THE STRIPPER PGD

K041435 · Mid-Atlantic Diagnostics, Inc. · MQH · Sep 29, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K041435
• Device Name: THE STRIPPER PGD
• Applicant: Mid-Atlantic Diagnostics, Inc.
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: Sep 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6130
• Device Class: Class 2

Indications for Use

The transfer of the removed blastomere from a holding vessel to a transport vessel. This device is NOT intended for blastomere biopsy from an embryo.

Device Story

The Stripper PGD® Micropipette is a manual laboratory tool used in assisted reproduction clinics. It facilitates the transfer of a blastomere (previously removed from an embryo) from a holding vessel to a transport vessel. The device is operated by embryologists or laboratory technicians. It functions as a mechanical handling instrument; it does not perform biopsy or diagnostic analysis. The device assists in the safe movement of biological samples within the clinical laboratory environment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual micropipette and associated tip for laboratory use in assisted reproduction. Class II device under 21 CFR 884.6130. No electronic, software, or energy-based components.

Indications for Use

Indicated for the transfer of a previously removed blastomere from a holding vessel to a transport vessel in assisted reproduction procedures. Not indicated for blastomere biopsy.

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.

Submission Summary (Full Text)

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## Public Health Service

## SEP 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan J. Bush Regulatory Affairs MidAtlantic Diagnostics, Inc. 438 N. Elmwood Road * Marlton NJ 08053

Re: K041435

Trade/Device Name: Stripper PGD® Micropipette and associated tip Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II

Product Code: 85 MQH Dated: August 23, 2004 Received: August 26, 2004

Dear Ms. Bush:

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 (OS) 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 us letter will and in your of substantial equivalence of your device to a legally prematicated predicated." The aclassification 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 11 you deen bepoent 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 Other over to premarket notification" (21CFR Part 807.97) you may obtain. Other general by reference to promation 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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## Indications for Use

510(k) Number (if known): __ K041435

Device Name: The Stripper PGD®

Indications for Use:

- The transfer of the removed blastomere from a holding vessel to a ﺳ transport vessel.
- This device is NOT intended for blastomere biopsy from an embryo. -

Prescription Usc (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Legmann

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 84143. 510(k) Number _

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