(132 days)
No
The device description and performance studies focus on the physical characteristics, illumination properties, and safety of the endoilluminators. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The devices are endoilluminators, indicated for use during surgery to provide illumination, making them surgical tools or accessories rather than therapeutic devices designed to treat a condition. While integral to the surgical process, they do not directly provide therapy.
No
The devices are endoilluminators used to provide illumination during surgical procedures, not to diagnose a condition.
No
The device description clearly details physical components such as fiber optics, sapphire lenses, stainless steel cannulas, and stiffeners, indicating it is a hardware device.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use is for "posterior segment ophthalmic surgery." This describes a surgical procedure performed directly on the patient's eye, not a test performed on a sample taken from the body.
- Device Description: The descriptions detail devices that are inserted into the eye to provide illumination during surgery. They are tools used during a medical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. These devices are clearly surgical instruments used for illumination during ophthalmic surgery.
N/A
Intended Use / Indications for Use
Alcon 27GA Chandelier
The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery.
Alcon 27+ DS Wide Angle Endoilluminator
The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery.
Alcon 27+ DS Endoilluminator
The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.
Product codes (comma separated list FDA assigned to the subject device)
MPA
Device Description
As part of this premarket notification Alcon presents three new endoilluminators, compatible with the UNITY VCS device cleared in K233876 (clearance date: June 21, 2024). The table below lists the endoilluminators covered within scope of this premarket notification.
Device Name:
- Alcon 27 GA Chandelier
- Alcon 27+ DS Wide Angle Endoilluminator
- Alcon 27+ DS Endoilluminator
Alcon 27GA Chandelier
The Alcon 27GA Chandelier provides a hands-free wide field of illumination for vitreoretinal procedures. The distal end of the device incorporates a short, tapered fiber optic to provide wide angle illumination projected from a pars plana position of the eye. The distal end consists of a tapered fiber, which is inserted into the eye through the Alcon 27GA entry system. The fiber is malleable so the physician can shape it to form a stable service loop, position the tip, and minimize interference with the lid speculum.
Alcon 27+ DS Wide Angle Endoilluminator
The Alcon 27+ DS WA Endoilluminator offers wide-angle illumination, featuring a sapphire lens at the distal end of the probe. This design ensures consistent, low-glare illumination across a broad field of view. Additionally, it incorporates a Dynamic Stiffener (DS) element-a retractable stiffener designed to minimize needle deflection at the proximal end of the stainless steel cannula. as opposed to the fixed stiffener used in previous models.
Alcon 27+ DS Endoilluminator
The Alcon 27+ DS Endoilluminator transmits light energy into the eye and incorporates a DS element at the proximal end of the stainless-steel cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment ophthalmic
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)
Non-Clinical Testing:
Biocompatibility: Alcon conducted biocompatibility testing on the patient-contacting devices and met ISO 10993. Biocompatibility of medical devices requirements for chemical characterization, cytotoxicity, sensitization, irritation, and acute systemic toxicity. Packaging materials passed cytotoxicity requirements from ISO 11607-1, Packaging for terminally sterilized medical devices and ASTM F2475. Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials.
Sterilization and Shelf Life: Alcon performed sterilization testing on the subject devices. Tested devices passed the predetermined acceptance criteria in accordance with ISO 11135, Sterilization of health-care products - Ethylene oxide and ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals. The subject devices were sterilized by ethylene oxide (EO). The subject devices have been shown to be sterilizable to a sterility assurance level (SAL) of 10-6, and the sterilization process has been validated per the required standard.
The subject devices utilize the same packaging configuration as their predicates, undergoing ethylene oxide (EO) sterilization and pre-conditioning in accordance with ASTM D4169, Standard Practice for Performance Testing of Shipping Containers and Systems. Additionally, accelerated aging was performed in compliance with ASTM F1980, the Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. All tested units successfully met the predetermined acceptance criteria for package integrity, which included visual inspection, seal strength, and bubble leak tests, in accordance with ISO 11607-1, Packaging for Terminally Sterilized Medical Devices.
Performance Testing: Safety tests demonstrated the compliance of the subject devices to the appropriate standards. Biocompatibility evaluations of materials coming into contact with the patient fluid path demonstrated compliance with the appropriate standard from the ISO 10993 series.
Technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. Like the predicate devices have been developed and manufactured in compliance with the following standards:
- ISO 14971, Medical devices Application of risk management to medical devices
- ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods, Part 1: General requirements applicable to all ophthalmic instruments
- ISO 15752, Ophthalmic Instruments - Endoilluminators - Fundamental Requirements and Test Methods for Optical Radiation Safety
- ANSI Z80.36, Ophthalmics Light Hazard Protection for Ophthalmic Instruments
Light Hazard Testing: The three subject devices were evaluated for luminous flux, aphakic irradiance and thermal irradiance for the purposes of comparison with the predicate devices and compliance to ANSI Z80.36, Ophthalmics - Light Hazard Protection for Ophthalmic Instruments and ISO 15752, Ophthalmic Instruments - Endoilluminators - Fundamental Requirements and Test Methods for Optical Radiation Safety.
The subject devices have a similar luminous flux and meet aphakic and thermal safety standards comparable to the predicate devices.
Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the subject devices are equivalent to the predicate devices.
Animal/Clinical Testing: The risk assessment for the subject devices did not require any animal or clinical testing as mitigation against any identified risks.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
December 4, 2024
Alcon Laboratories, Inc. Ganesh Balachandar Regulatory Affairs Manager 6201 South Freeway Fort Worth, Texas 76134
Re: K242184
Trade/Device Name: Alcon 27GA Chandelier; Alcon 27+ DS Wide Angle Endoilluminator; Alcon 27+ DS Endoilluminator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: MPA Dated: October 25, 2024 Received: October 25, 2024
Dear Ganesh Balachandar:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CLAUDINE H. KRAWCZYK -S
Claudine Krawczyk Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242184
Device Name
• Alcon 27GA Chandelier
• Alcon 27+ DS Wide Angle Endoilluminator
• Alcon 27+ DS Endoilluminator
Indications for Use (Describe)
Alcon 27GA Chandelier
The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery.
Alcon 27+ DS Wide Angle Endoilluminator
The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery.
Alcon 27+ DS Endoilluminator
The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
In accordance with 21 CFR 807.92, Alcon hereby provides the 510(k) summary for the Alcon Endoilluminators.
1. SUBMITTER
| Applicant | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Ganesh Balachandar
Regulatory Affairs Manager
Alcon Research LLC,
on behalf of Alcon Laboratories, Inc.
20511 Lake Forest Drive
Lake Forest, CA 92630-7741
+1 (949) 322-5101
ganesh.balachandar@alcon.com |
| Secondary Correspondent | Ophelia Biggs
Senior Director, Regulatory Affairs
Alcon Research LLC,
on behalf of Alcon Laboratories, Inc.
20511 Lake Forest Drive
Lake Forest, CA 92630-7741
+1 (949) 217-3854
ophelia.biggs@alcon.com |
| Date Prepared | December 4, 2024 |
5
2. SUBJECT DEVICES
| Device Trade Name | Alcon 27GA Chandelier Alcon 27+ DS Wide Angle Endoilluminator Alcon 27+ DS Endoilluminator |
|---|---|
| Classification | |
| Number and Name | |
| (Product Code in | |
| Parentheses) | 21 CFR 876.1500 Endoscope and accessories (MPA) |
| Regulatory Class | II |
3. PREDICATE DEVICES
| For Alcon 27GA Chandelier: | |
|---|---|
| Predicate Device | 25GA Chandelier |
| 510(k) Number | K875005 |
| Classification | |
| Number and Name | |
| (Product Code in | |
| Parentheses) | 21 CFR 876.1500 Endoscope and accessories (MPA) |
| Regulatory Class | II |
| For Alcon 27+ DS Wide Angle Endoilluminator: | |
|---|---|
| Predicate Device | 25GA Wide Angle Endoilluminator |
| 510(k) Number | K875005 |
| Classification | |
| Number and Name | |
| (Product Code in | |
| Parentheses) | 21 CFR 876.1500 Endoscope and accessories (MPA) |
| Regulatory Class | II |
| For Alcon 27+ DS Endoilluminator: | |
|---|---|
| Predicate Device | 27+ Straight Endoilluminator |
| 510(k) Number | K110951 |
| Classification | |
| Number and Name | |
| (Product Code in | 21 CFR 876.1500 Endoscope and accessories (MPA) |
6
510(k) Summary: K242184 Alcon 27GA Endoilluminator
| Parentheses) | |
|---|---|
| Regulatory Class | II |
7
DEVICE DESCRIPTION 4.
As part of this premarket notification Alcon presents three new endoilluminators, compatible with the UNITY VCS device cleared in K233876 (clearance date: June 21, 2024). The table below lists the endoilluminators covered within scope of this premarket notification.
| Device Name | Catalog
Number | Device
Classification | Product
Code | CFR
Number |
|--------------------------------------------|-------------------|--------------------------|-----------------|-----------------------------------------------|
| Alcon 27 GA Chandelier | 8065000252 | | | |
| Alcon 27+ DS Wide Angle
Endoilluminator | 8065000253 | Class II | MPA | 21 CFR 876.1500,
Endoscope and accessories |
| Alcon 27+ DS
Endoilluminator | 8065000256 | | | |
Alcon 27GA Chandelier
The Alcon 27GA Chandelier provides a hands-free wide field of illumination for vitreoretinal procedures. The distal end of the device incorporates a short, tapered fiber optic to provide wide angle illumination projected from a pars plana position of the eye. The distal end consists of a tapered fiber, which is inserted into the eye through the Alcon 27GA entry system. The fiber is malleable so the physician can shape it to form a stable service loop, position the tip, and minimize interference with the lid speculum.
