The Oxyless Blood Tubing set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodialyzer. The compatibility of available configurations is the responsibility of the physician in charge.

Device Description

The Oxyless Blood Tubing Set is a hemodialysis blood tubing set designed to transport blood from a patient for acute or chronic hemodialysis treatment from the point of access to the dialyzer fixed to the hemodialysis machine and returning to the patient to complete the extracorporeal circuit. The tubing line components are preconfigured and packaged as an arterial line, a venous line and in some configurations, a priming line, for use with various dialysis machines from Fresenius, Nikkiso, B. Braun and Gambro. The components of the Oxyless Blood Tubing Set include pump tubing, air trap chambers, pressure monitoring lines, injection ports, service lines and tubing clamps. Major materials used for the various components of the Oxyless Blood Tubing Set are polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP), polytetrafluoroethylene (PTFE) and silicone. The device is DEHP-free. Each Oxyless Blood Tubing Set is packaged as sterile and for single use only. It is for prescription use only on the order of a healthcare professional.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device, the Oxyless Blood Tubing Set. It details the device's comparison to a predicate device to establish substantial equivalence, rather than a study proving the device meets acceptance criteria based on performance metrics against a clinical ground truth.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of the requested AI/algorithm evaluation. The "acceptance criteria" discussed in this document refer to engineering and biocompatibility testing for a physical medical device, not performance metrics of an AI model against a diagnostic or predictive ground truth.

However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves as the "study" in this context.

Here's a breakdown of what can be derived from the provided text, reinterpreting the request for AI-specific criteria to fit the presented information about a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here refer to engineering performance and biocompatibility standards for a physical medical device. The "reported device performance" indicates that these criteria were met, not specific quantitative results for each test.

Test Category	Specific Test	Acceptance Criteria (Implied)	Reported Device Performance
Bench Performance Testing	Pressure Leak Testing	Device does not leak under specified pressure conditions.	Met acceptance criteria.
	Pump Segment Endurance Testing	Device withstands prolonged use with pump action.	Met acceptance criteria.
	Injection Port Endurance Testing	Injection ports withstand repeated access without failure.	Met acceptance criteria.
	Priming Volume Assessment	Priming volume is within specified limits.	Met acceptance criteria.
	Tensile Testing of Joints/Materials	Components maintain structural integrity under tension.	Met acceptance criteria.
	Pressure Transducers Leak Testing	Transducers do not leak under specified pressure conditions.	Met acceptance criteria.
	Clamp Performance Testing	Clamps effectively occlude tubing as intended.	Met acceptance criteria.
	Tubing Kink Resistance	Tubing resists kinking during typical use.	Met acceptance criteria.
	Blood Tubing Set Operational Testing (with blood analog fluid for 4 hours at 37°C)	Device functions as intended for specified duration/conditions.	Met acceptance criteria.
Biocompatibility Testing	Cytotoxicity	No evidence of cytotoxic effects.	Biocompatible for intended use.
	Sensitization	No evidence of sensitization.	Biocompatible for intended use.
	Irritation or Intracutaneous Reactivity	No evidence of irritation or intracutaneous reactivity.	Biocompatible for intended use.
	System Toxicity (Acute)	No evidence of acute systemic toxicity.	Biocompatible for intended use.
	Genotoxicity	No evidence of genotoxicity.	Biocompatible for intended use.
	Hemocompatibility and Hemolysis	Acceptable haemocompatibility and no significant hemolysis.	Biocompatible for intended use.
	Pyrogenicity	Device is non-pyrogenic.	Biocompatible for intended use.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated as a single number. The testing included multiple specific tests (pressure, endurance, tensile, etc.) for which a sample size would have been used for each. The document states "Bench performance testing of the Oxyless Blood Tubing Set was conducted and compared to the predicate device."
Data Provenance: Not applicable in the traditional sense of a clinical or imaging dataset. The "data" here are the results from in-vitro (bench) and material (biocompatibility) tests performed on the physical device. The testing was conducted to "the predicate device for its 501(k) submission" and "in accordance with the performance testing described in the FDA Guidance for Hemodialysis Blood Tubing Sets."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of diagnostic AI refers to a definitive clinical diagnosis or label. For this physical blood tubing set, the verification is against engineering specifications and biocompatibility standards, not against "ground truth" established by human experts in the diagnostic sense. The "ground truth" are the test specifications themselves, likely set by engineering and regulatory standards.

