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 Description

The submitted device system composition includes: Power unit, Turbine motor, Fixed keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses. The power unit includes: Vacuum pump, Battery, Vacuum release valve, Knob to regulate gas pressure, Gas & vacuum pressure gauges, Vacuum & turbine quick connectors, Battery charger unit. The turbine motor is gas powered with adjustable speed 0 to 20 000 RPM (recommended 14 000 RPM), made of stainless steel, titanium and aluminium, with no gear system. The keratome is made of stainless steel with a fixed single piece head and safety allowing only one cut depth. Pneumatic fixation rings are made of stainless steel with double dovetails. Applanation lenses are made of clear plastic + stainless handle with engraved inner reticle diameter.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the Plancon Microlamellar Keratome - EVOLUTION power unit. This submission is focused on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, much of the requested information regarding a formal study with acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

However, based on the "Safety and effectiveness analysis" (Excerpt 1) and the comparison table of features (Excerpt 2 & 4), we can infer the manufacturer's approach to demonstrating safety and effectiveness.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in the typical sense (e.g., accuracy, sensitivity, specificity values). Instead, the acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. The "performance" is therefore described in terms of design improvements and safety features that either address known problems or enhance the existing functionality of predicate devices.

Problem Reported (or Feature Improved)	Causes (or Previous State)	Submitted Device Solution/Performance (Improvement stated)
Machine performance, Poor cut quality, Poor suction	Quality of maintenance and cleaning procedure, Insufficient I.O.P., Poor suction	- Vacuum level gage: Liquid crystal display (vs. needle indicator) - Turbine pressure gage: Liquid crystal display (vs. needle indicator) - Insufficient vacuum indicator: Red LED and audible tone (new feature) - Wrong turbine pressure indicator: Red LED and audible tone (new feature) - Dual level vacuum function: Vacuum can be decreased from 600 mmHg to 150 mmHg with a switch and LED indicator, allowing a softer hold after surgery (new feature) - Two vacuum pumps: Second pump acts as backup for vacuum loss (new feature) - Dry chamber: Double cavity dry chamber for increased prevention of fluid aspiration (vs. single cavity) - Test function: Self-checking function for pumps, nitrogen, and turbine pressure (new feature)
Wrong assembly, Microkeratome incision too deep/shallow	Forgetting pieces or not following check-list, Incorrect setting/checking, Incorrectly assembled Keratome	- Keratome head assembly: Stated as "problem cancelled with submitted device" for blade and blade holder assembly (vs. predicate devices) - Fixed Keratome head: Single piece head, only one cut depth allowed by head principle (vs. adjustable heads in predicate devices, potentially simplifying setup)
Sterility / cleaning more stringent	Poor maintenance, cleaning, and sterilization	- Cleaning & Sterilization: Stated as "problem cancelled with new device" for disassembling, cleaning, sterilizing (implies improved design for easier/more effective processes, though details aren't provided beyond the statement).
Battery autonomy	1 battery of 12 Volts, Capacity: 6 Ah (predicate device)	- Battery: 1 battery of 12 Volts, Capacity: 12 Ah for higher autonomy (improvement)
Undesired unplugging of vacuum connector	LUER lock type (predicate device)	- Vacuum connector: LUER lock plus a safety lock plate to prevent undesired unplugging (new safety feature)
Insufficient nitrogen pressure supply	None (predicate device)	- Tank input pressure indicator: Visible indicator in case of insufficient nitrogen pressure supply (new feature)

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study with a "test set" in the sense of patient data. The basis for equivalence relies on comparing the new device's design and features to existing legally marketed devices (K960395 and K970377).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No clinical test set or ground truth establishment by experts is described for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study is mentioned. The submission is focused on device design comparison for substantial equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Not applicable. This is a medical instrument (Keratome power unit), not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" implicitly refers to the known problems and safety/effectiveness performance of existing predicate devices and the general understanding of microlamellar keratoplasty. The manufacturer asserts that the new features address these known problems effectively.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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 cleaningprocedure
Wrong assembly	Forgetting pieces or not following thecheck-list
Poor centration of the cut	Poor centration of the suction ring on theeye
Poor cut quality	Insufficient I.O.P.,Poor suction
Poor suction	Conjunctival chemosis due to retrobulbaranesthesia
Debris at the interface or epithelial allproliferation 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 theKeratomeIncorrectly assembled Keratome
Wound infection	Sterility / cleaning more stringent than forother surgeries
Excessive I.O.P. or vascular occlusion	Excessive vacuum level
Irregular / incomplete cut	Poor blade's quality