Alcon 27+ DS Wide Angle Endoilluminator
The Alcon 27+ DS WA Endoilluminator offers wide-angle illumination, featuring a sapphire lens at the distal end of the probe. This design ensures consistent, low-glare illumination across a broad field of view. Additionally, it incorporates a Dynamic Stiffener (DS) element-a retractable stiffener designed to minimize needle deflection at the proximal end of the stainless steel cannula. as opposed to the fixed stiffener used in previous models.
Alcon 27+ DS Endoilluminator
The Alcon 27+ DS Endoilluminator transmits light energy into the eye and incorporates a DS element at the proximal end of the stainless-steel cannula.
8
ર. INDICATIONS FOR USE
Alcon 27GA Chandelier
The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery.
Alcon 27+ DS Wide Angle Endoilluminator
The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery.
Alcon 27+ DS Endoilluminator
The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE
Tables 1 to 3 below compare the intended use and technological characteristics of each Alcon 27GA Endoilluminator with their respective predicate devices. These tables illustrate how the subject endoilluminators are substantially equivalent with the predicate devices, as the subtle differences in technological attributes do not raise concerns of safety of effectiveness.
| Attributes | 25 GA
Chandelier
(Predicate device, K875005) | 27 GA
Chandelier
(Subject device, K242184) |
|----------------------------------------------------|----------------------------------------------------|--------------------------------------------------|
| Intended Use | Endoscope and accessories | Same |
| Energy sources | Light | Same |
| Patient contact material
(Direct or fluid path) | PMMA, Polyimide, Adhesive
(Cyanoacrylate) | PMMA, ABS, Adhesive
(Cyanoacrylate) |
Table 1: SE Table 25GA Chandelier (K875005) and 27GA Chandelier (K242184)
9
510(k) Summary: K242184 Alcon 27GA Endoilluminators
| Attributes | 25 GA
Chandelier
(Predicate device, K875005) | 27 GA
Chandelier
(Subject device, K242184) |
|----------------------------------------------|----------------------------------------------------|--------------------------------------------------|
| Length (Fiber optic) | 0.26'' | Same |
| (Device only) Tip Outer
Diameter | (Fiber and End of Hub) 25 Ga -
0.014" | (Fiber and End of Hub) 27 Ga -
0.010" |
| Light Transmission (Universal
Flux Ratio) | 0.150 UFR | 0.096 UFR |
| Connector | RFID, ACMI | Same |
| Method of sterilization | Ethylene Oxide | Same |
10
| Attributes | 25 GA
Chandelier
(Predicate device, K875005) | 27 GA
Chandelier
(Subject device, K242184) |
|-------------------------|----------------------------------------------------------------------------|--------------------------------------------------|
| Packaging configuration | Needle cover: Polypropylene
Lid: Tyvek
Soft tray: Thermoforming film | Same |
| Shelf life | 2 years | Same |
Table 2: SE Table 25+ Wide Angle (K875005) and 27+ DS Wide Angle (K242184)
| Attributes | 25+ Wide Angle
(Predicate Device, K875005) | 27+ DS Wide Angle (Subject
device, K242184) |
|----------------------------------------------------|-----------------------------------------------|------------------------------------------------|
| Intended Use | Endoscope and accessories | Same |
| Energy sources | Light | Same |
| Patient contact material (Direct
or fluid path) | Stainless steel, Sapphire | Stainless steel, MP35N, Sapphire |
| Length (Device only) | 3.9" (Shell and Needle) | Same |
| Tip Outer Diameter | 25 Ga - 0.020'' | 27 Ga - 0.016" |
| Light Transmission (Universal
Flux Ratio) | 0.060 UFR | 0.047 UFR |
11
| Attributes | 25+ Wide Angle
(Predicate Device, K875005) | 27+ DS Wide Angle (Subject
device, K242184) |
|-------------------------|----------------------------------------------------------------------------|------------------------------------------------|
| Connector | RFID, ACMI | Same |
| Method of sterilization | Ethylene Oxide | Same |
| Packaging configuration | Needle cover: Polypropylene
Lid: Tyvek
Soft tray: Thermoforming film | Same |
| Shelf life | 3 years | 2 years |
Table 3: SE Table 27+ Endoilluminator (K110951) and 27+ DS Endoilluminator (K242184)
| Attributes | 27+ Endoilluminator
(Predicate Device, K110951) | 27+ DS Endoilluminator
(Subject device, K242184) |
|----------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | Endoscope and accessories | Same |
| Energy sources | Light | Same |
| Patient contact material
(Direct or fluid path) | Stainless steel, PMMA, Teflon,
Adhesive (Cyanoacrylate) | Stainless steel, PMMA |
| Length (Device only) | 3.9"(Shell and Needle) | Same |
12
| Attributes | 27+ Endoilluminator
(Predicate Device, K110951) | 27+ DS Endoilluminator
(Subject device, K242184) |
|----------------------------------------------|----------------------------------------------------|-----------------------------------------------------|
| Tip Outer Diameter | 27 Ga - 0.016" | Same |
| Light Transmission (Universal
Flux Ratio) | 0.075 UFR | Same |
| Connector | RFID, ACMI | Same |
| Method of sterilization | Ethylene Oxide | Same |
| Shelf life | 2 years | Same |
13
SUMMARY OF STUDIES 7.
