The VitreQ CryoTreQ is indicated for use in ophthalmic surgery for retinal detachment, cyclodestructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryodestruction of lash follicles for trichiasis and the treatment of retinopathy of prematurity (ROP).

Device Description

The VitreQ CryoTreQ is a disposable, handheld instrument intended for use in ophthalmic cryotherapy. The device tip is made of stainless steel. The device utilizes a pressurized cryogen which is circulated to the tip. The cryogenic material remains enclosed within the tip during application, serving to cool the metal tip during therapy. Rapid gas expansion in the tip causes freezing to the Joule-Thompson principle.

AI/ML Overview

The provided text describes the safety and effectiveness of the CryoTreQ device. The device is a disposable, handheld instrument for ophthalmic cryotherapy.

Based on the provided information, the following answers can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Pre-specified criteria were met" for non-clinical freeze and defrost testing. However, specific numerical acceptance criteria and precise performance values are not provided in a table format. The text only indicates the types of tests performed and a general conclusion that the device performed "as well as the identified legally marketed devices."

Acceptance Criteria Category	Reported Device Performance
Non-clinical Freeze and Defrost Testing	"Pre-specified criteria were met"
External Temperature Achieved	Performance comparable to predicate devices
Ice Ball Formation	Performance comparable to predicate devices
Defrost Duration	Performance comparable to predicate devices
Traction	Performance comparable to predicate devices
Device Activation Mechanism	Evaluated and met requirements
Dimensional Analyses	Evaluated and met requirements
Device Sterility	Evaluated and met requirements
Shelf Life	Evaluated and met requirements
Biocompatibility	Evaluated and met requirements
Ventilation Safety	Evaluated and met requirements
Usability	Evaluated and met requirements
Transport Stability	Evaluated and met requirements
Sterile Barrier Integrity	Evaluated and met requirements

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

The document mentions "Testing performed on CryoTreQ devices" but does not specify the sample size for any of the non-clinical tests.

The data provenance is non-clinical laboratory testing conducted to evaluate the device's performance, safety, and functionality. There is no information regarding the country of origin of this testing or whether it involved retrospective or prospective data collection from human subjects, as no clinical studies were performed.

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

This information is not provided. As no clinical studies were performed, there was no ground truth based on expert medical opinion needed for the test set. The ground truth for the non-clinical tests would be defined by engineering specifications and standards.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. Since no clinical studies were performed and the testing was non-clinical, there would be no expert adjudication process for image interpretation or clinical outcomes.

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

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted to compare human readers with or without AI assistance.

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

Not applicable. The device described is a physical medical instrument (cryophthalmic unit), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The device's performance was evaluated through non-clinical laboratory tests as a physical medical device.

7. The Type of Ground Truth Used:

The ground truth used was based on engineering specifications, pre-specified criteria, and direct physical measurements for the non-clinical performance tests (e.g., external temperature achieved, ice ball formation, defrost duration, dimensional analyses). It was not based on expert consensus, pathology, or outcomes data, as no clinical studies were conducted.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of AI development.

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

Not applicable. As the device is not an AI/ML model, there is no training set or ground truth establishment method for one.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

December 30, 2020

Vitreq B.V. % Debora Stapleton Regulatory Affairs Consultant Dynamic Strategies Inc. 25 Granite Street Medway, Massachusetts 02053

Re: K202038

Trade/Device Name: CryoTreQ Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic unit Regulatory Class: Class II Product Code: HPS Dated: November 23, 2020 Received: November 24, 2020

Dear Ms. Stapleton:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for LT Charles Chiang Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202038

Device Name CryoTreQ

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Submitter:

Submitter's Information

Vitreq BV Seggelant-Noord 2 Vierpolders Zuid-Holland, NL 3237 MG

Contact Person: Debora Stapleton Telephone Number: 774-277-2320 Date Prepared: 12/30/2020

Name of the Device

Trade or Proprietary Device Name: CryoTreQ Common Name: Cryophthalmic Unit Classification Name: Cryophthalmic Unit Classification Regulation: 21 CFR 886.4170 Product Code: HPS, Class II

Legally Marketed Predicate

Primary Predicate Device Name: D.O.R.C. Cryo Unit, 510(k) Number K940373 Secondary Predicate Device Name: Keeler Cryomatic MKII Cryosurgical System, 510(k) Number K131787 Reference Predicate Device Name: PHAKOS Disposable Retinal Cryo Probe, 510(k) Number K162756

Description of Subject Device

Intended Use

The device is intended for patients suffering from eye disease which are diagnosed to have a condition or conditions which may benefit from ophthalmic cryotherapy.

Indications for Use

The VitreQ CrvoTreQ is indicated for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclodestructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryodestruction of lash follicles for trichiasis and the treatment of retinopathy of prematurity (ROP).

Summary of Technological Characteristics

The CryoTreQ has materials, basic design, and cryogen type which are the same as for the predicate. The operational mechanism is the same; cryogenic material moves toward a closed metal tip and remains within the metal cavity during application, serving as a means to cool the tip.

{4}------------------------------------------------

Comparison to Predicate - Technological Differences

The differences between the CryoTreQ and predicate cryotherapeutic devices are that the CryoTreQ is a fully disposable unit and the cryogenic function does not require connection to other devices. The predicate devices utilize connection of a handpiece (or probe), a footswitch (or footpedal) to an electronic console for activation, and a compressed gas cylinder for cryogenic function. The CryoTreQ is self contained. The cryogen-containing canister is supplied within the instrument for single procedure use.

Characteristic	VitreQCryoTreQ	D.O.R.C. CryoUnit	KeelerCryomaticMKIICryosurgicalSystem	PHAKOSDisposableRetinal CryoProbe
510(k) NumberProduct Code(s)	K202038	K940373	K131787	K162756
Intended Use	Ophthalmiccryotherapy	Ophthalmiccryotherapy	Ophthalmiccryotherapy	Ophthalmiccryotherapy
OperationMechanism	Cooled metalcontact	Cooled metalcontact	Cooled metalcontact	Cooled metalcontact
Non-clinicalFreeze andDefrost Testing	Pre-specifiedcriteria weremet	Not evaluated	Comparisons to CryoTreQ – external temperature achieved, ice ball formation, defrost duration, and traction
ActivationMethod	Buttonactivation	Footswitchactivation	Footswitchactivation	Footswitchactivation
Electrical Sourcefor Activation	None	Battery	Mains	Mains
Cryogen SupplyFormat	Internalcompressedgas canister	Externalcompressedgas cylinder	Externalcompressedgas cylinder	Externalcompressedgas cylinder
CryogenicMedium	N2O gas	CO2 or N2Ogas	CO2 or N2Ogas	CO2 or N2Ogas
Disposable orReusable	Disposableunit	Reusableprobes	Disposableand reusableprobes	Disposableprobe

Table Comparison of Features of Vitre® CryoTreQ and Predicate Devices

Summary of Clinical Testing

No clinical studies were performed.

Summary of Non-Clinical Testing

Testing performed to evaluate the device included evaluations of the device activation mechanism, external temperature achieved, ice ball layer thickness formation, freezing events, defrost performance, dimensional analyses, device sterility, shelf life, evaluation of traction, bio-compatibility, ventilation safety, usability, transport stability, and sterile barrier integrity.

The body of testing performed on CryoTreQ devices demonstrated that they perform as well as the identified legally marketed 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.