4. Adjudication method for the test set

Not applicable. This is not a study involving human adjudication of results for a diagnostic or predictive task. Test results are objective measurements against defined criteria.

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 document is for a physical medical device (blood tubing set), not an AI algorithm or a diagnostic assistive device.

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

Not applicable. This describes a physical medical device submission, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's evaluation consists of:

Established engineering specifications and performance criteria for hemodialysis blood tubing sets (e.g., specific pressure limits, endurance cycles, tensile strengths).
Biocompatibility standards as outlined in "Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
The performance characteristics of the legally marketed predicate device (Nipro Blood Tubing Set) with which it claims "substantial equivalence."

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

Not applicable. As there is no training set for an AI model, there is no ground truth established for one.

Summary

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

February 23, 2016

Oxyless Ltd. % Bob Duffy President Bob Duffy Associates 16405 Summer Sage Road Poway, CA 92064

Re: K150304

Trade/Device Name: Oxyless Blood Tubing Set Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: FJK Dated: January 28, 2016 Received: January 29, 2016

Dear Bob Duffy.

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. 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 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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for 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 (if known) K150304

Device Name Oxyless Blood Tubing Set

Indications for Use (Describe)

The Oxyless Blood Tubing set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodiality of available configurations is the responsibility of the physician in charge.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Oxyless Blood Tubing Set

21CFR 807.92 (a)(1) SUBMITTER

Submitter Name: Oxyless LTD Submitter Address: Bewlay House 2 Swallow Place London W1B 2AE UK Submitter Telephone Number: +44 (0) 207 383 9887 Contact Person: Bob Duffy President Bob Duffy Associates 16405 Summer Sage Road Poway, California 92064 858-487-1859 bduffy@bobduffyassociates.com 510(K) Summary prepared: 2/22/2016

21CFR 807.92 (a)(2) DEVICE NAME

Trade Name: Oxyless Blood Tubing Set Common Name: Hemodialysis Blood Tubing Set Classification Name: Hemodialysis System and Accessories Product Code: FJK

21CFR 807.92 (a)(3) PREDICATE DEVICE

The predicate for the Oxyless Blood Tubing Set is the:

Nipro Blood Tubing Set cleared under 510(k) K072024:

a. Device Proprietary Name: Blood Tubing Set with Transducer Protector and Priming Set
b. Manufacturer: Nipro Medical Corporation
c. Product Code: FJK
d. Indications for Use: Disposable blood lines intended to provide extracorporeal access to the patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

The basis for the Oxyless Blood Tubing Set Abbreviated 510(k) submission is for a new device.

21CFR 807.92 (a)(4) DEVICE DESCRIPTION

The components of the Oxyless Blood Tubing Set include pump tubing, air trap

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chambers, pressure monitoring lines, injection ports, service lines and tubing clamps.

Major materials used for the various components of the Oxyless Blood Tubing Set are polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP), polytetrafluoroethylene (PTFE) and silicone. The device is DEHP-free.

Each Oxyless Blood Tubing Set is packaged as sterile and for single use only. It is for prescription use only on the order of a healthcare professional.

21CFR 807.92 (a){5) INDICATIONS FOR USE/INTENDED USE

The Oxyless Blood Tubing Set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodialyzer. The compatibility of available configurations is the responsibility of the physician in charge.

21CFR 807.92 (a)(6) COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The Oxyless Blood Tubing Set with transducer protector and optional priming set has the same technological characteristics (i.e. design, material, chemical composition. energy source) as the predicate device identified above. The following table provides a summary of the technological characteristics of the new device in comparison to those of the predicate device.

