(67 days)
No
The document describes a surgical lighting system with standard features and accessories, with no mention of AI or ML capabilities.
No
This device is a surgical lighting system designed to illuminate the surgical field, not to treat a condition or restore function.
No
The device is described as a surgical lighting system designed to provide illumination and video support during surgical procedures. Its purpose is to assist the medical staff by making the surgical field visible, not to identify or assess a medical condition.
No
The device is described as a "Surgical lighting System" with a "Lighthead" and numerous physical accessories (Ambient Light System, IR remote control, Fiber Optic Light, Camera Module, Monitors, Battery Backup, Wall Control Unit, etc.). This clearly indicates a hardware-based medical device, not a software-only one.
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 visible illumination and video support during surgical procedures. This is a direct interaction with the patient and the surgical field, not the examination of specimens in vitro (outside the body).
- Device Description: The description focuses on the physical components of a surgical lighting system, including lightheads, suspension systems, and accessories like cameras and monitors. These are all tools used during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This surgical lighting system does not perform such functions.
N/A
Intended Use / Indications for Use
The proposed Harmony LED-1 Surgical lighting System subjected in this submission is a variable pattern/ intensity surgical light designed to provide visible illumination of the surgical field and patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
Product codes
FSY
Device Description
The proposed Harmony LED-1 Surgical Lighting System subjected in this submission is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
The proposed Harmony LED-1 Surgical Lighting System Lighthead is specifically designed to be the next generation lighthead which can be added to the existing center mounted suspension system supporting the horizontal arms, spring arms and yokes of the predicate device Amsco Harmony Surgical Lighting and Media System cleared for market on December 13, 2001 as K013242 (STERIS Corporation). Like the predicate device the system operates via an electronic controller.
The proposed Harmony LED-1 Surgical Lighting System accessories are as follows:
- . Ambient Light System.
- . IR remote control for camera module.
- DeepSite Fiber Optic Light. .
- Fiber Optic Video Enabled Video. ●
- . STERIS ACT Interface.
- Camera Module.
- . Dual or Single Flat Panel Monitors.
- . CRT.
- . 24VDC Battery Backup support.
- . Secondary Spindle Mount.
- . Low Profile Wall Control Unit.
- . Remote Power Module Unit.
- . Sterile Disposable Handle Covers.
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
hospital staff
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)
Performance testing was conducted to verify that the proposed Harmony LED-1 Surgical Lighting System meet the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41.
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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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION HARMONY LED-1 SURGICAL LIGHTING SYSTEM
1. Device Name
OCT 5 * 2007
| Trade Name: | Harmony LED-1 Surgical Lighting System |
|---|---|
| Common Name: | Light, Surgical, Ceiling Mounted. |
| Classification Name: | Light, Surgical, Ceiling Mounted. |
| Classification Number: | 21 CFR 878.4580 |
| Product Code: | FSY |
2. Predicate Devices
- POWERLED™ Surgical Light System cleared for market on March 16, 2007 as ● K070442 (Getinge USA, Inc).
- . iLED cleared for market on June 22, 2006 as K061317 (Trumpf Kreuzer Medizin).
- . Amsco Harmony Surgical Lighting and Media System cleared for market on December 13, 2001 as K013242 (STERIS Corporation).
3. Device Description
The proposed Harmony LED-1 Surgical Lighting System subjected in this submission is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
The proposed Harmony LED-1 Surgical Lighting System Lighthead is specifically designed to be the next generation lighthead which can be added to the existing center mounted suspension system supporting the horizontal arms, spring arms and yokes of the predicate device Amsco Harmony Surgical Lighting and Media System cleared for market on December 13, 2001 as K013242 (STERIS Corporation). Like the predicate device the system operates via an electronic controller.
The proposed Harmony LED-1 Surgical Lighting System accessories are as follows:
- . Ambient Light System.
- . IR remote control for camera module.
- DeepSite Fiber Optic Light. .
- Fiber Optic Video Enabled Video. ●
- . STERIS ACT Interface.
1
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION HARMONY LED-1 SURGICAL LIGHTING SYSTEM
- Camera Module. �
- . Dual or Single Flat Panel Monitors.
- . CRT.
- . 24VDC Battery Backup support.
- . Secondary Spindle Mount.
- . Low Profile Wall Control Unit.
- . Remote Power Module Unit.
- . Sterile Disposable Handle Covers.
4. Intended Use
The proposed Harmony LED-1 Surgical Lighting System subjected in this submission is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures. The performance of the Harmony LED-1 Surgical Lighting System meets the general requirements for safety as defined in CEI/IEC 60601-1 and IEC 60601-2-41 for Medical Electrical Equipment.
5. Description of Safety and Substantial Equivalence
The proposed Harmony LED-1 Surgical Lighting System, like its predicate devices is a variable pattern, variable intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures. The Proposed device, is identical in function, intended use, components, technology, and performance to the predicate devices: AMSCO Harmony LA Surgical Light System (K013242) manufactured and owned by STERIS Corporation and the iLED (K061317) manufactured by Trumpf Kreuzer Medizin Systeme.
The differences between the proposed and predicate devices are limited to differences in design, material, and operational. These differences do not raise any new issues of safety and efficacy.
6. Performance Testing
Performance testing was conducted to verify that the proposed Harmony LED-1 Surgical Lighting System meet the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles or faces stacked on top of each other, creating a sense of depth and connection.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
STERIS Corporation % Mr. Jack Scoville Fellow, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060-1834
OCT 5 *
Re: K072072
Trade/Device Name: Harmony LED 1 Surgical Lighting System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: September 24, 2007 Received: September 25, 2007
Dear Mr. Scoville:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 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); good manufacturing practice requirements as set
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Page 2 - Mr. Jack Scoville
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,
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072072
Device Name: Harmony LED 1 Surgical Lighting System
Indications For Use:
The proposed Harmony LED-1 Surgical lighting System subjected in this submission is a variable pattern/ intensity surgical light designed to provide visible illumination of the surgical field and patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
Mark A. Mulkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Prescription Use _
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
CONFIDENTIAL