(171 days)
884.6110
Not Found
No
The device description and performance studies focus on the physical properties and biological safety of a malleable stylet, with no mention of AI or ML technology.
No.
The device is used to assist in an IVF procedure by helping to pass a catheter through an impeded cervix, which is a procedural aid rather than a direct therapeutic intervention on the patient's condition.
No
The device is described as a stylet used to facilitate the passage of a catheter during in vitro fertilization procedures when the cervix is impeded. Its purpose is to physically aid in the procedure, not to diagnose a condition or disease.
No
The device description explicitly states it is comprised of physical components (stainless steel wire, FEP sheath, plastic luer hub) and undergoes physical and biological testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used in conjunction with a Wallace Catheter for in vitro fertilization procedures where passage through the cervix is impeded." This describes a device used during a medical procedure to facilitate the delivery of something (presumably the catheter and its contents) into the body.
- IVD Definition: In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description details a physical tool (a stylet) designed to aid in the insertion of another device (a catheter) into the cervix. It does not describe a device that analyzes biological samples.
- Performance Studies: The performance studies focus on the physical and biological safety of the device itself (visual, dimensional, functional, embryo assay, endotoxin assay, biocompatibility), not on the accuracy or performance of a diagnostic test.
- Predicate Device: The predicate device is classified under "Assisted reproduction catheters," which are also not IVDs.
In summary, the Wallace Malleable Stylet is a medical device used in vivo (within the body) to assist in a medical procedure, not a device used in vitro (outside the body) to diagnose or analyze biological samples.
N/A
Intended Use / Indications for Use
The Family of Wallace Malleable Stylets are a sterile single-use device intended to be used in conjunction with a Wallace Catheter for in vitro fertilization procedures where passage through the cervix is impeded.
Product codes
85 MQF
Device Description
The Wallace Malleable Stylet comprises a soft stainless steel wire, which is totally encapsulated within a Fluoroethylenepropylene (FEP) sheath. The FEP tubing is formed and closed at one end into a smooth rounded tip, and is encapsulated at the other end within an insert plastic molded luer hub. The stylet is supplied with a FEP outer sheath, which is insert molded into a plastic luer hub. The models are available in two sizes, 18 cm and 23 cm of working length and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests have been developed which are considered sufficient to ensure the efficacy and safety of the device(s) for its intended use. Such tests include - Visual; Dimensional; Functional; one-cell Mouse Embryo Assay; and Bacterial Endotoxin (Limulus Amoebocyte) Assay.
The biological safety assessment of the Wallace Catheters has been performed in accordance with the International Standard ISO 10993, Part 1:1994, "Biological Evaluation of Medical Devices: Evaluation and Testing." In addition to ISO 10993 the selection of tests, taking into consideration the particular application of the product e.g. collection of human oocytes, transfer of embryos and washed spermatozoa, embryo toxicity and bacterial endotoxin test were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
884.6110 Assisted reproduction catheters
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
90349
JUL 26 1999
510(k) SUMMARY
The Summary of Safety and Effectiveness on Malleable Stylets Catheters 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 Affairs
CooperSurgical
15 Forest Parkway
Shelton, CT 06484 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | 203/929-6321 |
| Facsimile | 203/925-0135 |
| Date | February 01, 1999 |
| Name | Wallace Malleable Stylets |
| Classification | Assisted Reproduction Catheters, 21 CFR 884.6110 |
| Predicate: | 884.6110 Assisted reproduction catheters
21 CFR Part 884
[Docket No. 97N – 0335]
Obstetric and Gynecologic Devices; Reclassification of Medical Devices Used for
In Vitro Fertilization and Related Assisted Reproduction Procedures.
Effective Date: October 13, 1998 |
| Description | The Wallace Malleable Stylet comprises a soft stainless steel wire, which is totally
encapsulated within a Fluoroethylenepropylene (FEP) sheath. The FEP tubing is
formed and closed at one end into a smooth rounded tip, and is encapsulated at the
other end within an insert plastic molded luer hub. The stylet is supplied with a
FEP outer sheath, which is insert molded into a plastic luer hub. The models are
available in two sizes, 18 cm and 23 cm of working length and are for single use
only. |
| Intended Use | The Family of Wallace Malleable Stylets are a sterile single-use device intended to
be used in conjunction with a Wallace Catheter for in vitro fertilization procedures
where passage through the cervix is impeded. |
| Contraindications | 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. |
| Technological
Characteristics | There are no published standards for these particular types of products, and as such
tests have been developed which are considered sufficient to ensure the efficacy
and safety of the device(s) for its intended use. Such tests include - Visual;
Dimensional; Functional; one-cell Mouse Embryo Assay; and Bacterial Endotoxin
(Limulus Amoebocyte) Assay. |
| Data Submitted | The biological safety assessment of the Wallace Catheters has been performed in
accordance with the International Standard ISO 10993, Part 1:1994, "Biological
Evaluation of Medical Devices: Evaluation and Testing." In addition to ISO 10993
the selection of tests, taking into consideration the particular application of the
product e.g. collection of human oocytes, transfer of embryos and washed
spermatozoa, embryo toxicity and bacterial endotoxin test were performed. |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or abstract shapes, arranged in a cascading or flowing manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Mr. Thomas G. Williams Director of Quality Assurance And Regulatory Affairs CooperSurgical, Inc. 15 Forest Parkway Shelton, CT 06484
Dear Mr. Williams:
Re: K990349 Wallace Malleable Stylets Dated: June 25, 1999 Received: June 28, 1999 Requiatory 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 II (Special Controls) or 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 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,
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
2
| 510(k) Number (if known): | K990349 |
|---|---|
| --------------------------- | --------- |
Wallace Malleable Stylets Device Name: ____
Indications For Use:
The Family of Wallace Malleable Stylets are a sterile single-use device intended to be used in conjunction with a Wallace Catheter for in vitro fertilization procedures where passage through the cervix is impeded.
Contraindication:
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
Over-The-Counter-Use _
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
(Optional Format 1-2-96)