(67 days)
The Ti Clip Applier is indicated for ligation of the vas deferens.
Ti Clip Applier
The provided text is a 510(k) clearance letter from the FDA for a device called "Ti Clip Applier." This document primarily focuses on the regulatory clearance process, substantial equivalence to a predicate device, and labeling requirements. It does not contain information about acceptance criteria, detailed study designs, or performance metrics from a study proving criteria were met.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training set.
- How ground truth for the training set was established.
The document only states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination is the primary "acceptance criterion" for 510(k) clearance, and it means the device is as safe and effective as a legally marketed predicate device. The letter also includes a labeling limitation regarding its effectiveness for permanent male sterilization not being evaluated in comparison to standard vasectomy procedures.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
Mr. Brian S. Zimovan Engineering Manager Gyrx, LLC 11222 St. Johns Industrial Parkway Jacksonville, Florida 32246
Re: K034029 Trade/Device Name: Ti Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NJC Dated: December 5, 2003 Received: December 29, 2003
Dear Mr. Zimovan:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nowed your 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 for use stated in the encreations of the enactment date of the Medical Device Amendments, or to eonimered pror to Tria) 2011-12-11 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls and Cosmode Her (110) - Tee limitations described below. The general controls provisions of the provisions of the Actualia the minual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Develop Dram intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The effectiveness of using the Ti Clip Applier for permanent male sterilization has not been evaluated in comparison to standard vasectomy procedures.
Please note that the above labeling limitations are required by Section 513(i)(l)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate r he 1 Dr rinaing of basilication for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Scction mance." This letter will ation if the limitation statement described above is added to your labeling.
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Page 2 - Mr. Brian S. Zimovan
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 r roase of acribed 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 or any I odotal batates and regirements, 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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 PER 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,
Daniel G. Schultz, M.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX E Indications for Use
510(k) Number (if known): Not known
Device Name: Ti Clip Applier
Indications For Use:
The Ti Clip Applier is indicated for ligation of the vas deferens.
Prescription Use Yes (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)
Division Sig. Off.
Page 1 of _ '
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K034029
37
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.