EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S

K050521 · Inntec, Inc. · MQF · May 2, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050521
• Device Name: EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
• Applicant: Inntec, Inc.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: May 2, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InnTec, Inc. Embryo Transfer Catheter and Accessory Stylet is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.

Device Story

The Embryo Transfer Catheter and Accessory Stylet is a sterile, single-patient use, disposable device designed to facilitate the transfer of in vitro fertilized embryos into the uterus. The system consists of a 5 Fr catheter housed within a 7 Fr guide sheath, both available in 18 and 23 cm lengths. The catheter and sheath feature 1 cm interval markings for insertion depth and color-coded hubs for length identification. An optional accessory stylet is provided to assist in the initial placement of the guide sheath. The device is used by clinicians during assisted reproduction procedures. The catheter provides a pathway for the embryo to be introduced into the uterus. The device is supplied in sterile barrier pouches.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile, single-patient use, disposable catheter system. Comprises 5 Fr catheter and 7 Fr guide sheath (18/23 cm lengths). Features 1 cm depth markings and color-coded hubs. Includes optional accessory stylet. Materials and manufacturing processes are identical to the predicate device.

Indications for Use

Indicated for use in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.

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

• Embryo Glide™ Embryo Transfer Catheter and Accessory (K992307)

Submission Summary (Full Text)

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K050521

## MAY - 2 2005

| Summary of Safety and Effectiveness | | | | | | |
|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------|-----------------|-------|------------------------------------------------------------|
| Company Name: InnTec, Inc.<br>401 E. Edgewater St.<br>Portage, WI 53901 | | | | | | |
| InnTec, Inc | Contact: Michael Kvalo, PE | | | | | |
| Office-<br>401 E. Edgewater St.<br>Portage, WI. 53901<br>Phone [phone]<br>Fax [phone] | Phone: [phone] | | | | | |
| | Fax: [phone] | | | | | |
| | Summary Date: February 24 ,2005 | | | | | |
| Shipping & Receiving-<br>121 Evco Circle<br>DeForest, WI. 53532 | Trade Name: Embryo Transfer Catheter and Accessory Stylet | | | | | |
| | Common Name: Embryo Transfer Catheter | | | | | |
| | Classification Name: 21 CFR ; Product Code: | | | | | |
| | | Predicate Device:<br>510(k) | Manufacturer | Product<br>Code | Class | Trade Name |
| | | K992307 | Life Tech<br>Medical, Inc. | MQF | II | Embryo Glide™ Embryo<br>Transfer Catheter and<br>Accessory |
| IUI<br>Catheters | 1.0 Description of Device<br>The Embryo Transfer Catheter and Accessory Stylet are sterile, single<br>patient use, disposable devices supporting transfer of an in vitro<br>fertilized embryo to the uterus. | | | | | |
| Oocyte<br>Retrieval<br>Needle<br>Sets | The Embryo Transfer Catheter is a 5 Fr Catheter within a 7 Fr Guide<br>Sheath. The 5 Fr Catheter is in contact with the embryo and the uterus.<br>The embryo passes through the Catheter, which is open at the end. The<br>Catheter is available in 18 and 23 cm lengths. The Catheter has marks a<br>1 cm intervals for depth of insertion. | | | | | |
| Embryo<br>Transfer<br>Catheters | The 7 Fr Guide Sheath provides a smooth passage into the uterus and<br>is open at the end. This Guide Sheath is available in 18 and 23 cm<br>lengths. The Guide Sheath has marks at 1 cm intervals for depth of<br>insertion. Both the 5 Fr Catheter and 7 Fr Guide Sheath have color-<br>coded hubs to indicate the length variation. | | | | | |
| Custom<br>Product<br>Design &<br>Manufacturing | An optional accessory stylet is available to aid in the initial placement of<br>the Guide Sheath. Both 18 and 23 cm length stylets are available. | | | | | |

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The assembly of Embryo Transfer Catheter and Guide Sheath are packaged in a commercially available, sterile barrier pouch. The Accessory Stylet is also placed in a commercially available, sterile barrier pouch.

## 2.0 Intended Use

The InnTec, Inc. Embryo Transfer Catheter and Accessory Stylet is an assisted reproduction The thir Foo, Inc. Linery of the reproduction procedures to introduce embryo(s) into the female uterus.

## 3.0 Technology

The technology of the device is the same as the predicate.

## 4.0 Conclusions

Contrasions
The intended use, technology, materials and manufacturing processes of the InnTec, Inc. Embryo The meeter and Accessory Stylet are the same as the predicate device. No new questions of safety or effectiveness are raised.

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Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

· Public Health Service

MAY - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

InnTec, Inc. % Mr. Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane STOUGHTON WI 53589

Re: K050521 Trade/Device Name: Embryo Transfer Catheter and Accessory Stylet Regulatory Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: MQF Dated: April 18, 2005 Received: April 19, 2005

Dear Mr. Syring:

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 (Premarket Approval), 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 (QS) 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) I mis lotter will and in your read finding of substantial equivalence of your device to a legally premaired nothleation: "The PDF macily site of the site 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 rryou desire spoorne de nee of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picase note the regulation entires), formation on your responsibilities under the Act from the 807.77). Tou may oounn ourer general and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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510(k) Number (if known): Ko5052 (

Device Name: Embryo Transfer Catheter and Accessory Stylet Indications for Use:

> The InnTec, Inc. Embryo Transfer Catheter and Accessory Stylet is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

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Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 4050521 510(k) Number