(119 days)
Cryojet Plus is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Cryojet Plus is composed of main body (including power supply system, cooling system), power cable, supporting arm rod (a group of supporting rod, two support clips), wind tube, adapters, casters and other accessories. Control system consists of LCD screen display and control board, etc; Cooling system includes compressor, evaporator, radiator, fan, water tank; Power supply system is composed of power cable, filter and ON/OFF switch power.
The provided text describes a medical device called "Cryojet Plus" and its substantial equivalence to a predicate device "Cryo 7". However, it does not contain a study comparing the device's performance against specific acceptance criteria in a comparative effectiveness study involving human readers or standalone AI performance.
Therefore, many of the requested sections cannot be filled from the provided document.
Here's a breakdown of what information is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison of technical specifications between the proposed device (Cryojet Plus) and the predicate device (Cryo 7). While these are performance characteristics, they are not explicitly presented as "acceptance criteria" met by a study designed to prove them. Instead, they are presented as part of a substantial equivalence comparison.
| Specification | Predicate Device (Cryo 7) Performance | Proposed Device (Cryojet Plus) Performance | Discussion of Similarities/Differences (Acceptance/Conformance) |
|---|---|---|---|
| Product Code and Regulation | GEX – Powered Laser Surgical Instrument | GEX – Powered Laser Surgical Instrument | Identical |
| Device Description | Compressor, evaporator, fan to cool skin | Compressor, evaporator, fan to cool skin | Identical |
| Intended Use | Minimize pain & thermal injury; temporary topical anesthetic relief | Minimize pain & thermal injury; temporary topical anesthetic relief | Identical |
| Outlet Temperature | -30°C ± 3°C | -25°C ± 3°C | Similar, not significantly different |
| Outlet Air Speed | 210 ± 40 to 600 ± 100 liters/minute | 200 ± 50 to 620 ± 60 liters/minute | Similar, not significantly different |
| Cooling Method, Operation Principle | Cooling agent-based condenser, evaporation system | Cooling agent-based condenser, evaporation system | Identical |
| Cooling Material | Gas (Air) | Gas (Air) | Identical |
| Mains Voltage | 100V - 120V / 50-60Hz | 100V - 120V / 50-60Hz | Identical |
| Main Fuse | 16A circuit breaker | Without circuit breaker | No impact |
| Power Consumption | Max. 10A | Max. 8A | No impact (Lower consumption is generally seen as positive/neutral) |
| IP Classification | IP20 | IPX0 | No impact |
| Design | Internal metal chassis, plastic shell | Internal metal chassis, industrial designed ABS plastic shell, adapter ABS+PC | Similar, no impact on safety/effectiveness |
| Materials | R452a, closed loop cooling system | R404a, closed loop cooling system | No impact (Both environmentally approved) |
| Cooling Spot Size | Varies, 10cm² at 5cm distance | Varies, 10cm² at 5cm distance (with 3 adapter sizes) | Difference in adapter quantity does not raise different safety/effectiveness questions |
| Fan Speed Settings | 1-9 | 1-10 | Similar, not significantly different |
| Interface | USB 2.0, RS232 | TTL, PWM | Difference doesn't affect safety/effectiveness |
| Therapy Time | 1:00 - 100:00 min - adjustable | 1:00 - 100:00 min - adjustable | Identical |
| Time Delay to Operate | Immediate from pressing START button | Immediate from pressing START button | Identical |
| Compatibility with Environment | R452a Ozone destruction level 0 | R404 Ozone destruction level 0 | Both environmentally approved, no impact |
| Display | 5.0 inch touch screen | 10.1 inch touch screen | Different screen sizes have no impact on safety/effectiveness |
| Net Weight | 60kg | 65kg | Similar, not significantly different |
| Dimensions | H1060 mm x W500 mm x D560 mm | H810 mm x W400 mm x D845mm | Different dimensions have no impact on safety/effectiveness |
| Working Environment Temperature | 10 - 35°C | 10 - 35°C | Identical |
| Working Environment Humidity | 20-80% RH (no condensation) | 20-80% RH (no condensation) | Identical |
| Working Environment Pressure | 900-1030 hPa | 900-1030 hPa | Identical |
| Storage & Transport Temperature | -10 - 50°C | -10 - 50°C | Identical |
| Storage & Transport Humidity | 10-90% RH (no condensation) | 10-90% RH (no condensation) | Identical |
| Storage & Transport Pressure | 700-1060 hPa | 700-1060 hPa | Identical |
| Environmental Specifications | For indoor use only | For indoor use only | Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is not an AI/ML diagnostic or image analysis device, and no clinical testing was performed or reported. The submission focuses on substantial equivalence based on technical characteristics and non-clinical testing.
