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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PHAKOS Disposable Retinal Cryo Probe. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on its own performance metrics. Therefore, many of the requested categories for a study proving device performance are not applicable or cannot be extracted from this document directly.

Here's a breakdown of the information that can be extracted and a clear statement where information is not available within the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria as a quantitative benchmark for the PHAKOS Disposable Retinal Cryo Probe's own performance (e.g., a specific ice ball size or temperature achieved in a defined time). Instead, it focuses on demonstrating that its characteristics are identical to a legally marketed predicate device.

Therefore, the "acceptance criteria" are implied to be "being identical to the predicate device in terms of intended use, design, materials used, mechanical safety, and performances." The "reported device performance" is then its similarity to the predicate.

Characteristic	Acceptance Criteria (Implied: Identical to Predicate)	PHAKOS Disposable Retinal Cryo Probe Performance (Statement)
Indications for Use	Same as Keeler Cryomaster Probes	Same
Disposable	Yes	Yes
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 console via disposable probe adapter	Connected to console via disposable probe adapter
Freeze Zone	End freeze	End freeze
Construction (Materials)	Same materials as Keeler Cryomaster Probes	Probe tip: Stainless steel; Connector: Polyacetal; Sleeve: Aluminum; Tube: PVC; Nozzle: Stainless steel; Adapter: Stainless steel
Dimensions	Same as Keeler Cryomaster Probes	Same
Sterilization	EO sterilized	EO sterilized
Overall Equivalence	Strictly equivalent to predicate in design, materials, processing, and similar IFU	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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes non-clinical bench testing, not a human-subject study with a "test set" in the context of clinical data. The non-clinical tests performed were:

Operation of adapters for single-use cryodes on different equipment.
EO residual measurement.
Pyrogenicity evaluation using the Limulus amebocyte lysate (LAL) assay.

The sample sizes for these bench tests are not specified in the document. The data provenance is also not specified, though the manufacturer (PHAKOS) is based in France.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This was a non-clinical bench study, not a study involving expert-established ground truth for diagnostic or interpretative performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this was not a study requiring adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device, nor was an MRMC study performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (cryo probe), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" would be established by standardized laboratory methods and specifications (e.g., maximum allowable endotoxin levels for pyrogenicity, acceptable ranges for EO residuals, functional integrity during operation). The document states the device "meets the recommended maximum endotoxin level," which implies comparison against an established standard.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not a machine learning model.

9. How the ground truth for the training set was established

Not applicable, as this is a physical medical device and not a machine learning model.

Summary of Key Findings from the Document:

The PHAKOS Disposable Retinal Cryo Probe underwent non-clinical bench testing to demonstrate its substantial equivalence to its predicate device, the Keeler Cryomaster Probes. The "acceptance criteria" were primarily focused on demonstrating identical characteristics and performance to the predicate device in aspects like indications for use, disposable nature, cryogen type, freeze system, control mechanisms, construction materials, dimensions, and sterilization method.

Specific non-clinical tests included evaluating the operation of adapters, measuring EO residuals, and assessing pyrogenicity using the LAL assay, with the device reportedly meeting recommended maximum endotoxin levels. No clinical studies were performed for this 510(k) submission, and therefore, there are no details on clinical efficacy, human reader performance, or AI-related metrics.

Summary

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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 (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

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Indications for Use

510(k) Number (if known)

K162756

Device Name

PHAKOS Disposable Retinal Cryo Probe

Indications for Use (Describe)

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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510(k) Summary: PHAKOS Disposable Retinal Cryo Probe

Date Prepared	April 26, 2017
Submitted By	PHAKOS62 Rue Kléber93100 MontreuilFRANCE
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-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 PredicateDevice	Keeler Cryomaster Probes - Keeler Instruments, Inc. (K062412 & K112093)
Device Description	The PHAKOS Disposable Retinal Cryo Probe is a single use item used withcryopexy equipment. It produces an ice ball at the tip of the pencil allowing you totreat the detachment of the retina by welding the tissues together. The ice ball isthe result of a specific gas released at a high pressure, N2O or CO2, allowing thewelding 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)SilasticLexan (ASTM D3935)
Indications for Use	The PHAKOS Disposable Retinal Cryo Probe is for use in ophthalmic surgery incryopexy for retinal detachment, cyclo destructive procedures in refractoryglaucoma, 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 RetinalCryo Probe	Keeler Cryomaster Probes
	Indications for Use	Same	Same
	Disposable	Yes	Yes
TechnologicalCharacteristics	Cryogen Type	CO² or N²O	CO² or N²O
	Freeze systempressure regulation	Automatic	Automatic
	Freeze control	Footswitch	Footswitch
	Purge cycle	Automatic	Automatic
	Auto clean	Yes	Yes
	Audible indicator	Yes	Yes
	Cryo probe connectionmechanism	Quick release	Quick release
	Disposable probeconnection	Connected to the console viadisposable probe adapter	Connected to the console viadisposable probe adapter
	Freeze zone	End freeze	End freeze
	Construction	Probe tip Stainless steelConnector PolyacetalSleeve AluminumTube PVCNozzle Stainless steelAdapter Stainless steel	Probe tip Stainless steelConnector PolyacetalSleeve AluminumTube PVCNozzle Stainless steelAdapter Stainless steel
	Dimensions	Same	Same
	Sterilization	EO sterilized	EO sterilized
SubstantialEquivalence Claimedto Predicate Devices	The PHAKOS Disposable Retinal Cryo Probe is fully identical to the predicatedevice in terms of intended use, design, materials used, mechanical safety andperformances.
Non-clinical TestSummary	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 indesign, materials and processing to the predicate device listed above and has asimilar IFU.

Regulation Number and Section

§ 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.