(375 days)
Not Found
No
The device is a physical filter and the summary describes standard performance testing for filtration efficiency and biocompatibility, with no mention of AI or ML.
No.
The device is a bacterial/viral filter intended to protect from contamination by reducing the spread of viruses and bacteria, not to treat or alleviate a disease or condition.
No
Explanation: The device is described as a bacterial/viral filter intended to reduce the spread of viruses and bacteria, and to protect patient circuits and ventilators from contamination. Its function is to filter and prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a "Breathing Circuit Bacteria Filter," which is a physical, disposable accessory. The performance studies also focus on physical properties like filter efficiency and biocompatibility, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Servo Guard is a bacterial/viral filter for applications in respiratory care. Its purpose is to filter air in breathing circuits to reduce the spread of viruses and bacteria and protect equipment. This is a physical filtration function, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces its function as a filter for gases used in respiratory devices, protecting from contamination and reducing particles.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The performance studies focus on filtration efficiency and biocompatibility, not diagnostic accuracy.
Therefore, the Servo Guard is a medical device used in respiratory support, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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/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.
Product codes
CAH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Neonatal to adult patient populations
Intended User / Care Setting
Not Found
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)
Summary of Non-clinical testing:
Test Method: ISO 23328-1 Filter efficiency; Purpose: Verify the filter efficiency for the Servo Guard filter; Acceptance Criteria: Servo Guard shall have a filter efficiency > 99.3 % measured in both flow directions; Result: Filter efficiency: 99,329 %- 99,93%. Pass
Test Method: ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency; Purpose: Verify the bacterial and viral filtration efficiency for the Servo Guard filter; Acceptance Criteria: BFE/VFE filter efficiency shall be > 99.999 %.; Result: BFE: 99.99951%- 99.999984 % VFE: 99.99960% - 99.999980 Pass
Test Method: ISO 18562-2: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter; Purpose: Verify that the amount of particulate matter are below the acceptance limit; Acceptance Criteria:
§ 868.5260 Breathing circuit bacterial filter.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: (011) 46 10 335 7300
| Contact Persons for this submission: | Jerker Åberg
Regulatory Affairs Manager
Phone: direct: (011) 46 10 335 7985
e-mail: jerker.aberg@getinge.com |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Mark Dinger
Sr. Regulatory Affairs Specialist
Maquet Medical Systems USA
45 Barbour Pond Drive
Wayne, NJ 07470
e-mail: mark.dinger@getinge.com
Phone: 973-709-7691
Fax: 973-909-9954 |
Date prepared: September 19th, 2019
| Trade Name: | Model no: |
|---|---|
| Servo Guard | 6595487 |
Device Classification
| Common Name | Classification
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.
4
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
5
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 | ||
| EH88E) | Servo Guard version (model no |
-
| |
| Manufacturer | Maquet Critical Care AB | Maquet Critical Care AB | |
| Device
Classification
Name | Breathing circuit bacterial filter. CAH | Breathing circuit bacterial filter. CAH | |
| 510(k)
Number | K030071 | K182862 | |
| Indications for Use
according to the
510(k) Summary | The Servo Guard is an efficient bacterial and viral
filter for applications in respiratory care and
anesthesia. The Servo Guard is a disposable
single-use device that provides filtration for
reducing possible cross contamination between
patient and equipment | 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 to 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. | Similar The intended
use of the changed
device does not
include anesthesia.
Limitiation of
compatible
ventilators. |
| Physical properties | | | |
| Placement | To be used on the expiratory or/and inspiratory
limb of a breathing circuit. | To be used on the expiratory or/and inspiratory
limb of a breathing circuit. | Identical |
| Filter Volume | 150 ml | 150 ml | Identical |
| Bacterial/viral
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
l/min (wet) | different |
| Connections | ISO 5356-1 M22/F15 (male/female, inlet)
ISO 5356-1 F22 (female, outlet) | ISO 5356-1 M22/F15 (male/female, inlet)
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 |
6
Summary of Non-clinical testing:
| Test Method | Purpose | Acceptance
Criteria | Result | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------|----------------------------|
| ISO 23328-1
Filter efficiency | Verify the
filter
efficiency for
the Servo
Guard filter | Servo Guard
shall have a
filter efficiency
99.3 %
measured in
both flow
directions | Filter efficiency: 99,329 %- 99,93%.
Pass | | |
| ASTM F2101-14
Standard Test
Method for
Evaluating the
Bacterial Filtration
Efficiency | Verify the
bacterial and
viral filtration
efficiency for
the Servo
Guard filter | BFE/VFE filter
efficiency shall
be > 99.999 %. | BFE: 99.99951%- 99.999984 %
VFE: 99.99960% - 99.999980
Pass | | |
| ISO 18562-2: 2017
Biocompatibility
evaluation of
breathing gas
pathways in
healthcare
applications -- Part
2: Tests for
emissions of
particulate
matter | Verify that the
amount of
particulate
matter are
below the
acceptance
limit |