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. No clinical test set with ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was used.
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. No MRMC comparative effectiveness study was done. The device is a non-AI therapeutic cooling device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established or used for the purpose of this 510(k) submission. The "ground truth" for the device's technical performance would be engineering measurements as per the standards listed.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML algorithm and therefore does not have a training set.
Study/Evidence that Proves the Device Meets Acceptance Criteria:
The document states that the Cryojet Plus has been considered to comply with several voluntary standards through investigation and test. These standards cover aspects like electrical safety, electromagnetic compatibility, usability, software lifecycle processes, risk management, biocompatibility assessment (lack of direct patient contact negates further testing), and quality management systems.
Specifically mentioned are:
- IEC 60601-1:2005;A1:2012;A2:2020 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC 60601-1-2:2014 (Medical electrical equipment – Electromagnetic disturbances - Requirements and tests)
- IEC 60601-1-6:2013 (Medical electrical equipment – Usability)
- IEC 62366-1:2015 (Medical devices – Application of usability engineering to medical devices)
- IEC 62304:2015 (Medical devices software – software life cycle processes) - Software verification and validation tests were performed successfully and met acceptance criteria.
- ISO 14971:2019-12 (Medical devices – Application of risk management to medical devices)
- ISO 15223-1:2016 (Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements)
- ISO 13485:2016 (Medical devices – Quality management systems--Requirements for regulatory purposes)
- ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) - Biocompatibility was assessed, and no additional testing was deemed necessary due to no direct patient contact.
Non-clinical testing for Cryojet Plus included:
- Electrical safety testing according to IEC 60601-1.
- Electromagnetic compatibility testing according to IEC 60601-1-2.
- Software verification and validation.
The conclusion is that the Cryojet Plus is substantially equivalent to the predicate device (Cryo 7) in intended use, device characteristics, and application parameters, based on these technical comparisons and non-clinical testing. No clinical testing was included in this 510(k).
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February 6, 2024
Beijing Sano Laser S&T Development Co., Ltd % Zhao Huifang Correspondent Microkn Business Consulting (Shanghai) Co., Ltd. Room 1319, Block A, No 3699, Gonghexin Road Jingan District Shanghai, 200040 China
Re: K233416
Trade/Device Name: Cryojet Plus (SHE-ACP001-1) 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 26, 2023 Received: December 26, 2023
Dear Zhao Huifang:
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/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.
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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.
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 (QS) 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 820.70) 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.
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 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).
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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. Tanisha L.Hithe -S 2024.02.06 Hithe -S 17:09:18 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & 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) K233416
Device Name Cryojet Plus (SHE-ACP001-1)
Indications for Use (Describe)
Cryojet Plus 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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I. Contact Details
| Applicant Name: | Beijing Sano Laser S&T Development Co., Ltd. |
|---|---|
| Room 201, 2nd Floor, No.7 Building, Maohuagongchang, NO.1CAIDA Third Street, Nancai Town, Shunyi District, Beijing, China | |
| TEL: 086-10-57150601 | |
| Contact: | Hongbo Zhang, CEO |
| 360349720@qq.com |
Date Prepared: Oct 06, 2023
II. Device Name
Device Name : Cryojet Plus (Model: SHE-ACP001-1)
Generic Name: Powered Laser Surgical Instrument
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21CFR 878.4810)
Regulatory Class: II
Product Code: GEX
III. Predicate Device
| 510(k) Number | Product Code | Trade Name | Applicant |
|---|---|---|---|
| K220020 | GEX | Cryo 7 | Zimmer MedizinSysteme GmbH |
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. Device Description
Cryojet Plus is intended to minimize pain and thermal injury during laser and dermatological treatments and for the temporary topical anesthetic relief for injections. And it shall be used by professionally trained medical operators.
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Cryojet Plus is composed of main body (including power supply system, cooling system), power cable, supporting arm rod (a group of supporting rod, two support clips), wind tube, adapters, casters and other accessories. Control system consists of LCD screen display and control board, etc; Cooling system includes compressor, evaporator, radiator, fan, water tank; Power supply system is composed of power cable, filter and ON/OFF switch power.
