(374 days)
The Retriever II is indicated for use in the retrieval of intravascular occlusion coils misplaced during interventional radiological procedures in peripheral and neurovasculature.
The Retriever II (R-II) is a single use, disposable endovascular Snare. The R-II consists of a flexible core wire, radiopaque coils at the distal end of the corewire facilitate fluoroscopic visualization. Fiber strands are attached to the distal tip of the core wire. A platinum tip marker is attached at the distal end of the fibers to facilitate fluoroscopic visualization. The fibers, when manipulated, work to ensnare the misplaced coil.
No, the provided document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.
The document is a 510(k) summary and the FDA's clearance letter for the Retriever II Endovascular Snare Device. It states that:
- "TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION: The results of bench testing (tensile, turns to failure, tip flexibility, fiber retention), animal studies, and Biocompatibility testing support the substantial equivalence claims of the R-II for its intended use."
- "Results of the bench testing, animal studies, and Biocompatibility testing in conjunction with the substantial equivalence claims as outlined in this premarket notification, effectively demonstrate that the R-II is substantially equivalent to the predicate device."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Details of a standalone (algorithm only) performance study (as this is a medical device, not an AI/algorithm-based device).
- Type of ground truth used (again, this is physical device testing).
- Sample size for training set (not applicable for this type of device submission).
- How ground truth for the training set was established (not applicable).
The document focuses on demonstrating substantial equivalence to a predicate device (Retriever-18) through general descriptions of bench testing, animal studies, and biocompatibility, rather than presenting a detailed performance study against specific acceptance criteria.
{0}------------------------------------------------
K9164210
Image /page/0/Picture/4 description: The image shows the logo for Target Therapeutics. The logo consists of a black circle with a horizontal line extending from its right side. To the right of the circle and line, the word "TARGET" is printed in large, bold, sans-serif letters, with the line running underneath it. Below "TARGET", the word "THERAPEUTICS" is printed in smaller, sans-serif letters.
OCT 31 1997
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
CONTACT PERSON:
Laraine Pangelina Sr. Manager, Regulatory Affairs Target Therapeutics, Inc. 47201 Lakeview Blvd. Fremont, CA 94538-6530
DEVICE NAME:
Retriever II Endovascular Snare Device, Class II
DEVICE DESCRIPTION:
The Retriever II (R-II) is a single use, disposable endovascular Snare. The R-II consists of a flexible core wire, radiopaque coils at the distal end of the corewire facilitate fluoroscopic visualization. Fiber strands are attached to the distal tip of the core wire. A platinum tip marker is attached at the distal end of the fibers to facilitate fluoroscopic visualization. The fibers, when manipulated, work to ensnare the misplaced coil.
INDICATIONS FOR USE:
The Retriever II is indicated for use in the retrieval of intravascular occlusion coils misplaced during interventional radiological procedures in peripheral and neurovasculature.
PREDICATE DEVICE: Target Therapeutics' Retriever-18
TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION: The results of bench testing (tensile, turns to failure, tip flexibility, fiber retention), animal studies, and Biocompatibility testing support the substantial equivalence claims of the R-II for its intended use. Results of the bench testing, animal studies, and Biocompatibility testing in conjunction with the substantial equivalence claims as outlined in this premarket notification, effectively demonstrate that the R-II is substantially equivalent to the predicate device.
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) of the USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 31 1997
Ms. Linda Guthrie Senior Requlatory Affairs Specialist Target Therapeutics 47201 Lakeview Boulevard P.O. Box 5120 Fremont, California 94537-5120
Re: K964210 Retriever II Requlatory Class: II (two) Product Code: DOO Dated: July 28, 1997 Received: August 4, 1997
Dear Ms. Guthrie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the . Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this-response to your premarket notification submission does not affect any obligation you might have
{2}------------------------------------------------
under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Target Therapeutics. The logo consists of a black circle on the left, followed by the word "TARGET" in large, bold, black letters. Below the word "TARGET" is the word "THERAPEUTICS" in smaller, black letters. A horizontal line connects the circle to the word "TARGET".
INDICATIONS FOR USE STATEMENT
510(k) Number: K964210
Device Name: Retriever II
Indications for Use:
The Retriever II is indicated for use in the retrieval of intravascular occlusion coils misplaced during interventional radiological procedures in peripheral and neurovasculature.
Tan A. A
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number
Response to FDA Questions received 05/13/97
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).