The OASIS Disposable N-PE (Precision Edge) Microkeratome Blade (Catalog #0412) is a replacement blade for the Nidek MK-2000 Microkeratome for lamellar resection of the cornea.

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 Stainless Steel, packaged and sterilized using the same methods. The OASIS Disposable N-PE Microkeratome Blades are single-use, disposable blades.

AI/ML Overview

The OASIS Disposable N-PE Microkeratome Blades are replacement blades for the Nidek MK-2000 Microkeratome, intended for lamellar resection of the cornea. The study aimed to demonstrate substantial equivalence to the legally marketed Nidek MK-2000 microkeratome blades (K990900).

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Acceptance Criteria (Predicate Device K990900)	Reported Device Performance (OASIS N-PE Blade)
Intended Use	As indicated by the predicate device manufacturer (for lamellar resection of the cornea).	Same (for lamellar resection of the cornea).
Target Population	As indicated by the predicate device manufacturer.	Same.
Performance	Compatibility with Nidek MK-2000 Microkeratome.	Dimensional Equivalency Test: Physical measurements are substantially equivalent.Sharpness Tests: Performs as well as the predicate device.Fit Test: Fit into the Nidek MK-2000 Microkeratome has been tested and shown to be acceptable.Non-clinical Testing: Corneal lamellar sections on porcine eyes are equivalent to the predicate devices.
Blade Material	Low carbon stainless steel.	Same (400 Series Stainless Steel).
Biocompatibility	Biocompatibility for Stainless Steel Blades.	Same (for Stainless Steel Blades).
Mechanical Safety	Assured.	Same (Assured).
Sterilization	Sterilized by a validated process (e.g., ethylene oxide with SAL of 10^-5^).	Sterilized by exposure to ethylene oxide to a SAL of 10^-5^ according to a validated process in compliance with EN 550.
Labeling	Pouch indicates manufacturer name, address, product identification, lot number, sterilization process, single use, and federal law statements.	Pouch indicates OASIS name, address, product identification, lot number, sterilization process, single use, and federal law statements.

Study Details:

The provided document describes a 510(k) Premarket Notification Summary which aims to demonstrate substantial equivalence of the OASIS Disposable N-PE Microkeratome Blades to a predicate device. This is primarily a comparative study against a legally marketed device rather than a standalone study with defined acceptance criteria for de novo clinical performance. The "acceptance criteria" are effectively the characteristics and performance of the predicate device that the new device must match or be equivalent to.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly mentions non-clinical testing on porcine eyes. It does not specify the exact number of porcine eyes used, making the sample size for this part of the testing unknown from the provided text. The data provenance for this specific test would be non-human (animal model), likely conducted in a laboratory setting. No country of origin is specified. The study is retrospective in the sense that it aims to demonstrate equivalence to a pre-existing medical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the use of human experts to establish ground truth for the test set. The evaluations appear to be based on objective physical measurements (dimensional equivalency), biomechanical tests (sharpness, fit), and direct comparison of lamellar sections from porcine eyes.

4. Adjudication Method for the Test Set:

No adjudication method is described, as the evaluation methods are primarily quantitative and comparative against the predicate rather than involving subjective interpretation by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The device is a surgical blade, and the assessment focuses on its physical and functional equivalence, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This question is not applicable. The device is a physical surgical tool and does not involve an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" for the equivalence demonstration is primarily established through:

Physical measurements and specifications of the predicate device.
Performance characteristics (sharpness, fit) as demonstrated by the predicate device.
Resulting tissue sections (corneal lamellar sections) obtained using the predicate device.

Specifically for the OASIS blade, the "ground truth" for its performance is its ability to produce measurements, sharpness, fit, and lamellar sections equivalent to those of the predicate device.

8. Sample Size for the Training Set:

This question is not applicable. The device is a physical product and does not involve machine learning algorithms or a "training set" in the computational sense. The "training" for the manufacturing process would be part of Standard Operating Procedures (SOPs) and Quality System Regulations (QSRs), not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the reasons stated above.

Summary

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510-528 S. Vermont Avenue Glendora, CA 91741 (626) 914-2891 FAX (626) 914-2285

510(k) Premarket Notification Summary Ref:

To: Document Control Clerk:

This is to notify you of the intention of OASIS Medical, Inc. to manufacture and market the following device:

Disposable N-PE Microkeratome Blades

KO22205

Establishment Registration Number: 2083373

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 concerning the presentation and content of a 510(k) summary.