How It Works: Gaseous refrigerant is compressed into high-temperature and high-pressure gas by high-power compressor and sent to condenser for cooling. Refrigerant can produce cold air by condenser and evaporation system for skin cooling through conduction, evaporation and forced convection. Evaporator absorbs heat in air and vaporizes the heat, then heat is gaseous, then the gas is back to compressor and continue to be compressed. Thus cooling is done through such circulation. Defrosting system melts the frost inside evaporation system into liquid water and discharge the water through drain valve.
Software is used for system initialization, displaying user interface and cooling system control. Parameter setting (therapy time and wind level) can be done by touching LCD screen, thus START/STOP and defrosting of device can be controlled. The software can be used in conjunction with hardware system during treatment to minimize thermal damage to tissues and reduce pain.
V. Intended Use/Indications for use
Cryojet Plus is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Main components of device are listed below:
| Components | Function Description |
|---|---|
| Air Switch | Control of Device Power ON/OFF |
Table 2 Main Components of Proposed Device
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| Touch Screen | Display User Interface, Operation Control System, TreatmentParameter Setting |
|---|---|
| Wind Tube | Deliver cold air from blower to adapter. |
| Adapter | Different sizes of adapters are applicable to different body parts to betreated. |
VI. Substantial Equivalence Comparison / Comparison of technological characteristics with the predicate device
The predicate device for this submission is Cryo 7(K220020) from Zimmer MedizinSysteme GmbH that has been approved under K220020.
The submitted proposed device (Cryojet Plus) and predicate device (Cryo 7) are both classified as II. They are both for skin cooling by blowing cold wind to patient's local skin parts (the device is not intended to be in contact with patient). The indications of proposed device (Cryojet Plus) and predicate device (Cryo 7) are the same.
The submitted proposed device (Cryojet Plus) and predicate device (Cryo 7) are based on the same scientific theories:
- The working theories principles are identical. They both apply compressor cooling. Refrigerant is compressed into high-temperature and high-pressure gas (by high-power compressor) and sent to condenser for cooling and liquefaction. Refrigerant goes through expansion valve for throttle in evaporator and it absorbs heat in air and generate cold air surrounding it. Meanwhile, the fan blows natural air into evaporator for coldness and heat exchange, then the cold air is conducted to skin by wind tube. Forced convection makes skin cooling. Refrigerant absorbs heat in evaporator and becomes evaporated, then back to compressor to continue compression. Thus cooling is done through such circulation.
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Defrosting system melts the frost inside evaporation system into liquid water and discharge the water through drain valve.
-
- While the wind current flow level range, lowest temperature of output wind, cooling spot coverage area at a distance of 5cm, therapy time and defrost for both devices are identical or similar to reach the indicated effect, they do differ in appearance, size (dimension), weight and the product code of control system. The whole device is supported and moved through casters.
- Product Components: The two devices are both substantially composed of compressor, 3. evaporator, condenser, DC brushless motor, fan, temperature sensor and wind tubes.
-
- Their energy sources are also identical.
The comparison of technical characteristics between proposed device (Cryojet Plus) and predicate device (Cryo 7) are as follows:
-
- For Cryojet Plus produced by SANO Laser, there are 3 sizes of adapters (listed below) for therapy on different body parts; for Cryo 7 produced by Zimmer, there is no adapter for choice, wind is blown out from end of wind tube directly. (Vary in cooling spot coverage area at a distance of 5cm).
| Item | Adapter Specifications | Size | Intended for use |
|---|---|---|---|
| 1 | Small Sized RoundAdapter | Image: Small Sized Round Adapter | For small areatreatment and skincooling meanwhile(e.g. eyebrow,armpits, forehead.) |
| 2 | Medium SizedSquare Adapter | Image: Medium Sized Square Adapter | For medium areatreatment and skincooling meanwhile(especially used forhair removal on arms,armpits and legs, inconjunction with hair |
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| removal machine.) | |||
|---|---|---|---|
| 3 | Large Sized SquareAdapter | Image: Adapter | For large areatreatment and skincooling meanwhile(especially used forhair removal onthighs, abdomen, inconjunction with hair |
-
- Different Display Screen Size: Proposed device (Cryojet Plus) screen size is 10.1 inch and predicate device (Cryo 7) screen size is 5 inch;
- IP Protection Level Difference: Proposed device (Cryojet Plus) is IPX0 and predicate 3. device (Cryo 7) is IP20;
- Weight Difference: Proposed device (Cryojet Plus) is 65kg and predicate device (Cryo 7) 4. is 60kg.
