The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

The Surgistar 2410-CB Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

The Surgistar 2420-M2 Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer II Keratome also known as the M2. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

Device Description

The Surgistar 2400-LSK is a replacement microkeratome blade for the Moria LSK-ONE Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2400-LSK blades are single-use, disposable blades.

The Surgistar 2410-CB is a replacement microkeratome blade for the Moria Carriazo Barraquer Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2410-CB blades are single-use, disposable blades.

The Surgistar 2420-M2 is a replacement microkeratome blade for the Moria Carriazo Barraquer II Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2420-M2 blades are single-use, disposable blades.

AI/ML Overview

The provided text describes three medical devices: Surgistar Microkeratome Blade Models 2400-LSK, 2410-CB, and 2420-M2. All three are replacement blades for specific Moria microkeratomes, intended for use in corneal lamellar resection surgery. The studies presented aim to demonstrate substantial equivalence to their respective predicate devices.

Here's an analysis of the acceptance criteria and the studies that prove the devices meet them, for each model:

Surgistar Microkeratome Blade, Model No. 2400-LSK

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Required Performance for Substantial Equivalence to Predicate)	Reported Device Performance (Surgistar 2400-LSK)	Meets Criteria?
Dimensional Equivalency: Substantial equivalence to predicate's specifications.	Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.	Yes
Sharpness: Performs equivalently to the predicate blade.	Sharpness tests indicate the Surgistar 2400-LSK performs equivalently to the Moria LSK-ONE.	Yes
Keratome Fit: Acceptable fit with the predicate keratome head.	Fit tests with the Moria LSK-ONE Keratome head demonstrated that the Surgistar 2400-LSK fit was acceptable.	Yes
Corneal Lamellar Sections (Functionality): Equivalent to predicate.	Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2400-LSK and the Moria LSK-ONE.	Yes

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

The document does not specify the exact sample size for each performance test (dimensional, sharpness, fit).
For the non-clinical porcine eye studies, the sample size is also not specified.
The data provenance is stated as "non-clinical porcine eye studies," indicating animal studies. The country of origin is not explicitly mentioned but implied to be within the manufacturer's operation given the context of a 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable as these are primarily engineering and observational performance tests. The "ground truth" for these tests would be objective measurements and direct observation of functionality, not expert consensus on qualitative data.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective measurements (dimensional, sharpness, fit) and direct observation of results (corneal lamellar sections in porcine eyes).

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

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems involving human interpretation.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone algorithm-only performance study was not done. The device is a physical blade, not an AI algorithm.

7. Type of Ground Truth Used:

Dimensional Equivalency: Manufacturer's specifications for the predicate device.
Sharpness: Standardized sharpness testing criteria.
Keratome Fit: Engineering specifications for the predicate keratome head.
Corneal Lamellar Sections: Visual and/or histological assessment of the sections produced in porcine eyes, compared to those produced by the predicate, without specific details on the exact metrics or how "equivalence" was defined.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

Surgistar Microkeratome Blade, Model No. 2410-CB

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Required Performance for Substantial Equivalence to Predicate)	Reported Device Performance (Surgistar 2410-CB)	Meets Criteria?
Dimensional Equivalency: Substantial equivalence to predicate's specifications.	Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.	Yes
Sharpness: Performs equivalently to the predicate blade.	Sharpness tests indicate the Surgistar 2410-CB performs equivalently to the Moria C-B Microkeratome blade.	Yes
Keratome Fit: Acceptable fit with the predicate keratome head.	Fit tests with the Moria Carriazo Barraquer Keratome head demonstrated that the Surgistar 2410-CB fit was acceptable.	Yes
Corneal Lamellar Sections (Functionality): Equivalent to predicate.	Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2410-CB and the Moria C-B Microkeratome blade.	Yes

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

The document does not specify the exact sample size for each performance test.
For the non-clinical porcine eye studies, the sample size is also not specified.
The data provenance is stated as "non-clinical porcine eye studies," indicating animal studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable.

4. Adjudication Method for the Test Set:

Not applicable.

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

6. Standalone (Algorithm Only) Performance Study:

7. Type of Ground Truth Used:

Dimensional Equivalency: Manufacturer's specifications for the predicate device.
Sharpness: Standardized sharpness testing criteria.
Keratome Fit: Engineering specifications for the predicate keratome head.
Corneal Lamellar Sections: Visual and/or histological assessment of the sections produced in porcine eyes, compared to those produced by the predicate, without specific details.

8. Sample Size for the Training Set:

Not applicable.

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

Not applicable.

