for Use (Describe)

The Servo Guard is a bacterial/viral filter for applications in respiratory care.The filter is intended to be used in patient circuits to reduce the spread of viruses and bacteria from patient/persomel and to protect the patient circuits and ventilators from contamination. The filter shall only be used with the ventilators Servo-i and Servo-s.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: large;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) SUMMARY as required by section 21 CFR 807.92

#### Submitter Name & Address

Maquet Critical Care AB Röntgenvägen 2 SE-171 54 Solna, Sweden Phone: [phone]

| Contact Persons for this submission: | Jerker Åberg<br>Regulatory Affairs Manager<br>Phone: direct: (011) 46 10 335 7985<br>e-mail: [e-mail] |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Mark Dinger<br>Sr. Regulatory Affairs Specialist<br>Maquet Medical Systems USA<br>45 Barbour Pond Drive<br>Wayne, NJ 07470<br>e-mail: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |

Date prepared: September 19th, 2019

| Trade Name: | Model no: |
|-------------|-----------|
| Servo Guard | 6595487 |

#### Device Classification

| Common Name | Classification<br>Number | Class | Regulation Number |
|-----------------------------------|--------------------------|-------|-------------------|
| Breathing Circuit Bacteria Filter | CAH | II | 21 CFR 868.5260 |

#### Predicate Device Identification

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|----------------------------------------------------------------|----------|
| Servo Guard Model number 64 81 290 EH88E | K030071 |

### Indications for Use

The Servo Guard is a bacterial/viral filter for applications in respiratory care. The filter is intended to be used in patient circuits to reduce the spread of viruses and bacteria from patient/personnel and to protect the patient circuits and ventilators from contamination. The filter shall only be used with the ventilators Servo-u, Servo-n, Servo-i and Servo-s.

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### Device Description

A Breathing Circuit Bacteria Filter is intended to protect from contamination as well as to reduce particles such as dust and microbiological matters from gases used in the patient circuit of a respiratory device. The bacterial/viral filter is a disposable accessory normally used on the expiratory limb of the ventilator breathing system to reduce possible cross contamination between patient and equipment and between patient. It can also be used on the inspiratory pipe, in order to reduce dust particles to the patient.

Image /page/4/Picture/3 description: The image shows a clear, rectangular medical filter with two cylindrical ports on either side. The filter has a label with two arrows pointing upwards and the word "UP" between them, indicating the correct orientation for use. There is also a "LOT 03 15" marking on the filter, likely referring to a batch or manufacturing date. The filter appears to be made of a transparent plastic material, allowing the internal filtration components to be visible.

Figure 1 Servo Guard filter with water trap

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## Technological Characteristics

Shown below are a comparison of the technological characteristic between the subject device and predicate.

| | Cleared Device | Changed Device | Conclusion |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Device | Servo Guard (model no 64 81 290<br>EH88E) | Servo Guard version (model no<br>6595487) | |
| Manufacturer | Maquet Critical Care AB | Maquet Critical Care AB | |
| Device<br>Classification<br>Name | Breathing circuit bacterial filter. CAH | Breathing circuit bacterial filter. CAH | |
| 510(k)<br>Number | K030071 | K182862 | |
| Indications for Use<br>according to the<br>510(k) Summary | The Servo Guard is an efficient bacterial and viral<br>filter for applications in respiratory care and<br>anesthesia. The Servo Guard is a disposable<br>single-use device that provides filtration for<br>reducing possible cross contamination between<br>patient and equipment | The Servo Guard is a bacterial/viral filter for<br>applications in respiratory care.<br>The filter is intended to be used in patient circuits<br>to reduce the spread of viruses and bacteria from<br>patient to patient/personnel and to protect the<br>patient circuits and ventilators from<br>contamination. The filter shall only be used with<br>the ventilators Servo-u, Servo-n, Servo-i and<br>Servo-s. | Similar The intended<br>use of the changed<br>device does not<br>include anesthesia.<br>Limitiation of<br>compatible<br>ventilators. |
| Physical properties | | | |
| Placement | To be used on the expiratory or/and inspiratory<br>limb of a breathing circuit. | To be used on the expiratory or/and inspiratory<br>limb of a breathing circuit. | Identical |
| Filter Volume | 150 ml | 150 ml | Identical |
| Bacterial/viral<br>removal efficiency | >99,999% | >99,999% | Identical |
| Resistance | 1.5 cm H2O@60 l/min | 2.0 cmH2O@60 l/min (dry) and 2.2 cmH2O@60<br>l/min (wet) | different |
| Connections | ISO 5356-1 M22/F15 (male/female, inlet)<br>ISO 5356-1 F22 (female, outlet) | ISO 5356-1 M22/F15 (male/female, inlet)<br>ISO 5356-1 F22 (female, outlet) | Identical |
| Weight | 60 g | 75 g including water trap | Similar |
| Recommended use | Single use, replace every 24 hour | Single use, replace every 24 hour | Identical |
| Type of filter | mechanical | mechanical | Identical |
| Shelf life | 1 year | 3 years | Improved |
| Dimensions | L: H:W = 92 x 66 x 66 mm | L:H:W = 92 x 89 x 66 mm | Similar |
| Patient range | Neonatal to adult patient populations | Neonatal to adult patient populations | Identical |

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### Summary of Non-clinical testing:

| Test Method | Purpose | Acceptance<br>Criteria | Result | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------|----------------------------|
| ISO 23328-1<br>Filter efficiency | Verify the<br>filter<br>efficiency for<br>the Servo<br>Guard filter | Servo Guard<br>shall have a<br>filter efficiency<br>> 99.3 %<br>measured in<br>both flow<br>directions | Filter efficiency: 99,329 %- 99,93%.<br>Pass | | |
| ASTM F2101-14<br>Standard Test<br>Method for<br>Evaluating the<br>Bacterial Filtration<br>Efficiency | Verify the<br>bacterial and<br>viral filtration<br>efficiency for<br>the Servo<br>Guard filter | BFE/VFE filter<br>efficiency shall<br>be > 99.999 %. | BFE: 99.99951%- 99.999984 %<br>VFE: 99.99960% - 99.999980<br>Pass | | |
| ISO 18562-2: 2017<br>Biocompatibility<br>evaluation of<br>breathing gas<br>pathways in<br>healthcare<br>applications -- Part<br>2: Tests for<br>emissions of<br>particulate<br>matter | Verify that the<br>amount of<br>particulate<br>matter are<br>below the<br>acceptance<br>limit | <12 $[µg/m3]$ | 1.4 $[µg/m3]$<br>Pass | | |
| ISO 18562-3<br>Biocompatibility<br>evaluation of<br>breathing gas<br>pathways in<br>healthcare<br>applications - Part<br>3: Tests for<br>emissions of<br>volatile organic<br>compounds<br>(VOCs) | Verify that the<br>amount of<br>Volatile<br>substances are<br>below the<br>acceptance<br>limit | The MOS<br>(Margin Of<br>Safety) value<br>shall be higher<br>than 1 for<br>identified<br>substances. | Substance | MOS<br>Neonate | MOS<br>Pediatric/<br>Adult |
| | | | Cyclohexane | 35.0 | 83.3 |
| | | | Ethylbenzene | 7.8 | 32.5 |
| | | | m+p-Xylene | 4.2 | 10.0 |
| | | | o-Xylene | 15.0 | 35.7 |
| | | | Tetrachloroethylene | 4.7 | 11.1 |
| | | | Trichlorofluoromethane | 27.6 | 65.6 |
| | | | Pass | | |

### Conclusion:

The conclusions drawn from the clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K030071).