IMAGE STORAGE SYSTEM, MODEL KSS-400

K081797 · Konan Medical, Inc. · NFJ · Jan 22, 2009 · Radiology

Device Facts

• Record ID: K081797
• Device Name: IMAGE STORAGE SYSTEM, MODEL KSS-400
• Applicant: Konan Medical, Inc.
• Product Code: NFJ · Radiology
• Decision Date: Jan 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The KSS-400 Image Storage System is a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes

Device Story

KSS-400 is a software-based image management system for corneal specular microscopy. It accepts corneal images captured by compatible specular microscopes as input. The software performs automated analysis to calculate clinical metrics: cell density, coefficient of variation, and hexagonality. It also provides data storage functionality. The system is designed to run on a standard personal computer. Healthcare providers use the output metrics to assess corneal health and support clinical decision-making regarding corneal status. The device benefits patients by providing standardized, automated quantification of corneal endothelial cell characteristics.

Clinical Evidence

No new clinical data was generated for this submission. The manufacturer states that extensive clinical testing was performed for this system as part of the clearance of one of the predicate devices. The software underwent extensive non-clinical validation and testing.

Technological Characteristics

Software-only product designed for installation on a user-provided personal computer. Performs automated image analysis of corneal specular microscopy images. Connectivity is via standard PC interfaces for image import and storage.

Indications for Use

Indicated for automatic analysis and storage of corneal images captured by specular microscopes. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Konan Noncon Robo Pachy (K980357)
• SNT Image Processing System (K992354)
• Konan Noncon Robo F&A Specular Microscope (K062763)

Submission Summary (Full Text)

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JAN 2 2 2009

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## Konan Medıcal Inc

### Konan KSS-400 Image Storage System

510(k) Submissıon

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510(k) Summary

- (1) Submitter Information
Name Konan Medical Inc

Address 10-29 Mıyanıshı-Cho

Nıshımomıya

662 Japan

Telephone Number 011-81-798-36-3456

Contact Person Dr George Myers (Official Correspondent)

Medsys Inc

377 Rt 17 S

Hasbrouck Heights, NJ 07604

201-727-1703

Date Prepared January 16, 2009

(2) Name of Device

Trade Name Konan KSS-400 Image Storage System

Common Name Computer system for analysis of specular microscope images

Classification Name System, Image management, Ophthalmıc

(3) Equivalent legally-marketed devices

Konan Noncon Robo Pachy, K980357

SNT Image Processing System, K992354

Konan Noncon Robo F&A Specular Microscope, K062763

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#### (4) Description

The KSS 400 Image Storage System is a software product that permits users to analyze corneal images made by Konan specular microscopes in a separate computer and to store them in the computer's memory

### (5) Intended Use

The KSS-400 Image Storage System is a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes "

(6) Technological characterist1cs

The KSS-400 1s a software product, to be used with the purchaser's own Personal Computer

(b) Performance data

(1) Non-clinical tests

The software has been extensively validated and tested

(2) Clinical tests

Extensive clinical tests were performed for this system as part of the clearance of one of the predicate devices

(3) Conclusions

The Konan KSS 400 is equivalent in safety and efficacy to the legally marketed predicate devices

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Konan Medical. Inc c/o George H Myers, Sc D Medsys, Inc 377 Route 17 South Hasbrouck Heights, NJ 07604

JAN 2 2 2009

Re K081797

Trade/Device Name Konan KSS-400 Image Storage System Regulation Number 21 CFR 892 2050 Regulation Name Picture archiving and communications system Regulatory Class Class II Product Code NFJ, NQE Dated January 7, 2009 Received January 8, 2009

Dear Dr Myers

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, Insting 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

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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 [phone] 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 Brometric'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 [phone] or [phone] or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours.

M.B. Egolston, mD

Malvina B Evdelman, 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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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (1f known) K081797

Device Name KSS-400 Image Storage System

Indications for Use

"The KSS-400 Image Storage System 1s a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonalıty usıng ımages taken by the specular mıcroscopes "

Prescription Use_ X___________________________________________________________________________________________________________________________________________________________

OR

Over-the-Counter Use ------------

(Per 21 CFR 810 109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rebel Re

f Onhthalmic and Far. and Throat Dev

K081797 510(k) Number.