(113 days)
This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract
The Liquefracture device is designed to assist ophthalmic surgeons in the removal of cateractous lenses (cataracts) for the purpose of restoration of impaired sight due to the formation of a cataract. The Liquefracture device combines the prefreatment and emulsification functions. It will be packaged into a handpiece used directly by the surgeon within the sterile field. The handpiece will be driven by a Ophthalmic Surgery system containing irrigation and aspiration functions as currently provided in cataract surgery equipment. In addition, a low power DC power source will be included in the Ophthalmic Surgery system to control the fluid heating function of the handpiece. A user interface will also be provided by the Ophthalmic Surgery system, which is placed external to the sterile environment (field) just as in most cataract surgery equipment.
The provided text describes a 510(k) premarket notification for the Alcon Cataract Liquefracture Device. The submission aims to establish substantial equivalence to predicate devices, not necessarily to meet specific, pre-defined acceptance criteria in a quantitative sense as might be found in a clinical trial for a novel device. Instead, the submission focuses on demonstrating that the new device is "as safe and effective" as existing, legally marketed devices.
Therefore, the requested information elements related to specific acceptance criteria and the study proving the device meets them might not be directly available in the format you expect for a statistically powered clinical trial with clear thresholds for success. The provided 510(k) summary focuses on demonstrating equivalence through comparison of technological characteristics and performance data to predicate devices.
However, I can extract and infer information based on the 510(k) document to answer as many of your points as possible:
1. Table of Acceptance Criteria and Reported Device Performance
As a 510(k) submission, explicit "acceptance criteria" for a novel performance threshold are not present. Instead, the "acceptance criteria" are implicitly demonstrating that the device is substantially equivalent in safety and effectiveness to predicate devices. The "reported device performance" is compared against the performance of these predicate devices in key areas.
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Safety: Anterior chamber temperature rise comparable to U/S phacoemulsification | Reported to be comparable to U/S phacoemulsification. (Specific numerical data not provided in this summary.) |
| Safety: Histological impact of hot BSS pulses in vivo comparable to U/S phacoemulsification | Reported to be comparable to U/S phacoemulsification. (Specific histological findings not provided in this summary.) |
| Effectiveness: Efficiency of cataract aspiration comparable to U/S phacoemulsification | Reported to be comparable to U/S phacoemulsification. (Specific quantitative measures of efficiency not provided in this summary.) |
| Overall Equivalence: Device is as safe and effective as predicate devices. | The testing and calculations provided in the Premarket Notification show the device to be as safe and effective in the removal of cataracts as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not specify the sample size for any test set or in vivo studies.
The data provenance is implied to be from Alcon Laboratories, Inc., likely conducted in the USA (given the submission to the FDA).
It is not explicitly stated whether the studies were retrospective or prospective. Due to the nature of product development and safety/performance testing, it's generally expected that such tests (especially in vivo histology) would be prospectively designed experiments.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The summary does not mention a panel of experts used to establish "ground truth" in the context of diagnostic accuracy, as this device is a surgical tool, not a diagnostic aid. The evaluation of histological impact would involve expert pathologists, but the number and specific qualifications are not detailed in this summary.
4. Adjudication Method
Not applicable as there is no diagnostic ground truth or expert panel adjudication described for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned in the summary. This type of study is typically associated with diagnostic imaging devices where human reader performance is a key metric. This device is a surgical instrument. Effects on human readers/surgeons are not described in terms of AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
The concept of "standalone (algorithm only)" performance is not applicable to this device. The Alcon Cataract Liquefracture Device is a physical surgical handpiece operated by a human surgeon. It does not operate as an algorithm in a standalone capacity.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the objective measurements and histological analyses collected during the performance and safety testing.
- Physiological measurements: Anterior chamber temperature rise.
- Histology: In vivo impact of hot BSS pulses (presumably assessed by expert pathologists).
- Performance metrics: Efficiency of cataract aspiration. These are compared directly to the performance of predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical surgical tool and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The "training set" concept is irrelevant here.
9. How the Ground Truth for the Training Set was Established
Not applicable for the reasons stated in point 8.
