Over a long period of time Used intravenously for chemotherapy, anti-biotics; anti-viral drugs, and for parenteral nutrition. They are also used for blood transfusions or blood sampling in small quantities.

Device Description

The Celsite® Implantable Port with Valved Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993-1 and have been determined to be suitable for the intended use of this product.

AI/ML Overview

This looks like a 510(k) summary for a medical device (Celsite® Implantable Port with Valved Catheter) and not a study with acceptance criteria for device performance in the way you might expect for an AI/Software as a Medical Device (SaMD).

Here's an analysis based on the provided text, addressing your points as much as possible:

Analysis of Provided Text for Acceptance Criteria and Study Information:

This document is a 510(k) Pre-market Notification, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study in the way a diagnostic AI might. The "safety and effectiveness" section provided describes quality control and manufacturing processes, not a performance study against predefined metrics.

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

Based on the provided text, there are no specific numerical acceptance criteria or reported device performance metrics in the context of a diagnostic or predictive device's accuracy (e.g., sensitivity, specificity, AUC).

The document states:

"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."

These statements refer to manufacturing quality control and product design specifications, which are internal acceptance criteria for the manufacturing process to ensure the product is built correctly, rather than external performance criteria for a diagnostic function. The document confirms that these tests are performed and the product must meet them, but it doesn't list the specific criteria (e.g., tensile strength, flow rate) or the exact reported performance values from these internal tests.

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

Not applicable. This document does not describe a performance study involving a "test set" of data in the context of a diagnostic or AI device. The "testing" mentioned refers to manufacturing quality control of the physical device.

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. There is no diagnostic "ground truth" establishment described, as this is a physical medical device (implantable port) and not a diagnostic AI system.

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

Not applicable. No diagnostic ground truth or test set adjudication method is described.

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 is a physical device, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. There is no diagnostic ground truth mentioned. The "ground truth" for this type of device would generally be conformance to engineering specifications and biological compatibility (as indicated by ISO 10993-1 testing). The document mentions material testing according to ISO 10993-1, which is a standard for biocompatibility evaluation of medical devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" as this is not an AI/ML device.

Summary based on the provided text:

The provided document is a 510(k) submission for a physical medical device. It focuses on demonstrating "substantial equivalence" to a predicate device and adherence to manufacturing quality control processes. It does not present acceptance criteria or study results in the manner one would expect for a diagnostic device or an AI/ML-based medical device. The "testing" referred to is manufacturing quality control to ensure the device meets its design specifications and is biologically compatible.

Summary

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993024

September 7, 1999

II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

B. Braun Medical, Inc 901 Marcon Boulevard Allentown, PA 18103 (610)266-0500 ext. 2261

Contact: Mark S. Alsberge, Regulatory Affairs Director Product Name: Celsite® Implantable Port with Valved Catheter Trade Name: Catheter, Intravascular, Long Term

Unclassified, LJT

SUBSTANTIAL EQUIVALENCE1 TO:

510(k) number	Name	Applicant
K952548	Celsite Venous Access System	B. Braun Medical, Inc.

Device Description:

Classification name:

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 Celsite® Implantable Port with is used intravenously over a long period of time for the administration of drugs for chemotherapy, anti-biotics, anti-viral drugs, and for parenteral nutrition. They are also used for blood transfusions or blood sampling in small quantities.

Material:

1 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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Substantial equivalence:

The Celsite® Implantable Port with Valved Catheter is similar in materials, form and intended use to the Celsite® Venous Access System, K952548 cleared by B. Braun Medical Inc. formally known as Burron Medical. We have not made any modifications to the port or the port connector. This submission is to introduce a new valved catheter that may be offered as an option to the predicate catheter in K952548. There are no new issues of safety or effectiveness raised by the Celsite® Implantable Port with Valved Catheter.

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 cGMP"s.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, composed of three curved lines. The eagle faces to the right. Surrounding the eagle is a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2000

Mr. Mark S. Alsberge Requlatory Affairs Director B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, Pennsylvania 18103

Re : K993024 Celsite® Implantable Port with Valved Trade Name: Catheter Unclassified Regulatory Class: Product Code: LJT Dated: January 26, 2000 Received: January 27, 2000

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 The general controls provisions of the Act 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. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory 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

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Page 2 – Mr. Alsberge

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 "http://www.fdap.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K9G302 4 Device Name: Celsife Implantable Port with Valved Catheter

Indications For Use:

ling period of time the Over a Used intravenously for chemother apy , anti-biotics ; drugs of administration for parenter at nutrition. I hey anti - Viral gruys, and transfusions or blood sampline also used for olood quanti ties Small

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

Concurrence of CDRH, Office of Device Evaluation (ODE

Viola Holland for Pat Cucerti

(Division Sign-Off) Division of Dental, Infection Contr and General Hospital Devi 99302 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.