CRYOTIP

K041562 · Irvine Scientific Sales Co., Inc. · MQH · Aug 9, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K041562
• Device Name: CRYOTIP
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: Aug 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6130
• Device Class: Class 2

Indications for Use

The CryoTip is a cryopreservation device that is intended to be used to contain, freeze and maintain oocytes and/or embryos.

Device Story

CryoTip is a medical-grade plastic straw designed for cryopreservation of oocytes and embryos. Device features a fine tip (approx. 200 micrometers inner diameter) and a sliding stainless steel cover sleeve for protection. Embryologist loads specimens into the fine tip, then uses an impulse heat sealer to seal both ends, creating a closed system. Sealed device is stored in a liquid nitrogen reservoir. Used in clinical embryology laboratories to facilitate long-term storage of reproductive specimens. Benefits include secure containment and protection of specimens during the freezing and storage process.

Clinical Evidence

Bench testing only. Performance evaluated by five independent field laboratories using one-cell mouse embryos and standard mouse embryo assay protocols. Feedback indicated the device was effective for cryopreservation procedures and easy to use. Lot-specific sterility and mouse embryo assay testing are performed as a condition of release.

Technological Characteristics

Medical-grade plastic straw; stainless steel cover sleeve; fine tip (approx. 200 micrometers ID); heat-sealed closed system; non-electronic; manual operation.

Indications for Use

Indicated for the containment, cryopreservation, and maintenance of oocytes and/or embryos in an assisted reproduction setting.

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

• Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

Submission Summary (Full Text)

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# AUG - 9 2004

# 510(k) Summary as REQUIRED BY SECTION 807.92(c) KO 41 5 6 2

| Submitted by: | Irvine Scientific Sales Co., Inc.<br>2511 Daimler Street<br>Santa Ana, CA 92705-5588 |
|---------------|---------------------------------------------------------------------------------------|
| | Telephone: [phone]<br>Facsimile: [phone] |

Contact: Wendell Lee, Pharm. D.

Date Submitted: June 9, 2004

#### Device Identification:

| Trade Name: | CryoTip |
|----------------------|----------------------------------------------------|
| Common Name: | Cryopreservation container and microtool |
| Classification Name: | Assisted Reproduction Microtools (21 CFR 884.6130) |

#### Predicate Device:

Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

#### Description:

The CryoTip is a medical grade plastic drawn device designed to contain, freeze and maintain oocytes and/or embryos. It has a fine tip at one end (drawn to an inner diameter of ~200 micrometers), along with a stainless steel cover sleeve which can slide along the length of the CryoTip to expose or cover and protect the fine drawn tip. This device is designed to be heat sealed on each end of the plastic straw to create a closed system for long-term frozen storage of oocytes and/or embryos. The CryoTip has four (4) identifiable marks at specified locations to aid the Embryologist in loading the specimens into the optimal reqions of the device during Cryo Preservation procedures.

The device is designed to be heat sealed using an impulse heat sealer after the oocytes and/or embryos have been drawn into the fine tip. The fine tip

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end of the CryoTip is heat sealed first. The Embryologist aseptically places the fine tip of the CryoTip onto the bottom base of the heat sealer just below the first marking on the CryoTip. The pressure lever is then lowered onto the fine tip of the CryoTip for sealing. When the heat sealing process is complete the pressure lever is lifted and the CryoTip is removed. The Embryologist will then carefully slide the metal cover sleeve over the heat sealed fine tip. After the fine tip of the CryoTip is sealed the connector is aseptically removed from the CryoTip. The open end of the CryoTip is then placed onto the center of the bottom base of the heat sealer just above the fourth marking. The pressure level is lowered onto the CryoTip for sealing. When the heat sealing process is complete the pressure lever is lifted from the CryoTip and the CryoTip is removed from the heat sealer. After both ends of the CryoTip have been sealed the Embryologist places the sealed CryoTip into a liquid nitrogen reservoir for storage.

#### Intended Use:

The CryoTip is a cryopreservation device that is intended to be used to contain, freeze and maintain oocytes and/or embryos.

#### Performance Data:

The CryoTip device has been studied by five (5) independent field laboratories, using one-cell mouse embryos and the protocol for mouse embryo assay. The response and feedback from the laboratories that evaluated the device indicates it was well received in terms of its application, ease of use, and effectiveness in the cryopreservation procedures.

### Additional Information:

Mouse Embryo Assays and sterility tests will be performed as a condition i of release for these products, as appropriate. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling. Please refer to the proposed certificate of analysis and

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.

presented in Appendix C and the proposed labeling presented in section 14 of this submission.

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## Conclusion:

The results from the field testing of these products demonstrates that CryoTips are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Admin 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Wendell Lee, Pharm. D. Vice President, Quality Systems and Regulatory Affairs Irvine Scientific Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

Re: K041562 Trade/Device Name: CryoTip, Cryopreservation container Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: 85 MQH Dated: June 9, 2004 Received: June 10, 2004

Dear Dr. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device WE nave reviewed your becaon >10(t) pe device is substantially equivalent (for the indications felerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosure, to regally manation of the Medical Device American so to commerce prior to hay 20, 1976, the classified in accordance with the provisions of the Federal Food, Drug, devices that have occh resulted in accessed in accore approval of a premarket approval application (PMA). alla Cosmelle Act (Act) that do not require of to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of genceral controls provisions of the rest 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 If your device is classince (see acoro) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controlly. Like 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I ouch. In the Federal Revice 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 of any regeral statures and regalations administration and listing (21 CFR Part willi an the Act s requirements, modaling, one tice requirements as set forth in the 807); adocling (21 CFR art 820); and if applicable, the electronic product quality Systems (Sections (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 5 10(k) I his lefter will anow you to ocgin harketing of substantial equivalence of your device to a legally premarket notification. THE PDA inding of backland on 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
s and the many of the comments of the comment of the regulation If you desire specific advice for your decide on 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 Additionally, for questions on the promotion and the regulation entitled, "Misbranding Othce of Compliance at [phone]. This, production) you may obtain. Other general by relerence to premarket notification (21 OF Act are and the More the Division of Small Information on your responsionalists and consumer Assistance at its toll-free number [phone] or Manufacturers, International and Oolisamer 1986-1997 of h/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brygdon

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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Irvine Scientific

#### INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(k) Number (if known): 《04/562

Device Name:_CryoTip

Indications For Use:

The CryoTip is a cryopreservation device that is intended to be used to contain, is
t the CryoTip is a cryoprese w The Oryonip whitain oocytes and/or embryos.

Prescription Use _X_ (Part 21 CFR 801 Subpart D) AND/OR

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)

Nancy Brandon

Division of Reproduc e. Abdominal, and Radiological De 510(k) Number