WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST

K990349 · CooperSurgical, Inc. · MQF · Jul 26, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K990349
• Device Name: WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
• Applicant: CooperSurgical, Inc.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2

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. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

Device Story

Wallace Malleable Stylet is a sterile, single-use accessory for Wallace Catheters used during in vitro fertilization (IVF). Device consists of soft stainless steel wire encapsulated in Fluoroethylenepropylene (FEP) sheath with rounded tip and plastic luer hub. Available in 18 cm and 23 cm lengths. Operated by physicians in clinical settings to provide structural support to catheters, facilitating navigation through impeded cervical passages. Device does not perform automated analysis or processing; it serves as a mechanical aid to improve catheter placement success, thereby assisting in oocyte collection or embryo transfer procedures.

Clinical Evidence

Bench testing only. Testing included visual and dimensional inspection, functional testing, one-cell Mouse Embryo Assay for toxicity, and Limulus Amoebocyte Lysate (LAL) test for bacterial endotoxins. Biological safety assessment performed per ISO 10993-1:1994.

Technological Characteristics

Materials: Stainless steel wire, Fluoroethylenepropylene (FEP) sheath, plastic luer hub. Dimensions: 18 cm and 23 cm working lengths. Principle: Mechanical support/stiffening for catheters. Sterilization: Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients undergoing in vitro fertilization procedures where cervical passage is impeded. Contraindicated in patients with recent pelvic inflammatory disease, chronic cervical infection, or for intrafallopian tube procedures.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Predicate Devices

• Assisted reproduction catheters (21 CFR 884.6110)

Submission Summary (Full Text)

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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 Affairs<br>CooperSurgical<br>15 Forest Parkway<br>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<br>21 CFR Part 884<br>[Docket No. 97N – 0335]<br>Obstetric and Gynecologic Devices; Reclassification of Medical Devices Used for<br>In Vitro Fertilization and Related Assisted Reproduction Procedures.<br>Effective Date: October 13, 1998 |
| Description | The Wallace Malleable Stylet comprises a soft stainless steel wire, which is totally<br>encapsulated within a Fluoroethylenepropylene (FEP) sheath. The FEP tubing is<br>formed and closed at one end into a smooth rounded tip, and is encapsulated at the<br>other end within an insert plastic molded luer hub. The stylet is supplied with a<br>FEP outer sheath, which is insert molded into a plastic luer hub. The models are<br>available in two sizes, 18 cm and 23 cm of working length and are for single use<br>only. |
| Intended Use | The Family of Wallace Malleable Stylets are a sterile single-use device intended to<br>be used in conjunction with a Wallace Catheter for <i>in vitro</i> fertilization procedures<br>where passage through the cervix is impeded. |
| Contraindications | Not intended for use in the presence of or after recent pelvic inflammatory disease<br>or chronic cervical infection.<br><br>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<br>Characteristics | There are no published standards for these particular types of products, and as such<br>tests have been developed which are considered sufficient to ensure the efficacy<br>and safety of the device(s) for its intended use. Such tests include - Visual;<br>Dimensional; Functional; one-cell Mouse Embryo Assay; and Bacterial Endotoxin<br>(Limulus Amoebocyte) Assay. |
| Data Submitted | The biological safety assessment of the Wallace Catheters has been performed in<br>accordance with the International Standard ISO 10993, Part 1:1994, "Biological<br>Evaluation of Medical Devices: Evaluation and Testing." In addition to ISO 10993<br>the selection of tests, taking into consideration the particular application of the<br>product e.g. collection of human oocytes, transfer of embryos and washed<br>spermatozoa, embryo toxicity and bacterial endotoxin test were performed. |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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)