(88 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of replacement surgical blades, with no mention of software, algorithms, or data processing.
Yes
The device is a replacement blade for a microkeratome, which is used in surgery for lamellar resection of the cornea, indicating its use in a medical procedure to treat a condition.
No
The device is a microkeratome blade, which is used for the surgical procedure of lamellar resection of the cornea. It is an instrument used for treatment, not diagnosis.
No
The device description explicitly states the device consists of a stainless steel blade and a plastic holder, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Surgistar Microkeratome blades are described as replacement blades for surgical instruments used in procedures on the cornea. Their intended use is for "initial lamellar resection of the cornea" in patients undergoing surgery. This is a surgical procedure performed directly on the patient's body, not an examination of a specimen taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic information derived from testing specimens.
Therefore, the Surgistar Microkeratome blades are surgical instruments, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
86 HNO
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.
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)
-
- 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 equivalently to the Moria LSK-ONE.
-
- Keratome Fit Fit tests with the Moria LSK-ONE Keratome head demonstrated that the Surgistar 2400-LSK fit was acceptable.
-
- 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 equivalent to the predicate Moria LSK-ONE.
-
- Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
-
- Sharpness Sharpness tests indicate the Surgistar 2410-CB performs equivalently to the Moria C-B Microkeratome blade.
-
- Keratome Fit Fit tests with the Moria Carriazo Barraquer Keratome head demonstrated that the Surgistar 2410-CB fit was acceptable.
-
- Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2410-CB and the Moria C-B Microkeratome blade.
-
- Conclusion The Surgistar 2410-CB was demonstrated to be substantially equivalent to the predicate Moria C-B Microkeratome blade.
-
- Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
-
- Sharpness Sharpness tests indicate the Surgistar 2420-M2 performs equivalently to the Moria M2 Microkeratome blade.
-
- Keratome Fit Fit tests with the Moria Carriazo Barraquer II Keratome head demonstrated that the Surgistar 2420-M2 fit was acceptable.
-
- Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2420-M2 and the Moria M2 Microkeratome blade.
-
- Conclusion The Surgistar 2420-M2 was demonstrated to be substantially equivalent to the predicate Moria M2 Microkeratome blade.
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
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 Cedro
Carlsbad, CA. 92009 |
|--------------------------------|----------------------------------------------------------------|
| Telephone: | (760) 431-7400
Fax: (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 MICROLAMELLAR
KERATOME; LSK-1 Keratome (Blade only) |
|------------------------|----------------------------------------------------------------|
| Manufacturer: | PLANCON INSTRUMENTS (Moria, Inc.) |
| 510(k) Number: | K970377 |
Description of the Device:
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.
1
March 19, 2003 Premarket Notification
Page 2 of 2 Summary
Intended use of the device:
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.
Summary of Technological characteristics of device compared to predicate device.
| CHARACTERISTICS | MORIA LSK-ONE BLADE
(PREDICATE) | SURGISTAR LSK-2400
BLADE |
|----------------------|-------------------------------------------------------|-----------------------------|
| Intended Use | As Indicated | Same |
| Target population | As Indicated | Same |
| Performance | Indication for use with the
LSK-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:
-
- 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.
-
- Keratome Fit Fit tests with the Moria LSK-ONE Keratome head demonstrated that the Surgistar 2400-LSK fit was acceptable.
-
- 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)
2
March 19, 2003 Premarket Notification
Page 1 of 2
510(K) Summary
Surgistar 2410-CB
| Submitter: | Surgistar, Inc.
6068 Corte Del Cedro
Carlsbad, CA. 92009 |
|--------------------------------|----------------------------------------------------------------|
| Telephone: | (760) 431-7400
Fax: (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 BARRAQUER
MICROKERATOME (Blade only) |
|------------------------|--------------------------------------------------|
| Manufacturer: | MORIA, Inc. |
| 510(k) Number: | K981741 |
Description of the Device:
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.
3
Page 2 of 2 Summary
Intended use of the device:
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.
Summary of Technological characteristics of device compared to predicate device.
| CHARACTERISTICS | MORIA C-B BLADE
(PREDICATE) | SURGISTAR LSK-2400
BLADE |
|----------------------|---------------------------------------------------------------------|-----------------------------|
| Intended Use | As Indicated | Same |
| Target population | As Indicated | Same |
| Performance | Indication for use with the
Carriazo Barraquer
Microkeratome. | 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:
-
- Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
-
- Sharpness Sharpness tests indicate the Surgistar 2410-CB performs equivalently to the Moria C-B Microkeratome blade.
-
- Keratome Fit Fit tests with the Moria Carriazo Barraquer Keratome head demonstrated that the Surgistar 2410-CB fit was acceptable.
-
- Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2410-CB and the Moria C-B Microkeratome blade.
-
- Conclusion The Surgistar 2410-CB was demonstrated to be substantially equivalent to the predicate Moria C-B Microkeratome blade.
(Premarket Notification [510(k)] Number)
4
March 19, 2003 Premarket Notification
Page 1 of 2
510(K) Summary
Surgistar 2420-M2
| Submitter: | Surgistar, Inc.
6068 Corte Del Cedro
Carlsbad, CA. 92009 |
|--------------------------------|----------------------------------------------------------------|
| Telephone: | (760) 431-7400
Fax: (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:
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.
5
Page 2 of 2 Summary
Intended use of the device:
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.
Summary of Technological characteristics of device compared to predicate device.
| CHARACTERISTICS | MORIA CARRIAZO
BARRAQUER II
MICROKERATOME BLADE
(PREDICATE) | SURGISTAR M2-2420
BLADE |
|----------------------|------------------------------------------------------------------------|----------------------------|
| Intended Use | As Indicated | Same |
| Target population | As Indicated | Same |
| Performance | Indication for use with the
Carriazo Barraquer II
Microkeratome. | 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:
-
- Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
-
- Sharpness Sharpness tests indicate the Surgistar 2420-M2 performs equivalently to the Moria M2 Microkeratome blade.
-
- Keratome Fit Fit tests with the Moria Carriazo Barraquer II Keratome head demonstrated that the Surgistar 2420-M2 fit was acceptable.
-
- Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2420-M2 and the Moria M2 Microkeratome blade.
-
- Conclusion The Surgistar 2420-M2 was demonstrated to be substantially equivalent to the predicate Moria M2 Microkeratome blade.
(Premarket Notification [510(k)] Number)
6
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.
A
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.
7
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
8
d.
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)
lit. Köblichers
I hroat I
i Number K030891
(Optional Format 3-10-98)
9
March 19, 2003 Premarket Notification
d.
510(k) Number (if known): K030891
Device Name: Surgistar 2400-LSK Microkeratome Blade
Indications for Use
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.
(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)
10
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)