(32 days)
No
The device description and performance studies focus on the physical properties and performance of a replacement surgical blade, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a replacement blade for a microkeratome, which is a surgical tool used for lamellar resection of the cornea. It is an accessory to a surgical device, not a therapeutic device itself that provides therapy.
No
The device description indicates that the OASIS N-PE Microkeratome Blades are replacement blades used for lamellar resection of the cornea, which is a surgical procedure, not a diagnostic one. No diagnostic function is mentioned in the "Intended Use / Indications for Use" or "Device Description" sections.
No
The device is a physical, disposable blade made of stainless steel, intended for use with a microkeratome. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "lamellar resection of the cornea" using a microkeratome. This is a surgical procedure performed on a patient's eye.
- Device Description: The device is a replacement blade for a surgical instrument (microkeratome).
- Lack of Diagnostic Purpose: There is no mention of the device being used to test a sample (like blood, urine, or tissue) to diagnose a disease or condition. IVDs are used in vitro (outside the body) to provide information about a patient's health status.
This device is a surgical instrument component, not a diagnostic test.
N/A
Intended Use / Indications for Use
The OASIS N-PE Microkeratome Blades are designed as replacement blades for the Nidek MK-2000 Microkeratome for lamellar resection of the cornea.
Product codes
86 HNO
Device Description
The OASIS Disposable N-PE Microkeratome Blades are replacement stainless steel blades for the Nidek MK-2000 Microkeratome blade. The Disposable N-PE Microkeratome Blades are made of 400 series low carbon stainless steel, packaged and sterilized using the same methods. The OASIS Disposable N-PE Microkeratome Blades are single-use, disposable blades.
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)
Performance Tests and Conclusions:
-
- Dimensional Equivalency Test - Physical measurements of the predicate device are substantially equivalent to the measurements of blades manufactured by OASIS Medical, Inc.
-
- Sharpness Tests - Sharpness tests show that the OASIS N-PE blades perform as well as the predicate device.
-
- Fit into the Nidek MK-2000 Microkeratome has been tested and shown to be acceptable.
-
- Non-clinical testing on porcine eyes resulted in corneal lamellar sections equivalent to the predicate devices.
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
510(k) SUMMARY
032297
This 510(k) summary of safety and effectiveness for the OASIS Microkeratome Blades is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92, and follows the Office of Device Evaluation guidance conceming the presentation and content of a 510(k) summary.
- Submitter's name, address, telephone number, contact person, and date the ﻬﻨﺘﻬﻢ summary was prepared:
| a. | Applicant: | OASIS Medical, Inc.
514 South Vermont Avenue
Glendora, CA 91741 |
|----|-------------------|-----------------------------------------------------------------------|
| b. | Telephone Number: | (909) 305-5400 |
| | Facsimile Number: | (626) 914-9372 |
- Contact Person: Yvonne Fernandez - RA/QA Director C.
- Date Summary Prepared: 7/22/03 ರ.
-
- Name of the Device, including trade name, the common or usual name, and the classification:
- Trade/Proprietary Name: Disposable N-PE Microkeratome Blades a.
- Common/Usual Name: Keratome Blade b.
- Classification Name: Keratome (Blade Only) - 21CFR §886.4370 C.
- Class I ದ. Classification:
- Product Code: 86 HNO e.
- f. Classification Panel: Ophthalmic
-
- Identification of legally marketed devices to which equivalence is being claimed:
The OASIS Medical, Inc. Disposable N-PE Microkeratome Blades are substantially equivalent in design, material and function to the devices as marketed by:
| Company | Device | 510(k) Number |
|---|---|---|
| Nidek | Nidek MK-2000 | K990900 |
- ব Description of the Device:
The OASIS Disposable N-PE Microkeratome Blades are replacement stainless steel blades for the Nidek MK-2000 Microkeratome blade. The Disposable N-PE Microkeratome Blades are made of 400 series low carbon stainless steel, packaged and sterilized using the same methods. The OASIS Disposable N-PE Microkeratome Blades are single-use, disposable blades.
1
Certification of Safety and Effectiveness:
When used according to the microkeratome manufacturer's instructions, there are no adverse safety indications the OASIS N-PE blade.
Sterilization Methodology:
All blades are sterilized by exposure to ethylene oxide to a Sterilization Assurance Level (SAL) of 10 according a validated process in compliance with EN 550.
Labeling:
The pouch will indicate OASIS name, address, product identification, lot number, sterilization process, single use, and federal law statements.
-
ഗ് Intended Use for the Device:
The OASIS N-PE Microkeratome Blades are designed as replacement blades for the Nidek MK-2000 Microkeratome for lamellar resection of the comea. -
Summary of the technological characteristics of the submitted device compared to 6. predicate devices:
| Characteristics | Nidek MK-2000 Blade | OASIS 0412 N-PE |
|---|---|---|
| Intended Use | As indicated | Same |
| Target population | As indicated | Same |
| Performance | Comparable to Nidek MK-2000 Microkeratome | Same |
| Blade Material | Low carbon stainless steel | Same |
| Biocompatibility | For Stainless Steel Blades | Same |
| Mechanical Safety | Assured | Same |
| Sterilization | Ethylene Oxide | Same |
| Flap Diameter | Measured | Equivalent |
| Flap Thickness | Measured | Equivalent |
| Dimensions | Measured | Equivalent |
Summary of Technological Characteristics of Device Compared to Predicate Device
Performance Tests and Conclusions:
-
- Dimensional Equivalency Test - Physical measurements of the predicate device are substantially equivalent to the measurements of blades manufactured by OASIS Medical, Inc.
-
- Sharpness Tests - Sharpness tests show that the OASIS N-PE blades perform as well as the predicate device.
-
- Fit into the Nidek MK-2000 Microkeratome has been tested and shown to be acceptable.
-
- Non-clinical testing on porcine eyes resulted in corneal lamellar sections equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white seal. The seal is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". In the center of the seal are three curved lines that resemble a stylized human figure.
AUG 2 6 2003
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OASIS Medical, Inc. c/o Yvonne Fernandez RA/QA Director OASIS Medical Inc. 512 S. Vermont Ave. Glendora, CA 91740
Re: K032297
Trade/Device Name: Disposable N-PE Microkeratome Blades Regulation Number: 21CFR 886.4370 Regulatory Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: July 23, 2003 Received: July 30, 2003
Dear Ms. Fernandez:
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.
3
Page 2 - Yvonne Fernandez
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,
A. Paleri forentthal
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
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Indications For Use Statement
510(k) Number (if known):
Device Name:
Disposable N-PE Microkeratome Blades
5032297
The OASIS Disposable N-PE Microkeratome Blade is designed as a replacement blade for the Nidek MK-2000 Microkeratome for 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)
일렉스트 유튜브 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Doxie Lee 8-21-2003
: vision Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K032297
X Prescription Use: (Per 21 CFR 801.109) (Optional Format 1-2-96)