(30 days)
No
The summary describes a device that uses a cooling circuit and software for control and user interface, but there is no mention of AI or ML capabilities, image processing, or data training/testing. The updates are described as "state-of-the-art updates" which typically refer to hardware or basic software improvements, not AI/ML.
Yes
The device description explicitly states, "The Cryo 7 is a non-invasive Therapeutic device."
No
The device is described as a "non-invasive Therapeutic device" intended to minimize pain and thermal injury and provide temporary topical anesthetic relief, rather than to diagnose conditions.
No
The device description explicitly details numerous hardware components including a housing, chassis, rollers, shelf plate, compressor, evaporator, condenser, fans, and electrical power components. While it mentions software controlling these components and the user interface, the device itself is a physical apparatus that delivers cold air therapy.
Based on the provided information, the Cryo 7 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections." This describes a therapeutic and pain management function, not a diagnostic one.
- Device Description: The description calls it a "non-invasive Therapeutic device" and explains that it cools and dehumidifies air to cool the patient's skin locally. This aligns with a physical therapy or pain relief device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information.
Therefore, the Cryo 7 falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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 (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Cryo 7 has been investigated and tested against and complies with the following voluntary standards:
- ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 60601-1-2:2014 (Edition 4.0) - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- 60601-1-6:2013 (Edition 3.1) - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- 62366-1:2015 (Edition 1.0) - Medical devices - Part 1: Application of usability engineering to medical devices
- 62304:2015 (Edition 1.1) - Medical devices software -software life cycle processes
- 14971:2019-12 (Edition 3.0) - Medical devices - Application of risk management to medical devices
- 15223-1:2016 (Edition 3) - Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
- 10993-1:2018 (Edition 5) - Biological evaluation of medical devices - Part 1: Evaluation and testing 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. 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cryo V6.0 (K060395)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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 GmbH
Junkersstrasse 9
89231 Neu-Ulm, Germany
Establishment Registration: 8010720
Ms. Ute Killet
Manager, Regulatory Affairs
Phone: +49-731-9761-216
Fax: +49-731-9761-118
E-mail: u.klllet@zimmer.de |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Scott Blood
Principal Consultant
Phone: 978.729.5978
Fax: +49-731-9761-118
E-mail: scottqara@gmail.com |
| DATE PREPARED: | December 29, 2021 |
| TRADE NAME: | Cryo 7 |
| COMMON NAME: | Laser surgical instrument for use in general and plastic
surgery 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 the
Predicate Device | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
Cryo 7 (This Submission) | PREDICATE DEVICE
Zimmer MedizinSysteme GmbH
Cryo V6.0 (K060395) | Discussion |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Product Code and
Regulation | General & Plastic Surgery
21 CFR 878.4810
GEX - Powered Laser Surgical
Instrument | General & Plastic Surgery
21 CFR 878.4810
GEX - Powered Laser Surgical
Instrument | Identical |
| Device Description | The Cryo 7 Cold Air Device
utilizes a compressor, evaporator
and fan to cool the patient's skin
locally and contactless. | The Zimmer Cryo V6.0 Cold Air
Device utilizes a compressor,
evaporator and fan to cool room air
and then direct it onto skin. | Similar |
| Intended Use | The Cryo 7 is intended to
minimize pain and thermal injury
during laser and dermatological
treatments and for temporary
topical anesthetic relief for
injections. | The Cryo V6.0 Cold Air Device is
intended to minimize pain and
thermal injury during laser and
dermatological treatments and for
temporary topical anesthetic relief
for injections. | Identical |
| Performance
Characteristics
Measurement at
device outlet | -30°C ± 3°C
At an air speed of
210 ± 40 to 600 ± 100
liters/minute. | -30°C
At an air speed of
100 to 1000 liters/minute. | Similar, not
significantly
different |
| Cooling Method,
Operation principle | Cooling agent-based condenser
and evaporation system. Cold air
is produced which is then directed
onto the skin. Conduction,
evaporation, and forced
convection cool the skin. | Cooling agent-based condenser
and evaporation system. Cold air
is produced which is then directed
onto the skin. Conduction,
evaporation, and forced convection
cool 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 by
industrial designed plastic housing | Metal enclosure | Similar, not
important for
the device
safety and
effectiveness
evaluation |
| Materials | Environmentally approved R452a,
closed loop cooling system | Environmentally approved R507,
closed loop cooling system | Both
environment-
ally
approved, no
impact |
| Cooling spot Size | Varies with distance from distal
end of air hose to tissue - 10cm²
@ 5cm distance | Varies with distance from distal
end of air hose to tissue - 10cm²
@ 5cm distance | Identical |
| Fan speed settings | 1 - 9 | 1 - 9 | Identical |
| Comparison with the
Predicate Device | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
Cryo 7 (This Submission) | PREDICATE DEVICE
Zimmer MedizinSysteme GmbH
Cryo V6.0 (K060395) | Discussion |
| Interface | USB 2.0, RS 232 | N/A | Product
feature with
no effect to
safety or
effectiveness
evaluation |
| Therapy time,
treatment time | 1:00 - 100:00 min - user
selectable | 1-99 minute timer - user
selectable | Similar, not
significantly
different |
| Time delay to
operate | Immediate from pressing start
button once unit achieves standby
mode | Immediate from pressing start
button once unit achieves standby
mode | Identical |
| Compatibility with
the environment | R452a
Ozone destruction level 0 | R507
Ozone destruction level 0 | Both
environment-
ally
approved, no
impact |
| Display | 10.1 inch touch display | LCD display | Product
feature with
no effect to
safety or
effectiveness
evaluation |
| Weight without
accessories | 60 kg | 60 kg | Identical |
| Dimensions | H 1060 mm x W 500 mm x D 560
mm | H 645 mm x W 390 mm x D 680
mm | Different
dimensions
have no
influence on
the device
safety and
effectiveness
evaluation |
| Operating Ambient
Temperature and
Humidity | Temperature: 10 - 35°C
Humidity: 20-80% relative humidity
without condensation
Air pressure: 900-1030 hPa | Temperature: 10 - 35°C
Humidity: 20-80% relative humidity
without condensation
Air pressure: 900-1060 hPa | 30hPa lower
air pressure
has no
impact |
| Storage and
Transport | Temperature: -10 - 50°C
Humidity: 10-90% relative
humidity without condensation
Air pressure: 700-1060 hPa | Storage: Temperature: 0 - 40°C
Humidity: 10-90% relative humidity
without condensation
Air pressure: 600-1060 hPa
Transport: Temperature: -10 -
50°C
Humidity: 10-90% relative humidity | 10°C higher
storage
temperature
and 100 hPa
higher air
pressure has
no influence |
| Comparison with the
Predicate Device | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
Cryo 7 (This Submission) | PREDICATE DEVICE
Zimmer MedizinSysteme GmbH
Cryo V6.0 (K060395) | Discussion |
| | | without condensation
Air pressure: 600-1060 hPa | on the
device safety
and
effectiveness
evaluation |
| Environmental
Specifications | 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 | Standards
Organization | Standards Title |
|---------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ES60601-1:2005/(R)2012
and A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text) | ANSI AAMI | Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance |
| 60601-1-2:2014
(Edition 4.0) | IEC | Medical electrical equipment - Part 1-2: General requirements for
basic 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 for
basic safety and essential performance - Collateral standard: Usability |
| 62366-1:2015
(Edition 1.0) | IEC | Medical devices - Part 1: Application of usability engineering to
medical 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: General
requirements |
| 10993-1:2018
(Edition 5) | ISO | Biological evaluation of medical devices - Part 1: Evaluation and
testing 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.