The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gaseous carbon dioxide level, temperature, artial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits.

Device Description

The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products. The enhanced software (version VH4-HXE) is fully compatible with previously sold versions of these monitors. A retrofit will be offered to the owners of units with the previous revision software (version VGx-HXE and VHx-HXE) where x is the revision number. The Neonatal Monitors use the same hardware with enhanced software to accommodate the neonatal population of patients.

AI/ML Overview

The provided text describes a 510(K) submission for an enhanced software version of the Siemens Sirecust 960/961, 1260/1261, and 1280/1281 Series Neonatal Monitors. The enhancement specifically increases the patient population to include neonates.

However, the document does not contain specific acceptance criteria tables, reported device performance metrics, or details of a study that directly proves the device meets such criteria for the enhanced software version. Instead, it relies on demonstrating substantial equivalence to a predicate device (Siemens Neonatal Monitor Model 404N, K844187/A).

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of acceptance criteria and the reported device performance

Missing from the document. The document states:
- "The Neonatal Monitors use the same hardware with enhanced software to accommodate the neonatal population of patients."
- "The performance specifications for the neonatal applications are identical to the performance specifications of the Siemens Medical Systems Neonatal Monitor Model 404N (reference 510(K) K844187/A)"
Implication: The acceptance criteria are implicitly those established for the predicate device, Model 404N. The reported performance is asserted to be "identical" to the predicate device, suggesting a claim of equivalence rather than a new empirical performance evaluation with defined acceptance criteria. Specific numerical performance metrics (e.g., accuracy, precision for heart rate, respiration, BP, etc., in neonates) are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing from the document. There is no mention of a specific clinical "test set" or data used to evaluate the enhanced software's performance in neonates.
The argument for substantial equivalence relies on the software being "the same" as the predicate device's software, and the enhanced version is "fully compatible with previously sold versions of these monitors." This suggests that new clinical data specific to the neonatal population for this enhanced software might not have been generated for this 510(K) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing from the document. No information is provided regarding experts, ground truth establishment, or clinical studies for this specific submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing from the document. No information is provided as no specific "test set" or clinical study with adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physiological monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or relevant to this type of device.

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

The document implies a standalone performance assertion based on equivalence. It states: "The performance specifications for the neonatal applications are identical to the performance specifications of the Siemens Medical Systems Neonatal Monitor Model 404N". This suggests that the standalone performance is considered equivalent to the predicate device, which would have had its own standalone performance validated. However, details of this specific device's standalone performance in neonates (other than claiming it's "identical" to the predicate) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Missing from the document for this submission. For a physiological monitor, "ground truth" would typically come from highly accurate reference measurement devices or established clinical standards. However, the document relies on the predicate device's established ground truth and performance validation.

8. The sample size for the training set

Not applicable / Missing from the document. This submission is for an enhanced software version for a physiological monitor, not a machine learning model requiring a distinct training set in the typical sense. If the software involved algorithms, their development would have been part of the Siemens Product Planning Process, but specific training set sizes are not mentioned.

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

Not applicable / Missing from the document. As above, this is generally not relevant for this type of device in the context of this 510(K) summary.

Summary of Device Acceptance & Study Evidence from the Provided Text:

The provided document details a 510(K) submission based on substantial equivalence to an existing predicate device (Siemens Neonatal Monitor Model 404N).

The core argument is that:

The enhanced software is the "same as the software used in the predicate device" (Model 404N) and has the "same intended use."
"The performance specifications for the neonatal applications are identical to the performance specifications of the Siemens Medical Systems Neonatal Monitor Model 404N."
"The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products."

Therefore, the "study" proving the device meets acceptance criteria is implicitly the original validation study of the predicate Model 404N, combined with a demonstration that the enhanced software for the Sirecust series maintains identical performance specifications and uses the same core software for neonatal applications. The document does not describe new, specific clinical studies or performance evaluations for this enhanced software version. It primarily relies on regulatory precedent and a direct comparison to an already cleared device.

Summary

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510 (K) Sirecust 960/961 1260/1261 1280/1281

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The 960/961 1260/1261 and 1280/1281 Series Neonatal Monitoring is an enhanced software version of the 960/961 1260/1261 and 1280/1281 Series monitors. The enhanced software version increases the patient population to include neonatal applications. The enhanced software is substantially equivalent to the software used in the Siemens Neonatal Monitor Model 404N (reference 510(K) 844187/A). The Intended Use Statement for the enhanced software is the same as the Intended Use for the Model 404 Neonatal Monitor.

