(29 days)
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.
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. There are secondary back-up operating devices to allow operation of the table should the primary control or power supply fail.
This 510(k) summary describes a mobile operating table, the OPT 80, and asserts its substantial equivalence to a predicate device (AMSCO Quantum 3080 SP, K930493). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring clinical trials to establish new performance metrics. Therefore, many of the requested details regarding acceptance criteria and study design for performance are not typically included in these types of submissions, especially for Class I devices like operating tables.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
For a Class I device like an operating table, "acceptance criteria" primarily revolve around meeting recognized industry standards and demonstrating functional equivalence to a predicate device. Performance is largely described by its features and adherence to these standards.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Safety and Quality Standards: | |
| IEC 601-1 performance and quality standards | OPT tables are constructed under good manufacturing processes and meet IEC 601-1 performance and quality standards: VDE 0750 IMQ |
| Functional Equivalence to Predicate Device: | |
| Similar positioning capabilities | The devices have similar positioning capabilities. |
| Similar weight capacity | The table system is designed to hold a patient of 180 Kg. (400 Lbs.) |
| Similar primary and backup controls | The devices have similar primary and backup controls with manual override for emergency situations. There are secondary back-up operating devices to allow operation of the table should the primary control or power supply fail. |
| Similar caster locks | The devices have similar caster locks. |
| Similar base material | The devices have similar base material. |
| Similar overall size and weight | The devices have similar overall size and weight. |
| Ability to perform specified movements (trendelenburg, reverse trendelenburg, lateral tilt, back, leg, head plate) | The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. |
| Provision for additional accessories | It has side rails for fitting additional accessories as may be required by a particular procedure. |
| Instruction Manual and compliance with manufacturer's instructions | Officine di Protesi Trento S.p.A provides an instruction manual to inform the customer on how to properly install and start the surgical table. To avoid failure, the user must follow the manufacturer's instructions for installation, use, cleaning and maintenance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a device like an operating table, especially a Class I device seeking substantial equivalence, formal test sets with statistical sample sizes in the clinical sense are not typically required. The "testing" primarily refers to engineering verification and validation against design specifications and relevant standards, often using a limited number of prototypes or production units. The focus is on demonstrating that the physical device functions as intended and meets the technical characteristics of the predicate, not on a clinical performance study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not applicable in the context of this 510(k) submission for an operating table. "Ground truth" from expert panels is relevant for diagnostic or screening devices where expert judgment is needed to validate algorithm outputs. For an operating table, functionality is verified against engineering specifications and industry standards by engineers and quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable. Adjudication methods are typically used in clinical studies or performance evaluations involving human interpretation (e.g., medical image analysis) where there might be disagreement among experts. For an operating table, functional tests have defined pass/fail criteria, not subjective adjudication among experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided and is not applicable. MRMC studies are used for evaluating the impact of AI-assisted diagnostic tools on human reader performance. An operating table is a mechanical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. "Standalone performance" refers to the performance of an algorithm or AI system by itself. An operating table does not have an "algorithm" in this sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for an operating table's performance is its adherence to engineering specifications, recognized safety and quality standards (e.g., IEC 601-1, VDE 0750 IMQ), and direct comparison of functional and safety features to a legally marketed predicate device. There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the clinical sense for this device.
8. The sample size for the training set
This information is not provided and is not applicable. "Training set" refers to data used to train AI/ML models. Since this is a mechanical operating table, it does not involve AI or machine learning, and therefore no training set is used.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no training set for an operating table.
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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.
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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)
§ 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.