(474 days)
Not Found
No
The summary describes a passive filtration device with no mention of AI or ML capabilities.
No
The device provides filtration to reduce cross-contamination, but it does not treat or cure a disease or condition in a patient.
No
Explanation: The device description states its purpose is "filtration for reducing possible cross contamination between patient and equipment." This describes a protective or preventative function, not a diagnostic one. There is no mention of identifying, detecting, or measuring a condition.
No
The device description clearly states it is a "disposable single-use device" and a "bacterial and viral filter," indicating it is a physical hardware component, not software.
Based on the provided information, the Servo Guard is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Servo Guard's Function: The Servo Guard is described as a filter for reducing cross-contamination in respiratory care and anesthesia. It acts as a barrier between the patient and the equipment, filtering air or gases.
- No Sample Analysis: The description does not mention the Servo Guard analyzing any biological samples from the patient. Its function is purely mechanical filtration.
Therefore, the Servo Guard falls under the category of a medical device used in respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment. The device is intended for adult, pediatric and infant populations. The device is indicated for use by qualified medical personnel only.
Product codes (comma separated list FDA assigned to the subject device)
CAH
Device Description
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.
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
adult, pediatric and infant populations.
Intended User / Care Setting
qualified medical personnel only.
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)
Not Found
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
§ 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
APR 2 6 2004
Servo Guard -510(k) Sun
| | Document Type
Traditional 510(k) | Section-Page
E-2 |
|-----------------------|-------------------------------------|---------------------|
| mmary & Certification | Doc-ID
EVU-108704 - 01 | |
510 (k) Summary as required by section 807.92(c)
Subscribers Name & Address
Maquet Critical Care AB Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: + 46 8 730 7300 Fax: + 46 8 730 7838
Contact Person and Official correspondent: Veronica Ekstroem, Regulatory Affairs
Official Correspondent:
Jamie Yieh, Regulatory Affairs Manager Maquet Inc. , 1140 Route 22 East, Suite 202, Bridge water, NJ 08807
Trade Name
Servo Guard Part No 64 81 290 EH88H
Device Classification
| Common Name | Classification
Number | Class | Regulation Number |
|-----------------------------------|--------------------------|-------|-------------------|
| Breathing Circuit Bacteria Filter | | II | 21 CFR 868.5260 |
Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Siemens Main Flow Bacteria Filter | K871366 |
| End expiratory filter, Model RT020 | K002839 |
Device Description (for detailed description see Section F)
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.
Maquet Critical Care AB
COMPANY CONFIDENTIAL
Traditional 510(k) ServoGuard
1
| MAQUET | Document Type
Traditional 510(k) | Section-Page
E-3 | |
|---------------------------------------------|-------------------------------------|---------------------|-----------|
| Object/Subject | | Doc-ID | Issue no. |
| Servo Guard -510(k) Summary & Certification | | EVU-108704 | 01 |
Intended Use of the Device:
The Servo Guard is an efficient bacterial and viral filter for applications in respiratory care and anestheria. The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment.
Summary of technological characteristics of Device and Predicate Device:
The dimensions of the three devices are different. The Servo Guard filter has a more efficient bacterial/viral filtration than the predicate devices. The Servo guard may be used both on the inspiratory and the expiratory limbs of the breathing circuit, while the RT020 only can be used on the expiratory side.
COMPANY CONFIDENTIAL
Maquet Critical Care AB
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes above three wave-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
Mr. Jamie Yieh Maquet Medical, Inc. 1140 Route 22E Suite 202 Bridgewater, New Jersey 08807
Re: K030071
Tradc Name: Servo Guard Model 64 81 290 EH88E Regulation Number: 868.5260 Regulation Name: Bacterial Breathing Circuit Filter Regulatory Class: II Product Code: CAH Dated: March 3, 2004 Received: March 8, 2004
Dear Mr. Yieh:
We have reviewed your Section 510(k) premarket notification of intent to market the device refercnced 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requircments, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Jamie Yieh
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Clus
Chia-Lin Pi, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| | Document Type
Traditional 510(k) | Section-Page
H-2 | |
|--------------------------------------|-------------------------------------|---------------------|-----------|
| Object/Subject | | Doc-ID | Issue no. |
| Servo Guard- Indicated Use Statement | | EVU-108704 | - 01 |
510(k) Number (if known):
Device Name: Servo Guard
Indications For Use:
The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment. The device is intended for adult, pediatric and infant populations. The device is indicated for use by qualified medical personnel only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Cotury
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K030071
Maquet Critical Care AB
COMPANY CONFIDENTIAL
Traditional SIO(k) ServoGuard