(30 days)
The Cryo 7 is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
The Cryo 7 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 Cryo 7 device is the same as the currently-cleared Cryo 6 (K060395), except for branding and state-of-the-art updates. Both the subject device and predicate device are manufactured by Zimmer MedizinSysteme GmbH. 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 touchscreen. 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 capacitive touch display. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface.
The provided text describes the Zimmer MedizinSysteme Cryo 7 device, its intended use, and its comparison to a predicate device (Cryo V6.0, K060395). It also details the performance data and testing conducted to support its substantial equivalence.
Here's an analysis of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values as typically found in a clinical study report comparing a device against specific thresholds for accuracy, sensitivity, or specificity.
Instead, the performance characteristics are described in comparison to the predicate device in a qualitative manner, and compliance with various standards is listed. The key performance comparison is for the air temperature and speed.
| Feature / Criteria | Predicate Device (Cryo V6.0 - K060395) Performance | Subject Device (Cryo 7) Performance | Comparison Summary / Acceptance |
|---|---|---|---|
| Performance Characteristics | |||
| Measurement at device outlet | -30°C at an air speed of 100 to 1000 liters/minute. | -30°C ± 3°C at an air speed of 210 ± 40 to 600 ± 100 liters/minute. | Similar, not significantly different. |
| Compliance and Testing | |||
| Software Verification & Validation | N/A | Performed against IEC 62304 standards; all tests met acceptance criteria. | Successful. |
| Biocompatibility | N/A (implied) | Assessed per ISO 10993-1; no additional requirements since no patient contact. | Met. |
| Electrical Safety & EMC | N/A (implied) | Complies with ES60601-1 and IEC 60601-1-2. | Met. |
| Usability | N/A (implied) | Complies with IEC 60601-1-6 and IEC 62366-1. | Met. |
| Risk Management | N/A (implied) | Complies with ISO 14971. | Met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" of patient data in the conventional sense for evaluating diagnostic accuracy or treatment effectiveness using AI. The Cryo 7 is a non-invasive therapeutic device for cooling, and the evaluation focuses on its physical and functional performance, safety, and substantial equivalence to a predicate device.
Therefore, there is no sample size for a test set of patient data mentioned, nor is there information on data provenance (country of origin, retrospective/prospective). The study described is primarily a bench testing and engineering verification study rather than a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there is no "test set" of patient data requiring clinical ground truth established by experts, this information is not applicable and not provided in the document.
4. Adjudication Method
As there is no clinical test set requiring ground truth establishment, no adjudication method (e.g., 2+1, 3+1) is mentioned or relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
No MRMC study was conducted. The device is not an AI-assisted diagnostic or therapeutic aid for human readers. Its function is to provide cold air. Therefore, evaluating human reader improvement with AI assistance is not applicable to this device.
6. Standalone (Algorithm Only) Performance Study
The Cryo 7 is a physical medical device, not an algorithm, so a standalone algorithm-only performance study is not applicable. The software integral to the device was verified, but this is different from an "algorithm only" study for AI.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on engineering specifications, compliance with recognized standards (e.g., electrical safety, EMC, software lifecycle, usability), and physical performance measurements (e.g., air temperature and speed) compared to its predicate and its own design requirements. It's not a clinical ground truth like pathology or outcome data.
8. Sample Size for the Training Set
There is no "training set" in the context of machine learning or AI algorithms mentioned for this device. The development process would involve standard engineering design, testing, and verification.
9. How the Ground Truth for the Training Set Was Established
As there is no training set as understood in AI/ML, this question is not applicable. The device's design and performance are based on established engineering principles and regulatory standards, not on learning from a dataset.
In summary: The provided document describes a 510(k) premarket notification for the Cryo 7 device, which is a physical cold air therapy device. The evaluation presented is focused on demonstrating substantial equivalence to a predicate device through engineering and performance comparisons, safety testing, and compliance with general medical device standards. It does not involve AI/ML components or clinical studies that would require the establishment of complex ground truth for patient data by experts.
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February 4, 2022
Zimmer MedizinSysteme GmbH % Scott Blood Principal Consultant Quality and Regulatory Services 151 Gleasondale Road Stow, Massachusetts 01775
Re: K220020
Trade/Device Name: Cryo 7 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: December 29, 2021 Received: January 5, 2022
Dear Scott Blood:
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.
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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 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 mediation-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.
