← Product Code [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) · K980924 # PLANCON MICROLAMELLAR KERATOME EVOLUTION (K980924) _Plancon Instruments · HNO · Apr 15, 1998 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K980924 ## Device Facts - **Applicant:** Plancon Instruments - **Product Code:** [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO.md) - **Decision Date:** Apr 15, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4370 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use This device is intended for use in refractive surgery, to perform , microlamellar keratoplasty or keratomileusis in-situ for the correction of myopia and hyperopia. ## Device Story The Plançon Microlamellar Keratome-Evolution power unit is a surgical system used by ophthalmologists to perform refractive surgery. It consists of a power unit, gas-powered turbine motor, keratome head, blade, pneumatic fixation rings, and applanation lenses. The device uses a vacuum pump system to fixate the eye and a turbine-driven blade to perform corneal incisions. The Evolution unit introduces safety enhancements over previous models, including dual vacuum pumps for redundancy, a self-checking test function, and digital displays for vacuum and turbine pressure. It provides audible and visual (LED) alerts for insufficient vacuum or incorrect pressure. A dual-level vacuum function allows for softer suction post-surgery. The device is operated by a surgeon in a clinical setting to create corneal flaps for vision correction. By automating and monitoring critical surgical parameters, the device aims to reduce risks associated with manual assembly, suction loss, and cut depth errors, potentially improving surgical outcomes and patient safety. ## Clinical Evidence Bench testing only. No clinical data provided. The submission relies on design verification, safety feature implementation (redundant pumps, self-test functions, digital monitoring), and comparison of technical specifications to predicate devices to demonstrate safety and effectiveness. ## Technological Characteristics Materials: stainless steel, titanium, aluminum, clear plastic. Energy: gas-powered turbine (0-20,000 RPM), 12V battery (12 Ah). Connectivity: standalone. Features: dual vacuum pumps, digital LCD gauges for vacuum/pressure, LED/audible alarms for pressure/vacuum status, self-checking diagnostic function, double-cavity dry chamber. Keratome head: fixed single-piece design. Sterilization: not specified. ## Regulatory 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. ## Predicate Devices - PLANCON INSTRUMENTS ([K960395](/device/K960395.md)) - PLANCON INSTRUMENTS ([K970377](/device/K970377.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ APR 1 5 1998 K980924 ## 510 K SUBMISSION PLANCON INSTRUMENTS 15 RUE GEORGES BESSE - 92160 ANTONY - (FRANCE) Re. : 510 K submission Safety and effectiveness summary Dear Sirs, I certify that I have conducted a reasonable search of information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for the Keratome. I further certify that I am aware of the types of problems to which the Keratome is susceptible and that the following summary of the types and causes of safety and/or effectiveness problems about the Keratome is complete and accurate : | Problems reported for the Lamellar Keratoplasty and causes | | |------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Problem | Causes | | Machine performance | Quality of maintenance and cleaning
procedure | | Wrong assembly | Forgetting pieces or not following the
check-list | | Poor centration of the cut | Poor centration of the suction ring on the
eye | | Poor cut quality | Insufficient I.O.P.,
Poor suction | | Poor suction | Conjunctival chemosis due to retrobulbar
anesthesia | | Debris at the interface or epithelial all
proliferation at the interface | Insufficient sweeping of bed and cap | | Loss of flap during operation | Flap not stored on moist chamber | | Microkeratome incision too deep
(perforation) or too shallow (corneal flap incomplete | Incorrect setting and checking of the
Keratome
Incorrectly assembled Keratome | | Wound infection | Sterility / cleaning more stringent than for
other surgeries | | Excessive I.O.P. or vascular occlusion | Excessive vacuum level | | Irregular / incomplete cut | Poor blade's quality | {1}------------------------------------------------ ## Safety and effectivenesses analysis The microlamellar Keratoplasty has been evolving from nearly 20 years. The problems associated with this surgery and devices are well known. They can be classified as follows : 1) Problems related to instrument assembly and in particular Keratome head assembly : - Blade assembly (problem cancelled with submitted device) i - Blade holder assembly (problem cancelled with submitted device) - Mounting of the head on the turbine - 2) Problems related to instrument setting and checking : - Cut depth (problem cancelled with new device), - Vacuum level. - Blade quality - 3) Problems related to poor maintenance, cleaning and sterilization : - Disassembling (problem cancelled with new device), - Cleaning, - Sterilizina. ﺑ 4) Problems related to the surgical procedure. Same as filed submitted for 510 K document number K 960395 and K 970377. Printed name of person required to submit 510 (k) : Alain DUPRAT Signature of person required to submit 510 (k) : Title of person submitting 510 (k) : General Manager Name of Company : PLANCON INSTRUMENTS Date : March 10th, 1998 Sincerely yours. Azuta {2}------------------------------------------------ | | Predicated device ①
510 K Document number
K 960395 | Predicated device ②
510 K Document number :
K 970377 | Submitted device | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Designation /
Feature | PLANCON INSTRUMENTS | PLANCON INSTRUMENTS | PLANCON INSTRUMENTS | | Intended use | To perform microlamellar
keratoplasty for the correction
of myopia or hyperopia | To perform micro lamellar
keratoplasty for the correction
of myopia or hyperopia | To perform microlamellar
keratoplasty for the correction
of myopia or hyperopia | | System
composition | Power unit
Turbine motor
Adjustable keratome head
Keratome blade
Pneumatic fixation rings
Applanation lenses
Plate checking gauge | Power unit
Turbine motor
Adjustable keratome head
Keratome blade
Pneumatic fixation rings
Applanation lenses
Plate checking gauge | Power unit
Turbine motor
Fixed keratome head
Keratome blade
Pneumatic fixation rings
Applanation lenses | | Power unit | Vacuum pump
Battery
Vacuum release valve
Knob to regulate gas pressure
Gas & vacuum pressure
gauges
Vacuum & turbine quick
connectors
Battery charger unit | Vacuum pump
Battery
Vacuum release valve
Knob to regulate gas pressure
Gas & vacuum pressure
gauges
Vacuum & turbine quick
connectors
Battery charger unit | Vacuum pump
Battery
Vacuum release valve
Knob to regulate gas pressure
Gas & vacuum pressure
gauges
Vacuum & turbine quick
connectors
Battery charger unit | | Power unit
functions | See document attached | | | | | Predicated device ①
510 K Document number
K 960395 | Predicated device ②
510 K Document number :
K 970377 | Submitted device | | Designation /
Feature | PLANCON INSTRUMENTS | PLANCON INSTRUMENTS | PLANCON INSTRUMENTS | | Turbine motor | Gas powered
Adjustable speed 0 to 20 000
RPM (recommended 14 000
RPM)
Material : stainless steel,
titanium and aluminium.
