THECURVE, ITEM 507

K012935 · Select Medical Systems, Inc. · MFD · Oct 11, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K012935
• Device Name: THECURVE, ITEM 507
• Applicant: Select Medical Systems, Inc.
• Product Code: MFD · Obstetrics/Gynecology
• Decision Date: Oct 11, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.

Device Story

TheCurve™ is a single-use, sterile, disposable, flexible catheter used for intrauterine artificial insemination. The device consists of a long polyethylene tube partially encased in a polypropylene sheath, attached to a luer lock hub. The distal tip is open, and the distal portion is curved to facilitate insertion into the cervical os and through the cervical canal. It features graduation markings at 5, 6, 7, 8, 9, and 10 cm from the distal tip. The device is operated by a clinician to deliver sperm into the uterus. It functions as a conduit for fluid flow. The curved design is intended to ease navigation through the cervical canal compared to straight catheters.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and functional comparison to the predicate device.

Technological Characteristics

Materials: Polyethylene tube, polypropylene sheath, luer lock hub. Dimensions: 19.9 cm overall length, 1.1 mm inner diameter. Design: Single-channel catheter with curved distal tip. Sterilization: Sterile, single-use. Connectivity: None.

Indications for Use

Indicated for intrauterine artificial insemination.

Regulatory Classification

Identification

A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

Predicate Devices

• Select IUI (K012935)

Submission Summary (Full Text)

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OCT 1 1 2001

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SELECT MEDICAL SYSTEMS INC.

K012935
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Section M Page 1 of 2

Food and Drug Administration Center for Devices and Radiological Health (HFZ-401) 9200 Corporate Boulevard Rockville MD 20850

510(k) Summary

Select Medical Systems, Inc Submitter 30 Winter Sport Lane Williston VT 05495

> Ph [phone]

[phone]

Fx

Contact person

Date of Summary

MM DD YY

Monique Girard

TheCurve™ Device prorietary name

Device common/usual name Intrauterine insemination catheter

Intrauterine insemination cannula Device classification name

Select IUl@ Predicate device name

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

Intended use

As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.

Description of new device and comparison with predicate device.

TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility.

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K012935
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Section M Page 2 of 2

The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings.

Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter.

The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.

## Product specifications - Summary

| | TheCurve (new device) | Select IUI (predicate device) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Length | 17.2 cm (effective)<br>19.9 cm (overall) | 17 cm (effective)<br>20 cm (overall) |
| ID (inner diameter) | 1.1 mm for effective length | 1.6 mm for effective length |
| OD (outer diameter) | 2.6 mm stepped down to<br>1.6 mm for distal 4.5 cm of<br>length | 2.6 mm stepped down to<br>2.1 mm for distal 4.5 cm of<br>length |
| Graduation marks | Identical for both devices | |
| Design | Identical for both devices. The distal portion, however of<br>TheCurve is curved while the distal portion of the Select IUI<br>is straight. | |
| Function | Identical for both devices | |
| Materials | Identical for both devices | |
| Intended use | Identical for both devices | |

## Substantial equivalence

TheCurve is substantially equivalent in safety and effectiveness to the Select IUI as both devices are identical in terms of raw materials, intended use, function, graduation markings and they have a similar design. There are three minor differences: (i) TheCurve is 1 mm shorter than the Select IUI: (ii) TheCurve has an ID of 0.5 mm smaller than the Select IUI; (iii) and, the distal portion of TheCurve is slightly curved to ease its insertion into the cervical os and through the cervical canal.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2001

Ms. Monique Girard Regulatory Affairs Manager Select Medical Systems, Inc. 30 Winter Sport Lane P.O. Box 966 WILLISTON VT 05495-0966 Re: K012935

Trade/Device Name: TheCurve™ Item 507 Intrauterine Insemination Cannula Regulation Number: 21 CFR 884.5250 Regulation Name: Cervical Cap Regulatory Class: II Product Code: 85 MFD Dated: August 29, 2001 Received: August 31, 2001

Dear Ms. Girard:

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 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 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 this 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" (21 CFR Part 807.97). 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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## SECTION C – PAGE 1 OF 1

## STATEMENT OF INDICATIONS FOR USE

510(k) number (if known)

K012935

Device name

Miles (14) 1940 1940 1940) 1978-1999

TheCurve™

Indication(s) for use

Intrauterine artificial insemination

Nancy C Brogdon

**Division of Reproductive, Abdominal**
**and Radiological Devices**
**510(k) Number** K012925

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