(76 days)
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."
The ORCA is a small image intensified fluoroscopic C-Arm, for imaging extremities in orthopedic applications.
The provided text is a 510(k) summary for a medical device called ORCA, an image-intensified fluoroscopic C-Arm. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in the provided text.
The document focuses on comparing the technical characteristics of the ORCA to a predicate device (OEC Medical Systems Inc. Series 6600 Digital Mobile C-Arm) to establish substantial equivalence.
Here's a breakdown of what is available from the text and why the requested information is absent:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria/Performance: The document presents a "Summary of Technical Characteristics" table comparing features of the ORCA to its predicate device. This table effectively is the "performance" data used to argue for substantial equivalence, rather than a separate set of acceptance criteria based on clinical outcomes. For example, it compares X-Ray source specifications (e.g., 0.3mm focal spot vs. 0.25mm), image intensifier size (6 inch vs. 4 or 6 inch), and scatter radiation to operator (< 2 mR/Hr vs. < 5 mR/Hr).
- Conclusion: The conclusion states, "No new safety or effectiveness questions are raised by the ORCA device," implying that its performance is considered equivalent and safe based on the technical comparisons to the predicate.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. This document does not describe a clinical study with a test set of data. It's a technical comparison and regulatory filing.
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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):
- Not present. There is no mention of a test set requiring expert ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not present. No test set, no adjudication method.
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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:
- Not present. This device is an imaging system (C-Arm), not an AI diagnostic tool. No MRMC study is described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not present. This question is not applicable as the device is a hardware imaging system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not present. There is no clinical data or ground truth discussed in the context of device performance. The "ground truth" for this submission is the established performance and safety of the predicate device.
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The sample size for the training set:
- Not present. This question is not applicable as it's a hardware device, not a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not present. Not applicable.
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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 SyringLUNAR Corporation313 West Beltline HighwayMadison, 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 System21CFR 892.1650 |
| Predicate Device: | K95 1765OEC 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.
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| 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 toOperator: | < 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 - 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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9.3 CONCLUSION
(
No new safety or effectiveness questions are raised by the ORCA device.
Tony Ayring
signed
Gary Syring Printed Name
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
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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 (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
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. 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)
N/A