(69 days)
The Intratubal Transfer Sets are used to inject either sperm, gametes or embryos into the uterine ostium of the fallopian tube via ultrasound guidance. The device is sterile and intended for one time use.
The Intratubal Transfer Sets are used to inject either sperm, gametes or embryos into the uterine ostium of the fallopian tube via a transvaginal approach utilizing ultrasound guidance. The materials used in these sets are TFE, echosight polyethylene, polyethylene, and stainless steel. All materials are widely used in the medical field and biocompatibility testing has been assured.
The provided text is a 510(k) Premarket Notification for "Intratubal Transfer Sets" and does not contain information about acceptance criteria or a study proving that the device meets those criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting their device is as safe and effective as a legally marketed device that existed prior to May 28, 1976 (or has been reclassified).
Therefore, I cannot provide the requested information based on the given text.
Here's why:
- No Acceptance Criteria or Performance Data: The document states the device will be manufactured under process controls and a Quality Assurance Program, and will undergo similar packaging. It does not define specific acceptance criteria (e.g., a certain percentage of successful transfers, a specific breakage rate, or measurable biological outcomes) or include any performance data from a specific study.
- Focus on Substantial Equivalence: The core of this 510(k) submission is to argue that the "Intratubal Transfer Sets" are "substantially equivalent to other sperm, gametes or embryo transfer sets in terms of indications for use, design, construction and materials equivalence." This is a regulatory pathway that often relies on comparison to existing devices rather than a de novo performance study with defined acceptance criteria.
- "Predicate Devices: Cook Australia products": The document explicitly states that Cook OB/GYN used Cook Australia products as predicates "to illustrate safety and effectiveness." This implies that the safety and effectiveness are established by the predicate devices, and the new device is considered equivalent.
If this were a newer type of submission, or a device that didn't have substantial equivalency to a predicate, then performance data and acceptance criteria would be essential components.
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510(k) Premarket Notification Intratubal Transfer Sets Cook OB/GYN
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
0EC 2 1 1998
Submitted By:
,
I.
Debbie Schmitt Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 October 13, 1998
Device
Trade Name: Proposed Classification Name: Intratubal Transfer Sets Assisted Reproduction Catheters Class II 85MQF
Predicate Devices:
Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectiveness.
The Intratubal Transfer Sets are substantially equivalent to other sperm, gametes or embryo transfer sets in terms of indications for use, design, construction and materials equivalence. Specifically, these sets are similar to the Embryo and Gamete Intratubal Transfer Sets manufactured by Cook Australia.
Device Description:
The Intratubal Transfer Sets are used to inject either sperm, gametes or embryos into the uterine ostium of the fallopian tube via a transvaginal approach utilizing ultrasound guidance. The materials used in these sets are TFE, echosight polyethylene, polyethylene, and stainless steel. All materials are widely used in the medical field and biocompatibility testing has been assured.
Substantial Equivalence:
These sets will be manufactured according to specified process controls and a Quality Assurance Program. These sets will undergo packaging similar to the devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials and physical construction to predicate devices, these sets meet the requirements for section 510(k) substantial equivalence.
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest. The profiles are surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1998
Debbie Schmitt Cook Ob/Gyn 1100 West Morgan Street Spencer, IN 47460
Re: K983591 Transvaginal Intratubal Transfer Sets Dated: October 13, 1998 Received: October 13, 1998 Regulatory Class: II 21 CFR 884.6110/Procode: 85 MQF
Dear Ms. Schmitt:
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 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). 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 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 Regulations, 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 regulatory 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 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) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
J. J. T.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K983
K983591
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not yet assigned
Device Name: Intratubal Transfer Sets
The Intratubal Transfer Sets are used to inject either sperm, gametes Indications for Use: or embryos into the uterine ostium of the fallopian tube via ultrasound guidance. The device is sterile and intended for one time use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
. Over-The-Counter Use
Simil h. Srymm
(Division Sign-Off) 4 Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).