Surgistar Microkeratome Blade, Model No. 2420-M2

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Required Performance for Substantial Equivalency to Predicate)	Reported Device Performance (Surgistar 2420-M2)	Meets Criteria?
Dimensional Equivalency: Substantial equivalence to predicate's specifications.	Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.	Yes
Sharpness: Performs equivalently to the predicate blade.	Sharpness tests indicate the Surgistar 2420-M2 performs equivalently to the Moria M2 Microkeratome blade.	Yes
Keratome Fit: Acceptable fit with the predicate keratome head.	Fit tests with the Moria Carriazo Barraquer II Keratome head demonstrated that the Surgistar 2420-M2 fit was acceptable.	Yes
Corneal Lamellar Sections (Functionality): Equivalent to predicate.	Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2420-M2 and the Moria M2 Microkeratome blade.	Yes

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

The document does not specify the exact sample size for each performance test.
For the non-clinical porcine eye studies, the sample size is also not specified.
The data provenance is stated as "non-clinical porcine eye studies," indicating animal studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable.

4. Adjudication Method for the Test Set:

Not applicable.

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

6. Standalone (Algorithm Only) Performance Study:

7. Type of Ground Truth Used:

Dimensional Equivalency: Manufacturer's specifications for the predicate device.
Sharpness: Standardized sharpness testing criteria.
Keratome Fit: Engineering specifications for the predicate keratome head.
Corneal Lamellar Sections: Visual and/or histological assessment of the sections produced in porcine eyes, compared to those produced by the predicate, without specific details.

8. Sample Size for the Training Set:

Not applicable.

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

Not applicable.

Summary of Device Substantial Equivalence Claims:

For all three blades, Surgistar conducted a series of performance tests to demonstrate substantial equivalence to their respective predicate devices. These tests focused on:

Dimensional Equivalency: Comparing the new blade's dimensions to the specifications of the predicate.
Sharpness: Ensuring the new blade performs equivalently in sharpness tests.
Keratome Fit: Confirming the new blade properly fits the specified microkeratome head.
Non-clinical Porcine Eye Studies: Verifying that the new blade produces equivalent corneal lamellar sections in an animal model, indicating comparable functional performance during the intended surgical procedure.

The conclusions for all three devices stated "substantially equivalent" based on these performance tests. The studies are not designed for AI/ML algorithms or human reader performance, but rather for physical device characteristics and functionality in a laboratory/animal setting.

Summary

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KO30891

Page 1 of 2

Surgistar, Inc. Replacement Keratome Blades

March 19, 2003 Premarket Notification

JUN 1 7 2003

510(K) Summary

Surgistar 2400-LSK

Submitter:	Surgistar, Inc.6068 Corte Del CedroCarlsbad, CA. 92009
Telephone:	(760) 431-7400Fax: (760) 431 6768
Contact person:	Jonathan Woodward
Date Prepared:	March 19, 2003
Device Trade Name:	Surgistar Microkeratome Blade,Model No. 2400-LSK
Device Common Name:	Keratome Blade, Microkeratome Blade
Device Classification Name:	Keratome (Blade Only)
Classification Regulation No.:	CLASS 1, Reserved
Classification Panel:	OPHTHALMIC
Product Code:	86 HNO

Legally marketed device to which we are claiming equivalence:

Predicate Device Name:	PLANCON MICROLAMELLARKERATOME; LSK-1 Keratome (Blade only)
Manufacturer:	PLANCON INSTRUMENTS (Moria, Inc.)
510(k) Number:	K970377

Description of the Device:

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March 19, 2003 Premarket Notification

Page 2 of 2 Summary

Intended use of the device:

Summary of Technological characteristics of device compared to predicate device.

CHARACTERISTICS	MORIA LSK-ONE BLADE(PREDICATE)	SURGISTAR LSK-2400BLADE
Intended Use	As Indicated	Same
Target population	As Indicated	Same
Performance	Indication for use with theLSK-ONE Microkeratome.	Same
Blade Material	Low Carbon Stainless Steel	Same
Biocompatibility	For Stainless Steel Blades	Same
Mechanical Safety	Assured	Same
Sterilization Method	Gamma Irradiation	Same

Performance tests and conclusions:

1. Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
Sharpness Sharpness tests indicate the Surgistar 2400-LSK performs 2. equivalently to the Moria LSK-ONE.
1. Keratome Fit Fit tests with the Moria LSK-ONE Keratome head demonstrated that the Surgistar 2400-LSK fit was acceptable.
1. Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2400-LSK and the Moria LSK-ONE.
Conclusion The Surgistar 2400-LSK was demonstrated to be substantially ર. equivalent to the predicate Moria LSK-ONE.

(Premarket Notification [510(k)] Number)

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March 19, 2003 Premarket Notification

Page 1 of 2

510(K) Summary

Surgistar 2410-CB

Submitter:	Surgistar, Inc.6068 Corte Del CedroCarlsbad, CA. 92009
Telephone:	(760) 431-7400Fax: (760) 431 6768
Contact person:	Jonathan Woodward
Date Prepared:	March 19, 2003
Device Trade Name:	Surgistar Microkeratome Blade,Model No. 2410-CB
Device Common Name:	Keratome Blade, Microkeratome Blade
Device Classification Name:	Keratome (Blade Only)
Classification Regulation No.:	CLASS 1, Reserved
Classification Panel:	OPHTHALMIC
Product Code:	86 HNO

Legally marketed device to which we are claiming equivalence:

Predicate Device Name:	CARRIAZO BARRAQUERMICROKERATOME (Blade only)
Manufacturer:	MORIA, Inc.
510(k) Number:	K981741

Description of the Device:

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Page 2 of 2 Summary

Intended use of the device:

Summary of Technological characteristics of device compared to predicate device.

