(92 days)
Not Found
No
The summary describes 3D reconstruction from X-ray images, which is a standard image processing technique and does not explicitly mention or imply the use of AI or ML.
No
The device is described as an X-Ray system used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures. It provides imaging (2D and 3D) for the physician but does not directly provide therapy.
Yes
The device provides radiological guidance and visualization during diagnostic procedures and intra-operatively generated 3D information.
No
The device description explicitly states that "Both hardware and software additions are added to the BV Pulsera C-Arm X-Ray System to produce the 3D-RX Option." This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The BV Pulsera system and its 3D-RX option are described as an X-Ray system used for radiological guidance, visualization, and 3D imaging during procedures. It directly interacts with the patient's body using X-rays to create images.
- Intended Use: The intended use clearly states it's for "radiological guidance and visualization during diagnostic, interventional and surgical procedures" and provides 3D imaging of anatomical structures. This is a form of medical imaging, not in vitro testing of specimens.
The device's function and intended use fall under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / 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.
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 .
Product codes (comma separated list FDA assigned to the subject device)
90 IZL
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Skull (Ear Nose and Throat, Maxillo Facial), Cervical spine, Fore arm, Elbow, Hand /Wrist, Knee, Lower leg, Foot / Ankle
Indicated Patient Age Range
All patients except babies
Intended User / Care Setting
Physician / health care facilities both inside the operating room, sterile as well as non-sterile environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 Company
22100 Bothell Everett Highway
Bothell, WA 98021-8431 | SEP 15 2006 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------|-------------|
| Registration No: | 1217116 | |
| Contact Person:
Telephone No.: | Lynn Harmer
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.
Veenpluis 4-6
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.
1
510(k) Summary 3D-RX option
Page 2 ﺎﺭ 2
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.
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):
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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