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Image /page/0/Picture/2 description: The image shows the logo for Alcon Laboratories. The word "Alcon" is in large, bold, black letters. Below that, the word "LABORATORIES" is in smaller, black letters.
ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY FORT WORTH, TEXAS 76134-2099 (817) 293-0450
January 21, 1998
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
TBD Cataract Liquefracture Device Phacofragmentation System (per 21 CFR 886.4670)
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1. Predicate Device
The legally marketed device(s) to which we are claiming equivalence to are:
Phacoemulsification function associated with Alcon's: 11808, Gemini Ophthalmic Surgery System (being marketed as the Series 20,000 Legacy® (STTL)).
Automated HydroSonics® function: K902798
2. Device Description
The Liquefracture device is designed to assist ophthalmic surgeons in the removal of cateractous lenses (cataracts) for the purpose of restoration of impaired sight due to the formation of a cataract. Currently, their are two common methods used to complete this procedure. The first is to remove the lens in its entirety or in large sections by manually grasping and explanting (extracapsular cataract extraction or ECCE). The second is to use ultrasound to fragment the cataract into small pieces that are simultaneously drawn out of the eye through an aspiration tube (phacoemulsification). Alcon has developed and marketed a cataract pretreatment method (Automated HydroSonics") to Improve the efficiency of ultrasonic phacoemulsification.
The Liquefracture device combines the prefreatment and emulsification functions. It will be packaged into a handpiece used directly by the surgeon within the sterile field. The handpiece will be driven by a Ophthalmic Surgery system containing irrigation and aspiration functions as currently provided in cataract surgery equipment. In addition, a low power DC power source will be included in the Ophthalmic Surgery system to control the fluid heating function of the handpiece. A user interface will also be provided by the Ophthalmic Surgery system, which is placed external to the sterile environment (field) just as in most cataract surgery equipment.
3. Intended Use of the Device
This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract.
4. Summary of the Technological Characteristics of the Device
The Automated HydroSonics® instrument is marketed and used to soften a cataract allowing easier ultrasonic emulsification. The mechanism for this softening is a delamination of the layers of the cataract. By increasing the temperature of the delivered fluid and by improving the efficiency of the fluid delivery, not only is the cataract delaminated, the layers are fragmented into portions that are easily aspirated using similar aspiration parameters currently used in phacoemulsification.
The Liquefracture handpiece containing BSS iniection and I/A capability is inserted into the eye. The heated BSS pulses are directed at the cataract while aspiration is engaged to remove emulsified material. Irrigation is also utilized to maintain space and pressure in the anterior segment of the eye.
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The heated BSS pulses are created by heating and pressurizing a small volume of fluid within the handpiece. Controlled volumetric infusion of heated BSS is then expressed out of the handpiece when activated by the operator (surgeon).
The heated BSS pulses affect the cataract in the same manner as ultrasound. With ultrasound, the vibrating tip creates forward moving pressure waves which impact the cataract causing fragmentation. For the Liquefracture device, the heated BSS exils the handpiece lumen in pressure waves causing the same fragmentation result when they impact the cataract.
5. Summary of the Performance Data
The testing and calculations provided in this Premarket notification show the device to be as safe and effective in the removal of cataracts as the predicate devices. Specifically, the anterior chamber temperature rise, the histological impact of hot BSS pulses in vivo and the efficiency of cataract aspiration are all comparable to U/S phacoemulsification.
8. Conclusions
Therefore, based on the data provided in this Premarket notification, the Alcon Cataract Liquefracture Device has been shown to be substantially equivalent to predicate devices such as those devices described in Item 1 (above).
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1998
Mr. Martin A. Kaufman Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099
Re: K980292 Trade Name: Cataract Liquefracture Device Regulatory Class: II Product Code: 86 MUS Dated: March 20, 1998 Received: March 26, 1998
Dear Mr. Kaufman:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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,
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Martin A. Kaufman
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
A. Roepk. Lorenthel
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4980292 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Cataract Liquefracture Device.
Indications For Use:
This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED). Concurrence of CDRH, Office of Device Evaluation (ODE)
Sta C. Clewory
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number. K980292
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
§ 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.