(149 days)
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Not Found
No
The document describes a physical medical device (catheter) and its materials and dimensions. There is no mention of software, algorithms, image processing, AI, or ML.
No
The device is used to introduce embryos into the body, which is a procedural step rather than a direct treatment of a disease or condition. While part of a medical procedure, it serves a delivery function, not a therapeutic one itself.
No
The device is an Embryo Transfer Catheter, used to introduce embryos into the body, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical catheter made of medical polymers, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "introduce embryos into the body." This is a direct intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description details a physical catheter designed for insertion into the body. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device is a medical device used for a therapeutic procedure (embryo transfer), not a diagnostic test.
N/A
Intended Use / Indications for Use
Embryo Transfer Catheter used to introduce embryos into the body.
Product codes (comma separated list FDA assigned to the subject device)
85 MQF
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
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
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 |
|---|---|
| --------------- | --------- |