The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.

Device Description

The D.O.R.C. Disposable Cryo Probe is a single-use, handheld medical device intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery. When the foot pedal of the CryoStar Console is pressed, high pressure gas (CO2 or N2O) is supplied via a small aperture to target tissue.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the D.O.R.C. Disposable Cryo Probe, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Freeze Rate: After 10s operation, an ice ball diameter shall be at least 4mm when immersed 2mm in water of 20°C with both CO2 and N₂O.	Freeze Performance: The Disposable Cryo Probe (1540.D) produced an ice ball of on average 4.9mm after 10s operation when immersed in water of 20°C with both CO2 and N2O. This meets the "at least 4mm" criterion.
Defrost Rate: Within 5s, the ice ball of at least 4mm shall be released when the defrost function is activated with both CO2 and N₂O.	Defrost Performance: The Disposable Cryo Probe (1540.D) released the ice ball of at least 4mm within 5s after activation of the defrost function with both CO2 and N2O. This meets the "within 5s" criterion.
Biocompatibility: In accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.	Biocompatibility Evaluation: The biocompatibility evaluation of the D.O.R.C. Disposable Cryo Probe was conducted in accordance with the specified FDA memorandum and International Standard ISO 10993-1, as recognized by FDA. While specific test results (e.g., cytotoxicity, irritation, sensitization) are not detailed here, the statement indicates compliance.
Compatibility with Cryostar Cryosurgical System: Demonstrated compatibility.	Both the 'freeze performance' test and the 'defrost performance' test were performed using the Cryostar (1500.III), "showing the compatibility of the Disposable Cryoprobe (1540.D) with this Cryosurgical System."

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

The document does not explicitly state the specific sample size (number of probes tested) for the freeze and defrost performance tests. It refers to the "Disposable Cryo Probe (1540.D)" and "Reusable Cryoprobe (1540)" generically, indicating these were the devices tested.

Data Provenance: The studies were laboratory (bench) performance tests, conducted internally by the manufacturer (D.O.R.C. Dutch Ophthalmic Research Center International B.V.). There is no indication of country of origin of the data beyond the manufacturer's location in The Netherlands. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

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

Not applicable. This device is a surgical instrument. The performance testing (freeze/defrost rate) involved objective measurements (ice ball diameter, time to release) rather than subjective assessment requiring expert interpretation or "ground truth" to be established by experts.

4. Adjudication Method for the Test Set

Not applicable. As the performance tests involved objective measurements, there was no need for adjudication involving human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (e.g., AI for image diagnosis) where human readers' performance with and without AI assistance is compared. The D.O.R.C. Disposable Cryo Probe is a surgical tool, and its performance is evaluated through objective physical parameters.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done in the sense that the performance of the device itself (the D.O.R.C. Disposable Cryo Probe) was evaluated objectively through laboratory (bench) tests without human intervention as part of the primary measurements (freeze and defrost rates). The study directly measured the physical output (ice ball size, defrost time) of the probe when operated with the Cryostar system.

7. Type of Ground Truth Used

The "ground truth" for the performance tests was based on objective physical measurements rather than clinical outcomes, pathology, or expert consensus.

Freeze Performance: The ground truth was the measured diameter of the ice ball (in mm).
Defrost Performance: The ground truth was the measured time (in seconds) for the ice ball to release.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical tool and does not employ a machine learning algorithm or AI that requires a "training set" of data.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

Summary

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

January 23, 2017

Dutch Ophthalmic Research Center International BV Ms. Linda van Leeuwen Manager Regulatory Affairs Scheijdelveweg 2 Zuidland, 3214 VN The Netherlands

Re: K160591

Trade/Device Name: D.O.R.C. Disposable Cryo Probe Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic Unit Regulatory Class: Class II Product Code: HRN Dated: November 29, 2016 Received: December 21, 2016

Dear Ms. van Leeuwen:

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 Industry and Consumer Education 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 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,

Denise L. Hampton -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 H

Enclosure

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Indications for Use

510(k) Number (if known) K160591

Device Name D.O.R.C. Disposable Cryo Probe

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)



Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

This summary is in accordance with 21 CFR 807.92.

Submitter

The submitter of the 510(k) is:

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Scheijdelveweg 2 3214 VN Zuidland The Netherlands

Contact person: Mrs. Daniëlle Sleegers, Manager Regulatory Affairs Phone: +31 181 458080 Email: RAUSA&Canada@dorc.eu

Date Prepared: January 20th, 2017

Device

Device Subject to this 510(k):

Trade Name:	D.O.R.C. Disposable Cryo Probe
Common Name:	Cryophthalmic Probe
Classification:	II
Classification Name:	Cryophthalmic unit (21 CFR 886.4170, Product Code HRN)

The following regulations are applicable for this 510(k):

21 CFR 886.4170 Cryophthalmic unit ●

Predicate Devices

510(k) Number	Device
K012821	Cryostar Cryosurgical System Reusable Cryo Probe (D.O.R.C.)
K131787	Cryomatic Disposable Cryo Probes (Keeler Ltd.)

Device Description

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Indications for Use

The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior or anterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.

Comparison of Technological Characteristics with the Predicate Devices

There are no technological characteristics or features of the D.O.R.C. Disposable Cryo Probe that have not been previously cleared in predicate devices as is shown in the following table.

