The Siremobil Compact is a mobile x-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Siremobil Compact can operate in four different modes, Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy and cassette exposures which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of a intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Device Description

The Siremobil Compact is a mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a monitor trolley which consists of the digital memory device, image monitor(s), and user interface. The Siremobil Compact is designed to meet the space and clinical requirements of the clinical environments identified below. The Siremobil Compact is designed for easy maneuverability, durability and high efficiency and performance. The system operation is designed to provide the user with an ergonomic clinically optimized interface. The Siremobil Compact can operate in three modes, Fluoroscopy with Last Image Hold, Pulsed Fluoroscopy with Last Image Hold and Digital Radiography, The user can process the images utilizing such techniques as recursive filtration, summation or spatial noise suppression, spatial frequency filtration, motion detector, edge enhancement, and contrast enhancement.

AI/ML Overview

Here's an analysis of the provided text regarding the Siemens Siremobil Compact Mobile X-ray System, focusing on acceptance criteria and study details.

Based on the provided Siemens 510(k) summary (K963093), no specific acceptance criteria or a study proving the device meets them are explicitly detailed in a quantitative manner.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is a common pathway for 510(k) clearance. The provided documentation highlights the device's technological characteristics and intended uses are similar to those of its predicates, implying it will perform in a comparable safe and effective manner.

Here's how to break down the requested information based on the available text:

Acceptance Criteria and Reported Device Performance

Since specific
quantitative acceptance criteria are not provided for the Siemens Siremobil Compact, a table in the traditional sense cannot be created. The document focuses on qualitative descriptions of the device's design and intended operational modes, implying performance similar to predicate devices.

Acceptance Criteria (Quantitative/Qualitative)	Reported Device Performance (Quantitative/Qualitative)
Not explicitly stated as numerical criteria.	Qualitative statements of design and intended function:
Substantial equivalence to predicate devices (Siremobil 2000, Stenoscop 6000/9000, BV 29 Series, 9600 - OEC).	"designed for easy maneuverability, durability and high efficiency and performance."
Conformance to 21 CFR, Subchapter I and J (Performance Standards).	"All system components to which the above standard applies are certified to conform with 21 CFR subchapter J."
Designed for specific clinical environments.	"intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine."
Operates in specific modes.	"Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy and cassette exposures."
Allows certain image processing techniques.	"recursive filtration, summation or spatial noise suppression, spatial frequency filtration, motion detector, edge enhancement, and contrast enhancement."
Achieves specified C-arm movements.	Rotational: ± 12.5 °; Orbital: 125° (-35 to +90); Angulation: ± 190°; Horizontal travel: 20 cm (7.9"); Vertical travel: 45 cm (17.7"); C-arm depth: 66 cm (29").
Minimization of electrical, mechanical, and radiation hazards.	"Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing."

Study Details

Sample size used for the test set and the data provenance:
- Not explicitly stated. The document refers to the device being designed for and operating in various clinical environments (Operating room, Traumatology, Endoscopy, etc.), but it doesn't describe a specific "test set" in terms of patient data or images used for performance evaluation or comparison. This is typical for a 510(k) where substantial equivalence is demonstrated through engineering specifications, design comparisons, and compliance with recognized standards, rather than a clinical trial with a defined patient population.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. No specific "ground truth" establishment process for a test set is described in the provided summary. The evaluation relies on comparing technical specifications and intended uses to predicate devices. The "experts" involved would likely be Siemens' internal engineers and regulatory personnel, and potentially external regulatory bodies like the FDA, who review the submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None stated. No formal adjudication method involving multiple readers or experts for a test set is described.
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. The Siremobil Compact is a mobile X-ray system, not an AI-powered diagnostic tool. Therefore, a MRMC study evaluating human reader performance with or without AI assistance is not relevant or mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an imaging modality, not an algorithm, so standalone performance in that context is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Indirect. The "ground truth" for demonstrating substantial equivalence primarily relies on engineering specifications, compliance with recognized performance standards (e.g., 21 CFR subchapter J), and the established safety and effectiveness of the predicate devices. There is no mention of patient-level ground truth data (like pathology or outcomes) being used for this specific 510(k) submission.
The sample size for the training set:
- Not applicable. As this is not an AI/machine learning device, there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no "training set," this question is not relevant.

