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.

AI/ML Overview

The acceptance criteria for the OASIS Disposable N-PE Microkeratome Blades and the study proving its performance are detailed below. It's important to note that this device is a Class I medical device (keratome blade) and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than complex clinical studies typically associated with higher-risk devices or software.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence:
Intended Use	Same as predicate device (Nidek MK-2000 Microkeratome blade)
Target Population	Same as predicate device
Performance	Comparable to Nidek MK-2000 Microkeratome blade
Fit into Nidek MK-2000	Tested and shown to be acceptable
Material/Design Equivalence:
Blade Material	Low carbon stainless steel (same as predicate)
Biocompatibility	For Stainless Steel Blades (same as predicate)
Sterilization Method	Ethylene Oxide (same as predicate), SAL of 10-6
Performance Measurements:
Flap Diameter	Measured, shown to be Equivalent to predicate device
Flap Thickness	Measured, shown to be Equivalent to predicate device
Dimensions	Measured, shown to be Substantially equivalent to predicate device
Sharpness	Tests show performance as well as the predicate device
Safety:
Mechanical Safety	Assured (same as predicate)
Adverse Safety Indications	No adverse safety indications when used per manufacturer's instructions

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

Sample Size: The document does not specify a precise numerical sample size for the "test sets" of blades used in the dimensional equivalency, sharpness, and fit tests. It implies that these tests were performed on a sufficient number of OASIS blades to draw conclusions about their equivalence to the predicate.
Data Provenance: The data provenance for the non-clinical testing is "non-clinical testing on porcine eyes." This indicates that the testing was performed on animal models. There is no mention of country of origin for this data specifically, nor is it specified if it was retrospective or prospective, though non-clinical tests are typically prospective for device validation.

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

This type of information (number and qualifications of experts for ground truth) is typically not applicable for a 510(k) submission of a Class I device focused on substantial equivalence to a predicate. The evaluation relies on direct material and performance comparisons, not expert interpretation of results that would require consensus for a "ground truth" in the way it's used in AI/diagnostic studies.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements (dimensions, sharpness, fit) or direct comparisons, not requiring expert adjudication for ambiguous results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation is involved. This submission is for a surgical blade, where performance is assessed through physical and functional equivalence.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical surgical tool, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established characteristics and performance of the predicate device (Nidek MK-2000 blade). The OASIS blades are directly compared against these known attributes through:

Objective Measurements: Such as dimensional equivalency.
Functional Demonstrations: Such as sharpness testing and fit into the microkeratome.
Performance Equivalence in a Model: Confirmed by producing "corneal lamellar sections equivalent to the predicate devices" on porcine eyes.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable, as there is no training set.

Summary

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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 AvenueGlendora, 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.
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.
- 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
1. 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.

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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:

1. Dimensional Equivalency Test - Physical measurements of the predicate 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 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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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.

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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)

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.