However, these differences do not affect the substantial equivalence; they are still based on the same technical characteristics to achieve the same purpose. For technical characteristics and operating principle associated with therapy, proposed device (Cryojet Plus) and predicate device (Cryo 7) are identical similarities and differences between the proposed device and the predicate device are described below in the comparison table. The differences do not raise any new issues of safety or effectiveness.
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| Specification | PROPOSED DEVICEBeijing Sano Laser S&T DevelopmentCo., Ltd.Cryojet Plus (This Submission) | PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo 7 (K220020) | Discussion ofSimilarities/Differences |
|---|---|---|---|
| Product Code andRegulation | General & Plastic Surgery 21 CFR878.4810 GEX – Powered Laser SurgicalInstrument | General & Plastic Surgery 21 CFR 878.4810GEX - Powered Laser Surgical Instrument. | Identical |
| DeviceDescription | The Cryojet Plus Air Device consists of acompressor, evaporator and fan to cool thepatient's skin locally without contact toskin. | The Cryo 7 Cold Air Device consists of acompressor, evaporator and fan to cool thepatient's skin locally without contact to skin. | Identical |
| Intended Use | The Cryojet Plus is intended to minimizepain and thermal injury during laser anddermatological treatments and fortemporary topical anesthetic relief forinjections. | The Cryo 7 is intended to minimize pain andthermal injury during laser and dermatologicaltreatments and for temporary topical anestheticrelief for injections. | Identical |
| PerformanceCharacteristicsMeasurement atdevice outlet | -25°C ± 3°C, At an air speed of 200 ± 50to 620 ± 60 liters/minute. | -30°C ± 3°C, At an air speed of 210 ± 40 to600 ± 100 liters/minute. | Similar, notsignificantlydifferent |
| Cooling Method,OperationPrinciple | Cooling agent-based condenser andevaporation system. Cold air is producedwhich is then delivered to skin for skincooling by conduction, evaporation, andforced convection. | Cooling agent-based condenser and evaporationsystem. Cold air is produced which is thendelivered to skin for skin cooling by conduction,evaporation, and forced convection. | Identical |
| Specification | PROPOSED DEVICEBeijing Sano Laser S&T DevelopmentCo., Ltd.Cryojet Plus (This Submission) | PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo 7 (K220020) | Discussion ofSimilarities/Differences |
| Cooling Material | Gas (Air) | Gas (Air) | Identical |
| Mains Voltage | 100V - 120V / 50-60Hz | 100V - 120V / 50-60Hz | Identical |
| Main Fuse | Without circuit breaker in main switch | 16A circuit breaker in main switch | No impact |
| PowerConsumption | Max. 8A | Max. 10A | No impact |
| IP Classification | IPX0 | IP20 | No impact |
| Design | Internal metal chassis and framework byindustrial designed ABS plastic shell,adapter material is ABS+PC | Internal metal chassis covered by industrialdesigned plastic shell | Similar, noimpact ondevice safetyandeffectivenessevaluation |
| Materials | Environmentally approved R404a, closedloop cooling system | Environmentally approved R452a, closed loopcooling system | No impact |
| Specification | PROPOSED DEVICEBeijing Sano Laser S&T DevelopmentCo., Ltd.Cryojet Plus (This Submission) | PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo 7 (K220020) | Discussion ofSimilarities/Differences |
| Cooling Spot Size | Varies in cooling spot size (coverage area)with a distance of 5cm from wind outletpart to skin - 10cm $^{2}$ | Varies in cooling spot size (coverage area) witha distance of 5cm from wind outlet part to skin -10cm $^{2}$ | Thedifference ofadapterquantity doesnot raisedifferentquestions ofsafety andeffectiveness:SANOCryojet Plusmachine has 3adapter sizesfor choiceaccording todifferent bodyparts to betreated;Zimmermachine hasonly oneadapter size. |
| Specification | PROPOSED DEVICEBeijing Sano Laser S&T DevelopmentCo., Ltd.Cryojet Plus (This Submission) | PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo 7 (K220020) | Discussion ofSimilarities/Differences |
| Fan SpeedSettings | 1-10 | 1-9 | Similar, notsignificantlydifferent |
| Interface | TTL, PWM | USB 2.0, RS232 | Difference ininterfacesdoesn't affectdevice safetyandeffectivenessevaluation |
| Therapy time,Treatment time | 1:00 - 100:00 min - adjustable for users | 1:00 - 100:00 min - adjustable for users | Identical |
| Time Delay toOperate | Immediate from pressing STARTbutton when system turns to standby mode | Immediate from pressing STARTbutton when system turns to standby mode | Identical |
| Compatibility withthe environment | R404 Ozone destruction level 0 | R452a Ozone destruction level 0 | Bothenvironmentally approved,no impact |