No gear system | Gas powered
Adjustable speed
Material : stainless steel
No gear system | Gas powered
Adjustable speed 0 to 20 000
RPM (recommended 14 000
RPM)
Material : stainless steel,
titanium and aluminium.
No gear system | | Keratome | Material : stainless steel
Adjustable
Safety : maximum cut depth,
and checking gauge | Material : stainless steel
Adjustable
Permanent adjustable head
with adjustment knob
Safety : maximum cut depth
and checking gauge | Material : stainless steel
Fixed single piece head
Safety : only one cut depth
allowed by head principle | | Pneumatic
fixation rings | Material : stainless steel
Double dovetails | Material : stainless steel
Double dovetails | Material : stainless steel
Double dovetails | | Applanation
lenses | Material : clear plastic +
stainless handle
Engraved inner reticle
diameter | Material : clear plastic +
stainless handle
Engraved inner reticle
diameter | Material : clear plastic +
stainless handle
Engraved inner reticle
diameter | {3}------------------------------------------------ #### SAFETY AND EFFECTIVENESS SUMMARY 2/3 1 {4}------------------------------------------------ 3/3 | FUNCTION /
SAFETY FEATURES | PREDICATED DEVICES
K 96 03 95
K 97 03 77 | SUBMITTED DEVICE | |-------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1) Vacuum level gage | Indicator by needle | Liquid cristal display | | 2) Turbine pressure gage | Indicator by needle | Liquid cristal display | | 3) Unsufficient vacuum indicator | None | Red LED and audible tone indicating usufficient vacuum level | | 4) Wrong turbine pressure indicator | None | Red LED and audible tone indicating uncorrect pressure setting | | 5) Battery charge indicator | Indicator by needle gage | Indication by LEDS green and red | | 6) Vacuum connector | LUER lock type | LUER lock plus a safety lock plate to prevent undesired unplugging | | 7) Turbine connector | | No change, identical to approved device | | 8) Tank input pressure indicator | None | Visible indicator in case of unsufficient nitrogen pressure supply | | 9) Main switch | | No change, identical to approved device | | 10)Dual level vacuum function | None | The vacuum level can be decreased from 150 mmHg to 600 mmHg
by means of a switch.
A LED indicator is « ON » when low vacuum is selected.
This function allows the surgeon to hold the eye after the surgery
with a much softer vacuum level. | | 11)Battery | 1 battery of 12 volts
Capacity : 6 Ah | 1 batterie of 12 volts
Capacity : 12 Ah for higher autonomy | | 12) Vacuum pump | 1 vacuum pump | 2 vacuum pumps
The second acts as a back up in case of loss of vacuum detected
by a built in monitoring system | | 13) Battery charge | | No change, identical to approved device | | 14) Pedal
No | | No change, identical to approved device | | 15) Nitrogen supply connector | | No change, identical to approved device | | 16) Test function | None | The unit has a self checking function operated by depressing a
switch. This function will check the efficiency of the 2 pumps, the
nitrogen supply pressure and the adjustement of pressure to the
turbine. The unit can only be operated if the test is passed. If test is
not passed, blinking and audible signals indicate why test is not
passed. | | 17) Dry chamber | Single cavity dry chamber | Double cavity dry chamber for increased prevention of fluid to be
aspirated by the pumps. | {5}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES - USA Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 1 5 1998 Mr. Alain Duprat General Manager PLANCON INSTRUMENTS 15 Rue Georges Besse Antony, France Re: K980924 > Trade Name: Plancon Microlamellar Keratome-Evolution power unit Regulatory Class: I Product Code: 86 HNO Dated: January 8, February 11, and March 10, 1998 Received: January 11, February 14, and March 12, 1998 Dear Mr. Duprat: 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. {6}------------------------------------------------ Page 2 - Mr. Alain Duprat 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. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ K980924 510(k) Number (if known) : #### Device Name : Plançon Microlamellar Keratome - EVOLUTION power unit. ### Indications for use : This device is intended for use in refractive surgery, to perform , microlamellar keratoplasty or keratomileusis in-situ for the correction of myopia and hyperopia. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Deyice Evaluation (ODE) (Division Sign Off) Division of Ophthalmic Devices 510(k) Number K980924 Prescription Use × (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K980924](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K980924) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com