(160 days)
No
The device description and performance studies focus on the physical mechanism of cryotherapy and do not mention any computational or data-driven aspects indicative of AI/ML.
Yes
The device is used for cryotherapy in various ophthalmic conditions and retinal surgery, which are therapeutic interventions.
No
The device is described as being for "ophthalmic cryotherapy" and focuses on treatment procedures rather than diagnosis.
No
The device description clearly states it is a disposable, handheld instrument with a stainless steel tip that utilizes a pressurized cryogen, indicating it is a hardware device.
Based on the provided information, the VitreQ CryoTreQ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for ophthalmic surgery procedures (retinal detachment, glaucoma, cataract extraction, etc.). These are therapeutic or surgical interventions, not diagnostic tests performed on samples taken from the body.
- Device Description: The description details a handheld instrument that uses cryotherapy to freeze tissue. This is a treatment modality, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The VitreQ CryoTreQ's function is to directly treat tissue through freezing.
N/A
Intended Use / Indications for Use
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).
Product codes
HPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No clinical studies were performed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 (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
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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
CryoTreQ | D.O.R.C. Cryo
Unit | Keeler
Cryomatic
MKII
Cryosurgical
System | PHAKOS
Disposable
Retinal Cryo
Probe |
|-----------------------------------------------|----------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| 510(k) Number
Product Code(s) | K202038 | K940373 | K131787 | K162756 |
| Intended Use | Ophthalmic
cryotherapy | Ophthalmic
cryotherapy | Ophthalmic
cryotherapy | Ophthalmic
cryotherapy |
| Operation
Mechanism | Cooled metal
contact | Cooled metal
contact | Cooled metal
contact | Cooled metal
contact |
| Non-clinical
Freeze and
Defrost Testing | Pre-specified
criteria were
met | Not evaluated | Comparisons to CryoTreQ – external temperature achieved, ice ball formation, defrost duration, and traction | |
| Activation
Method | Button
activation | Footswitch
activation | Footswitch
activation | Footswitch
activation |
| Electrical Source
for Activation | None | Battery | Mains | Mains |
| Cryogen Supply
Format | Internal
compressed
gas canister | External
compressed
gas cylinder | External
compressed
gas cylinder | External
compressed
gas cylinder |
| Cryogenic
Medium | N2O gas | CO2 or N2O
gas | CO2 or N2O
gas | CO2 or N2O
gas |
| Disposable or
Reusable | Disposable
unit | Reusable
probes | Disposable
and reusable
probes | Disposable
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.