The Drager Sola surgical lights (Sola 1000, 700, 500) are intended to locally illuninate an operating or examination area of the patient's body with high intensity light.

The Drager Sola 300 is intended to be used as an examination light or as a satellite light within a surgical lighting system.

Device Description

Not Found

AI/ML Overview

The provided document describes the acceptance criteria and a study demonstrating the Dräger Sola surgical lights meet these criteria.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard / Requirement)	Reported Device Performance
Electrical Hazards
IEC 60601-1 (Generic Standard)	Passed all requirements
IEC 60601-2-41 (Specific Additional Electrical Requirements)	Fulfill the requirements
Mechanical Strength
IEC 60601-2-41 (Specific requirements)	Fulfill the requirements
Calculated with safety factor of 4x	Met (stated to be 4x)
Movable Parts
IEC 60601-2-41 (Conformity)	Conform to requirements
Light head maintains position	Achieved via mechanical/electromechanical brakes
Feather arm compensates weight	Achieved via optimal compensation
Suspended Loads
Detachment of light head prevented	Not possible when properly installed; safety mechanisms for screws
Loads calculated with safety factor of 4x	Met (stated to be 4x)
Illumination
IEC 60601-2-41 (Additional requirements for illumination of infrared and ultraviolet emission)	Fulfill the requirements
FDA Guidance Document (General)	Intended to locally illuminate an operating or examination area with high intensity light
Accuracy of Operation Data
IEC 60601-2-41 (Additional requirements)	Fulfill the requirements
Bulb Explosion
Potential danger from glass splinters eliminated	Fully enclosed light system eliminates potential danger
Diffusing Lens
Cannot be broken when properly used	Manufacturing standards and in-house inspection eliminate residual risks
IEC 60601-1 (General)	Met
Insufficient Energy (Power Supply)
Switchover to emergency power supply initiated upon interruption/reduction	Relay initiates switchover to user-provided emergency power supply
Labeling
IEC 60601-2-41 (Additional requirements to exactly define intended use)	Fulfill the requirements

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a numerical count of devices tested. The report indicates that the "Sola series were tested," implying a representative sample of Dräger Sola 1000, 700, 500, and 300 models.
Data Provenance: The document is dated December 1998 and refers to "many years of experience in manufacturing lights" and this product being "on the market in Europe for 4 years" (referencing the current and previous product MLxx0) with no registered complaints. This suggests a retrospective analysis of field performance data and compliance testing based on European market experience. The testing against IEC standards is described as having been performed on the devices. The report originates from Germany ("Dräger Medizintechnik GMBH").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The report does not mention a specific number of experts or their qualifications for establishing ground truth in the context of a "test set" for performance evaluation, as one might see in a clinical study.
The evaluation is based on compliance with established international engineering and medical device safety standards (IEC 60601-1, IEC 60601-2-41) and internal engineering calculations and experience. The implication is that the "ground truth" for safety and performance is defined by these standards and the engineering principles applied during development and testing.

4. Adjudication method for the test set:

No adjudication method (e.g., 2+1, 3+1, none) is described in the context of a typical clinical test set with human readers. The evaluation is focused on compliance testing against objective engineering standards and internal risk assessments, which would not involve such 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:

No. This document describes a submission for a surgical lamp (Dräger Sola series), which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not performed.

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

No. As mentioned above, this is a physical medical device (surgical lamp), not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

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

The "ground truth" for the device's compliance is primarily defined by:
- International engineering standards and regulations: IEC 60601-1 and IEC 60601-2-41.
- Engineering calculations and safety factors: E.g., 4x safety factor for mechanical strength and suspended loads.
- Manufacturing standards and in-house inspection: For components like diffusing lenses.
- Retrospective field experience: "No complaints have been registered," "No complaints have been received which have necessitated a change in the product."

8. The sample size for the training set:

Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no concept of a "training set" in the context described. The device's design and manufacturing rely on established engineering principles and standards, not data-driven model training.

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

Not applicable. There is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. Above and to the right of the word, there is a handwritten inscription that appears to be a serial number or code, "K984611". The text is black against a white background.

Summary Report with respect to the Guidance Document (Section 12)

The guidance document with the standard mentioned in the guidance for Surgical Lamps were taken into consideration to evaluate and to reduced the risk of the surgical light. Most of the technological solution to avoid any risk associated with the device are given in the IEC 60601-1 and IEC 60601-2-41 standard.

