FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN

K082727 · Vitrolife Sweden AB · MQE · Feb 6, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K082727
• Device Name: FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
• Applicant: Vitrolife Sweden AB
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6100
• Device Class: Class 2

Indications for Use

Follicle Aspiration Set, Reduced Single Lumen is intended for flushing and/or aspiration of oocytes from ovarian follicles

Device Story

Follicle Aspiration Set, Reduced Single Lumen is a modified needle for oocyte retrieval. Device features a standard needle shaft with a distal 40-60 mm segment reduced from 1.2 mm to 0.6 mm inner diameter. Used by clinicians in clinical settings for ovarian follicle aspiration and flushing. Reduced tip diameter facilitates access; wall thickness in reduced section is at least 50% thicker than standard section to maintain structural integrity. Device connects to aspiration equipment to collect gametes. Benefits include improved access to follicles during assisted reproduction procedures.

Clinical Evidence

No clinical data. Bench testing only. Testing performed per ISO 9626 to verify resistance of tubing to breakage and structural integrity of the reduced needle tip.

Technological Characteristics

Needle for oocyte aspiration. Distal 40-60 mm segment reduced to 0.6 mm inner diameter; standard section 1.2 mm inner diameter. Wall thickness in reduced section is 50% thicker than standard section. Tested per ISO 9626 for resistance to breakage.

Indications for Use

Indicated for flushing and/or aspiration of oocytes from ovarian follicles in patients undergoing assisted reproduction procedures.

Regulatory Classification

Identification

Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

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

• Follicle Aspiration Set (K991273)

Submission Summary (Full Text)

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1082727)

# FEB - 6 2009

#### X PREMARKET NOTIFICATION SUMMARY

Submitted by:

Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN

Contact Person:

Date Prepared:

Trade Name:

Common Name:

Classification Name:

Predicate Device:

Mr Kjell Kjörk Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN Phone [phone] [phone] Fax [e-mail] Mail

5 February 2009

Follicle Aspiration Set, Reduced Single Lumen

Follicle Aspiration Set

Assisted Reproduction Needles (21 C.F.R. § 884.6100)

Follicle Aspiration Set (K991273)

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### Description of the Device:

The Follicle Aspiration Set, Reduced Single Lumen device is a modification of the current Vitrolife Follicle Aspiration Set (K991273). The Follicle Aspiration Set, Reduced Single has the same intended use as the predicate device technological characteristics related to safety and effectiveness.

The predicate device Follicle Aspiration Set (K991273) has a broad 510(k) clearance
covering single lumen, double lumen and Luer lumen. The device is intended to be used to obtain gametes from the body.

A thinner type of needle end is being introduced, and the last 40-60 mm close to the tip of a standard needle is reduced from an inner diameter of 1.2 mm to an inner diameter of 0.6 mm.

#### Intended Use

Follicle Aspiration Set, Reduced Single Lumen is intended for flushing and/or aspiration of oocytes from ovarian follicles

### Technological Characteristics:

The Follicle Aspiration Set, Reduced Single lumen device is a modification of the current Vitrolife Follicle Aspiration Set (K991273). The Follicle Aspiration Set, Reduced Single as the same intended use as the predicate de technological characteristics related to safety and effectiveness.

A thinner type of needle end is being introduced, and the last 40-60 mm close to the tip of
a standard needle is reduced from an inner diameter of 1.2 mm to an inner diameter mm.

The main safety concern regarding this change is the reduced part of the needle breaking off during the procedure as noted in the risk analysis. However, the needle has undergone testing according to ISO 9626 with respect to resistance of tubing to breakage to verify the safety in this aspect. The needle has also been tested e test to an extended angle and passed. It should be noted t is at least 50% thicker than the wall of the standard part. the manufacturing method where the same cross-se d part to the thinner, reduced part.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 resembling an eagle or bird in flight, composed of three curved lines.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB - 6 2009

Mr. Kjell Kjörk Pharmacist, Regulatory Affairs Manager Vitrolife Sweden AB Box 9080 SE-400 92 Göteborg SWEDEN

Re: K082727

Trade/Device Name: Follicle Aspiration Set, Reduced Single Lumen Regulation Number: 21 CFR §884.6100 Regulation Name: Assisted reproduction needles Regulatory Class: II Product Code: MQE Dated: January 22, 2009 Received: January 23, 2009

Dear Mr. Kjörk:

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.

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Acting 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 STATEMENT XI.

510(k) Number (if known):

K082727

Device Name:

Follicle Aspiration Set, Reduced Single Lumen

Indications for Use:

Follicle Aspiration Set, Reduced Single Lumen is indicated for flushing and/or aspiration of oocytes from ovarian follicles

(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 C.F.R. § 801.109)

OR

Over-the Counter Use

Agnetha Whing

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