Purva Pandya 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) K220020
Device Name Cryo 7
Indications for Use (Describe) The Cryo 7 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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Image /page/3/Picture/1 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font. Below the word "zimmer" is the word "MedizinSysteme" in a smaller, sans-serif font. The logo is simple and modern.
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| I. SUBMITTER: | Zimmer MedizinSysteme GmbHJunkersstrasse 989231 Neu-Ulm, GermanyEstablishment Registration: 8010720Ms. Ute KilletManager, Regulatory AffairsPhone: +49-731-9761-216Fax: +49-731-9761-118E-mail: u.klllet@zimmer.de |
|---|---|
| CONTACT: | Scott BloodPrincipal ConsultantPhone: 978.729.5978Fax: +49-731-9761-118E-mail: scottqara@gmail.com |
| DATE PREPARED: | December 29, 2021 |
| TRADE NAME: | Cryo 7 |
| 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:
The Cryo 7 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 Cryo 7 device is the same as the currently-cleared Cryo 6
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Image /page/4/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern, and the use of a bold font and horizontal line makes it easily recognizable.
(K060395), except for branding and state-of-the-art updates. Both the subject device and predicate device are manufactured by Zimmer MedizinSysteme GmbH.
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 touchscreen.
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 capacitive touch display. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface.
V. INDICATONS FOR USE:
Cryo 7 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 this device delivers remain unchanged from the predicate device. The device produces cold air for blowing on patient's skin locally and is intended to be contactless.
Updates were made to the predicate device (K060395) system hardware, mechanical layout and the display (new, 10.1 inch touch display). Also, the software was adapted according to the hardware modifications. Specifically, the cooling parameters remain unchanged.
The technological similarities and differences between the subject device and the predicate device are described below in the comparison table. The differences do not raise any new questions regarding safety or effectiveness.
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Image /page/5/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font. The logo is in grayscale.
| Comparison with thePredicate Device | SUBJECT DEVICEZimmer MedizinSysteme GmbHCryo 7 (This Submission) | PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo V6.0 (K060395) | Discussion |
|---|---|---|---|
| Product Code andRegulation | General & Plastic Surgery21 CFR 878.4810GEX - Powered Laser SurgicalInstrument | General & Plastic Surgery21 CFR 878.4810GEX - Powered Laser SurgicalInstrument | Identical |
| Device Description | The Cryo 7 Cold Air Deviceutilizes a compressor, evaporatorand fan to cool the patient's skinlocally and contactless. | The Zimmer Cryo V6.0 Cold AirDevice utilizes a compressor,evaporator and fan to cool room airand then direct it onto skin. | Similar |
| Intended Use | The Cryo 7 is intended tominimize pain and thermal injuryduring laser and dermatologicaltreatments and for temporarytopical anesthetic relief forinjections. | The Cryo V6.0 Cold Air Device isintended to minimize pain andthermal injury during laser anddermatological treatments and fortemporary topical anesthetic relieffor injections. | Identical |
| PerformanceCharacteristicsMeasurement atdevice outlet | -30°C ± 3°CAt an air speed of210 ± 40 to 600 ± 100liters/minute. | -30°CAt an air speed of100 to 1000 liters/minute. | Similar, notsignificantlydifferent |
| Cooling Method,Operation principle | Cooling agent-based condenserand evaporation system. Cold airis produced which is then directedonto the skin. Conduction,evaporation, and forcedconvection cool the skin. | Cooling agent-based condenserand evaporation system. Cold airis produced which is then directedonto the skin. Conduction,evaporation, and forced convectioncool the skin. | Identical |
| Cooling Material | Gas (Air) | Gas (Air) | Identical |
| Mains Voltage | 100V - 120V / 50-60Hz | 100V - 120V / 50-60Hz | Identical |
| Main Fuse | 16A circuit breaker in main switch | 16A circuit breaker in main switch | Identical |
| Power Consumption | Max. 10A | Max. 9 - 11A | No impact |
| IP classification | IP20 | IPX0 | Identical |
| Design | Internal metal chassis covered byindustrial designed plastic housing | Metal enclosure | Similar, notimportant forthe devicesafety andeffectivenessevaluation |
| Materials | Environmentally approved R452a,closed loop cooling system | Environmentally approved R507,closed loop cooling system | Bothenvironment-allyapproved, noimpact |
| Cooling spot Size | Varies with distance from distalend of air hose to tissue - 10cm²@ 5cm distance | Varies with distance from distalend of air hose to tissue - 10cm²@ 5cm distance | Identical |