Category	Oxyless Blood Tubing SetNew Device	Nipro Blood Tubing SetPredicate Device
1. Trade Name	Oxyless® Set - BloodTubing Set with TransducerProtector and optionalPriming Set	Nipro® Set - Blood TubingSet with TransducerProtector and Priming Set
2. Model Number	LK36355RO, LK76154RO,LK14529RO, LK46451RO,CK84-14-B, CK84-14-C,CK84-14-D, CK84-14-E	A201-A219, V801-V806,5M9634, 5M9693
3. 510(k) submitter/holder	Oxyless Ltd.	Nipro Medical Corporation
4. Manufacturer	Oxyless Ltd.	Nipro Medical Corporation
5. 510(k) Number	K150304	K072024
6. Regulation Number	21 CFR 876.5820	21 CFR 876.5820
7. Regulation Name	Hemodialysis system andaccessories	Hemodialysis system andaccessories
8. Regulatory Class	Class II	Class II
Category	Oxyless Blood Tubing SetNew Device	Nipro Blood Tubing SetPredicate Device
9. Product Code	FJK	FJK
10. Intended Use/Indicationsfor Use	The Oxyless Blood TubingSet with transducer protectorand optional priming setcomprises disposable bloodtubing lines intended toprovide extracorporeal accessto the patient's blood duringhemodialysis. This bloodtubing set is indicated for usewith a medically prescribedhemodialyzer. Thecompatibility of availableconfigurations is theresponsibility of thephysician in charge.	Disposable blood tubinglines intended to provideextracorporeal access to thepatient's blood duringhemodialysis. Thecompatibility of availableconfigurations is theresponsibility of thephysician in charge.
11. Device design	Blood Tubing linesconfigured as:1. Arterial line2. Venous line3. Priming line (onsome models)	Blood Tubing linesconfigured as:1. Arterial line2. Venous line3. Priming line (onsome models)
12. Blood Tubing SetComponents	Tubing, air trap chambers,pressure monitoring lines,service lines, injection portsand tubing clamps	Tubing, air trap chambers,pressure monitoring lines,service lines, injection portsand tubing clamps
13. Sterility	Sterile	Sterile
14. Pyrogenicity	Non-pyrogenic	Non-pyrogenic
15. Single use or reuse	Single use	Single use

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In summary, the comparison demonstrates that the Oxyless Blood Tubing Set is substantially equivalent to the Predicate device.

21CFR 807.92 (b)(1) NON-CLINICAL TESTING

Bench performance testing of the Oxyless Blood Tubing Set was conducted and compared to the predicate device to support substantial equivalence, in accordance with the performance testing described in the FDA Guidance for Hemodialysis Blood Tubing Sets. This testing consisted of:

1. pressure leak testing

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1. pump segment endurance testing
1. injection port endurance testing
1. priming volume assessment
1. tensile testing of joints and materials of all tubing segments
1. pressure transducers leak testing
1. clamp performance testing
1. tubing kink resistance
1. blood tubing set operational testing with a blood analog fluid for four hours at 37°C

Biocompatibility testing, similar to that performed on the predicate device for its 501(k) submission, was conducted as described in "Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The following suggested tests were conducted and demonstrate that the materials in the Oxyless Blood Tubing Set are biocompatible for its Intended Use:

. Cytoxicity
Sensitization .
. Irritation or Intracutaneous Reactivity
System Toxicity (Acute)
Genotoxicity ●
Hemocompatibility and Hemolysis ●
Pyrogenicity ●

21CFR 807.92 (b)(2) CLINICAL TESTING

No clinical tests are submitted, referenced, or relied on in this premarket notification submission for a determination of substantial equivalence.

21CFR 807.92 (b)(3) CONCLUSIONS FROM NON-CLINICAL TESTS

The results of the performance testing of both the Oxyless Blood Tubing Set and the predicate device meet the acceptance criteria for all tests. The results of the testing also demonstrate that the Oxyless Blood Tubing Set is as safe, as effective and performs as well as the legally marketed predicate device, thus demonstrating substantial equivalence. Biocompatibility testing for the Oxyless Blood Tubing Set, similar to that conducted for the predicate device, demonstrates that the materials used are biocompatible for its intended use.

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.