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.

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.

AI/ML Overview

The Siemens SC9000/SC9015 Transcutaneous Gas Module (tpO2/CO2) is indicated for continuous, noninvasive trend monitoring of transcutaneous oxygen in the neonatal population (when not under gas anesthesia) and transcutaneous carbon dioxide partial pressure in any patient population.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) Notification, primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance in a tabular format. The document states: "Currently there are no FDA standards for this device." However, it does mention that "The transcutaneous gas module (tpO2/CO2) was deemed to be safe and effective." This suggests that the device's performance was evaluated against the general safety and effectiveness requirements expected for devices of its type, likely by demonstrating similar performance characteristics to the predicate devices.

Acceptance Criteria (Inferred from Substantial Equivalence and Predicate Device Characteristics):

The acceptance criteria are not explicitly defined with numerical thresholds but are implicitly based on the performance of the predicate devices. The study likely aimed to show that the Siemens Transcutaneous tpO2/CO2 Gas Module performs similarly to the predicate devices across key operational parameters.

Parameter	Acceptance Criteria (Inferred from Predicate Device)	Reported Device Performance
tpO2 Monitoring	- Measuring Range: 0 to 800 mmHg (from Radiometer predicate) - Correction Factor: No (from Radiometer predicate) - Temperature Setting: 37 to 45°C (from Radiometer predicate) - Heating Power: 0 to 600 mW ± 10 mW (from Radiometer predicate) - Calibration: Single point (from Radiometer predicate) - Alarm: Alarms >.2°C from selected electrode temperature (from Radiometer predicate)	The Siemens SC9000/SC9015 Transcutaneous Gas Module is stated to have the "Same" performance characteristics as the Radiometer predicate device for tpO2 monitoring, implying it meets or operates within these established ranges and functionalities.
tpCO2 Monitoring	- Measuring Range: 0 to 200 mmHg (from Siemens SIRECUST 404/404N predicate) - Correction Factor: Yes (from Siemens SIRECUST 404/404N predicate) - Temperature Setting: 37 to 45°C (from Siemens SIRECUST 404/404N predicate) - Heating Power: 0 to 600 mW ± 10 mW (from Siemens SIRECUST 404/404N predicate) - Calibration: Single point (from Siemens SIRECUST 404/404N predicate) - Alarm: Alarms >.2°C from selected electrode temperature (from Siemens SIRECUST 404/404N predicate)	The Siemens SC9000/SC9015 Transcutaneous Gas Module is stated to have the "Same" performance characteristics as the Siemens SIRECUST 404/404N predicate device for tpCO2 monitoring, implying it meets or operates within these established ranges and functionalities.
Intended Use	Continuous, noninvasive trend monitoring of transcutaneous oxygen (neonatal, not under gas anesthesia) and transcutaneous carbon dioxide (any patient population).	The device's intended use is stated as "Same" as the predicate device (Siemens SIRECUST 404/404N for tpCO2 and Radiometer for tpO2 portions), indicating it aligns with the established uses of the predicate devices.
Intended Population	Neonatal (for tpO2), Adult, Neonatal (for tpCO2).	The device's intended population for tpO2 is "Neonatal" (same as predicate). For tpCO2, while the predicate was "Adult, Neonatal," the new device specifies "Neonatal," but the overarching indication for tpCO2 is "any patient population." This indicates a compliance with, and potentially broader applicability for, tpCO2 than one of the predicates.
Safety and Effectiveness	Overall deemed safe and effective for its intended use. (General regulatory expectation)	"The transcutaneous gas module (tpO2/CO2) was deemed to be safe and effective."

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state the sample size used for any testing. It mentions "Assessment of non-clinical performance data for equivalence" and "Assessment of clinical performance data for equivalence," but it does not provide details on the number of subjects or cases included in these assessments.

The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given document. The summary focuses on comparing the device to predicates based on performance specifications rather than a new clinical study involving expert ground truth determination.

4. Adjudication Method for the Test Set

This information is not provided in the given document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission is a 510(k) notification, which typically focuses on demonstrating substantial equivalence through technical and functional comparisons, not necessarily on comparative effectiveness studies with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a "Transcutaneous Gas Module" which directly measures physiological parameters. It is not an imaging AI algorithm, and therefore the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI in imaging is not applicable in this context. The module itself performs the measurements.

7. The Type of Ground Truth Used

The document implies that the ground truth for establishing equivalence and "deeming safe and effective" would be based on the established performance and safety profiles of the predicate devices. The phrase "Assessment of clinical performance data for equivalence" suggests that data was collected to show agreement with current clinical standards or established measurement methods, but the specific "type of ground truth" (e.g., expert consensus, pathology, directly measured outcomes from a reference standard) is not explicitly stated. Given the nature of a transcutaneous gas module, the ground truth would typically come from a more invasive, established method (e.g., arterial blood gas analysis for oxygen and carbon dioxide partial pressures) if a new clinical study was performed. However, the document does not elaborate on this.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant for machine learning or AI algorithms. Since this device is a physical medical monitor, there is no mention or applicability of a training set in the context of AI. The device's calibration and performance would be based on engineering design and validation, not on a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

As there is no training set applicable to this device, this question is not relevant.

Summary

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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: (508) 750-7500 Fax: (508) 777-3398 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	ClassificationNumber	Class	Regulation Number
Monitor, Carbon-Dioxide, Cutaneous	73LKD	II	868.2480
Monitor, Oxygen, Cutaneous, for infant notunder 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:

1. 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: (978) 907-7500 Fax: (978) 750-6879 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.

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

	Substantial Equivalent Device	Substantial Equivalent Device	Applicant
	Siemens Medical SystemstSIRECUST 404/404N	Radiometer America, Inc.Combined TranscutaneousTcPO2/TCPCO2 Elect.	Siemens Medical SystemsSC9000/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 oftranscutaneous carbon dioxide partial pressure		Same
Intended Population	Adult, Neonatal		Neonatal
Intended Environment	In an environment where healthcare is provided byhealthcare professionals, i.e.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 selectedelectrode 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 theselected electrodetemperature		User Selectable
Oxycardiorespirogram	In conjunction with HR +RESP values		Same

7 Table of Device Similarities and differences to predicate device

Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device.

1. 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.
1. Biocompatability: Not applicable
1. Sterilization: Not applicable

... ..

1. 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

Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)

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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.

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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 (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. 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

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Page 1 of 1

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

Device Name: Siemens Transcutaneous TpO2/CO2 Gas Module

Indications for Use:

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.

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

510(k) Number.
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.2500 Cutaneous oxygen (PcO2) monitor.

(a)
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.(b)
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.