(14 days)
Not Found
No
The description focuses on mechanical and optical aspects of the device and does not mention AI or ML.
No
The device is used for shaving the cornea to create a flap or prior to transplant, which are surgical procedures, not therapeutic treatments.
No
The device is described as a microkeratome used for shaving the cornea or creating a flap, which are surgical procedures, not diagnostic ones. Its function is to perform a physical alteration (cutting) rather than to identify or analyze a medical condition.
No
The device description explicitly lists hardware components such as a console, cutting heads, suction rings, and foot switches, in addition to monitoring software.
Based on the provided information, the Carriazo-Pendular Microkeratome is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "shave the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea." This is a surgical procedure performed directly on a living patient's tissue.
- Device Description: The device is a surgical instrument used for cutting tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
The Carriazo-Pendular Microkeratome is a surgical device used for ophthalmic procedures.
N/A
Intended Use / Indications for Use
The Carriazo-Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.
Product codes (comma separated list FDA assigned to the subject device)
HNO
Device Description
The Carriazo-Pendular is an AC powered microkeratome.
Cutting head and blade are designed in a convex form similar to the cornea itself. Due to the unique pendulum motion of the Carriazo-Pendular, the cornea becomes more applanated in the center than in the periphery. This technology provides a homogeneous and predictable flap thickness and smooth cutting edges.
The Carriazo-Pendular consists of:
- Carriazo-Pendular console: The console controls and guards the cutting process and guides the surgeon through the use of the microkeratome. Additional parameters will be saved for later analysis.
- Cutting heads: Different heads are available in order to adjust for different flap thicknesses.
- Suction rings: The suction ring is necessary to fixate the eye during the cut. Different suction rings for different flap diameters are available. The hinge position can be freely selected (360 degrees).
- Foot switches: The foot switch starts the vacuum, and forward and backward movement of the microkeratome.
- Monitoring software: The software was developed for read out of relevant monitored data, which are stored during the operation in the Carriazo-Pendular console. These data can be used for quality insurance, supporting the doctor in the process of improving the cutting execution and analysis of potential cut complications.
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
Test on pig eyes and clinical performance data on human eyes shows that the new cutting heads perform flaps similar to the existing heads except for the different flap thicknesses.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test on pig eyes and clinical performance data on human eyes shows that the new cutting heads perform flaps similar to the existing heads except for the different flap thicknesses.
Functional testing, cleaning validation and biocompatibility tests demonstrate that the device performs as intended.
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.
Carriazo-Pendular Microkeratome (K032910), BD K-4000 TM Microkeratome (K023092), INTRALASE FS Laser (K041893)
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 logo for SCHWIND eye-tech-solutions CARRIAZO-PENDULAR. The word "SCHWIND" is in large, bold, sans-serif font at the top of the image. Below that is a curved line, and below that is the phrase "eye-tech-solutions" in a smaller font. The words "CARRIAZO-PENDULAR" are in a bold, sans-serif font at the bottom of the image.
:
082043
Page 1 of 3
510(k) Summary
AUG - 1 2008
| Applicant: | SCHWIND eye-tech-solutions |
|---|---|
| Address: | Mainparkstrasse 6-10 |
| Germany 63801 Kleinostheim | |
| Manufacturer: | SCHWIND eye-tech-solutions GmbH & Co.KG |
| Mainparkstrasse 6-10 | |
| Germany 63801 Kleinostheim | |
| Registration Number: 8010873 | |
| Telephone: | +49/6027 5080 |
| Fax Number: | +49/6027 508208 |
| Contact Person: | Mr. Rolf Schwind |
| Preparation Date: | |
| (of the Summary) | May 2007 |
| Device Name: | Carriazo-Pendular Microkeratome |
| Common Name: | Keratome (microkeratome) |
| Classification: | 21 CFR 886.4370 |
| Class I | |
| Product Code: HNO | |
| Panel: 86 | |
| Predicated Devices: | Carriazo-Pendular Microkeratome (K032910) |
| BD K-4000 TM Microkeratome (K023092) | |
| INTRALASE FS Laser (K041893) |
1
Image /page/1/Picture/0 description: The image contains the logo for "SCHWIND" in a bold, sans-serif font. Below the logo is a curved line with the text "eye-tech-solutions" centered underneath. The words "CARRAIAZO-PENDULAR" are printed in a bold, sans-serif font at the bottom of the image.
