The MyoScience Cryo-Touch 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 is nog indicated for treatment of central nervous system tissue.

Device Description

The MyoScience Cryo-Touch is a hand-held, single patient-use disposable, cryogenic device used to destroy nervous tissue or produce lesions in peripheral nervous tissue by the application of cold to the selected site for the purposes of blocking pain. The Cryo-Touch has been developed for applications in cryoanalgesia. Cryoanalgesia for 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 (N₂Q)) to the selected site and activation of the freeze control. An iceball forms around the tip of the needle assembly and the adjacent nerve. The Cryo-Touch may be used with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.

AI/ML Overview

The MyoScience Cryo-Touch is a cryogenic surgical device intended to produce lesions in peripheral nervous tissue by applying cold to block pain. The submission, K100447, describes modifications to a previously cleared device (K083493), specifically the addition of a proprietary internal filter and an enhanced target treatment temperature of -65°C.

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

The provided document does not explicitly state quantitative acceptance criteria in a table format with specific thresholds (e.g., "temperature must be -65°C +/- 2°C"). Instead, it describes general design requirements and performance goals. However, the key performance aspect highlighted for the modified device is its ability to achieve a specific temperature.

Acceptance Criterion (Implicit)	Reported Device Performance
System Performance (General)	Met design requirements for system performance.
Temperature Profiling during Simulated Use Conditions	Met design requirements for temperature profiling.
Target Treatment Temperature within Range of Predicate Devices	Delivers a target treatment temperature of -65°C. This temperature is within the range of the other predicate devices (Cryo-PaC, Painblocker WA5000, and Neurostat), which target -55°C to -80°C.
Cryolesioning Effects on Peripheral Nerves	Evaluated impact on physiologic function and histologic changes in a preclinical rat model.
Safety (Biocompatibility)	Identical to predicate device, implying biocompatible patient-contacting materials.

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

Sample Size: The document does not specify a distinct "test set" sample size for the verification testing. For the preclinical animal study, it mentions "a rat model" but does not provide the number of animals used.
Data Provenance:
- Verification testing: Performed internally by MyoScience. The country of origin is not specified, but MyoScience is based in Redwood City, CA, USA, suggesting the testing was likely conducted in the USA.
- Preclinical animal study: Performed using a "rat model." The location of the study is not specified.
- Nature of data: Both verification testing and the preclinical animal study were prospective in nature, designed specifically to evaluate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the submission. The studies described are non-clinical (device performance verification and animal study) and do not involve human expert interpretation for "ground truth" in the way a diagnostic AI device would.

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

This information is not applicable/not provided as the described studies are non-clinical and do not involve human expert adjudication of a test set in the context of diagnostic accuracy.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. This submission is for a therapeutic cryogenic surgical device, not a diagnostic imaging AI algorithm that would typically involve human readers. The study focuses on the device's physical performance and biological effect, not on human interpretation or decision-making.

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

This question is not applicable as the device is a physical surgical instrument, not a standalone algorithm. The device's performance is inherently "standalone" in terms of its mechanical and thermal operation.

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

Verification Testing: The "ground truth" for system performance and temperature profiling would be based on engineering specifications and established measurement standards, comparing measured physical parameters to pre-defined design requirements.
Preclinical Animal Study: The "ground truth" for evaluating the impact of cryotreatment on peripheral nerves would be based on physiological function assessments and histological changes observed in the rat model. This involves direct observation and analysis of biological tissue and function.

8. The sample size for the training set

This information is not applicable/not provided. This device does not employ machine learning or AI that would require a "training set." The development relies on engineering design, physical principles, and biological testing.

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

This information is not applicable/not provided as there is no training set for this device.

Summary

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K100447

MyoScience

JUN 2 5 2010

Premarket Notification

Section 5: 510(k) Summary

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

a. Predicate Device Information:

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

510(k) Number	Product	Sponsor
K083493	Cryo-Touch	MyoScience, Inc
K050272	Cryo-PaC™ System	Cryomedical Instruments
K854334	Painblocker WA 5000	Wallach Surgical Devices
K831963	Cryomedics Neurostat	Spembly Medical Ltd

b. Date Summary Prepared

June 21, 2010

c. Description of Device

The device is based on introduction of a cryoprobe cooled by the cryogenic fluid (liquid nitrous oxide (N₂Q)) to the selected site and activation of the freeze control. An iceball forms around the tip of the needle assembly and the adjacent nerve.

The Cryo-Touch may be used 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:

Section 5: 510k Summary

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· MyoScience

Premarket Notification

a control unit (controller) with cryogen cap, 1)
needle assembly (Cryoprobe), and 2)
a cryogen cylinder(Nitrous Oxide). 3)

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

The Crvo-Touch controller is battery operated; the battery powers electronics within the controller that control the nitrous oxide flow and regulate light emitting diodes (LEDs) that provide feedback to the user when the device is ready to use.

