HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q by BAXTER HEALTHCARE CORP.

The HomeChoice Integrated APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.

The HomeChoice Low Recirculation Volume APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy in pediatric and adult renal failure patients requiring fill volumes of 60 - 1000 ml, using only the HomeChoice Automated Personal Cycler with Low Fill Mode Drain Logic.

The Lineo OptiCap is for protection of the Lineo Connector (patient line) of APD Disposable Sets with Lineo Connector that are intended for delivery of peritoneal dialysis therapy.

The HomeChoice Automated PD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.

Device Description

HomeChoice APD Set with Lineo Connector is a disposable tubing administration set used in automated peritoneal dialysis therapies. It provides for connection of the patient and the peritoneal dialysis solutions to the automated cycler.

AI/ML Overview

The provided 510(k) summary (K031676) for the HomeChoice APD Set with Lineo Connector and related products (HomeChoice Integrated APD Set with Lineo Connector, HomeChoice Low Recirculation Volume APD Set with Lineo Connector, and Lineo Opticap) does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with AI/ML devices.

This submission is for a medical device that is a disposable tubing administration set used in automated peritoneal dialysis therapies. The evaluation of this type of device primarily relies on biocompatibility, sterilization, and functional/physical testing to ensure safety and effectiveness, rather than clinical performance metrics like those found in AI/ML products.

Therefore, many of the requested categories for AI/ML device studies are not applicable to the information provided in this 510(k) summary.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Met biological requirements of ISO 10993-1: Biological Evaluation of Medical devices - Part: Guidance on selection of tests.	Components of the subject HomeChoice APD Set with Lineo Connector have met the biological requirements of ISO 10993-1.
Sterilization	Validated to ensure a Sterility Assurance Level (SAL) of ≥ 10⁻⁶.	Sterilization of the HomeChoice APD Set with Lineo Connector is by a method determined and validated to ensure an SAL of ≥ 10⁻⁶.
Functional and Physical Testing	Performed prior to product release.	Functional and physical testing is performed prior to product release.

2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for biocompatibility, sterilization, or functional testing. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for these types of engineering and materials tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert labels on medical images) is not relevant for the biocompatibility, sterility, or functional testing of a disposable tubing set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not relevant for the biocompatibility, sterility, or functional testing of a disposable tubing set.

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 MRMC comparative effectiveness study was not done. This is a disposable medical device, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the types of tests described (biocompatibility, sterilization, functional/physical), the "ground truth" would be established by:

Biocompatibility: Standardized laboratory tests according to ISO 10993-1 guidelines, with 'truth' being the measured biological response against established thresholds for safety.
Sterilization: Microbiological testing and validation processes to confirm an SAL of ≥ 10⁻⁶.
Functional/Physical Testing: Engineering specifications and performance standards for mechanical integrity, flow rates, leak resistance, etc.

8. The sample size for the training set
Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.

Summary of Device and Performance Evaluation Approach:

This submission uses the "Substantial Equivalence" pathway (510(k)) based on comparison to predicate devices (HomeChoice APD Sets and disconnect caps with povidone iodine). The primary argument for safety and effectiveness is that the "technological characteristics of the HomeChoice APD Set with Lineo Connector do not raise any new types of safety and effectiveness issues, when compared to the predicate product."

The evaluation focuses on:

Similar Design and Materials: The new device incorporates disinfectant features of existing disconnect caps into the patient connector of the set, maintaining the general design and materials similar to predicate devices.
Biocompatibility: Conformance to ISO 10993-1.
Sterilization: Validated to an SAL of ≥ 10⁻⁶.
Functional and Physical Testing: Routine testing performed before release (details not provided in the summary).

The clinical data section explicitly states "N/A," reinforcing that a clinical study with human subjects, or any study measuring diagnostic performance outcomes, was not required or submitted for this type of device and submission.