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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 :

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
1. Problems related to instrument setting and checking :
- Cut depth (problem cancelled with new device),
- Vacuum level.
- Blade quality
1. Problems related to poor maintenance, cleaning and sterilization :
- Disassembling (problem cancelled with new device),
- Cleaning,
- Sterilizina. ﺑ

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

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	Predicated device ①510 K Document numberK 960395	Predicated device ②510 K Document number :K 970377	Submitted device
Designation /Feature	PLANCON INSTRUMENTS	PLANCON INSTRUMENTS	PLANCON INSTRUMENTS
Intended use	To perform microlamellarkeratoplasty for the correctionof myopia or hyperopia	To perform micro lamellarkeratoplasty for the correctionof myopia or hyperopia	To perform microlamellarkeratoplasty for the correctionof myopia or hyperopia
Systemcomposition	Power unitTurbine motorAdjustable keratome headKeratome bladePneumatic fixation ringsApplanation lensesPlate checking gauge	Power unitTurbine motorAdjustable keratome headKeratome bladePneumatic fixation ringsApplanation lensesPlate checking gauge	Power unitTurbine motorFixed keratome headKeratome bladePneumatic fixation ringsApplanation lenses
Power unit	Vacuum pumpBatteryVacuum release valveKnob to regulate gas pressureGas & vacuum pressuregaugesVacuum & turbine quickconnectorsBattery charger unit	Vacuum pumpBatteryVacuum release valveKnob to regulate gas pressureGas & vacuum pressuregaugesVacuum & turbine quickconnectorsBattery charger unit	Vacuum pumpBatteryVacuum release valveKnob to regulate gas pressureGas & vacuum pressuregaugesVacuum & turbine quickconnectorsBattery charger unit
Power unitfunctions	See document attached
	Predicated device ①510 K Document numberK 960395	Predicated device ②510 K Document number :K 970377	Submitted device
Designation /Feature	PLANCON INSTRUMENTS	PLANCON INSTRUMENTS	PLANCON INSTRUMENTS
Turbine motor	Gas poweredAdjustable speed 0 to 20 000RPM (recommended 14 000RPM)Material : stainless steel,titanium and aluminium.No gear system	Gas poweredAdjustable speedMaterial : stainless steelNo gear system	Gas poweredAdjustable speed 0 to 20 000RPM (recommended 14 000RPM)Material : stainless steel,titanium and aluminium.No gear system
Keratome	Material : stainless steelAdjustableSafety : maximum cut depth,and checking gauge	Material : stainless steelAdjustablePermanent adjustable headwith adjustment knobSafety : maximum cut depthand checking gauge	Material : stainless steelFixed single piece headSafety : only one cut depthallowed by head principle
Pneumaticfixation rings	Material : stainless steelDouble dovetails	Material : stainless steelDouble dovetails	Material : stainless steelDouble dovetails
Applanationlenses	Material : clear plastic +stainless handleEngraved inner reticlediameter	Material : clear plastic +stainless handleEngraved inner reticlediameter	Material : clear plastic +stainless handleEngraved inner reticlediameter

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SAFETY AND EFFECTIVENESS SUMMARY 2/3

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3/3

FUNCTION /SAFETY FEATURES	PREDICATED DEVICESK 96 03 95K 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 mmHgby 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 surgerywith a much softer vacuum level.
11)Battery	1 battery of 12 voltsCapacity : 6 Ah	1 batterie of 12 voltsCapacity : 12 Ah for higher autonomy
12) Vacuum pump	1 vacuum pump	2 vacuum pumpsThe second acts as a back up in case of loss of vacuum detectedby a built in monitoring system
13) Battery charge		No change, identical to approved device
14) PedalNo		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 aswitch. This function will check the efficiency of the 2 pumps, thenitrogen supply pressure and the adjustement of pressure to theturbine. The unit can only be operated if the test is passed. If test isnot passed, blinking and audible signals indicate why test is notpassed.
17) Dry chamber	Single cavity dry chamber	Double cavity dry chamber for increased prevention of fluid to beaspirated by the pumps.

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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.

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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

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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)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.