CombiSets Hemodialysis Blood Tubing Set: The Fresenius CombSets are intended for use as the extracorporeal blood circuit during Hemodialysis, They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Venous Blood Tubing Set: The Fresenius Venous Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Arterial Blood Tubing Set: The Fresenius Arterial Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Fresenius Arterial Bloodline is intended to for use with conventional and high flux negative pressure hemodialyzer equipment.

Device Description

The Split Septum Injection Sites are designed for use during hemodialysis with either a 21 gauge metal needle or plastic needles that have a 19% priming volume. The injection site plug features a tapered split to accommodate either needle described above. This is the only change to the Fresenius Hemodialysis Blood Tubing Sets currently offered. The housing and septa are identical to that of the current standard injection site.

AI/ML Overview

This document, K041042, is a 510(k) premarket notification for "Split Septum Injection Sites," which are components of Fresenius Bloodlines used in hemodialysis. This is a submission for a minor device modification to existing Fresenius Hemodialysis Blood Tubing Sets.

The document does not describe a study that uses acceptance criteria in the way typically associated with AI/ML device performance (e.g., sensitivity, specificity, AUC). This is a traditional medical device submission, focusing on physical and functional equivalence to predicate devices, and demonstrating that a minor design change (the split septum injection site) does not adversely affect safety and performance.

Therefore, many of the requested categories for AI/ML device studies (sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity, and specific types of ground truth like pathology or outcomes data) are not applicable to this submission.

Here's a breakdown based on the information provided, highlighting the differences from an AI/ML context:

Acceptance Criteria and Device Performance (for a traditional medical device modification)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance (Summary)
Functional Equivalence	"The intended use, technological characteristics, design features, and materials are substantially equivalent to the predicate device."
Design Control Compliance	"Fresenius Medical North America has provided certification of compliance to 21 CFR 820.30 - Design Control requirements."
Performance Testing (Validation)	"A summary of the results of validation testing (performance testing) for the minor device modification" was provided.
Needle Compatibility	Designed for use with either a 21 gauge metal needle or plastic needles with a 19% priming volume.
Injection Site Design	Tapered split to accommodate specified needles; housing and septa identical to current standard injection site.
Intended Use Equivalence	Maintains the intended use as extracorporeal blood circuits for hemodialysis (single-use, with conventional and high flux negative pressure hemodialyzer equipment).

Note: Specific quantitative performance metrics (e.g., flow rates, leak testing results, material compatibility data) are implied by "validation testing" and "summary of the results," but the detailed data and specific acceptance thresholds are not provided in this 510(k) summary. The summary focuses on substantiating substantial equivalence, not on presenting raw performance data.

Information Typically Associated with AI/ML Studies (and why they are not applicable here):

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device modification, not a data-driven algorithm. Testing would involve engineering validation and verification (e.g., mechanical stress tests, leak tests, biocompatibility, flow dynamics).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established through engineering specifications, material standards, and functional requirements, not expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. There is no "human reader" or "AI assistance" involved in the function of this split septum injection site.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is based on engineering specifications, material standards, validated manufacturing processes, and functional performance requirements as an extracorporeal blood circuit component. The key "ground truth" for this modification is that the new split septum maintains the safety and effectiveness of the previous design and functions as intended with standard needles, without introducing new risks.
8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary regarding the device and its assessment:

This 510(k) submission for the Fresenius Split Septum Injection Sites is a "Special 510(k)," which is used for minor modifications to marketed devices where the modification does not affect the intended use or fundamental scientific technology. The primary 'study' proving acceptance criteria is the design control process and validation testing that demonstrates the modified device remains substantially equivalent to its predicate devices in terms of safety and effectiveness. The acceptance criteria are implicit in meeting the requirements for substantial equivalence and compliance with relevant regulations (e.g., 21 CFR 820.30 for Design Control). The performance data cited are from internal validation testing, but the specifics are not detailed in this summary.

Summary

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K041042

JUL 1 6 2004

Split Septum Injection Sites "Special" 510(k) Premarket Notification

510K Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the Fresenius Combiset with Access Flow Reversing Connector.

Company: Fresenius Medical Care North America 95 Hayden Ave. Lexington, MA 02420 April 20, 2004 Date: Trade Name: Split Septum Injection Sites Common Name: Blood Tubing for Hemodialysis Classification Name and Reference: 21 CFR §876.5820 Blood Tubing Set, with or without Anti-Regurgitation Valve - Class II Device Product Code and Panel Code: KOC, 78 and FJK, 78 Predicate Device(s):

· Fresenius CombiSets® Hemodialysis Blood Tubing Sets; K962081, SE 11/01/96
· Fresenius CombiSets® Hemodialysis Blood Tubing Sets: K001107. SE 06/23/00
· Fresenius CombiSets® Hemodialysis Blood Tubing Sets; K000451, SE 05/09/00
· Fresenius Arterial Blood Tubing Sets; K971313, SE 10/27/97
· Fresenius Venous Blood Tubing Sets; K971687, SE 07/29/97
· Fresenius Single Use Arterial Bloodline Sets with Alternate Pump Segment Material, K012242, 08/16/01

Description:

Intended Use:

Venous Blood Tubing Set

The Fresenius Venous Bloodlines are intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Arterial Blood Tubing Set

The Fresenius Arterial Bloodlines are intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Fresenius Bloodlines are intended to for use with Hemodialysis arterial blood tubing sets in conventional and high flux negative pressure hemodialyzer equipment.

CombiSets Hemodialysis Blood Tubing Set

The Fresenius CombiSets are intended for use as the extracorporeal blood circuit during Hemodialysis. They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Safety and Performance:

The intended use, technological characteristics, design features, and materials are substantially equivalent to the predicate device. In support of this Special 510K, Fresenius Medical North America has provided certification of compliance to 21 CFR 820.30-Design Control requirements, and a summary of the results of validation testing (performance testing) for the minor device modification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2004

Mr. Arthur Eilinsfeld Director, Regulatory Affairs Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420

Re: K041042

Trade/Device Name: Fresenius Split Septum Injection Sites Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Product Code: 78 FJK and KOC Regulation Number: 21 CFR §880.5440 Regulation Name: Intravascular administration set Product Code: 78 FPA Regulatory Class: II Dated: June 15, 2004 Received: June 16, 2004

Dear Mr. Eilinsfeld:

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 (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.

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This letter will allow you to begin marketing your device as described in your Section SI0(k) I ms letter will and your te FDA finding of substantial equivalence of your device to a legally premately nonification. The 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 rryou desire specific as not 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 Addisonally, 1001) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general of receitos to premation of your responsibilities under the Act may be obtained from the Division of Small mioritation on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmaldsmamain.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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Indications for Use Statement

Device Name:

Split Septum Injection Sites (a component of Fresenius Bloodlines)

Indications for Use:

CombiSets Hemodialysis Blood Tubing Set

The Fresenius CombSets are intended for use as the extracorporeal blood circuit during Hemodialysis, They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Venous Blood Tubing Set

The Fresenius Venous Bloodline is intended for use as the extracorporeal blood circuit during It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is Hemodialysis. indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Arterial Blood Tubing Set

The Fresenius Arterial Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Fresenius Arterial Bloodline is intended to for use with conventional and high flux negative pressure hemodialyzer equipment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use

000034

Fresenius Medical Care North America

510(k) Number

Corporate Headquarters: Lexington, MA 02420 (781) 402-9000 Division Sign Off oroductive and Radiological Device

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.