(79 days)
Not Found
No
The device description details a mechanical system with a DC motor and foot switch control, without mentioning any computational or learning components.
Yes.
Explanation: The device is intended to perform corneal resections, which is a therapeutic intervention for eye conditions.
No
This device is designed to perform surgical resections ("anterior, lamellar, circular corneal resections") rather than provide diagnostic information. Its function is to cut tissue, not to analyze or evaluate the patient's condition.
No
The device description clearly outlines physical components including a disposable keratome, power/suction supply, DC motor, foot actuated switch, cutting blade, and gears. It is a hardware device with some electrical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "perform anterior, lamellar, circular corneal resections of a predetermined diameter and thickness." This describes a surgical procedure performed directly on the patient's body (the cornea).
- Device Description: The device is a surgical instrument (a keratome) used for cutting tissue. It involves mechanical components, a motor, and suction, all designed for a physical intervention.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on the analysis of such specimens.
Therefore, the ADK is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Automated Disposable Keratome is an AC-powered device that is intended to shave a partial lamellar section of the cornea.
ADK (Automated Disposable Keratome) is intended to perform anterior, lamellar, circular corneal resections of a predetermined diameter and thickness.
Product codes (comma separated list FDA assigned to the subject device)
86 HNO
Device Description
The Automated Disposable Keratome consists of two components: (a) disposable keratome, (b) power / suction supply and DC motor with foot actuated switch.
The ADK is a keratome designed to perform anterior lamellar circular corneal resections of a predetermined diameter and thickness based upon the principle of a carpenter's plane. A cutting blade emerges from the center of the keratome plane. The stainless steel blade oscillates by a small DC motor controlled by foot switch. The keratome, which is fabricated from high density engineering plastic (except the blade and motor), has a one piece head that is pre-assembled with a fixed foot plate, and is available in two standard head sizes, 130 or 160 microns, depending upon the thickness of corneal section desired.
The keratome head has dovetail guides, which correspond to guides on the suction ring that is placed upon the ocular globe. Tandem gears on both sides of the keratome head and corresponding gears on the suction ring automatically move the cutting blade along the dovetail guides. Whereas gears on competitive keratomes are exposed, the gears on the ADK are covered to minimize entrapment of lashes and lids. A DC motor controls the gears and blade movement via the foot switch control. The cutting principle is the same as with manual keratomes and other automated keratomes. The automatic movement of the keratome allows for a more uniform translation across the suction ring and thusly across the cornea.
The power supply provides the power to both the keratome motor and the suction supply for holding the suction ring in place on the cornea. The ADK has three settings for vacuum control: "off", "low", "high"; whereas predicate devices have only two vacuum settings, "on" and "off". The vacuum suction of predicate devices in the "on" position is the same as the suction of the "high" setting of the ADK. The "low" suction setting of the ADK provides the option of using the suction ring to aid in globe fixation after the resection. Predicate devices require the surgeon to use the "off" position for globe fixation after resection, where residual suction declines variably back to 0 mmHg. The keratome is provided sterile in a sealed blister/Tyvek® tray and is discarded after single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
corneal
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 techniques and instrumentation for lamellar keratoplasty were introduced 45 years ago. Keratomes have been in use for nearly 30 years, beginning with the introduction into commercial distribution of the Steinway/Barraquer In Situ Microkeratome Set in 1965. A review of the published literature on keratomes indicates that these devices are associated with acceptable clinical results in terms of postoperative refraction and visual acuity, and minimal postoperative complications.
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
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.
0
1774004
JAN - 8 1998
Summary of Safety and Effectiveness for 510(k) K974004
- Submitter of Information 1.
