The AIM 200® OR Major Surgical Light is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The AIM 2000 OR Major Surgical Light is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.

Device Description

The new AIM 200® OR is intended to be used in Acute care arena in operating theaters, emergency rooms, trauma centers, and endo-suites as well as in ASC's for endo-suites, plastic surgery, ophthalmology and orthopedic procedures. It is available in floor, wall, single ceiling and double ceiling models. The new AIM 200® OR combines the smart and versatile styling of the existing AIM 50® and AIM 100® with the increased luminance of a Major OR product. The AIM 200® OR uses proven AIM 100® optical modules at increased powers to yield illuminance of 90,000 Lux at 1 meter while meeting the D50/D10 light distribution ratio required by the IEC 60601-2-41 standard for Major Surgical Lighting.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the AIM 200® OR Major Surgical Light, and its substantial equivalence to a predicate device, the AIM 100® Minor Surgery Light. The focus is on demonstrating that the new device is as safe and effective as the previously cleared device, rather than proving that it meets specific acceptance criteria through a clinical study involving AI or human readers.

Therefore, many of the requested categories in your prompt are not applicable to the information contained in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on compliance with harmonized standards. The performance is reported in comparison to the predicate device and the standards.

Criterion	Acceptance (Standard)	Reported Device Performance (AIM 200® OR Major Surgical Light)
Illuminance	90,000 Lux at 1 meter (required by IEC 60601-2-41 for Major Surgical Lighting)	90,000 Lux at 1 meter
D50/D10 Light Distribution Ratio	Required by IEC 60601-2-41 for Major Surgical Lighting	Meets the D50/D10 light distribution ratio.
Safety and Performance Standards Compliance (General)	- UL 60601-1 (Issued 2003-04-25 Ed.:1 Rev:2006/04/26) - CSA C22.2#601.1 (Issue 1990/0101, Amendment 2 - February 1998, Update No. 2 (R2001)) - IEC 60601-2-41:2000 Ed:1	Meets all requirements as defined in the above Safety and Performance standards. Issued an "Authorization to Mark" by Intertek. Performed as well as, or better than, the legally marketed predicate device (AIM 100™).
Intended Use (Scope)	To provide required illumination for surgeries, procedures, and examinations of patients in various healthcare facilities, including operating rooms. (Expanded from predicate's "Minor Surgery" to "Major Surgery").	Designed to provide the required illumination for surgeries, procedures, and examinations of patients. To be used with various mounting configurations in operating rooms, examination rooms, emergency rooms, and all other healthcare facilities where additional illumination is needed. (Acknowledged modification from Minor to Major Surgery compared to predicate.)
Electrical Safety / EMC	IEC/UL 60601 / IEC 60601-1-2 / IEC 60601-2-41 / MDD 93/42/EEC / CAN/CSA C22.2 601-1 M90	Complies with IEC/UL 60601 / IEC 60601-1-2 / IEC 60601-2-41 / MDD 93/42/EEC / CAN/CSA C22.2 601-1 M90. (This is implied by meeting "all requirements as defined in the above Safety and Performance standards" and the certifications listed in the comparison table are identical to the predicate.)
Physical/Operational Specifications (e.g., Color Temp, Light Field Diameter, etc.)	Equivalent to or better than predicate device (e.g., Color Temp: 3500K for predicate; Light Field Diameter: 25-30cm; Depth of Illumination: 119cm; Number of bulbs: 3; Light Sources: 35W IRC, 12V, bi-pin; Swivel Radius: 160cm max; Height Movement: 104cm vertical; Power: 116 Watts for predicate)	Color Temperature: 3700 K Light Field Diameter: 25 – 30 cm (10 – 12 inches) Depth of illumination: 119 cm (47 inches) Number of bulbs: 3 Light Sources (Halogen): 35 W IRC, 12 volt, bi-pin Rated life of Halogen Lamp: 1,400 hours (Predicate: 2,000 hours, this is a difference but not framed as a failure of acceptance, rather a characteristic of the higher illumination) Swivel Radius of Lam Housing – Ceiling Mounted: 160 cm (63 inches) max. Height Movement of Lamp Housing – Ceiling Mounted: 104 cm (41 inches) vertical movement Power: 105 Watts

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

This submission is for a surgical light, not an AI/software device that analyzes data. Therefore, there is no "test set" in the context of diagnostic performance or image analysis. The "testing" referred to is against electrical, safety, and performance standards for a physical medical device.

