The Freddo is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Device Description

The Freddo is a non-invasive therapeutic device. The cold air therapy device cools and dehumidifies the air, which can be used to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. The cold air therapy device is intended to cool the patient's skin locally and is intended to be used contactless. The subject Freddo device is substantially equivalent as the currently cleared Cryo 6 (K060395).

The mechanical assembling consists of a housing, a chassis with 4 rotating rollers and a shelf plate. The chassis includes all technical components, like compressor, evaporator, condenser, fans, and all electrical power components. On the upper front cover, the user interface control it operated via membrane keyboard.

The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface. The user interface can be controlled via membrane keyboard. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface.

AI/ML Overview

The provided text does not contain information about specific clinical studies or performance data for the FREDDO device that would allow for a detailed description of acceptance criteria and a study proving device performance in the manner requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Cryo V6.0, K060395) through a comparison of technological characteristics and compliance with general safety and performance standards.

Here's what can be extracted and what is missing:

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

The document lists performance characteristics in a comparison table, but these are specifications rather than acceptance criteria derived from a clinical study.

Performance Characteristic (for the subject device, Freddo)	Reported Device Performance (Freddo)	Predicate Device Performance (Cryo V6.0)	Discussion/Acceptance Implication
Measurement at device outlet (Temperature)	-17°C to -28°C (± 3°C)	-31°C	Similar, not significantly different
Measurement at device outlet (Air speed)	160 to 780 liters/minute (± 10%)	100 to 1000 liters/minute	Similar, not significantly different
Therapy time, treatment time	15:00 – 90:00 min timer – user selectable	1-99 minute timer - user selectable	Similar, not significantly different

No explicit "acceptance criteria" for clinical effectiveness are provided, as this is a substantial equivalence submission based on technical similarity rather than a new clinical claim. The "acceptance criteria" here implicitly revolve around meeting the performance specifications to be considered substantially equivalent to the predicate.

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

This information is not provided in the document. The submission relies on technical verification and validation, and comparison to a predicate device, not a specific clinical test set.

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)

This information is not provided in the document. Experts were not involved in establishing ground truth for a clinical test set because no such test set is described.

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

This information is not provided in the document, as no clinical test set requiring adjudication is described.

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

This information is not provided in the document. The FREDDO device is a cold air therapy device, not an AI-assisted diagnostic or interpretative tool, so an MRMC study is not relevant.

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

This information is not provided in the document. The device is a medical instrument, not an algorithm.

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

This information is not provided as no clinical ground truth was established for the purpose of a clinical performance study. The "ground truth" in this submission relates to the functional performance of the device against engineering specifications and its equivalence to the predicate.

8. The sample size for the training set

This information is not provided in the document. This device is not an AI/ML algorithm that would require a training set.

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

This information is not provided in the document, as there is no training set for this type of device.

Summary of available information regarding the study that proves the device meets acceptance criteria:

The "study" demonstrating the device meets performance expectations and is safe and effective largely consists of:

Compliance with recognized standards: The device was investigated and tested against various IEC and ISO standards related to medical electrical equipment, basic safety, essential performance, electromagnetic disturbances, usability, software life cycle processes, risk management, symbols, and biocompatibility.
- Standards include: IEC 60601-1 Ed. 3.2, IEC 60601-1-2 Ed. 4.1, IEC 60601-1-6 Ed. 3.2, IEC 62366-1 Ed. 1.1, IEC 62304 Ed. 1.1, ISO 14971 Ed. 3, ISO 15223-1 Ed. 4, ISO 10993-1 Ed. 5.
Software Verification and Validation Testing: Performed according to IEC 62304. All tests were successful and met acceptance criteria, demonstrating suitability for intended use and no identified risks.
Biocompatibility Testing: Assessed per ISO 10993-1. Concluded that no additional biocompatibility requirements existed because the device does not contact the patient and the user contacts it only via gloved hands.
Electrical Safety and Electromagnetic Compatibility (EMC): Underwent testing and complies with IEC 60601-1 Ed. 3.2 and IEC 60601-1-2 Ed. 4.1.
Comparison to Predicate Device (Cryo V6.0, K060395): The submission argues that the FREDDO device has similar technological characteristics, identical intended use, and similar performance characteristics to the legally marketed predicate device, with differences not raising new questions of safety or effectiveness.

In conclusion, the approval of the FREDDO device is based on its substantial equivalence to a predicate device and compliance with established performance and safety standards, rather than a clinical study evaluating its direct clinical performance against specific acceptance criteria.

