(178 days)
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The ViewPoint is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:
- Intra-cranial surgical procedures involving space occupying lesions or malformations . (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or . resection of spinal neoplasms.
- ENT procedures. .
- Orthopedic surgical procedures. .
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
This looks like a 510(k) clearance letter for a medical device called "ViewPoint ENT/Orthopedic Option," not a study or a technical report with detailed acceptance criteria and performance data.
The provided text does not include the specific details required to complete your request, such as a table of acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document primarily states:
- Intended Use: "to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures."
- Indications for Use: Intra-cranial, spinal, ENT, and orthopedic surgical procedures where stereotactic surgery is suitable and a rigid anatomical reference exists.
- Regulatory Clearance: The device was found substantially equivalent to pre-amendment devices under a 510(k) submission. This is a regulatory pathway for market approval, not a detailed scientific study report.
Therefore, based only on the provided text, I cannot fill in the requested table and answer the study-related questions. The 510(k) summary and clearance letter typically do not contain this level of detail about specific performance studies and their methodology. These details would usually be found in a separate study report or the full 510(k) submission if it were publicly available and contained such performance data.
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OCT 1999 8
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
General Information 1.
Classification:
Class II Image Assisted Surgery Device
Image Assisted Surgery Device Option
Common/Usual Name:
ViewPoint ENT/Orthopedic Option
Proprietary Name:
Establishment Registration:
Picker International, Inc. World Headquarters 595 Miner Road Highland Heights, Ohio 44143 Contact: Elaine K. Keeler, Ph.D. Phone Number: (440) 473-3000
FDA Owner Number: #1580240 FDA Registration Number: #1525965
Performance Standards:
No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act.
2. Intended Uses
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The ViewPoint is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:
- Intra-cranial surgical procedures involving space occupying lesions or malformations . (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or . resection of spinal neoplasms.
- ENT procedures. .
- Orthopedic surgical procedures. .
PICKER INTERNATIONAL, INC.
(BS) O/ORTHO) 10/8/99
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three figures instead of the traditional snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 OCT !
Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143
Re: K991256
Trade Name: ViewPoint ENT/Orthopedic Option Regulatory Class: II Product Code: HAW Dated: July 12, 1999 Received: July 13, 1999
Dear Dr. Keeler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Elaine K. Keeler, Ph.D.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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W. W.
Page 1 of 1
510(k) Number (if known): K991256
ViewPoint ENT/Orthopedic Option Device Name:
Indications for Use:
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The ViewPoint is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:
- Intra-cranial surgical procedures involving space occupying lesions or malformations • (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or . resection of spinal neoplasms.
- ENT procedures. •
- Orthopedic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
| (Division Sign-Off) | ||||
| Division of General Restorative Devices | K991256 | |||
| 510(k) Number | ||||
| Prescription Use | OR | Over-The-Counter Use | ||
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).