The Keeler Cryomatic System and probes are for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis and treatment of retinopathy of prematurity (ROP).

Device Description

The Cryomatic MKII console is a self-contained system. The console consists of a rigid PU enclosure, housing the principle subsystems, switch mode power supply, controller PCB and pneumatic control module. On the front of the console is an LCD screen and membrane key panel. The console provides the connection point for the range of probe (reusable and disposable), footswitch, mains electricity, gas supply and scavenging system.

There is a variety of Keeler Re-usable Cryomatic Probes whose stainless tips are shaped depending on surgical application. The plastic handle is permanently connected to flexible pressure hose and integral connector, which connects to Cryomatic MKII Console.

The Keeler Disposable Cryo Probe comprises a stainless steel stem with a metal handle connected to a 2m long bi-lumen high-pressure plastic hose contained within a protective outer tube and terminated with a customdesigned plastic connector for insertion into the Cryomatic MKII console.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Keeler Cryomatic MKII System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Evaluated Aspects)	Reported Device Performance
a) Probe external temperature and repeatability	Confirmed to be comparable with the predicate device.
b) Iceball growth capability	Confirmed to be comparable with the predicate device.
c) Defrost performance	Confirmed to be comparable with the predicate device.
d) Tractive power	Confirmed to be comparable with the predicate device.
Electrical Safety (IEC 60601-1)	In compliance with the standard.
Electromagnetic Compatibility (IEC 60601-1-2)	In compliance with the standard.
Sterilization of Re-usable Probes	Validation of the steam sterilization process was carried out to demonstrate that the sterilization parameters outlined in the instruction for use are sufficient to sterilize the modified probes. The modified device's sterilization methods (Pre-vacuum (porous load) 134 - 137 °C, 3 minutes and 18 minutes) were validated and deemed acceptable, despite differing from the predicate's gravity method and having only one method instead of two for some parameters.
Intended Use	Unchanged from the predicate device and the original 510(k) clearances (K062412 & K112093). The device maintains its indications for use in ophthalmic surgery (cryopexy for retinal detachment, cyclodestructive procedures, extraction of fragments, cataract extraction, cryodestruction of lash follicles, and treatment of retinopathy of prematurity). This was confirmed through a comparison of IFUs and overall assessment that the modifications do not affect safety or effectiveness.
Coupling Mechanism	The new quick-release coupling mechanism accepts both Keeler Cryomatic disposable and re-useable probes without an adaptor. This was observed as a design modification that did not affect safety or effectiveness.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each verification test. It refers to "verification tests" and "all tests," implying a comprehensive evaluation.

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that Keeler Instruments Inc. is based in Broomall, PA, USA, and the 510(k) is submitted to the FDA, it is highly probable that the testing was conducted in a manner consistent with US regulatory requirements for medical devices. The nature of the modifications (simplification of a coupling mechanism) suggests bench testing and internal validation rather than clinical trials with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish "ground truth" in the context of diagnostic accuracy. This submission is for a modification to an existing surgical system, not a diagnostic imaging device that requires expert interpretation. The "ground truth" for this device's performance would be established through engineering and performance testing against predefined specifications and recognized standards.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this is a modification to a surgical device, not a diagnostic AI system requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study is not mentioned and would not be relevant for this type of device modification. This device is a surgical instrument, not an assistive technology for diagnostic interpretation.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

Not explicitly applicable in the context of a "standalone algorithm." The device itself functions as a "standalone" surgical tool in that it performs its intended function without requiring human input beyond operating it. The "verification tests" described are essentially standalone performance evaluations of the modified hardware and associated software.

7. The Type of Ground Truth Used

The "ground truth" for this device modification is based on:

Engineering Specifications: The device's performance (probe temperature, iceball growth, defrost, tractive power) was measured against established specifications for the predicate device and the new design.
Safety Standards: Compliance with recognized international standards (IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility).
Sterilization Validation: Specific protocols and measurements to ensure the re-usable probes could be adequately sterilized according to defined parameters.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for this device would be its design, engineering tolerances, and manufacturing processes.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reasons as point 8.

Summary

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K131787

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510(k) Summary of Safety and Effectiveness

Submitter Name and Address 1.

