The Aesculap Celsite®/Celsite® Concept™ Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.

Device Description

The Celsite®/ Celsite® Concept™ Access Ports are an implantable port and catheter system which allows safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.

AI/ML Overview

The provided document is a 510(k) summary for the Celsite®/Celsite® Concept™ Access Ports. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond a general statement about biomechanical testing.

Therefore, many of the requested elements for describing acceptance criteria and a study cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document.	Biomechanical testing results showed to be similar in performance to the previously cleared Aesculap® Access Ports with similar indications. Specific quantitative metrics or thresholds are not provided.

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

Sample Size: Not specified in the document. The document refers to "biomechanical testing results" but does not provide details on the number of devices or components tested.
Data Provenance: Not specified in the document. It's likely that the testing was conducted by or for the manufacturer (Aesculap®, Inc.) based in the USA, but no explicit statement is given. The nature of the testing (e.g., in-vitro, ex-vivo, in-vivo) is also not detailed.

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 applicable to the type of device and study described. Biomechanical testing of medical devices typically relies on engineering and material science principles, not expert diagnostic interpretation to establish ground truth in the same way as, for example, an imaging AI study.

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

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, which is not the primary focus of the "biomechanical testing" mentioned for this device.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This study type is irrelevant for an implantable access port and catheter system. The device is not an AI-assisted diagnostic tool.

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

No, a standalone (algorithm-only) performance study was not done. This device is a physical medical device, not a software algorithm.

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

The concept of "ground truth" as it applies to diagnostic or prognostic studies is not directly relevant here. For biomechanical testing, the "ground truth" would be established by standardized engineering measurements and established material properties, comparing the device's performance against predefined thresholds or established performance characteristics of the predicate devices. The document states that testing showed to be similar in performance to the previously cleared Aesculap® Access Ports. This implies that the predicate devices' performance serves as the "truth" for comparison.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for a physical medical device.

Summary

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Kolo1424

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510(k) SUMMARY (as required by 21 CFR 807.92) в.

Celsite®/Celsite® Concept™ Access Ports May 3, 2006

JUL 3 1 2006

COMPANY:	Aesculap®, Inc.
	3773 Corporate Parkway
	Center Valley, PA 18034
Establishment Registration Number:	2916714

Lisa M. Boyle CONTACT: 800-258-1946 (phone) 610-791-6882 (fax)
Celsite®/Celsite® Concept™ Access Ports TRADE NAME:

Port & Catheter, Implanted, Subcutaneous, Intravascular COMMON NAME:

CLASSIFICATION NAME: Port & Catheter, Implanted, Subcutaneous, Intravascular 880.5965 REGULATION NUMBER: LJT PRODUCT CODE:

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Celsite®/ Celsite® Concept™ Access Ports are substantially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deitec Inc., PORT-A-CATH® II (K032557, K992697, K932840).

DEVICE DESCRIPTION

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}

The Aesculap Celsite®/ Celsite® Concept™ Access Ports is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing results of the subject device showed to be similar in performance to the previously cleared Aesculap® Access Ports with similar indications.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2006

Ms. Lisa Boyle Regulatory Affairs Specialist Aesculap®, Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K061424

Trade/Device Name: Celsite®/Cclsite® Concept™ Access Ports Regulation Number: 880.5965 Regulation Name: Subcutaneous. Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: Mav 22, 2006 Received: May23, 2006

Dear Ms. Boyle:

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 Hi (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Boyle

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.

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 (240) 276-0115. 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 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/industry/support/index.html.

Sincerely yours.

Chi-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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A. INDICATIONS FOR USE STATEMENT

510(k) Number:_j/061424

Device Name:

Indications for Use:

Prescription Use	X	and/or Over-the-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Ad. D. Peranio 7/31/2006

... Jr. ()ff) of Anesthesiblogy, General Hosp on Control Dental Devid : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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.