(56 days)
To perform microlamellar keratoplasty for the correction of myopia or hyperopia
Power unit, Turbine motor, Fixed keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses
This device is a surgical keratome, intended to perform microlamellar keratoplasty for the correction of myopia or hyperopia. The provided text is a summary comparing the submitted device with predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on comparing the features and specifications of the submitted device with existing predicate devices to demonstrate substantial equivalence, rather than presenting performance data against defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To be able to answer your questions, I would need a document that includes:
- Specific performance metrics (e.g., cut depth accuracy, cut quality, safety outcomes).
- Numerical acceptance criteria for these metrics.
- Details of a clinical or non-clinical study (e.g., preclinical testing, animal studies, human clinical trials) where the device's performance was evaluated against these criteria.
- Information regarding sample sizes, ground truth establishment, expert qualifications, and adjudication methods for such a study.
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HAR 3 | 1997
SAFETY AND EFFECTIVENESS SUMMARY K970377 p. 1/2
Plancon Instruments, 15 Rue Georges Besse, 92160 Antony, France Te Contact person: Mr. Alain DUPRAT, General Manager Date: December 13, 1996
ilist
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|---|---|---|---|---|
| ------------------------- | -- | -- | -- | ---- |
| Predicated device ①510 K Document numberK 960395 | Predicated device ②510 document number :Not known | Predicated device ③510 K document number :K 935342 | Submitted device | |
|---|---|---|---|---|
| Designation /Feature | PLANCON INSTRUMENTSMicrolamellar Keratome | EYE TECHNOLOGY | SCMD | PLANCON INSTRUMENTSMicrolamellar Keratome(single piece head) |
| Intended use | To perform microlamellarkeratoplasty for the correctionof myopia or hyperopia | To perform micro lamellarkeratoplasty 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 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 | Vacuum pumpBatteryVacuum release valveKnob to regulate gas pressuGas & vacuum pressuregaugesVacuum & turbine quickconnectorsBattery charger unit |
参考
参考
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SAFETY AND EFFECTIVENESS SUMMARY K970377 p. 2/2
| Predicated device ①510 K Document numberK 960395 | Predicated device ②510 document number :Not known | Predicated device ③510 K document number :K 935342 | Submitted device | |
|---|---|---|---|---|
| Designation /Feature | PLANCON INSTRUMENTSMicrolamellar Keratome | EYE TECHNOLOGY | SCMD | PLANCON INSTRUMENTSMicrolamellar Keratome(single piece head) |
| 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 from 10 to24 000 RPMPre-set speed 14 000 RPMMaterial : stainless steel andbrassNo 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 steelAdjustableSafety : 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 | 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 | Material : clear plastic +stainless handleEngraved inner reticlediameter |
§ 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.