COOK ULTRA QUIET VACUUM PUMP & REGULATOR

K992070 · Cook Urological, Inc. · MQG · Oct 27, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K992070
• Device Name: COOK ULTRA QUIET VACUUM PUMP & REGULATOR
• Applicant: Cook Urological, Inc.
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

The COOK® Ultra Quiet Vacuum Pump & Regulator is a powered aspiration pump designed for use in assisted reproduction procedures. It provides a high vacuum range of -30 to -300 ± 5 mmHg with low flow, intermittent suction. The device is operated by clinical staff to aspirate eggs (ova) from patients. By providing controlled, low-flow vacuum, the device facilitates the retrieval of oocytes, supporting the clinical workflow of assisted reproduction. The device is intended for prescription use in a clinical setting.

Clinical Evidence

Bench testing only; electromagnetic compatibility testing performed.

Technological Characteristics

Powered aspiration pump; vacuum range -30 to -300 ± 5 mmHg; low flow, intermittent operation; electrical power source.

Indications for Use

Indicated for the aspiration of eggs (ova) during assisted reproduction procedures. Intended for prescription use.

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

• 63 FR 48428 (September 10, 1998)

Submission Summary (Full Text)

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510(k) Premarket Notification: COOK® Ultra Quiet Vacuum Pump & Regulator

KPP2070 OCT 27 1999

#### 510(K) SUMMARY த

### Submitted By:

Brenda Davis Regulatory Affairs COOK OB/GYN TM 1100 West Morgan Street Spencer, Indiana, 47460. June 17, 1999

# Names of Device:

| Trade Name: | COOK® Ultra Quiet Vacuum Pump & Regulator |
|----------------------|------------------------------------------------------|
| Common/Usual Name: | Powered Aspiration Pump |
| Classification Name: | Powered Aspiration Pump<br>21 CFR §884.6120 (85) MQG |

Predicate Device:

63 FR 48428, September 10, 1998

## Device Description:

The COOK® Ultra Quiet Vacuum Pump & Regulator provides high vacuum, ranging from -30 to -300 ± 5 mmHg, low flow aspiration.

## Intended Use:

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

# Substantial Equivalence:

The COOK® Ultra Quiet Vacuum Pump & Regulator is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.

### Discussion of Tests and Test Results:

The COOK® Ultra Quiet Vacuum Pump & Regulator was subjected to testing to assure satisfactory electromagnetic compatibility. The COOK® Ultra Quiet Vacuum Pump & Regulator passed the requirements of all tests.

# Conclusions Drawn from Tests:

This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 1999

Ms. Brenda Davis Regulatory Affairs COOK® OB/GYN™ 1100 W. Morgan Street Spencer, IN 47460

Re: K992070

COOK® Ultra Quiet Vacuum Pump & Regulator Dated: August 20, 1999 Received: August 24, 1999 Regulatory Class: Ii 21 CFR 884.6120/Procode: 85 MQG

Dear Ms. Davis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have We nave reviewed your obtion of o(i) newalent (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 manced production according that have been reclassified in accordance with the provisions of the Medical Booked Knortener, or to actived . You may, therefore, market the device, subject to the general controls r cocial 1 000, Drug, and Ooomolo root (10), i visions of the Act include requirements for annual registration, listing of provisions of the fitne who general be, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may if your device to such additional controls. Existing major regulations affecting your device can be found in the Code of be subject to Juditional Controlly Extrang Hastory Hastory Hally equivalent determination assumes compliance with r cacran Requirements, This Er, Parts one of Coocerements, as set forth in the Quality System Regulation (QS) for the Gurient Ooo Manufacturing Prastion (21 CFR Part 820) and that, through periodic QS inspections, the Food and Medical Devices: ' Ocheral regulation (ET OF FT Press, and that the GMP regulation may result in Drug Kanninoration (r 27 ) mill von you blish further announcements concerning your device in the Federal regulation action. In addition, PDF may painter notification submission does not affect any obligation Control register. Tridao noter the roppende v542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification for This retter will anow you to begin 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 and additionally 809.10 for in r you door opposite datable for your contact the Office of Compliance at [phone]. Additionally for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Allso, the promotion and advontions by reference to premarket notification"(21 CFR 807.97). Other production on your responsibilities under the Act may be obtained from the Division of Small Manufacturers general more at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K992070 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: __ COOK® Ultra Quiet Vacuum Pump & Regulator

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dny Hh for DB-S

vicion Si Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109)