(375 days)
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.
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.
This document is a 510(k) summary for the Servo Guard bacterial/viral filter. It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the information requested based on the provided text, focusing on the study that proves the device meets the acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Type of Study) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 23328-1 Filter efficiency | > 99.3 % measured in both flow directions | 99.329 % - 99.93% |
| ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency | BFE/VFE filter efficiency shall be > 99.999 % | BFE: 99.99951% - 99.999984 % VFE: 99.99960% - 99.999980 % |
| ISO 18562-2: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter | < 12 [µg/m3] | 1.4 [µg/m3] |
| ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs) | The MOS (Margin Of Safety) value shall be higher than 1 for identified substances. | Cyclohexane: 35.0 (Neonate), 83.3 (Pediatric/Adult)Ethylbenzene: 7.8 (Neonate), 32.5 (Pediatric/Adult)m+p-Xylene: 4.2 (Neonate), 10.0 (Pediatric/Adult)o-Xylene: 15.0 (Neonate), 35.7 (Pediatric/Adult)Tetrachloroethylene: 4.7 (Neonate), 11.1 (Pediatric/Adult)Trichlorofluoromethane: 27.6 (Neonate), 65.6 (Pediatric/Adult) |
2. Sample Size for the Test Set and Data Provenance
The document describes non-clinical testing (laboratory studies), not a clinical trial with human subjects. Therefore, the concept of "test set" in the context of data provenance and sample size of human data is not directly applicable here. The tests were performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The ground truth for these non-clinical tests is established by standardized test methods (e.g., ISO, ASTM) and physical/chemical measurements, not by expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable, as this refers to human expert review processes in clinical studies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This document describes non-clinical performance testing of a medical device (a filter), not a study involving human readers or comparative effectiveness of AI vs human performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device or an algorithm. It's a physical filter.
7. The type of ground truth used
The ground truth used for these tests is based on standardized physical and chemical measurements according to established international and national standards (ISO 23328-1, ASTM F2101-14, ISO 18562-2, ISO 18562-3). For example:
- Filter efficiency is measured precisely through laboratory methods.
- Bacterial and viral filtration efficiency is measured with specific microbial challenge tests.
- Particulate matter and VOC emissions are measured using analytical chemistry techniques.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
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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 (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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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: (011) 46 10 335 7300
| Contact Persons for this submission: | Jerker ÅbergRegulatory Affairs ManagerPhone: direct: (011) 46 10 335 7985e-mail: jerker.aberg@getinge.com |
|---|---|
| Application Correspondent: | Mark DingerSr. Regulatory Affairs SpecialistMaquet Medical Systems USA45 Barbour Pond DriveWayne, NJ 07470e-mail: mark.dinger@getinge.comPhone: 973-709-7691Fax: 973-909-9954 |
Date prepared: September 19th, 2019
| Trade Name: | Model no: |
|---|---|
| Servo Guard | 6595487 |
Device Classification
| Common Name | ClassificationNumber | 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 290EH88E) | Servo Guard version (model no6595487) | |
| Manufacturer | Maquet Critical Care AB | Maquet Critical Care AB | |
| DeviceClassificationName | Breathing circuit bacterial filter. CAH | Breathing circuit bacterial filter. CAH | |
| 510(k)Number | K030071 | K182862 | |
| Indications for Useaccording to the510(k) Summary | The Servo Guard is an efficient bacterial and viralfilter for applications in respiratory care andanesthesia. The Servo Guard is a disposablesingle-use device that provides filtration forreducing possible cross contamination betweenpatient and equipment | The Servo Guard is a bacterial/viral filter forapplications in respiratory care.The filter is intended to be used in patient circuitsto reduce the spread of viruses and bacteria frompatient to patient/personnel and to protect thepatient circuits and ventilators fromcontamination. The filter shall only be used withthe ventilators Servo-u, Servo-n, Servo-i andServo-s. | Similar The intendeduse of the changeddevice does notinclude anesthesia.Limitiation ofcompatibleventilators. |
| Physical properties | |||
| Placement | To be used on the expiratory or/and inspiratorylimb of a breathing circuit. | To be used on the expiratory or/and inspiratorylimb of a breathing circuit. | Identical |
| Filter Volume | 150 ml | 150 ml | Identical |
| Bacterial/viralremoval 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@60l/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 |
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Summary of Non-clinical testing:
| Test Method | Purpose | AcceptanceCriteria | Result | ||
|---|---|---|---|---|---|
| ISO 23328-1Filter efficiency | Verify thefilterefficiency forthe ServoGuard filter | Servo Guardshall have afilter efficiency> 99.3 %measured inboth flowdirections | Filter efficiency: 99,329 %- 99,93%.Pass | ||
| ASTM F2101-14Standard TestMethod forEvaluating theBacterial FiltrationEfficiency | Verify thebacterial andviral filtrationefficiency forthe ServoGuard filter | BFE/VFE filterefficiency shallbe > 99.999 %. | BFE: 99.99951%- 99.999984 %VFE: 99.99960% - 99.999980Pass | ||
| ISO 18562-2: 2017Biocompatibilityevaluation ofbreathing gaspathways inhealthcareapplications -- Part2: Tests foremissions ofparticulatematter | Verify that theamount ofparticulatematter arebelow theacceptancelimit | <12 $[µg/m3]$ | 1.4 $[µg/m3]$Pass | ||
| ISO 18562-3Biocompatibilityevaluation ofbreathing gaspathways inhealthcareapplications - Part3: Tests foremissions ofvolatile organiccompounds(VOCs) | Verify that theamount ofVolatilesubstances arebelow theacceptancelimit | The MOS(Margin OfSafety) valueshall be higherthan 1 foridentifiedsubstances. | Substance | MOSNeonate | MOSPediatric/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).
§ 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).