(110 days)
The Leica FL800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.
The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope to produce excitation light and resolve fluorescence light from the fluorescent agent ICG. The generated fluorescence signal depicts the distribution of the infra-red dye in the patient's blood vessels during the operation (fluorescence video angiography).
This document (K141136) is a 510(k) premarket notification for a modification to an existing device, the Leica FL800. It doesn't describe a new clinical study to establish new acceptance criteria or new performance data in the typical sense for a brand new AI device. Instead, it demonstrates the substantial equivalence of a modified version of an already cleared device to its predicates.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a modification to an already cleared device (Leica FL800), and the manufacturer states "There will be no change to the intended use of the device nor the alteration of the device's fundamental scientific technology," there aren't new clinical performance acceptance criteria established or new performance data reported as you would expect for an initial clearance of a novel diagnostic or AI-driven device.
The "acceptance criteria" here are compliance with recognized standards for safety and electromagnetic compatibility to ensure the modification does not negatively impact the device's performance or safety.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance |
|---|---|
| IEC 60601-1-2 Edition 3:2007 (EMC) | Conforms |
| IEC 60601-1 Edition 3:2005 (Electrical Safety) | Conforms |
The device's functional performance related to "viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery" is considered equivalent to the predicate devices because the fundamental scientific technology and intended use have not changed. The modification is primarily a change in configuration (external to internal) for ergonomic and aesthetic reasons.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a clinical test set with patient data to evaluate a new diagnostic or AI performance. The testing was for engineering standards conformance (EMC, electrical safety) on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth was established by experts from patient data, as this was not a clinical performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a clinical test set was employed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-driven device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable for clinical performance. The "ground truth" for the reported conformance is adherence to the specified engineering standards.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it's not an AI/machine learning product.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2014
Leica Biosystems Richmond, Inc. Barbara-Ann Conway-Myers Senior Regulatory Affairs Specialist 5205 Route 12 Richmond, Illinois 60071
Re: K141136
Trade/Device Name: Leica FL800 Regulation Number: 21 CFR 892.1600 Regulatory Name: Angiographic x-ray system Regulatory Class: Class II Product Code: IZI Dated: May 16, 2014 Received: May 21, 2014
Dear Ms. Conway-Myers:
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 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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
cc: Enclosed
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Indications for Use
510(k) Number (if known) K141136
Device Name Leica FL800
Indications for Use (Describe)
The Leica FL800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 5- 510(k) Summary of Safety and Effectiveness
Submitter Leica Biosystems Richmond, Inc 5205 Route 12 Richmond, IL 60071 Barbara-Ann Conway-Myers - Contact Person April 24, 2014 - Date Summary was Prepared
Device Name:
- Trade Name Leica FL800 ●
- Common Name - Fluorescent Angiographic System
- Classification Name System, X-Ray, Anqiographic per 21 CFR 892.1600 ●
- FDA Product Code IZI; subsequent product code is EPT (Surgical Microscope and Accessory) ●
Devices for Which Substantial Equivalence in Claimed:
- Leica Microsystems (Schweiz) AG, Leica FL800 (K061871)
- Leica Microsystems (Schweiz) AG, Leica FL800 (K080612)
Device Description:
The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope to produce excitation light and resolve fluorescence light from the fluorescent agent ICG. The generated fluorescence signal depicts the distribution of the infra-red dye in the patient's blood vessels during the operation (fluorescence video angiography).
Intended Use of the Device:
The Leica FL800is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area, blood flow of the coronary vascular and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.
Substantial Equivalence:
The Leica FL800 is an existing device which was granted market clearance by the FDA following the submission of a 510(k) pre-market notification (K061871 and K080612). Leica Microsystems seeks only to include a variant of the Leica FL800 which is a modification of the existing devices cleared under the two 510(k) mentioned above. There will be no change to the intended use of the device nor the alteration of the device's fundamental scientific technology.
The table below depicts the modifications associated with the Leica FL800 variant.
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Image /page/4/Picture/1 description: The image shows the logo for Leica Biosystems. The word "Leica" is written in a stylized red font. Below the word "Leica" is the word "BIOSYSTEMS" written in a smaller, sans-serif font. The logo is simple and modern.
| Proposed Accessory Description | |||
|---|---|---|---|
| K061871 | K080612 | Leica FL800 | Leica FL800 ULT |
| Standard Leica M520 OH3Microscope (Class Iexempt) | Additional Leica SurgicalMicroscopes available foruse with the Leica FL800as a result of extension toindications for use. | Accessory to Leica Surgical Microscopes intended for defined surgeries | |
| Sony XC-E1 50 NIR (nearinfra-red) camera (part ofLeica FL800 upgrade) | No change | External NIR CameraICG Filter | Dual Video Adaptorconsisting of• Internal NIRCamera |
| Leica Dual CCD SurgicalMicroscope CameraAdapter (part of LeicaFL800 upgrade) | No Change | Dual Video Adaptor• Beam Splitter• Beam Mirror | • ICG Filter• Beam Splitter |
| Leica modification ofstandard 300 Watt Xe lightsource (part of LeicaFL800 upgrade) | Introduced possibility touse 400Watt Xeillumination as supplied onsome Leica SurgicalMicroscopes | Light Source part of the Leica Surgical Microscope | |
| Leica FL800 electroniccontrol unit (part of theFL800 upgrade) | No Change | No Change | No Change |
| ICG Fluorescence Dye(labelled for use with theLeica FL800) | No Change | Not part of the Leica System |
Table 1: Comparison of Predicate devices (K061871 and K080612) to the Leica FL800 variant
Standards Used in Demonstrating Conformance
The Leica FL800 device is an accessory to the Leica surgical microscopes and as an accessory was not individually tested to any recognized standard. However, this accessary was tested in combination with the Leica surgical microscopes to demonstrate that it did not neqatively impact the safety and effectiveness of the Surgical Microscope.
For Electromagnetic Compatibility (EMC) the Leica FL800 ULT has been tested and showed conformance to standard IEC 60601-1-2 Edition 3:2007.
For Electrical Safety the Leica FL800 ULT has been tested and showed conformance to standard IEC 60601-1 Edition 3:2005.
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Image /page/5/Picture/1 description: The image shows the logo for Leica Biosystems. The logo consists of the word "Leica" in a stylized, red font. Below the word "Leica" is the word "BIOSYSTEMS" in a smaller, black font. The logo is simple and modern.
Conclusion
The modification of the Leica FL800 (variant) consists of the relocation of this accessory from an external configuration to an internal configuration which services 2 distinct advantages:
- It decreases the likelihood of any external disturbances to the Leica FL800 either by the surgeon . or the operating room staff.
- . The aesthetically pleasing design makes the device more ergonomic which is a value to the surgeon.
There is no alteration to either the intended use or the device's fundamental scientific technology and for this reason, Leica Microsystems seeks a Special 510k for the clearance of this device.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.