(131 days)
63 FR 48428
Not Found
No
The summary describes a vacuum pump and regulator for aspiration, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used for the aspiration of eggs (ova) during assisted reproduction procedures, which is a medical intervention aimed at treating infertility.
No
Explanation: The device is intended for the aspiration of eggs during assisted reproduction procedures, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it is a "Vacuum Pump & Regulator," which are hardware components. The summary also mentions testing for electromagnetic compatibility, which is relevant to hardware.
Based on the provided information, the COOK® Ultra Quiet Vacuum Pump & Regulator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration of eggs (ova) during assisted reproduction procedures. This is a procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The device is a vacuum pump and regulator, which is a piece of equipment used in a medical procedure. It doesn't perform any analysis or testing of biological samples.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is a medical device used in a clinical procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MQG
Device Description
The COOK® Ultra Quiet Vacuum Pump & Regulator provides high vacuum, ranging from -30 to -300 ± 5 mmHg, low flow aspiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
63 FR 48428
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.6120 Assisted reproduction accessories.
(a)
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.
(b)
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.
0
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 |
| 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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.
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 (301) 594-4613. Additionally for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
2
Page_1_of_1_
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)