Summary of the K963093 Submission's Approach:

The Siemens K963093 submission for the Siremobil Compact relies on the substantial equivalence pathway to FDA clearance. This means Siemens demonstrated that its new device has the same intended use and similar technological characteristics (design, materials, safety, performance, energy used, operating principles) as legally marketed predicate devices. The "study" in this context is primarily a technical and regulatory comparison rather than a clinical trial with specific performance metrics and patient data analysis against a ground truth. The acceptance is based on the FDA's regulatory review determining that the device is as safe and effective as its predicates.

Summary

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

SIEMENS

3 1996

K963093

510 (k) SUMMARY

•

I. GENERAL INFORMATION: Establishment:

• Address:

· Registration Number:

186 Wood Avenue South Iselin, NJ. 08830

Siemens Medical Systems, Inc.

2240869

Kathleen Rutherford Manager, Regulatory Submissions Telephone: (908) 321- 4779 TELEFAX: (908) 321 - 4841

Date of Summary Preparation:

Device Name: · Trade Name:

·Contact Person:

Siremobil Compact

·Common Name:

· Classification Name:

Mobile X-ray System

Class II

·Classification:

Performance Standards:

21 CFR, Subchapter I

All system components to which the above standard applies are certified to conform with 21 CFR subchapter J

SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE II. SUBSTANTIAL EQUIVALENCE DETERMINATION.

Device Description:

Siemens Medical Systems, Inc.

186 Wood Avenue South Tel: (908) 321-4500 Iselin, NJ 08830 Fax: (908) 494-2250

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

SIEMENS

The Siremobil Compact is designed for easy maneuverability, durability and high efficiency and performance. The system operation is designed to provide the user with an ergonomic clinically optimized interface. The Siremobil Compact can operate in three modes, Fluoroscopy with Last Image Hold, Pulsed Fluoroscopy with Last Image Hold and Digital Radiography, The user can process the images utilizing such techniques as recursive filtration, summation or spatial noise suppression, spatial frequency filtration, motion detector, edge enhancement, and contrast enhancement.

Intended Use:

Technological Characteristics:

The Siremobil Compact is designed for an optimal range of movement. The rotational, orbital, and angulation movement ranges for the C-arm are as follows: ± 12.5 °, 125° (-35 to +90) orbital movement and ± 190° angulation. The horizontal and vertical movement of the C-arm is optimized for use in clinical applications. The horizontal travel is 20 cm (7.9") and the vertical travel is 45 cm (17.7"). The large C-arm depth, 66 cm (29"), provides the user with excellent patient access during examinations.

General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling and the information provided will enable the trained healthcare professional to operate the device in a safe and efficacious manner. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

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

SIEMENS

Substantial Equivalence:

The Siremobil Compact, Mobile X-ray System, has similar technological characteristics and intended uses as the predicate devices described in the Equivalency Information section of this premarket notification. Also, the Laser Targeting Devices (one unit attached to the image intensifier and one unit to attached to the x-ray tube) configured with the Siremobil Compact are the same as the device currently configured with the commercially available Siremobil 2000.

Siemens Medical Systems, Inc. believes that the Siremobil Compact, the subject of this premarket notification, is substantially equivalent to the following medical devices currently in commercial distribution.

Model

Company

FDA K-Number

Siremobil 2000 Stenoscop 6000/9000 BV 29 Series 9600

Siemens Medical Systems, Inc. General Electric, Inc. Philips, Inc. OEC, Inc.

Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions

8/7/96
Date

Date

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

NOV 17 2011

Ms. Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NJ 08830

Re: K963093

Trade/Device Name: Siremobil Compact Mobile X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: August 7, 1996 Received: August 8, 1996

Dear Ms. Rutherford:

This letter corrects our substantially equivalent letter of September 3, 1996.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely Yours,

ullD'O'Rhm For

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Attachment L: Indications for Use

963093 510(k) Number (if known): Siremobil Compact Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Siremobil Compact is a mobile x-ray system intended for use in The Sitentoon Compact 22 - 2016 - 11:20 PM Intensive Care Station, Pediatrics, Operating Toom, Tradikator 87.
Ambulatory patient care and in Veterinary Medicine. The Siremobil Compact Amoulatory patient cases.
can operate in four different modes, Digital Radiography, Fluoroscopy and can operate in four aniesesses exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, wide variety of cimied positions pail implant in various positions, low huoroscopic as pay in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Yamil. U. Lession
(Division Sign Off)

(Division Sign-Off)
Division of Reproductive, Abdoirinal, ENT,
and Radiological Devices
510(k) Number K963093

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Siremobil Compact 510 (k) Premarket Notification August 6, 1996

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.