SIEMENS SC9000/SC9015 TCP02/C02 MODULE

K980287 · Siemens Medical Solutions USA, Inc. · KLK · Aug 12, 1998 · Anesthesiology

Device Facts

• Record ID: K980287
• Device Name: SIEMENS SC9000/SC9015 TCP02/C02 MODULE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KLK · Anesthesiology
• Decision Date: Aug 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2500
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Siemens Transcutaneous tpO2/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous oxygen in the neonatal population when the patient is not under gas anesthesia. Siemens Transcutaneous tp02/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous carbon dioxide partial pressure in any patient population. The device is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required. MRI Compatibility Statement: The Siemens tpO2/CO2 gas module is not intended for use in an MRI magnetic field.

Device Story

Transcutaneous Gas Module (tpO2/CO2 pod) functions as an add-on to Siemens SC9000 patient monitoring series; provides continuous, noninvasive trend monitoring of peripheral tissue oxygen and carbon dioxide partial pressures. Device utilizes solid-state sensors applied to patient skin; sensors feature user-selectable temperature settings (37-45°C) and heating power control. System performs single-point calibration; provides user-selectable alarms for temperature deviations. Output displayed on SC9000/SC9015 monitor; integrated with heart rate and respiratory values to generate oxycardiorespirograms. Operated by physicians, nurses, or technicians in clinical environments. Benefits include real-time physiological trend data to assist clinical decision-making for neonatal and general patient populations. Not MRI compatible.

Clinical Evidence

The device was deemed safe and effective based on clinical performance data provided in Section V of the submission. No specific study metrics (e.g., sensitivity, specificity) are detailed in the provided text.

Technological Characteristics

Solid-state transcutaneous O2/CO2 sensors; heating power 0-600 mW ± 10 mW; temperature range 37-45°C; single-point calibration; IEC 601-1 Type CF applied part; module form factor for integration with Siemens SC9000/SC9015 patient monitors.

Indications for Use

Indicated for continuous noninvasive trend monitoring of transcutaneous oxygen (neonates, not under gas anesthesia) and transcutaneous carbon dioxide (all patient populations). Used by healthcare professionals in clinical settings.

Regulatory Classification

Identification

A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.

Predicate Devices

• Siemens SIRECUST Transcutaneous Carbon Dioxide Monitoring System (K891481)
• Radiometer Combined Transcutaneous TcPO2/TCPCO2 Elect. (K900333)

Submission Summary (Full Text)

{0}------------------------------------------------

# AUG 1 2 1998

K980287

510(k) Notification

Siemens SC9000/SC9015 Transcutaneous Gas Module (tpO2/CO2)

# 510(k) SUMMARY

as required per 807.92(c)

#### Submitters Name, Address: 2.

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Jacqueline Emery Date submission was prepared: January 23, 1998

#### Trade Name, Common Name and Classification Name: 3.

### A. Trade Name:

Siemens Transcutaneous tpO2/CO2 Gas Module

- B. Common Name, Classification Name, Class and Regulation Number:

| Common Name | Classification<br>Number | Class | Regulation Number |
|--------------------------------------------------------------------|--------------------------|-------|-------------------|
| Monitor, Carbon-Dioxide, Cutaneous | 73LKD | II | 868.2480 |
| Monitor, Oxygen, Cutaneous, for infant not<br>under gas anesthesia | 73KLK | II | 868.2500 |

- Predicate Device Identification: 4.
Siemens SIRECUST Transcutaneous Carbon Diexide Monitoring System 510(k) Number: K891481 (02 sensor, Radiometer K900333)

#### ર. Device Description:

The Transcutaneous Gas Module (tpO/CO2 pod) is an addition to Siemens SC9000 patient monitoring series which provides transcutaneous measurement of partial pressures of the 02 and CO2 in the peripheral tissue of a patient.