Sample Size: Not applicable in the context of an AI/diagnostic study. The device (AIM 200® OR Major Surgical Light) was tested.
Data Provenance: Not applicable. The testing was conducted by Underwriters Laboratory (UL) and completed by Intertek. These are certification bodies, and the testing is performed on the physical device itself.

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. Ground truth, in the context of diagnostic imaging or AI, is not relevant here. The device's performance is measured against objective technical standards (e.g., lux levels, color temperature, safety standards).

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

Not applicable. There is no diagnostic "test set" or adjudication process.

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 is a physical surgical light, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical surgical light, not an algorithm.

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

The "ground truth" for this device's performance is defined by the technical specifications and requirements of the referenced international and national standards (e.g., IEC 60601-2-41 for surgical luminaries). Compliance is demonstrated through objective measurements and tests performed by accredited laboratories.

8. The sample size for the training set

Not applicable. This is a physical surgical light, not a machine learning model.

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

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

Summary

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101537

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Image /page/0/Picture/2 description: The image shows the logo for Burton Luxo Medical Products. The word "burton" is written in a stylized font inside a black rounded rectangle. Below the rectangle, the words "Luxo Medical Products" are written in a smaller, simpler font.

Submitter:	Scot D. KinghornQuality Assurance Regulatory Affairs ManagerBurton Medical Products Corporation21100 Lassen StreetChatsworth, CA 91311	SEP 30 2010
Contact Person:	Scot D. KinghornQuality Assurance Regulatory Affairs ManagerBurton Medical Products Corporation21100 Lassen StreetChatsworth, CA 91311Phone: 800-444-9909 x 181email: skinghorn@burtonmedical.com
Date prepared:	28-May-10
Trade/Device name:	AIM 200® OR Major Surgical Light
Regulation number:	21CFR 878.4580
Regulation name:	Surgical Lamp
Regulatory Class:	Class II
Product Code:	FSY
Predicate Device:	Outpatient®III, Minor Surgical Light (Note: the name of thisdevice was changed to "AIM 100® Minor Surgery Light"subsequent to clearance by the FDA.)
Predicate "K" number:	K042395
Predicate submitter:	Burton Medical Products Inc.
Predicate clearance date:	01-Dec-2004
Product description:	"Description and Application: · The new AIM 200® OR isintended to be used in Acute care arena in operating theaters,emergency rooms, trauma centers, and endo-suites as well as inASC's for endo-suites, plastic surgery, ophthalmology andorthopedic procedures. It is available in floor, wall, single ceilingand double ceiling models. · The new AIM 200® OR combines thesmart and versatile styling of the existing AIM 50® and AIM100® with the increased luminance of a Major OR product. · TheAIM 200® OR uses proven AIM 100® optical modules at increased

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Intended Use:

Difference from Predicate Device: powers to yield illuminance of 90,000 Lux at 1 meter while meeting the D50/D10 light distribution ratio required by the IEC 60601-2-41 standard for Major Surgical Lighting. · Supported by an industry leading 5 year warranty, the AIM 200® OR is yet another Burton product that exceeds our customers' demands" Source: Burton AIM Family Expansion Launch Manual.

ourton

Luxo Medical Products

The AIM 200® OR Major Surgical Light is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The AIM 200® OR Major Surgical Light is to be used with various mounting configurations in operating rooms. examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.

The Indications For Use submitted with the predicate device (Outpatient III, Minor Surgical Light aka AIM 100® Minor Surgery Light) indicated applications for Minor Surgery. The product for this submission (AIM 2000 OR Major Surgical Light) has modified this application to include Major Surgery. It should be noted that AIM 100® and the AIM 200® OR are identical by composition. An alternate wiring from the transformer employed in the AIM 2000 OR provides additional voltage at the light bulbs resulting in greater illumination than present in the AIM 100% configuration.

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Image /page/2/Picture/1 description: The image shows the logo for Burton Luxo Medical Products. The word "burton" is in a stylized font inside a black rectangle with rounded corners. Below the rectangle, the words "Luxo Medical Products" are printed in a smaller, simpler font.

