(51 days)
Not Found
No
The device description and performance studies focus on mechanical function and ice ball creation, with no mention of AI/ML terms or data processing.
Yes
The device is described as "PHAKOS Disposable Retinal Cryo Probe and Accessories" and its intended use is "for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis." These are all medical procedures aimed at treating conditions or diseases, thus qualifying it as a therapeutic device.
No
The device is a surgical tool used for cryopexy and other procedures, not for identifying a condition or disease.
No
The device description clearly details a mechanical accessory (cryoprobe adapter) and a disposable retinal cryo probe, which are hardware components used in ophthalmic surgery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The PHAKOS Disposable Retinal Cryo Probe and Accessories are used directly in ophthalmic surgery to perform procedures like cryopexy, cyclo destructive procedures, and extraction of fragments. They are surgical tools that physically interact with the patient's eye.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient, not tests performed on samples from the patient.
The device is a surgical instrument used in ophthalmic procedures, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.
Product codes
HRN
Device Description
The cryoprobe adapter is a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe is the same for all adapters; the body varies according to the generator used. The adapter is fitted on the generator in the place of the original cryoprobe, and remains in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal rear end piece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical tests: The following analyses were conducted: creation of the ice ball. The results of these evaluations indicate that the Frigitronics Adapter is equivalent to predicate devices.
Clinical tests: No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 16, 2018
Phakos % J D Webb Authorized Contact Person The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681
Re: K180195
Trade/Device Name: Frigitronics adapter Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic unit Regulatory Class: Class II Product Code: HRN Dated: January 19, 2018 Received: January 24, 2018
Dear J D Webb:
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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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 of medical devicerelated 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley S. Cunningham -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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Indications for Use
510(k) Number (if known) K180195
Device Name Frigitronics Adapter
Indications for Use (Describe)
The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.
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: Frigitronics Adapter
| Date Prepared | March 09, 2018 | |
|---|---|---|
| Submitted By | PHAKOS | |
| 62 Rue Kléber | ||
| 93100 Montreuil | ||
| FRANCE | ||
| o.aumaitre@phakos.com | ||
| Primary Contact | J.D. Webb | |
| 1001 Oakwood Blvd | ||
| Round Rock, TX 78681 | ||
| 512-388-0199 Tele | ||
| e-mail: jdwebb@orthomedix.net | ||
| Trade Name | Frigitronics Adapter | |
| Common Name | cryomatic probe adapter | |
| Classification Name | Unit, Cryophthalmic, Ac-powered | |
| Class | II | |
| Product Code | HRN | |
| CFR Section | 21 CFR section 886.4170 | |
| Device Panel | Ophthalmic | |
| Primary Predicate | ||
| Device | PHAKOS Disposable Retinal Cryo Probe (K162756) | |
| Device Description | The cryoprobe adapter is a mechanical accessory used to adapt the PHAKOS Disposable | |
| Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected | ||
| to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe | ||
| is the same for all adapters; the body varies according to the generator used. | ||
| The adapter is fitted on the generator in the place of the original cryoprobe, and remains | ||
| in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal | ||
| rear end piece. | ||
| Materials | Stainless steel per ASTM F899 | |
| Polyoxymethylene (acetal) per ASTM D6778 | ||
| Substantial | ||
| Equivalence Claimed | ||
| to Predicate Devices | The Frigitronics Adapter is substantially equivalent to the predicate devices in terms of | |
| intended use, design, materials used, mechanical safety and performances. | ||
| Summary of the | ||
| technological | ||
| characteristics | ||
| compared to | ||
| predicate | Criteria | Demonstration of Equivalency |
| Intended Use | The intended use of the Frigitronics Adapter is the same as the other Phakos adapters. | |
| Material | The PHAKOS Frigitronics Adapter uses the same material as the other PHAKOS adapters. | |
| Design | The Frigitronics Adapter and the other PHAKOS adapters are equivalent in terms of shape, | |
| Disposable probe | ||
| connection | The disposable cryo probes are connected to the console via the Frigitronics Adapter and the other PHAKOS adapters. | |
| Non-clinical Test | ||
| Summary | The following analyses were conducted: | |
| • creation of the ice ball | ||
| The results of these evaluations indicate that the Frigitronics Adapter is equivalent to predicate devices. | ||
| Clinical Test | ||
| Summary | No clinical studies were performed | |
| Conclusions: Non- | ||
| clinical and Clinical | PHAKOS considers the Frigitronics Adapter to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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