← Product Code [MQF](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF) · K991266 # EMBRYO TRANSFER CATHETER CC GLIDER (K991266) _ Intl., Inc. · MQF · Sep 9, 1999 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF/K991266 ## Device Facts - **Applicant:** Intl., Inc. - **Product Code:** [MQF](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF.md) - **Decision Date:** Sep 9, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.6110 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** Therapeutic ## Indications for Use Embryo Transfer Catheter used to introduce embryos into the body. ## Device Story The CC Glider™ Embryo Transfer Catheter is a medical device designed for the transfer of embryos into the uterus during assisted reproduction procedures. The device consists of two models: a standard model and a model for difficult transfers. The design features an inner catheter (5 French) and an outer catheter (9 French tapering to 7 French). The inner catheter includes a support/holding marking along the handle end. The inner catheter extends 5 cm beyond the outer catheter in the standard model and 3 cm in the difficult transfer model. The device is constructed from implant-grade medical polymers and is intended for single use. It is sterilized via gamma radiation or E-Beam. The catheter is operated by a clinician in a clinical setting to facilitate embryo placement, potentially improving the success of assisted reproduction. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Materials: Implant-grade medical polymers. Design: Two-component catheter system (inner 5F, outer 9F tapering to 7F). Sterilization: Gamma radiation or E-Beam. Single-use. ## Regulatory 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. ## Special Controls *Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ g 1999 SEP international, Inc. 510(K) Premarket Notification 510K Summary K991266 - Device Name: Assisted Reproduction Accessories a) Embryo Transfer Catheter Proprietary Name: CC Glider™ - Establishment Registration Number: 9003605 b) international, Inc. 170 Fort Path Road Madison, CT 06443 ... Tel: 203-245-4901 Fax: 203-245-4994 E-mail: genxintl@aol.com Contact Individual: Michael D. Cecchi President - Classification: Class II C) Assisted Reproductive Catheter Product: Embryo Transfer Catheter Procode: 85 MQF CFR#: 884.6110 - Performance Standards/Special Controls: d) Performance Standardsropodal Controler Food and Drug Administration has developed no Performance standard have Food and Drug Administration has developedial special Controls have section 514 or the Action this dones. From the assurance of the safety and been identified in Order to procession assisted reproduction procedures. - Proposed Label, Promotion, and Advertising e) Proposed Label, Promotion material is included in the appropriate section of this application. - Statement of Substantially Equivalence f) international Inc. considers this catheter to be substantially equivalent in international mo. Concerner of predicated catheters legally marketed in United States. These cathers are discussed in the appropriate section. - Device Description, Intended Use and Direction for Use ಡಿ) Product Design 1.0 {1}------------------------------------------------ The Embryo Transfer Catheter There will be two (2) catheters made The Linbryo Transhals in order to accommodate the market from the same basic and for more difficult transfers. The catalog numbers of the two models are GECT-100 and GETC-200. The basic design of the two models will consist of an inner catheter of 5 French The basic dosign of theter of 9 French tapering to 7 French O.D. with a one O.D.and an outlor batheter of the inner catheter has a support/holding continution mailking on from the handle end along the catheter for 5 cm. The inner catheter will extend approximately 5 cm out of the outer catheter when f no inner catiforer will the standard model and 3 cm for the difficult transfer model. The materials are of implant grade medical polymers, to be wrapped for single use. ## Sterilization Procedures and Facilities h) There will be three variations of the catheter made to suit the market needs. All will be of a polymer that may be gamma radiated or E-Beamed. We consider these to be equivalent in the method and results, and may use both in the process. h) ... {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Image /page/2/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUM" written around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo appears to be a symbol or emblem associated with a health-related organization. a 1999 SEP Mr. Michael D. Cecchi President International, Inc. 170 Fort Path Road, Unit 14 Madison, CT 06443 Re: K991266 Embryo Transfer Catheter CC Glider™ Dated: June 10, 1999 Received: June 23, 1999 Regulatory Class: II 21 CFR §884.6110/Procode: 85 MQF Dear Mr. Cecchi: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have We have reviewed your Section 510(phones and of the indications for use stad on the enclosure) to legally determined the device is substantialy equivalent (for the enactment determined the device is substially equivalit (in the normerce prior of the enactment date of the enactment date of the marketed predicate devices markets in merce phot to min accordance with the provisions of the Medical Device Amendments, or to devices marter market the device, subject to proceente on the censtered control. Federal Food, Drug, and Cosmetic Act (Act in el instruct mar Federal Food, Drug, and Cosmetic Act (Ac). You may, the Act include requirements for annual registration, listing of provisions of the Act. The general contrible provisions provisions of the Act. The general controls provisions of the Act Post Manager of the Armanian and adulteration. lf your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may If your device is classified (see above) into entre class it (ofecal other or clevice can be found in the Code of the Code of be subject to such addiional control . Existing million and downloans management manaliance with Federal Regulations, Title 21, Parts 800 to 805. A substantially equivalio Federal Regulations, Title 21, Parts 800 to 855. A substantially System Regulation (QS) for the Current Good Manufacturing Practice requirence as a not the condicio Collections, the Food and Medical Devices: General regulation (CFR Fart ozol) polit the Comments of Child Clear (regulation may result in Drug Administration (FDA) will verify such assumptions Failu Drug Administration (FDA) will vehil such assumply nor in onne mo ver device in the Federal regulatory action. In addition, FDA may publish futher an otherning your device i regulatory action. In addition, FDA may publication submission submission does not affect any obligation your Register. Please note: this response to your premarke notifi Register. Please note: this response to your plentalien door soundom around for and of the control of the program. might have under sections 531 through 542 of the Act for 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 for This letter will allow you to begin marketing your deviced in your of your be results in a classification for nnoing or substantial oqurvits your device to proceed to the market. If you desire specific advice for your labeling regulation (21 CFF Part 801 and additionally for guestions on lf you desire specific advice to your device on our light of Compliance at (301) 504 (101) 1914) (1919) 1919) 1919 (1999) 1999) yited diagnostic devices), please contract the Office of Comlinere at (301) 594-4639. Also, the promotion and advertising of your device, please contact the Office of Combi the promotion and advertising of your devel, persons to oremarket notification (21 CFR 807.97). Other please note the regulation entilled, "Mishander to prehistor from the Division of Small Manufacturers general information on your responsibilities under (1991) of the niem ad general information on your responsibilities and the Autor May 25 on 11:10 internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, 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 {3}------------------------------------------------ ## Indication for Use ______________________________________________________________________________________________________________________________________________________________________________ 510 (k) Number ( if known )___________________________________________________________________________________________________________________________________________________ Device Names: Embryo Transfer Catheter Indication for Use: Embryo Transfer Catheter used to introduce embryos into the body. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ) Concurrence of CDRH, Office of Device Evaluation (ODE | Prescription Use | | |------------------|--| |------------------|--| or | Over-the Counter Use | | |----------------------|--| |----------------------|--| | | (Division Sign-Off) | |--|--------------------------------------------------------------------| | | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | 510(k) Number | K991266 | |---------------|---------| |---------------|---------| --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF/K991266](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF/K991266) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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