(76 days)
K95 1765
K95 1765
No
The document describes a standard fluoroscopic C-Arm with image processing capabilities, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
No.
The device is an imaging device (fluoroscopic C-Arm) used for diagnostic purposes (imaging extremities), not for treating conditions.
No
This device is an imaging device used to visualize extremities, not to diagnose a condition. It assists in orthopedic applications by providing real-time imaging during procedures.
No
The device description explicitly states it is a "small image intensified fluoroscopic C-Arm," which is a hardware device. While it mentions image processing, this is a function of the hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is for "imaging extremities in orthopedic applications." This involves imaging the human body directly, not testing samples taken from the body (like blood, urine, or tissue).
- Device Description: It's described as a "fluoroscopic C-Arm," which is an imaging device used in medical procedures.
- Input Imaging Modality: It uses "Image Intensified Fluoroscopic X-Ray System," which is an in-vivo imaging technique.
- Anatomical Site: It targets "Extremities," which are parts of the human body.
- Federal Law Statement: The "CAUTION: Federal Law (USA) restricts this device to sale and use by or on the order of a physician" is typical for medical devices used directly on patients, not for IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used to visualize the inside of the body directly.
N/A
Intended Use / Indications for Use
The ORCA is a small image intensibled 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."
Product codes
OXO
Device Description
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.
Mentions image processing
Image Memory/Processing: 512 X 512 X 12, 1024 X 1024 X 12
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image Intensified Fluoroscopic X-Ray
Anatomical Site
patient's extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
K95 1765
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
0
LUNAR
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
(608) 274-2663
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: | (608) 274-2663 |
| Fax: | (608) 274-0853 |
| 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.
1
| Feature | Predicate OEC MINI 6600 | ORCA |
|---|---|---|
| Intended Use: | Provide physician with general | Provide physician with general |
| fluoroscopic visualization of the | fluoroscopic visualization of | |
| patient's extremities | patient's extremities | |
| X-Ray Source: | Stationary Anode | Stationary Anode |
| 0.25 mm focal spot | 0.3 mm focal spot | |
| 75 KVp/0.1 mA (7.5w) | 80 KVp/0.7 mA (56w) | |
| 40 cm SID | 45 cm SID | |
| Image Information: | Motorized Image Rotation | Digital Image Rotation |
| 4 or 6 inch image intensifier | 6 inch image intensifier | |
| 16 inch monitor | 17 inch monitor | |
| Fluoroscopy: | Manual Control - | Manual Control - |
| (combined KVp/mA) | (combined KVp/mA) | |
| Automatic Exposure: Rate | Automatic Exposure Rate | |
| Control | Control | |
| Image Memory/Processing: | 640 X 510 X 10 | 512 X 512 X 12 |
| 1024 X 1024 X 12 | ||
| Image Handling Interface: | Printer | Printer |
| VCR Option | VCR Option | |
| DICOM 3 | DICOM 3 | |
| Parallel Port | Parallel Port | |
| C-Arm Specification: | 30 cm Opening (with variance) | 35 cm Opening (with variance) |
| 9 cm Source to Skin | 10 cm Source to Skin | |
| Distance (with variance) | Distance (with variance) | |
| Manual mechanical positioning | Manual mechanical positioning | |
| 200 degrees of orientation | 270 degrees of orientation | |
| Scatter Radiation to | ||
| Operator: | Director, Regulatory Affairs Title |
Summary of Safety, Effectiveness Page 3 of 3
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
NOV 1 7 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
4
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 (2) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely Yours,
l D. Odom for
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
5
. Page _ of _
510(k) Number (if known):
Device Name: ORCA
Indications For Use:
The ORCA is a small image intensibled 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. Seymann
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Deylossy
510(k) Number K960907
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)