- 6. Intended Use:
The intended use of Siemens Transcutaneous tpO2/CO2 Gas Module is for the continuous, noninvasive trend monitoring of transcutaneous oxygen and transcutaneous carbon dioxide partial pressure, in the neonatal patient population when the patient is not under gas anesthesia, by healthcare professionals, i.e. Physicians, Nurses, Technicians.

### 1

## COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

Image /page/0/Picture/25 description: The image shows a handwritten number nine inside of an oval shape. The number nine is written in a simple, cursive style. The oval shape surrounds the number nine, creating a border around it. The image is in black and white.

{1}------------------------------------------------

# 510(k) Notification Siemens SC9000/SC9015 Transcutaneous Gas Module (tpO2/CO2)

| | Substantial Equivalent Device | Substantial Equivalent Device | Applicant |
|----------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------|
| | Siemens Medical Systemst<br>SIRECUST 404/404N | Radiometer America, Inc.<br>Combined Transcutaneous<br>TcPO2/TCPCO2 Elect. | Siemens Medical Systems<br>SC9000/SC9015 tpO2/CO2 module |
| Manufacturer | Siemens Medical Systems | Radiometer | Siemens Medical Systems |
| 510(k) Number | K891481 | K900333 | To be assigned |
| Intended Use | Continuous, noninvasive trend monitoring of<br>transcutaneous carbon dioxide partial pressure | | Same |
| Intended Population | Adult, Neonatal | | Neonatal |
| Intended Environment | In an environment where healthcare is provided by<br>healthcare professionals, i.e.<br>doctors, nurses, technicians. | | Same |
| O2 only sensor | | Solid State | Same |
| O2 + CO2 sensor | Solid State | Solid State | Same |
| tpO2 | | | Same |
| Measuring Range | | 0 to 800 mmHg | |
| Correction Factor | | No | Same |
| Temperature setting | | 37 to 45°C | Same |
| Heating Power | | 0 to 600 mW ± 10 mW | Same |
| Calibration | | Single point | Same |
| Alarm | | Alarms >.2°C from the selected<br>electrode temperature | User Selectable |
| tpCO2 | | | Same |
| Measuring Range | 0 to 200 mmHg | | |
| Correction Factor | Yes | | Same |
| Temperature setting | 37 to 45°C | | Same |
| Heating Power | 0 to 600 mW ± 10 mW | | Same |
| Calibration | Single point | | Same |
| Alarm | Alarms >.2°C from the<br>selected electrode<br>temperature | | User Selectable |
| Oxycardiorespirogram | In conjunction with HR +<br>RESP values | | Same |

- 7 Table of Device Similarities and differences to predicate device
8. Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device.

- 9. Assessment of clinical performance data for equivalence: The transcutaneous gas module (tpO2/CO2) was deemed to be safe and effective. See Section V of this submission.
- 10. Biocompatability: Not applicable
- 11. Sterilization: Not applicable

... ..

- 12. Standards and Guidances: IEC 601-1 Type CF Applied Part
2

# COMPANY CONFIDENTIAL

# Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

10

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three abstract human figures facing right, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 1998

Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

Re: K980287 SC9000/SC9015 Transcutaneous Gas Module (tpO2/tpCO2 pod) Regulatory Class: II (two) Product Code: 73 KLK Dated: May 20, 1998 Received: May 22, 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 regulations 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 requlation may result in regulatory 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.

{3}------------------------------------------------

### Page 2 - Mr. David 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K980287

Device Name: Siemens Transcutaneous TpO2/CO2 Gas Module

# Indications for Use:

Siemens Transcutaneous tpO2/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous oxygen in the neonatal population when the patient is not under gas anesthesia.

Siemens Transcutaneous tp02/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous carbon dioxide partial pressure in any patient population.

The device is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required.

MRI Compatibility Statement: The Siemens tpO2/CO2 gas module is not intended for use in an MRI magnetic field.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Cou (Option |
|---------------------------------------|-------------------------|
|---------------------------------------|-------------------------|

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

| 510(k) Number. | |
|----------------|--|
|----------------|--|

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)