(343 days)
Not Found
No
The device description focuses on mechanical and electronic features, with no mention of AI or ML algorithms for image analysis, decision support, or automated control based on complex data patterns.
Yes
The device is used for "shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea," which are medical procedures intended to treat or manage a condition (e.g., as part of a transplant procedure for corneal disease or to correct vision).
No
The device is a microkeratome, which is used for "shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea." This is a surgical tool, not a device that diagnoses a condition.
No
The device description clearly details numerous hardware components and mechanical functions (head/ring coupling, vacuum pump, blade shape, cutting head, rings, mains). It is a physical surgical instrument.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 the patient's body.
- Device Description: The description details a mechanical surgical instrument (a microkeratome) used for cutting tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a surgical procedure.
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
HNO
Device Description
The Carriazo Pendular Microkeratome is a device designed for ophthalmologic procedures. It features automatic head/ring coupling, adjustable vacuum up to 675 mm Hg, a double-headed vacuum pump, and electronic detection and signaling of cable breaks. The device utilizes a curved blade and a ball-shaped cutting head. Its stopping mechanism in the final position is automatic, and it includes distinct rings for the right and left eyes. The head is guided by two separate mains, a departure from predicates that use a single pivot on the ring, which can lead to micro-scattering on the stromal bed. The Carriazo-Pendular Microkeratome’s tissue-contact materials are biocompatible, and its sterilization methods have been validated.
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
A clinical study in 200 eyes was conducted to collect data to primarily provide reasonable assurance of the safety and effectiveness of the Carriazo-Pendular Microkeratome in a clinical setting.
An additional study has been performed at another site (Dr. Maria Arbelaez) with special focus on flap thickness, flap diameter and hinge size with different cutting heads and suction rings as declared in the product specification. This study provides evidence of the validity of labeled flap thicknesses and diameters which the different cutting heads are capable of producing.
The studies include the consistent and predictable performance of the device in meeting the clinically-selected parameters.
The results of clinical studies constitute valid scientific evidence (as described in 21 CFR 860.7) which provides reasonable assurance that the Carriazo-Pendular Microkeratome is safe and effective for its intended use. Moreover, the results of the studies also provide valid scientific evidence that the observed differences in specifications between the Carriazo-Pendular Microkeratome and its predicates are not significant in terms of the clinical performance of the device. Further, the results of clinical studies corroborate its claim of substantial equivalence to the cited predicate microkeratomes.
Key Metrics
Not Found
Predicate Device(s)
K981741, K972808, K980924, K021640, K990227, K014000
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K0329/0
SECTION 11
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the SCHWIND eye-tech-solutions Cariazo Pendular Microkeratome is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | SCHWIND eye-tech-solutions |
|---|---|
| Address: | Mainparkstrasse 6-10 |
| Kleinostheim 63801 | |
| Germany | |
| Manufacturer: | SCHWIND eye-tech-solutions GMBH & CO. KG |
| Mainparkstrasse 6-10 | |
| Kleinostheim | |
| Germany 63801 | |
| Registration Number: | 8010873 |
| Telephone: | +49/6027 508273 |
| Contact Person: | Mr. William T. Kelley |
| Telephone: | 949-292-8477 |
| Fax Number: | 509-479-4840. |
| Preparation Date: | |
| (of the Summary) | August 2004 |
| Device Name: | Carriazo Pendular Microkeratome |
| Common Name: | Keratome (microkeratome) |
| Classification: | 21 CFR 886.4370 |
| Class I | |
| Product Code: HNO | |
| Panel: 86 | |
| Predicate devices: | Carriazo Barraquer Microkeratome M2 (K981741); Hansatome Micro-keratome (K972808); Plancon Microlamellar Keratome (K980924); |
| Hansatome Excellus (K021640); UltraShaper System (K990227); Visitone |
20-10 Microkeratome (K014000).
1
The Carriazo Pendular Microkeratome is indicated for shaving the cornea Indications: prior to lamellar (partial thickness) transplant or to create a flap in the cornea.
Performance Data: A clinical study in 200 eyes was conducted to collect data to primarily provide reasonable assurance of the safety and effectiveness of the Carriazo-Pendular Microkeratome in a clinical setting.
Moreover, an additional study has been performed at another site (Dr. Maria Arbelaez) with special focus on flap thickness, flap diameter and hinge size with different cutting heads and suction rings as declared in the product specification. This study provides evidence of the validity of labeled flap thicknesses and diameters which the different cutting heads are capable of producing.
The studies include the consistent and predictable performance of the device in meeting the clinically-selected parameters.
The differences in specifications between the Carriazo-Pendular (CP) Microkeratome and its predicates (e.g., the Carriazo-Barraquer or CB) have been evaluated. Selected differences in specifications include head/ring coupling (the CP couples automatically; predicates use manual coupling); the CP vacuum is adjustable to 675 mm Hg; the predicates are constant at 625 mm Hg); the CP has a double-headed vacuum pump and the predicates single-headed vacuum pumps; the CP electronically detects and signals a cable break; the predicates lack this feature); shape of the blade (CP is curved: the predicates are straight); the CP has a ball-shaped cutting head; the predicates are straight; at the stop in final position - the CP is automatic; the predicates are not; the CP has right and left eye rings, the predicates do not; and the CP head is guided by two separate mains; the predicates by a single pivot on the ring only and the head can move up and down during the cut which can result in micro-scattering on the stromal bed). Manv specifications of the Carriazo-Pendular Microkeratome and its cited predicates are substantially the same, e.g., hinge width, diameter of the ring, conformance to EN standards and meeting CE Mark requirements.
The tissue-contact materials used in the fabrication of the Carriazo-Pendular Microkeratome have been shown to be biocompatible and the sterilization methods have been validated to a sterility assurance level of at least 10° and the packaging has been tested to assure its performance in maintaining the sterility of the components supplied sterile.
Summary:
The claim of substantial equivalence of the SCHWIND Carriazo-Pendular Microkeratome is based on clinical studies, comparisons of its specifications, intended use, and other information with the claimed predicates.
2
The results of clinical studies constitute valid scientific evidence (as described in 21 CFR 860.7) which provides reasonable assurance that the Carriazo-Pendular Microkeratome is safe and effective for its intended use. Moreover, the results of the studies also provide valid scientific evidence that the observed differences in specifications between the Carriazo-Pendular Microkeratome and its predicates are not significant in terms of the clinical performance of the device. Further, the results of clinical studies corroborate its claim of substantial equivalence to the cited predicate microkeratomes.
- Based on the information in this notification SCHWIND eye-tech-solutions CONCLUSION: believes that Carriazo Pendular Microkeratome is substantially equivalent to the claimed predicates under conditions of use described in the labeling of the Carriazo-Pendular Microkeratome.
rev. 8/2004
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2004
Schwind Eye-Tech-Solutions % William T. Kelley 23832 Via Monte Coto de Caza, CA 92679
Re: K032910
Trade/Device Name: Carriazo Pendular Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: September 18, 2003 Received: September 22, 2003
Dear Mr. Kelley:
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.
4
Page 2 -- William T. Kelley
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 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
Enclosure
5
SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ Ko32910
Device Name: Carriazo Pendular Microkeratome__________________________________________________________________________________________________________________________________
Indications for Use Statement:
The Carriazo Pendular Microkeratome is indicated for shaving the cornea The Carria20 Fondular (partial thickness) transplant or to create a flap in the cornea.
发
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use V (Per 21 CFR 801.109) OR
Over-The Counter Use ________________________________________________________________________________________________________________________________________________________
Clay R. Buttner
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K032910