(128 days)
Not Found
No
The description focuses on the mechanical and cryogenic aspects of the device for nerve freezing and pain blocking. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used to produce lesions in peripheral nervous tissue by applying cold to block pain, which directly serves a therapeutic purpose.
No
Explanation: The device description states it is used to "destroy nervous tissue or produce lesions" for "blocking pain." It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a hand-held, single patient-use disposable, cryogenic device that uses a cryoprobe and cryogenic fluid (liquid nitrous oxide) to produce lesions. This involves significant hardware components and physical interaction with the patient.
Based on the provided information, the MyoScience Cryo-Touch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Cryo-Touch Function: The Cryo-Touch directly interacts with the patient's body by applying cold to peripheral nervous tissue in vivo (within the living organism) to block pain. It does not analyze samples taken from the body.
The description clearly states its purpose is to produce lesions in peripheral nervous tissue by applying cold to a selected site for pain blocking. This is a therapeutic intervention performed directly on the patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for 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 nog indicated for treatment of central nervous system tissue.
Product codes
GXH
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.
The device is comprised of three main components:
- a control unit (controller) with cryogen cap,
- needle assembly (Cryoprobe), and
- a cryogen cylinder(Nitrous Oxide).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nervous tissue, Peripheral nerves
Indicated Patient Age Range
Adults
Intended User / Care Setting
Qualified medical personnel (doctors, specialists) in hospital or medical environment
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
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.
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
Key Metrics
Not Found
Predicate Device(s)
K083493, K050272, K854334, K831963
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
MyoScience
JUN 2 5 2010
Premarket Notification
Section 5: 510(k) Summary
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor / Submitter: | MyoScience, Inc |
| 525 Chesapeake Drive | |
| Redwood City, CA 94063 | |
| (650) 474-2600 | |
| (650) 474-2700 | |
| Correspondent Contact | |
| Information: | Tracey Henry |
| Sr. Director RAQA, Clinical Compliance | |
| 525 Chesapeake Drive | |
| Redwood 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 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.
Device Design
The device is comprised of three main components:
Section 5: 510k Summary
1
· 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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Image /page/2/Picture/1 description: The image contains the word "MyoScience" in a simple, sans-serif font. The text is black against a white background. There is a small mark to the left of the word.
Premarket Notification
| This Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Parameter | MyoScience | ||||
| Cryo-Touch | MyoScience | ||||
| Cryo-Touch | |||||
| K083493 | Cryomedical | ||||
| Instruments | |||||
| Cryo-PaC™ | |||||
| System K050272 | Wallach Surgical | ||||
| Devices | |||||
| Painblocker | |||||
| WA5000 K854334 | Spembly | ||||
| Medical Ltd | |||||
| Cryomedics | |||||
| Neurostat | |||||
| K831963 | |||||
| Intended Use | Identical to all | ||||
| predicates | Destroy tissue through freezing | ||||
| Target | |||||
| Population | Identical to all | ||||
| predicates | Adults | ||||
| Anatomical Sites | Identical to | ||||
| predicates | Not specified | Peripheral nerves | |||
| Intended | |||||
| users/clinical | |||||
| setting | Identical to all | ||||
| predicates | Qualified medical personnel (doctors, specialists) in hospital or medical environment | ||||
| Technology | Identical to Cryo- | ||||
| Touch. Similar to | |||||
| Cryo-Pac, | |||||
| Painblocker WA5000 | |||||
| and Neurostat. | Cryogenic surgical device with needle which penetrates treatment area. | ||||
| Energy used/or | |||||
| delivered | Identical to all | ||||
| predicates | Cryotherapy/ | ||||
| Nitrous Oxide | Cryotherapy/ | ||||
| Nitrous Oxide | Cryotherapy/ | ||||
| Nitrous Oxide or | |||||
| Carbon Dioxide | Cryotherapy/ | ||||
| Nitrous Oxide or | |||||
| Carbon Dioxide | |||||
| Human Factors | Identical to Cryo- | ||||
| Touch. | Hand-held and or portable device containing cryogen. Some units have footswitch | ||||
| and detachable cryoprobes. | |||||
| Biocompatibility | Identical to all | ||||
| predicates | Biocompatible patient contacting materials | ||||
| Operating | |||||
| Principle | Identical to all | ||||
| predicates | Joule-Thomson Effect | ||||
| Patient | |||||
| contacting | |||||
| materials | Identical to Cryo- | ||||
| Touch | Closed-tip stainless steel cryoprobe | ||||
| Ranging from 12 - 30 gauge | |||||
| Treatment | |||||
| Temperature | Identical to Cryo-Pac, | ||||
| Painblocker WA5000 | |||||
| and 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 to | ||||
| Cryo-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.
Page 3
Section 5: 510k Summary
3
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.
4
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
5
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
6
· / MyoScience
Cryo-Touch Premarket Notification
Section 4: Indications for Use Statement
510(k) Number:
Device Name:
MyoScience Cryo-Touch
Indications for 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 nog indicated for treatment of central nervous system tissue.
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