CryoTreQ

K202038 · VitreQ BV · HPS · Dec 30, 2020 · Ophthalmic

Device Facts

• Record ID: K202038
• Device Name: CryoTreQ
• Applicant: VitreQ BV
• Product Code: HPS · Ophthalmic
• Decision Date: Dec 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4170
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Disposable, handheld ophthalmic cryotherapy instrument. Operates via Joule-Thomson principle; pressurized N2O cryogen contained within internal canister circulates to stainless steel tip. Rapid gas expansion cools tip to create ice ball for tissue destruction or adhesion. Used by surgeons in clinical settings. Self-contained design eliminates need for external consoles, footswitches, or gas cylinders required by predicate systems. Surgeon activates cooling via button on device. Output is localized freezing of ocular tissue; facilitates surgical procedures like retinal reattachment or glaucoma management. Benefits include portability, ease of use, and elimination of reusable probe reprocessing.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by non-clinical bench testing, including evaluation of activation mechanism, external tip temperature, ice ball thickness, freezing/defrost performance, dimensional analysis, sterility, shelf life, traction, biocompatibility, ventilation safety, and usability.

Technological Characteristics

Disposable handheld cryophthalmic unit. Materials: stainless steel tip. Energy source: internal pressurized N2O gas canister. Principle: Joule-Thomson effect for tip cooling. Form factor: self-contained, single-use device. No electrical power source required for activation. Sterilization: sterile barrier packaging.

Indications for Use

Indicated for ophthalmic surgery including retinal detachment cryopexy, refractory glaucoma cyclodestructive procedures, vitreous cavity fragment extraction, cataract extraction, trichiasis lash follicle cryodestruction, and retinopathy of prematurity (ROP) treatment.

Regulatory Classification

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.

Predicate Devices

• D.O.R.C. Cryo Unit (K940373)
• Keeler Cryomatic MKII Cryosurgical System (K131787)

Reference Devices

• PHAKOS Disposable Retinal Cryo Probe (K162756)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K202038

Device Name CryoTreQ

#### Indications for Use (Describe)

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).

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

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

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.

## 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.

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## 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 | VitreQ<br>CryoTreQ | D.O.R.C. Cryo<br>Unit | Keeler<br>Cryomatic<br>MKII<br>Cryosurgical<br>System | PHAKOS<br>Disposable<br>Retinal Cryo<br>Probe |
|-----------------------------------------------|----------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| 510(k) Number<br>Product Code(s) | K202038 | K940373 | K131787 | K162756 |
| Intended Use | Ophthalmic<br>cryotherapy | Ophthalmic<br>cryotherapy | Ophthalmic<br>cryotherapy | Ophthalmic<br>cryotherapy |
| Operation<br>Mechanism | Cooled metal<br>contact | Cooled metal<br>contact | Cooled metal<br>contact | Cooled metal<br>contact |
| Non-clinical<br>Freeze and<br>Defrost Testing | Pre-specified<br>criteria were<br>met | Not evaluated | Comparisons to CryoTreQ – external temperature achieved, ice ball formation, defrost duration, and traction | |
| Activation<br>Method | Button<br>activation | Footswitch<br>activation | Footswitch<br>activation | Footswitch<br>activation |
| Electrical Source<br>for Activation | None | Battery | Mains | Mains |
| Cryogen Supply<br>Format | Internal<br>compressed<br>gas canister | External<br>compressed<br>gas cylinder | External<br>compressed<br>gas cylinder | External<br>compressed<br>gas cylinder |
| Cryogenic<br>Medium | N2O gas | CO2 or N2O<br>gas | CO2 or N2O<br>gas | CO2 or N2O<br>gas |
| Disposable or<br>Reusable | Disposable<br>unit | Reusable<br>probes | Disposable<br>and reusable<br>probes | Disposable<br>probe |

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.