The SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. One device package includes 1 arterial line (A226Y), 1 venous line (V813), 1 attached but removable priming set and two pre-attached Transducer Protectors. The SLIMLINE is packaged sterile and labeled for single use only. There is no ability to clean and reuse this device. It is restricted for sale by or on the order of a physician.

AI/ML Overview

The document provided is a 510(k) summary for a medical device called the "Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, much of the information requested about acceptance criteria and studies in the context of AI/diagnostic devices (e.g., sample size, ground truth, expert consensus, MRMC studies) is not applicable here.

However, I can extract information related to the device's performance, the type of testing conducted, and the basis for its clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance in the way one might see for an AI diagnostic algorithm's sensitivity/specificity. Instead, it details bench testing conducted to demonstrate that the device is safe and effective and performs equivalently to its predicate. The "acceptance criteria" in this context are implicitly that the device passes these bench tests successfully.

Test Category	Specific Test (Implicit Acceptance Criteria: Successful Completion/Passing)	Reported Device Performance (Implicit: Passed All Tests)
Physical Integrity	Package integrity	Passed
	Pressure leak (positive and negative)	Passed
	Tensile testing of joints and materials of all tubing segments	Passed
	Performance testing of tubing to resist kinking after repeated clamping, particularly in the post pump tubing segment	Passed
Functional Performance	Endurance test of pump segment at maximum flow rate and pressures of the dialysis machine	Passed
	Pump segment performance	Passed
	Endurance testing of any injection port after penetrated by 18G hypodermic needle	Passed
	Priming volume assessment	Passed
	Ability of Transducer protector to withstand leakage when subjected to pressures up to 2 times the maximum labeled pressure (Strikethrough test)	Passed
	Performance test of the device's clamps	Passed
Biocompatibility	Hemocompatibility test	Passed

The successful completion of these non-clinical (bench) tests forms the basis for the conclusion that the device performs equivalently to the predicate device and is safe and effective when used as intended.

The following questions are not applicable to this 510(k) submission, as it pertains to a physical medical device (blood tubing set) and relies on bench testing for substantial equivalence, not clinical studies or AI algorithm performance validation.

Sample sizes used for the test set and the data provenance: Not applicable. Bench testing, not a diagnostic test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense needed for this device.
Adjudication method for the test set: Not applicable.
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 not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device like this is its ability to meet performance specifications and safety criteria through bench testing.
The sample size for the training set: Not applicable. This is not an AI algorithm.
How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, abstract symbol on the left, resembling an infinity symbol or a stylized double helix. To the right of the symbol is the company name, "NIPRO," in bold, sans-serif font, with "MEDICAL CORPORATION" printed in a smaller font size below it.

3150 NW 107th Avenue Miami FL 33172 Tel: 305.599.7174 Fax: 305.592.4621

510(k) Summary:

Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set

807.92(a)(1)

Applicant: Establishment Reg.:

Contact Person:

Nipro Medical Corporation 1056186

SEP 28 2012

Jessica Oswald Regulatory Affairs Specialist

Date of summary preparation: February 22, 2012

807.92(a)(2)

Trade Name: Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set Common Name: Blood tubing line

Classification Name: set, tubing, blood, with and without anti-regurgitation valve Regulation Number: 21 CFR 876.5820

Panel: 78

Product Code: FJK

807.92(a)(3)

Legally marketed substantial equivalent device: K072024 - NIPRO Set - Blood Tubing Set with Transducer Protector and Priming Set.

807.92(a)(4)

Description of device:

The SLIMLINE is packaged sterile and labeled for single use only. There is no ability to clean and reuse this device. It is restricted for sale by or on the order of a physician.

807.92(a)(5)

Indications for Use:

The NIPRO Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.

