(90 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and performance of a disposable surgical blade, with no mention of AI or ML.
No
The device is a disposable 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.
No
The device is a disposable blade for a microkeratome, which is a surgical device used for corneal resection, not a diagnostic device.
No
The device description clearly states it is a physical, disposable stainless steel blade for a microkeratome, which is a hardware component.
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 directly on the patient's body.
- Device Description: The device is a replacement blade for a surgical instrument (microkeratome).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a surgical tool used in vivo (within the body) during a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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 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 (0412) 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): 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
Image /page/0/Picture/0 description: The image shows the word "OASIS" in a stylized font, with a palm tree above the letter "A". Above the word "OASIS" is the date "OCT 03 2002". The text and image are in black and white.
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 Avenue
Glendora, 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
-
- 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.
0 D
0 3 9
- d. Classification: Class I
- Product Code: 86 HNO e.
- f. Classification Panel: Ophthalmic
1
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:
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.
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.
.
2
Image /page/2/Picture/0 description: The image shows the word "OASIS" in a stylized font. A palm tree is above the letter "A" in the word. The letters are thick and black. The background is white.
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.
-
- Sharpness Tests - Sharpness tests show that the OASIS N-PE blades (0412) 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.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three heads, representing health, human services, and the USA. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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.
4
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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Image /page/5/Picture/0 description: The image shows a logo for "OASIS" with a palm tree above the letters. The letters are stylized and bold, with a unique design. The palm tree is silhouetted and positioned above the "A" in "OASIS". The overall design is simple and eye-catching.
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):
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)
0 2 9 l L