PULSERA

K061685 · Philips Medical Systems North America Co. · IZL · Sep 15, 2006 · Radiology

Device Facts

• Record ID: K061685
• Device Name: PULSERA
• Applicant: Philips Medical Systems North America Co.
• Product Code: IZL · Radiology
• Decision Date: Sep 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

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 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 Story

Mobile C-Arm X-Ray system; provides 3D imaging functionality as an extension to BV Pulsera Release 2.2. Operator performs rotation run to acquire X-ray images; integrated 3D workstation performs 3D reconstruction; provides tools for processing and analysis. Used in OR or clinical environments by physicians for intra-operative visualization of high-contrast objects and anatomical structures. Output allows physician to view 3D anatomical information to guide surgical or interventional procedures; benefits patient through improved intra-operative guidance.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and compliance with safety standards.

Technological Characteristics

Mobile C-Arm X-ray system; hardware and software additions to BV Pulsera. Complies with 21 CFR 1020.10, 1040.10 and UL 60601-1. Provides 3D reconstruction from rotational X-ray acquisition.

Indications for Use

Indicated for patients (excluding babies) requiring radiological guidance and visualization during diagnostic, interventional, and surgical procedures. Specific anatomical application areas include skull (ENT, maxillo-facial), cervical spine, forearm, elbow, hand/wrist, knee, lower leg, and foot/ankle.

Regulatory Classification

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.

Predicate Devices

• Siemens ArcadisOrbic 3D (K042646)

Submission Summary (Full Text)

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K061685
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## 510(k) Summary

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

| Company name:<br>Address: | Philips Medical System North America Company<br>22100 Bothell Everett Highway<br>Bothell, WA 98021-8431 | SEP 15 2006 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------|-------------|
| Registration No: | 1217116 | |
| Contact Person:<br>Telephone No.: | Lynn Harmer<br>425-487-7312 | |
| 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.<br>Veenpluis 4-6<br>5684 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:

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.

## Indications for Use:

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.

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510(k) Summary 3D-RX option

K061685

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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 .

## 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.

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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

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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 [phone] or [phone]

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

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# Indications for Use

510(k) Number (if known):

K061685

Device Name: 3D-Rx Option for BV Pulsera

Indications For Use:

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.

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

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