Device Description:
The Carriazo-Pendular is an AC powered microkeratome.
Cutting head and blade are designed in a convex form similar to the cornea itself. Due to the unique pendulum motion of the Carriazo-Pendular, the cornea becomes more applanated in the center than in the periphery. This technology provides a homogeneous and predictable flap thickness and smooth cutting edges.
The Carriazo-Pendular consists of:
| Carriazo-Pendular console: | The console controls and guards the cutting
process and guides the surgeon through the use
of the microkeratome. Additional parameters
will be saved for later analysis. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cutting heads: | Different heads are available in order to adjust
for different flap thicknesses. |
| Suction rings: | The suction ring is necessary to fixate the eye
during the cut. Different suction rings for
different flap diameters are available. The hinge
position can be freely selected (360 degrees). |
| Foot switches: | The foot switch starts the vacuum, and forward
and backward movement of the microkeratome. |
| Monitoring software: | The software was developed for read out of
relevant monitored data, which are stored
during the operation in the Carriazo-Pendular
console. These data can be used for quality
insurance, supporting the doctor in the process
of improving the cutting execution and analysis
of potential cut complications. |
Intended Use:
The Carriazo-Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.
2
Image /page/2/Picture/0 description: The image shows the logo for SCHWIND eye-tech-solutions CARRAIAZO-PENDULAR. The text "SCHWIND" is in a bold, sans-serif font at the top of the image. Below that, the text "eye-tech-solutions" is in a smaller, sans-serif font. The text "CARRAIAZO-PENDULAR" is in a bold, sans-serif font at the bottom of the image.
Page 3 of 3
Technological Characteristics:
The Carriazo-Pendular is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Carriazo-Pendular (K032910), amongst others.
The new Carriazo-Pendular has the following similarities compared to the predicate Carriazo-Pendular (K032910):
- . same intended use,
- same fundamental scientific technology and the same operating principle, .
- . same manufacturing processes,
- . construction of identical materials.
Compared to the predicated Carriazo-Pendular (K032910) the new Carriazo-Pendular differs in the following features:
- . additional cutting heads,
- . different sterilization process,
- . improved blade box,
- . Pendular Monitoring Software.
Performance tests/data:
Test on pig eyes and clinical performance data on human eyes shows that the new cutting heads perform flaps similar to the existing heads except for the different flap thicknesses.
Functional testing, cleaning validation and biocompatibility tests demonstrate that the device performs as intended.
Conclusion:
Based on the information in the notification, SCHWIND eye-tech-solutions believes that Carriazo-Pendular Microkeratome is substantially equivalent to the claimed predicate devices and does not raise new questions in terms of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2008
SCHWIND eye-tech-solutions c/o Mr. Stefan Preiss TÜV SÜD America Inc. 1775 Old Highway 8 NW New Brighton, MN 55112-1891
Re: K082043
| Trade/Device Name: | Carriazo-Pendular Microkeratome |
|---|---|
| Regulation Number: | 21 CFR 886.4370 |
| Regulation Name: | Keratome, AC-Powered (Microkeratome) |
| Regulatory Class: | I |
| Product Code: | HNO |
| Dated: | July 11, 2008 |
| Received: | July 18, 2008 |
Dear Mr. Preiss:
Wc 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.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Edwards, and
Malvina B, Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1/1
Indications for Use
510{k) Number (if known):
Device Name:
082043
Carriazo Pendular Microkeratrom
The Carriazo Pendular Microkeratom indicated for Indications for Use: shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea. Over-The-Counter Use OR Prescription Use × (Per 21 CFR 801.109) . . . . . . . PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED Cocurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K092043