ORCA

K960907 · Lunar Corp. · OXO · May 20, 1996 · Radiology

Device Facts

• Record ID: K960907
• Device Name: ORCA
• Applicant: Lunar Corp.
• Product Code: OXO · Radiology
• Decision Date: May 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The ORCA is a small image intensified fluoroscopic C-Arm, for imaging extremities in orthopedic applications. The ORCA Operator's manual contains the following statement: "CAUTION: Federal Law (USA) restricts this device to sale and use by or on the order of a physician."

Device Story

ORCA is a mobile image-intensified fluoroscopic C-Arm for orthopedic extremity imaging. Device utilizes an X-ray source (stationary anode, 0.3 mm focal spot) to generate fluoroscopic images; system features digital image rotation, 6-inch image intensifier, and 17-inch monitor. Operated by physicians in clinical settings for real-time visualization of extremities. Output consists of fluoroscopic images displayed on a monitor, supporting clinical decision-making during orthopedic procedures. System includes image memory/processing capabilities (512x512x12 or 1024x1024x12) and interfaces for printers, VCRs, and DICOM 3 connectivity. Benefits include low operator radiation exposure and enhanced positioning flexibility (270-degree orientation) compared to predicate. Device complies with 21 CFR 1020.30-32 and various IEC safety standards.

Clinical Evidence

Bench testing only. Device performance verified against 21 CFR 1020.30-32 and IEC 601 series standards. Radiation exposure metrics provided: operator exposure < 2 mR/hr; skin entrance dose < 5 R/min, which is 2x below the 10 R/min regulatory limit.

Technological Characteristics

Mobile C-arm fluoroscopic system. X-ray source: stationary anode, 0.3 mm focal spot, 80 KVp/0.7 mA. 6-inch image intensifier. 17-inch monitor. Digital image processing (512x512x12 or 1024x1024x12). Connectivity: DICOM 3, printer, VCR. Power: 110VAC, 600W. Compliance: 21 CFR 1020.30-32, IEC 601-1, 1-1, 1-2, 1-3, 2-7, 2-28, 2-32.

Indications for Use

Indicated for fluoroscopic visualization of patient extremities in orthopedic applications. Restricted to use by or on the order of a physician.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OEC Medical Systems Inc. Series 6600 Digital Mobile C-Arm (K951765)

Submission Summary (Full Text)

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LUNAR
K960907
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
[phone]
MAY 20 1996

# 9.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).

Contact Person: Gary Syring
LUNAR Corporation
313 West Beltline Highway
Madison, WI 53713

Phone: [phone]
Fax: [phone]

Date: February 23, 1996

Device/Trade Name: ORCA
Common Name: Ortho C-Arm

Classification Name: Image Intensified Fluoroscopic X-Ray System
21CFR 892.1650

Predicate Device: K95 1765
OEC Medical Systems Inc.
Series 6600 Digital Mobile C-Arm

# 9.1 DESCRIPTION OF THE DEVICE:

The ORCA is a small image intensified fluoroscopic C-Arm, for imaging extremities in orthopedic applications. The ORCA is substantially equivalent to the Series 6600 Digital Mobile C-Arm, manufactured by OEC Medical Systems, Inc.

# 9.2 SUMMARY OF TECHNICAL CHARACTERISTICS

The technical characteristics of the ORCA are substantially equivalent to the Series 6600 Digital Mobile C-Arm. A comparison table of technical characteristics follows.

Summary of Safety, Effectiveness Page 1 of 3
Page 2/

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| Feature | Predicate OEC MINI 6600 | ORCA |
| --- | --- | --- |
| Intended Use: | Provide physician with general fluoroscopic visualization of the patient's extremities | Provide physician with general fluoroscopic visualization of patient's extremities |
| X-Ray Source: | Stationary Anode
0.25 mm focal spot
75 KVp/0.1 mA (7.5w)
40 cm SID | Stationary Anode
0.3 mm focal spot
80 KVp/0.7 mA (56w)
45 cm SID |
| Image Information: | Motorized Image Rotation
4 or 6 inch image intensifier
16 inch monitor | Digital Image Rotation
6 inch image intensifier
17 inch monitor |
| Fluoroscopy: | Manual Control -
(combined KVp/mA)
Automatic Exposure Rate Control | Manual Control -
(combined KVp/mA)
Automatic Exposure Rate Control |
| Image Memory/Processing: | 640 X 510 X 10 | 512 X 512 X 12
1024 X 1024 X 12 |
| Image Handling Interface: | Printer
VCR Option
DICOM 3
Parallel Port | Printer
VCR Option
DICOM 3
Parallel Port |
| C-Arm Specification: | 30 cm Opening (with variance)
9 cm Source to Skin
Distance (with variance)
Manual mechanical positioning
200 degrees of orientation | 35 cm Opening (with variance)
10 cm Source to Skin
Distance (with variance)
Manual mechanical positioning
270 degrees of orientation |
| Scatter Radiation to Operator: | < 5 mR/Hr | < 2 mR/Hr |
| Power Requirements: | 110VAC, 1500 W | 110VAC, 600 W |

The x-ray technique factors of ORCA are higher than those of the predicate. However, the resulting extremity radiation exposure is below the 10 R/min limit of 21 CFR 1020.32.

The ORCA is designed to meet U.S. standards 21 CFR 1020.30 through 1020.32 with a variance for source to skin distance. The ORCA is designed to meet applicable International standards; IEC 601 - 1, IEC 601 - 1-1, IEC 601 - 1-2, IEC 601 - 1-3, IEC 601 - 2-7, IEC 601 - 2-28, IEC 601 - 2-32.

The typical operator radiation exposure is quite low, at less than 0.5 mR/hr @ 50 cm for Hand and less than 2.0 mR/hr @ 50 cm for Knee. The skin entrance dose of less than 5 R/min is a factor of 2x below the 10 R/min limit of 21 CFR 1020.32.

Summary of Safety, Effectiveness Page 2 of 3

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Summary of Safety, Effectiveness Page 3 of 3
Page 23

## 9.3 CONCLUSION

No new safety or effectiveness questions are raised by the ORCA device.


Gary Syring
Printed Name

Director, Regulatory Affairs
Title

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HUMAN SERVICES, INC.
DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

NOV 17 2011

Mr. Gary Syring
Director, Regulatory Affairs
Lunar Corporation
313 W. Beltline Highway
MADISON WI 53713

Re: K960907
Trade/Device Name: Mobile Orthopedic C-Arm
Regulation Number: 21 CFR 892.1650
Regulation Name: Image intensified fluoroscopic x-ray system, mobile
Regulatory Class: II
Product Code: OXO
Dated: February 29, 1996
Received: March 5, 1996

Dear Mr. Syring:

This letter corrects our substantially equivalent letter of May 20, 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

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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/ReportaProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely Yours,

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

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Page 1 of 1

510(k) Number (if known): K960907

Device Name: ORCA

Indications For Use:

The ORCA is a small image intensified fluoroscopic C-Arm, for imaging extremities in orthopedic applications. The ORCA Operator's manual contains the following statement:

"CAUTION: Federal Law (USA) restricts this device to sale and use by or on the order of a physician."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seyman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K960907

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)