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

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GENERAL INFORMATION

A. TRADE NAME

Siemens Sirecust 1200 Series Neonatal Monitoring which includes: 1260 Neonatal Monitoring (Monochrome Display) 1261 Neonatal Monitoring (Color Display) 1280 Neonatal Monitoring (Monochrome Display) 1281 Neonatal Monitoring (Color Display)

Siemens Sirecust 960 Series Monitoring (Retrofit) which includes: 960 Monitor (Monochrome Display) 961 Monitor (Color Display)

Siemens Sirecust 1200 Series Monitoring (Retrofit) 1260 Monitor (Monochrome Display) 1261 Monitor (Color Display) 1280 Monitor (Monochrome Display) 1281 Monitor (Color Display)

B. COMMON NAME, CLASSIFICATION NUMBER, CLASS, and REGULATION NUMBER

Monitor, Cardiac (Include. Cardiotachometer & Rate Alarm)	74DRT	II	870.2300
Monitor, Cardiac Output (Thermal)	74KFN	II	870.1435
Monitor, Breathing Frequency	73BZQ	II	868.2365
Monitor, Indwelling Blood Pressure	74CAA	II	870.1110
Monitor, Electrocardiograph	74BRS	II	870.2370
Monitor, Electroencephalograph	84BRR	II	882.1400
Monitor, Temperature	80BWX	II	880.2910
Monitoring Spirometer	73BZK	II	868.1850
Oximeter	74DQA	II	870.2700
Monitor, Carbon Dioxide	73ILKD	II	868.4280
Monitor, Noninvasive Blood Pressure	74BXD	II	876.1130

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C. ESTABLISHMENT REGISTRATION NUMBER 1220063

D. ADDRESS OF MANUFACTURER

Siemens Medical Electronics, Inc. 16 Electronics Avenue Danvers, MA 01923

Telephone: (508) 750-7500 Fax: (508) 774-8342

Contact Person:

Mr. Thomas Connelly

E. NEW OR MODIFICATION

The enhanced software (version VH4-HXE) is fully compatible with previously sold versions of these monitors. A retrofit will be offered to the owners of units with the previous revision software (version VGx-HXE and VHx-HXE) where x is the revision number.

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INTENDED USE STATEMENT

Intended Operator:

The Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used be Healthcare providers, i.e. Physicians, Nurses, and Technicians.

The device labeling contains instructions for use which assures safe and effective use of the device.

CAUTION: Federal law in the United States restricts this device to sale by, or on the order of a physician. All Siemens bedside monitors, parameter cartridges, central displays, recorders, ancillary displays, peripheral equipment, and accessories are intended for use only by qualified medical personnel. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.

Intended Patient Populations:

The enhanced software for the Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used with Neonatal populations.

Intended Use Environment:

The Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used in the environment where patient care is provided by Healthcare Professionals.

Performance Standard: None established under Section 514 or Section 358

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510 (K) Sirecust 960/961 1260/1261 1280/1281

510 (K) Decision Making Chart

Is the device compared to Marketed device? Yes, Model 404N Neonatal Monitor (K 844187/A) Manufactured by Siemens Medical Systems, Danvers, Ma.
Does the device have the same Indication Statement? Yes the enhanced software has the same intended use as the predicate device.

1. Does the new device have the same intended use and may be "substantially equivalent"? Yes the new device uses the same software that is used in the predicate device.
1. Does the device have the same Technological Characteristics, e.g. Design, materials, etc? Yes, the software is the same as the software used in the predicate device.
1. Are the descriptive characteristics precise enough to ensure equivalence? Yes, the specifications are identical.

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510 (K) Sirecust 960/961 1260/1261 1280/1281

SAFETY AND EFFECTIVENESS INFORMATION II.

ELECTRICAL:

The results of the environmental, electrical safety, and mechanical test results which were performed on the monitors are presented in Exhibit P.

OPERATION:

The device labeling contains instructions for use which assures safe and effective use of the device.

CAUTION: Federal law in the United States restricts this device to sale by, or on the order of a physician. All Siemens bedside monitors, parameter cartridges, central displays, recorders, ancillary displays, perioheral equipment, and accessories are intended for use only by qualified medical personnel. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.

DEVELOPMENT:

Medical device development is conducted in accordance with an approved Siemens Product Planning Process. Product specifications, hazards analysis, software development plan and device test plan are required parts of the device development process. Oualification test results which demonstrate that the device performs in accordance with its specification are required before product release.

III. SUBSTANTIAL EQUIVALENCE

The Neonatal Monitors use the same hardware with enhanced software to accommodate the neonatal population of patients. The performance specifications for the neonatal applications are identical to the performance specifications of the Siemens Medical Systems Neonatal Monitor Model 404N (reference 510(K) K844187/A)

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Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.