(29 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on illumination and video support, not intelligent analysis or processing.
No
The device provides illumination and video support for surgical procedures but does not directly treat or diagnose a disease condition. Its purpose is to facilitate the surgical act performed by others.
No
The device is a surgical lighting system designed to illuminate the surgical field and provide video support, not to diagnose medical conditions.
No
The device description explicitly lists hardware components such as a Camera Module, Flat Panel Monitors, Battery Backup, and Remote Power Module Unit, indicating it is a hardware system with potential software control, not a software-only device.
Based on the provided information, the Harmony vLED Surgical Lighting System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide visible illumination of the surgical field and the patient, and to provide video-visual procedural support. This is a function related to surgical procedures and visualization, not the examination of specimens derived from the human body.
- Device Description: The description reinforces its role as a surgical light and its accessories are related to its function in the operating room (camera, monitors, power, handles).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The Harmony vLED Surgical Lighting System does not perform this function.
N/A
Intended Use / Indications for Use
The proposed Harmony vLED Surgical Lighting System 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 Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to mgnide video-visual procedural support for the hospital staff during surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
FSY, FST
Device Description
The Harmony vLED Surgical Lighting System 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 Harmony vLED Surgical Lighting System is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities. The Harmony vLED Surgical Lighting System accessories are as follows: - STERIS ACT Interface o - o Camera Module - Dual or Single Flat Panel Monitors o - o 24VDC Battery Backup support - Remote Power Module Unit 0 - Sterile Disposable Handle Covers o
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 / surgical procedures
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 Harmony vLED Surgical Lighting System meets 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
STERIS®
MAR ] 7 2010
510(k) Summary
For
Harmony vLED Surgical Lighting System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459
Contact:
Robert F. Sullivan Senior Director, Regulatory Affairs
440 392 7695 Telephone: 440 357 9198 Fax No:
Submission Date:
ﻪ ﻣﻦ ﻣﺎﻳﻮ
February 12, 2010
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Harmony vLED 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 Device
Harmony LED-1 Surgical Lighting System (K072072)
3. Device Description
The Harmony vLED Surgical Lighting System 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 Harmony vLED Surgical Lighting System is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities.
The Harmony vLED Surgical Lighting System accessories are as follows:
- STERIS ACT Interface o
- o Camera Module
- Dual or Single Flat Panel Monitors o
- o 24VDC Battery Backup support
- Remote Power Module Unit 0
- Sterile Disposable Handle Covers o
4. Intended Use
The proposed Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field
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and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
The performance of the Harmony vLED 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.
Description of Safety and Substantial Equivalence 5.
The proposed Harmony vLED Surgical Lighting System, like its predicate device, is a variable pattern, variable intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide optional videovisual procedural support for the hospital staff during surgical procedures. The proposed device has the same function, intended use, components, technology, and performance as the predicate device, Harmony LED-1 Surgical Lighting System (K072072) manufactured and owned by STERIS Corporation.
The differences between the proposed and predicate devices are limited to differences in design and operation. These differences do not raise any new issues of safety and efficacy.
Performance Testing 6.
Performance testing was conducted to verify that the Harmony vLED Surgical Lighting System meets the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is inscribed along the border of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAR 1 7 2010
STERIS Corporation % Mr. Robert F. Sullivan Senior Director. Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K100395
Trade/Device Name: Harmony vLED Surgical Lighting System Regulation Number: 21 CFR 878,4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FST Dated: February 12, 2010 Received: February 16, 2010
Dear Mr. Sullivan:
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 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
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Page 2 - Mr. Robert F. Sullivan
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
incerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K100395 510(k) Number (if known):
Device Name:
Harmony vLED Surgical Lighting System
Indications For Use:
The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to mgnide video-visual procedural support for the hospital staff during surgical procedures.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number. K100398
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