(53 days)
Not Found
No
The description focuses on mechanical and manufacturing improvements to a microkeratome, with no mention of AI or ML capabilities. The use of 3-D CAD modeling is a design tool, not an indication of AI/ML in the device's operation.
No
The device creates a corneal flap for LASIK surgery, which is a surgical preparatory step, not a therapeutic treatment itself.
No
The device is a surgical instrument used to create a corneal flap, not to diagnose a condition.
No
The device description clearly details a physical instrument (microkeratome) with mechanical components (translational drive, cutting head, suction ring, blade) used for surgical procedures. There is no mention of software being the primary or sole component.
Based on the provided information, the Bausch & Lomb Zyoptix™ XP Microkeratome is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to create a corneal flap in patients undergoing LASIK surgery or other treatments requiring lamellar resection of the cornea. This is a surgical procedure performed directly on a living patient's tissue.
- Device Description: The device is a precision-manufactured instrument used for a surgical procedure. It's a physical tool used to cut tissue.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
The Zyoptix™ XP Microkeratome is a surgical instrument used in vivo (within the living body) during a surgical procedure, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
The Bausch & Lomb Zyoptix™ XP Microkeratome is a precision-manufactured instrument indicated for creating a corneal flap in patients undergoing LASIK inotrery or other treatment requiring initial lamellar resection of the cornea.
Product codes (comma separated list FDA assigned to the subject device)
HNO
Device Description
The Zyoptix™ XP Microkeratome is an automated pivoting keratome that is The Zyoptix comected to, and outronious by the translational drive mechanism to across the corneal flap of a predetermined diameter and thickness. The create a filmgod ournour hap oth the Zyoptix™ XP Microkeratome as with the Same Options are available than and including flap depths of 160, 180 and Hansatome® Exocilias - Mi8.5 mm or 9.5 mm flap diameter, and two sizes of suction rings, a 19 mm and 20 mm suction ring. The device is designed to Suction Thigs, a 15 min and Eu-n Baction ring-to-eye interface snarsetry as the Hansatome® Excellus™ Microkeratome.
The translation drive has been changed from a rack and pinion gear drive to a two-link pivot mechanism that provides an identical motion. Corresponding two-lifications have been made to cutting head and suction ring that supports the modifications neve boommatic to ew cutting head is also easier for the operator two-link offe hounding the component parts were designed for ease of ത onfacture, assembly, interchangeability, and improved reliability.
The Zyoptix™ XP Blade is produced by a more exacting manufacturing process and is designed to be used exclusively with the Zyoptix™ XP Microkeratome. and is assigriou to a ufacturing process reduces the tolerance of blade extension variation. An analysis of the dimensional specifications based on 3-D CAD Modeling (3 dimensional computer aided design) established that the average Modoling (of the corneal flap produced by the Zyoptix™ XP Microkeratome and the Hansatome® Excellus™ Microkeratome are equivalent.
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): 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.
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
MAR 2 2 2004
510(k) SUMMARY
FOR
Zyoptix™ XP Microkeratome
1. SUBMITTER INFORMATION
Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609
Debra Ketchum Contact Person: Manager, Regulatory Affairs Telephone No.: (585) 338-8638 (585) 338-0702 Fax No.:
DEVICE NAME 2.
Classification Name: Keratome
Zyoptix™ XP Microkeratome Proprietary Name:
PREDICATE DEVICES 3.
Hansatome® Excellus™ Microkeratome
1
4. DESCRIPTION OF DEVICE
The Zyoptix™ XP Microkeratome is an automated pivoting keratome that is The Zyoptix comected to, and outronious by the translational drive mechanism to across the corneal flap of a predetermined diameter and thickness. The create a filmgod ournour hap oth the Zyoptix™ XP Microkeratome as with the Same Options are available than and including flap depths of 160, 180 and Hansatome® Exocilias - Mi8.5 mm or 9.5 mm flap diameter, and two sizes of suction rings, a 19 mm and 20 mm suction ring. The device is designed to Suction Thigs, a 15 min and Eu-n Baction ring-to-eye interface snarsetry as the Hansatome® Excellus™ Microkeratome.
