PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)

K033904 · Cook Urological, Inc. · MQH · Jan 16, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K033904
• Device Name: PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
• Applicant: Cook Urological, Inc.
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.6130
• Device Class: Class 2

Intended Use

The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of Blastomeres for pre-implantation genetic diagnosis.

Device Story

Pre-Implantation Genetic Diagnosis Pipettes are manual microtools used by clinicians in assisted reproduction laboratories. The device consists of a borosilicate glass pipette used for the physical aspiration of blastomeres from embryos. It is a single-use, sterile device. The clinician operates the pipette to perform the biopsy, which allows for subsequent genetic analysis of the aspirated cells. The device facilitates the collection of samples necessary for pre-implantation genetic diagnosis, aiding in the selection of embryos for implantation.

Clinical Evidence

Bench testing only. The device underwent Mouse Embryo Toxicity testing and Endotoxin testing to verify material safety and biocompatibility for use in assisted reproduction.

Technological Characteristics

Material: Borosilicate glass. Form factor: Micro-pipette. Energy source: None (manual). Sterilization: Sterile (single-use).

Indications for Use

Indicated for the aspiration of blastomeres for pre-implantation genetic diagnosis in patients undergoing assisted reproduction procedures.

Regulatory Classification

Identification

Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

• Cook Australia Pipettes (no 510(k) number provided)

Submission Summary (Full Text)

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JAN 1 6 2004

# OOK®

K033904

Cook Ob/Gyn 1100 W. Morgan Street Spencer, IN 47460 USA Phone: [phone] Fax: [phone] www.cookgroup.com

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Submitted By:

Brenda Davis Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 [phone] [e-mail] Decemember 15, 2003

#### Device:

Trade Name:

Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes)

| Proposed Classification Name: | Class II Assisted Reproduction Microtools |
|-------------------------------|-------------------------------------------|
| | 85MQH |
| CFR Reference: | 884.6130 |

#### Predicate Devices:

Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used Cook Australia devices as our predicate to illustrate safety and effectiveness.

The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are substantially equivalent to other pipettes in terms of indications for use, design, construction and material equivalence.

Specifically, these devices are similar to the Pipettes manufactured and distributed in Europe by Cook Docencialia, 12 Electronics Street, Brisbane Industrial Park, Eight Miles Plains, Queensland, 4113, Australia.

#### Device Description:

The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are used for the aspiration of The Tre Implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile.

These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests.

#### Substantial Equivalence:

Substantial inquiratened according to specified process controls and a Quality Assurance Program. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 6 2004

Ms. Brenda Davis Regulatory Affairs, Technical Writer Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460 USA

Re: K033904

Trade/Device Name: Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: 85 MQH Dated: December 15, 2003 Received: December 17, 2003

Dear Ms. Davis:

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 (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 his letter will and in you to organ finding of substantial equivalence of your device to a legally prematication. "The 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 If you desire specific at ne 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 Addition of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Other or of or oremarket 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 miorination on Journational 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. Brygden

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): K033904

- Pre-Implantation Genetic Diagnosis Pipettes Device Name: (Biopsy Pipettes)
- The Pre-Implantation Genetic Diagnosis Pipettes are used Indications For Use: for the aspiration of Blastomeres for pre-implantation genetic diagnosis.

Prescription Use × (Part 21 CFR 801 Subpart D) ANBIOR

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)

David A. Layman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number

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