CHARACTERISTICS	MORIA C-B BLADE(PREDICATE)	SURGISTAR LSK-2400BLADE
Intended Use	As Indicated	Same
Target population	As Indicated	Same
Performance	Indication for use with theCarriazo BarraquerMicrokeratome.	Same
Blade Material	Low Carbon Stainless Steel	Same
Biocompatibility	For Stainless Steel Blades	Same
Mechanical Safety	Assured	Same
Sterilization Method	ETO	Same

Performance tests and conclusions:

1. Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
1. Sharpness Sharpness tests indicate the Surgistar 2410-CB performs equivalently to the Moria C-B Microkeratome blade.
1. Keratome Fit Fit tests with the Moria Carriazo Barraquer Keratome head demonstrated that the Surgistar 2410-CB fit was acceptable.
1. Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2410-CB and the Moria C-B Microkeratome blade.
1. Conclusion The Surgistar 2410-CB was demonstrated to be substantially equivalent to the predicate Moria C-B Microkeratome blade.

(Premarket Notification [510(k)] Number)

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March 19, 2003 Premarket Notification

Page 1 of 2

510(K) Summary

Surgistar 2420-M2

Submitter:	Surgistar, Inc.6068 Corte Del CedroCarlsbad, CA. 92009
Telephone:	(760) 431-7400Fax: (760) 431 6768
Contact person:	Jonathan Woodward
Date Prepared:	March 19, 2003
Device Trade Name:	Surgistar Microkeratome Blade,Model No. 2420-M2
Device Common Name:	Keratome Blade, Microkeratome Blade
Device Classification Name:	Keratome (Blade Only)
Classification Regulation No.:	CLASS 1, Reserved
Classification Panel:	OPHTHALMIC
Product Code:	86 HNO

Legally marketed device to which we are claiming equivalence:

Predicate Device Name:	CARRIAZO BARRAQUER II MICROKERATOME (Blade only)
Manufacturer:	MORIA, Inc.
510(k) Number:	K002191

Description of the Device:

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Page 2 of 2 Summary

Intended use of the device:

Summary of Technological characteristics of device compared to predicate device.

CHARACTERISTICS	MORIA CARRIAZOBARRAQUER IIMICROKERATOME BLADE(PREDICATE)	SURGISTAR M2-2420BLADE
Intended Use	As Indicated	Same
Target population	As Indicated	Same
Performance	Indication for use with theCarriazo Barraquer IIMicrokeratome.	Same
Blade Material	Low Carbon Stainless Steel	Same
Biocompatibility	For Stainless Steel Blades	Same
Mechanical Safety	Assured	Same
Sterilization Method	ETO	Same

Performance tests and conclusions:

1. Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
1. Sharpness Sharpness tests indicate the Surgistar 2420-M2 performs equivalently to the Moria M2 Microkeratome blade.
1. Keratome Fit Fit tests with the Moria Carriazo Barraquer II Keratome head demonstrated that the Surgistar 2420-M2 fit was acceptable.
1. Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2420-M2 and the Moria M2 Microkeratome blade.
1. Conclusion The Surgistar 2420-M2 was demonstrated to be substantially equivalent to the predicate Moria M2 Microkeratome blade.

(Premarket Notification [510(k)] Number)

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Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2003

Surgistar, Inc. c/o Jonathan Woodward President 6068 Corte Del Cedro Carlsbad, CA 92009

Re: K030891

Trade/Device Name: Surgistar Microkeratome Blade Models No. 2400-LSK, 2410-CB, and 2420 M2 Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: March 19, 2003 Received: March 21, 2003

Dear Mr. Jonathan Woodward:

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 docs 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 - Mr. Jonathan Woodward

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. Paulyi 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

Enclosure

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510(k) Number (if known): 503089|

Device Name: Surgistar 2420-M2 Microkeratome Blade

Indications for Use

The Surgistar 2420-M2 Microkeratome is indicated for use as a replacement blade in the Moria M2 Microkeratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

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i Number K030891

(Optional Format 3-10-98)

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March 19, 2003 Premarket Notification

510(k) Number (if known): K030891

Device Name: Surgistar 2400-LSK Microkeratome Blade

Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

lukas hicholav

Ophthalmic Ear. Throat Devises

510(k) Number K030891

(Optional Format 3-10-98)

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March 19, 2003 Premarket Notification

ﮯ

510(k) Number (if known): K030891

Device Name: Surgistar 2410-CB Microkeratome Blade

Indications for Use

The Surgistar 2410-CB Microkeratome is indicated for use as a replacement blade in the Moria Carriazo Barraquer Microkeratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use . (Per 21 CFR 801.109)

Mi R.B. Nicholas

vision of Ophthalmic Ear. Nose and Throat Devises

KO 30891 510(k) Number

(Optional Format 3-10-98)

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.