(48 days)
The CryoShape is intended to destroy tissue during surgical procedures by applying extreme cold.
The CryoNeedle Cryoprobe manufactured by Etgar Group H.M.Y.A. Ltd. (U.S Patent 6.503,246) is a hand-held cryosurgical instrument for destroving tissue during surgical procedures by intralesional application of extremely cold cryoprobe. The device is based on intralesional application of a needle cooled by the cryogenic fluid (liquid nitrogen with boiling temperature -196℃ (-320.8ºF)) to a selected area to effect cellular destruction. . The needle is cooled by the cryogenic fluid (liquid nitrogen - boiling temperature -196°C (-320.8°F)) is applied intralesionally to a selected area to effect cellular destruction. By forcing liquid nitrogen to circulate through the needle an ice ball around the CryoNeedle developed causing the abutted HSK tissue to be completely frozen. As this iceball grows, its leading edge advances through tissue. Tissue that comes into contact with the iceball is destroyed. Temperatures of -25℃ to -50℃ (-139F to -58°F) are achieved within 30 seconds.
The provided text describes a medical device, the CryoNeedle (also referred to as CryoShape in the FDA letter), and its intended use, but it does not contain information about a study that proves the device meets specific acceptance criteria.
The document is primarily a 510(k) premarket notification summary and an FDA clearance letter. It establishes substantial equivalence to a predicate device and states the intended use. It mentions that the device "meets all the declared requirements of its intended use" and "presents no adverse health effect or safety risks," but it does not provide any specific quantitative acceptance criteria or evidence from a study to back these claims.
Therefore, I cannot populate the table or answer many of the questions as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what is explicitly missing:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria are provided in the text. | The device achieves temperatures of -25℃ to -50℃ (-139F to -58°F) within 30 seconds. This is a functional description, not a performance metric against a stated acceptance criterion. |
2. Sample size used for the test set and the data provenance:
- Not provided. The document does not describe any specific clinical or performance test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No test set or ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No test set or adjudication process is 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:
- No. This device is a cryosurgical instrument, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical cryosurgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No ground truth for any study is mentioned. The clearance is based on substantial equivalence to a predicate device and adherence to a consensus standard (ASTM F882-84(2002)).
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not provided. No training set is mentioned.
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1. Device Definition and Intended Use
The CryoNeedle Cryoprobe manufactured by Etgar Group H.M.Y.A. Ltd. (U.S Patent 6.503,246) is a hand-held cryosurgical instrument for destroving tissue during surgical procedures by intralesional application of extremely cold cryoprobe.
The device is based on intralesional application of a needle cooled by the cryogenic fluid (liquid nitrogen with boiling temperature -196℃ (-320.8ºF)) to a selected area to effect cellular destruction. . The needle is cooled by the cryogenic fluid (liquid nitrogen - boiling temperature -196°C (-320.8°F)) is applied intralesionally to a selected area to effect cellular destruction. By forcing liquid nitrogen to circulate through the needle an ice ball around the CryoNeedle developed causing the abutted HSK tissue to be completely frozen. As this iceball grows, its leading edge advances through tissue. Tissue that comes into contact with the iceball is destroyed. Temperatures of -25℃ to -50℃ (-139F to -58°F) are achieved within 30 seconds.
The device is intended to destroy tissue during surgical procedures by applying extreme cold.
Substantial Equivalence (SE) 2.
The CryoNeedle manufactured by Etgar Group H.M.Y.A. Ltd. is considered to be SE to the CryoprobeTM by H&O Equipments NV/SA, Inc.
3. Consensus Standard
- FDA has recognized consensus standard relevant to the CryoNeedle: a.
ASTM F882-84(2002), Standard Performance and Safety Specification for Cryosurgical Medical Instruments. (General Plastic Surgery/General Hospital)
- The modification relative to the cleared predicate device does not introduce any new b. hazards and does not affect the mitigations and CAPA.
4. Summarv
The CryoNeedle constitutes a safe, reliable and effective medical device meeting all the declared requirements of its intended use. The device presents no adverse health effect or safety risks to patients when used as intended.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2006
Etgar Group H.M. Y.A., Ltd. c/o Mr. Benny Arazy 37a Rothschild Street, 44449 Kfar-Saba, Israel
Re: K060928
Trade/Device Name: CryoShape Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: January 11, 2006 Received: April 4, 2006
Dear Mr. Arazy:
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 (OS) 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 - Mr. Benny Arazy
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliken
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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KD60928 510(k) Number:
Device Name: CryoShape
Indication for Use:
.
The CryoShape is intended to destroy tissue during surgical procedures by applying extreme cold.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
区 Prescription Use
Over-The-Counter Use
(Per 21 CFR 801:109)
Hubert Romero
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060928
§ 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.