The translation drive has been changed from a rack and pinion gear drive to a two-link pivot mechanism that provides an identical motion. Corresponding two-lifications have been made to cutting head and suction ring that supports the modifications neve boommatic to ew cutting head is also easier for the operator two-link offe hounding the component parts were designed for ease of ത onfacture, assembly, interchangeability, and improved reliability.
The Zyoptix™ XP Blade is produced by a more exacting manufacturing process and is designed to be used exclusively with the Zyoptix™ XP Microkeratome. and is assigriou to a ufacturing process reduces the tolerance of blade extension variation. An analysis of the dimensional specifications based on 3-D CAD Modeling (3 dimensional computer aided design) established that the average Modoling (of the corneal flap produced by the Zyoptix™ XP Microkeratome and the Hansatome® Excellus™ Microkeratome are equivalent.
5. INDICATIONS FOR USE
The Bausch & Lomb Zyoptix™ XP Microkeratome is a precision-manufactured instrument indicated for creating a corneal flap in patients undergoing LASIK inotrery or other treatment requiring initial lamellar resection of the cornea.
6. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE
The Medical Devices Risk Analysis applies to the changes made from the existing Hansatome® Excellus™ Microkeratome to the proposed Zyoptix™ XP The analysis concluded there are no unacceptable risks Microkeratome. known.
2
7. SUBSTANTIAL EQUIVALENCE
:
Substantial Equivalence Summary Table
SIMILARITIES
| Characteristics | Current Hansatome Excellus
Microkeratome | Proposed Zyoptix XP 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 across
the cornea within controlled parameters. | Electrically driven oscillating blade housed in
a head, which guides the blade across the
cornea within controlled parameters. |
| Patient contact portion | Suction Ring Microkeratome Head Blade | Suction Ring Microkeratome Head Blade |
| Materials Suction ring Microkeratome Head Blade | Stainless Steel Stainless Steel Low Carbon Stainless steel | Stainless Steel Stainless Steel Low Carbon Stainless steel |
| Keratome Mechanism Suction ring Microkeratome head thickness plate Electric motor Control mechanism Cutting Principle | Single port annular suction fixation 3 interchangeable heads with fixed thickness DC powered 6 to 9 volts Footswitch Blade oscillation | Single port annular suction fixation 3 interchangeable heads with fixed thickness DC powered 6 to 9 volts Footswitch Blade oscillation |
| DIFFERENCES | | |
| Characteristics | Current Hansatome Excellus
Microkeratome | Proposed Zyoptix XP Microkeratome |
| Components | Matched | Interchangeable |
| Left/Right Procedure Set-Up | Left/Right Adaptor | Selector Switch |
| Gear Box | Hand built gearbox | Integrated motor and gearbox |
| Head to Hand piece Interface | Screws into head | Snaps into head |
| Translation Drive | Rack and pinion | Two-link pivot mechanism |
3
meccocures
: 上一
4
Substantial Equivalence
SubStantial Equivaloree Excellus ™ Microkeratome cleared in the Premarket Notification K021640 on June 19, 2002.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2004
Bausch & Lomb Surgical, Inc. c/o Debra L. B. Ketchum Manager Global Regulatory Affairs 1400 N. Goodman Street Rochester, NY 14609
Re: K040204
Trade/Device Name: Zyoptix™ XP Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: March 2, 2004 Received: March 3, 2004
Dear Ms. Ketchum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2 - Debra L. B. Ketchum
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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Akepe lorentthal
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
Enclosure
7
Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609
Indications for Use Statement
510(k) Number (if known): K040204
Zyoptix™ XP Microkeratome Device Name:
Indications for Use:
The Zyoptix™ XP Microkeratome is a precision-manufactured instrument indicated The Zyoptix - XI Microkeratorie is a procleronic is undergoing LASIK surgery or other for aso in orealing 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 | ✓ |
|---|---|
| OR | |
| Over-The-Counter-Use ________ | |
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, |
510(k) Number K040204
Nose and Throat Devise