(80 days)
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No
The summary describes a standard electro-hydraulically operated surgical table with no mention of AI, ML, or image processing capabilities.
No
A surgical table is used to position a patient during surgery; it does not directly treat a medical condition or restore health.
No
The device description states it is a "general surgical table" used for "flexible articulation and image amplification of the surgical patient," which points to a role in surgical procedures and patient positioning, not diagnosis. There is no mention of it being used to identify or analyze medical conditions.
No
The device description explicitly states it is a "mobile, electro-hydraulically operated general surgical table," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "general surgical table that provides flexible articulation and image amplification of the surgical patient." This describes a device used on a patient during surgery, not a device used to test samples from a patient outside the body.
- Device Description: The description "mobile, electro-hydraulically operated general surgical table" further reinforces that it's a piece of surgical equipment used directly with the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Mentioning reagents, assays, or laboratory procedures
An IVD is a medical device used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The AMSCO Surgical Table does not fit this description.
N/A
Intended Use / Indications for Use
The AMSCO® Surgical Table is a mobile, electro-hydraulically operated general surgical patient table that provides flexible articulation and image amplification of the surgical patient.
Product codes
FQO
Device Description
The AMSCO® Surgical Table is a mobile, electro-hydraulically operated general surgical patient table that provides flexible articulation and image amplification of the surgical patient.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 878.4960 Operating tables and accessories and operating chairs and accessories.
(a)
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle, with the text "DEPARTMENT OF HEALTH & HUM SERVICES • USA" arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Raymond E. Ursick Director of Regulatory Affairs and Compliance STERIS® Corporation . .................... 5960 Heisley Road Mentor, Ohio 44060-1834
JUN 2 7 1997
Re: K971307 Trade Name: AMSCO® Surgical Table Regulatory Class: I Product Code: FQO Dated: April 7, 1997 Received: April 8, 1997
Dear Mr. Ursick:
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 requirements , 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
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devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
Stephen Charles
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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Indications For Use 10.0
The AMSCO® Surgical Table is a mobile, electro-hydraulically operated general surgical pairent The AMSCO® Surgical Table is a moone, electronic of the surgical patient.
table that provides flexible articulation and image amplification of the surgical patient.
Stetus Rhodes