The Mobilett XP and Mobilett XPhybrid are radiographic systems designed for use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.

Device Description

The Mobilett XP and Mobilett XP hybrid x-ray systems are microprocessor controlled mobile x-ray systems developed for routine bedside radiographic procedures in intensive care, emergency, central X-ray, and pediatric departments, as well as operating rooms.

AI/ML Overview

This 510(k) submission (K033238) for the Mobilett XP and Mobilett XPHybrid describes a mobile x-ray system. The information provided does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in terms of performance metrics (e.g., accuracy, sensitivity, specificity).	The device is described as "microprocessor controlled mobile x-ray systems developed for routine bedside radiographic procedures."
Substantial equivalence to predicate device Siemens Mobilett Plus/Mobilett Plus HP (K932106).	The submission aims to demonstrate substantial equivalence to the predicate device. The FDA's letter confirms a finding of substantial equivalence.
Compliance with general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).	The FDA's letter states that the applicant "must comply with all the Act's requirements."
Intended Use: For use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres, and central X-ray departments.	The reported intended use aligns with this criterion.

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

Not Applicable. The submission does not describe a clinical performance study with a test set. The basis for clearance is substantial equivalence to a predicate device.

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

Not Applicable. No ground truth establishment by experts for a test set is described.

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

Not Applicable. No test set or adjudication method 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:

No. This submission is for an x-ray system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant here.

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

No. This submission describes an x-ray system, not an algorithm.

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

Not Applicable. There is no mention of ground truth in the context of a performance study. "Substantial equivalence" to a legally marketed predicate device is the basis for clearance, implying that the predicate's established performance and safety serve as the benchmark.

8. The sample size for the training set:

Not Applicable. As this is an x-ray system and not an AI/machine learning device, there is no concept of a "training set" in the context of this submission. Device design and validation would likely rely on engineering tests, compliance with standards, and comparison to the predicate.

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

Not Applicable. (See point 8)

Summary

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K033238

NOV 1 4 2003

510(K) SUMMARY FOR THE MOBILETT XP AND MOBILETT XPHYBRID

Submitted by:

Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355

September 26, 2003

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Contact Person: 1.

Ms. Nealie Hartman 51 Valley Stream Parkway Malvern, PA 19355 Phone: (610) 448-1769 Fax: (610) 448-1787

2. Device Name and Classification:

Trade Name:	Mobilett XP and Mobilett XPHybrid
Classification Name:	Mobile X-Ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1720
Device Classification:	Class II
Product Code:	IZL

3. Substantial Equivalence:

The Mobilett XP and Mobilett XPhybrid x-ray systems are microprocessor controlled mobile x-ray systems developed for routine bedside radiographic procedures. The systems are substantially equivalent to the following devices:

Predicate Device Name	FDA Clearance Number FDA Clearance Date
Siemens Mobilett Plus/Mobilett Plus HP	K932106	09/14/94

4. Device Description:

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5. Intended Use of the Device:

nealie K. Hartman

Nealie Hartman Technical Specialist, Regulatory Affairs Submissions Siemens Medical Systems, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2003

Ms. Nealie Hartman Technical Specialist Regulatory Affairs Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K033238

Trade/Device Name: Mobilett XP and Mobilett XP Hybrid Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: October 3, 2003 Received: October 17, 2003

Dear Ms. Hartman:

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 application (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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K.03 323 8 Device Name: _ Mobilett XP and Mobilett XP wbrid

INDICATIONS FOR USE:

The Mobilett XP and Mobilett XPsybrid are radiographic systems designed for use in wards, intensive care and premature-birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.

(Please do not write below this line - continue on another page if needed) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of the CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use_ Prescription Use _ OR 1 (Per 21 CFR 801.109) Mico

(Division Sign-Off) Division of Reproductive, Abdomit and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.