(115 days)
The MyoScience Cryo-Touch device is intended to destroy tissue during surgical procedures by applying freezing cold.
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.
The provided document is a 510(k) summary for the MyoScience Cryo-Touch device. It describes the device, its intended use, and comparison to predicate devices, and a high-level summary of supporting data. However, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a specific study that proves the device meets those criteria.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully answered. The document states, "Performance testing has demonstrated that the device is in compliance with pertinent standards, the medical community's expectations and the product labeling." This is a general statement and does not provide specific acceptance criteria (e.g., minimum freeze time, temperature achieved, etc.) nor does it report specific device performance metrics against those criteria. It only indicates that performance testing was done and compliance was achieved.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered. The document mentions "Performance testing" but does not provide any details about the sample size used for this testing or the provenance of any data generated (e.g., country of origin, retrospective/prospective).
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)
- Cannot be answered. The document does not describe any test set that would require expert-established ground truth. The performance testing mentioned likely relates to engineering and functional performance of the device itself (e.g., cooling capabilities), not an assessment of diagnostic accuracy or treatment efficacy by experts on a patient dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered. As there's no mention of a test set with expert-established ground truth, an adjudication method is not applicable and therefore not described.
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
- Cannot be answered. This device is a cryosurgical unit, not an AI-assisted diagnostic or therapeutic tool for "human readers." Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant to this device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered. This device is a physical cryosurgical instrument, not an algorithm. Therefore, "standalone algorithm" performance is not applicable and not discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be answered. As discussed in point 3, the nature of the device (cryosurgical unit) implies that "ground truth" as typically defined for diagnostic or AI-driven devices (like pathology or expert consensus on images) is not relevant for its performance testing in this context. Performance testing would likely involve physical measurements (e.g., temperature, freeze size, consistency).
8. The sample size for the training set
- Cannot be answered. This device is a physical cryosurgical unit, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Cannot be answered. As there is no training set for this type of device, this question is not applicable.
Summary of available information regarding compliance:
The document states that:
- "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."
These statements indicate that some form of testing was conducted to show compliance with relevant standards and expectations, but the specific details of these tests, including acceptance criteria, sample sizes, and detailed results, are not present in this 510(k) summary. Such details would typically be found in the full 510(k) submission, which is not provided here.
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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, Inc525 Chesapeake DriveRedwood City, CA 94063(650) 474-2600(650) 474-2700 |
| Correspondent ContactInformation: | Tracey HenryDirector RAQA, Clinical Compliance525 Chesapeake DriveRedwood 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
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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.
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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
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- 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)
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Nul Rl. Qad. Forman
(Division Sign-Q Division of General, Restorative, and Neurological Devices
510(k) Number K083493
Section 4: Indications for Use Statement
§ 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.