(30 days)
Not Found
No
The device description focuses on mechanical and electrical components for surgical cutting and vacuum control, with no mention of AI or ML terms or functionalities.
Yes
The device is described as an instrument used in LASIK surgery or other treatments requiring lamellar resection of the cornea, which directly intervenes in the physiological function of the body for a therapeutic purpose.
No
The device is a surgical instrument used for lamellar resection of the cornea during LASIK surgery, which is a therapeutic procedure, not a diagnostic one.
No
The device description explicitly details physical components like a cutting head, pivot pin, rolling gear, arcuate gear rack, suction ring, vacuum regulator, vacuum tank, battery pack, and LCD display, indicating it is a hardware device with potential software control.
Based on the provided information, the Bausch & Lomb Hansatome Excellus Microkeratome is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "initial lamellar resection of the cornea" in patients undergoing LASIK surgery. This is a surgical procedure performed directly on a living patient's tissue.
- Device Description: The description details a mechanical instrument used for cutting tissue. It does not describe a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Anatomical Site: The device is used on the cornea, which is part of the living human body. IVD devices typically analyze samples taken from the body (like blood, urine, tissue biopsies).
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical instrument used on the body.
N/A
Intended Use / Indications for Use
The Bausch & Lomb Hansatome Excellus Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Product codes
HNO
Device Description
The Hansatome® Excellus™ Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. It functions identically to the existing Hansatome Microkeratome in that the cutting head rotates about a piyot pin. Propulsion is via a rolling gear within the head which engages with an arcuate gear rack affixed to the suction ring. In addition, the Hasatome Excellus Power/Suction Supply Unit includes 1) a vacuum regulator to allow the physician to set vacuum prior to surgery, 2) a vacuum tank that provides reserve vacuum in the event the vacuum pump fails or power is interrupted during the course of surgery, and 3) a battery pack back-up power supply to the microkeratome motor in the event power is interrupted during the course of surgery. The microkeratome's LCD also contains a back-lit display so the User can read the LCD display in low/no light conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea
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)
Reference Device(s)
Not Found
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
JUN 1 9 2002
Hnasatome Excellus Microkeratome
510(k) SUMMARY (per 21 CFR §807.92)
| Submitter's Name:
Address: | Bausch & Lomb
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122 |
|-----------------------------------|--------------------------------------------------------------------------|
| Telephone #:
Fax #: | (636) 226-3183
(636) 226-3245 |
| Official Correspondent: | Dennis PozZO
Regulatory Affairs Specialist |
| Date Summary Prepared: | May 15, 2002 |
| Device Name/
Proprietary name: | Hansatome® Excellus™ Microkeratome |
| Classification/Common Name | Keratome |
| Class: | I |
| Panel: | Ophthalmic |
| Product Code: | ΗΝΟ |
The marketed device(s) to which substantial equivalence is claimed: Hansatome® Microkeratome
PRODUCT DESCRIPTION:
The Hansatome® Excellus™ Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. It functions identically to the existing Hansatome Microkeratome in that the cutting head rotates about a piyot pin. Propulsion is via a rolling gear within the head which engages with an arcuate gear rack affixed to the suction ring. In addition, the Hasatome Excellus Power/Suction Supply Unit includes 1) a vacuum regulator to allow the physician to set vacuum prior to surgery, 2) a vacuum tank that provides reserve vacuum in the event the vacuum pump fails or power is interrupted during the course of surgery, and 3) a battery pack back-up power supply to the microkeratome motor in the event power is interrupted during the course of surgery. The microkeratome's LCD also contains a back-lit display so the User can read the LCD display in low/no light conditions.
1
Substantial Equivalent Basis
The Hansatome® Excellus™ Microkeratome is substantially equivalent to the Hansatome® Microkeratome (K972808 and K010260), see Comparison Martix below.
| COMPARISON MATRIX | |
|---|---|
| and and and the management of the commendent of the promotive of the promotive of the management of the manufactures and the manufacturer of the comments of the contraction o |
SIMILARITIES
| CHARACTERISTICS | Current Hansatome
Microkeratome | PROPOSED Hansatome Excellus
Microkeratome |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Lamellar resection of the cornea
preceding LASIK surgery or other
treatment requiring initial lamellar
resection of the cornea | Lamellar resection of the cornea
preceding LASIK surgery or other
treatment requiring initial lamellar
resection of the cornea |
| Operating Principle | Electrically driven oscillating blade
housed in a head which guides the
blade ascross the cornea within
controlled parameters. | Electrically driven oscillating blade
housed in a head which guides the
blade ascross the cornea within
controlled parameters. |
| Patient contact portion | Suction Ring Microkeratome Head Blade | Suction Ring Microkeratome Head Blade |
| Materials | Stainless Steel Stainless Steel Low Carbon Stainless Steel | Stainless Steel Stainless Steel Low Carbon Stainless Steel |
| Keratome Mechanism | Single arcuate gear rack with temporal pivot pin 3 interchangable heads with fixed thickness DC powered 6-9 volts Footswitch Blade oscillation | Single arcuate gear rack with temporal pivot pin 3 interchangable heads with fixed thickness DC powered 6-9 volts Footswitch Blade oscillation |
2
COMPARISON MATRIX
DIFFERENCES
| CHARACTERISTICS | Current Hansatome
Microkeratome | PROPOSED Hansatome Excellus
Microkeratome |
|---------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Power Switch | Power Switch is on front of power
supply | Power Switch is on back of power
supply |
| Front Panel Labeling | Symbology and verbiage on front
panel. | Symbology only on front panel. |
| Vacuum Pump | Less efficient pump, can only
operate at elevations up to 6500 feet
above sea level. | More efficient pump, can operate at
elevations up to 7000 feet above sea
level. |
| | The vacuum pump is listed with
safety agencies. | The vacuum pump is not listed with
safety agencies. |
| Power/Suction Supply Unit | Not UL Listed | UL Listed |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked one behind the other. The profiles are rendered in a simple, abstract manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2002
Bausch & Lomb, Inc. c/o Mr. Dennis Pozzo Regulatory Affairs Specialist 3655 Tree Court Industrial Blvd. St. Louis. MO 63122-6694
Re: K021640
Trade/Device Name: BAUSCH & LOMB Hansatome® Excellus™ Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: 86 HNO Dated: May 17, 2002 Received: May 20, 2002
Dear Mr. Pozzo:
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 Ouality System Regulation (OS) 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.
4
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
5
510(K) Number
510(K) Number -
Device Name: Hansatome® Excellus™ Microkeratome
Indications for Use:
The Bausch & Lomb Hansatome Excellus Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ V ____ OR Over-the-Counter Use __________________________________________________________________________________________________________________________ R. Binfa hickotons
(Division Sign-Off)
510(k) Number KOR 1640
Bausch & Lomb Surgical