IUI CATHETER, MODEL 9057

K052059 · Inntec, Inc. · MQF · Nov 22, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K052059
• Device Name: IUI CATHETER, MODEL 9057
• Applicant: Inntec, Inc.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InnTec, Inc. Intrauterine Insemination (IUI) Catheter is used for intrauterine insemination.

Device Story

InnTec IUI Catheter is a sterile, single-use device designed for intrauterine insemination. The catheter measures 17.5cm in length, tapering from 7 Fr at the hub to 5 Fr at the distal tip. The tip is closed and rounded with opposing eyelets; internal volume is 0.07cc. Centimeter markings (6, 7, 8, 9, 10cm) are printed on the shaft. The device is used by clinicians in a clinical setting to facilitate the delivery of sperm into the uterus. It functions as a conduit for insemination, aiding in assisted reproduction. The device is manually operated by a physician or trained healthcare professional.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Catheter length 17.5cm; tapers 7 Fr to 5 Fr; closed rounded tip with 180-degree eyelets; 0.07cc internal volume; non-toxic ink markings. Sterilization per ANSI/AAMI/ISO 11135; biocompatibility per ANSI/AAMI/ISO 10993.

Indications for Use

Indicated for intrauterine insemination in patients requiring assisted reproduction 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

• IUI Catheter (K921518)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo for InnTec, Inc. The logo features a stylized letter 'C' that wraps around a lowercase 'i'. The 'i' has a circular dot above it. Below the symbol is the text "InnTec, Inc".

## 510(k) Summary

Company Name: InnTec, Inc. 401 E. Edgewater St. Portage, WI 53901

Contact: Michael Kvalo, PE

Office-401 E. Edgewater St. Portage, WI. 53901 Phone [phone] Fax [phone]

Phone: [phone] Fax: [phone]

Summary Date: October 10, 2005

Shipping & Receiving-121 Evco Circle DeForest, WI. 53532

Trade Name: IUI Catheter

Common Name: Assisted Reproduction Catheter

Classification Name: 21 CFR 884.6110; Product Code: MQF

Predicate Device:

| 510(k) | Manufacturer | Product Code | Class | Trade Name |
|---------|--------------------------|--------------|-------|--------------|
| K921518 | Lifetek<br>Medical, Inc. | MFD | II | IUI Catheter |

របា Catheters 1.0

Oocyte

Needle

Sets

Retrieval

### Description of Device

The InnTec IUI Catheter has been specifically designed for Intrauterine Inseminations. The over all Catheter length is 17.5cm, and tapers from 7 Fr. at the hub down to 5 Fr at the distal tip which is 5cm long. The tip is closed and smoothly rounded, eyelets are located at 180° from one another. Catheter internal volume is .07cc. Centimeter marks are printed at 6, 7, 8, 9, & 10cm from the tip, the ink is non-toxic and will not rub off.

2.0 Embryo Transfer

The InnTec, Inc. Intrauterine Insemination (IUI) Catheter is used for

Intended Use

intrauterine insemination.

Catheters

Custom Product

Design &

Manufacturing

#### 3.0 Technology

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

#### 4.0 Conclusions

The intended use, technology, materials and manufacturing processes of the Inn Tec, Inc. IUI Catheter are the same as the predicate device. No new questions of safety or effectiveness are raised.

File name: IUI 510(k) K052059 Reply to Questions 10-24-2005

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510(k) Number:

K052059 InnTec, Inc. - IUI Catheter

Standard Organization No: Standard Identification No: CDRH Internal Reference No: ANSI/AAMI/ISO 10993 Part 7 10

| Declaration of Conformity Elements: | | | |
|-------------------------------------------------------|-----|----|----|
| Any Adaptations Applied | yes | no | X |
| Any Requirements Not Applicable | yes | no | X |
| Any Deviations Applied | yes | X | no |
| Any Differences in Device Tested and Finished Product | yes | no | X |
| *Is There a Third Party or Test Lab Involved | yes | X | no |

Was there another standard used in the review of this submission? X yes no If another standard was used, please fill out an additional form.

... . . . . . . . . . . . . . . . . . . . .

* This is not the third party that reviews 510ks

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# Standards Data Form for Abbreviated 510(k)s

510(k) Number:

K052059 InnTec, Inc. - IUI Catheter

Standard Organization No: Standard Identification No: CDRH Internal Reference No: ANSI/AAMI/ISO 11135 7

| Declaration of Conformity Elements: | | | | |
|-------------------------------------------------------|-----|---|----|---|
| Any Adaptations Applied | yes | | no | X |
| Any Requirements Not Applicable | yes | X | no | |
| Any Deviations Applied | yes | | no | X |
| Any Differences in Device Tested and Finished Product | yes | | no | X |
| *Is There a Third Party or Test Lab Involved | yes | X | no | |

X Was there another standard used in the review of this submission? yes no

... .............

If another standard was used, please fill out an additional form.

* This is not the third party that reviews 510ks

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K052059 Re.:

NOV 2 2 2005

Trade/Device Name: IUI Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: MQF Dated: October 24, 2005 Received: October 31, 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 (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 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) This letter will anow you to ogin maning of substantial equivalence of your device to a legally premaired notheation: "The PDF mainly of 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 If you desire specific advice to: your as 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, prease note the regulation on your responsibilities under the Act from the 607.77). Tou may ooum outer 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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## Indications for Use

510(k) Number (if known): Kos 2059

Device Name: IUI Catheter

Indications for Use:

The InnTec, Inc. Intrauterine Insemination (IUI) Catheter is used for intrauterine insemination.

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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David A. Grayson

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(Division Sign-Off) Abdominal, Division of Reproductive, and Radiological Devi 510(k) Number