LaserSight Technologies, Inc. 12249 Science Drive, Suite 160 Orlando, Florida 32826 Contact Person:
Charles W. Stewart, O.D. Executive Vice President Business Development Tel (407) 382-2700 Fax (407) 382-2701 e-mail: cstewart@lasetech.com
-
- Name of Device:
| Trade / Proprietary Name: | Automated Disposable Keratome (ADK) |
|---|---|
| Classification / Usual Name: | Keratome |
| Device Classification: | Class I, 86 HNO |
| (21 CFR, Section 886.4370) |
3. Predicate Devices:
The Automated Disposable Keratome for which marketing clearance is requested is substantially equivalent to the following predicate devices:
- Automatic Corneal Shaper, manufactured and distributed by Chiron Vision Corporation, . 9342 Jeronimo Road, Irvine, CA [cleared under K941550].
- Steinway-Barraquer In-Situ Microkeratome Set, manufactured and distributed by . Steinway Instrument Company, Inc., San Diego, CA. This device is identical to the Allergan Medical Optics Barraquer-Krumeich Refractive Set [cleared under K860001].
- Micro Refractive System Model 1000, manufactured and distributed by Micro Precision ● Instrument Company, 2323 N. Central Avenue, Suite 2105, Phoenix, AZ [cleared under K903912].
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Descriptions of Subject Device: 4.
Device Description: The Automated Disposable Keratome consists of two components: (a) disposable keratome, (b) power / suction supply and DC motor with foot actuated switch.
The ADK is a keratome designed to perform anterior lamellar circular corneal resections of a predetermined diameter and thickness based upon the principle of a carpenter's plane. A cutting blade emerges from the center of the keratome plane. The stainless steel blade oscillates by a small DC motor controlled by foot switch. The keratome, which is fabricated from high density engineering plastic (except the blade and motor), has a one piece head that is pre-assembled with a fixed foot plate, and is available in two standard head sizes, 130 or 160 microns, depending upon the thickness of corneal section desired.
The keratome head has dovetail guides, which correspond to guides on the suction ring that is placed upon the ocular globe. Tandem gears on both sides of the keratome head and corresponding gears on the suction ring automatically move the cutting blade along the dovetail guides. Whereas gears on competitive keratomes are exposed, the gears on the ADK are covered to minimize entrapment of lashes and lids. A DC motor controls the gears and blade movement via the foot switch control. The cutting principle is the same as with manual keratomes and other automated keratomes. The automatic movement of the keratome allows for a more uniform translation across the suction ring and thusly across the cornea.
The power supply provides the power to both the keratome motor and the suction supply for holding the suction ring in place on the cornea. The ADK has three settings for vacuum control: "off", "low", "high"; whereas predicate devices have only two vacuum settings, "on" and "off". The vacuum suction of predicate devices in the "on" position is the same as the suction of the "high" setting of the ADK. The "low" suction setting of the ADK provides the option of using the suction ring to aid in globe fixation after the resection. Predicate devices require the surgeon to use the "off" position for globe fixation after resection, where residual suction declines variably back to 0 mmHg. The keratome is provided sterile in a sealed blister/Tyvek® tray and is discarded after single use.
న్. Intended Use of the Subject Device:
The Automated Disposable Keratome is an AC-powered device that is intended to shave a partial lamellar section of the cornea.
ல் Comparison of Technological Characteristics with Predicate Devices:
The Automated Disposable Keratome (ADK) operates on the same principles and has the same technological characteristics as other legally marketed keratomes. However, the ADK is most similar to the Chiron Automated Corneal Shaper (ACS). The ADK shares the same primary drive mechanism as the Chiron ACS. Historically this DC-powered gear drive design, which automatically draws the blade across dovetail guides, has proven itself safe and effective in producing precise sections of corneal tissue. The ADK has an additional
2
gear and track which creates a dual parallel drive action across the cornea. Torque induced by single sided drives, such as the Chiron ACS, may allow inadvertent jamming of the drive mechanism. Refer to TABLE 1 for a comparison of features for substantially equivalent devices.
