(29 days)
Not Found
No
The document describes an "automatic head recognition system" which could potentially use image processing, but there is no mention of AI, ML, or any learning algorithms. The description focuses on standard electrical and safety testing, not performance metrics typical of AI/ML systems.
No
The device provides illumination for surgical procedures, it does not treat or directly affect a disease or medical condition.
No
The device is a surgical light system that provides illumination, not a diagnostic assessment.
No
The device description clearly states it is a "Surgical Light System" and describes hardware components like LEDs and an automatic head recognition system. While it mentions software testing, the core device is a physical light system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The MAQUET POWERLED™ Surgical Light System is designed to provide visible illumination of the surgical area or the patient. It is a light source used during surgery or examination, directly on or around the patient's body.
- Intended Use: The intended use clearly states its purpose is to provide illumination for surgical procedures and examinations. It does not involve testing or analyzing biological specimens.
Therefore, based on the provided information, the device's function and intended use fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The POWERLED™ Surgical Lights are intended to be used to provide visible illumination of the surgical area or the patient.
An "LED inside" feature is available which produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examination.
An added optional patented automatic head recognition system feature is available to reduce the heat projected on to the surgeon's head, and to compensate for loss of illumination due to an obstacle in front of the cupola.
Product codes (comma separated list FDA assigned to the subject device)
FSY
Device Description
The POWERLED™ Surgical Light System is a new product designation intended to identify a family of surgical lights that will use a similar set of design principles as the ALM X'TEN® (X10) Surgical Light Systems.
The POWERLED™ Surgical Light provides a broadened set of features and options that include LEDs as the main light source as well as an added optional automatic head recognition system feature as a result of this redesign effort.
The POWERLED™ Product Family currently has multiple configurations available, as shown within Table 1.
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
Not Found
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 test data supports conformance to:
- UL 60601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements . for Safety
- CSA C22.2 No. 60601.1 Medical Electrical Equipment, Part 1: General Requirements . for Safetv
- CSA C.22.2 No. 60601-2-41 Medical electrical equipment Part 2-41: Particular . requirements for the safety of surgical luminaires for diagnostics
- IEC 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for . the safety of surgical luminaires and luminaires for diagnostics
- EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety . - Collateral standard: Electromagnetic compatibility - Requirements and tests
- FCC Part 15 .
- Software used in the POWERLED™ Surgical Light was tested according to the . appropriate FDA Software Guidance Documents, per its determination as a Minor Level of Concern.
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.
ALM X'TEN® (X10) Surgical Light System (K040735)
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).
Note: additional model configurations are planned for development. These will incorporate MAQUET POWERLED™ lighthead subassemblies.
§ 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
KO70442
510(k) SUMMARY
POWERLED™ Surgical Light System
MAR 1 6 2007
| Submitted by: | Getinge USA, Inc. (as MAQUET S.A.'s US Agent)
1777 E Henrietta Road
Rochester, NY 14623-3133 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kevin M. Tompkins
Quality Analyst
Phone: (585) 272-5078
Fax: (585) 272-5299
Email: Kevin.Tompkins@getingeusa.com |
| Date prepared: | February 13, 2007 |
| Proprietary Name: | POWERLED™ Surgical Light System |
| Common Name: | Surgical Light |
| Device Classification: | Surgical Lamp (78 FSY) |
| | Class II, as listed per 21 CFR 878.4580 |
| Predicate Device: | ALM X'TEN® (X10) Surgical Light System (K040735) |
Description of Device:
The POWERLED™ Surgical Light System is a new product designation intended to identify a family of surgical lights that will use a similar set of design principles as the ALM X'TEN® (X10) Surgical Light Systems.
The POWERLED™ Surgical Light provides a broadened set of features and options that include LEDs as the main light source as well as an added optional automatic head recognition system feature as a result of this redesign effort.
The POWERLED™ Product Family currently has multiple configurations available, as shown within Table 1.
346
1
MAQUET S.A. FDA 510(k) Summary
Device: POWERLED™ Surgical Light System
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Table 1:
| Article code | Alias Code | Description |
|---|---|---|
| ARD568411110C | PWD70SF | POWERLED SURGICAL LIGHT, PWD70SF, CEILING MOUNTED, ONE POWERLED CUPOLA INCLUDING AMBIENT LIGHT (LEDINSIDE FUNCTION), SINGLE FORK, 1150MM SA SUSPENSION |
| ARD568411210C | PWD77SF | SAME AS PWD70SF, TWO POWERLED CUPOLAS |
| ARD568411511C | PWD70SFXS09 | SAME AS PWD70SF, AND ONE FLAT SCREEN ( |