Comparison Table:

Comparison Table	Predicate device	Submission device
Device name	Outpatient®III, Minor SurgicalLight (AIM 100® Minor SurgeryLight)	AIM 200® OR Major SurgicalLight
Indications For Use	The Outpatient®III, MinorSurgical Light is designed toprovide the required illuminationfor surgeries, procedures, andexaminations of patients.Outpatient®III, Minor SurgicalLight is to be used with variousmounting configurations inoperating rooms, examinationrooms, emergency rooms and allother health care facilities wherethe need for additionalillumination exists.	The AIM 200® OR MajorSurgical Light is designed toprovide the required illuminationfor surgeries, procedures, andexaminations of patients. TheAIM 200® OR Major SurgicalLight is to be used with variousmounting configurations inoperating rooms, examinationrooms, emergency rooms and allother health care facilities wherethe need for additionalillumination exists.
Illuminance	63,000 Lux at 1 meter	90,000 Lux at 1 meter
Color Temperature	3500 K	3700 K
Diameter ofLighthead	51 cm (20 inches)	51 cm (20 inches)
Light Field Diameter	25 – 30 cm (10 – 12 inches)	25 – 30 cm (10 – 12 inches)
Depth of illumination	119 cm (47 inches)	119 cm (47 inches)
Focusing	Adjustable by rotating centerhandle	Adjustable by rotating centerhandle
Number of bulbs	3	3
Light Sources(Halogen)	35 W IRC, 12 volt, bi-pin	35 W IRC, 12 volt, bi-pin
Rated life of HalogenLamp	2,000 hours	1,400 hours
Swivel Radius ofLam Housing –Ceiling Mounted	160 cm (63 inches) max.	160 cm (63 inches) max.
Height Movement ofLamp Housing –Ceiling Mounted	104 cm (41 inches) verticalmovement	104 cm (41 inches) verticalmovement
Power	116 Watts	105 Watts
Certifications	IEC/UL 60601 / IEC 60601-1-2 /IEC 60601-2-41 / MDD93/42/EEC / CAN/CSA C22.2601-1 M90	IEC/UL 60601 / IEC 60601-1-2 /IEC 60601-2-41 / MDD93/42/EEC / CAN/CSA C22.2601-1 M90
Mounting options	Single Ceiling, Double Ceiling,Floor, Wall	Single Ceiling, Double Ceiling,Floor, Wall
Warranty	5 year limited warranty	5 year limited warranty
Origin	Manufactured in the USA	Manufactured in the USA

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Image /page/3/Picture/2 description: The image shows the logo for Burton Luxo Medical Products. The word "burton" is written in a stylized font with rounded edges, and it is placed on a black background. Below the word "burton", the words "Luxo Medical Products" are written in a smaller, sans-serif font.

Performance Data:

The AIM 100® and the AIM 200® OR were tested (together) to the following standards:

Standard for Safety Medical Electrical Equipment, Part 1: . General Requirements for Safety UL 60601 - 1, Issued 2003-04-25 Ed.:1 Rev:2006/04/26
. Medical Electrical Equipment - Part 1: General Requirements for Safety General Instruction No 1: Supplement 1; 1994; CSA C22.2#601.1, Issue 1990/0101. Amendment 2 - February 1998, Update No. 2 (R2001)
. Medical Electrical Equipment - Part 2-41: Particular Requirements for the Basic Safety and Essential Performance of Surgical Luminaries and Luminaries for Diagnosis, IEC 60601-2-41:2000 Ed:1

A copy of the reports for this testing is included in tab 13 of this submission. This testing was initiated by Underwriters Laboratory and completed by Intertek.

The products meet all requirements as defined in the above Safety and Performance standards and were issued an "Authorization to Mark" by Intertek. A copy of this document can also be found in tab 12 Performance testing. The AIM 200® OR performed as well as. or better than, the legally marketed predicate device, the AIM 100TM (aka Outpatient III). The AIM 200® OR Major Surgery Light is thereby deemed to be safe and effective for it's intended use.

Substantial Equivalence:

Conclusion:

The AIM 200® OR Major Surgical Light is substantially equivalent to the legally marketed predicate device, the AIM 100™ Minor Surgery Light (aka Outpatient II).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 3 0 2010

Burton Medical Products Corporation % Mr. Scot D. Kinghorn Quality Assurance Regulatory Affairs Manager 21100 Lassen Street Chatsworth, California 91311

Re: K101537

Trade/Device Name: AIM 200® OR Major Surgical Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: September 17, 2010 Received: September 24, 2010

Dear Mr. Kinghorn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Scot D. Kinghorn

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Poh Nollm Din

Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

Indications for Use

510(k) Number (if known): K101537

Device Name: AIM 200® OR Major Surgical Light

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Osido formtm
(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K101537

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.