(29 days)
930493
Not Found
No
The description focuses on mechanical positioning and weight capacity, with no mention of AI/ML terms or functionalities.
No
The device supports and positions patients during diagnostic or surgical procedures, but it does not actively treat or alleviate a medical condition itself.
No
The device is described as an "Operating Table" used to support and position a patient during diagnostic examinations or surgical procedures. Its function is to facilitate procedures, not to perform diagnosis itself.
No
The device description clearly states it is a "Mobile Operating Table" made up of physical components like a column, tabletops, and trolley, indicating it is a hardware device.
Based on the provided information, the OPT 80 Mobile Operating Table is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "support and position a patient during diagnostic examinations or surgical procedures." This describes a device used on a patient, not a device used to examine specimens from a patient (which is the core function of an IVD).
- Device Description: The description details the physical components and functionalities related to patient positioning and support. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
- Measuring biomarkers or other biological indicators
The OPT 80 is clearly a piece of medical equipment used in a clinical setting to facilitate procedures performed on a patient.
N/A
Intended Use / Indications for Use
The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table.
Product codes
FQO
Device Description
The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AMSCO Quantum 3080 SP 510(k) No. 930493
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image shows the logo for OPT. USA, INC. The logo is black and white and features a stylized "OPT" followed by "USA, INC." The letters are bold and sans-serif.
LEADING TECHNOLOGY IN OPERATING TABLES
K972810
"510(k) Summary"
Mobile Operating Table
Classification Name:
Table Operating Room, AC-Powered 79GDC
Common/Usual Name:
OPT 80 Proprietary Name:
Establishment Registration Number: 2437463
Classification:
Class I
Establishment Name and Contact Information:
O.P.T.-USA Inc. 235 Sackett Street Brooklyn, NY 11231 Contact Person: Maria Coria (718) 596-0848 Tel. (718) 596-0848 Fax.
Safety and Effectiveness Information:
OPT tables are constructed under good manufacturing processes and meet the following IEC 601-1 performance and quality standards: VDE 0750 IMQ
Substantial Equivalence:
The general use and technological characteristics of the device do not differ significantly from those of the currently marketed AMSCO Quantum 3080 SP 510(k) No. 930493. Attached is a table which compares the operational and safety features for the OPT 80 and the Quantum 3080SP. The devices have similar positioning capabilities, weight capacity, primary and backup controls with manual override for emergency situations, caster locks, base material and overall size and weight.
It is the conclusion of O.P.T.-USA that the OPT 80 table is substantially equivalent to AMSCO's Quantum 3080SP table currently being marketed in the US.
Image /page/0/Picture/20 description: The image is a black and white logo. The logo is a circle with a gear-like border. Inside the circle are the letters "OPT" stacked on top of a symbol that resembles a table or a stand.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three curved lines that resemble a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marie Coria Managing Director O.P.T. USA, Inc. 235 Sackett Street Brooklyn, New York 11231
AUG 26 1997
Re: K972810 Trade Name: Mobile Operating Table OPT 80 Regulatory Class: I Product Code: FQO Dated: July 24, 1997 Received: July 28, 1997
Dear Ms. Coria:
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: Genera! 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 - Ms. Marie Coria
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,
tocellefe
a 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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510(k) Number (if known): K9728/0
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table.
Officine di Protesi Trento S.p.A provides an instruction manual to inform the customer on how to To avoid failure, the user must follow the properly install and start the surgical table. manufacturer's instructions for installation, use, cleaning and maintenance. There are secondary back-up operating devices to allow operation of the table should the primary control or power supply fail. Incorrect use and failure of the surgical table can lead to interruption of a surgical procedure and injury to the patient.
(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 | |
| 510(k) Number | K972810 |
| Prescription Use (Per 21 CFR 801.109) ✓ | OR | Over-The-Counter Use _____ |
|---|---|---|
| ------------------------------------------------------------------------------------------ | ---- | ----------------------------------------------------------------------------- |
(Optional Format 1-2-96)