The BV Pulsera system is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients except babies, within the limits of the systems. The system is to be used in health care facilities both inside the operating room, sterile as well as non-sterile environments, with a variety of procedures.

The 3D-RX functionality on the BV Pulsera provides 3D imaging and intended to be used whenever the physician benefits from intra-operatively-generated 3D information of high-contrast objects and anatomical structures.

The 3D application areas for the BV Pulsera are:

Skull (Ear Nose and Throat, Maxillo Facial)
. Cervical spine
. Fore arm
Elbow .
Hand /Wrist ●
. Knee
Lower leg ●
Foot / Ankle .

The 3D-RX Option on the BV Pulsera provides 3D imaging functionality and is intended to be used whenever the physician benefits from intra-operated 3D information of high contrast objects and anatomical structures.

Device Description

The Philips 3D-RX Option for BV Pulsera is a mobile C-Arm X-Ray System offering Radiographic and Fluoroscopic techniques, which extends the functionality of the BV Pulsera Release 2.2 with 3D imaging. Using the 3D-RX Option on the BV Pulsera, an operator another a rotation run to acquire images. These images are used by an integrated 3D workstation which creates a 3D reconstruction, and which provides tools for further processing and analysis. Both hardware and software additions are added to the BV Pulsera C-Arm X-Ray System to produce the 3D-RX Option.

AI/ML Overview

This submission K061685 describes the 3D-RX Option for BV Pulsera, Release 2.2, a mobile C-Arm X-Ray System with 3D imaging capabilities. The
review indicates this is a traditional 510(k), and therefore this device was found substantially equivalent to predicate devices via performance testing. However:

A table of acceptance criteria and the reported device performance: No specific acceptance criteria or quantitative performance metrics are provided within the document. The submission focuses on substantial equivalence to the predicate device (Siemens ArcadisOrbic 3D, K042646) based on general safety and effectiveness, and compliance with applicable standards.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information is provided regarding the sample size of a test set, data provenance, or study design (retrospective or prospective). The submission primarily discusses compliance with safety standards and substantial equivalence.
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): No information is provided about experts establishing ground truth, as no specific performance study with a test set is detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information is provided about an adjudication method for a test set, as no specific performance study is detailed.
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 MRMC study or AI assistance is mentioned in the document. The device is a 3D imaging option for an X-ray system, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an imaging system providing 3D reconstructions, not a standalone algorithm for diagnosis without human-in-the-loop performance. Its functionality is to provide 3D information for physicians during procedures.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): No specific ground truth type is mentioned, as no performance study is detailed. The assessment is based on the system's ability to create 3D reconstructions of high-contrast objects and anatomical structures, implying visual assessment by physicians would be the primary verification method in clinical use.
The sample size for the training set: Not applicable. The submission does not describe a machine learning or AI algorithm development that would require a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

Summary

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

K061685
Page 1 of 2

510(k) Summary

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

Company name:Address:	Philips Medical System North America Company22100 Bothell Everett HighwayBothell, WA 98021-8431	SEP 15 2006
Registration No:	1217116
Contact Person:Telephone No.:	Lynn Harmer425-487-7312
Date prepared:	16 May 2006
Device (Trade Name):	3D-RX Option for BV Pulsera, Release 2.2
Regulation Name:	Mobile x-ray system
Regulation No.:	21 CFR 892.1720
Regulatory Class:	II
Product Code:	90 IZL
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC Best, The Nederlands

Predicate Device:

The Philips 3D-RX Option for BV Pulsera is substantially equivalent to the Siemens ArcadisOrbic 3D (FDA Number K042646).

Device Description:

Indications for Use:

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

510(k) Summary 3D-RX option

K061685

Page 2 ﺎﺭ 2

The 3D application areas for the BV Pulsera are:

Skull (Ear Nose and Throat, Maxillo Facial)
. Cervical spine
. Fore arm
Elbow .
Hand /Wrist ●
. Knee
Lower leg ●
Foot / Ankle .

General Safety and Effectiveness:

The device and its labeling will comply with the applicable requirements of the federal performance standards (Code of Federal Regulations, Title 21, subchapter J-Radiological Health, parts 1020.10 and 1040.10).

The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL 60601-1. All required documents and reports have been or will be submitted to the appropriate oversight agency to establish compliance with the applicable requirements.

Conclusion

The 3D-RX Option for BV Pulsera release 2.2 does not introduce new potential hazards. Philips Medical Systems considers the 3D-RX Option for BV Pulsera release 2.2 substantially equivalent with the predicate device.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is oriented to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 1 5 2006

Philips Medical Systems North America c/o Ms. Michelle S. Lee Senior Project Engineer/Reviewer UL Conformity Assessment Services Underwriters Laboratories, Inc.® 2600 N. W. Lake Road CAMAS WA 98607-8542

Re: K061685

Trade/Device Name: 3D-RX Option for BV Pulsera Regulation Number: 21 CFR §892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: August 25, 2006 Received: August 28, 2006

Dear Ms. Lec:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, the numbers "1906 - 2006" are displayed, indicating a centennial celebration. Below the letters, the word "Centennial" is written in a cursive font, and three stars are aligned horizontally beneath it. The entire logo is enclosed within a dotted circle.

Protecting and Promoting Public 3

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

Page 2 -

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 (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.

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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/edriv/industry/support/index.html.

Sincerely yours.

Nancy C. Brogdon

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

Enclosure

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

Indications for Use

510(k) Number (if known):

K061685

Device Name: 3D-Rx Option for BV Pulsera

Indications For Use:

Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Canela 4 Neuland for N.C. Biogdon

(Sign-Off)
of Reproductive, Abdominal,
ical Devices

Number 12061685
Appendix 15

Page 1 of

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.