(171 days)
884.6110
Not Found
No
The device description focuses on the physical components and materials of a catheter for assisted reproductive procedures, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
Yes.
The device introduces substances (embryos or spermatozoa) into the body to achieve a therapeutic effect (assisted reproduction).
No.
The device is used for introducing embryo(s) or washed spermatozoa into the uterine cavity, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details physical components (catheter, sheath, Luer hubs, tip protector) and materials, 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 for the introduction of embryos or spermatozoa into the uterine cavity. This is a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a catheter designed for physical insertion into the uterus. It facilitates the transfer of biological material, but it does not analyze or test any biological sample.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely procedural – facilitating the physical transfer of material.
N/A
Intended Use / Indications for Use
The Family of Wallace Catheters are sterile, single-use devices intended to be used for the introduction of embryo(s) or washed spermatozoa into the uterine cavity during assisted reproductive procedures.
Product codes
85 MQF
Device Description
The Family of Wallace Catheters are designed for use in Assisted Reproduction Techniques (ART) and In-Vitro Fertilization (IVF) procedures.
MODELS 1816, 1816N and 2316: These devices consist of a two (2) piece assembly comprised of a detachable outer sheath through which a flexible open-ended Catheter has been inserted and held firm by means of a pressure fitting at the Luer hubs, which are supplied as secure syringe connections. The overall length for this assembly ranges from 18cm (model 1816) to 23cm (models 1816N and 2316) with a consistent outer diameter of approximately 0.060 inches, which is equal to a Stubs Needle Gauge of 16. At the distal tip of the catheter is a single, smooth, rounded opening to aide in atraumatic uterine insertion with centimeter markings at the proximal end to assist in visualization of the degree of penetration into the uterus. The sheath also carries centimeter markings; these however are at the distal tip to assist in visualization of penetration through the external cervical Os. Each catheter is packed inside of the outer sheath, covered by the tip protector. This serves to protect the catheter from distortion or damage during shipment.
NOTE: MODEL 2316 catheter is manufactured of a slightly higher durometer material resulting in a slightly stiffer device. This stiffness may be preferred when greater control is desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (according to caution: "Federal law (U.S.A.) restricts this device to sale by or on the order of a 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)
Not Found
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
JUL 26 1999
510(k) SUMMARY
The Summary of Safety and Effectiveness on the Wallace Catheters reflects data available and represented at I he builting you bately and interestion should be exercised in interpreting the data. The results of end this called 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 Catheters |
| 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 Family of Wallace Catheters are designed for use in Assisted Reproduction
Techniques (ART) and In-Vitro Fertilization (IVF) procedures.
MODELS 1816, 1816N and 2316: These devices consist of a two (2) piece
assembly comprised of a detachable outer sheath through which a flexible open-
ended Catheter has been inserted and held firm by means of a pressure fitting at the
Luer hubs, which are supplied as secure syringe connections. The overall length
for this assembly ranges from 18cm (model 1816) to 23cm (models 1816N and
2316) with a consistent outer diameter of approximately 0.060 inches, which is
equal to a Stubs Needle Gauge of 16. At the distal tip of the catheter is a single,
smooth, rounded opening to aide in atraumatic uterine insertion with centimeter
markings at the proximal end to assist in visualization of the degree of penetration
into the uterus. The sheath also carries centimeter markings; these however are at
the distal tip to assist in visualization of penetration through the external cervical
Os. Each catheter is packed inside of the outer sheath, covered by the tip protector.
This serves to protect the catheter from distortion or damage during shipment.
NOTE: MODEL 2316 catheter is manufactured of a slightly higher durometer
material resulting in a slightly stiffer device. This stiffness may be preferred when
greater control is desired. |
| Intended Use | The Family of Wallace Catheters are sterile, single-use devices intended to be used
for the introduction of embryo(s) or washed spermatozoa into the uterine cavity
during assisted reproductive procedures. |
| 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 Lysate) 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. transfer of embryos and washed spermatozoa, embryo toxicity and
bacterial endotoxin test were performed. |
1
K 990350
Page 2 of 2
Page 2
510(k) SUMMARY
f
The Summary of Safety and Effectiveness on the Wallace 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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, featuring a staff with three wavy lines representing snakes or ribbons.
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
Re: K990350
Wallace Catheters (Transfer) Dated: June 25, 1999 Received: June 28, 1999 Requiatory Class: II 21 CFR §884.6110/Procode: 85 MQF
Dear Mr. Williams:
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 requlation (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 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 requiation 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
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
Page 9 9 of _ 84
510(k) Number (if known): kb90350
Device Name: Wallace Catheters
Indications For Use:
For the introduction of embryo(s) or washed spermatozoa into the uterine cavity during assisted reproductive procedures.
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 Devic 510(k) Number
(Optional Format 1-2-96)