Ophthalmic Instruments

Keeler Instruments Inc 459 Parkway Broomall PA 19008

Contact:	Eugene R Van Arsdale (Marketing Manager)
Phone:	1 610 353 4350
Fax:	1 610 353 7814
Email:	erv@keelerusa.com

April 2013 (revised December 2013) Date Prepared:

2. Device Name (Unmodified)

Trade Name: Common/Usual Name: Classification Name: 886.4170 Regulation No: Device Regulatory Class: II HRN Product Code: Review Panel: Ophthalmic 510(k) Number: K062412 & K112093

Cryomatic System and Probes Cryophthalmic Surgical System and Probes Unit, Cryophthalmic, AC-powered

3. Proposed Modification

. '

The proposed modification described in this Special 510(k) covers the simplification of the coupling mechanism to accept both Keeler Cryomatic disposable and re-useable probes without the use of a special adaptor.

Since the launch of the Keeler Cryomatic System , a disposable version of the Retinal Probe has become available which has a different interface connection than that of the Keeler Re-usable Probe range which resulted in Keeler developing an adaptor so that the disposable variant could be connected to the console.

The modification has simplified the probe coupling system. It is a safe, quick release coupling that accepts both the Keeler range of modified reuseable probes and Keeler disposable probes (unchanged), without the need for a special adaptor.

The intended use of the Keeler Cryomatic System and Probes is unchanged following the introduction of the new coupling mechanism. The control of the freeze and defrost functions is the same as that for the current Keeler range of non-disposable probes.

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Keeler

Ophthalmic Instruments

4. Device Description Console

Crvomatic Probes

Method of Operation

When the footswitch is pressed, high pressure cryogen gas is circulated through the Cryo probe, rapid gas expansion in the probe tip causes freezing according to the Joule-Thompson principle. This gas supply to the probe tip is controlled using solenoid valves interconnected via an arrangement of galleries in a manifold.

The system displays user information by means of a graphical LCD on the front panel. All relevant information such as operating state, warnings, condition of gas cylinder and any fault information is displayed in an unambiguous fashion.

5. Labeling and Intended Use

Instructions for use (IFU) for the Keeler Cryomatic System have been updated to incorporate the use of the new coupling mechanism.

A separate reusable probe IFU will no longer be supplied with each probe as is currently the case. Instead a copy of the IFU supplied with the console will be supplied with the probes.

Console labels have been updated to identify the MKII model, and packaging labels for the reusable probes have been updated with revised part numbers of the modified versions.

The IFU for the disposable probes has also been updated to reference the new Cryomatic System.

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The intended use of the Keeler Cryomatic System & Probes (including the disposable probe) is the same as originally cleared under the original 510(k) premarket notifications (K062412 &K112093).

6. Materials Biocompatibility

With respect to materials that come into direct contact intentionally with the eve during surgery, there are no changes. In both types of probe, the exposed stem is made of stainless steel with a smooth welded tip. This tip is formed by electron beam welding utilizing the parent material, which does not require addition of any other materials such as flux or weld filler.

7. Sterilization and Shelf Life

The Sterilization method (pre-sterilised with ethylene oxide gas) for the single use Disposable Cryo Probes is unchanged.

The recommended method for sterilizing re-usable probes is steam sterilization, which remains unchanged. As the design of the re-usable probes has changed, validation of the steam sterilization process was carried out to demonstrate that the sterilization parameters outlined in the instruction for use are sufficient to sterilize the modified probes.

Comparison of the device with the Predicate 8.

The comparison table below summarizes the similarities and differences between both systems, with respect to safety and effectiveness, which are discussed in more detail in the following sections.

CharacteristicFeatures	Modified Device	Cryomatic Systemand Probes	Notes
GeneralArrangement	Desktop console withOptional trolley	Desktop console withOptional trolley	No change
Cryogen Type	CO2 or N2O	CO2 or N2O	No change
Single cylinderconnection	Yes	Yes	No change
Freeze systempressureregulation	Automatic	Automatic	No change
Freeze control	Footswitch	Footswitch	No change

