COOK Vacuum Pump

K160753 · William A. Cook Australia Pty. , Ltd. · MQG · Jun 13, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K160753
• Device Name: COOK Vacuum Pump
• Applicant: William A. Cook Australia Pty. , Ltd.
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Jun 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The COOK Vacuum Pump is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.

Device Story

The COOK Vacuum Pump is an electrically-powered device used in clinical settings for ovum aspiration during IVF procedures. It generates a vacuum ranging from -10 mmHg to -500 mmHg, controlled by a microprocessor. The system includes a disposable vacuum line with a hydrophobic filter that connects to an aspiration needle. A foot pedal is used to operate the device. The pump features a 'boost' function, allowing the user to increase vacuum pressure up to -500 mmHg to clear blockages in the aspiration line or needle while outside the patient. The device provides consistent, low-flow, intermittent vacuum to facilitate the collection of eggs from ovarian follicles. Healthcare providers use the device to safely retrieve oocytes, which are then used in subsequent laboratory fertilization processes, potentially improving the efficiency of the egg collection procedure.

Clinical Evidence

Bench testing only. Studies included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software verification and validation, sterilization validation (ISO 11135), and shelf-life testing (ASTM F1886, F1929, F88). Mechanical testing confirmed vacuum compatibility and tensile strength.

Technological Characteristics

Electrically-powered vacuum pump; microprocessor-controlled; vacuum range -10 to -500 mmHg; flow rate 20-25 mL/min. Disposable vacuum line with hydrophobic filter (ethylene oxide sterilized). Connectivity includes foot pedal interface. Software-based control system.

Indications for Use

Indicated for the aspiration of eggs (ova) during assisted reproduction procedures in patients undergoing IVF.

Regulatory Classification

Identification

Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova). (2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures. (3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation. (4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature. (5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.

Special Controls

*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation 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 Ultra Quiet Vacuum Pump & Regulator (K992070)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of 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 symbol that resembles a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 13, 2017

William A. Cook Australia Pty Ltd Gordana Pozvek, Ph.D. Senior Regulatory Affairs Specialist 95 Brandl Street Eight Mile Plains, QLD 4113 Australia

Re: K160753 Trade/Device Name: COOK Vacuum Pump Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted Reproduction Accessories Regulatory Class: II Product Code: MOG Dated: May 10, 2017 Received: May 15, 2017

Dear Gordana Pozvek:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Charles Viviano -S

For

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160753

Device Name COOK Vacuum Pump

Indications for Use (Describe)

The COOK Vacuum Pump is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K160753 Page 1 of 3

Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif letters, with the registered trademark symbol next to it. Below "COOK", the word "MEDICAL" is written in smaller, white, sans-serif letters.

WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 BRANDL STREET BRISBANE TECHNOLOGY PARK, EIGHT MILE PLAINS BRISBANE, QLD 4113, AUSTRALIA PHONE: [phone] FAX: [phone] WWW.COOKMEDICAL.COM ABN 79 005 526 723

# 510(k) Summary

### SUBMITTED BY:

William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains QLD 4113 Australia

| Contact Person: | Gordana Pozvek Ph.D.<br>Senior Regulatory Affairs Specialist<br>William A. Cook Australia Pty Ltd |
|-----------------|---------------------------------------------------------------------------------------------------|
| Tel: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

June 11, 2017 Date Prepared:

# DEVICE IDENTIFICATION:

| Trade Name: | COOK Vacuum Pump |
|----------------------|-----------------------------------------------------|
| Common Name: | Vacuum Pump |
| Classification Name: | Assisted Reproduction Accessories (21 CFR 884.6120) |
| Product Code: | MQG (Accessory, Assisted Reproduction) |
| Regulatory Class: | II |

# PREDICATE DEVICE:

COOK Ultra Quiet Vacuum Pump & Regulator (K992070), manufactured by COOK Urological, Inc. This predicate device has not been subject to any design related recalls.

### DEVICE DESCRIPTION:

The COOK Vacuum Pump (K-MAR-5200) is an electrically-powered, vacuum pump that is used for the collection of ova (eggs) from ovarian follicles for use in in vitro fertilization (IVF) procedures. The COOK Vacuum Pump provides vacuum levels ranging from -10 mmHg to -500 mmHg. . It is supplied non-sterile.

The disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240) is an accessory to the COOK Vacuum Pump and is used to connect the vacuum pump to an ovum aspiration needle. This component has been designed and tested to withstand the maximum vacuum

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pressures associated with the COOK Vacuum Pump. The Vacuum Line with Hydrophobic Filter (K-DVLF-240) is provided sterile (ethylene oxide sterilization) for single use only, and has a shelf-life of three years.

# INDICATIONS FOR USE:

The COOK Vacuum Pump is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.

#### COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF SUBJECT AND PREDICATE DEVICES:

| Device/Predicate Devices | SUBJECT DEVICE:<br>COOK Vacuum Pump | PREDICATE DEVICE:<br>COOK Ultra Quiet Vacuum Pump &<br>Regulator (K992070) |
|--------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Same as predicate device | The COOK Ultra Quiet Vacuum Pump &<br>Regulator is intended for the aspiration of<br>eggs (ova), during assisted reproduction<br>procedures using low flow, intermittent<br>vacuum. |
| Fundamental technology | Same as predicate device | A single diaphragm pump is attached to a<br>motor. The suctioned air is collected in the<br>pressure reservoir. A pressure gauge is<br>connected to the pressure reservoir and the<br>pressure is displayed. The aspiration pressure<br>sensor detects the set aspiration pressure and<br>the aspiration pressure during the boost<br>operation. A motor controlled by an<br>aspiration pressure control circuit adjusts the<br>detected pressure and maintains the set<br>pressure. |
| Vacuum range | -10 mmHg to -500 mmHg | -30 mmHg to -300 mmHg |
| Recommended flow rate | Same as predicate device | 20-25 mL/min |
| Vacuum range accuracy | Same as predicate device | ± 5 mmHg |
| Boost function | The vacuum can be boosted to<br>-500 mmHg from any setting<br>during operation | No |
| Foot pedal | Same as predicate device | Yes |
| Controller | Microprocessor electronic<br>control | Analogue electronic control |
| Software | Yes | No |

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| Device/Predicate Devices | SUBJECT DEVICE: | PREDICATE DEVICE: |
|--------------------------|-------------------------------------------------------|-------------------|
| COOK Vacuum Pump | COOK Ultra Quiet Vacuum Pump &<br>Regulator (K992070) | |

The subject and predicate devices have the same indications for use and intended use. They also use the same fundamental technology to create a vacuum and have the same recommended flow rate for ovum (egg) aspiration procedures.

The subject device has a vacuum range from -10 mmHg to -500 mmHg, whereas the predicate device has a vacuum rage from -10 mmHg to -300 mmHg. The higher vacuum pressure provided by the subject device (from -300 mmHg to -500 mmHg) is only intended to be applied during use of the "boost" function to clear blockages in the aspiration line or aspiration needle is outside the patient. Therefore, the difference in vacuum range does not raise different questions of safety or effectiveness.

Unlike the predicate device that used an analogue electronic control of the subject device is done using a microprocessor and software. This difference does not raise different types of safety and effectiveness questions.

## SUMMARY OF NON-CLINICAL PERFORMANCE TESTING:

The following studies have been performed to support substantial equivalence to the predicate devices:

- Electrical Safety Testing per IEC 60601-1: 2005
- Electromagnetic Compatibility Testing per IEC 60601-1-2:2007 ●
- Software Verification and Validation Testing in accordance with FDA's Guidance ● for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Sterilization Validation Testing on the Vacuum Line with Hydrophobic Filter per ISO 11135:2014
- Shelf-Life Testing on the Vacuum Line with Hydrophobic Filter, including: ●
- Visual Inspection per ASTM F1886/F1886M-09, —
- Dye Penetration Test per ASTM F1929-15,
- -Seal Strength Test per ASTM F88/F88M-15, and
- Mechanical Test (vacuum compatibility of the entire unit and tensile strength at joints) with justified acceptance criteria.

### CONCLUSION:

The subject and predicate devices have the same indications for use and intended uses. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.