Incubators series CB provide suitable growth-conditions for NaHCO3 -buffered cell cultures of ova or embryos with controlled temperature at or near 37°C (98.6°F) and carbon-dioxide atmosphere (optional additionally at hyper oxide or hypo oxide atmosphere) at a high humidity. A automatic dry heat decontamination process of the empty incubator, applicable between different loadings assists to avoid contaminations of the cell cultures.

Device Description

BINDER incubators series CB are bench top or floor standing units. There are two different sizes available. One of approximately 5.3 cubic feet inner volume (150 liters) and one with 7.4 cubic feet volume (210 liters). One multi-channel controller with a large area LCD screen controls the growth parameters temperature and inner carbon-dioxide (CO2) concentration and provide elevated humidity. The inner chamber volume is closed against the environment. Optionally the units are equipped with a control channel for Oxygen (O2). Temperature, CO2 concentration (optional also O2 concentration) are microprocessor controlled. Constant and reliable temperatures are achieved by the patented air-jacked heating system. The air-jacket provides highly precise and homogeneous temperatures within the incubator which is ideal for long term culturing. The system has very short recovery times upon door openings. The concentration of CO2 is controlled by a single beam infrared (IR) difference detector. The IR sensor has an auto correction function and is characterized by minimal reaction latencies. The detection system for the optional Oxygen control bases on the amperometric system of a Zirconium-Dioxide (ZrO2) electrode.

The incubator is equipped with a dry-heat decontamination function at 187°C (368.6°F).

AI/ML Overview

This document is a 510(k) summary for the BINDER CO2 incubator series CB. It describes a medical device, its intended use, and its comparison to a predicate device. It also includes the FDA's clearance letter.

Here's an analysis based on your request, highlighting that this document is not about an AI/ML device, and therefore several requested categories are not applicable.

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria with reported performance values in a table format. However, it indicates successful completion of various tests.

Test Category	Reported Performance / Outcome (Implicit Acceptance)
Electrical Safety	Successfully passed
Electromagnetic Compatibility	Successfully passed
Operating Performance	Successfully passed
Decontamination Testing	Successfully passed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The tests performed are engineering and functional tests on the device itself, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The tests mentioned (electrical safety, EMC, operating performance, decontamination) are engineering and regulatory compliance tests. They do not involve expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human assessment or adjudication of data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a CO2 incubator, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.

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

Not applicable. The device is a CO2 incubator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests (electrical safety, EMC, operating performance, decontamination), the "ground truth" would be established by relevant engineering standards, regulatory requirements, and the expected functional specifications of the incubator. For example, for temperature control, the ground truth would be the specified temperature range and stability.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The tests relate to the physical device's performance.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/ML device.

Summary

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K032526

1. 510(k) Summary (in accordance to 21 CFR 807.92)

Submitted by:	Dr. Paul Distler (Product Manager)BINDER GmbHBergstrasse 14, D-78532 Tuttlingen, GermanyPhone Number: ++49 7461 179254Fax Number: ++49 7461 1792854e-mail: paul.distler@binder-world.com www.binder-world.com
Date:	May 13, 2003
Names of Devices:	Binder CO2 incubator series CB (CB 150-UL and CB 210-UL)
Trade Name:	CO2 Incubator / Embryo Incubator
Common/Usual Name:	CO2 Incubator / Embryo Incubator
Classification Name:	21 CFR 884.6120
Predicate Device:	Forma Scientific Universal Water Jacked Incubator(ThermoQuest Corp.)Reference No. K991408, cleared 07/19/1999

Device description:

The incubator is equipped with a dry-heat decontamination function at 187°C (368.6°F).

Intended Use:

Comparison to predicate device:

The two incubators are very similar except that the BINDER incubator has an air-jacket heating system that allows to proceed a dry-heat decontamination at 187 °C (368.6°F) of the inner chamber and the interior equipment whereas the Forma incubator is equipped with a water jacket and no decontamination facility.

Discussion of non clinical tests:

The BINDER incubator passed through tests for electrical safety, electromagnetic compatibility testing, operating performance testing and decontamination testing successfully.

Discussion of clinical tests: not applicable

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Image /page/1/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest movement and feathers. The bird is oriented to the right. The logo also includes a circular border made up of small, evenly spaced dots. The logo is black and white.

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 2 9 2003

Ms. Pamela Gwynn Engineering Team Leader Underwriters Laboratories, Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K032526 Trade/Device Name: BINDER CO2 incubator series CB Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: 85 MQG

Dated: July 21, 2003 Received: August 15, 2003

Dear Ms. Gwynn:

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 (OS) 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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3-3 Indication for Use Statement
----------------------------------

Ver/ 3 - 4/24/96
------------------

Applicant:	BINDER GmbH
510(k) Number (if known):	K032526
Device Name:	BINDER CO2 incubator series CB
Indications For Use:

Incubators series CB provide suitable growth-conditions for NaHCO3 -buffered cell cultures of ova or embryos with controlled temperature at or near 37°C (98.6°F) and carbon-dioxide atmosphere (optional additionally at hyper oxide or hypo oxide atmosphere) at a high humidity. An automatic dry heat decontamination process of the empty incubator, applicable between different loadings assists to avoid contaminations of the cell cultures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Prescription Use	✓
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K032526

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.