(119 days)
No
The 510(k) summary describes a surgical light and its performance against safety and performance standards. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a surgical light designed to provide illumination during medical procedures, not to treat or diagnose patients.
No
The device is described as a surgical light designed to provide illumination for surgeries, procedures, and examinations, not to diagnose medical conditions.
No
The device description clearly states it is a "Major Surgical Light" and describes various physical configurations (floor, wall, ceiling models), indicating it is a hardware device providing illumination.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide illumination for surgeries, procedures, and examinations of patients. This is a direct interaction with the patient's body or the area being examined/operated on.
- Device Description: The description focuses on the physical characteristics and performance of a surgical light.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are designed to perform tests on these samples.
The device is a surgical light, which is a medical device used to illuminate the surgical field or examination area. It does not perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
FSY
Device Description
"Description and Application: · 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. · Supported by an industry leading 5 year warranty, the AIM 200® OR is yet another Burton product that exceeds our customers' demands"
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
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.
Operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.
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)
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
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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. Kinghorn
Quality Assurance Regulatory Affairs Manager
Burton Medical Products Corporation
21100 Lassen Street
Chatsworth, CA 91311 | SEP 30 2010 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Scot D. Kinghorn
Quality Assurance Regulatory Affairs Manager
Burton Medical Products Corporation
21100 Lassen Street
Chatsworth, CA 91311
Phone: 800-444-9909 x 181
email: 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 this
device 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 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 | |
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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 Surgical | |
| Light (AIM 100® Minor Surgery | ||
| Light) | AIM 200® OR Major Surgical | |
| Light | ||
| Indications For Use | The Outpatient®III, Minor | |
| Surgical Light is designed to | ||
| provide the required illumination | ||
| for surgeries, procedures, and | ||
| examinations of patients. | ||
| Outpatient®III, Minor 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 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. | ||
| Illuminance | 63,000 Lux at 1 meter | 90,000 Lux at 1 meter |
| Color Temperature | 3500 K | 3700 K |
| Diameter of | ||
| Lighthead | 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 center | |
| handle | Adjustable by rotating center | |
| handle | ||
| 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 Halogen | ||
| Lamp | 2,000 hours | 1,400 hours |
| Swivel Radius of | ||
| Lam Housing – | ||
| Ceiling Mounted | 160 cm (63 inches) max. | 160 cm (63 inches) max. |
| Height Movement of | ||
| Lamp Housing – | ||
| Ceiling Mounted | 104 cm (41 inches) vertical | |
| movement | 104 cm (41 inches) vertical | |
| movement | ||
| Power | 116 Watts | 105 Watts |
| Certifications | IEC/UL 60601 / IEC 60601-1-2 / | |
| IEC 60601-2-41 / MDD | ||
| 93/42/EEC / CAN/CSA C22.2 | ||
| 601-1 M90 | IEC/UL 60601 / IEC 60601-1-2 / | |
| IEC 60601-2-41 / MDD | ||
| 93/42/EEC / CAN/CSA C22.2 | ||
| 601-1 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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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the department's three main goals: protecting the health of all Americans, providing essential human services, and strengthening the nation's health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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
5
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
6
Indications for Use Form
Indications for Use
510(k) Number (if known): K101537
Device Name: AIM 200® OR Major Surgical Light
Indications for Use:
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.
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