B-Capta is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours.

Device Description

B-Capta is intended to be used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation.

B-Capta is designed to work with a Stöckert S5 System (K071318) heart-lung machine.

Provided in-line measured parameters of B-Capta are: In the Venous line:

Haematocrit / Haemoglobin (Hct/Hb)
Venous blood oxygen saturation (sO2)
Venous blood temperature (venT)

In the Arterial line:

Arterial blood oxygen partial pressure (pO2)
Arterial blood temperature (artT)

The duration of application is limited to 6 hours of continuous use.

B-Capta consist of the following components / disposables:

B-Capta Venous and Arterial Sensors
B-Capta Sensor Module
B-Capta Venous and Arterial Reference Element Holders
B-Capta disposable Venous and Arterial Cuvettes

B-Capta is a microprocessor based device. The venous sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology. Moreover, an infrared technology is used to measure the temperature of the venous blood.

The arterial sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, partial pressure of oxygen using an optical fluorescence technology. Moreover, an infrared technology is used to measure the temperature of the arterial blood.

Both sensors are functionally connected to the compatible heart-lung machine via a cable plugged in the sensor module and communicate with B-Capta firmware via a RS232 interface according to a dedicated communication protocol. Data are displayed on the graphical user interface of the heart-lung machine.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the B-Capta device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data to establish acceptance criteria and prove device performance against them.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert qualifications for ground truth are not present in this regulatory document. The document primarily highlights non-clinical testing performed to support substantial equivalence.

Here's a breakdown based on the information available:

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

This information is not explicitly available in the provided text. The document states "Design functionality testing confirms that the product meets its product requirements," but it does not specify what those requirements (acceptance criteria) are or provide quantitative performance results against them.

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 available. The document mentions "Design Verification and Validation Testing" and "Software verification and validation testing," but it does not provide details on sample sizes, data provenance, or the nature of these "test sets" for performance evaluation in a clinical or simulated clinical context.

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)

This information is not available. Given that no clinical testing was required or submitted, there's no mention of experts establishing a ground truth for a test set.

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

This information is not available. No adjudication method is mentioned as there's no reported test set requiring expert adjudication.

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

This information is not applicable/not available. The B-Capta is an on-line blood gas monitor, not an AI-assisted diagnostic imaging device that would involve human readers or MRMC studies.

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

The B-Capta device itself is a standalone measurement device, intended for in-line continuous monitoring. Its performance is evaluated on its ability to accurately measure blood parameters. While "standalone performance" was implicitly assessed through design verification and validation, the document does not present this as a separate study with specific metrics (e.g., sensitivity, specificity) against a reference standard in the way an AI algorithm's standalone performance might be described. It focuses on functional compliance and safety.

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

For the performance of measuring blood parameters, the ground truth would typically be established by:

Reference laboratory methods: For blood gas parameters, this usually involves validated laboratory blood gas analyzers.
Traceable standards: For temperature measurements, calibrated temperature probes.

The document does not explicitly state the specific "ground truth" methods used during its design verification and validation, but these would be the standard approaches for such a device.

8. The sample size for the training set

This information is not available. The B-Capta is described as a "microprocessor based device" with optical and infrared sensors. It's not explicitly framed as a machine learning/AI device requiring a "training set" in the typical sense of deep learning or predictive models. Its functionality is based on established physical principles for sensing.

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

This information is not available and likely not applicable, as explained in point 8.

Summary

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April 1, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

LivaNova Deutschland GmbH Mattia Ronchetti Regulatory Affairs Director Lindberghstr. 25 Munich, Bavaria 80939 Germany

Re: K202154

Trade/Device Name: B-Capta Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary Bypass On-Line Blood Gas Monitor Regulatory Class: Class II Product Code: DRY Dated: February 26, 2021 Received: March 1, 2021

Dear Mattia Ronchetti:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202154

Device Name B-Capta

Indications for Use (Describe)

