(88 days)
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Not Found
No
The summary describes a mechanical surgical device with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to perform microlamellar kerato-o asty for the correction of myopia or hyperopia, indicating a therapeutic intervention.
No
The device is described as performing "microlamellar keratoo asty for the correction of myopia or hyperopia," indicating it is a surgical or therapeutic device, not one used for diagnosis.
No
The device description lists multiple hardware components (Power unit, Turbine motor, Adjustable keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses, Plate checking gauge), indicating it is a physical medical device, not software-only.
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 keratoo asty for the correction of myopia or hyperopia." This describes a surgical procedure performed directly on a patient's eye to correct vision.
- Device Description: The device components listed (Power unit, Turbine motor, Adjustable keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses, Plate check ng gauge) are all instruments used in a surgical setting for cutting and manipulating tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health or condition. The provided description does not mention any interaction with biological specimens or diagnostic testing.
Therefore, this device is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
To perform microlamellar keratoo asty for the correction of myopia or hyperopia
Product codes
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Device Description
PLANCON INSTRUMENTS for microlamellar keratoplasty consists of a Power unit, Turbine motor, Adjustable keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses, and Plate checking gauge. 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, has an adjustable speed from 0 to 20,000 RPM (recommended 14,000 RPM), is made of stainless steel, titanium, and aluminium, and has no gear system. The Keratome is made of stainless steel, is adjustable, and includes safety features like maximum cut depth and checking gauge. 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 have an engraved inner reticle diameter.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K960395
PR 26 1996
SAFETY AND EFFECTIVENESS SUMMARY
| Designation / | Submitted device | Predicated device ① | Predicated device ② |
|---|---|---|---|
| Feature | PLANCON INSTRUMENTS | ||
| Intended use | To perform microlamellar | ||
| keratoo asty for the correction of | |||
| myopia or hyperopia | To perform micro lamellar | ||
| keratop asty for the correction of | |||
| myopia or hyperopia | To perform micro lamellar keratoplasty for | ||
| the correctior of myopia or hyperopia | |||
| System composition | Power urit | ||
| Turbine motor | |||
| Adjustable keratome head | |||
| Keratome blade | |||
| Pneumatic fixation rings | |||
| Applanation lenses | |||
| Plate check ng gauge | Power urit | ||
| Turbine motor | |||
| Adjustable keratome head | |||
| Keratome blade | |||
| Pneumat c fixation rings | |||
| Applanat on lenses | |||
| Plate checking gauge | Power unit | ||
| Turbine motor | |||
| Adjustable keratome head | |||
| Keratome blade | |||
| Pneumatic fixation rings | |||
| Applanation lenses | |||
| Plate checking gauge | |||
| Power unit | Vacuum pump | ||
| Battery | |||
| Vacuum release valve | |||
| Knob to regulate gas pressure | |||
| Gas & vacuum pressure gauges | |||
| Vacuum & turbine quick connectors | |||
| Battery charger un.t | Vacuum pump | ||
| Battery | |||
| Vacuum release valve | |||
| Knob to regulate gas pressure | |||
| Gas & vacuum pressure gauges | |||
| Vacuum & turbine quick connectors | |||
| Battery charger un t | Vacuum pump | ||
| Battery | |||
| Vacuum release valve | |||
| Knob to regulate gas pressure | |||
| Gas & vacuum pressure gauges | |||
| Vacuum & turbine quick connectors | |||
| Battery charger unit |
1
K960395
SAFETY AND EFFECTIVENESS SUMMARY
| PLANCON INSTRUMENTS | PREDICATED DEVICE 1 | PREDICATED DEVICE 2 | |
|---|---|---|---|
| Turbine motor | Gas powered | ||
| Adjustable speed 0 to 20 000 RPM | |||
| (recommended 14 000 RPM) | |||
| Material : stainless steel, t tanium, | |||
| 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 | |||
| 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 |
| Pneumatic fixation
rings | Material : stainless steel
Double dovetails | Material : stainless steel
Double dovetails | Material : stainless steel
Double covetails |
| 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 |