(35 days)
K 960395, K 970377
Not Found
No
The device description focuses on mechanical components and pneumatic systems, with no mention of AI, ML, image processing, or data-driven algorithms. The lack of information regarding training/test sets and performance metrics further supports the absence of AI/ML.
No
The device is used for refractive surgery to correct vision issues like myopia and hyperopia, which is a therapeutic intervention, but it is a surgical tool, not a therapeutic device directly applying energy or substances to treat a condition.
No
This device is described as being used for refractive surgery to perform procedures like microlamellar keratoplasty or keratomileusis, which are surgical corrections, not diagnostic assessments.
No
The device description explicitly lists multiple hardware components, including a power unit, turbine motor, keratome head, blade, fixation rings, and applanation lenses. This indicates it is a hardware-based 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 for refractive surgery to correct vision problems (myopia and hyperopia) by modifying the cornea. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components are surgical instruments and equipment used to perform the surgical procedure. They are not designed to analyze biological samples (like blood, urine, or tissue) outside of the body.
- Anatomical Site: The device is used on the cornea, which is part of the living patient. IVDs analyze samples taken from the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
86 HNO
Device Description
The submitted device is a PLANCON INSTRUMENTS Microlamellar Keratome system, consisting of:
- Power unit: includes Vacuum pump (2 vacuum pumps, 1 acting as backup), Battery (12 Volts, 12 Ah capacity), Vacuum release valve, Knob to regulate gas pressure, Gas & vacuum pressure gauges, Vacuum & turbine quick connectors, Battery charger unit. Features include liquid crystal display for vacuum level and turbine pressure, red LED and audible tone for insufficient vacuum and incorrect pressure, LED indicators for battery charge (green and red), LUER lock type vacuum connector with safety lock plate, and a visible indicator for insufficient nitrogen pressure supply. It also has a dual level vacuum function allowing decrease from 150 mmHg to 600 mmHg with a switch and LED indicator for low vacuum.
- Turbine motor: Gas powered, adjustable speed 0 to 20,000 RPM (recommended 14,000 RPM), made of stainless steel, titanium, and aluminum, with no gear system.
- Fixed keratome head: Made of stainless steel, fixed single piece head. Safety feature ensures only one cut depth is allowed by the head principle.
- Keratome blade
- Pneumatic fixation rings: Made of stainless steel with double dovetails.
- Applanation lenses: Made of clear plastic with a stainless handle, featuring an engraved inner reticle diameter.
- Test function: The unit has a self-checking function that tests the efficiency of the 2 pumps, nitrogen supply pressure, and turbine pressure adjustment. Operation is only allowed if the test passes, with blinking and audible signals indicating failure.
- Dry chamber: Double cavity dry chamber for increased prevention of fluid aspiration by the pumps.
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 970377
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
APR 1 5 1998
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 :
- 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
-
- Problems related to instrument setting and checking :
- Cut depth (problem cancelled with new device),
- Vacuum level.
- Blade quality
-
- 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
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)