(90 days)
The Leibinger system for non-invasive fixation is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.
The Leibinger system for non-invasive fixation is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.
Not Found
This submission does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.
The document is a 510(k) summary for a "Non-Invasive Patient Fixation System." It declares substantial equivalence of the device to existing patient fixation systems.
Here's a breakdown of why the requested information cannot be provided from the given text:
- No acceptance criteria are mentioned. The document focuses on demonstrating substantial equivalence to predicate devices, not on specific performance metrics or thresholds.
- No study proving the device meets acceptance criteria is described. The 510(k) summary lists the intended use and states that the device "does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed." This implies a comparison to existing devices rather than a detailed performance study against defined criteria.
Therefore, many of the specific points requested (sample size, data provenance, ground truth establishment, MRMC study, standalone performance) are not applicable or not present in this type of regulatory filing.
The document is a regulatory submission for premarket notification (510(k)), typically used for devices that are substantially equivalent to a legally marketed predicate device, rather than a detailed clinical or technical study report.
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JAN 1 3 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: NON-INVASIVE PATIENT FIXATION SYSTEM
General Information
| Proprietary Name: | Non-Invasive Patient FixationSystem |
|---|---|
| Common Name: | Patient Fixation |
| Classification Name(s): | System, Radiation Therapy, ChargedParticle, Medical |
| Classification Code(s): | 90LHN |
| Submitter: | Stryker CorporationStryker Leibinger4100 East Milham AvenueKalamazoo, MI 49001800-253-7370 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Kelli J. BitterburgRegulatory Affairs AssociatePhone: 616-323-7700 x4026Fax: 616-324-5454 |
| Summary Preparation Date: | October 14, 2002 |
Summary of Safety and Effectiveness
The Leibinger system for non-invasive fixation is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.
The Stryker Non-Invasive Patient Fixation System is equivalent in intended use, safety, and effectiveness to existing patient fixation systems being marketed by companies such as Stryker, BrainLab and Medical Intelligence. It does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Non-Invasive Patient Fixation System is substantially equivalent to these existing devices.
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Kelli J. Ritterburg
Kelli-J. Bitterburg
Regulatory Affairs Associate
October 14, 2002
.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2003
Ms. Kelli J. Bitterburg Regulatory Affairs Associate Stryker Leibinger 4100 East Milham Avenue KALAMAZOO MI 49001
Re: K023449 Trade/Device Name: Non-Invasive Patient Fixation System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle Radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: October 15, 2002 Received: October 16, 2002
Dear Ms. Bitterburg:
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 (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 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.
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This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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| 510(K) Number (if known): | K023449 |
|---|---|
| Device Name: | Non-Invasive Patient Fixation System |
Page 1 of 1Indication for Use:
The Leibinger system for non-invasive fixation is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻟﻌﺼﺮ Prescription Use (per 21 CFR 801.109)
or
Over-The-Counter Use ________
Nancy Chrzadon
(Division Sign-Off) Division of Reproduct ve. A and Radiological Devices 510(k) Number _
(Optional Format 1-2-96)
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.