Summary

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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 18, 2024

Fabinject Industria e Comercio Importacao e Exportacao Ltda % Aleksandro Gardano Principal Consultant, Regulatory Affairs Regulab 34 Pinar del Rio Avenue Brownsville, Texas 78526

Re: K242132

Trade/Device Name: FREDDO Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 2, 2024 Received: July 22, 2024

Dear Aleksandro Gardano:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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).

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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-devices/deviceadvice-comprehensive-regulatory-assistance/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.

TANISHA L. HITHE -S

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K242132

Device Name Freddo

Indications for Use (Describe) The Freddo is indicated to be used to:

Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

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

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER:	Fabinject Ind Com Imp Exp LtdaRua Eng Joao Porfirio Macedo, 40112072-270 Taubaté-SP, BrazilEstablishment Registration: 02.289.126/0001-53
	Mr. Gianmaria Cominato FilhoManager, CEOPhone: +55-12-36021415Cell phone: +55-11-995881511E-mail: gcf@fabinject.com.br
CONTACT:	Aleksandro Garrido GardanoPrincipal Consultant Regulatory AffairsPhone: +55-11-36021415Cell phone: +55-11-993352632E-mail: agg@fabinject.com.br
DATE PREPARED:	October 17, 2024
II. DEVICE:
TRADE NAME:	Freddo
COMMON NAME:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
CLASSIFICATION NAME:	Powered Laser Surgical
Instrument DEVICE CLASSIFICATION:	Class II, 21 CFR
§878.4810 PRODUCT CODE:	GEX
III. PREDICATE DEVICE:	Cryo V6.0 (K060395)

IV. DEVICE DESCRIPTION:

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V. INDICATONS FOR USE:

Freddo is indicated to be used to:

Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The technological characteristics and operating principle associated with the treatment of Freddo delivers remain unchanged from the predicate device produces cold air for blowing on patient's skin locally and is intended to be contactless.

The technological similarities and differences between the subject device (Freddo) and the predicate device (Zimmer Cryo-6) are described below in the comparison table. The differences do not raise any new questions regarding safety or effectiveness.

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Comparison with thePredicate Device	SUBJECT DEVICEFabinject Ind Com Imp Exp LtdaFreddo (This Submission)	PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo V6.0 (K060395)	Discussion
Product Code andRegulation	General & Plastic Surgery 21CFR 878.4810GEX - Powered Laser SurgicalInstrument	General & Plastic Surgery 21CFR 878.4810GEX - Powered Laser SurgicalInstrument	Identical
Device Description	The Freddo Cold Air Device utilizesa compressor, evaporator, and fanto cool the patient's skin locally andcontactless.	The Zimmer Cryo V6.0 Cold AirDevice utilizes a compressor,evaporator and fan to cool room airand then direct it onto skin.	Identical
Intended Use	The Freddo is intended to minimizepain and thermal injury during laserand dermatological treatments andfor temporary topical anestheticrelief for injections.	The Cryo V6.0 Cold Air Device isintended to minimize pain and thermalinjury during laser and dermatologicaltreatments and for temporary topicalanesthetic relief for injections.	Identical
PerformanceCharacteristicsMeasurement atdevice outlet	-17°C to -28°C (± 3°C)At an air speed of160 to 780 liters/minute (± 10%).	-31°CAt an air speed of100 to 1000 liters/minute.	Similar, notsignificantly different
Cooling Method,Operation principle	Cooling agent-based condenser andevaporation system. Cold air isproduced which is then directed ontothe skin. Conduction,evaporation, and forcedconvection cool the skin.	Cooling agent-based condenser andevaporation system. Cold air isproduced which is then directed ontothe skin. Conduction,evaporation, and forced convectioncool the skin.	Identical
Cooling Material	Gas (Air)	Gas (Air)	Identical
Mains Voltage	120V / 60Hz	100V - 120V / 50-60Hz	Similar, not importantfor the device safetyand effectivenessevaluation
Main Fuse	16A circuit breaker in main switch for120V10A circuit breaker in main switch for220V	16A circuit breaker in main switch	Similar, not importantfor the device safetvand effectivenessevaluation
Power Consumption	Max. 11A	Max. 9 - 11A	No impact
IP classification	IPX0	IPX0	Identical
Design	Metal enclosure	Metal enclosure	Identical
Materials	Environmentally approved R404,closed loop cooling system	Environmentally approved R507,closed loop cooling system	Both environmentallyapproved, no impact
Cooling spot Size	Varies with distance from distal endof air hose to tissue - 10cm² @ 5cmdistance	Varies with distance from distal endof air hose to tissue - 10cm² @ 5cmdistance	Identical
Fan speed settings	1 - 3	1 - 9	No impact
Comparison with thePredicate Device	SUBJECT DEVICEFabinject Ind Com Imp Exp LtdaFreddo (This Submission)	PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo V6.0 (K060395)	Discussion
Interface	N/A	N/A	Identical
Therapy time,treatment time	15:00 – 90:00 min timer – userselectable	1-99 minute timer - userselectable	Similar, notsignificantlydifferent
Time delay tooperate	Immediate from pressing start buttononce unit achieves standby mode	Immediate from pressing start buttononce unit achieves standby mode	Identical
Compatibility withthe environment	R404Ozone destruction level 0	R507Ozone destruction level 0	Bothenvironmentallyapproved, noimpact
Display	LCD display	LCD display	Identical
Weight withoutaccessories	55 kg	60 kg	No impact
Dimensions	H 710 mm x W 480 mm x D 510 mm	H 645 mm x W 390 mm x D 680 mm	Different dimensionshave no influenceon the device safetyandeffectivenessevaluation
Operating AmbientTemperature andHumidity	Temperature: 10 - 35°CHumidity: 20-80% relative humiditywithout condensationAir pressure: 900-1060 hPa	Temperature: 10 - 35°CHumidity: 20-80% relative humiditywithout condensationAir pressure: 900-1060 hPa	Identical
StorageandTransport	Storage: Temperature: 0 - 40°CHumidity: 10-90% relative humiditywithout condensationAir pressure: 600-1060 hPaTransport: Temperature: -10 - 50°CHumidity: 10-90% relative humiditywithout condensationAir pressure:600-1060 hPa	Storage: Temperature: 0 - 40°CHumidity: 10-90% relative humiditywithout condensationAir pressure: 600-1060 hPaTransport: Temperature: -10 - 50°CHumidity: 10-90% relative humiditywithout condensationAir pressure:600-1060 hPa	Identical
EnvironmentalSpecifications	For indoor use only	For indoor use only	Identical