The protection of the user and the patient regarding electrical hazards were covered by the generic standard IEC 60601-1. The device were tested with respect to the standard and passed all requirements.

The particular standard IEC 60601-2-41 that is also required to be fulfilled by FDA's guidance document for surgical lamps covers among other things the following aspects:

1.) specific additional electrical requirements for surgical lamps
2.) additional requirements about the accuracy of operation data
additional requirements for the illumination of infrared and ultra violet emission 3.)
4.) additional requirements for the mechanical strength
5.) additional requirements for the labeling to exactly define the intended use of the lamp

These specific requirements covers the hazards of the surgical lamps and are specific for those devices. If these requirements are fulfilled the potential hazard will be avoided. The Sola series were tested with respect to the standard IEC 60601-2-41 and fulfil the requirements.

Other criteria of the guidance document that covers supplements like e.g. biocompatibility and software issues were not taken into consideration because they do not apply for the Dräger Sola series.

Nevertheless, we evaluated the probability of risks for surgical lights and their estimations. Please find attached the evaluation of the potential hazards have already been eliminate by carrying out the development due to the solution given in the evaluation.

Emmmy

Frank Clanzett, Regulatory Affairs

Dec. 1998

{1}------------------------------------------------

Evaluation of potential hazards (with respect to En 1441)

• Risk Propability

: .

1 1 1 1 1 1 1 1 1

Potential danger	Probability	Estimation of risks
Electricity	A	- According to IEC 60601-1 and IEC 60601-2-41- Based on many years of experience in manufacturing lights during which no complaints have been registered, there is no danger to the user or patient from electrical energy
Mechanical Strength	A	- The stated carrying capacity and torque are calculated with a safety factor of 4x. (Also requirements in IEC 60601-2-41)
Movable parts	A	- Feather arm. The vertical adjustment optimally compensates for the weight of the light head. Further adjustment can be made as described in the User's Manual
Movable parts	A	- The light head maintains the position in which it is placed. The moveable parts are held in place with the help of mechanical or electromechanical brakes.- Conformity to IEC 60601-2-41
Suspended loads	A	- Detachment of the light head from the feather arm. Not possible when properly installed.- The loads are calculated with a safety factor of 4x.- Parts held in place by screws are protected against detachment by specific safety mechanisms
Insufficient energy	B	- In case of interruption of the main power supply or a large voltage reduction, a relay will initiate a switchover to the emergency power supply provided by the user.
Bulb explosion	A	- Seldom occurs. The fully enclosed light system eliminates any potential danger from glass splinters
Diffusing lens	A	- When properly used, the diffuser lens cannot be broken. Manufacturing standards and in-house inspection of each lens nearly eliminate all residual risks. (Also IEC 60601-1)

A: unlikely

B: could occur if a defect is present

C: could occur if several defects are present

{2}------------------------------------------------

• Assessment of the riks

This product, inclusive of the previous product MLxx0, has been on the market in Europe for 4 years. It satisfies the demands of the user. No complaints have been received which have necessitated a change in the product.

The development has generally followed the fundamentals of the accepted standards and is also based on the experience and findings of the previous product generation.

• Evaluation of the product`s safety

The data supports the assertion that the risks are negligible when device is used in accordance with its intended use.

Note: This document is a translated version of the original German document.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 1999

Mr. Frank Clanzett Regulatory Affairs Drager Medizintechnik GMBH 53/55 Moislinger Allee 23542 Luebeck Germany

Re: K984611 Trade Name: Sola Surgical Lights Regulatory Class: II Product Code: FSY Dated: December 23, 1998 Received: December 29, 1998

Dear Mr. Clanzett:

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 requirement, 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2- Mr. Frank Clanzett

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,

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

{5}------------------------------------------------

Appendix 2

Indications for Use Form

Page 1 _ of _ 1

510(k) Number (if known): K9846) l

Sola Surgical Lights Device Name:

Indications for Use:

The Drager Sola surgical lights (Sola 1000, 700, 500) are intended to locally illuninate an operating or examination area of the patient's body with high intensity light.

The Drager Sola 300 is intended to be used as an examination light or as a satellite light within a surgical lighting system.

: (新)

1 11 11:11 11

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER I'AGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801/109)

Over-The-Counter Use_

$\downarrow$
$\xi$

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11:11

(Optional Format 1-2-96)

Division Sign-Off

(Division Sign-Off) Division of General Re 510(k) Number

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.