(171 days)
The Wallace Trial Transfer Catheter is a sterile single-use device intended to assess advancement through the cervical canal and positioning of the uterus
The Wallace Trial Transfer Catheter is a single use, sterile, disposable, soft, and flexible catheter with a unique round smooth distal end. The tip has a blind/closed end. The device has an overall length of 23cm including a, polypropylene Luer Lock adapter that is affixed at its proximal end. The inner catheter is a clear tube with a 1.8-mm outer diameter and a 0.8 inner diameter that is uniform throughout its length. An outer sheath with a 2.3-mm outer diameter surrounds this inner catheter. The distal 0.1-cm of length gradually tapers, leaving the distal 5 cm of the inner catheter exposed. The proximal circumferences of the outer sheath and inner catheter are molded directly into the distal end of the Luer Lock adapter. Five black graduation markings are located on the distal portion of the outer sheath at 1- cm increments to indicate the degree of advancement into the cervix. Four black graduation markings are located on the proximal portion of the inner catheter at 1 cm increments indicate the degree of advancement into the uterus.
My apologies, but the provided text describes a medical device, the "Wallace Trial Transfer Catheter," and its 510(k) submission to the FDA. This submission focuses on establishing substantial equivalence to a predicate device based on technological characteristics and safety (biocompatibility, bacterial endotoxin, and ethylene oxide residuals).
The document does not describe the use of an AI device, nor does it contain any information related to acceptance criteria for an AI algorithm's performance, human reader studies, ground truth establishment methods, or sample sizes typically associated with AI model development and validation.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them in the context of an AI device. The information provided is for a physical medical catheter, not a software or AI-driven device.
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JUL 26 1999
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510(k) SUMMARY
The Summary of Safety and Effectiveness on Wallace Trial Transfer Catheter reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
| Applicant | Debra Pekar, Manager Regulatory AffairsCooperSurgical15 Forest ParkwayShelton, CT 06484 |
|---|---|
| Telephone | 203/929-6321 |
| Facsimile | 203/925-0135 |
| Date | February 01, 1999 |
| Name | Wallace Trial Transfer Catheter |
| Classification | Assisted Reproduction Catheters, 21 CFR 884.6110 |
| Predicate: | 884.6110 Assisted reproduction catheters21 CFR Part 884[Docket No. 97N – 0335]Obstetric and Gynecologic Devices; Reclassification of Medical Devices Used forIn Vitro Fertilization and Related Assisted Reproduction Procedures.Effective Date: October 13, 1998 |
| Description | The Wallace Trial Transfer Catheter is a single use, sterile, disposable, soft, andflexible catheter with a unique round smooth distal end. The tip has a blind/closedend. The device has an overall length of 23cm including a, polypropylene LuerLock adapter that is affixed at its proximal end. The inner catheter is a clear tubewith a 1.8-mm outer diameter and a 0.8 inner diameter that is uniform throughoutits length. An outer sheath with a 2.3-mm outer diameter surrounds this innercatheter. The distal 0.1-cm of length gradually tapers, leaving the distal 5 cm of theinner catheter exposed. The proximal circumferences of the outer sheath and innercatheter are molded directly into the distal end of the Luer Lock adapter. Fiveblack graduation markings are located on the distal portion of the outer sheath at 1-cm increments to indicate the degree of advancement into the cervix. Four blackgraduation markings are located on the proximal portion of the inner catheter at 1cm increments indicate the degree of advancement into the uterus. |
| Intended Use | The Wallace Trial Transfer Catheter is sterile single-use device intended to assessadvancement through the cervical canal and positioning of the uterus |
| Contraindications | Not intended for the insertion and introduction of washed spermatozoa and or otherappropriate material into the cervical canal or uterine cavity.Not intended for use in the presence of or after recent pelvic inflammatory diseaseor chronic cervical infection.Not intended for intrafallopian tube procedures. |
| Caution | Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. |
| TechnologicalCharacteristics | There are no published standards for these particular types of products, and as suchtests have been developed which are considered sufficient to ensure the efficacyand safety of the device(s) for its intended use. Such tests include - Visual;Dimensional; Functional; and Bacterial Endotoxin (Limulus Amoebocyte Lysate)Assay. |
| Data Submitted | The biological safety assessment of the Wallace Trial Transfer Catheters has beenperformed in accordance with the International Standard ISO 10993, Part 1:1994,"Biological Evaluation of Medical Devices: Evaluation and Testing." In additionto ISO 10993 the selections of tests, taking into consideration the particularapplication of the product bacterial endotoxin test and ethylene oxide residuals test |
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510(k) SUMMARY
The Summary of Safety and Effectiveness on Wallace Trial Transfer Catheter reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with three lines representing its wings and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Mr. Thomas G. Williams Director, of Quality Assurance and Requlatory Affairs CooperSurgical, Inc. 15 Forest Parkway Shelton, CT 06484
Dear Mr. Williams:
Re: K990348 Wallace Trial Transfer Catheter Dated: June 25, 999 Received: June 28, 1999 Regulatory Class: II 21 CFR §884.6110/Procode: 85 MQF
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 (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 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 Requlation (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 obliqation 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance 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,
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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K990348 510(k) Number (if known):
Wallace Trial Transfer Catheters Device Name: _
Indications For Use:
The Wallace Trial Transfer Catheter is a sterile single-use device intended to assess advancement through the cervical canal and positioning of the uterus.
Contraindication:
Not intended for the insertion and introduction of washed spermatozoa and or other appropriate material into the cervical canal or uterine cavity.
Not intended for use in the presence of or after recent pelvic inflammatory disease or chronic cervical infection.
Not intended for intrafallopian tube procedures.
Caution:
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
(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 01.109)
OR
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological I 510(k) Number
Over-The-Counter-Use _
(Optional Format 1-2-96)
§ 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).