(57 days)
No
The device description and performance studies focus on mechanical adaptation and ice ball creation, with no mention of AI/ML terms or functionalities.
Yes
The device is used for cryopexy in retinal detachment, destructive procedures in glaucoma, and cryo destruction of lash follicles, which are all therapeutic medical procedures.
No
The device is described as a "cryoprobe" and "adapter" used in ophthalmic surgery for procedures like cryopexy and cryodestruction, which are therapeutic interventions. There is no mention of its use for diagnosis or obtaining diagnostic information.
No
The device description clearly states it is a mechanical accessory (ADAPTER) and a disposable cryo probe, both of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in ophthalmic surgery for procedures performed on the patient's eye (cryopexy, cyclo destructive procedures, extraction, cataract extraction, cryo destruction of lash follicles). This is a therapeutic and surgical application, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a cryoprobe and an adapter used to connect it to a cryosurgery generator. This is a surgical instrument, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
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
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)
The following analyses were conducted: creation of the ice ball The results of these evaluations indicate that the MIRA ADAPTER is equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
June 02, 2020
PHAKOS % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven. UT 84401
Re: K200911
Trade/Device Name: MIRA Adapter Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic unit Regulatory Class: Class II Product Code: HRN Dated: March 30, 2020 Received: April 6, 2020
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. 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 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
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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-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 Advice (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 Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200911
Device Name MIRA 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: MIRA ADAPTER
| Date Prepared | May 28, 2020 | |
|---|---|---|
| Submitted By | PHAKOS | |
| 62 Rue Kléber | ||
| 93100 Montreuil | ||
| FRANCE | ||
| o.aumaitre@phakos.com | ||
| Primary Contact | J.D. Webb | |
| 4313 W. 3800 S | ||
| West Haven, UT 84401 | ||
| 512-5905810 Tele | ||
| e-mail: jdwebb@orthomedix.net | ||
| Trade Name | MIRA 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) | |
| Reference Predicates | FRIGITRONICS ADAPTER (K180195) | |
| 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 MIRA ADAPTER is substantially equivalent to the predicate devices in terms of | |
| intended use, design, materials used, mechanical safety and performances. | ||
| 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. | ||
| Summary of the | ||
| technological | ||
| characteristics | ||
| compared to | ||
| predicate | Criteria | Demonstration of Equivalency |
| Intended Use | The intended use of the MIRA ADAPTER is the same as the | |
| other Phakos ADAPTERS. | ||
| Material | The PHAKOS MIRA ADAPTER uses the same material as the | |
| other PHAKOS ADAPTERS. | ||
| Design | The MIRA 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 MIRA ADAPTER and the other PHAKOS ADAPTERS. | ||
| Non-clinical Test | ||
| Summary | The following analyses were conducted: | |
| creation of the ice ballThe results of these evaluations indicate that the MIRA ADAPTER is equivalent to | ||
| predicate devices. | ||
| Clinical Test | ||
| Summary | No clinical studies were performed | |
| Conclusions: Non- | ||
| clinical and Clinical | PHAKOS considers the MIRA ADAPTER to be substantially 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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