(247 days)
Not Found
No
The summary describes a laser system for phacofragmentation and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device is used to perform phacofragmentation of the cataractous crystalline lens, which is a medical treatment.
No
The device is indicated for phacofragmentation of the cataractous crystalline lens, which is a therapeutic procedure rather than a diagnostic one.
No
The device description explicitly states it is a laser system with a console, probe, and is used with a Phaco machine, all of which are hardware components. The performance studies also include testing for electrical safety, laser safety, and sterilization, indicating hardware validation.
Based on the provided information, the Cetus Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Cetus System Function: The description clearly states the Cetus Laser System is used for "phacofragmentation of the cataractous crystalline lens." This is a surgical procedure performed directly on the patient's eye to break up a cataract. It does not involve testing samples taken from the body.
The device is an ophthalmic surgical laser system used for treating cataracts.
N/A
Intended Use / Indications for Use
The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.
Product codes
HQE
Device Description
The Cetus system is a 1064nm. pulsed, Nd: YAG Q-switched laser system used together with a sterile, single use laser probe and a Phaco machine. The system console has a digital touch screen and it is used in conjunction with the Cetus probe and a Phacoemulsification machine in the operating room. The probe converts the laser light energy into acoustic energy which is used to perform the fragmentation of the the crystalline lens and has integrated aspiration and irrigation functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Crystalline lens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room
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)
Non clinical Performance Data: Performance testing was conducted in order to demonstrate that the A.R.C. Cetus System is as safe and as effective as the cleared predicate device.
The Cetus system has been tested for Electrical Safety compliance to AAMI ANSI ES60601-1:2005(R) 2012 and A1:2012, for Laser Safety to IEC 60825-1:2007, for Electromagnetic Compatibility to IEC 60601-1-2:2007, Sterilization to DIN EN ISO 11135-1:2014, Packaging Integrity to ASTM F1886/ F1886M-09:2013, Accelerated ageing of sterile barrier to ASTM F1980-07:2011, Sterile Packaging to DIN EN 868-5:2009, Microbial ranking of porous packaging materials to ASTM F1608-00:2009, Biological evaluation of EO residuals to DIN ISO 10993-7:2009 and Risk Management been conducted according to ISO 14971: 2007 + Am 2010.
According to the test results provided in this submission, we conclude that the Cetus system is as safe and effective as the predicate device.
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Public Health Service
Image /page/0/Picture/2 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2017
A.R.C. Laser GmbH % Angela Thyzel General Manager Bessemer St. 14 Nurnberg, 90411 DE
Re: K170183
Trade/Device Name: Cetus System, Cetus Probe Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: Class II Product Code: HQE Dated: August 24, 2017 Received: August 24, 2017
Dear Angela Thyzel:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Bradley S. Cunningham -S
for Malvina Eydelman, 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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Indications for Use
510(k) Number (if known) K170183
Device Name Cetus System
Indications for Use (Describe)
The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters. Below that, the word "LASER" is in a white box. Underneath the box, the phrase "enlighten your surgery" is written in a smaller, cursive font.
510(k) SUMMARY
| Title: | A.R.C. Cetus System |
|---|---|
| Submitter: | A.R.C. Laser GmbH |
| Bessemer St. 14 | |
| 90411, Nurnberg | |
| Germany | |
| Contact : | Angela Thyzel |
| Tittle : | General Manager |
| Phone : | 0911-21779-0 |
| Fax : | 0911-21779-99 |
| E-Mail: | a.thyzel@arclaser.de |
| Address: | Bessemer St. 14 |
| 90411, Nurnberg | |
| Germany | |
| Date | |
| Prepared: | September 26, 2017 |
| Device Trade | |
| Name: | Cetus System |
| Common | |
| Name: | Phacofragmentation System |
| Classification | |
| Name: | Vitreous aspiration and cutting instrument, ophthalmic |
| Device product | |
| code: | HQE |
| Device | |
| Classification | 21 CFR 886.4150 |
| Predicate | |
| Device: | Laser Photolysis System, K993154 |
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Image /page/4/Picture/1 description: The image features a logo for A.R.C. Laser, set against a vibrant blue background. The acronym "A.R.C." is prominently displayed in large, bold white letters, with the word "LASER" directly beneath it in a smaller, yet still noticeable, white font. Below the word "LASER" is a tagline in a cursive font that reads "enjoyed in your surgery".
Device Description:
The Cetus system is a 1064nm. pulsed, Nd: YAG Q-switched laser system used together with a sterile, single use laser probe and a Phaco machine. The system console has a digital touch screen and it is used in conjunction with the Cetus probe and a Phacoemulsification machine in the operating room. The probe converts the laser light energy into acoustic energy which is used to perform the fragmentation of the the crystalline lens and has integrated aspiration and irrigation functions.
Intended Use:
The Cetus Laser System is indicated for use in for phacofragmentation of the cataractous crystalline lens.
Substantial Equivalence:
The Cetus system have the same mechanism of action, same intended use and the same technological characteristics as the predicate device, the Laser Photolysis System (K993154). and that the minor differences should not raise concerns regarding safety and/ or effectiveness.
| Specification laser
| system | Subject Device | Predicate |
|---|---|---|
| 510(k) # | K170183 | K993154 |
| Manufacturer | A.R.C. Laser | A.R.C. Laser |
| Indications for Use | Intended for use in | |
| phacofragmentation of the | ||
| cataractous crystalline lens | Intended for use in | |
| phacofragmentation of the | ||
| cataractous crystalline lens | ||
| Submission includes | Cetus laser system & Cetus probe | |
| only | Laser photolysis system, probe & | |
| phaco machine | ||
| Laser media | Nd: YAG | Nd: YAG |
| Mode of operation | Pulsed, Q-Switch | Pulsed, Q-Switch |
| Wavelength | 1064 nm | 1064 nm |
| Used in combination | with a probe and a Phaco machine | with a probe and a Phaco machine |
| Laser mechanism | Shockwave | Shockwave |
| Repetition rate | Max. 20Hz | Max. 20Hz |
| Laser Class | I | I |
| Pulse length |