(171 days)
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.
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.
The provided text describes the 510(k) summary for the Wallace Malleable Stylets, a medical device. Based on the information, here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission 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."
The document doesn't provide specific numerical acceptance criteria (e.g., minimum tensile strength, maximum toxicity levels) for each test. Instead, it lists the types of tests performed and implies that the device "meets" these implicitly defined criteria by virtue of the 510(k) clearance.
| Acceptance Criteria Category | Reported Device Performance (as implied by successful 510(k) clearance) |
|---|---|
| Visual Inspection | Device passed visual inspection requirements. |
| Dimensional Verification | Device met specified dimensional requirements. |
| Functional Testing | Device demonstrated appropriate functionality for its intended use. |
| One-cell Mouse Embryo Assay (MEA) | Device demonstrated non-embryotoxic properties. |
| Bacterial Endotoxin (Limulus Amoebocyte) Assay (LAL) | Device met bacterial endotoxin limits, indicating sterility. |
| Biocompatibility (ISO 10993-1:1994) | Device was biologically safe for its intended use, as per ISO 10993-1. |
| Application-Specific Tests (e.g., related to oocyte collection, embryo transfer, washed spermatozoa) | Device performance was deemed suitable for these sensitive applications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the tests (Visual, Dimensional, Functional, MEA, LAL, or ISO 10993 biocompatibility).
The data provenance is not specified in terms of country of origin, nor is it explicitly stated whether the studies were retrospective or prospective. Given the nature of medical device testing for 510(k) clearance, these would typically be prospective laboratory and possibly animal (for biocompatibility) studies conducted by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for material and functional tests would typically be defined by engineering specifications and recognized laboratory standards, not by human expert consensus in the same way clinical imaging studies might be. For biological assays like MEA and LAL, the "ground truth" is established by the assay's methodology and controls.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods are more relevant for subjective assessments, particularly in clinical studies involving interpretation. For the objective tests described (visual, dimensional, functional, biological assays), the results are typically determined by specific measurement techniques and pass/fail criteria, rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The device is a physical malleable stylet, not an AI or imaging diagnostic tool that would typically undergo such a study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question is not applicable. The Wallace Malleable Stylet is a physical medical device, not an algorithm or AI system. Its performance is inherent to its material properties and design, used by a clinician, and not a "standalone" algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for performance validation appears to be a combination of:
- Engineering Specifications/Standards: For visual, dimensional, and functional characteristics.
- Biological Assay Standards: For the one-cell Mouse Embryo Assay (MEA) and Bacterial Endotoxin (Limulus Amoebocyte) Assay (LAL), where the "ground truth" is defined by the assay's ability to demonstrate lack of toxicity or presence of sterility within specified limits.
- International Standard ISO 10993, Part 1:1994: For biological safety assessment (biocompatibility). This standard defines the framework and types of tests to establish biological safety.
The "ground truth" is therefore established by adherence to established scientific and engineering principles, and recognized testing methodologies, rather than clinical outcomes or pathology reports in the traditional sense of a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Wallace Malleable Stylets is a physical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no "training set" for this type of device.
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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 AffairsCooperSurgical15 Forest ParkwayShelton, 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 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 Malleable Stylet comprises a soft stainless steel wire, which is totallyencapsulated within a Fluoroethylenepropylene (FEP) sheath. The FEP tubing isformed and closed at one end into a smooth rounded tip, and is encapsulated at theother end within an insert plastic molded luer hub. The stylet is supplied with aFEP outer sheath, which is insert molded into a plastic luer hub. The models areavailable in two sizes, 18 cm and 23 cm of working length and are for single useonly. |
| Intended Use | The Family of Wallace Malleable Stylets are a sterile single-use device intended tobe used in conjunction with a Wallace Catheter for in vitro fertilization procedureswhere passage through the cervix is impeded. |
| 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) 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. collection of human oocytes, transfer of embryos and washedspermatozoa, embryo toxicity and bacterial endotoxin test were performed. |
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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
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| 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)
§ 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).