(76 days)
Not Found
No
The description focuses solely on the illumination and cooling mechanisms of an LED headlight, with no mention of AI, ML, image processing, or data analysis.
No
The device is a surgical headlight system providing illumination for visualization, not directly performing therapeutic actions.
No
The device is a surgical headlight system, which provides illumination to aid visualization during procedures. While it mentions "diagnostic procedures" in its intended use, its primary function is illumination, not diagnosis itself.
No
The device description explicitly details hardware components such as an LED light source, battery pack, direct power supply, and a cooling system with a fan and ducts.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures." This describes a device used on or during a procedure on a patient, not a device used to examine samples from a patient outside the body.
- Device Description: The description details a surgical headlight system, which is a piece of equipment used in a clinical setting to provide light for a procedure. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
An IVD is a medical device used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Integra™ LED Surgical Headlight System is a surgical tool used for illumination during procedures.
N/A
Intended Use / Indications for Use
The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
Product codes
FSR
Device Description
The Integra™ LED Surgical Headlight System is a self-contained headlight system that can be operated using either battery or direct power supply. Using a battery pack gives the surgeon complete portability allowing unrestricted movement in and around the operating suite. The direct power supply option can be used as a primary power source for unlimited operating time, or as a back-up to the battery system.
The Integra™ LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air at a very low flow rate through ports on the side and back of the headlight module, quietly cooling the LED. The air is drawn through a system of ducts and is gently exhausted behind the surgeon.
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 Integra™ LED Surgical Headlight is substantially equivalent to the legally marketed predicate device based on performance testing. The Integra™ LED Surgical Headlight System has the same intended use, technological characteristics, and general operation as the predicate device identified. Minor differences between these devices simply improve performance and operating characteristics of the device and do not raise any new questions in regards to the system's safety or effectiveness.
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
§ 886.4335 Operating headlamp.
(a)
Identification. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.(b)
Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/0 description: The image shows the word "INTEGRA" in all capital letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller capital letters. To the right of the word "INTEGRA" are four squares of varying sizes stacked on top of each other.
589 Davies Drive
York, Pa 17402
Phone (717) 940-8335
Toll Free (800) 221-1344
Fax (717) 840-9347
www. Integralife.com
1 1 2011
510(k) Summary
| Submitted by: | Integra Burlington MA, Inc.
22 Terry Avenue, Burlington, MA 01803 USA | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Stephanie Sheesley, Regulatory Affairs Manager
Integra York PA, Inc.
589 Davies Drive, York, PA 17402 USA
Phone: (717) 717-840-2774 Fax: (717) 840-3509 | |
| Date Prepared: | February 16, 2011 | |
| Device Trade Name: | Integra™ LED Headlight System | |
| Device Common Name: | Surgical Headlight | |
| Classification Name: | Light, Headband, Surgical | |
| Device Class: | Class II | |
| Product Code: | FSR | |
| CFR Classification: | 21 CFR 886.4335 | |
| Predicate Device: | 510(k) #K031548
Welch Allyn's Solid State Procedure Headlight | |
Device Description:
The Integra™ LED Surgical Headlight System is a self-contained headlight system that can be operated using either battery or direct power supply. Using a battery pack gives the surgeon complete portability allowing unrestricted movement in and around the operating suite. The direct power supply option can be used as a primary power source for unlimited operating time, or as a back-up to the battery system.
The Integra™ LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air at a very low flow rate through ports on the side and back of the headlight module, quietly cooling the LED. The air is drawn through a system of ducts and is gently exhausted behind the surgeon.
1
Image /page/1/Picture/0 description: The image shows the word "INTEGRA" in bold, black letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller, thinner letters. To the right of the word "INTEGRA" are four squares of varying sizes, arranged in a descending order.
Indications For Use:
The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
Predicate Device:
| 510(k) # | Device | Manufacturer |
|---|---|---|
| K031548 | Solid State Procedure Headlight | Welch Allyn Inc. |
Performance Standards:
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the Integra™ LED Surgical Headlight conforms to the following standards:
- CAN/CSA-C22.2 No. 601.1-M90 "Medical Electrical Equipment Part 1: . General Requirements for Safety"
- EN 60601-1: 1990 + A1: 1992 + A2: 1995 "Medical Electrical Equipment Part . 1 : General Requirements for Safety
- IEC 60601-1: 1988 + A1: 1991 + A2: 1995 "Medical Electrical Equipment Part . 1 General Requirements for Safety"
- UL 60601-1, First Edition, 2003 "Medical Electrical Equipment Part 1: General . Requirements for Safety"
- IEC 60601-1-8: 2003 (First Edition) in conjunction with IEC 60601-1 (1988) . including Amendments 1 (1991) and 2 (1995).
- CAN/CSA E60335-1/4E. Fourth Edition, 2003 "Household and Similar . Electrical Appliances Safety Part 1: General Requirements"
- UL 60335-1. Fourth Edition, 2004 "UL Standard for Safety of Household and . Similar Electrical Appliances, Part 1:General Requirements"
- IEC 60335-2-29:2002 (Fourth Edition) + A1:2004 + A2:2009 in conjunction with . IEC 60335-1:2001 (Fourth Edition) incl. Corrigendum 1:2002 + A1:2004 + A2:2006 incl. Corrigendum 1:2006
2
Image /page/2/Picture/0 description: The image shows the word "INTEGRA" in bold, black letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller, black letters. To the right of the word "INTEGRA" are four squares of varying sizes, arranged in a column.
589 Davies Drive York Pa 17402 hone (717) 940-83 oll Free (800) 221-13 Fax (717) 840-9347 www. Integralife.com
Technological Characteristics:
| Feature | Integra LED
Surgical Headlight | Welch Allyn Solid
State Headlight |
|--------------------------------------------|-----------------------------------|--------------------------------------|
| LED Light Source | YES | YES |
| AC/DC Powered | YES | YES |
| Battery Powered | YES | YES |
| User Control of Attenuated Light Level | YES | NO |
| Fan Monitoring and Control | YES | NO |
| Over Temperature Monitoring and
Control | YES | NO |
| Adjustable Light Positioning | YES | YES |
| Adjustable Illuminated Spot Size | YES | YES |
Substantial Equivalence:
The Integra™ LED Surgical Headlight is substantially equivalent to the legally marketed predicate device based on performance testing. The Integra™ LED Surgical Headlight System has the same intended use, technological characteristics, and general operation as the predicate device identified. Minor differences between these devices simply improve performance and operating characteristics of the device and do not raise any new questions in regards to the system's safety or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 1 2011
Integra Life Sciences Corporation % Integra York PA, Inc. Ms. Stephanie Sheesley Regulatory Affairs Manager 589 Davies Drive York, Pennsylvania 17402
Re: K110528
Trade/Device Name: Integra™ LED Headlight System Regulation Number: 21 CFR 886.4335 Regulation Name: Operating headlamp Regulatory Class: Class II Product Code: FSR Dated: February 23, 2011 Received: February 24, 2011
Dear Ms. Sheesley:
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.
4
Page 2 - Ms. Stephanie Sheesley
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); 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.
for
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
KII0528
510(k) Number (if known):
Device Name:
IntegraTM LED Surgical Headlight System
Indications for Use:
The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
Prescription Use______________________________________________________________________________________________________________________________________________________________
AND/OR Use
Over-The-Counter-
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil RP Ogden for mkm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110528
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INTEGRA