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Ophthalmic Instruments

Purge Cycle	Manual	Automatic	Purge cycle is notrequired for thedisposable probe,user initiates thepurge cycle forreusable probes.The purge cycle isintended toremove any debrisleft in the reusableprobes followingthe sterilizationprocess.The modificationdoes not affect thesafety oreffectiveness ofthe device
Auto-clean	Yes	Yes	No change
Audible Indicator	Yes	Yes	No change
Cryo-probeconnectionmechanism	Quick release	Quick releaseConsole - 2 maleplugsProbes - 2 femaleplug sockets	The couplingmechanism hasbeen updated toaccommodateboth disposableand reusableprobes.The modificationdoes not affect thesafety oreffectiveness ofthe device
Disposable probeconnection	No adaptor required	Connected to theconsole viadisposable probeadaptor	The couplingmechanism hasbeen updated toaccommodateboth disposableand reusableprobes.The modificationdoes not affect thesafety oreffectiveness ofthe device
Instruction forUse (IFU)	The IFU (Part # EP59-11410) has beenupdated to includeinstructions on how tooperate the newcoupling mechanism,new graphics havebeen added to thesymbols section, thelist of probes usedwith the devices hasbeen updated toreference the modifiedprobe part numbersas well the disposableprobes and theTrouble Shootingsection has beenupdated.	IFU supplied with theconsole (Part # 2509-P-8012)The list of probesused with theCryomatic Consoledoes not referencethe disposable probe	The intend use ofthe device has notchangedThe modificationsdo not affect thesafety oreffectiveness ofthe device
Instruction forUse (IFU)	IFU (part # EP59-11410) supplied withthe console and theprobes	IFU supplied with theconsole (part # 2509-P-8012)IFU supplied withprobes (part #KCU402)	The IFU (part #EP59-11410)contains all theinformationneeded to safelyoperate andconsole andprobes
Disposable probeIFU (Part # 2508-P-7022)	IFU (Part # EP59-41003) updated toapprove use withmodified console.For use only with theKeeler DisposableProbe Adapter (2508-P-8026) andCryomatic Console(2509-P-1000) or theCryomatic MKIIConsole (2509-P-1010)	For use only with theKeeler DisposableProbe Adapter (2508-P-8026) andCryomatic Console(2509-P-1000)	Allows use withthe modifiedconsole
Freeze Zone	End freeze	End freeze	No change
Construction	Stainless steel(Electron beamwelding)	Stainless steel(Electron beamwelding)	No change
Probe range	Full range ofophthalmic probes	Full range ofophthalmic probes	No change
Electrical supply	mains	mains	No change
Control system	Embedded micro-controller (embeddedsoftware)	Embedded micro-controller (embeddedsoftware)	Software has beenupdated toincorporatedchanges to thecouplingmechanismThe modificationdoes not affect thesafety oreffectiveness ofthe device
Sterilization	Pre-vacuum (porousload) 134 - 137 °C(273-279 °F)3 minutesPre-vacuum (porousload) 134 - 137 °C(273-279 °F)18 minutes	Pre-vacuum (porousload) 134 - 137 °C(273-279 °F)3 minutesGravity 121-124°C(250-255°F)30 minutes	No requirement tohave two methodsof sterilization.The sterilizationmethods havebeen validatedThe modificationdoes not affect thesafety oreffectiveness ofthe device

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Keeler

Ophthalmic Instruments

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Ophthalmic Instruments

9. Performance and Safety

Verification tests have been carried out to confirm that the cryogenic performance and safety aspects of the modified console and probes are comparable with the Keeler Cryomatic System and Probes cleared for marketing under 510(k) K062412 and K112093.

These verification tests evaluated the following aspects:

a) Probe external temperature and repeatability
b) Iceball growth capability
c) Defrost performance
d) Tractive power

The modified Keeler Cryomatic System and probes have been evaluated against the requirements of IEC 60601-1 for electrical safety and to IEC 60601-1-2 for electromagnetic compatibility.

In all tests the modified device was in compliance with these FDA recognized standards.

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Keeler

Ophthalmic Instruments

Substantial Equivalence 10.

The modified Keeler Cryomatic System and Probes (Keeler Cryomatic MKII System), is considered to be substantially equivalent to the Cryomatic System and Probes described in the original 510(k) submissions (K062412 &K112093).

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Image /page/7/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird in flight, positioned to the right. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is presented in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

December 23, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Keeler Instruments, Inc. Mr. Eugene R. Van Arsdale Marketing Manager 456 Parkway Broomall, PA 19008-4295

Re: K131787

Trade/Device Name: Cryomatic MKII Console, Cryomatic MKII Probes, Disposable Cryo Probes Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic Unit Regulatory Class: Class II Product Code: HRN Dated: November 25, 2013

Received: November 26, 2013

Dear Mr. Van Arsdale:

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.

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Page 2 - Mr. Eugene R. Van Arsdale

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 (reporting of medical device-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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Deborah L. Falls -S

for 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

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2. Indications for Use Statement

510(k) Number (if known): K131787

Device Name: Keeler Cryomatic MKII Cryosurgical System.

Indications for Use:

Prescription Use _ V__________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles Chiang -S 2013.12.16 11:46:15 -05'00'

Regulation Number and Section

§ 886.4170 Cryophthalmic unit.

(a)
Identification. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.(b)
Classification. Class II.