An assortment of needle assemblies is available for the Cryo-Touch, ranging from a single to a dual needle, from 25 gauge to 30 gauge, and from 10mm to 25 mm 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 only patient contacting component of the Cryo-Touch. 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 rest with NJO gas. A single nitrous oxide 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 Jouled 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

The MyoScience Cryo-Touch 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 is not indicated for treatment of central nervous system tissue.

e. Comparison to Predicate Devices

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

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Premarket Notification

	This Device	Predicate Device
Parameter	MyoScienceCryo-Touch	MyoScienceCryo-TouchK083493	CryomedicalInstrumentsCryo-PaC™System K050272	Wallach SurgicalDevicesPainblockerWA5000 K854334	SpemblyMedical LtdCryomedicsNeurostatK831963
Intended Use	Identical to allpredicates	Destroy tissue through freezing
TargetPopulation	Identical to allpredicates	Adults
Anatomical Sites	Identical topredicates	Not specified	Peripheral nerves
Intendedusers/clinicalsetting	Identical to allpredicates	Qualified medical personnel (doctors, specialists) in hospital or medical environment
Technology	Identical to Cryo-Touch. Similar toCryo-Pac,Painblocker WA5000and Neurostat.	Cryogenic surgical device with needle which penetrates treatment area.
Energy used/ordelivered	Identical to allpredicates	Cryotherapy/Nitrous Oxide	Cryotherapy/Nitrous Oxide	Cryotherapy/Nitrous Oxide orCarbon Dioxide	Cryotherapy/Nitrous Oxide orCarbon Dioxide
Human Factors	Identical to Cryo-Touch.	Hand-held and or portable device containing cryogen. Some units have footswitchand detachable cryoprobes.
Biocompatibility	Identical to allpredicates	Biocompatible patient contacting materials
OperatingPrinciple	Identical to allpredicates	Joule-Thomson Effect
Patientcontactingmaterials	Identical to Cryo-Touch	Closed-tip stainless steel cryoprobeRanging from 12 - 30 gauge
TreatmentTemperature	Identical to Cryo-Pac,Painblocker WA5000and Neurostat	-15° C to -25°C(5°F to -13°F) for Cryo-Touch, -55°C to -80 (-67°F to -112°F) for other predicates
Power Source	Yes. Identical toCryo-Touch	Battery powered	Mains powered	Battery powered	Battery powered

The device that is the subject of this 510(k) application is identical to the previously cleared Cryo-Touch device with the following exceptions:

(1) A proprietary filter was added internally. The filter has no direct patient contact.
(2) The Cryo-Touch now delivers a target treatment temperature of -65 C which is within the range of the other predicate devices, the Cryo-Pac, the Painblocker WA5000 and the Neurostat.

f. Summary of Supporting Data

Verification testing was performed on the Cryo-Touch device to Nonclinical testing Submitted: demonstrate that the product met the design requirements for system performance and temperature profiling during simulated use conditions.

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Section 5: 510k Summary

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1 MyoScience

Premarket Notification

A preclinical animal study designed to evaluate the effects of cryotreatment with the Cryo-Touch device on peripheral nerves in a rat model was performed. The study evaluated the impact of the cryolesioning treatment on peripheral nerves in terms of physiologic function and histologic changes.

All other relevant performance testing was submitted as part of the submission for the predicate Cryo-Touch device.

Clinical Testing Submitted: None

g. Conclusion

MyoScience concludes that the Cryo-Touch described in this substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

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 Quality Assurance 525 Chesapeake Drive Redwood City. CA 94063

JUN 2 5 2010

Re: K100447

Trade/Device Name: Cryogenic Surgical Device Regulation Number: 21 CFR 882.4250 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GXH Dated: June 21, 2010 Received: June 22, 2010

Dear Ms. Henry:

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. Ilsting 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 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

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Page 2 - Ms. Tracey Henry

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/CDRH/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Image /page/5/Picture/8 description: The image shows the name and title of Malvina B. Eydelman, M.D. The title is Director, Division of Ophthalmic, Neu, Nose and Throat Devices. The text is black and the background is white.

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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· / MyoScience

Cryo-Touch Premarket Notification

Section 4: Indications for Use Statement

510(k) Number:

K100447

Device Name:

MyoScience Cryo-Touch

Indications for Use:

Prescription Use X (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

Dani Kaufman

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

510(k) Number K100447

Page 1 ·

Section 4: Indications for Use Statement

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).