RODENSTOCK LASER SLITLAMP by G. RODENSTOCK INSTRUMENTE GMBH

The Rodenstock RO 5000 AR, RO 5000 FDY, and RO 5000 AR/FDY Laser Slitlamps are indicated for diagnostic opthalmologic examination of patients with eye disorders. When interfaced with a laser, the device is used for therapeutic treatment of patients where retinal coagulation is indicated.

Device Description

The above models of the modified Rodenstock RO 5000 are slitlamp instruments fitted with a laser adapters, and motor activated, metal-coated safety filters. When used with a laser, the laser beam and the beam path of the slit projection are coupled coaxially via beam splitter cubes. This results in the laser focus and the slit image being projected in a common plane. The beam splitter is operated by a micromanipulator, and can be adjusted in any desired direction by pneumatically driven elements.

AI/ML Overview

This 510(k) summary does not contain information regarding detailed acceptance criteria or a study proving that the device meets specific performance metrics. It's a submission for substantial equivalence based on technological characteristics and intended use compared to a predicate device, not a performance study report for a new AI/software-driven device.

Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be filled from the provided text.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

Not provided. The document is a 510(k) summary for substantial equivalence of a laser slitlamp, not a performance study for an AI-driven device with specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that uses a "test set" of data.

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)

Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that requires expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device with a test set requiring adjudication.

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

Not applicable. This document describes a physical medical device (laser slitlamp), not an AI-assisted diagnostic tool for which an MRMC study would be conducted to evaluate human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document describes a physical medical device (laser slitlamp), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that relies on a specific type of ground truth for performance evaluation.

8. The sample size for the training set

Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that uses a "training set."

9. How the ground truth for the training set was established

Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that uses a "training set."

Summary of Device and Regulatory Context (from the provided text):

The document is a 510(k) Premarket Notification for the Rodenstock RO 5000 AR, RO 5000 FDY, and RO 5000 AR/FDY Laser Slitlamps. The core of this submission is to demonstrate substantial equivalence to an existing legally marketed device, the Zeiss SL 130 laser slitlamp.

Intended Use: Primarily for diagnostic ophthalmologic examinations and as a laser delivery system for treatment of patients with eye disorders. When interfaced with a laser, it's used for therapeutic applications to perform retinal coagulation. The indications are for retinal treatment only.
Technological Characteristics: The devices are slitlamp instruments fitted with laser adapters and motor-activated, metal-coated safety filters. The laser beam and slit projection beam path are coupled coaxially via beam splitter cubes, ensuring the laser focus and slit image are projected in a common plane. The beam splitter is adjustable via a micromanipulator and pneumatic elements.
Substantial Equivalence: The submitter asserts that the devices are substantially equivalent to the predicate Zeiss SL 130 laser slitlamp based on similar technological characteristics and intended use, noting that the Rodenstock device's indications are within, but not as broad as, those claimed by the predicate device.

Key Takeaway: This document is a regulatory submission focused on comparing a new medical device to a legally marketed predicate device to establish substantial equivalence, rather than providing detailed performance study data against specific acceptance criteria for a novel technology or AI application.

Summary

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Section 9 510 (k) Summary

K973220

510 (k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements Information is ical Devices Act of 1990 and 21 C.F.R. S 807.92.

The submitter of this premarket notification is: David Link, Executive Vice-President EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742-5307 Tel.: (508) 371 - 0066 Fax : (508) 371 - 1676 This summary was prepared on August 21, 1997.
The names of these devices are the Rodenstock RO 5000 AR, the RO 5000 FDY, and the RO 5000 AR/FDY. The common name is laser slitlamp, and its classification name is ACpowered slitlamp biomicroscope (with laser adapter).
The above models of the Rodenstock RO 5000 slitlamp, modified for laser system delivery, are substantially equivalent to the Zeiss SL 130 laser slitlamp fitted with the Zeiss Visulink Diode for use with the Zeiss Visulas Diode II argon laser that is manufactured by Carl Zeiss, Inc.
The above models of the modified Rodenstock RO 5000 are slitlamp instruments fitted with a laser adapters, and motor activated, metal-coated safety filters. When used with a laser, the laser beam and the beam path of the slit projection are coupled coaxially via beam splitter cubes. This results in the laser focus and the slit image being projected in a common plane. The beam splitter is operated by a micromanipulator, and can be adjusted in any desired direction by pneumatically driven elements.
The devices are intended primarily for diagnostic ophthalmologic examinations, and as a laser delivery system for treatment of patients with eye disorders. When interfaced with a laser, the device can be used in therapeutic applications to perform retinal coagulation.

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The indications are for retinal treatment only, and therefore, are within, but not as broad as those claimed by the predicate device.

The technological characteristics are the same or similar to those found with the predicate device where the eye is either examined by slitlamp, or treated by using the laser adapted slitlamp.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

G. Rodenstock Instrumente GmbH °c/o Mr. David Link EXPERTech™ Associates, Inc. 100 Main Street, Suite 120 Concord, Massachusetts 01742

NOV - 4 1997

Re: K973220

Trade Name: Rodenstock RO 5000 AR, RO 5000 FDY, and RO 5000 AR/FDY Laser Slitlamps Regulatory Class: II Product Code: HQF Dated: August 25, 1997 Received: August 27, 1997

Dear Mr. Link:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (OS) 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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

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Page 2 - Mr. David Link

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

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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510(k) Number (if known): K973220

Rodenstock RO 5000 AR, RO 5000 FDY, RO 5000 AR/FDY Device Name: Laser Slitlamp

Indications For Use:

The following prescription legend will appear on the labeling for products distributed in the United States:

CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

P. O'Reilly

(Division Sign-Off) Y
Division of General Restorative Devices
510(k) Number K973220

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Ontical Spenst 1-2-25

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.