Summary

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K031676

Page 1/2

NOV 2 0 2003

510(K) SUMMARY

Submitter's Name:	David E. Curtin, RAC
Address:	1620 Waukegan Rd. MPGR-A2E
Phone:	(847) 473-6079
Fax:	(847) 473-6952
Contact:	David E. Curtin
Date Prepared:	May 30, 2003
Trade Name:	HomeChoice APD Set with Lineo Connector
Common Name:	Sets, Administration, for Peritoneal Dialysis, Disposable
Classification Name:	Peritoneal Dialysis System and Accessories 21 CFR 876.5630
Equivalent Predicate:	HomeChoice APD Set (Baxter Healthcare Corp., K923065),HomeChoice Low Recirculation Volume APD Set (Baxter Healthcare Corp., K012988), High Dose Disconnect Cap andMiniCap with Povidone Iodine (Baxter Healthcare Corp., K972579) and Disconnect Caps with Povidone Iodine (Baxter Healthcare Corp., K895631)
Device Description:	HomeChoice APD Set with Lineo Connector is a disposabletubing administration set used in automated peritoneal dialysistherapies. It provides for connection of the patient and theperitoneal dialysis solutions to the automated cycler.
Intended Use:	The HomeChoice APD Set with Lineo Connector is intendedfor use with the HomeChoice Automated Personal Cycler

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Summary of theTechnologicalCharacteristicsCompared to the	The general design and material of the HomeChoice APD Setwith Lineo Connector is to the HomeChoice APD Set(K923065 and K012988) and High Dose DisconnectCap/MiniCap (K972579 and K895631) in that it incorporatesthe disinfectant feature of the Disconnect Cap/MiniCap into thepatient connector of the set. The technological characteristicsof the HomeChoice APD Set with Lineo Connector do notraise any new types of safety and effectiveness issues, whencompared to the predicate product.
Predicate Device:	HomeChoice APD Set (Baxter Healthcare Corp), HomeChoiceLow Recirculation Volume APD Set (Baxter HealthcareCorp.), High Dose Disconnect Cap and MiniCap withPovidone Iodine (Baxter Healthcare Corp.) and DisconnectCaps with Povidone Iodine (Baxter Healthcare Corp)
Clinical Data:	N/A
Conclusions Drawn	Components of the subject HomeChoice APD Set with LineoConnector have met the biological requirements of ISO 10993-1: Biological Evaluation of Medical devices - Part: Guidanceon selection of tests.Sterilization of the HomeChoice APD Set with LineoConnector is by a method determined and validated to ensurean SAL of ≥ 106. Functional and physical testing is performedprior to product release

Additional
Information Requested by FDA:

None to date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird with three curved lines representing its body and wings. The bird is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

Public Health Service

NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David E. Curtin, RAC Associate Director, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road MCGAW PARK IL 60085

Re: K031676

Trade/Device Name: HomeChoice Automated PD Set with Lineo Connector; #5C4469Q, 5C4468Q HomeChoice Integrated APD Set with Lineo Connector; #5C4531Q HomeChoice Low Recirculation Volume APD Set with Lineo Connector; #5C8302Q and Lineo Opticap; #5C4599Q

Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: 78 KDJ Dated: August 29, 2003 Received: September 2, 2003

Dear Mr. Curtin:

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. Iisting 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 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 one 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 Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.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

Page 2

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510(k) Number (if known): K031676

Device Name: HomeChoice Integrated APD Set with Lineo Connector

Indications For Use:

(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

Nancy C Brogdon
(Division Sign-Off)

Division of Reproduct and Radiological Devices 510(k) Number

G:\510k\Lineo\response!\Indications for Use Statement

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510(k) Number (if known):________________________________________________________________________________________________________________

Device Name: HomeChoice Low Recirculation Volume APD Set with Lineo Connector

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomi nd Radiological Dev

G:\510k\Lineo\response 1\Indications for Use Statement

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K031676 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Lineo OptiCap

Indications For Use:

The Lineo OptiCap is for protection of the Lineo Connector (patient line) of APD Disposable Sets with Lineo Connector that are intended for delivery of peritoneal dialysis therapy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

Nancy C Brogdon
Division Sign Off

Reproductive, Abdom and Radiological D 510(k) Number

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510(k) Number (if known): K031676

Device Name: HomeChoice Automated PD Set with Lineo Connector

Indications For Use:

(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

Nancy Brogdon
(Division Sign-Off)

vision of Reproductive, Abdo and Radiological De 510(k) Number

G:\510k\Lineo\response 1\Indications for Use Statement

Regulation Number and Section

§ 876.5630 Peritoneal dialysis system and accessories.

(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.