B-Capta is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrithemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

l. SUBMITTER

Name:	LivaNova Deutschland GmbH
Address:	Lindberghstrasse 25D-80939 München, Germany
EstablishmentRegistration Number	9611109 (Manufacturer: LivaNova Deutschland: B-CaptaEquipment)9680841 (Manufacturing site : Sorin Group Italia- B-CaptaDisposable)
Contact Person:	Florian Goetz
Phone:	+49 89 323 01 236
Email:	florian.goetz@livanova.com
Secondary Contact:	Mattia Ronchetti
Phone:	+39 342 762 1974
Email:	mattia.ronchetti@livanova.com
Date Prepared:	July 31, 2020

II. DEVICE

Proprietary Name:	B-Capta
Common Name:	Extracorporeal blood-gas monitor
Classification Name:	Cardiopulmonary bypass on-line blood gas monitor
Regulation Number:	21CFR870.4330
Product Code:	DRY
Device Class:	Class II

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III. PREDICATE DEVICE INFORMATION

B-Capta is substantially equivalent in function and intended use to SORIN DATA MASTER (K001388) and the SORIN B-CARE 5 (K103168).

IV. INDICATIONS FOR USE

V. DEVICE DESCRIPTION

B-Capta is intended to be used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation.

B-Capta is designed to work with a Stöckert S5 System (K071318) heart-lung machine.

Provided in-line measured parameters of B-Capta are: In the Venous line:

Haematocrit / Haemoglobin (Hct/Hb) ■
Venous blood oxygen saturation (sO2)
" Venous blood temperature (venT)

In the Arterial line:

Arterial blood oxygen partial pressure (pO2)
Arterial blood temperature (artT) 트

The duration of application is limited to 6 hours of continuous use.

B-Capta consist of the following components / disposables:

B-Capta Venous and Arterial Sensors
B-Capta Sensor Module l
l B-Capta Venous and Arterial Reference Element Holders
I B-Capta disposable Venous and Arterial Cuvettes

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

LivaNova's B-Capta and its predicates have the same intended use, clinical setting, target user, target patient population, and principle of operation.

B-Capta provides arterial and venous blood measurements. Data Master also provides arterial and venous blood measurements, while B-Care5 provides only venous blood measurements. B-Capta is designed to work integrated with a Stöckert S5 System, as is B-Care5. Any differences between B-Capta and its predicates are minor and do not raise new issues of safety or effectiveness.

B-Capta and its predicate, Data Master have the following system functions:

Blood parameters are measured or calculated in real time and displayed to users . on a digital display
- o Haematocrit / Haemoqlobin (Hct/Hb)
- Venous blood oxygen saturation (sO2) O
- Venous blood temperature (venT) o
- o Arterial blood oxygen partial pressure (pO2)
- Arterial blood temperature (artT) o
Display may be adjusted by the user
Display may provide alerts for user-defined alert limits

B-Capta and its predicate, B-care5 have the following system function:

I Integration into a heart lung machine

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VII. PERFORMANCE DATA

The following non-clinical testing was performed to support the substantial equivalence of the B-Capta to its legally marketed predicate devices:

I Electromagnetic Compatibility and Electrical Safety
- Evaluation for electrical safety and EMC testing was performed for B-O Capta. B-Capta complies with IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for EMC.
I Design Verification and Validation Testing
- Design functionality testing confirms that the product meets its product o requirements. Summative use testing following ISO 62366 confirms that the product fulfills user needs.
I Software verification and validation
- o Software verification and validation testing was completed successfully. The software level of concern is "moderate".
I Sterilization and Shelf Life
- The product (cuvettes only) is provided sterile with a 3-year shelf life. с Product sterility, shelf life, and packaging/transport testing confirms product safety and effectiveness.
I Biocompatibility Testing
- o The sterile, disposable cuvettes in the system are limited bloodcontacting, and have been tested per ISO 10993. Biocompatibility testing confirms that the products can be used as intended.

Animal testing was not required to demonstrate the substantial equivalence of the B-Capta to its predicate devices and is not included as part of this premarket notification.

Clinical testing was not required to demonstrate the substantial equivalence of the B-Capta to its predicate devices and is not included as part of this premarket notification.

VIII. CONCLUSION

Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, B-Capta is substantially equivalent to its predicate devices.

Regulation Number and Section

§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.

(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).