7.1 Non-Clinical Testing
Biocompatibility
Alcon conducted biocompatibility testing on the patient-contacting devices and met ISO 10993. Biocompatibility of medical devices requirements for chemical characterization, cytotoxicity, sensitization, irritation, and acute systemic toxicity. Packaging materials passed cytotoxicity requirements from ISO 11607-1, Packaging for terminally sterilized medical devices and ASTM F2475. Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials.
Sterilization and Shelf Life
Alcon performed sterilization testing on the subject devices. Tested devices passed the predetermined acceptance criteria in accordance with ISO 11135, Sterilization of health-care products - Ethylene oxide and ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals. The subject devices were sterilized by ethylene oxide (EO). The subject devices have been shown to be sterilizable to a sterility assurance level (SAL) of 10°, and the sterilization process has been validated per the required standard.
The subject devices utilize the same packaging configuration as their predicates, undergoing ethylene oxide (EO) sterilization and pre-conditioning in accordance with ASTM D4169, Standard Practice for Performance Testing of Shipping Containers and Systems. Additionally, accelerated aging was performed in compliance with ASTM F1980, the Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. All tested units successfully met the predetermined acceptance criteria for package integrity, which included visual inspection, seal strength, and bubble leak tests, in accordance with ISO 11607-1, Packaging for Terminally Sterilized Medical Devices.
Performance Testing
Safety tests demonstrated the compliance of the subject devices to the appropriate standards. Biocompatibility evaluations of materials coming into contact with the patient fluid path demonstrated compliance with the appropriate standard from the ISO 10993 series.
Technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. Like the predicate devices have been developed and manufactured in compliance with the following standards:
- ISO 14971, Medical devices Application of risk management to medical devices ●
- ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods, Part ● 1: General requirements applicable to all ophthalmic instruments
- ISO 15752, Ophthalmic Instruments - Endoilluminators - Fundamental Requirements and Test Methods for Optical Radiation Safety
14
- ANSI Z80.36, Ophthalmics Light Hazard Protection for Ophthalmic Instruments ●
Light Hazard Testing:
The three subject devices were evaluated for luminous flux, aphakic irradiance and thermal irradiance for the purposes of comparison with the predicate devices and compliance to ANSI Z80.36, Ophthalmics - Light Hazard Protection for Ophthalmic Instruments and ISO 15752, Ophthalmic Instruments - Endoilluminators - Fundamental Requirements and Test Methods for Optical Radiation Safety.
The subject devices have a similar luminous flux and meet aphakic and thermal safety standards comparable to the predicate devices.
Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the subject devices are equivalent to the predicate devices.
Animal/Clinical Testing 7.2
The risk assessment for the subject devices did not require any animal or clinical testing as mitigation against any identified risks.
CONCLUSION 8.
The subject devices share the same intended use as the predicate devices. Their indications for use are equivalent with each other. The technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. Risk profiles are equivalent between the subject devices and the predicate devices. The predicate devices and the subject devices have been developed and manufactured in compliance with 21 CFR 820 and ISO 14971. Non-clinical testing noted above demonstrated that the functional requirements were met, and that the subject devices are equivalent to the predicate devices.
Therefore, the subject devices, the Alcon 27GA Chandelier, Alcon 27+ DS Wide Angle Endoilluminator, and Alcon 27+ DS Endoilluminator, are deemed substantially equivalent to their predicate devices, the 25GA Chandelier, 25GA Wide Angle Endoilluminator and 27+ Straight Endoilluminator, respectively.