| Fan speed settings | 1 - 9 | 1 - 9 | Identical |
| Comparison with thePredicate Device | SUBJECT DEVICEZimmer MedizinSysteme GmbHCryo 7 (This Submission) | PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo V6.0 (K060395) | Discussion |
| Interface | USB 2.0, RS 232 | N/A | Productfeature withno effect tosafety oreffectivenessevaluation |
| Therapy time,treatment time | 1:00 - 100:00 min - userselectable | 1-99 minute timer - userselectable | Similar, notsignificantlydifferent |
| Time delay tooperate | Immediate from pressing startbutton once unit achieves standbymode | Immediate from pressing startbutton once unit achieves standbymode | Identical |
| Compatibility withthe environment | R452aOzone destruction level 0 | R507Ozone destruction level 0 | Bothenvironment-allyapproved, noimpact |
| Display | 10.1 inch touch display | LCD display | Productfeature withno effect tosafety oreffectivenessevaluation |
| Weight withoutaccessories | 60 kg | 60 kg | Identical |
| Dimensions | H 1060 mm x W 500 mm x D 560mm | H 645 mm x W 390 mm x D 680mm | Differentdimensionshave noinfluence onthe devicesafety andeffectivenessevaluation |
| Operating AmbientTemperature andHumidity | Temperature: 10 - 35°CHumidity: 20-80% relative humiditywithout condensationAir pressure: 900-1030 hPa | Temperature: 10 - 35°CHumidity: 20-80% relative humiditywithout condensationAir pressure: 900-1060 hPa | 30hPa lowerair pressurehas noimpact |
| Storage andTransport | Temperature: -10 - 50°CHumidity: 10-90% relativehumidity without condensationAir pressure: 700-1060 hPa | Storage: Temperature: 0 - 40°CHumidity: 10-90% relative humiditywithout condensationAir pressure: 600-1060 hPaTransport: Temperature: -10 -50°CHumidity: 10-90% relative humidity | 10°C higherstoragetemperatureand 100 hPahigher airpressure hasno influence |
| Comparison with thePredicate Device | SUBJECT DEVICEZimmer MedizinSysteme GmbHCryo 7 (This Submission) | PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo V6.0 (K060395) | Discussion |
| without condensationAir pressure: 600-1060 hPa | on thedevice safetyandeffectivenessevaluation | ||
| EnvironmentalSpecifications | For indoor use only | For indoor use only | Identical |
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Image /page/6/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, lowercase letters. Below the word "zimmer" is the word "MedizinSysteme" in a smaller font size. The logo is in gray.
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Image /page/7/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern, and the use of a bold font and horizontal line makes it easily recognizable.
VII. PERFORMANCE DATA:
The Cryo 7 has been investigated and tested against and complies with the following voluntary standards:
| Standards | StandardsOrganization | Standards Title |
|---|---|---|
| ES60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text) | ANSI AAMI | Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance |
| 60601-1-2:2014(Edition 4.0) | IEC | Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests |
| 60601-1-6:2013(Edition 3.1) | IEC | Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability |
| 62366-1:2015(Edition 1.0) | IEC | Medical devices - Part 1: Application of usability engineering tomedical devices |
| 62304:2015(Edition 1.1) | IEC | Medical devices software -software life cycle processes |
| 14971:2019-12(Edition 3.0) | ISO | Medical devices - Application of risk management to medical devices |
| 15223-1:2016(Edition 3) | ISO | Medical devices - Symbols to be used with medical device labels,labeling, and information to be supplied - Part 1: Generalrequirements |
| 10993-1:2018(Edition 5) | 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 Cryo 7 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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Image /page/8/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo is in gray and features the word "zimmer" in a bold, sans-serif font. Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern.
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 as a result of the changes referenced. The system complies with ES60601-1:2005 + CORR: 1:2006 + CORR. 2:2007 + A1:2012 (Edition 3.1), and IEC 60601-1-2:2014 (Fourth Edition).
VIII. CONCLUSION:
The proposed indications for use for the Cryo 7 are the same as those cleared in K060395. The subject device described in this submission is essentially the same device cleared in K060395. The changes between the two devices have been conducted through the company's Design Controls process. The changes that have been made to the system's hardware, software, mechanical layout and the display, do not affect the intended use, performance or risk profile of the device. Other changes were cosmetic which included new housing for the unit and the new brand name: Cryo 7.
The Cryo 7 is substantially equivalent to the predicate device.
§ 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.