(146 days)
No
The description focuses on microprocessor control and standard environmental controls, with no mention of AI or ML.
No.
The device creates an environment for the development of ova or embryos but does not directly treat a disease or condition in a living organism.
No
This device is an incubator designed to provide a controlled environment for the development of ova or embryos, which is a supportive rather than a diagnostic function.
No
The device description clearly describes a physical incubator with hardware components such as a chamber, sensors, and a microprocessor for control. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a controlled environment for the development of ova or embryos. This is a biological process happening outside the human body, but it's not about analyzing a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on creating and maintaining specific environmental conditions (temperature, CO2, humidity, O2) for biological growth. It doesn't mention any analysis of biological samples or diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is an incubator designed to support the growth of biological material, which is a laboratory tool, but not a diagnostic one in the context of IVD regulations.
N/A
Intended Use / Indications for Use
The intended use of this incubator is to provide an environment with controlled temperature, CO2, elevated humidity, an automatic decontamination mode, and O2 at suppressed levels, for the development of ova or embryos at or near body temperature.
Product codes
85 MQG
Device Description
The Kendro HERAcell 240 incubators are bench top or floor standing units. The devices control CO2, temperature, provide elevated humidity, feature a decontamination mode, and control O- at suppressed levels to ensure the proper development of ova or embryos at or near body temperature. The conditions produced by the subject device are an exact simulation of physiological conditions. Controlled parameters and alarin functions are microprocessor controlled.
The basic model includes the auto-zero self-balancing CO2 control system, which ensures long term stability of CO2 levels. Each unit is equipped with a water level alarm to remind the user to refill the water reservoir.
As with the predicate device the user has the choice of a stainless steel or solid copper inner chamber. Additionally, the user can choose from additional options such as Oxygen control, Infra-Red Sensor, and the roller bottle system. The basic model includes the TC (thermal conductivity) sensor, however the user can choose the Infra-Red Sensor option.
The main differences between the subject device and the predicate device are related to new options that are offered with the new device as listed below:
- Oxygen O2 control ranges (1-21% for applications requiring hypoxic conditions or a wide . range of 5-90%).
- Infra-red CO2 Sensor. .
- Roller Bottle System (a system with up to 4 bottle turning devices for roller between . 58-186mm in diameter).
- . Water Level Alarm (included in all HERAcell 240 units)
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
The subject device complies with internationally accepted electrical safety standards as well as other requirements such as CE marking.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
KO23465
510 (k) Summary fas required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(1)|
October 14, 2002
Submitter's Information [21 CFR 807.92(a)(1)]
Joseph M. Azary C/o Kendro Laboratory Products L.P. P.O. Box 2156 Huntington, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor Kendro Laboratory Products L.P., 31 Pecks Lane, Newtown, CT 06470.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are: Kendro Laboratory Products HERAcell 240 Common Name: Assisted Reproduction Accessories, Embryo Incubator
Predicate Device [21 CFR 807.92(a)(3)]
- . Kendro HERAcell CO2 Incubator - K002805
There are a few minor differences between the subject device (HERAcell 240) and the predicate device (HERAcell). The differences revolve around the options that are now offered with the HERAcell 240 including Oxygen O2 control ranges (1-21% for applications requiring hypoxic conditions or a wide range of 5-90%), Infra-red CO2 Sensor, Roller Bottle System, and the Water Level Alarm.
The predicate device allowed the user to control the Carbon Dioxide levels directly and indirectly control Oxygen and Nitrogen levels by the manipulation of CO2 levels. The subject device allows for the direct control of Carbon Dioxide and Oxygen. The concept of controlling Oxygen levels in incultators is not new. The Forma Scientific Incubator (510k# K991408) allows for the direct control of oxygen levels (2-20%).
Description of the Device [21 CFR 807.92(a)(4)]
The Kendro HERAcell 240 incubators are bench top or floor standing units. The devices control CO2, temperature, provide elevated humidity, feature a decontamination mode, and control O- at suppressed levels to ensure the proper development of ova or embryos at or near body temperature. The conditions produced by the subject device are an exact simulation of physiological conditions. Controlled parameters and alarin functions are microprocessor controlled.
1
The basic model includes the auto-zero self-balancing CO2 control system, which ensures long term stability of CO2 levels. Each unit is equipped with a water level alarm to remind the user to refill the water reservoir.
As with the predicate device the user has the choice of a stainless steel or solid copper inner chamber. Additionally, the user can choose from additional options such as Oxygen control, Infra-Red Sensor, and the roller bottle system. The basic model includes the TC (thermal conductivity) sensor, however the user can choose the Infra-Red Sensor option.
The main differences between the subject device and the predicate device are related to new options that are offered with the new device as listed below:
- Oxygen O2 control ranges (1-21% for applications requiring hypoxic conditions or a wide . range of 5-90%).
- Infra-red CO2 Sensor. .
- Roller Bottle System (a system with up to 4 bottle turning devices for roller between . 58-186mm in diameter).
- . Water Level Alarm (included in all HERAcell 240 units)
Intended Use [21 CFR 807.92(a)(5)]
The intended use of this incubator is to provide an environment with controlled temperature, CO2, elevated humidity, an automatic decontamination mode, and O2 at suppressed levels, for the development of ova or embryos at or near body temperature.
Technological Characteristics |21 CFR 807.92(a)(6)]
Kendro Laboratory Products L.P. believes that the addition of a few options in the subject device is a minor change from the predicate device. Therefore, it is believed that the substantially equivalent to the predicate device.
Performance Data [21 CFR 807.92(b)(1)]
The subject device complies with internationally accepted electrical safety standards as well as other requirements such as CE marking.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.
2
Image /page/2/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 a stylized image of a human figure with three overlapping profiles, suggesting a sense of community and service.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kendro Laboratory Products, L.P. % Mr. Joseph M. Azary Azary Technologies, LLC P.O. Box 2156 HUNTINGTON CT 06484
Re: K023465
MAR 1 0 2003
Trade/Device Name: HERAcell 240 Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: 85 MQG Dated: January 18, 2003 Received: January 21, 2003
Dear Mr. Azary:
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 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 (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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance 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,
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
4
5 10(k) Number (if known): _
): KD23465
Device Name: Kendro Laboratory Products L.P. HERAcell 240
Indications For Use: The intended use of this incubator is to provide an environment with controlled temperature, CO2 elevated humidity, an automatic decontamination mode, and O2 at suppressed levels, for the development of ova or embryos at or near body temperature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
L Prescription Use (Per 21 CFR 801.109)
OR
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Page 4 HERAcell 240 510(k)