WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER

K033084 · Portex , Ltd. · MQF · Dec 19, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K033084
• Device Name: WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
• Applicant: Portex , Ltd.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation. Trial Transfer Catheters are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter

Device Story

Embryo replacement and trial transfer catheters; single-use; ultrasound-guided. Embryo replacement catheter: flexible inner cannula, detachable outer sheath, Luer taper connection; used for embryo introduction into uterine cavity. Trial transfer catheter: flexible inner cannula with blind end, detachable outer sheath; used to assess cervical passage. Both devices feature 1cm graduations for depth monitoring. Operated by clinicians during IVF procedures. Enhanced material composition improves visibility under ultrasound imaging. Output is physical placement of embryos or assessment of cervical patency. Benefits include improved visualization during transfer, potentially increasing procedure success.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Single-use catheters; 18cm and 23cm lengths; 1.5mm OD/0.76mm ID. Consists of inner cannula and detachable outer sheath with Luer taper. Materials identical to predicates, modified for ultrasound visibility. Graduations at 1cm intervals. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing in vitro fertilization requiring embryo transfer into the uterine cavity or cervical passage assessment prior to transfer.

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

• Wallace Embryo Transfer Catheter range 18-23cm (K990350)
• Wallace Trial Transfer Catheter range 18-23cm (K990348)
• Cook Echotip® Soft-Pass Embryo Transfer Catheter (K983594)

Submission Summary (Full Text)

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DEC 1 9 2003

#### Wallace (Sure View IM) Embryo Replacement Catheters & Trial Transfer Catheters. 510(K) Notification

# K-23084

#### SECTION 5.0 : 510K SUMMARY

27 August 2003 DATE SUBMITTED:

SUBMITTER: Portex Ltd Hythe Kent England, CT21 6JL

CONTACT PERSON: Mr Steve Ogilvie, Regulatory and Scientific Affairs Director, Portex Ltd, Military Road, Hythe, Kent, England. CT21 6DB Phone [phone] Fax [phone]

> Wallace (Sure View TM )Embryo Replacement Catheter DEVICE NAME: & Trial Transfer Catheter.

## COMMON NAME AND CLASSIFICATION:

Ultra sound visible embryo transfer catheter Class II MQF, 21 CFR 884.6110

#### PREDICATE DEVICES:

- Predicate 1: Wallace Embryo Transfer Catheter range 18-23cm already marketed in the USA . under K990350
- Predicate 2: Wallace Trial Transfer Catheter range 18-23cm already marketed in the USA under . K990348
- Predicate 3: Cook Echotip® Soft-Pass Embryo Transfer Catheter already marketed in the USA t under K983594

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## Wallace (Sure View TM) Embryo Replacement Catheters & Trial Transfer Catheters. 510(K) Notification

## SECTION 5.0 : 510K SUMMARY

### DEVICE DESCRIPTION:

#### Embryo Replacement Catheters

The Embryo Replacement Catheters (for use in ultrasound-guided transfers) are single use devices for the introduction of embryos into the uterine cavity following in-vitro fertilisation. The devices have overall lengths; 18cm (CE 118A) and 23cm (CE 123A) and consist of a soft, flexible inner cannula, with end opening, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a lumen that is uniform throughout its length, with a series of 1cm graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the

# Trial Transfer Catheters.

distal end.

The Trial Transfer Catheters (for use in ultrasound-guided transfers) are single use devices used to assess the passage through the cervix prior to embryo transfer.

The devices have overall lengths; 18cm (CE 418A) and 23cm(CE 423A) and consist of a flexible inner cannula, with blind end, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a series of graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end.

## TECHNOLOGICAL CHARACTERISTICS OF PROPOSED VERSUS PREDICATE DEVICES:

The proposed devices are substantially equivalent to Predicate devices 1 & 2 -Wallace Embryo Transfer Catheter (K990350) & Wallace Trial Transfer Catheter (K990348) in all the following aspects:

- Tip protector. The tip protector for the proposed devices 1 & 2 is identical in material . composition to that of Predicate 1 & 2.
- Outer sheath. The outer sheath for the proposed devices 1 & 2 is identical in material . composition and profile to that of Predicate 1 & 2.
- . The print markings. The print ink for the proposed devices 1 & 2 is identical in composition to the ink used for Predicate 1 & 2. The print layout for the proposed device displays identical information as the layout on Predicate 1 & 2.
- Outer and inner hub. The material composition for the outer and inner hub is identical . for both the proposed devices 1 & 2 and Predicate 1 & 2.
- Inner catheter. The proposed devices are made from the same materials as Predicate 1 ● & 2. with the exception that the material is modified to enhance the visibility of the catheter under ultrasound. In this respect, the inner catheter is substantially equivalent to Predicate 3.

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## Wallace (Sure View TM ) Embryo Replacement Catheters & Trial Transfer Catheters. 510(K) Notification

## SECTION 5.0 : 510K SUMMARY

## PERFORMANCE / CLINICAL DATA:

Comparison of the performance of the proposed device with the predicate confirms substantial equivalence in all aspects.

#### CONCLUSION:

Comparison of the proposed device to the predicate devices supports the conclusion that the proposed Comparison of the equivalent to existing legally marketed devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Mr. Barry Smith Regulatory Affairs Manager Portex, Ltd. Boundary Road, Hythe Kent CT21 6JL UNITED KINGDOM

Re: K033084

Trade/Device Name: Wallace (Sure View™) Embryo Replacement Catheter and Trial Transfer Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheter Regulatory Class: II Product Code: 85 MQF Dated: August 27, 2003 Received: September 30, 2003

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Wallacc (Sure View TM ) Embryo Replacement Catheters & Trial Transfer Catheters. 510(K) Notification

#### SECTION 4.0: STATEMENT OF INDICATION FOR USE

#### 510(K) Number (if known): K033084

Page 1 of 1

#### DEVICE NAME:

Wallace (Sure View TM) Embryo Replacement Catheters & Trial Transfer Catheters.

#### INDICATIONS FOR USE:

Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation.

Trial Transfer Catheters are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David M. Sezeram

-productive, Abdor 510(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .