The MyoScience Cryo-Touch II is used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch II is not indicated for treatment of central nervous system tissue.

Device Description

The MyoScience Cryo-Touch II is a hand-held, single patient-use disposable, cryogenic device used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The device is based on introduction of a cryoprobe cooled by the cryogenic fluid (liquid nitrous oxide) to the target nervous tissue and controlled by the user via a freeze control. An iceball forms around the tip of the needle assembly and the adjacent nerve. The Cryo-Touch II may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired. The device is comprised of three main components: a control unit (controller), probe assembly, and a cryogen cylinder assembly (Nitrous Oxide). The entire device is hand-held and for single patient-use. The Cryo-Touch II controller is battery operated; the battery powers electronics within the controller and provide feedback to the user when the device is ready to use. An assortment of needle assemblies is available for the Cryo-Touch II, ranging from a single to a triple needle, from 25 gauge to 30 gauge and 6mm in length. All needle assemblies are made of stainless steel and have a closed-tip that fully contains the cryogen so that it does not enter the target tissue. The needle assembly is the sterile patient contacting component of the Cryo-Touch II. The user removes the needle assembly from the sterile packaging and attaches it to the controller by inserting the needle hub end into the distal end of the controller. The cryogen is provided as a nitrous oxide cylinder. The cartridge is filled with liquid N₂O (83%) and the cylinder treats for approximately 180 seconds. The cylinder, once empty, may be replaced with a new cylinder by the user.

AI/ML Overview

The provided 510(k) summary for the MyoScience Cryo-Touch II is for a cryosurgical unit and accessories, which is a Class II device. This type of device relies on established physical principles for its operation (cryotherapy) rather than complex algorithms or AI for diagnostic/interpretive functions. Therefore, many of the requested categories related to algorithm performance, ground truth, expert consensus, and comparative effectiveness studies with AI are not applicable to this type of medical device submission.

The "acceptance criteria" for a device like the Cryo-Touch II are typically its ability to function as intended, consistently apply the specified temperature, and meet safety and performance standards. The "study" mentioned refers to verification testing to ensure these criteria are met.

Here's the breakdown based on the provided text, with "N/A" for categories not applicable to this type of device submission:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from submission)	Reported Device Performance
Device meets design requirements for accurate temperature profiling	Verification testing demonstrated the product met the design requirements for accurate temperature profiling during simulated use conditions.
Consistent application of cold to selected site for blocking pain	(Demonstrated through functional testing, consistent with predicate device)
Operational reliability (e.g., battery operation, cryogen flow, iceball formation)	(Demonstrated through functional testing, consistent with predicate device)
Patient-contacting materials are biocompatible	(Confirmed as identical to predicate, implying biocompatibility established)
Treatment Temperature Range of -55° C to -75° C	(Confirmed as identical to predicate)

Detailed Information:

Sample size used for the test set and the data provenance:
- The document mentions "Verification testing was performed on the Cryo-Touch II device to demonstrate that the product met the design requirements for accurate temperature profiling during simulated use conditions." It does not specify a sample size for this testing nor the data provenance (country of origin, retrospective/prospective). This type of non-clinical testing typically involves a set number of devices or components tested under controlled laboratory conditions to ensure manufacturing and functional specifications are met.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device does not involve diagnostic interpretation or AI algorithms that require expert-established ground truth for a test set in the traditional sense. The "ground truth" for a cryosurgical device is its physical performance (e.g., temperature output, iceball size, durability), which is assessed through engineering and functional testing against design specifications, not expert interpretation of outputs.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically used in studies where human interpretation (e.g., reading medical images) is being evaluated and discrepancies exist. For performance testing of a physical device like this, results are objective measurements against specifications.
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:
- N/A. This device is a surgical tool, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study comparing human reader performance with or without AI assistance would have been conducted or is relevant for its 510(k) clearance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm-only device. It is a handheld surgical instrument operated by a medical professional.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" or reference standard for its performance is its engineering specifications and functional requirements (e.g., achieving a specific temperature range, proper cryogen flow, iceball formation). These are objective, measurable parameters, not subjective expert consensus, pathology, or outcomes data.
The sample size for the training set:
- N/A. This is not an AI/machine learning device; therefore, there is no "training set."
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.

Summary

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Cryo-Touch II

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

SEP 1 7 2010

Device Information:
Category	Comments
Sponsor / Submitter:	MyoScience, Inc525 Chesapeake DriveRedwood City, CA 94063(650) 474-2600(650) 474-2700
Correspondent ContactInformation:	Tracey HenrySr. Director RAQA, Clinical Compliance525 Chesapeake DriveRedwood City, CA 94063(650) 474-2600(650) 474-2900
Device Common Name:	Cryogenic Surgical device
Device Classification & Code:	Class II, GXH
Device Classification Name:	Cryosurgical unit and accessories (21 CFR 882.4250)
Device Proprietary Name:	MyoScience Cryo-Touch II

a. Predicate Device Information:

The Cryo-Touch is substantially equivalent to the following currently legally marked devices:

510(k) Number	.Product	Sponsor
K100447	A . A separate and a come of a colorCrvo-Touch11 11 400	MyoScience, Inc444-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------CONSULTION COLLECTION

b. Date Summary Prepared

July 16, 2010

c. Description of Device

e: Deseription of Denos
The MyoScience Cryo-Touch II is a hand-held, single patient-use disposable, cryogenic device used to me wyosalence aryo courted by on peripheral nervous tissue by the application of cold to the uestroy hervous tissus of blocking pain. The Cryo-Touch II has been developed for applications in screeted one for the more intractable pain involves the location and freezing of the nerve associated with the pain.