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Description	Proposed Device -Disposable Cryo Probe(D.O.R.C.)	Cryostar Cryosurgical SystemReusable Cryo Probe(D.O.R.C.)	Cryomatic Disposable CryoProbes(Keeler Ltd.)
510(k) #	K160591	K012821	K131787
ProductCode(s)	HRN	HRN	HRN
IntendedUses	Cryophthalmic surgery	Cryophthalmic surgery	Cryophthalmic surgery
Cryogen GasDelivered	Nitrous Oxide and Carbon Dioxide	Nitrous Oxide and Carbon Dioxide	Nitrous Oxide and Carbon Dioxide
Method ofOperation	Rapid expansion of cryogenic gascauses a freezing effect accordingto the Joule-Thompson principle	Rapid expansion of cryogenic gascauses a freezing effect accordingto the Joule-Thompson principle	Rapid expansion of cryogenic gascauses a freezing effect accordingto the Joule-Thompson principle
Freeze Rate	After 10s operation an ice balldiameter shall be at least 4mmwhen immersed 2mm in water of20°C with both CO2 and N₂O	After 10s operation an ice balldiameter shall be at least 4mmwhen immersed 2mm in water of20°C with both CO2 and N2O	Unknown
Defrost Rate	Within 5s the ice ball of at least4mm shall be released whendefrost function is activated withboth CO2 and N₂O	Within 5s the ice ball of at least4mm shall be released whendefrost function is activated withboth CO2 and N2O	Unknown
Compatiblewith System	Cryostar 1500.III (K012821)	Cryostar 1500.III (K012821)	Cryomatic MKII (K131787)
ControlMechanism	Footswitch of Cryostar	Footswitch of Cryostar	Footswitch of Cryomatic MKII
Single Use	Yes	No (Reusable)	Yes
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Tip Material	Stainless Steel	Stainless Steel	Stainless Steel
HandleMaterial	Acetal	Aluminum	Metal (Unknown)
Supply Tube	Stainless Steel	Flexible plastic	High-pressure plastic
ExhaustTube	Flexible Nylon	Flexible plastic	Unknown
Tip OuterDiameter,Geometry	2.5 mm, angled	2.5 mm, angled	Unknown
Length(Handpieceand Tip)	5.4 inches (136,3 mm)	5.9 inches (150 mm)	Unknown
Total Weight	58 grams	328 grams	Unknown
Packaging	Peel Pouch	Peel Pouch

Comparison of Features of the D.O.R.C. Disposable Cryo Probe and Predicate Devices

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Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation of the D.O.R.C. Disposable Cryo Probe was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

Performance Testing

Although animal and clinical performance testing was not required for the D.O.R.C. Disposable Cryo Probe to demonstrate efficacy, safety and substantial equivalence to predicate devices, a variety of laboratory (bench) performance tests have been conducted including freeze and defrost performance and compatibility testing with the Cryostar 1500.III Cryosurgical System. The 'freeze performance' test showed that both the Disposable Cryo Probe (1540.D) and the Reusable Cryoprobe (1540) produced an ice ball of on average 4.9mm after 10s operation when immersed in water of 20℃ with both CO2 and N20. The 'defrost performance' test showed that both the Disposable Cryo Probe (1540.D) and the Reusable Cryoprobe (1540) released the ice ball of at least 4mm within 5s after activation of the defrost function with both CO2 and N2O. Therefore it was concluded that the Disposable Cryoprobe (1540.D) is equivalent to the Reusable Cryoprobe (1540). Both the 'freeze performance' test and the 'defrost performance' test were performed using the Cryostar (1500.III), showing the compatibility of the Disposable Cryoprobe (1540.D) with this Cryosurgical System.

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Standard #	Title
EN ISO 10993-1:2009/AC:2010	Biological Evaluation Of Medical Devices -- Part 1: Evaluation AndTesting
EN ISO 10993-5:2009	Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
EN ISO 10993-7:2008/AC:2009	Biological Evaluation Of Medical Devices - Part 7: Ethylene OxideSterilization Residuals
EN ISO 10993-10:2010	Biological Evaluation Of Medical Devices - Part 10: Tests ForIrritation And Sensitization
ISO 10993-12: 2012	Biological Evaluation Of Medical Devices - Part 12: SamplePreparation and Reference Materials
ISO 11135-1:2007	Sterilization Of Health-Care Products - Ethylene Oxide – Part 1:Requirements for the Development, Validation and Routine Controlof a Sterilization Process for Medical Devices
EN ISO 14971:2012	Medical Devices: Application Of Risk Management To MedicalDevices
ISO 11607-1:2009	Packaging For Terminally Sterilized Medical Devices - Part 1:Requirements For Materials, Sterile Barrier Systems And PackagingSystems
ISO 11607-2:2006	Packaging for terminally sterilized medical devices - Part 2:Validation requirements for forming, sealing and assembly processes
ISO 15223-1:2012	Medical devices - Symbols to be used with medical device labels,labelling and information to be supplied - Part 1: Generalrequirements
ASTM D4169-14	Practice for performance testing of shipping containers and systemsPractice for performance testing of shipping containers and systems
EN 62366:2008	Medical devices - Application of usability engineering to medicaldevices

The device will comply with applicable sections of the following standards:

Conclusion

The information presented in this 510(k) premarket notification demonstrates that the

D.O.R.C. Disposable Cryo Probe is substantially equivalent to the legally marketed predicate devices.

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.