807.92(a)(6)

Comparison of technological characteristics:

The SLIMLINE is substantially equivalent to the predicate device in the following technological characteristics -

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K112628 20f3 page

Item ofComparison
	SLIMLINEModel # A226YV813	PredicateModel # A209YV803	SE determination
Physicalcharacteristics:	Color-coded Components: dripchambers, clamps, transducerprotectors, luer locks, luer lockcaps, injection ports and dialyzerconnections.	Same
	Tubing: main tubing, heparinline, saline pigtail and bloodpump segment	SE	Main tubing has beenshortened on theSLIMLINE to minimizepriming volume andbio-hazardous waste
Intended Use:	The NIPRO Set - SLIMLINE is adisposable bloodline intended toprovide extracorporeal access tothe patient's blood duringHemodialysis. It is compatiblewith the Fresenius 2008H,2008K/K2 and 2008T dialysismachines.	The Nipro Set -SLIMLINE is adisposable bloodlineintended to provideextracorporealaccess to thepatient's bloodduring Hemodialysis.The compatibility ofavailableconfigurations is theresponsibility of thephysician in charge.	Machine models addedto the SLIMLINEindications for use.Removal of sentence"The compatibility ofavailable configurationsis the responsibility ofthe physician in charge"
	SLIMLINE will attach the arterialline to the bottom of the dialyzerand the venous to the top, withthe dialysate running cross-current.	Arterial line attachedto the top, venous tothe bottom.Dialysate is crosscurrent.	Blood and dialysatefiltering through thedialyzer in oppositedirections
Operationaltechnique:	Priming set is provided pre-attached and needs to beremoved and reattached beforerecirculation	Priming set providedin package but notpre-attached.	Priming set providedwith arterial andvenous lines
	Dialyzer needs to be parallel tomachine module in order toprevent kinking of bloodlines	Tubing lengthsufficient to preventkinking	Kinking risks mitigated
Performance	(testing detailed below807.92.b.1)	SE	Shorter tubing length ofSLIMLINE allows moreblood to be processedduring the sametreatment time.

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807.92(b)(1)

Non-clinical tests submitted:

Bench testing was conducted to verify that the device is safe and effective for its intended use. Those tests include: Package integrity, Pressure leak (positive and negative), Endurance test of pump segment at Maximum flow rate and pressures of the dialysis machine, Pump segment performance, Endurance testing of any injection port after penetrated by 18G hypodermic needle, Priming volume assessment, Tensile testing of joints and materials of all tubing segment, ability of Transducer protector to withstand leakage when subjected to pressures up to 2 times the maximum labeled pressure (Strikethrough test), Performance test of the device's clamps, Hemocompatability test, Performance testing of tubing to resist kinking after repeated

clamping, particularly in the post pump tubing segment; these tests along with their associated results and conclusions are included in this submission.

807.92(b)(2)

Substantial equivalence was proven through bench testing. No clinical testing was required or performed in support of this 510k submission.

807.92(b)(3)

Conclusions drawn from non-clinical and clinical tests:

The results of the bench testing and the comparison of technological characteristics with the predicate device demonstrate that the SLIMLINE performs equivalent to the predicate device and is safe and effective when used as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and tail feathers.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Jessica Oswald Regulatory Affairs Specialist Nipro Medical Corporation 3150 NW 107th Ave. MIAMI FL 33172

SEP 2 8 2012

Re: K112628

Trade/Device Name: Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set

Regulation Number: 21 CFR& 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II . Product Code: FJK Dated: August 28, 2012 Received: August 29, 2012

Dear Ms. Oswald:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rovious your becared or 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 conimeres prior to May 20, 1977, ar eccordance with the provisions of the Federal Food, Drug, de noos that have boon rocaders of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dioroloro, maines of the Act include requirements for annual registration, listing of gences, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device 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 I Trase oc advised that I Dr F unstallion that your device complies with other requirements of the Act that I DA has made a actorminations administered by other Federal agencies. You must Of any I cueral sundes that vegaranents, including, but not limited to: registration and listing Comply with an the Att 1 roques one and 1); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-related advorse evone) (21 CFR Part 820); and if applicable, the electronic forth in are quarty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice to: your avviro soffices/CDRH/CDRHOffices/ucm115809.htm for go to mip.nam.ida.gov/rtoout Drives. Health's (CDRH's) Office of Compliance. Also, please the Concertion be noos and reading by reference to premarket notification" (21CFR Part note the regulation entitled, "insoranants of receiverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain other general mormances on J and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Ticho

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:_K112628

Device Name: Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set

Indications for Use:

The Nipro Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.

Prescription Use _ > (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Herbert Hoover

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number. K112628

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SLIMLINE

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis 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 an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.