(163 days)
Not Found
No
The description focuses on mechanical modifications to a vaporizer and does not mention any computational or learning capabilities.
No
This device is an anesthetic vaporizer designed for the administration of anesthetic gas mixtures, which is a supportive function in a surgical setting rather than directly treating or diagnosing a medical condition.
No
Explanation: The device is an anesthetic vaporizer used to administer sevoflurane, which is a therapeutic function, not a diagnostic one. It is used during surgery to provide anesthetic gas mixtures.
No
The device description clearly details physical modifications to a hardware device (an anesthetic vaporizer), including changes to a knob, scale, label, filling mechanism, and a capillary tube. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to vaporize a liquid anesthetic agent (sevoflurane) for controlled administration during surgery. This is a direct intervention on the patient's respiratory system to induce anesthesia.
- Device Description: The device is described as an anesthetic vaporizer used with a ventilator. Its function is to deliver a gas mixture to the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze human specimens.
The device is clearly intended for direct patient care and administration of a therapeutic agent, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Purpose and function of the Sevoflurane Vaporizer SV953: The Sevoflurane Vaporizer SV 953 is designed for use with the Servo Ventilator 900 and for vaporizing the liguid anesthetic agent sevoflurane in conjunction with the controlled administration of anesthetic gas mixtures during surgery.
Product codes
73BSZ, 73CAD
Device Description
The Sevoflurane Vaporizer 953 is an anesthetic vaporizer used together with Siemens Servo Ventilator 900 in anesthetic applications. It is a modification of the Siemens Vaporizers 950/951/952.
The modifications made are:
- At the knob a scale for Sevoflurane is added. The scale indicates concentration . values from 0.2% to 8%.
- The knob scale, label and filling mechanism, are yellow color coded. .
- To reach the concentration values 8% the inside diameter of a capillary tube is . 0.36mm instead of 0.30mm as in the other vaporizers
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, Infant and Neonatal populations.
Intended User / Care Setting
Intended Operator: The Sevoflurane Vaporizer SV953 is intended to be used by Healthcare providers, i.e. Physicians, Nurses and Technicians.
Intended Use Environment: The Sevoflurane Vaporizer SV953 is intended to be used in the environment where patient care is provided by Healthcare Professionals. The unit is designed to be used at the bedside. It -is not intended for transport use in ambulances or helicopters in the U.S. market.
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)
Tests Used in Determination of Substantial Equivalence: The design of the Seveflurane Vaporizer SV 953 has been thoroughly validated. All different settings of the new expanded indications has been tested, all test were passed according to criteria that are equal or more stringent than the test criteria which were applied to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).
0
AUG / 9 1998 510(k) Notification
Siemens Sevoflurane Vaporizer SV 953
510(k) Summary and Certification
Submitter's Name and Address
Siemens-Elema AB Röntgenvägen 2 S-171 95 Solna Sweden
Official Correspondent
Mr. David Simard
Telephone 978-907-7737 978-777-3398 Telefax
Contact Person for this Submission
Mr Wulf R. Trepte
Telephone 011-46 8 730 72 28 011-46 8 98 63 05 Telefax
Device Name
| Common Name: | Sevoflurane Vaporizer 953 |
|---|---|
| Classification Name: | Anesthetic Vaporizer |
| Regulation Number: | 21 CFR 868.5580 |
| Classification Number: | 73BSZ |
| 73CAD | |
| Class: | Class II |
Establishment Registration Number
The Establishment Registration Number for Siemens-Elema AB is: 8010042
Manufacturing Facility Address
Siemens-Elema AB S-171 95 Solna Sweden
Reason for Pre-market Notification
The reason for this pre-market notification is an expanded indication to the existing = ~*** device.
Company Confidential
Siemens-Elema AB Electromedical Systems Division Röntgenvägen 2 S-171 95 SOLNA SWEDEN
tel: (46) 8 730 7228 fax: (46) 8 98 63 05
198088
1
510(k) Notification
Siemens Sevoflurane Vaporizer SV 953
· ------------Predicate Device
The legally marketed device to which equivalence is being claimed is:
Siemens Vaporizers 950/951/952, i.e Halothane Vaporizer 950, Enflurane Vaporizer 951, Isoflurane Vaporizer 952, they were found Substantially Equivalent on June 7, 1984 (Premarket Notification K841157).
Device Description
The Sevoflurane Vaporizer 953 is an anesthetic vaporizer used together with Siemens Servo Ventilator 900 in anesthetic applications. It is a modification of the Siemens Vaporizers 950/951/952.
The modifications made are:
- At the knob a scale for Sevoflurane is added. The scale indicates concentration . values from 0.2% to 8%.
- The knob scale, label and filling mechanism, are yellow color coded. .
- To reach the concentration values 8% the inside diameter of a capillary tube is . 0.36mm instead of 0.30mm as in the other vaporizers
Intended Use
Purpose and function of the Sevoflurane Vaporizer SV953:
The Sevoflurane Vaporizer SV 953 is designed for use with the Servo Ventilator 900 and for vaporizing the liquid anesthetic agent sevoflurane in conjunction with the controlled administration of anesthetic gas mixtures during surgery.
