The provided text describes a 510(k) submission (K973371) for the Certodyn® RAECG Universal Adapter. This submission focuses on establishing substantial equivalence to a predicate device (Arrow-Johans ECG Adaptor, K843263), rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.

Therefore, many of the requested details about a study and its results, such as sample sizes, expert qualifications, and specific performance metrics, are not present in this document.

Here's a breakdown of the available information:

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

Acceptance Criteria	Reported Device Performance
Physical Testing as defined by Quality Control Test Procedure documents, conforming to product design specifications.	The device "must meet all required release specifications before distribution." This includes "physical testing, visual examination (in process and finished product)." The text states that "These tests are established testing procedures and parameters which conform to the product design specifications."
Material Suitability	"Composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product."
Substantial Equivalence in materials, form, and intended use to the predicate device (Arrow-Johans ECG Adaptor, K843263).	"The Certodyn® RAECG Universal Adapter is equivalent in materials, form, and intended use to our the Arrow-Johans ECG Adaptor currently marketed under K843263 by Arrow International, Inc."
No New Issues of Safety or Effectiveness raised compared to the predicate device.	"There are no new issues of safety or effectiveness raised by the Certodyn® RAECG Universal Adapter."

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

This information is not present in the document. The submission focuses on substantial equivalence based on manufacturing controls and material suitability rather than a clinical or performance study with a test set of 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)

This information is not present in the document. This type of information would typically be found in a study demonstrating clinical performance, which is not the primary focus of this 510(k) submission.

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

This information is not present in the document.

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

There is no indication of an MRMC comparative effectiveness study being done. The device is a physical adapter, not an AI-powered diagnostic tool.

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

This is not applicable as the device is a physical adapter and does not involve algorithms or AI.

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

The "ground truth" in this context is the established safety and performance of the predicate device (Arrow-Johans ECG Adaptor), combined with internal Quality Control Test Procedure documents for physical and visual examination, and Tripartite Guidance for Plastics for material suitability.

8. The sample size for the training set

This information is not present in the document. As this is not an AI/algorithm-based device, a "training set" in that sense would not be applicable. The "training" for the device's design and manufacturing relies on established engineering principles and regulatory guidelines.

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

The "ground truth" for the device's design and manufacturing (analogous to a training set for an algorithm) was established through:

Conformance to the predicate device: The new device's design and materials were based on demonstrating equivalence to the Arrow-Johans ECG Adaptor, which was already legally marketed.
Established Quality Control Test Procedures: Internal B. Braun Medical, Inc. documents define the testing procedures and parameters that conform to product design specifications.
Tripartite Guidance for Plastics: This guidance was used to determine the suitability of materials.

Summary

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K973371

NOV 2 4 1997

II. 510(k) SUMMARY of SAFETY and EFFECTIVENESS in ACCORDANCE with SMDA'90

B. Braun Medical, Inc 1997 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400

Contact: Mark S. Alsberge, Regulatory Affairs Director

Product Name: Epidural Catheter Connector

Trade Name: Conduction Anesthesia Kit

Classification Name:

Cardiovascular Class II, 74 DQY, Percutaneous Catheter 21 CFR 870.1250

Substantial Equivalence to:

510(k) number	Name	Applicant
K843263	Arrow-Johans ECG Adaptor	Arrow International, Inc.

Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Certodyn® RAECG Universal Adapter. The Adapter is designed to aid in the accurate placement of central venous catheters using the RAECG technique.

The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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Materials:

The Certodyn® RAECG Universal Adapter is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.

Substantial Equivalence:

The Certodyn® RAECG Universal Adapter is equivalent in materials, form, and intended use to our the Arrow-Johans ECG Adaptor currently marketed under K843263 by Arrow International, Inc. There are no new issues of safety or effectiveness raised by the Certodyn® RAECG Universal Adapter.

Safety and Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

NOV 2 4 1997

Mr.. Mark S. Alsberge Director, Regulatory Affairs B. Braun Medical, Inc. 824 12th Avenue Bethlehem, PA 18018-0027

Re: K973371 Trade Name: Certodyn RAECG Universal Adapter Regulatory Class: II ... Product Code: DOY Dated: September 3, 1997 Received: September 8, 1997

Dear Mr. Alsberge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Mark S. Alsberge

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K923321 - -510(k) Number (if known):

Device Name: Certody n RAEC G Universal Adapter

Indications For Use:

in the accurate placement of central aid ﺍﻟﻤ catheters using the RAECG technique Venous

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular,
and Neurological Devices
510(k) Number K973371

Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).