| Specification | PROPOSED DEVICEBeijing Sano Laser S&T DevelopmentCo., Ltd.Cryojet Plus (This Submission) | PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo 7 (K220020) | Discussion ofSimilarities/Differences |
| Display | 5.0 inch touch screen display | 10.1 inch touch screen display | Differentscreen sizeshave noimpact on thedevice safetyandeffectivenessevaluation |
| Net Weightwithoutaccessories | 65kg | 60kg | Similar, notsignificantlydifferent |
| Dimensions | H810 mm x W400 mm x D845mm | H1060 mm x W500 mm x D560 mm | Differentdimensionshave noimpact on thedevice safetyandeffectivenessevaluation |
| Specification | PROPOSED DEVICEBeijing Sano Laser S&T DevelopmentCo., Ltd.Cryojet Plus (This Submission) | PREDICATE DEVICEZimmer MedizinSysteme GmbHCryo 7 (K220020) | Discussion ofSimilarities/Differences |
| WorkingEnvironmentTemperature andHumidity | Temperature: 10 - 35°C | Temperature: 10 - 35°C | Identical |
| Humidity: 20-80% relative humidity (nocondensation) | Humidity: 20-80% relative humidity (nocondensation) | ||
| Atmosphere Pressure: 900-1030 hPa | Atmosphere Pressure: 900-1030 hPa | ||
| Storage andTransport | Temperature: -10 - 50°C | Temperature: -10 - 50°C | Identical |
| Humidity: 10-90% relative humidity (nocondensation) | Humidity: 10-90% relative humidity (nocondensation) | ||
| Atmosphere Pressure: 700-1060 hPa | Atmosphere Pressure: 700-1060 hPa | ||
| EnvironmentalSpecifications | For indoor use only | For indoor use only | Identical |
Table Summary of Similarities and Differences
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Cryojet Plus 510(k) Notification K233416 Performance Data
By investigation and test, Cryojet Plus has been considered to comply with the following voluntary standards:
| Standards | StandardsOrganization | Standards Title |
|---|---|---|
| IEC 60601-1:2005;A1:2012;A2:2020 | IEC | Medical electrical equipment-Part1:Generalrequirements for basic safety and essentialperformance |
| IEC 60601-1-2:2014 | IEC | Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essentialperformance – Collateral standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-6:2013 | IEC | Medical electrical equipment – Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability |
| IEC 62366-1:2015 | IEC | Medical devices – Part 1: Application of usabilityengineering to medical devices |
| IEC 62304:2015 | IEC | Medical devices software –software life cycleprocesses |
| ISO 14971:2019-12 | ISO | Medical devices – Application of risk management tomedical devices |
| ISO 15223-1:2016 | ISO | Medical devices - Symbols to be used with medicaldevice labels, labeling, and information to besupplied - Part 1: General requirements |
| ISO 13485:2016 | ISO | Medical devices – Quality management systems-- |
| Requirements for regulatory purposes | ||
| ISO 10993-1:2018 | ISO | Biological evaluation of medical devices – Part 1:Evaluation and testing within a risk managementprocess |
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Software Verification and Validation Testing
After evaluation on specified use conditions, it could be proved that the technical design (including software flow and device application) of Cryojet Plus is suitable to fulfill the specified intended use. In both formative and summative testing performed, no application problems were found that could lead to any risk for the user, patient or the third parties.
The verification of software requirements was performed according to 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 as per ISO 10993-1. Since the device is not intended to be in contact with the patient, and the user wears medical gloves when touching the device, there is no additional biocompatibility requirement for 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 IEC 60601-1:2005 + A1:2012+ A2:2020, and IEC 60601-1-2:2014+ A1:2020 .
Non-clinical Testing
Non-clinical testing for Cryojet Plus included electrical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2. The device has been assessed for the requirement of biocompatibility testing as per ISO 10993-1. Since the device is not intended to be in contact with the patient, and the user wears medical gloves when touching the device, there is no additional biocompatibility requirement for device. In addition, software verification and validation was completed.
Clinical Testing
No clinical testing is included in this 510(k).
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Summary / Conclusion
The Cryojet Plus are substantially equivalent to the Cryo 7 in intended use, device characteristics and application parameters.
§ 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.