The device is based on introduction of a cryoprobe cooled by the cryogenic fluid (liquid nitrous oxide The device is bascu on introduction of the freeze control. An iceball forms around the tip of the needle assembly and the adjacent nerve.

The Cryo-Touch II may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.

Device Design

The device is comprised of three main components:

a control unit (controller), 1)
probe assembly, and 2)
a cryogen cylinder assembly (Nitrous Oxide). 3)

Confidential Page 54

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The entire device is hand-held and for single patient-use.

The Cryo-Touch II controller is battery operated; the battery powers electronics within the controller the vace The Cryo-Tudch is controller is better) , eperated.) , ept. and provide feedback to the user when the device is ready to use.

An assortment of needle assemblies is available for the Cryo-Touch II, ranging from a single to a triple All assortment of necdle assemblies is a relies of the 6mm in length. All needle assemblies are made of needie, from 25 googs to be a closed-tip that fully contains the cryogen so that it does not enter the target stamess steel and have a sieed on patient contacting component of the Cryo-Touch II. The user tissue. The needle assembly from the sterile packaging and attaches it to the controller by inserting the needle hub end into the distal end of the controller.

The cryogen is provided as a nitrous oxide cylinder. The cartridge is filled with liquid N₂O (83%) and the rne cryben is pronued as a more of the cylinder treats for approximately 180 seconds. The cylinder, once empty, may be replaced with a new cylinder by the user.

Device Functionality/Scientific Concepts

The device functionality is based on the user introducing the needle assembly proximate to the target nervous tissue. The user then initiates the flow of cryogen by opening the start/stop valve. Liquid cryogen flows from the controller into the closed-tip needle is cooled by the louled by the Joule-Thompson effect; as the liquid cryogen expands into a gas, an iceball develops around the external surface of the needle assembly causing the surrounding tissue to be frozen. As the iceball grows, its leading edge advances through the tissue and tissue that comes into contact with the needle is frozen to a nominal target temperature of -65°C (-85°F). The user then stops the flow of cryogen by closing the start/stop valve and allows the iceball to thaw before removing the needle assembly.

d. Intended Use

e. Comparison to Predicate Devices

er Comparison Cryo-Touch II is substantially equivalent in intended use, technology, design and materials to the above listed legally marketed predicate device. The technological characteristics of the new device in comparison to the predicate devices are summarized below:

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ce 510(k): Device Modification

	This Device	Predicate Device
Parameter	MyoScienceCryo-Touch II	MyoScience Cryo-Touch K100447
Intended Use	Identical	Destroy tissue through freezing
Target Population	Identical	Adults
Anatomical Sites	Identical	Peripheral nerves
Intended users/clinical	Identical	Qualified medical personnel (doctors, specialists) inhospital or medical environment
Technology	Identical	Cryogenic surgical device with needle which penetratestreatment area.
Energy used/or delivered	Identical	Cryotherapy/Nitrous Oxide
Human Factors	Identical	Hand-held and or portable device containing cryogen.Some units have footswitch and detachable cryoprobes.
Biocompatibility	Identical	Biocompatible patient contacting materials
Operating Principle	Identical	Joule-Thomson Effect
Patient contactingmaterials	Identical	Closed-tip stainless steel cryoprobeRanging from 25 - 30 gauge
Treatment Temperature	Identical	-55° C to -75° C
Power Source	Identical	Battery powered

f. Summary of Supporting Data

Nonclinical testing:

Verification testing was performed on the Cryo-Touch II device to vermeation testing was poduct met the design requirements for acmonstrate that the perature profiling during simulated use conditions.

Nóne Clinical Testing Submitted:

g. Conclusion

g. Conclusion
MyoScience concludes that the Cryo-Touch described in this submission is substantialiy equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with three curved lines forming the body and head, and three wavy lines representing the legs and feet.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MyoScience, Inc. c/o Ms. Tracey Henry Sr. Director, Regulatory Affairs and Ouality Assurance 525 Chesapeake Drive Redwood City, CA 94063

SEP 1 7 2010

Re: K102021

Trade/Device Name: Myoscience Cryo-touch II Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: II Product Code: GXH Dated: August 23, 2010 Received: August 24, 2010

Dear Ms. Henry:

ﺎ

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Tracey Henry

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Keaia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Health Center for Devices and Radiological Health

Enclosure

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MVOSCIE 510(k): Device Modification Cryo-Touch II

Indications for Use Statment

510(k) Number:

Device Name:

SEP 1 7 2010

MyoScience Cryo-Touch II

Indications for Use:

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR · Over-the-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Jas L. Kaufman MA

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102031

Regulation Number and Section

§ 882.4250 Cryogenic surgical device.

(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).