(115 days)
Not Found
No
The description focuses on the mechanical and cryogenic aspects of the device, with no mention of AI or ML.
Yes
The device is intended to destroy tissue during surgical procedures, which is a therapeutic intervention.
No
Explanation: The device is intended to destroy tissue during surgical procedures by applying freezing cold, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a hand-held, single patient-use disposable, cryosurgical instrument with physical components like a needle and uses a cryogenic fluid (liquid nitrous oxide). This indicates it is a hardware device, not software-only.
Based on the provided information, the MyoScience Cryo-Touch device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "destroy tissue during surgical procedures by applying freezing cold." This is a therapeutic or surgical intervention performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a hand-held surgical instrument that uses a needle to apply cold directly to tissue. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The MyoScience Cryo-Touch device's function is to physically alter tissue through freezing, which is a surgical procedure.
N/A
Intended Use / Indications for Use
The MyoScience Cryo-Touch device is intended to destroy tissue during surgical procedures by applying freezing cold.
Product codes
GEH
Device Description
The MyoScience Cryo-Touch device is a hand-held, single patient-use disposable, cryosurgical instrument used for destroying tissue by subcutaneous insertion of a needle during general surgical procedures. The device is based on introduction of a needle cooled by the cryogenic fluid (liquid nitrous oxide (N₂O)) to a selected area. The needle is cooled by the Joule-Thompson effect.
The Cryo-Touch comes with a variety of stainless steel closed-tip needle assemblies for use in various applications.
The Cryo-Touch uses a commercially available nitrous oxide cylinder.
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)
Biocompatibility data demonstrates that the device is in compliance with ISO 10993.
Performance testing has demonstrated that the device is in compliance with pertinent standards, the medical community's expectations and the product labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.
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MAR 2 0 2009
Kof 349-
Crua Touch
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 |
| Director RAQA, Clinical Compliance | |
| 525 Chesapeake Drive | |
| Redwood City, CA 94063 | |
| (650) 474-2600 | |
| (650) 474-2900 | |
| Device Common Name: | Cryosurgical unit and accessories |
| Device Classification & Code: | Class II, GEH |
| Device Classification Name: | Cryosurgical unit and accessories (21 CFR 878.4350) |
| Device Proprietary Name: | MyoScience Cryo-Touch |
a. Predicate Device Information:
b. Date Summary Prepared
March 17, 2009
c. Description of Device
The MyoScience Cryo-Touch device is a hand-held, single patient-use disposable, cryosurgical instrument used for destroying tissue by subcutaneous insertion of a needle during general surgical procedures. The device is based on introduction of a needle cooled by the cryogenic fluid (liquid nitrous oxide (N₂O)) to a selected area. The needle is cooled by the Joule-Thompson effect.
The Cryo-Touch comes with a variety of stainless steel closed-tip needle assemblies for use in various applications.
The Cryo-Touch uses a commercially available nitrous oxide cylinder.
d. Intended Use
The MyoScience Cryo-Touch device is intended to destroy tissue during surgical procedures by applying freezing cold.
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.
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f. Summary of Supporting Data
Biocompatibility data demonstrates that the device is in compliance with ISO 10993.
Performance testing has demonstrated that the device is in compliance with pertinent standards, the medical community's expectations and the product labeling.
g. Conclusion
MyoScience concludes that the Cryo-Touch described in this submission is substantially equivalent to the predicate devices and no new issues of safety or efficacy have been introduced.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem featuring a stylized eagle with outstretched wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MyoScience, Inc. % Tracey Henry Director RA/QA, Clinical Compliance 525 Chesapeake Drive Redwood City, California 94063
MAR 2 0 2009
Re: K083493
Trade/Device Name: MyoScience Cryo-Touch Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: February 23, 2009 Received: February 25, 2009
Dear Tracey 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Tracey Henry
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sh.A.m.D., for.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Myoscience
Section 4: Indications for Use Statement
510(k) Number: K083493
Device Name: MyoScience Cryo-Touch
Indications for Use:
The MyoScience Cryo-Touch device is intended to destroy tissue during surgical procedures by applying freezing cold.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use ﺑ
(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 __
Nul Rl. Qad. Forman
(Division Sign-Q Division of General, Restorative, and Neurological Devices
510(k) Number K083493
Section 4: Indications for Use Statement