(215 days)
Not Found
No
The device description and performance studies focus on the mechanical and thermal properties of the cryo probe, with no mention of AI or ML.
Yes
The device is used to treat medical conditions, specifically retinal detachment and glaucoma, by creating an ice ball to weld tissues or for destructive procedures. This direct medical intervention for treatment classifies it as a therapeutic device.
No
The device is described as a surgical probe used for treatment (cryopexy) in ophthalmic surgery, not for diagnosing conditions.
No
The device description clearly states it is a "Disposable Retinal Cryo Probe" which is a physical probe used in surgery, not a software-only device. It also mentions producing an "ice ball" and using gas, indicating hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The PHAKOS Disposable Retinal Cryo Probe is a surgical tool used directly on the patient's eye during ophthalmic surgery. It creates an ice ball to treat retinal detachment and other eye conditions by physically interacting with the tissue.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient. Its function is entirely therapeutic and surgical.
The description clearly indicates a surgical instrument used for treatment, not a device for analyzing samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The PHAKOS Disposable Retinal Cryo Probe is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataraction, and cryo destruction of lash follicles for trichiasis.
Product codes (comma separated list FDA assigned to the subject device)
HRN
Device Description
The PHAKOS Disposable Retinal Cryo Probe is a single use item used with cryopexy equipment. It produces an ice ball at the tip of the pencil allowing you to treat the detachment of the retina by welding the tissues together. The ice ball is the result of a specific gas released at a high pressure, N2O or CO2, allowing the welding of the tissues by burn.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retinal, vitreous cavity, lash follicles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmic surgery
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 non-clinical testing was performed: The operation of the adapters for single use cryods on different equipment EO residual measurement Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The testing demonstrated that the subject device meets the recommended maximum endotoxin level.
No clinical studies were performed.
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles forming the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2017
PHAKOS % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681
Re: K162756
Trade/Device Name: PHAKOS Disposable Retinal Cryo Probe Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic Unit Regulatory Class: Class II Product Code: HRN Dated: April 12, 2017 Received: April 13, 2017
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.
1
Page 2 - J.D. Webb
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Denise L. Hampton -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
2
Indications for Use
510(k) Number (if known)
Device Name
PHAKOS Disposable Retinal Cryo Probe
Indications for Use (Describe)
The PHAKOS Disposable Retinal Cryo Probe is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataraction, and cryo destruction of lash follicles for trichiasis.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| Residential Use (Part 3 of CFR 201 Subpart B) One-Time Construction (Part 3 of CFR 201 Subpart C) | Residential Use (Part 3 of CFR 201 Subpart B) | One-Time Construction (Part 3 of CFR 201 Subpart C) | ||
| Residential Use (Part 3 of CFR 201 Subpart B) | One-Time Construction (Part 3 of CFR 201 Subpart C) |
Y Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary: PHAKOS Disposable Retinal Cryo Probe
| Date Prepared | April 26, 2017 |
|---|---|
| Submitted By | PHAKOS |
| 62 Rue Kléber | |
| 93100 Montreuil | |
| FRANCE | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | PHAKOS Disposable Retinal Cryo Probe |
| Common Name | cryomatic probe |
| Classification Name | Cryophthalmic unit |
| Class | II |
| Product Code | HRN |
| CFR Section | 21 CFR section 886.4170 |
| Device Panel | Ophthalmic |
| Primary Predicate | |
| Device | Keeler Cryomaster Probes - Keeler Instruments, Inc. (K062412 & K112093) |
| Device Description | The PHAKOS Disposable Retinal Cryo Probe is a single use item used with |
| cryopexy equipment. It produces an ice ball at the tip of the pencil allowing you to | |
| treat the detachment of the retina by welding the tissues together. The ice ball is | |
| the result of a specific gas released at a high pressure, N2O or CO2, allowing the | |
| welding of the tissues by burn. | |
| Materials | Polyacetal (ASTM F1855) |
| PVC (ASTM D1785) | |
| Polyamide (ISO 1874-PA11, E, 22-010) | |
| Aluminum (ASTM B221) | |
| Stainless steel (ASTM F899) | |
| Silastic | |
| Lexan (ASTM D3935) | |
| Indications for Use | The PHAKOS Disposable Retinal Cryo Probe 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. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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| | Characteristic | PHAKOS Disposable Retinal
Cryo Probe | Keeler Cryomaster Probes |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use | Same | Same |
| | Disposable | Yes | Yes |
| Technological
Characteristics | Cryogen Type | CO² or N²O | CO² or N²O |
| | Freeze system
pressure regulation | Automatic | Automatic |
| | Freeze control | Footswitch | Footswitch |
| | Purge cycle | Automatic | Automatic |
| | Auto clean | Yes | Yes |
| | Audible indicator | Yes | Yes |
| | Cryo probe connection
mechanism | Quick release | Quick release |
| | Disposable probe
connection | Connected to the console via
disposable probe adapter | Connected to the console via
disposable probe adapter |
| | Freeze zone | End freeze | End freeze |
| | Construction | Probe tip Stainless steel
Connector Polyacetal
Sleeve Aluminum
Tube PVC
Nozzle Stainless steel
Adapter Stainless steel | Probe tip Stainless steel
Connector Polyacetal
Sleeve Aluminum
Tube PVC
Nozzle Stainless steel
Adapter Stainless steel |
| | Dimensions | Same | Same |
| | Sterilization | EO sterilized | EO sterilized |
| Substantial
Equivalence Claimed
to Predicate Devices | The PHAKOS Disposable Retinal Cryo Probe is fully identical to the predicate
device in terms of intended use, design, materials used, mechanical safety and
performances. | | |
| Non-clinical Test
Summary | The following non-clinical testing was performed:
The operation of the adapters for single use cryods on different equipment EO residual measurement Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The testing demonstrated that the subject device meets the recommended maximum endotoxin level. | | |
| Clinical Test Summary | No clinical studies were performed | | |
| Conclusions: Non-
clinical and Clinical | PHAKOS considers the Disposable Retinal Cryo Probe to be strictly equivalent in
design, materials and processing to the predicate device listed above and has a
similar IFU. | | |