Submitter's name, address, telephone number, contact person, and date the 1 . summary was prepared:

a.	Applicant:	OASIS Medical, Inc.514 South Vermont AvenueGlendora, CA 91741
b.	Telephone Number:	(626) 914-2891
	Facsimile Number:	(626) 914-9372
c.	Contact Person:	Yvonne Fernandez - RA/QA Director

ರ. Date Summary Prepared: 7/2/02
1. Name of the Device, including trade name, the common or usual name, and the classification:
- Trade/Proprietary Name: Disposable N-PE Microkeratome Blades a.
- b. Common/Usual Name: Keratome Blade
- Classification Name: Keratome (Blade Only) - 21CFR §886.4370 C.

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d. Classification: Class I
Product Code: 86 HNO e.
f. Classification Panel: Ophthalmic

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Image /page/1/Picture/0 description: The image shows the word "OASIS" in a stylized font, with a palm tree above the letters "A" and "I". The letters are bold and black, and the palm tree is also black. The word is likely a logo or brand name. The image is simple and eye-catching.

(626) 914-2891 FAX (626) 914-2285 510-528 S. Vermont Avenue Glendora, CA 91741

ldentification of legally marketed devices to which equivalence is being 3. 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

4. Description of the Device:

Certification of Safety and Effectiveness:

When used according to the keratome manufacturer's instructions, there are no adverse safety indications the 0412 blade.

Sterilization Methodology:

All blades are sterilized by exposure to ethylene oxide to a Sterilization Assurance Level (SAL) of 105 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.

5. Intended Use for the Device:

The OASIS N-PE Microkeratome Blades (Catalog #0412) are designed as replacement blades for the Nidek MK-2000 Microkeratome for lamellar resection of the cornea.

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510-528 S. Vermont Avenue Glendora, CA 91741 (626) 914-2891 FAX (626) 914-2285

Summary of the technological characteristics of the submitted device 6. compared to predicate devices:

N-PE Blade - Summary of Technological Characteristics of Device Compared to Predicate Device1 [Section 807.92(a)(6)] - K981741

Characteristics	PD+ - Nidek MK-2000 Blade	OASIS 0412 N-PE Blade
Intended Use	As indicated	Same
Target population	As indicated	Same
Performance	Compatibility with Nidek MK-2000 Microkeratome	Same
Blade Material	Low carbon stainless steel	Same
Biocompatibility	For Stainless Steel Blades	Same
Mechanical Safety	Assured	Same

Performance Tests and Conclusions:

Dimensional Equivalency Test Physical measurements of the predicate 1. device are substantially equivalent to the measurements of blades manufactured by OASIS Medical, Inc.
1. Sharpness Tests - Sharpness tests show that the OASIS N-PE blades (0412) perform as well as the predicate device.
1. Fit into the Nidek MK-2000 Microkeratome has been tested and shown to be acceptable.
1. Non-clinical testing on porcine eyes resulted in corneal lamellar sections equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 3 2002

Oasis Medical, Inc. Ms. Yvonne Fernandez RA/QA Director 514 South Vermont Avenue Glendora, CA 91741

Re: K022205

Trade Name: Oasis Disposable N-PE Microkeratome Blade and Chip Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: 86 HNO Dated: July 2, 2002 Received: July 5, 2002

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. 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.

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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

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Glendora, CA 91741 (626) 914-2891 FAX (626) 914-2285 510-528 S. Vermont Avenue

OASIS Medical, Inc. Disposable N-PE (Precision Edge) Microkeratome Blades Indications For Use

510(k) Number (if known):

K022205

Device Name:

Disposable N-PE Microkeratome Blades

The OASIS Disposable N-PE (Precision Edge) Microkeratome Blade (Catalog #0412) The Oriolo Disposule No 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

MB Nichols

ision of Ophthalmic Ear. Nose and Throat Devises

510(k) Number K022205

X OR Over The Counter Use: Prescription Use: (Optional Format 1-2-96) (Per 21 CFR 801.109)

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Regulation Number and Section

§ 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.