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VII. PERFORMANCE DATA:

The Freddo has been investigated and tested against and complies with the following recognized standards:

Standards	StandardsOrganization	Standards Title
60601-1 Edition 3.2 2020-08CONSOLIDATED VERSION	IEC	Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance
60601-1-2 Edition 4.1 2020-09 CONSOLIDATEDVERSION	IEC	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests
60601-1-6 Edition 3.2 2020-07 CONSOLIDATEDVERSION	IEC	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability
62366-1 Edition 1.12020-06CONSOLIDATED VERSION	IEC	Medical devices - Part 1: Application of usability engineering tomedical devices
62304 Edition 1.12015-06CONSOLIDATED VERSION	IEC	Medical devices software -software life cycle processes
14971 Third Edition2019-12	ISO	Medical devices - Application of risk management to medical devices
15223-1 Fourth edition2021-07	ISO	Medical devices - Symbols to be used with medical device labels,labeling, and information to be supplied - Part 1: Generalrequirements
10993-1 Fifth edition2018-08	ISO	Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process

Software Verification and Validation Testing

After evaluation of the specified use conditions, it could be demonstrated that the technical design including software flow and device usage of the Freddo is suitable to fulfill the specified intended use. In both formative and summative testing performed, no application problems were identified that could lead to any risk for the user, patient or third.

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The verification of the software requirements was performed according IEC 62304. All the tests were performed successfully and met their acceptance criteria.

Biocompatibility Testing

The device has been assessed for the requirement of biocompatibility testing per ISO 10993-1. Since the device is not intended to contact the patient and the user contacts the device only through gloved hands, there are no additional biocompatibility requirements for the device.

Electrical safety and electromagnetic compatibility (EMC)

The device has undergone electrical and mechanical safety performance testing and electromagnetic compatibility testing. The system complies 60601-1 Edition 3.2 and 60601-1-2 Edition 4.1.

VIII. CONCLUSION:

The proposed indications for use for the Freddo are the same as those cleared in K060395. The subject device described in this submission is essentially the same device cleared in K060395. The Freddo device has the same intended use as the predicate and do not imply new technological characteristics.

According to the Risk-Benefit analysis, the global residual risk has been deemed acceptable since it falls in the area between negligible risks and acceptable risks.

The Freddo is substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.