(13 days)
Not Found
No
The summary describes a mechanical device (microkeratome accessory) for separating corneal epithelium and does not mention any AI/ML terms, image processing, or data-driven performance metrics.
No
The device is used for preparing the corneal epithelium for subsequent surgical procedures, not for treating a disease or condition itself.
No
This device is used for surgical preparation (delamination of corneal epithelium) and not for diagnosing a condition or disease.
No
The device description explicitly states that the system consists of physical components: the Epi Head and single-use Epi separator, which are accessories for a microkeratome (a hardware device).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Zyoptix XP Epi Separator System is used for the physical separation of the corneal epithelium during a surgical procedure. It directly interacts with the patient's tissue in vivo (within the living body).
- Lack of Diagnostic Testing: The description does not mention any analysis of biological samples or the generation of diagnostic information. Its purpose is purely procedural, preparing the cornea for subsequent surgery.
Therefore, the device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.
Product codes (comma separated list FDA assigned to the subject device)
HNO
Device Description
The Epi Separator System is designed exclusively for use with the Zyoptix XP Microkeratome. The Zyoptix XP Separator System, which consists of the Epi Head and single use Epi separator, are optional accessories for the Zyoptix XP microkeratome.
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)
Design verification was conducted to demonstrate compliance to design requirements and specifications for the Zyoptix XP Epi Separator System. Sufficient objective evidence was collected to conclude that the design met the requirements outlined in the product requirements and technical specifications.
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
510(k) SUMMARY for
SEP - 6 2006
Zyoptix XP Epi Separator System Prepared 23 May, 2006
1. Submitter Information
| Sponsor: | Bausch & Lomb, Inc. |
|---|---|
| 1400 North Goodman Street | |
| Rochester, NY 14609 |
| Contact Person: | Ned Luce |
|---|---|
| Director, Global Regulatory Affairs | |
| Telephone No.: | (585) 338-6368 |
| Fax No.: | (585) 338-0702 |
2. Device Name
| Classification Name: | Keratome
21 CFR 886.4370
HNO |
|----------------------|------------------------------------|
| Proprietary Name: | Zyoptix XP Epi Separator System |
3. Predicate Device
Zyoptix XP Microkeratome
4. Description of Device
The Epi Separator System is designed exclusively for use with the Zyoptix XP Microkeratome. The Zyoptix XP Separator System, which consists of the Epi Head and single use Epi separator, are optional accessories for the Zyoptix XP microkeratome.
5. Indications for Use
The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.
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6. Description of Safety and substantial equivalence
The Medical Device Risk Analysis was performed comparing the changes made to the Zyoptix XP Microkeratome. The analysis concluded there are no ad ditional unacceptable known risks.
7. Basis of Equivalence
The Zyoptix XP Epi Separator System is substantially equivalent to the Zyoptix XP Microkeratome cleared under 510(k) K040204 on March 22, 2004. A substantial equivalence Summary Table follows.
8. Safety and Effectiveness
Safety:
The Risk analysis applies to the changes made from the existing Zyoptix XP Microkeratome to the Zyoptix XP Epi Separator System. The analysis concluded there are no unacceptable risks known. A copy of the Risk Analysis is included in the appendix.
Effectiveness:
Design verification was conducted to demonstrate compliance to design requirements and specifications for the Zyoptix XP Epi Separator System. Sufficient objective evidence was collected to conclude that the design met the requirements outlined in the product requirements and technical specifications.
2
10, ... ر PREMARKET NOTIFICATION
Cyoptix XP Epi Separator System
Substantial Equivalence Summary Table
SIMILARITIES
| Characteristics | Zyoptix XP Microkeratome | Zyoptix XP Microkeratome with Zyoptix XP Epi Separator System |
|---|---|---|
| Operating Principal | 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 | Stainless Steel Stainless Steel Low Carbon Stainless Steel | Stainless Steel Stainless Steel Low Carbon Stainless Steel |
| Keratome Mechanism | Single port annular suction fixation DC powered 6 to 9 volts Footswitch Blade oscillation XP Blades EtO Instructions are in chapter 3 of the Operator's manual | Single port annular suction fixation DC powered 6 to 9 volts Footswitch Blade oscillation Epi Separators EtO (same cycle as XP blades) Same instructions for the Epi |
| Suction Ring | ||
| Electric motor | ||
| Control Mechanism | ||
| Cutting Principal | ||
| Sterilization | ||
| Cleaning, disinfection, sterilization by user | ||
| DIFFERENCES | ||
| Characteristics | Zyoptix XP Microkeratome | Zyoptix XP Microkeratome with Zyoptix |
| XP Epi Separator System | ||
| Intended Use | Lamellear resection of the cornea | |
| preceding Lasik surgery or other | ||
| treatment requiring initial lamellar | ||
| resection of the cornea, where the flap | ||
| is created in the Stromal layer | Partial or complete delamination of the corneal | |
| epithelium in preparation for subsequent | ||
| surgical procedures on the denuded cornea. | ||
| Microkeratome head thickness plate | 3 interchangeable heads with fixed | |
| thickness | 1 interchangeable head designed to separate | |
| epithelium layer from Bowman's layer | ||
| Microkeratome blade | Blade edge designed to cut a flap in | |
| the Stromal layer | Blade edge designed to separate epithelium | |
| layer from Bowman's layer | ||
| Microkeratome head | Two piece design | One piece design |
11-3
3
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Bausch & Lomb, Inc. 1400 North Goodman St. Rochester, NY 14609 Attn: Ned Luce
Re: K062465
Trade/Device Name: Zyoptix XP Epi Separator System Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome, AC-Powered Regulatory Class: Class I Product Code: HNO Dated: August 24, 2006 Received: August 24, 2006
Dear Mr. Luce:
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.
5
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
MB. Egdelmisi mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) PREMARKET NOTIFICATION Zyoptix XP Epi Separator System
510(K) Number- K062465
Device Name: Zyoptix XP Epi Separator System
Indications for Use:
The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded 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) | Clay R. Buttemess |
| (Division Sign-Off) |
(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number _
510(K) Number_KO62465