PHAKOS Disposable Retinal Cryo Probe

K162756 · Phakos · HRN · May 3, 2017 · Ophthalmic

Device Facts

• Record ID: K162756
• Device Name: PHAKOS Disposable Retinal Cryo Probe
• Applicant: Phakos
• Product Code: HRN · Ophthalmic
• Decision Date: May 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4170
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Single-use cryosurgical probe for ophthalmic procedures; connects to external cryopexy console. Operates by delivering high-pressure N2O or CO2 gas to probe tip; rapid gas expansion creates ice ball at tip. Surgeon uses footswitch to control freeze cycle; device features automatic purge and cleaning cycles. Used by ophthalmologists in clinical settings to weld tissues via cryo-burn or extract fragments. Benefits include sterile, disposable design eliminating cross-contamination risks associated with reusable probes.

Clinical Evidence

No clinical studies were performed. Bench testing included adapter operation, EO residual measurement, and pyrogenicity evaluation via Limulus amebocyte lysate (LAL) assay, confirming endotoxin levels within limits.

Technological Characteristics

Disposable cryo probe; materials: Polyacetal (ASTM F1855), PVC (ASTM D1785), Polyamide (ISO 1874-PA11), Aluminum (ASTM B221), Stainless steel (ASTM F899), Silastic, Lexan (ASTM D3935). Energy source: N2O or CO2 gas. Features: automatic pressure regulation, footswitch control, automatic purge/clean cycles, quick-release connection. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for ophthalmic surgery including cryopexy for retinal detachment, cyclo destructive procedures for refractory glaucoma, vitreous cavity fragment extraction, cataract extraction, and cryo destruction of lash follicles for trichiasis.

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

• Keeler Cryomaster Probes (K062412 & K112093)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known)

K162756

#### 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) | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| <table border="0"><tr><td></td><td> Residential Use (Part 3 of CFR 201 Subpart B) </td><td></td><td> One-Time Construction (Part 3 of CFR 201 Subpart C) </td></tr></table> | | 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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## 510(k) Summary: PHAKOS Disposable Retinal Cryo Probe

| Date Prepared | April 26, 2017 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | PHAKOS<br>62 Rue Kléber<br>93100 Montreuil<br>FRANCE |
| Contact | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>512-692-3699 Fax<br>e-mail: [e-mail] |
| 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<br>Device | Keeler Cryomaster Probes - Keeler Instruments, Inc. (K062412 & K112093) |
| Device Description | The PHAKOS Disposable Retinal Cryo Probe is a single use item used with<br>cryopexy equipment. It produces an ice ball at the tip of the pencil allowing you to<br>treat the detachment of the retina by welding the tissues together. The ice ball is<br>the result of a specific gas released at a high pressure, N2O or CO2, allowing the<br>welding of the tissues by burn. |
| Materials | Polyacetal (ASTM F1855)<br>PVC (ASTM D1785)<br>Polyamide (ISO 1874-PA11, E, 22-010)<br>Aluminum (ASTM B221)<br>Stainless steel (ASTM F899)<br>Silastic<br>Lexan (ASTM D3935) |
| Indications for Use | The PHAKOS Disposable Retinal Cryo Probe is for use in ophthalmic surgery in<br>cryopexy for retinal detachment, cyclo destructive procedures in refractory<br>glaucoma, extraction of fragments within the vitreous cavity, cataract extraction,<br>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<br>Cryo Probe | Keeler Cryomaster Probes |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use | Same | Same |
| | Disposable | Yes | Yes |
| Technological<br>Characteristics | Cryogen Type | CO² or N²O | CO² or N²O |
| | Freeze system<br>pressure regulation | Automatic | Automatic |
| | Freeze control | Footswitch | Footswitch |
| | Purge cycle | Automatic | Automatic |
| | Auto clean | Yes | Yes |
| | Audible indicator | Yes | Yes |
| | Cryo probe connection<br>mechanism | Quick release | Quick release |
| | Disposable probe<br>connection | Connected to the console via<br>disposable probe adapter | Connected to the console via<br>disposable probe adapter |
| | Freeze zone | End freeze | End freeze |
| | Construction | Probe tip Stainless steel<br>Connector Polyacetal<br>Sleeve Aluminum<br>Tube PVC<br>Nozzle Stainless steel<br>Adapter Stainless steel | Probe tip Stainless steel<br>Connector Polyacetal<br>Sleeve Aluminum<br>Tube PVC<br>Nozzle Stainless steel<br>Adapter Stainless steel |
| | Dimensions | Same | Same |
| | Sterilization | EO sterilized | EO sterilized |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The PHAKOS Disposable Retinal Cryo Probe is fully identical to the predicate<br>device in terms of intended use, design, materials used, mechanical safety and<br>performances. | | |
| Non-clinical Test<br>Summary | The following non-clinical testing was performed:<br>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-<br>clinical and Clinical | PHAKOS considers the Disposable Retinal Cryo Probe to be strictly equivalent in<br>design, materials and processing to the predicate device listed above and has a<br>similar IFU. | | |