AMSCO SURGICAL TABLE

K971307 · STERIS Corporation · FQO · Jun 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971307
• Device Name: AMSCO SURGICAL TABLE
• Applicant: STERIS Corporation
• Product Code: FQO · General, Plastic Surgery
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4960
• Device Class: Class 1

Intended Use

The AMSCO® Surgical Table is a mobile, electro-hydraulically operated general surgical table that provides flexible articulation and image amplification of the surgical patient.

Device Story

AMSCO Surgical Table is a mobile, electro-hydraulically operated platform for patient positioning during surgery. Device provides flexible articulation to facilitate surgical access and image amplification. Operated by surgical staff in clinical/OR settings. Supports patient weight up to 500 pounds. Benefits include improved patient positioning and surgical site access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mobile, electro-hydraulically operated surgical table. 500-pound weight capacity. Provides flexible articulation for patient positioning and image amplification compatibility.

Indications for Use

Indicated for use as a mobile, electro-hydraulically operated general surgical table to support and position patients during surgical procedures, providing flexible articulation and image amplification.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 27 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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Page 2 - Mr Raymond E. Ursick

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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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# 10.0 Indications For Use

The AMSCO® Surgical Table is a mobile, electro-hydraulically operated general surgical table that provides flexible articulation and image amplification of the surgical patient.


Prescription Use ☑
(Per 21 CFR 801.109)

Over-the-Counter Use ☐

510(k) - AMSCO® Surgical Table 500 Pound Capacity Modification
STERIS Corporation