PRECISION CAPILLARIES FOR MICROMANIPULATION

K024302 · Brinkmann Instruments, Inc. · MQH · Feb 19, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K024302
• Device Name: PRECISION CAPILLARIES FOR MICROMANIPULATION
• Applicant: Brinkmann Instruments, Inc.
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: Feb 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6130
• Device Class: Class 2

Intended Use

The Precision Capillaries are microcapillaries intended for the following uses in assisted reproduction procedures: - Holding human oocytes, blastocysts, or other suspension cells - Transferring and injecting sperm (or cells of a similar size) using the ICSI (Intracytoplasmic Sperm Injection) technique

Device Story

Precision Capillaries are borosilicate glass microtools used in assisted reproduction. VacuTips (blunt tip) hold oocytes/blastocysts; TransferTips (spiked tip) transfer/inject sperm during ICSI. Device shaft inserts into micromanipulator/microinjector holder. Used in clinical laboratory settings by embryologists/technicians. Packaged in 'Capillary Safe' holder/protective tube, sealed in foil. Output is physical manipulation of gametes; assists fertilization process. Benefits include precise cell handling and perforation for ICSI.

Clinical Evidence

Bench testing only. Testing included bioburden determination, endotoxin determination, embryotoxicity testing, application testing, and packaging evaluation. Results confirmed devices are non-embryotoxic, nonpyrogenic, successfully aspirate sperm, and effectively perforate oocytes.

Technological Characteristics

Borosilicate glass microcapillaries. Proximal end fits micromanipulator/microinjector; distal end drawn to blunt (VacuTips) or spiked (TransferTips) tip. Sterilized by gamma irradiation. Packaged in protective 'Capillary Safe' holder.

Indications for Use

Indicated for use in assisted reproduction procedures for holding human oocytes, blastocysts, or other suspension cells, and for transferring and injecting sperm or cells of similar size via ICSI technique.

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

• Scan-Med, Inc. Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes (K991700)
• Humagen Fertility Diagnostics, Inc. Intracytoplasmic Sperm Injection Micropipets (ICSI), Spermatid ICSI Micropipets, Holding Micropipets, Assisted Hatching Micropipets, Subzonal Injection Micropipets (SUZI), Partial Zona Dissection Micropipets (PZD), Denuding Micropipets (K990847)
• Prodimed Microinjection Pipettes (K983713)
• Cook OB/GYN Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching /Zona Drilling Pipettes (K983596)

Submission Summary (Full Text)

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KO₂4302

# 510(k) Summary for

FEB 1 9 2003

# Precision Capillaries for Micromanipulation

#### 1. SPONSOR

Brinkmann Instruments, Inc. One Cantiague Road P.O. Box 1019 Westbury, NY 11590-0207

Contact Person: Joel Lopez Telephone: [phone]

Date Prepared: December 23, 2002

### 2. DEVICE NAME

Proprietary Name: Precision Capillaries for Micromanipulation Common/Usual Name: Microcapillaries Assisted Reproduction Microtools Classification Name:

#### 3. PREDICATE DEVICES

- . Scan-Med, Inc. (K991700), Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes
- Humagen Fertility Diagnostics, Inc. (K990847), Intracytoplasmic Sperm ● Injection Micropipets (ICSI), Spermatid ICSI Micropipets, Holding Micropipets, Assisted Hatching Micropipets, Subzonal Injection Micropipets (SUZI), Partial Zona Dissection Micropipets (PZD), Denuding Micropipets
- Prodimed (K983713), Prodimed Microinjection Pipettes .
- Cook OB/GYN (K983596), Intracytoplasmic Sperm Injection (ICSI) Micro-. Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching /Zona Drilling Pipettes

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## 4. DEVICE DESCRIPTION

The proposed Precision Capillaries for Micromanipulation (Precision Capillaries) product line contains the following types of microcapillaries:

- VacuTips Holding Capillary, used for holding human oocytes, blastocysts, or ● other suspension cells
- TransferTips® (ICSI), used for transferring sperm and perforating oocytes . using the ICSI (Intracytoplasmic Sperm Injection) technique

# ર. INTENDED USE

The Precision Capillaries are microcapillaries intended for the following uses in assisted reproduction procedures:

- . Holding human oocytes, blastocysts, or other suspension cells
- Transferring and injecting sperm (or cells of a similar size) using the ICSI . (Intracytoplasmic Sperm Injection) technique

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Precision Capillaries and the substantially equivalent devices are borosilicate glass microcapillaries designed for use in assisted reproduction procedures. The proximal end of the shaft is inserted into the capillary holder of the micromanipulator or microinjector. The distal end is drawn to a narrow tip that contacts the gamete for transfer and/or perforation. The distal end of the VacuTips is blunt for cell transfer. The TransferTips (ICSI) have spiked tips for perforation of the gamete. Three forms of the TransferTips (ICSI) are described in the 510(k), TransferTips-F, TransferTips-R, and TransferTips-RP. The TransferTips vary in shaft length, tip length, and flexibility of the flange.

Each Precision Capillary is mounted in a "Capillary Safe" consisting of a holder and protective tube to protect the capillary and the user during transport and handling. The Precision Capillary mounted in the Capillary Safe is sealed in a foil pouch to maintain sterility. The packaged devices are sterilized by gamma irradiation.

Differences between the proposed and predicate devices are limited to minor differences in design such as the length of the shaft, tip angle, the inner and outer

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diameter of the tip, and the presence of a spike. These differences are minor and do not raise any new issues of safety or effectiveness.

#### 7. PERFORMANCE TESTING

Biological and functional testing conducted to evaluate the safety and efficacy of the Precision Capillaries for their uses in assisted reproduction procedures includes bioburden determination, endotoxin determination, embryotoxicity testing, application testing, and packaging evaluation. The test data obtained from these testing programs indicate that the Precision Capillaries are non-embryotoxic and nonpyrogenic. The Precision Capillaries successfully aspirated sperm and easily perforated oocytes. These results demonstrate that the Precision Capillaries are safe and effective for their uses in assisted reproduction procedures.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be part of a larger, abstract shape. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2003

Brinkmann Instruments, Inc. % Cynthia J. M. Nolte, Ph.D. Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K024302

Trade/Device Name: Precision Capillaries for Micromanipulation Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: 85 MQH Dated: December 23, 2002 Received: December 24, 2002

Dear Dr. Notle:

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 Section 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 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 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 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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K024302

# 510(k) Number (if known): ¥024302

Device Name: Precision Capillaries for Micromanipulation

Indications for Use:

The Precision Capillaries for Micromanipulation are microcapillaries intended for the following uses in assisted reproduction procedures:

- Holding human oocytes, blastocysts, or other suspension cells .
- Transferring and injecting sperm (or cells of a similar size) using the ICSI . (Intracytoplasmic Sperm Injection) technique

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Hagman

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use -----------------------------------------------------------------------------------------------

(Optional Format 1-2-96)

Brinkmann Instruments, Inc. 510(k) Precision Capillaries for Micromanipulation December 23, 2002

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