(171 days)
For the introduction of embryo(s) or washed spermatozoa into the uterine cavity during assisted reproductive procedures.
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.
The provided text is a 510(k) summary for the Wallace Catheters. It describes the device, its intended use, and the types of tests performed to ensure its efficacy and safety. However, this document does not contain the specific acceptance criteria or the detailed results of a study that directly compares the device's performance against those criteria.
Here's an breakdown based on the information available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Missing: Specific quantitative or qualitative acceptance criteria are not explicitly stated in the provided text. The document mentions that "tests have been developed which are considered sufficient to ensure the efficacy and safety of the device(s) for its intended use." | Missing: Actual test results or performance metrics against any acceptance criteria are not provided. The document lists the types of tests performed (Visual, Dimensional, Functional, one-cell Mouse Embryo Assay; and Bacterial Endotoxin (Limulus Amoebocyte Lysate) Assay), and states that a biological safety assessment was performed in accordance with ISO 10993, but it does not detail the outcomes of these tests in a quantifiable way. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The document mentions tests like "one-cell Mouse Embryo Assay" and "Bacterial Endotoxin (Limulus Amoebocyte Lysate) Assay," but the number of samples used for these tests is not indicated.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. The "ground truth" concept is usually relevant for studies involving human interpretation (e.g., medical imaging) where there's a need for expert consensus on a diagnosis or finding. The tests mentioned here (one-cell Mouse Embryo Assay, Bacterial Endotoxin Assay) are laboratory assays that typically have objective, measurable endpoints rather than requiring expert judgment for ground truth establishment.
4. Adjudication Method for the Test Set
- Not applicable for the types of tests described. The tests mentioned are objective laboratory assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The device described is a medical catheter used for embryo/spermatozoa transfer, not an AI or imaging diagnostic device that would typically involve human readers interpreting cases. Therefore, there is no mention of human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone algorithm study was not done. This device is a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
- The ground truth for the safety and efficacy of the device's materials and function would be established through objective laboratory measurements and biological assays. For example:
- Mouse Embryo Assay: The "ground truth" would be the observed viability and development of mouse embryos when exposed to the device's materials, demonstrating non-toxicity.
- Bacterial Endotoxin Assay: The "ground truth" would be the measured levels of endotoxin, required to be below a certain threshold.
- Dimensional/Visual/Functional Tests: The "ground truth" would be adherence to specified physical dimensions, visual integrity, and proper mechanical function.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for an AI model.
In summary: The provided 510(k) summary focuses on the device description, intended use, classification, and the types of tests performed to demonstrate safety and efficacy. It explicitly states, "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." However, it does not provide the specific numerical acceptance criteria or the quantitative results from the studies to show how the device met those criteria.
{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 AffairsCooperSurgical15 Forest ParkwayShelton, 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 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 Family of Wallace Catheters are designed for use in Assisted ReproductionTechniques (ART) and In-Vitro Fertilization (IVF) procedures.MODELS 1816, 1816N and 2316: These devices consist of a two (2) pieceassembly 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 theLuer hubs, which are supplied as secure syringe connections. The overall lengthfor this assembly ranges from 18cm (model 1816) to 23cm (models 1816N and2316) with a consistent outer diameter of approximately 0.060 inches, which isequal 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 centimetermarkings at the proximal end to assist in visualization of the degree of penetrationinto the uterus. The sheath also carries centimeter markings; these however are atthe distal tip to assist in visualization of penetration through the external cervicalOs. 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 durometermaterial resulting in a slightly stiffer device. This stiffness may be preferred whengreater control is desired. |
| Intended Use | The Family of Wallace Catheters are sterile, single-use devices intended to be usedfor the introduction of embryo(s) or washed spermatozoa into the uterine cavityduring assisted reproductive procedures. |
| Contraindications | 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; 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 inaccordance with the International Standard ISO 10993, Part 1:1994, "BiologicalEvaluation of Medical Devices: Evaluation and Testing." In addition to ISO 10993the selection of tests, taking into consideration the particular application of theproduct e.g. transfer of embryos and washed spermatozoa, embryo toxicity andbacterial 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)
§ 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).