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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Kendro Laboratory Products HERAcell 240 incubator, an assisted reproduction accessory. This submission focuses on demonstrating substantial equivalence to a predicate device (Kendro HERAcell CO2 Incubator - K002805) rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, specific performance studies, sample sizes, expert involvement, and ground truth are not available in the provided document. The submission relies on the concept of substantial equivalence to a previously cleared device.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The submission asserts substantial equivalence based on the device's technical characteristics and intended use being similar to a predicate device. Performance is generally implied to be acceptable because it's equivalent to the predicate, which already met regulatory requirements.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided. The submission does not describe a clinical performance study with a test set. This is a premarket notification for a device that relies on demonstrating substantial equivalence, not a new clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided. As no specific clinical test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

This information is not provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

No. An MRMC comparative effectiveness study was not done or described in this 510(k) submission. This type of study is typically for evaluating diagnostic algorithms with human readers, which is not applicable to an incubator. The submission focuses on device function for an intended environment for biological samples.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable to this device. The HERAcell 240 is an incubator, not an algorithm or AI system for diagnostic or interpretive purposes. Its performance is based on its ability to maintain environmental conditions.

7. The Type of Ground Truth Used:

This information is not explicitly stated as part of a formal study with "ground truth." For a device like an incubator, "ground truth" would generally refer to the accurate measurement and maintenance of physical parameters like temperature, CO2, O2, and humidity. Performance is implied to be acceptable based on the device's design, compliance with electrical safety standards, and its similarity to the predicate device. The statement "The subject device complies with internationally accepted electrical safety standards as well as other requirements such as CE marking" is the closest to a performance claim, suggesting compliance with established standards defines successful device operation.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not provided and is not applicable. This is not an AI/ML device.

Summary of Device Performance and Acceptance (based on available information):

The submission for the Kendro HERAcell 240 incubator sought to establish substantial equivalence to its predicate device (Kendro HERAcell CO2 Incubator - K002805).

Intended Use: 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.
Key "Performance" Claims/Characteristics:
- Direct control of Carbon Dioxide and Oxygen levels (the predicate only directly controlled CO2).
- New options: Oxygen O2 control ranges (1-21% or 5-90%), Infra-red CO2 Sensor, Roller Bottle System, Water Level Alarm.
- Complies with internationally accepted electrical safety standards and CE marking.
- "The conditions produced by the subject device are an exact simulation of physiological conditions."
Acceptance Criteria (Implicit via Substantial Equivalence): The device is considered to meet acceptance criteria because its technological characteristics and performance are "as safe and effective as the predicate devices" (Kendro HERAcell CO2 Incubator - K002805, and citing Forma Scientific Incubator - K991408 for oxygen control). This means it is expected to maintain the specified environmental conditions (temperature, CO2, O2, humidity) within levels suitable for ova or embryo development, akin to the predicate device.
Study: The submission relies on a comparison to a predicate device (Kendro HERAcell CO2 Incubator - K002805) and general compliance with electrical safety standards, rather than a specific clinical performance study with predefined acceptance criteria for the new features. The argument is that the key operational principles and safety are essentially the same, with minor additions that have also been demonstrated in other cleared devices (e.g., oxygen control in K991408).

Summary

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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)]

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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.

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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.

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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

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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)

(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)

Regulation Number and Section

§ 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.