(149 days)
Embryo Transfer Catheter used to introduce embryos into the body.
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.
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.
This is a 510(k) premarket notification for a medical device, the Embryo Transfer Catheter, seeking clearance based on substantial equivalence to predicate devices. This type of submission does not typically include a detailed clinical study with acceptance criteria and device performance as one might find for a PMA (Premarket Approval) device, especially for a Class II device like this one.
The provided documents focus on:
- Device identification and classification: Name, manufacturer, classification, and procode.
- Predicate devices: Stating that the device is substantially equivalent to legally marketed predicate catheters.
- Device description: Design, materials, and sterilization.
- Intended Use: "Embryo Transfer Catheter used to introduce embryos into the body."
- Regulatory clearance: The FDA's letter granting clearance based on substantial equivalence.
Therefore, many of the requested items (acceptance criteria, specific study results, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not typically part of a 510(k) submission for this type of device and are not present in the provided text.
Based on the provided text, here is the information that can be extracted, along with explanations for what is not applicable:
1. Table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. For a 510(k) submission, especially for a Class II device, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific quantifiable clinical performance metrics with statistical targets. The acceptance is based on the FDA's regulatory review of the declaration of substantial equivalence, material properties, sterilization validation, and intended use as compared to predicates. No specific performance metrics or acceptance criteria are reported in this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. The provided document does not describe a clinical "test set" or clinical study in the sense of a prospective performance evaluation on human subjects. This is a 510(k) premaket notification, which relies on demonstrating substantial equivalence to existing predicate devices, often through bench testing, material characterization, and comparison to published literature or predicate device specifications, rather than a new clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. As no clinical test set requiring ground truth establishment is described, this information is not relevant or present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. As no clinical test set requiring ground truth establishment is described, this information is not relevant or present in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided. This device is an "Embryo Transfer Catheter," a physical medical device. It is not an AI/Software as a Medical Device (SaMD) that involves "human readers" or AI assistance. Therefore, an MRMC study is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is a physical embryo transfer catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No clinical ground truth is established or used for this 510(k) submission.
8. The sample size for the training set
- Not Applicable / Not Provided. No "training set" in the context of machine learning or clinical study data is described for this 510(k) submission.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set mentioned, the method for establishing its ground truth is also not applicable.
Summary of focus for this 510(k) submission:
The Embryo Transfer Catheter (CC Glider™) secured 510(k) clearance (K991266) based on substantial equivalence to predicate devices already legally marketed in the United States. The submission detailed the device's design (inner catheter of 5 French O.D., outer catheter of 9 French tapering to 7 French O.D.), materials (implant grade medical polymers), and sterilization methods (gamma radiated or E-Beamed). Its intended use is simply stated as "Embryo Transfer Catheter used to introduce embryos into the body." The clearance process for such a Class II device primarily involves demonstrating that it is as safe and effective as existing devices through comparisons of technological characteristics, materials, and intended use, rather than extensive new clinical performance studies with acceptance criteria as would be required for a novel or higher-risk device.
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g 1999 SEP
international, Inc. 510(K) Premarket Notification
510K Summary
- 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
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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)
...
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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
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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 |
|---|---|
| --------------- | --------- |
§ 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).