(179 days)
The DermoTherap Gun is an electrical powered syringe needle injector intended to be used for intradermal administration of liquid medications in low preset doses to a precise needle penetration depth.
The DermoTherap Gun is an electrical powered syringe needle injector.
The provided text is a 510(k) clearance letter from the FDA for a device called "DermoTherap Gun." This document does not contain the kind of detailed information about acceptance criteria, study design, sample sizes, and ground truth establishment that you are requesting.
The letter explicitly states: "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..."
This means the device was cleared based on its equivalence to existing devices, not necessarily on a novel study demonstrating specific performance metrics against pre-defined acceptance criteria in the way a new drug or a more complex AI medical device might require.
Therefore, I cannot provide the requested information from the given text. A 510(k) summary (which might be a separate document submitted to the FDA) or the full 510(k) submission would typically contain such study details if they were required for clearance.
Here's a breakdown of why this document doesn't contain the requested information:
- Acceptance Criteria and Reported Performance: Not present. The letter focuses on "substantial equivalence."
- Sample Size and Data Provenance: Not present. No mention of a test set or data source.
- Number and Qualifications of Experts: Not present. No ground truth establishment is described.
- Adjudication Method: Not present.
- MRMC Comparative Effectiveness Study: Not mentioned.
- Standalone Performance Study: Not mentioned.
- Type of Ground Truth: Not applicable, as no study results are detailed.
- Training Set Sample Size: Not applicable, as no machine learning or AI component is mentioned.
- Ground Truth for Training Set: Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. On the left side of the seal, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DermoEquipos S.R.L. C/O Mr. Benny Arazy C.E.O & President Arazy Group Mitzpe Aviv, Industrial Park 13 M.P. Misgav, Israel 20187
5 2007 FEB
Re: K062339
Trade/Device Name: DermoTherap Gun Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: January 28, 2007 Received: February 1, 2007
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.
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Page 2-Mr. Arazy
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.
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/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K062339
Device Name: DermoTherap Gun
Indication for Use:
The DermoTherap Gun is an electrical powered syringe needle injector intended to be used for intradermal administration of liquid medications in low preset doses to a precise needle penetration depth.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ole
Page 1 of
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).