(80 days)
The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of I ne or re Fentually with respiratory failure or respiratory insufficiency. Servo' is a ventilator neonales, thanks and datas will respiratery gain. I o realthcare facilities and for in-hospital transport.
The ventilator is a platform with several selectable ventilation modes which monitor patients whom need respiratory assistance. The Non-Invasive Ventilation Option is a software controlled feature available on the Servo-i ventilator. The microprocessor control of this feature allows a larger range of flow capabilities designed to meet patient needs safely in a non-invasive application.
The provided text does not contain detailed acceptance criteria for a device, nor does it describe a study explicitly proving that the device meets such criteria. The document is primarily a 510(k) summary for a Special 510(k) submission regarding a "NIV option for Servo-i" ventilator and concerns its substantial equivalence to predicate devices.
Therefore, I cannot provide a response filling the requested table and sections as the information is not present in the provided text.
Specifically, the document focuses on:
- Identifying the device and its manufacturer.
- Listing predicate devices.
- Briefly describing the device as a software-controlled feature for the Servo-i ventilator, designed to handle non-invasive ventilation with features like disconnect/leakage detection.
- Stating that the intended uses and indications are largely the same as the unmodified Servo-i, with a minor change in the lower range for infant use with the NIV option.
- The FDA letter confirms the substantial equivalence determination but does not delve into detailed performance acceptance criteria or study results demonstrating compliance with such criteria.
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JUL 2 9 2004
Section-Page
EVU-116506
Doc-ID
135 (140)
Issue no.
- 00
| : | 1 | ||
|---|---|---|---|
Object/Subject NIV option for Servo-i
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: (011) 46 8 730 73 00 Fax: (011) 46 8 730 78 38
Contact Persons for this submission:
Mr. Anders Palm Tele. direct; (011) 46 8 730 74 88 Email: anders.palm@maquet.com
Document Type
Special 510(k)
USA Contact :
:
Mr. Jamie Yieh Manager, Regulatory Affairs Maquet Inc. 1140 Route 22 East, Suite 202 Bridgewater, NJ 08807 Phone: 908-947-2311 Fax: 908-947-2301 Cellphone; 908-227-8807 Email: jamie.yieh@maquet-inc.com
Trade Names
| Servo-i Ventilator System | article no.; 64 87 800 E407E | ||
|---|---|---|---|
| NIV option | article no.; 66 67 187 E407E | ||
| Device Classification | |||
| Common Name | ClassificationNumber | Class | Regulation Number |
| Ventilator, Continuous (Respirator) | 73 CBK | II | 868.5895 |
| Predicate Device Identification | |||
| Legally marketed devices to which equivalence is being claimed | 510(k) # | ||
| Servo-i Ventilatory System | K040221 | ||
| Evita 4, NIV option | K010093 |
{1}------------------------------------------------
| Document TypeSpecial 510(k) | Section-Page | 136 (140) | |
|---|---|---|---|
| Object/Subject | Doc-ID | Issue no. | |
| NIV option for Servo-i | EVU-116506 | - 00 |
Device Description
The ventilator is a platform with several selectable ventilation modes which monitor patients whom need respiratory assistance.
Summary of technological characteristics of modified Device and Predicate Device: NIV option for Non -Invasive ventilation
The Non-Invasive Ventilation Option is a software controlled feature available on the Servo-i ventilator. The microprocessor control of this feature allows a larger range of flow capabilities designed to meet patient needs safely in a non-invasive application.
To detect disconnect or excessive leakage there are two independent alarm functions:
- an alarm will be given if the leakage is excessive. .
- if the minimum PEEP will be unable to maintain (as in predicate device Servo-i) .
If leakage decreases the ventilation will resume automatically (or by manual start as in predicate Servo-i).
Intended Use of the Device:
The intended use(s) and indications of the Servo-i application, as described in its labelling, are the same as the intended uses and indications for the unmodified Servo-i, except for the intended population for Infant using the NIV option where the lower range is changed from 0,5 Kg to 3 KE:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2004
Maquet Critical Care AB C/O Mr. Jamie Yieh Manager, Regulatory Affairs Maquet, Incorporated 1140 Route 22 East, Suite 202 Bridgewater, New Jersey 08807
Re: K041223
Trade/Device Name: Modification to Servo-1 Ventilator System, Model 64 87 800 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 10, 2004 Received: May 10, 2004
Dear Mr. Yieh:
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. 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 (1 wr ), ice 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.
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Page 2 - Mr. Yieh
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and if the (2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 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), nl Jase 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,
Chiu Lin, 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}------------------------------------------------
| MAQUET | ||
|---|---|---|
| Document TypeSpecial 510(k) | Section-Page28 (140) | |
| Object/Subject | Doc-ID | Issue no. |
| NIV option for Servo-i | EVU-116506 | - 00 |
Indications for Use
510(k) Number (if known):
Device Name: Servo-i Ventilator System
Indications For Use:
INGICALONS I OF OSC.
The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of I ne or re Fentually with respiratory failure or respiratory insufficiency. Servo' is a ventilator neonales, thanks and datas will respiratery gain. I o realthcare facilities and for in-hospital transport.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 807 Subpart C) |
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ouu Sulton
Page 1 of _
(Division Sign-Qff)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: __
spital,
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).