(56 days)
K 960395, K 935342
Not Found
No
The summary describes a mechanical surgical device with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
Explanation: The device is intended to perform a medical procedure (microlamellar keratoplasty) to correct a health condition (myopia or hyperopia), which falls under the definition of a therapeutic device.
No
The intended use of the device is to perform microlamellar keratoplasty for the correction of myopia or hyperopia, which is a surgical procedure for treatment, not diagnosis. This device description lists components typical of a surgical instrument rather than a diagnostic one.
No
The device description explicitly lists multiple hardware components (Power unit, Turbine motor, Fixed keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses).
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 microlamellar keratoplasty for the correction of myopia or hyperopia." This describes a surgical procedure performed directly on a patient's eye, not a test performed on a sample taken from the body.
- Device Description: The components listed (power unit, motor, keratome head, blade, fixation rings, applanation lenses) are all instruments used in a surgical setting to physically modify tissue. They are not designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
In summary, this device is a surgical instrument used for a specific ophthalmic procedure, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
To perform microlamellar keratoplasty for the correction of myopia or hyperopia
Product codes
Not Found
Device Description
The PLANCON INSTRUMENTS Microlamellar Keratome (single piece head) consists of a Power unit, Turbine motor, Fixed keratome head, Keratome blade, Pneumatic fixation rings, and Applanation lenses. The Power unit includes a Vacuum pump, Battery, Vacuum release valve, Knob to regulate gas pressure, Gas & vacuum pressure gauges, Vacuum & turbine quick connectors, and a Battery charger unit. The Turbine motor is gas powered with an adjustable speed from 0 to 20,000 RPM (recommended 14,000 RPM), made of stainless steel, titanium, and aluminum, and has no gear system. The Keratome is made of stainless steel and features a fixed single-piece head, with safety measures allowing only one cut depth by head principle. The Pneumatic fixation rings are made of stainless steel and have double dovetails. The Applanation lenses are made of clear plastic with a stainless handle and an engraved inner reticle diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
K 960395, K 935342
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
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
| (33-1) 46 74 46
| el.: | 74 | |||
|---|---|---|---|---|
| ------------------------- | -- | -- | -- | ---- |
| | Predicated device ①
510 K Document number
K 960395 | Predicated device ②
510 document number :
Not known | Predicated device ③
510 K document number :
K 935342 | Submitted device |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Designation /
Feature | PLANCON INSTRUMENTS
Microlamellar Keratome | EYE TECHNOLOGY | SCMD | PLANCON INSTRUMENTS
Microlamellar Keratome
(single piece head) |
| 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 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
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 | Vacuum pump
Battery
Vacuum release valve
Knob to regulate gas pressu
Gas & vacuum pressure
gauges
Vacuum & turbine quick
connectors
Battery charger unit |
参考
参考
1
(
ी
!
11
SAFETY AND EFFECTIVENESS SUMMARY K970377 p. 2/2
| | Predicated device ①
510 K Document number
K 960395 | Predicated device ②
510 document number :
Not known | Predicated device ③
510 K document number :
K 935342 | Submitted device |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Designation /
Feature | PLANCON INSTRUMENTS
Microlamellar Keratome | EYE TECHNOLOGY | SCMD | PLANCON INSTRUMENTS
Microlamellar Keratome
(single piece head) |
| 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 from 10 to
24 000 RPM
Pre-set speed 14 000 RPM
Material : stainless steel and
brass
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
Adjustable
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 | 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 | Material : clear plastic +
stainless handle
Engraved inner reticle
diameter |