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.

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.

AI/ML Overview

The Siemens Sevoflurane Vaporizer SV 953 is an anesthetic vaporizer that has expanded indications compared to the predicate device, the Siemens Vaporizers 950/951/952 (Halothane Vaporizer 950, Enflurane Vaporizer 951, Isoflurane Vaporizer 952). The acceptance criteria for this device are based on its equivalence to the predicate device in terms of safety and effectiveness, and its compliance with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence to predicate devices (Siemens Vaporizers 950/951/952).	The functionality of the Sevoflurane Vaporizer SV 953 is reported as "identical to the functionality of the Siemens Vaporizers 950/951/952".
Safety and Effectiveness equivalent to, or better than, the predicate device under expanded indications.	"Analysis and tests have shown that the new expanded indications doesn't adversely affect patient safety." and "the modified device is as safe and effective, and performs as well or better as the predicate device."
Compliance with Test Criteria that are equal to or more stringent than those applied to the predicate device.	"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."
Compliance with Standards: ISO/DIS 8835-1.2 and ISO 5360.	The device "complies with the following standards: ISO/DIS 8835-1.2 and ISO 5360."
Specific Design Modifications:
- Knob scale for Sevoflurane (0.2% to 8%).	A scale for Sevoflurane is added at the knob, indicating concentration values from 0.2% to 8%.
- Yellow color-coding for knob scale, label, and filling mechanism.	The knob scale, label, and filling mechanism are yellow color-coded.
- Capillary tube inside diameter of 0.36mm (to reach 8% concentration).	The inside diameter of a capillary tube is 0.36mm (instead of 0.30mm in other vaporizers) to reach the concentration values up to 8%.

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of clinical or data-driven evaluation. Instead, it refers to "all different settings of the new expanded indications" being tested. The studies described are validation tests on the device itself, rather than a study on a patient population or data set.

The data provenance is not applicable in the traditional sense of clinical data. The tests are presumably conducted internally by Siemens-Elema AB as part of their design validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The device validation relies on engineering and performance testing against predefined criteria and standards, not on expert adjudication of a test set in a medical imaging or diagnostic sense.

4. Adjudication method for the test set

This section is not applicable, as there is no mention of a test set requiring adjudication in the context of this device's validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence through design and performance testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the Sevoflurane Vaporizer SV 953, as it is a mechanical medical device, not an AI or software algorithm. Its performance is inherent to its design and functionality, which is tested directly.

7. The type of ground truth used

The "ground truth" for the device's performance is established by:

Engineering specifications and design requirements: The device's operation must meet designed functional parameters.
Compliance with recognized standards: ISO/DIS 8835-1.2 and ISO 5360.
Comparison to predicate device performance: The device is deemed safe and effective if its performance is equivalent to or better than the previously approved predicate device under equivalent testing conditions.
Pre-defined acceptance criteria: Set for the tests conducted on the device's various settings.

8. The sample size for the training set

This section is not applicable, as this is a medical device approval based on design validation and performance testing, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

This section is not applicable, as there is no training set mentioned in the context of this device's approval.

Summary

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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:	73BSZ73CAD
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

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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:

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

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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

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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

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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.

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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

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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.

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510(k) Sevoflurane Vaporizer SV953

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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
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(Per 21 CFR 801.109)Siemens-Elema AB. Electromedical Systems Division.

. . . .

. .

Regulation Number and Section

§ 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).