(90 days)
No
The description focuses on the mechanical and ultrasonic aspects of the device, with no mention of AI or ML technologies.
Yes
The device is described as "automated phacoemulsification" which uses ultrasonic energy to emulsify and remove cataractous lens material from the eye, directly treating a medical condition.
No
Explanation: The device is described as an automated phacoemulsification system used to emulsify and remove cataractous lens material from the eye using ultrasonic energy. This is a therapeutic procedure, not a diagnostic one.
No
The device description clearly outlines hardware components like a handpiece, ultrasonic tip, irrigation sleeve, and the generation and delivery of electronic and ultrasonic energy. This is a hardware-based medical device with potential software control, but not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "the automated phacoemulsification of a cataractous natural crystalline lens." This describes a surgical procedure performed directly on the patient's eye to remove a cataract.
- Device Description: The device description details a system that uses ultrasonic energy to break down and remove lens material from the eye. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis. The device's function is purely mechanical/energy-based for surgical removal.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of this device is the automated phacoemulsification of a cataractous natural crystalline lens.
Product codes
Not Found
Device Description
The Series 20000 Legacy System and its predicate devices use ultrasonic energy to emulsify cataractous lens material and remove it from the eye (phacoemulsification). Electronic energy is generated in the machine, delivered to a handpiece and converted to ultrasonic energy delivered through a hollow titanium needle, or tip. Irrigation fluid is delivered to the eye via the combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the handpiece/tip assembly.
In this new system, an inner protective sleeve has been attached around the barrel of the ultrasonic tip in order to reduce the amount of undesirable heat transferred to the wound site. These ultrasonic tips will be available in three (3) styles each consisting of combinations of two (2) tip diameters and three (3) tip edge bevel angles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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
Performance of Alcon's Mackool system TSC's was compared to the predicate devices in three areas; thermal performance, fluidics performance and cutting performance.
Thermal performance was evaluated in bench tests and in post mortem eye tests by using thermocouples to measure the temperature at the wound site in simulated use tests. Alcon Mackool™ tips showed significantly lower temperature than Alcon standard 0.9 mm, and somewhat lower temperature than Storz MicroSeal tips
Fluidics performance was evaluated by measuring the infusion flow capability of the new device compared to the predicate devices. All TSC were found to have similar flow capability. The clinical relevance of this is that intraocular pressure during phaccemulsification procedures will be similar for all the devices, assuming the same steady aspiration flow rate.
Cutting performance was evaluated in bench tests by measuring tip stroke length and in the clinic by surgeon evaluation. Both tests showed Mackool tips have an acceptable cutting performance which is equal to (Alcon tips) or superior to (Storz tips) the cutting performance of the predicate devices.
The performance testing has shown that Alcon's Mackool system has similar or better thermal, fluidic, and cutting performance than the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K926512, K831836, K911808, K861380
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Alcon Laboratories. Above the logo is the number K955789. The word "Alcon" is in a large, bold font, and the word "Laboratories" is in a smaller, bold font below it.
MAN 2 1 - 1 -
LCON LABORATORIES, INC. 1 SOUTH FREEWAY WORTH, TEXAS 76134-2099 (817) 293-0450
December 15, 1995
510(K) SUMMARY
Submitted by:
Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 (817) 551-8388 (Phone) (817) 551-4630 (Fax)
Trade Name: Common Name Classification Name
f
Alcon Series 20000® LEGACY® Mackool™ System Phacoemulsification Tip and Sleeve Phacofragmentation System (per 21 CFR 886.4670)
1
1. Predicate Device
The currently marketed device(s) to which we are claiming equivalence are:
- K926512, Storz Modified Phaco Needle with Insulation Sleeve, a. (Storz Instrument Company)
- K831836, Epsilon Ultrasonic Tips & Accessories, (CooperVision/Alcon Laboratories) b.
- Phacoemulsification tips associated with Alcon's: C. K911808, Gemini Ophthalmic Surgery System (Series 20,000% Legacy") K861380, Series Ten Thousand Master
2. Device Description
The Series 20000 Legacy System and its predicate devices use ultrasonic energy to emulsify cataractous lens material and remove it from the eye (phacoemulsification). Electronic energy is generated in the machine, delivered to a handpiece and converted to ultrasonic energy delivered through a hollow titanium needle, or tip. Irrigation fluid is delivered to the eye via the combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the handpiece/tip assembly.
In this new system, an inner protective sleeve has been attached around the barrel of the ultrasonic tip in order to reduce the amount of undesirable heat transferred to the wound site. These ultrasonic tips will be available in three (3) styles each consisting of combinations of two (2) tip diameters and three (3) tip edge bevel angles.
3. Intended Use of the Device
The intended use of this device is the automated phacoemulsification of a cataractous natural crystalline lens.
4. Summary of the Technological Characteristics of the Device
The Alcon Mackool System Tip Sleeve Combination ( TSC) utilizes the same technology (and patents) as the Storz MicroSeal Ultrasonic Tip Sleeve Combination in that a portion the ultrasonic tip is covered by a thin plastic inner sleeve under the standard infusion sleeve. The inner sleeve reduces the unwanted heat generated, isolates the tip from the incision site, and reduces the chance of corneal burn during surgery. This improvement will also allow surgeons to use smaller surgical incisions, reduce wound leakage, promote a more stable eye chamber, and result in less corneal endothelium hydration
5. Summary of the Performance Data
Performance of Alcon's Mackool system TSC's was compared to the predicate devices in three areas; thermal performance, fluidics performance and cutting performance.
Thermal performance was evaluated in bench tests and in post mortem eye tests by using thermocouples to measure the temperature at the wound site in simulated use tests. Alcon Mackool™ tips showed significantly lower temperature than Alcon standard 0.9 mm, and somewhat lower temperature than Storz MicroSeal tips
Fluidics performance was evaluated by measuring the infusion flow capability of the new device compared to the predicate devices. All TSC were found to have similar flow capability. The clinical relevance of this is that intraocular pressure during phaccemulsification procedures will be similar for all the devices, assuming the same steady aspiration flow rate.
Cutting performance was evaluated in bench tests by measuring tip stroke length and in the clinic by surgeon evaluation. Both tests showed Mackool tips have an acceptable cutting performance which is equal to (Alcon tips) or superior to (Storz tips) the cutting performance of the predicate devices.
2
The performance testing has shown that Alcon's Mackool system has similar or better thermal, fluidic, and cutting performance than the predicate devices.
6. Conclusions
វ
Therefore, based on the data provided in this Premarket notification, the Alcon Mackool System has been proven to be substantially equivalent to predicate devices such as the Storz Modified Phaco Needle with Insulation Sleeve and other devices detailed in Item 1 (above).