Intended Operator:
The Sevoflurane Vaporizer SV953 is intended to be used by Healthcare providers, i.e. Physicians, Nurses and Technicians.
Intended Patient Populations:
The Sevoflurane Vaporizer SV953 is intended for general and critical ventilatory to be used on Adult, Pediatric, Infant and Neonatal populations.
Intended Use Environment:
The Sevoflurane Vaporizer SV953 is intended to be used in the environment where patient care is provided by Healthcare Professionals. The unit is designed to be used at the bedside. It -is not intended for transport use in ambulances or helicopters in the U.S. market.
Company Confidential
Siemens-Elema AB Electromedical Systems Division
Röntgenvägen 2 S-171 95 SOLNA SWEDEN
tel: (46) 8 730 7228 fax: (46) 8 98 63 05
2
510(k) Notification
Siemens Sevoflurane Vaporizer SV 953
Substantial Equivalence:
The enhanced functionality for the Sevoflurane Vaporizer SV953 is equivalent to the Siemens Halothane Vaporizer HV950.
The Siemens Halothane Vaporizer HV950 was granted pre-market approval under 510(k) file number K841157.
MRI Compatibility Statement:
The Sevoflurane Vaporizer SV953 is not compatible for use in a MRI magnetic field.
Biocompatibility
Not applicable
Sterilization
Not applicable
Specific Standards & Guidances
Siemens Sevoflurane Vaporizer SV 953 complies with the following standards:
- ISO/DIS 8835-1.2
- ISO 5360
Company Confidential
Siemens-Elema AB Electromedical Systems Division
Röntgenvägen 2 S-171 95 SOLNA SWEDEN
tel: (46) 8 730 7228 fax: (46) 8 98 63 05
3
510(k) Notification Siemens Sevoflurane Vaporizer SV 953
Comparison of Technological Characteristics
The hardware modification, compared to the predicate device, is:
- At the knob a scale for Sevoflurane is added. The scale indicates concentration . values from 0.2% to 8%.
- The knob scale, label and filling mechanism, are yellow color coded. .
- To reach the concentration values 8% the inside diameter of a capillary tube is 0.36 . mm instead of 0.30 mm as in the other vaporizers
The functionality of the Sevoflurane Vaporizer SV 953 is identical to the functionality of the Siemens Vaporizers 950/951/952; i.e Halothane Vaporizer 950, Enflurane Vaporizer 951, Isoflurane Vaporizer 952.
Tests Used in Determination of Substantial Equivalence
The design of the Seveflurane Vaporizer SV 953 has been thoroughly validated. All different settings of the new expanded indications has been tested, all test were passed according to criteria that are equal or more stringent than the test criteria which were applied to the predicate device.
Conclusion
Analysis and tests have shown that the new expanded indications doesn't adversely affect patient safety.
Therefor, we conclude that the requirements specifications and validation testing show that the modified device is as safe and effective, and performs as well or better as the predicate device.
Company Confidential
Siemens-Elema AB Electromedical Systems Division
Röntgenvägen 2 S-171 95 SOLNA SWEDEN
tel: (46) 8 730 7228 fax: (46) 8 98 63 05
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird, with three curved lines forming its body and wings. The overall design is simple and recognizable, representing the department's role in health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | 9 1998
Mr. David M. Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923
Re: K980884 Siemens Sevoflurane Vaporizer SV 953 Regulatory Class: II (two) Product Code: 73 CAD June 19, 1998 Dated: Received: July 1, 1998
Dear Mr. Simard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Mr. David M. Simard
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Collethon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Sevoflurane Vaporizer SV953
Indications for Use Statement:
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510(k) Number (if known): K980884
Sevoflurane Vaporizer SV953 Device Name:
Indications For Use:
Purpose and function of the Sevoflurane Vaporizer SV953:
The Sevoflurane Vaporizer SV 953 is designed for use with the Servo Ventilator 900 and for vaporizing the liguid anesthetic agent sevoflurane in conjunction with the controlled administration of anesthetic gas mixtures during surgery.
Intended Operator:
The Sevoflurane Vaporizer SV953 is intended to be used by Healthcare providers, i.e. Physicians, Nurses and Technicians.
Intended Patient Populations:
The Sevoflurane Vaporizer SV953 is intended for general and critical ventilatory to be used on Adult, Pediatric, Infant and Neonatal populations.
Intended Use Environment:
The Sevoflurane Vaporizer SV953 is intended to be used in the environment where patient care is provided by Healthcare Professionals. The unit is designed to be used at the bedside. It is not intended for transport use in ambulances or helicopters in the U.S. market.
Substantial Equivalence:
The enhanced functionality for the Sevoflurane Vaporizer SV953 is equivalent to the Siemens Halothane Vaporizer HV950.
The Siemens Halothane Vaporizer HV950 was granted pre-market approval under 510(k) file number K841157.
MRI Compatibility Statement:
The Sevoflurane Vaporizer SV953 is not compatible for use in a MRI magnetic lield.
7
510(k) Sevoflurane Vaporizer SV953
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
(Per 21 CFR 801.109)Siemens-Elema AB. Electromedical Systems Division.
. . . .
. .