- The primary drawbacks of the presently marketed keratomes are: (1) human error during 3. cleaning, re-assembly and final intra-operative assembly of the keratome, (2) wearing out of keratome parts as a function of re-use, and (3) the potential for residual tissue to jam or disrupt the gears during the resection procedure. The ADK eliminates these drawbacks by providing the keratome pre-assembled and pre-sterilized in a copolyester tray sealed with a Tyvek® lid, where the keratome is disposed of after single use. The sterilization of the ADK is performed under a validated gamma irradiation cycle, with a sterility assurance level (SAL) of 104, and dosimetric release. Certain parts of the keratome, except the stainless steel blade, have been replaced with high density plastic materials which have been tested according to FDA Tripartite Guidelines and the ISO 10993-1 Standard and are deemed The ADK power supply conforms to the IEC-601-1 electrical safety biocompatibile. standard.
Together with the proven reliability of the DC-powered gear drive mechanism and the elimination of the problems associated with cleaning, tedious assembly and component wear, the ADK offers an improvement over currently available keratomes. These differences between the ADK and currently marketed devices do not affect the safety and effectiveness of the device since they do not alter the energy source, cutting parts or principle of operation.
7. Discussion of Clinical Tests:
The techniques and instrumentation for lamellar keratoplasty were introduced 45 years ago. Keratomes have been in use for nearly 30 years, beginning with the introduction into commercial distribution of the Steinway/Barraquer In Situ Microkeratome Set in 1965. A review of the published literature on keratomes indicates that these devices are associated with acceptable clinical results in terms of postoperative refraction and visual acuity, and minimal postoperative complications.
3
| Company | |||||
|---|---|---|---|---|---|
| Parameter | LaserSight | Chiron Vision | Allergan Medical | Micro Precision | |
| Major | |||||
| Components | Console | Console | Console | Console | Console |
| 1 Fixed Height | |||||
| Suction Ring | 1 Adjustable | ||||
| Height Suction | |||||
| Ring | 25 Suction Rings | 25 Suction Rings | |||
| Fixed Depth | |||||
| Keratome Head | |||||
| (130μ or 160 μ) | Adjustable | ||||
| Keratome Head | Keratome Head | ||||
| with Thickness | |||||
| Plates | Adjustable | ||||
| Keratome Head | |||||
| Electric Motor | |||||
| 12 v DC | Electric Motor | ||||
| 12 v DC | Electric Motor | ||||
| 12 v DC | Turbine Motor | ||||
| Blade Oscillation | |||||
| 10,000 RPM | Blade Oscillation | ||||
| 7,500 RPM | Blade Oscillation | ||||
| Not known | Blade Oscillation | ||||
| 0-20,000 RPM | |||||
| Console Details | Electrical | 110/120 AC | 110/120 AC | 110/120 AC | None |
| Motor RPM | 10,000 RPM | 10,000 RPM | 10,000 RPM | 0-20,000 RPM | |
| Vacuum Pump | AC Powered | AC Powered | AC Powered | Nitrogen Gas | |
| Venturi Type | |||||
| Pump | |||||
| Blade Height | |||||
| Verification | At Factory with | ||||
| Micron Optical | |||||
| Comparator | Clinic Measured | ||||
| with Micron- | |||||
| Scope | None | Clinic measured | |||
| with Digital | |||||
| Indicator | |||||
| Foot Controls | DC Powered | DC Powered | DC Powered | Pneumatic |
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Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's emblem, which is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 1998
Charles W. Stewart, O.D. LaserSight Technologies, Inc. 12249 Science Drive, Suite 160 Orlando, Florida 32826
Re: K974004 Trade Name: Automated Disposable Keratome (ADK) Regulatory Class: I Product Code: 86 HNO Dated: December 19, 1997 Received: December 22, 1997
Dear Dr. Stewart:
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 QS 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 - Charles W. Stewart, O.D.
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 Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number: K974004
Device Name: Automated Disposable Keratorne (ADK)
Indications for Use: ADK (Automated Disposable Keratome) is intended to perform anterior, lamellar, circular corneal resections of a predetermined diameter and thickness.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Ada C. Callaway
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Image /page/6/Picture/7 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CRR 801.109)" in a smaller font. There is a check mark above the text, indicating that the prescription use is being acknowledged. The text is likely part of a form or document related to medical prescriptions.
Over-The-Counter Use
(Optional Format 1-2-96)